预约演示
更新于：2026-09-01
Cilgavimab/Tixagevimab
西加韦单抗/替沙格韦单抗
更新于：2026-09-01
概要
基本信息
药物类型 单克隆抗体 |
别名 AZD1061/AZD8895、AZD7442、Evusheld + [2] |
作用方式 抑制剂 |
作用机制 SARS-CoV-2 S protein抑制剂(冠状病毒刺突糖蛋白抑制剂) |
在研适应症 |
非在研适应症- |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2021-12-08), |
最高研发阶段(中国)无进展 |
特殊审评紧急使用授权 (美国) |
登录后查看时间轴
结构/序列
Sequence Code 616721365
Sequence Code 616721366
Sequence Code 616724218
Sequence Code 616724219
关联
32
项与 西加韦单抗/替沙格韦单抗 相关的临床试验NCT06156982
An Observational Study to Describe EVUSHELD™ (Tixagevimab/Cilgavimab) Pre-exposure Prophylaxis in Real-world Setting in Japan
This is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received EVUSHELD as PrEP against SARS-CoV-2 infection/COVID-19 in Japan.
All patients who have a record of administration of EVUSHELD in the database will be included in the study. The index date will be defined as the date of first EVUSHELD administration in the database (Day 0) and the patients will be followed up to 6 months after the index date (Day 1 to 180). The look back period is defined as the 12-month period prior to index date (Day -360 to -1). The exposure of interest will be defined as the administration of EVUSHELD for use as PrEP against COVID-19. As the result of feasibility assessment, sample size of the study expected to be approximately 280.
All patients who have a record of administration of EVUSHELD in the database will be included in the study. The index date will be defined as the date of first EVUSHELD administration in the database (Day 0) and the patients will be followed up to 6 months after the index date (Day 1 to 180). The look back period is defined as the 12-month period prior to index date (Day -360 to -1). The exposure of interest will be defined as the administration of EVUSHELD for use as PrEP against COVID-19. As the result of feasibility assessment, sample size of the study expected to be approximately 280.
开始日期2023-12-06 |
申办/合作机构 |
NCT05465876
A Multi-Center, Open-Label, Single-Arm Phase II Trial of Antibody Combination EVUSHELD (Tixagevimab and Cilgavimab) to Provide Passive Immunity Against COVID-19 in Vaccine Non-responsive Chronic Lymphocytic Leukemia
Chronic lymphocytic leukaemia (CLL) is a common lymphoid malignancy affecting older adults. CLL patients are immunocompromised by the disease itself and by several of its therapies. It has now been shown that many CLL patients do not mount an antibody response following COVID-19 vaccination and are therefore at risk of COVID-19 infection. Furthermore, patients with hematologic malignancies are known to be at increased risk of severe infection if they do acquire COVID-19 infection.
The purpose of this trial is to document evidence of passive immunity to COVID-19 infection after EVUSHELD administration with serologic and neutralization assays at multiple post administration time points in patients with no response to standard of care vaccination to COVID-19.
This trial will include a single dose of EVUSHELD to be administered, with a 1-year follow-up period, comprising of 8 health status visits.
Blood samples will be taken at screening, baseline and at multiple health status visits over the course of the year for various antibody testing and analysis. T cell reactivity to COVID-19 epitopes will be studied at baseline and again monthly for 3 months in any participants that become infected with COVID-19.
The purpose of this trial is to document evidence of passive immunity to COVID-19 infection after EVUSHELD administration with serologic and neutralization assays at multiple post administration time points in patients with no response to standard of care vaccination to COVID-19.
This trial will include a single dose of EVUSHELD to be administered, with a 1-year follow-up period, comprising of 8 health status visits.
Blood samples will be taken at screening, baseline and at multiple health status visits over the course of the year for various antibody testing and analysis. T cell reactivity to COVID-19 epitopes will be studied at baseline and again monthly for 3 months in any participants that become infected with COVID-19.
开始日期2023-10-01 |
申办/合作机构 |
NCT05569408
An Observational Study to Assess the Real-world Effectiveness of EVUSHELD™ (Tixagevimab/Cilgavimab) as Pre-exposure Prophylaxis Against COVID-19 Among EVUSHELD-eligible Populations in the United States Department of Defense Healthcare System
An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population treated in DoD Health system.
开始日期2023-08-10 |
申办/合作机构 |
100 项与 西加韦单抗/替沙格韦单抗 相关的临床结果
登录后查看更多信息
100 项与 西加韦单抗/替沙格韦单抗 相关的转化医学
登录后查看更多信息
100 项与 西加韦单抗/替沙格韦单抗 相关的专利（医药）
登录后查看更多信息
145
项与 西加韦单抗/替沙格韦单抗 相关的文献（医药）2026-05-01·CLINICAL PHARMACOKINETICS
Pharmacokinetic Comparability Assessment of Tixagevimab and Cilgavimab Developed for COVID-19 Prevention and Treatment Using Standard Exposure Metrics and Partial Area Under the Curve
Article
作者: Hirao, Lauren ; Chang, Lee-Jah ; Baronio, Roberta ; Cohen, Taylor S ; Gibbs, Michael ; Tullio, Antonella Nadia ; Kiazand, Alexandre ; Zhang, Huixia ; Dzutseva, Vitalina ; Sadow, Samuel ; Chen, Cecil Chi-Keung ; Tang, Weifeng
BACKGROUND AND OBJECTIVE:
AZD7442 is a combination of extended half-life monoclonal antibodies (mAbs; tixagevimab and cilgavimab), developed to neutralize SARS-CoV-2. This open-label Phase 1 study compared pharmacokinetics (PK) of three AZD7442 formulations in which component mAbs were (1) co-formulated versus separately formulated and (2) derived from clonal cell line or cell pool material when separately formulated.
METHODS:
Healthy adults were randomized 1:1:1 to receive intramuscular (IM) AZD7442 300 mg (150 mg each of tixagevimab and cilgavimab) via one injection of co-formulated tixagevimab and cilgavimab from clonal cell line material (treatment A), or two sequential injections of tixagevimab and cilgavimab formulated separately either from clonal cell line (treatment B) or cell pool material (treatment C). Serial blood samples were collected up to 360 days post-dose to evaluate serum concentrations and anti-drug antibody responses. Standard exposure metrics (Cmax, AUClast and AUCinf) were used for PK comparability assessment between treatments (A vs B, B vs C and A vs C). A post hoc analysis using partial area under the curve (pAUC) was also conducted.
RESULTS:
In total, 224 participants were randomized and dosed. Serum concentration-time profiles overlapped post dosing across treatments. Median time to reach peak concentration occurred within 2 weeks with mean terminal half-life 74-84 days. Pharmacokinetic comparability for tixagevimab, cilgavimab and AZD7442 was demonstrated between treatments, with geometric mean ratios (GMR) and 90% CI within 0.8000-1.2500 using traditional exposure metrics (Cmax, AUClast and AUCinf) and partial AUCs (pAUCs; AUC0-d30, AUC0-d60, AUC0-d90, or AUC0-d180), except for comparison of treatment A versus B for tixagevimab, where the lower 90% CI bound for AUClast GMR (0.7933) was slightly below the pre-defined threshold of 0.8000. Low immunogenicity and acceptable safety profiles were observed across treatments.
CONCLUSIONS:
Pharmacokinetic comparability of tixagevimab, cilgavimab and AZD7442 was demonstrated between the different treatments based on analyses using traditional bioequivalence metrics or pAUCs. Partial AUC could serve as an exposure metric when evaluating PK comparability for extended half-life mAbs.
TRIAL REGISTRY:
Clinical trials registration number: ClinicalTrials.gov NCT05166421.
2026-04-01·CLINICAL MICROBIOLOGY AND INFECTION
Efficacy, safety, pharmacokinetics, immunogenicity, and serum neutralizing activity of AZD7442 (tixagevimab-cilgavimab) in patients hospitalized with COVID-19: long-term results from the DisCoVeRy trial
Article
OBJECTIVES:
To report long-term clinical efficacy, safety, pharmacokinetics, immunogenicity and seroneutralization results of AZD7442 (monoclonal antibodies tixagevimab-cilgavimab) in patients hospitalized with COVID-19.
METHODS:
In this phase 3, double-blind, randomized, multicentre trial, hospitalized adults with PCR-confirmed SARS-CoV-2 infection were randomly assigned 1:1 to receive AZD7442 or placebo, and followed-up until day 456, with repeated blood sample collections until day 365. Clinical endpoints included clinical status, mortality, rehospitalization, SARS-CoV-2 reinfection, and adverse events. Antidrug antibodies and serum drug concentrations were measured. Analyses were performed on the modified intention-to-treat (mITT) populations, defined as participants who actually received the intervention.
RESULTS:
Between April 28, 2021, and June 23, 2022, 237 participants were randomly assigned to AZD7442 (n = 127) or placebo (n = 110), and 123 participants actually received AZD7442. Participants were infected with pre-Omicron variants in 58.8% (133/226) of cases, versus 33.2% (75/226) of Omicron BA1, BA2, or BA5, and 8% (18/226) missing data. There was no significant difference in the distribution of the 7-point ordinal scale between the AZD7442 and placebo groups, either on day 15 (primary endpoint) (OR = 0.93 [0.54-1.61], p 0.81), or any other time point. Significantly more rehospitalizations occurred between discharge and day 456 among participants who received AZD7442 in the global mITT population (OR = 2.04 [1.03-4.05], p 0.04), but not in the antigen-positive mITT population (OR = 1.78 [0.80-3.94], p 0.15). No significant differences were observed in mortality, SARS-CoV-2 reinfection, or adverse events. In the AZD7442 group, 12 of 87 participants (13.8%) had treatment-emergent antidrug antibodies versus 5 of 69 (7.2%) in the placebo group (OR = 2.02 [0.66-6.14], p 0.21). Serum drug concentrations were detectable up to day 365 for all sampled participants (35/35). Neutralizing antibody titres were significantly higher in the AZD7442 group up to day 180.
CONCLUSIONS:
AZD7442 did not demonstrate any clinical benefit and was safe up to 15 months. This study also provides valuable data on the pharmacokinetics, immunogenicity, and neutralizing activity of AZD7442 in patients hospitalized with COVID-19.
2026-04-01·INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES
Clinical outcomes of immunocompromised patients administered tixagevimab–cilgavimab as pre-exposure prophylaxis for COVID-19: Real-world experience in Taiwan
Article
作者: Liu, Szu-Yu ; Wang, Yi-Ting ; Ho, Yu-Chien ; Chuang, Chien ; Lin, Yi-Tsung ; Ho, Hsiang-Ling ; Chou, Sheng-Hua ; Chin, Wan
OBJECTIVES:
Immunocompromised patients with COVID-19 are at a higher risk of hospitalization and death. Low seroconversion rate after COVID-19 vaccination are common in immunocompromised patients. Evusheld, a combination of the anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) monoclonal antibodies tixagevimab-cilgavimab, was previously recommended as COVID-19 pre-exposure prophylaxis for immunocompromised patients. Our study aimed to present the real-world experience of tixagevimab-cilgavimab use in Taiwan.
METHODS:
Adults who received tixagevimab-cilgavimab at the Taipei Veterans General Hospital during October 2022-June 2023 were identified. The main outcomes were SARS-CoV-2 infection, severe or critical COVID-19, and the 6-month all-cause mortality rate. Multivariate Cox regression analysis was performed to identify factors associated with poor outcomes.
RESULTS:
Overall, 352 adult patients received tixagevimab-cilgavimab. The common indications were hematological malignancies (84.1%), autoimmune disease (10.5%), solid organ transplantation (4.8%), and the presence of solid tumors under treatment (4.5%). During the 6-month follow-up, 39 patients (11.1%) test COVID-19 positive, including 29 (8.2%) and 10 (2.8%) who developed mild-to-moderate and severe or critical COVID-19, respectively. The overall 6-month all-cause mortality rate was 4.8%. In patients with COVID-19, the corresponding rate was 1.1%. Age ≥ 70 years (P = 0.038) and the presence of solid tumors under treatment (P = 0.033) were independent risk factors for severe or critical COVID-19.
CONCLUSION:
Tixagevimab/cilgavimab -treated immunocompromised patients had a low rate of subsequent severe or critical COVID-19. Our study provides insights into the role of future monoclonal antibodies as COVID-19 pre-exposure prophylaxis among immunocompromised patients and emphasizes the need for ongoing research.
188
项与 西加韦单抗/替沙格韦单抗 相关的新闻（医药）2026-08-30
本文系统分析了FDA/EMA已上市药物中豁免开展生殖毒性研究的案例，共计统计了65种药物。从豁免理由分析，大致分为6大类，分别是指导原则明确的豁免类别（晚期肿瘤对生育力、围产期毒性的豁免）、证据权重分析、技术可行性（如无药理学相关动物种属或ADA原因）、人群适配（如用于老年或儿科人群）、暴露有限（如局部给药，外周暴露有限）、研究价值丧失（如EFD预实验已看到明确致畸或联用的药物具备明确致畸性），如下图所示。
65个案例的具体信息和豁免情况详述如下：
1、Zynyz
· 商品名/通用名：Zynyz/retifanlimab
· 药物类型：生物药（抗PD-1单克隆抗体）
· 适应症：成人转移性或复发性局部晚期默克尔细胞癌（MCC）单药治疗
· 生殖毒性研究：未开展（生育力与早期胚胎发育、胚胎胎仔发育EFD、围产期PPND均未开展）
· 未开展的理由：依据ICH S9，晚期肿瘤药无需开展生殖毒性研究。另基于机制和文献证据权重生殖风险评估，PD-1/PD-L1通路阻断可能导致流产/死胎风险增加及子代免疫介导疾病风险
· 监管结论：EMA接受。FDA也接受，认为按ICH S6(R1)/S9替代路径的权重评估可接受，并在说明书中反映胚胎-胎仔毒性风险
2、Zynlonta
· 商品名/通用名：Zynlonta/loncastuximab tesirine（抗CD19 ADC，载荷为PBD二聚体SG3199）
· 药物类型：生物药（抗体偶联药物ADC）
· 适应症：成人复发/难治性大B细胞淋巴瘤（≥2线系统治疗后，含DLBCL NOS、低度淋巴瘤转化而来DLBCL、高级别B细胞淋巴瘤）
· 生殖毒性研究：部分开展——正式的生殖毒性试验（生育力与早期胚胎发育、EFD、PPND）均未开展；但按ICH S6(R1)在13周食蟹猴重复给药毒性试验中评估了生殖器官（器官重量+病理），雄性见明显睾丸毒性
· 未开展的理由：载荷为强遗传毒性物，按ICH S9/S6(R1)无需开展，预期本身即有胚胎-胎仔毒性/致畸性（申请人立场）
· 监管结论：FDA接受，仅补充说明13周猴研究中一高剂量雌性未见新鲜黄体、与药物关系不确定；标签含胚胎-胎仔毒性警告及避孕时长要求
3、Ziihera
· 商品名/通用名：Ziihera/zanidatamab-hrii（ZW25）
· 药物类型：生物药（HER2双特异性抗体，IgG1样）
· 适应症：成人既往治疗、不可切除或转移性HER2阳性（IHC3+）胆道癌（BTC）
· 生殖毒性研究：未开展（生育力、EFD、PPND均未开展；专门生育力研究被认为无需开展）
· 未开展的理由：基于HER2类产品效应（文献提示羊水过少、肺发育不全、骨骼异常、新生儿死亡）的权重评估认定胚胎-胎仔毒性，无需新开DART研究（申请人立场）
· 监管结论：FDA接受，标签含胚胎-胎仔毒性警告，育龄女性需避孕至末次给药后4个月
4、Unloxcyt
· 商品名/通用名：Unloxcyt / cosibelimab-ipdl（CK-301，TG-1501）
· 药物类型：生物药（全人源抗 PD-L1 IgG1 单克隆抗体，Checkpoint Therapeutics）
· 适应症：不适用根治性手术或放疗的成人转移性（mCSCC）或局部晚期（laCSCC）皮肤鳞状细胞癌
· 未开展的理由：以基于文献的发育与生殖毒性风险评估替代 DART 研究，依据 ICH S6(R1)/S9 抗肿瘤药物非临床评价原则；cosibelimab 仅与人和猴 PD-L1 高亲和力结合，小鼠不结合，猴为唯一药理相关种属。FDA 立场：在 2022-07-28 Pre-BLA Type B 会议上 FDA 明确表示可采用证据权重法评估生殖风险，且非临床研究足以支持 BLA
· 监管结论：FDA 接受。同意以 WOE/文献评估替代 DART 研究批准上市；label 警示与注意事项（W&P）中列入胚胎-胎仔毒性，8 Use in Specific Populations 含妊娠、哺乳、避孕建议（FDA 仅做格式微调后同意）
5、Trodelvy
· 商品名/通用名：TRODELVY / sacituzumab govitecan-hziy（IMMU-132）
· 药物类型：生物药（ADC，抗体偶联药物，抗 Trop-2 抗体连接拓扑异构酶抑制剂 SN-38）
· 适应症：转移性三阴性乳腺癌（mTNBC），既往至少接受过两线转移性疾病治疗
· 生殖毒性研究：未开展（生育力、EFD、PPND 均未开展；依据 ICH S9）
· 未开展的理由：申请人未开展，FDA 审评员认可依据 ICH S9 对晚期癌症适应症无需开展。理由为晚期肿瘤患者人群按 ICH S9 可豁免生殖发育毒性研究，且 SN-38 具遗传毒性、作用于快速分裂细胞，预期有致畸/胚胎致死风险
· 监管结论：FDA 接受；标签 8.1 写明"There were no reproductive and developmental toxicology studies conducted with sacituzumab govitecan"，并基于作用机制+遗传毒性组分加 embryo-fetal toxicity 警示（女性避孕 6 个月、男性 3 个月）
6、Tivdak
· 商品名/通用名：TIVDAK / tisotumab vedotin-tftv（HuMax-TF-ADC）
· 药物类型：生物药（ADC，抗组织因子 TF 抗体连接 MMAE）
· 适应症：复发或转移性宫颈癌（化疗后疾病进展的成人患者）
· 生殖毒性研究：部分开展（①猴 13 周重复给药毒性中评估生殖器官毒性；②引用 MMAE 载荷在大鼠的 GLP EFD+TK 研究；tisotumab vedotin 本身的专门 EFD 未开展；生育力/早期胚胎发育、PPND 未开展
· 未开展的理由：申请人未开展专门研究，FDA 认可按 ICH S9 晚期癌人群无需开展，并以载荷 MMAE 数据外推
· 监管结论：FDA 接受；标签基于 MMAE 动物数据（大鼠 0.2 mg/kg 致畸、胚胎致死、胎盘转运）警示胚胎-胎儿毒性，女性避孕 2 个月、男性 4 个月
7、Tecvayli
· 商品名/通用名：TECVAYLI / teclistamab-cqyv
· 药物类型：生物药（双特异性抗体，BCMA×CD3 T 细胞重定向双抗）
· 适应症：复发/难治多发性骨髓瘤（既往≥4 线治疗，含蛋白酶体抑制剂、免疫调节剂和抗 CD38 抗体）
· 生殖毒性研究：未开展（生育力、EFD、PPND 均未开展）
· 未开展的理由：根据ICH S5(R3) 和S6(R1) 及FDA肿瘤相关指南，申请人以 WOE 方案替代，目标人群+BCMA 靶点生物学（BCMA 基因敲除小鼠数据）+作用机制+抗体转运文献，并指出 BCMA 在人生殖器官无基因/蛋白表达，on-target 风险低。而且，啮齿类无 teclistamab 结合、猴 5 周重复给药毒性因中和性 ADA 而信息有限，故生殖毒性研究不能提供更有意义的信息
· 监管结论：FDA 接受；标签基于 MoA（T 细胞激活/细胞因子释放、可经胎盘转运）警示胎儿危害，女性避孕 5 个月（按半衰期，FDA 将申请人提议的 3 个月改为 5 个月）
8、Talvey
· 商品名/通用名：TALVEY / talquetamab-tgvs
· 药物类型：生物药（双特异性抗体，GPRC5D×CD3 T 细胞重定向双抗，IgG4 基于）
· 适应症：复发/难治多发性骨髓瘤（既往≥4 线治疗）
· 生殖毒性研究：未开展（生育力、EFD、PPND 均未开展；采用证据权重 WOE 评估）
· 未开展的理由：多发性骨髓瘤多为老年患者、育龄女性罕见；GPRC5D无已知胚胎功能影响，且在正常组织表达受限、生殖组织低/无表达；无可比交叉反应的药理相关动物种属；猴毒性研究中生殖器官无不良影响
· 监管结论：FDA 接受WOE评估；USPI 纳入胚胎-胎儿毒性警示（可能经胎盘转运、T 细胞激活/细胞因子释放风险），女性避孕 3 个月（按半衰期 20.5 天的 5 倍取整）
9、Sarclisa
· 商品名/通用名：SARCLISA / isatuximab-irfc（SAR650984）
· 药物类型：生物药（单抗，CD38 导向溶细胞性 IgG1κ 人源化嵌合抗体）
· 适应症：复发/难治多发性骨髓瘤（联合泊马度胺+地塞米松）
· 生殖毒性研究：未开展（生育力、EFD、PPND 均未开展）
· 未开展的理由：EFD 采用证据权重 WOE 评估，缺少合适的药理学相关动物种属，且提供CD38 敲除动物文献（胎仔 CD38+免疫细胞耗竭、骨密度下降）、CD38 在体液免疫/胎母免疫耐受/早期胚胎发育中的作用、IgG 胎盘转运文献。另外，猴 3 周重复给药毒性，未见生殖器官不良影响的专门记录
· 监管结论：FDA 接受；标签基于 MoA+WOE 警示胎儿危害，女性避孕至末次给药后至少 5 个月（按半衰期约 28 天覆盖 5 个半衰期）；因可能耗竭胎儿免疫细胞，建议暴露新生儿/婴儿推迟接种活疫苗
10、Rybrevant
· 商品名/通用名：Rybrevant / amivantamab-vmjw
· 药物类型：生物药（双特异性人源 IgG1 单抗，低岩藻糖基化）
· 适应症：EGFR 外显子20插入突变的局部晚期或转移性非小细胞肺癌（NSCLC）
· 生殖毒性研究：未开展（以证据权重 WOE 替代，未用临床候选药本身开展任何 DART 研究）
· 未开展的理由： 1）生育力：未开展专门研究。以猴 3 个月重复给药毒性（120 mg/kg/周 IV）中生殖器官未见不良影响替代；2）EFD：未用 amivantamab 开展。以 WOE 评估替代——EGFR/MET 基因敲除小鼠文献、lazertinib（小分子 EGFR 抑制剂）大鼠 EFD 及生育力研究、zalutumumab（抗 EGFR 单抗）食蟹猴 EFD 研究；3）PPND：未开展
· 监管结论：FDA 同意豁免，理由为晚期肿瘤适应症+仅食蟹猴为相关种属，按 ICH S5(R3)/S6 及 FDA 肿瘤指南采用 WOE。此为 FDA 与申请人协商一致的立场。标签据此写入胚胎-胎仔毒性警告，并要求育龄女性治疗期间及末次给药后3个月有效避孕、哺乳期禁用
11、Ronapreve
· 商品名/通用名：Ronapreve / casirivimab + imdevimab（新冠中和抗体鸡尾酒组合）
· 药物类型：生物药（两种抗 SARS-CoV-2 刺突蛋白人源 IgG1 单抗组合）
· 适应症：12岁及以上、≥40 kg 人群的 COVID-19 治疗（不需吸氧、进展高风险者）及暴露后预防
· 生殖毒性研究：无专门生育力研究；以食蟹猴 4 周重复给药毒性（Study R10933-TX-20064）中睾丸、附睾、卵巢、子宫、阴道宏观/微观检查未见变化替代评估。EFD / PPND均未开展
· 未开展的理由：两抗体针对外源性靶点 SARS-CoV-2，按 ICH S6(R1) 无需开展专门生殖发育毒性研究，组织交叉反应亦未见与生殖/胚胎组织交叉反应。此理由在报告中为申请人阐述、CHMP 评估认可
· 监管结论：EMA/CHMP 接受
12、Regkirona
· 商品名/通用名：Regkirona / regdanvimab
· 药物类型：生物药（抗 SARS-CoV-2 刺突蛋白 RBD 重组人源 IgG1 单抗，Celltrion）
· 适应症：不需吸氧、有进展为重症风险的成人 COVID-19 确诊患者
· 生殖毒性研究：未开展。仅有重复给药毒性研究，报告中未见生殖器官评估的明确结论
· 未开展的理由：此类针对病毒蛋白的抗体不太可能引起生殖发育毒性，符合 ICH S6(R1)）
· 监管结论：EMA/CHMP 接受
13、Polivy
· 商品名/通用名：POLIVY / polatuzumab vedotin（泊洛妥珠单抗）
· 药物类型：生物药（ADC：抗 CD79b 人源化 IgG1 单抗链接 MMAE）
· 适应症：复发/难治性弥漫大 B 细胞淋巴瘤（DLBCL）
· 生殖毒性研究：部分开展
o生育力：未开展专门的生育力/早期胚胎发育（FEED）研究
oEFD：未对 ADC 本身开展专门 EFD 研究，但提交了 MMAE（SGD-1010）在大鼠的 GLP EFD+TK 研究
o围产期（PPND）：未开展
· 未开展的理由：
o生育力：基于 ICH S9：晚期肿瘤适应症无需专门生育力研究；但重复给药毒性已提示雄性生育力损害风险——睾丸生精小管变性
oEFD：基于阳性遗传毒性及对快速分裂细胞的影响，按 ICH S9 无需专门 EFD 研究；申请人仍自愿提交了 MMAE 的 EFD 数据
· 监管结论：FDA 接受。认定无需额外非临床研究即可批准，并依据 MMAE EFD 阳性结果（着床前后丢失、胚胎致死、畸形：吐舌、无颌、肢体旋转不良、腹裂）及胎盘转运证据，在说明书中加入胚胎-胎儿毒性警告及避孕建议（女性治疗后至少 3 个月、男性 5 个月）
14、Ordspono
· 商品名/通用名：Ordspono / odronextamab
· 药物类型：生物药（CD20×CD3 双特异性抗体）
· 适应症：单药治疗复发/难治性滤泡性淋巴瘤（r/r FL）及复发/难治性 DLBCL（NOS，含惰性淋巴瘤转化及高级别 B 细胞淋巴瘤），既往至少两线全身治疗后
· 生殖毒性研究：部分开展
o生育力：未开展专门研究，但在 16 周食蟹猴重复给药毒性研究中评价了生育力终点（雄性睾丸测量与精液分析、雌性月经周期）及生殖器官病理学，至 1 mg/kg/周 IV 未见药物相关影响
oEFD：未开展
o围产期（PPND）：未开展
· 未开展的理由：申请人认为，晚期肿瘤中 EFD 研究价值有限；猴中 B 细胞耗竭导致机会性感染/提前安乐死，若开展 EFD 研究预期出现类似情况干扰结果解读；故以文献+已有非临床数据的风险评估替代
· 监管结论：EMA 接受。CHMP 明确表示，孕晚期抗体转运致新生儿 B 细胞减少、细胞因子释放危及妊娠维持风险，并建议哺乳期限制使用
15、Niktimvo
· 商品名/通用名：NIKTIMVO / axatilimab-csfr（原 SNDX-6352）
· 药物类型：生物药（CSF-1R 阻断性抗体，IgG4 单抗）
· 适应症：≥40 kg（成人与儿科）患者经至少两线系统性治疗失败的慢性移植物抗宿主病（cGVHD）
· 生殖毒性研究：部分开展
o生育力：未开展专门生育力研究；在 13 周性成熟食蟹猴重复给药毒性研究中评价生育力终点（雌性动情周期/月经周期规律性与生殖道形态，雄性精子参数与生殖道形态），均未见 axatilimab 相关影响
oEFD：未开展。以文献证据权重（WoE）评估替代
o围产期（PPND）：未见
· 未开展的理由：申请人立场——CSF-1/CSF-1R 在生殖功能中作用重要（Csf1op/Csf1op 和 Csf1r-/- 基因缺陷小鼠显示激素水平、交配行为、精子数、排卵、着床、胎盘功能、动情周期、泌乳受影响），故采用 WoE 方案。文献显示 CSF-1/CSF-1R 完全缺失模型有胚胎致死、新生儿存活/产后生长受限、多器官畸形、不孕等表现，提示妊娠期用药潜在发育风险。而猴 13 周毒性研究生殖终点阴性提示对人体生殖功能影响可能性低
· 监管结论：FDA 认可 WoE 方案并批准。FDA 评估补充综述了 CSF1/CSF-1R 突变小鼠（围产期死亡、不孕、动情周期延长、泌乳腺发育障碍）、Csf1rKO 大鼠（幼年雌雄不孕、生殖器官不发育、精子严重减少、卵巢缩小/黄体缺失）及母胎界面巨噬细胞耗竭与自发性早产关联的文献，结论为 axatilimab 对生殖和胚胎-胎仔发育存在潜在风险。基于 5 个半衰期要求育龄女性末次给药后 30 天避孕；接受"动物研究未见生育力不良影响"的表述但增加了一句啮齿类 CSF-1R/CSF-1 靶向敲除致不孕的说明
16、Monjuvi
· 商品名/通用名：Monjuvi / tafasitamab-cxix（MOR208）
· 药物类型：生物药（单抗，CD19导向溶细胞性抗体，Fc优化IgG）
· 适应症：联合来那度胺治疗不适合ASCT的复发/难治弥漫大B细胞淋巴瘤（DLBCL）
· 批准/审评时间：2020年7月31日加速批准（审评完成2020/7/30）
· 生殖毒性研究：部分开展
o生育力：并入13周食蟹猴重复给药毒性研究（MOR208P008），生殖道组织病理+雌性月经周期评估，无药物相关变化（未交配）
oEFD：未开展；围产期（e)PPND：未开展
o替代材料：申请人提交了基于证据权重（WOE）的生殖发育风险评估
· 未开展的理由：申请人立场：按ICH S9并与FDA事先达成一致，因联合用药来那度胺为已知致畸/胚胎致死药物而无需开展EFD/ePPND。WOE评估引用CD19敲除小鼠等文献支持CD19非胚胎发育所必需
· 监管结论：FDA接受。
17、Lunsumio
· 商品名/通用名：Lunsumio / mosunetuzumab
· 药物类型：生物药（双特异性抗体，CD20导向CD3 T细胞衔接双抗）
· 适应症：两线及以上系统治疗后复发/难治滤泡性淋巴瘤（成人）
· 生殖毒性研究：部分开展
o生育力：并入26周食蟹猴慢性毒性研究（Study 16-1815），生殖器官重量/大体/镜检（含精子发生、月经周期），无药物相关影响（未交配）
oEFD：未开展；
o围产期ePPND：未开展
· 未开展的理由：提交基于证据权重（WOE）的发育风险评估（依据ICH S6(R1)），引用同公司已获批抗CD20抗体（利妥昔单抗、奥妥珠单抗、奥瑞珠单抗）数据，再加上抗体早孕期胎盘转运低、MOA等数据，提示致畸风险低，申请豁免灵长类EFD/围产期研究并获FDA书面同意
· 监管结论：FDA接受。FDA评估认可WOE方法（符合ICH S6(R1)），主要生殖风险为新生儿B细胞耗竭，已写入label。母体B细胞长期耗竭致机会性感染可能导致胎儿丢失、CRS可能有害于妊娠
18、Lynozyfic
· 商品名/通用名：Lynozyfic / linvoseltamab-gcpt（REGN5458）
· 药物类型：生物药（双特异性抗体，人IgG4型BCMA导向CD3 T细胞衔接双抗）
· 适应症：接受过至少4线治疗（含蛋白酶体抑制剂、免疫调节剂、抗CD38单抗）的复发/难治多发性骨髓瘤
· 批准/审评时间：2025年7月（审评完成2025/7/1，PDUFA 2025/7/10；为二类再提交后批准）
· 生殖毒性研究：未开展（无生育力、EFD、围产期动物研究）
· 未开展的理由：申请人提交基于证据权重（WOE）的生殖发育毒性风险评估，综合药物药理作用、靶点表达与生物学、重复给药毒性研究中的发现。本品由于T细胞激活/细胞因子释放的药理学风险及B细胞耗竭可由机制推定，label以警示与避孕建议管控
· 监管结论：FDA接受。FDA同意无需研究，但要求label含胚胎-胎毒性警示（与同类BCMAxCD3产品一致）。Label建议有生殖可能的女性治疗期间及末次给药后3个月有效避孕、停止哺乳期3个月
19、Loqtorzi
· 商品名/通用名：LOQTORZI / toripalimab-tpzi
· 药物类型：生物药（单抗，PD-1阻断抗体）
· 适应症：联合顺铂+吉西他滨一线治疗转移性/复发性局部晚期鼻咽癌（NPC）；单药治疗铂类进展后NPC
· 生殖毒性研究：未开展（无正式生育力交配研究、EFD、围产期研究）。生育力终点并入4周和26周食蟹猴GLP重复给药毒性研究（生殖器官重量、大体及镜检，无不良影响）
o替代材料：经FDA与TopAlliance讨论后提供基于证据权重（WOE）的机制风险评估（引用小鼠同种异体妊娠模型及抗PD-1临床病例文献）
· 未开展的理由：已有公开信息表明抗PD-1抗体可致胎儿损害，无需再开展生殖毒性研究；FDA补充认为在NHP中开展抗PD-1妊娠研究对人类风险评估无参考价值
· 监管结论：FDA接受。FDA认可WOE评估。胚胎-胎毒性风险及避孕建议写入label。FDA指出食蟹猴是唯一相关种属，但妊娠动物研究不能预测人类胎儿不良事件发生率
20、Leqembi
· 商品名/通用名：LEQEMBI / lecanemab（BAN2401，lecanemab-irmb）
· 药物类型：生物药（人源化 IgG1 单抗，抗 Aβ 原纤维）
· 适应症：早期阿尔茨海默病（轻度认知障碍及轻度痴呆期 AD，确认淀粉样蛋白病理）
· 生殖毒性研究：未开展（生育力、EFD、PPND 均未开展；仅在 4/39 周猴重复给药毒性中评估生殖器官，未见不良影响）
· 未开展的理由：理由与目标患者人群年龄相关。申请人声明 lecanemab 用于 50 岁及以上成人 AD 患者；FDA 于 2012-11-06 End of Phase 2 会议上主动告知申请人无需开展生殖发育毒性研究（除非适应症扩展至更年轻人群）——该立场为监管机构（FDA）立场，申请人遵照执行。另外，交叉反应研究中显示与人体胎盘、睾丸、子宫有胞浆结合（非膜结合，认为无临床相关性）
· 监管结论：FDA 接受，认定非临床数据足以支持批准
21、Kisunla
· 商品名/通用名：KISUNLA / donanemab-azbt（LY3002813）
· 药物类型：生物药（人源化 IgG1 单抗，靶向 N 端焦谷氨酸化 Aβ（AβN3pE））
· 适应症：早期症状性阿尔茨海默病（轻度认知障碍/轻度痴呆期，确认淀粉样病理）
· 生殖毒性研究：未开展（生育力、EFD、PPND 均未提交；申请人向 BLA 提交了一份生殖安全性综合评估文献综述）
· 未开展的理由：基于 AD 患病人群年龄，一般不要求。该立场由 FDA 于 2020-07-20 Type C 会议书面答复中明确告知申请人（监管机构立场），申请人遵照执行。另外，毒理学研究以猴（脱靶）和 PDAPP 转基因鼠+鼠源替代抗体 mE8c（靶向）评估，均未见不良影响。
· 监管结论：FDA 接受，认定非临床数据足以支持批准（"adequately support the approval of donanemab-azbt"）
22、Keytruda Qlex
· 商品名/通用名：KEYTRUDA QLEX / pembrolizumab and berahyaluronidase alfa-pmph（MK-3475A，皮下注射复方；MK-5180 为 berahyaluronidase alfa）
· 药物类型：生物药（PD-1 单抗 + 内切糖苷酶组合产品）
· 适应症：与静脉 pembrolizumab（BLA 125514）一致的全部实体瘤适应症（成人和 ≥12 岁儿科患者）
· 生殖毒性研究：部分开展——针对 MK-5180（berahyaluronidase alfa）已开展全套：生育力及早期胚胎发育（FEED，大鼠，至 18 mg/kg/日 >15,000 倍人剂量未见不良影响，仅见精子形态异常轻微统计学增加）；EFD（大鼠 + 兔）；PPND（大鼠，NOAEL 18 mg/kg/日 >9,000 倍，未见致畸）；针对 pembrolizumab 本身和 MK-3475A 复方：未开展
· 未开展的理由：Pembrolizumab 基于作用机制可致胎仔损害。根据ICH S9，不需开展生育力和早期胚胎发育研究。申请人和 FDA立场一致
· 监管结论：FDA 接受。MK-5180 各项生殖研究在临床相关剂量下未见不良生殖/发育毒性（兔 EFD NOAEL 0.99 mg/kg/日，>700 倍临床暴露；≥2.88 mg/kg 仅见胎仔发育延迟等，为 >2,500 倍人剂量）；胚胎-胎仔毒性、避孕（治疗期间及末次给药后 4 个月）与哺乳警告直接沿用 KEYTRUDA（IV）说明书
23、Kimmtrak
· 商品名/通用名：KIMMTRAK / tebentafusp-tebn
· 药物类型：生物药（双特异性融合蛋白：亲和力增强 TCR（靶向 gp100 peptide-HLA-A*02:01）+ 抗 CD3 scFv）
· 适应症：不可切除或转移性葡萄膜黑色素瘤（HLA-A*02:01 阳性）
· 生殖毒性研究：未开展（生育力、EFD、PPND 均未开展；申请人以文献WOE评估替代动物实验）
· 未开展的理由：因靶点为人特异性，无法在非临床种属开展 EFD 研究）。另外，申请人据此推断妊娠期用药不会损害胚胎-胎仔发育或妊娠维持
· 监管结论：FDA 不认可申请人的"无风险"结论：认为该分子量大小的生物药可透过胎盘，基于作用机制可能对发育中胎仔造成损害（尤其皮肤、内耳、眼），据此在说明书 Warnings and Precautions加入妊娠期用药风险警示；但未要求补做动物生殖毒性研究，批准照常
24、Keytruda
· 商品名/通用名：KEYTRUDA / pembrolizumab（MK-3475，SCH 900475）
· 药物类型：生物药（人源化 IgG4 PD-1 阻断单抗）
· 适应症：伊匹木单抗治疗后进展的不可切除或转移性黑色素瘤（原研 BLA 首个适应症）
· 生殖毒性研究：未开展（生育力、EFD、PPND 均未开展；申请人以科学文献评估替代，未做产品特异性动物生殖实验）
· 未开展的理由：依据 ICH S9/S6，监管机构同意以非产品特异性文献评估替代，申请人与 FDA 双方协商一致。另外，猴 EFD 研究因 PD-1 抑制相关高流产率叠加猴自发流产率 >20% 可能"无法解释"（uninterpretable）而放弃
· 监管结论：FDA 接受（认为进一步的胚胎-胎仔发育研究"not warranted at this time"）。文献显示 PD-1 通路阻断在同种异体妊娠模型中具有流产效应（胎仔丢失符合免疫排斥模式），说明书据此载入基于作用机制的胚胎-胎仔毒性警告及避孕/哺乳建议
25、Kadcyla
· 商品名/通用名：Kadcyla（ado-trastuzumab emtansine，T-DM1）
· 药物类型：生物药（抗体偶联药物 ADC：曲妥珠单抗 + 微管抑制剂 DM1）
· 适应症：单药用于既往接受曲妥珠单抗和紫杉烷治疗的 HER2 阳性转移性乳腺癌
· 生殖毒性研究：未开展（T-DM1 本身未开展任何新的生殖发育毒性研究；仅引用曲妥珠单抗 Herceptin 在食蟹猴的 3 项历史研究支持标签：EFD 研究、晚期妊娠毒性/胎盘转运/乳汁分泌研究、雌性月经周期生育力研究，均为曲妥珠单抗数据而非 T-DM1 数据）
· 未开展的理由：依据 ICH S9，结合 DM1 基因毒性及对快速分裂细胞的毒性，豁免生殖发育毒性研究。另外，既往食蟹猴重复给药毒性中可见生殖器官重量下降（附睾、前列腺、睾丸、精囊、子宫）。申请人与 FDA 双方立场一致
· 监管结论：FDA 接受。理由：T-DM1 很可能比曲妥珠单抗毒性更强、曲妥珠单抗临床已知有生殖毒性（羊水过少/无羊水）、DM1 基因毒且对快速分裂细胞有毒，符合 ICH S9；标签按胚胎-胎仔毒性（妊娠期用药 D 类/相应警示）处理
26、Inmazeb
· 商品名/通用名：Inmazeb（atoltivimab、maftivimab、odesivimab-ebgn，REGN-EB3）
· 药物类型：生物药（三种抗埃博拉病毒糖蛋白人 IgG1 单抗组合）
· 适应症：扎伊尔埃博拉病毒（Zaire ebolavirus）感染的治疗
· 生殖毒性研究：未开展（无生育力、EFD、PPND 研究；非临床仅有大鼠 3 周重复给药毒性 + 人/大鼠成体及人胎儿组织交叉反应性研究；另对胎儿组织交叉反应性做了后续探索性竞争阻断试验）
· 未开展的理由：药物靶向外源性病毒抗原、按 ICH S6(R1)通常只需短期重复给药研究，重复给药毒性中生殖器官无异常、MOA 不提示生殖风险
· 监管结论：FDA 接受。胎儿组织交叉反应性研究中宫颈/肺/眼/胸腺膜染色经竞争阻断试验判定为非特异性结合
27、Jemperli
· 商品名/通用名：Jemperli（dostarlimab-gxly，TSR-042）
· 药物类型：生物药（抗 PD-1 人源化 IgG4 单抗）
· 适应症：dMMR 复发或晚期子宫内膜癌（既往含铂方案治疗后进展），加速批准
· 生殖毒性研究：未开展（无生育力、EFD、PPND 专项研究；仅提供文献综述评估；猴 3 个月重复给药毒性中生殖器官无明显异常，但多数动物未性成熟）
· 未开展的理由：PD-1/PD-L1 阻断可能破坏母胎界面免疫耐受；药物仅对非人灵长类有活性，猴自发性流产率高、需大量动物方可获得可解释结果，遵循 3R 原则；且按 ICH S9 肿瘤适应症通常不要求生育力评估
· 监管结论：FDA 接受。文献数据（抗 PD-L1 抗体小鼠模型致流产率升高、PD-L1 敲除鼠表现）足以支持风险描述；标签载明可致胎儿危害、建议有生育潜力女性治疗期间及末次给药后至少 4 个月有效避孕（半衰期约 25 天）
28、Evusheld
· 商品名/通用名：Evusheld（tixagevimab + cilgavimab，组合单抗 AZD7442）
· 药物类型：生物药（两种长效 IgG1 单抗组合，含 YTE/TM Fc 修饰）
· 适应症：成人 COVID-19 的暴露前预防（prophylaxis of COVID-19 in adults）
· 生殖毒性研究：未开展（无生育力、EFD、PPND 研究）
· 未开展的理由：依据 ICH S6(R1)，靶点为病毒蛋白（外源性靶点），组织交叉反应性研究未见与人/胎儿组织结合，且重复给药毒理研究中生殖器官未见异常，故预期对胎儿/哺乳婴儿无影响。此为申请人立场，且 CHMP（监管机构）明示"acceptable"
· 监管结论：EMA（CHMP）接受该理由，未要求补做生殖毒性研究。
29、Exdensur
· 商品名/通用名：Exdensur（depemokimab）
· 药物类型：生物药（抗 IL-5 IgG1 单抗，经 Fc 工程化改造，FcRn 结合力约为 mepolizumab 的 13 倍，超长效）
· 适应症：2 型炎症重度哮喘的附加维持治疗（add-on maintenance treatment for severe asthma with type 2 inflammation，≥12 岁）
· 生殖毒性研究：未开展（无生育力、EFD/ePPND 的 in vivo 研究），采用证据权重（WoE）+ in silico 模型替代
· 未开展的理由：依据同类抗 IL-5 类单抗（mepolizumab ePPND 研究等）无生殖/发育毒性、基因修饰动物及一般毒理研究未见生殖器官影响，并用基于 mepolizumab ePPND 数据校准的 in silico 模型模拟显示 depemokimab 延长半衰期不会导致胎儿暴露显著蓄积（<2 倍）。此为申请人立场，CHMP 讨论后接受
· 监管结论：EMA（CHMP）接受该理由
30、Epkinly
· 商品名/通用名：Epkinly（epcoritamab，GEN3013/DuoBody-CD3×CD20）
· 药物类型：生物药（靶向 CD20×CD3 的 IgG1 双特异性 T 细胞衔接抗体）
· 适应症：成人复发/难治弥漫性大 B 细胞淋巴瘤（DLBCL，含惰性淋巴瘤转化及高级别 B 细胞淋巴瘤，≥2 线系统治疗后）
· 生殖毒性研究：未开展（无生育力/早期胚胎发育研究、无 EFD、无 PPND in vivo 研究），采用WOE风险评估
· 未开展的理由：依据 ICH S9 肿瘤药物豁免；猴 EFD 研究被豁免的理由是猴体内高免疫原性风险
· 监管结论：FDA 接受该理由，通过 WOE 评估+说明书管理风险：有生育潜力女性治疗期间及末次给药后 4 个月需有效避孕；哺乳期避免哺乳（末次给药后 4 个月）。
31、Emrelis
· 商品名/通用名：Emrelis / telisotuzumab vedotin-tllv
· 药物类型：生物药（ADC：c-Met 单抗 + MMAE 载荷）
· 适应症：经治的局部晚期/转移性 EGFR 野生型非鳞状 NSCLC（c-Met 高表达）
· 生殖毒性研究：部分开展——ADC 本身未开展生育力、EFD、PPND 研究；仅提供：①重复给药毒性中生殖器官评估（猴 4周 GLP：≥3 mg/kg 卵巢/子宫毒性，可逆；大鼠 2周非GLP：≥6 mg/kg 睾丸生殖细胞退变）；②引用 MMAE 载荷的大鼠 EFD 研究（经Adcetris/Tivdak 申报资料）。MMAE 大鼠 EFD 显示致畸+胚胎致死（0.2 mg/kg，约2倍临床暴露），且有胎盘转运证据
· 未开展的理由：依据 ICH S9，晚期肿瘤适应症无需开展
· 监管结论：FDA 接受。MMAE 为基因毒性物质且影响快速分裂细胞，符合 ICH S9；相关毒性已列入说明书，建议女性治疗中及末次给药后2个月、男性4个月有效避孕；标签含可能损害生育力警告
32、Enflonsia
· 商品名/通用名：Enflonsia / clesrovimab-cfor（MK-1654）
· 药物类型：生物药（重组人 IgG1 单抗，抗 RSV 融合蛋白 F 抗原位点 IV，含 YTE Fc 突变延长半衰期）
· 适应症：预防新生儿和婴儿（出生时或进入首个 RSV 季节时）的 RSV 下呼吸道疾病
· 生殖毒性研究：未开展（体内 DART 研究均未开展：无生育力、无 EFD、无 PPND）；替代证据：2周 GLP 大鼠重复给药毒性中无生殖毒性体征 + GLP 组织交叉反应性研究（成人/儿童/新生儿组织）无脱靶结合
· 未开展的理由：申请人立场，依据 ICH S6(R1)，针对外来靶点（病毒蛋白）的生物药一般无需 DART 研究；FDA 认可，另指出该药不用于有生殖潜能女性，适应症人群为新生儿/婴儿
· 监管结论：FDA 接受。监管历史中2016年 PIND 会议时 FDA 即同意非临床毒理学研究足以支持开发至3期
33、EMPLICITI
· 商品名/通用名：Empliciti / elotuzumab
· 药物类型：生物药（人源化 IgG1 单抗，靶向 SLAMF7）
· 适应症：联合来那度胺和地塞米松治疗既往接受过1-3线治疗的多发性骨髓瘤
· 生殖毒性研究：未开展（无生育力、无 EFD、无 PPND、亦无重复给药毒性和安全药理学研究）；申请人基于 SLAMF7 组织分布和公开文献提交了生殖发育毒性风险评估作为替代
· 未开展的理由：申请人立场，缺乏药理学相关动物种属；FDA 认可，另引用 ICH S9——晚期肿瘤用药一般不要求。Elotuzumab 为 IgG1 可能透过胎盘；SLAMF7 表达于子宫/宫颈浆细胞和免疫母细胞，但对体内生殖的影响未知；文献提示 SLAMF7 基因缺陷小鼠表型健康，提示其不参与胚胎-胎儿发育
· 监管结论：FDA 接受，非临床审评结论为支持批准；风险信息以说明书警示/联合来那度胺胚胎-胎儿风险提示管理
34、Elrexfio
· 商品名/通用名：Elrexfio / elranatamab（PF-06863135）
· 药物类型：生物药（双特异性抗体：BCMA 导向 CD3 T 细胞衔接器）
· 适应症：复发/难治多发性骨髓瘤（既往≥4线治疗，含蛋白酶体抑制剂、免疫调节剂和抗 CD38 单抗）
· 批准/审评时间：2023年8月（审评完成 2023-08-09，PDUFA 2023-08-19；加速批准，Project Orbis）
· 生殖毒性研究：未开展专门的生殖/发育毒性研究（无生育力、EFD、PPND）；
· 未开展的理由：申请人立场，依据 ICH S9 设计毒理学方案，晚期肿瘤适应症。替代：①3个月猴重复给药毒性中性成熟动物生殖器官评估（仅见非不良性附睾轻度单核细胞浸润，雌性生殖器官无发现），生殖器官浸润/炎症发现因发生率低、程度轻微且受 ADA 形成和细菌感染混杂，无法对生育力影响下结论②基于文献（BCMA/CD3/细胞因子在生殖发育中的作用）、非临床和临床数据的证据权重（WOE）风险评估——识别出胎儿损害风险
· 监管结论：FDA FDA 认可 WOE 评估——B 细胞耗竭及细胞因子释放（CRS）可能经炎症信号紊乱导致不良妊娠结局，风险已写入说明书。建议有生殖潜能女性治疗中及末次给药后4个月有效避孕
35、Elahere
· 商品名/通用名：ELAHERE / mirvetuximab soravtansine-gynx（IMGN853）
· 药物类型：生物药——抗体偶联药物（ADC）：抗叶酸受体 α（FRα）单抗 + DM4（maytansinoid 微管抑制剂）毒素
· 适应症：FRα 阳性、铂耐药卵巢癌（晚期癌症适应症）
· 生殖毒性研究：未开展（生育力、EFD、PPND 均未开展；仅开展了 DM4 及 S-methyl-DM4 的体内/体外遗传毒性试验，微核试验阳性）
· 未开展的理由：申请人立场：依据 ICH S9，基于 DM4 对活跃分裂细胞的预期不良影响及晚期癌症适应症，未开展专门生殖毒性研究。药物针对活跃分裂细胞且具有遗传毒性，预期可致畸和/或胚胎死亡，无需动物研究证实。FRα 基因突变与人神经管缺陷等出生缺陷相关，进一步支持致畸风险推定
· 监管结论：FDA 接受（依据 ICH S9 晚期癌症豁免原则），通过说明书管理风险：胚胎-胎仔毒性列入 Warnings and Precautions，要求育龄女性治疗期间及末次给药后 7 个月有效避孕，治疗期间及末次给药后 1 个月内禁止哺乳
36、Datroway
· 商品名/通用名：DATROWAY / datopotamab deruxtecan-dlnk（Dato-DXd）
· 药物类型：生物药——抗体偶联药物（ADC）：抗 TROP2 IgG1 单抗 + DXd（拓扑异构酶 I 抑制剂）毒素
· 适应症：EGFR 突变局部晚期/转移性非小细胞肺癌（既往 EGFR-TKI 及化疗后）（晚期癌症适应症）
· 生殖毒性研究：未开展（生育力 FEED、EFD、PPND 均未开展）；以大鼠/猴重复给药毒性研究中的生殖器官毒性 + DXd 遗传毒性数据替代
· 未开展的理由：
o申请人立场：依据 ICH S9 未开展任何生殖发育毒性研究。DXd 具遗传毒性且对快速分裂细胞有毒性，可致胎儿伤害
o监管机构立场（FDA）：FDA 同意。DXd 遗传毒性且对活跃分裂细胞有毒性，生殖毒性研究无必要。FDA 另行进行 Trop2 文献评估，Trop2 表达于滋养层细胞、胎盘及胚胎多种组织，耗竭可致胚胎-胎仔毒性
· 监管结论：FDA 接受（ICH S9 豁免）；重复给药毒性发现写入标签：大鼠 200 mg/kg 见睾丸/附睾不可逆退行性改变、卵巢闭锁卵泡增加，提示可能损害男性与女性生育力；说明书含胚胎-胎仔毒性 Warning，女性避孕 7 个月、男性避孕 4 个月，治疗期间及末次给药后 1 个月禁止哺乳
37、Darzalex
· 商品名/通用名：DARZALEX / daratumumab
· 药物类型：生物药——全人源抗 CD38 IgG1κ 单克隆抗体
· 适应症：多发性骨髓瘤（既往治疗进展后的单药治疗，孤儿药适应症）
· 生殖毒性研究：未开展（生育力、EFD、PPND 均未开展）
· 未开展的理由：
o申请人提出、监管机构（CHMP）接受：Daratumumab 仅与黑猩猩 CD38 交叉反应，生殖毒性试验在黑猩猩中不可行；曾考虑在食蟹猴用替代抗体（HuMab-CD38），但贫血和ADA限制了给药剂量和持续时间）
o患者群体考量：多数患者已过生育年龄，故认为此类研究对上市许可并非必要
· 监管结论：EMA/CHMP 接受，非临床总体结论为"considered sufficient for the proposed cancer indication"；无额外非临床研究要求
38、Darzalex
· 商品名/通用名：DARZALEX / daratumumab
· 药物类型：生物药——人源抗 CD38 IgG1κ 单克隆抗体（CDC/ADCC/ADCP、诱导凋亡等多机制）
· 适应症：多发性骨髓瘤（既往至少三线治疗含 PI 和 IMiD 或双难治患者）
· 生殖毒性研究：未开展（生育力、EFD、PPND）
· 未开展的理由：
o监管机构立场（FDA 审评备忘，与申请人评估一致）：缺乏药理学相关种属——仅黑猩猩相关但不可行；依 ICH S9 晚期癌症适应症此类研究无必要；患者群体总体已过生育年龄
o替代评估方法：采用基于 CD38 表达、潜在胚胎/胎仔暴露和 CD38 敲除小鼠数据的权重证据法撰写标签
· 监管结论：FDA 接受，无因未开展 DART 研究的批准阻碍；风险通过说明书管理：妊娠提示 DARZALEX 可能致胎仔骨髓/淋巴样细胞耗竭及骨密度降低（依据 CD38 KO 小鼠出生时骨密度降低、5 个月恢复；其他靶向白细胞单抗在猴中的可逆白细胞减少数据），建议育龄女性治疗期间及停药后 3 个月有效避孕
39、Danyelza
· 商品名/通用名：Danyelza / naxitamab-gqgk（Hu3F8）
· 药物类型：生物药（抗 GD2 人源化单克隆抗体，IgG1）
· 适应症：与 GM-CSF 联用治疗难治/复发高危神经母细胞瘤（骨/骨髓病变），主要儿科人群
· 生殖毒性研究：未开展（生育力、EFD、PPND 均未开展）
· 未开展的理由：
o申请人立场：考虑到目标患者人群，动物生殖发育研究不太可能提供与适应人群相关的有意义的安全性数据，故未开展
o监管机构立场：目标人群为儿科肿瘤患者，年龄主要≤5岁，FDA 认为传统生殖毒性研究不必要，未要求开展 EFD 研究
· 监管结论：FDA 接受（同意不开展），但要求 PMR（上市后要求）在相关动物种属中进一步探索 naxitamab 给药至少 2 个周期的毒性（聚焦神经发育影响），并在说明书中加入胚胎-胎儿毒性警示（IgG1 可通过胎盘、可结合神经外胚层来源正常细胞的 GD2）
40、Cyramza
· 商品名/通用名：Cyramza / ramucirumab（IMC-1121B）
· 药物类型：生物药（人 IgG1 单克隆抗体，VEGFR2 拮抗剂）
· 适应症：既往化疗后晚期胃癌/胃食管交界处腺癌（首次获批），后续扩展至 NSCLC、结直肠癌、肝细胞癌
· 生殖毒性研究：未开展（无生育力专项研究、无 EFD、无 PPND）；以文献为基础的评估替代
· 未开展的理由：
o申请人立场：依据 ICH S9/S6(R1)——EFD 研究对"已明确具有发育毒性类别"的药物非必需；晚期癌症药物生育力和围产期研究通常不需要，生育力评估以一般毒性研究中生殖器官的影响为基础；另引用 VEGF/VEGFR2 生物学文献支持。生育力影响依据 39 周猴毒性研究（卵巢卵泡矿化）
o监管机构立场（FDA 原文）：食蟹猴是唯一相关种属，FDA 事先同意可用非产品特异性文献评估替代，但要求纳入 VEGF 通路抑制对胎儿发育影响的文献及鼠替代抗体 DC101 数据
· 监管结论：FDA 接受。文献评估结论：VEGFR2 信号对维持妊娠和胚胎血管生成至关重要，VEGFR2 抑制延长卵泡期、降低激素水平，VEGFR2抑制可致妊娠丢失和胎儿畸形，故妊娠期不用除非获益大于风险；EFD 研究"not warranted at this time"
41、Columvi
· 商品名/通用名：Columvi / glofitamab-gxbm
· 药物类型：生物药（CD20×CD3 双特异性 T 细胞衔接抗体，2:1 结构）
· 适应症：经过两线及以上系统治疗后复发/难治弥漫性大 B 细胞淋巴瘤（DLBCL，非特指型及由滤泡性淋巴瘤转化者），加速批准
· 生殖毒性研究：未开展（生育力/EFD/PPND 均未开展）；提交了基于证据权重（WoE）的生殖发育风险评估报告
· 未开展的理由：
o申请人立场：依据 ICH S6(R1) 采用证据权重评估，基于本品非临床/临床数据及同类抗 CD20 抗体（rituximab、obinutuzumab、ocrelizumab、mosunetuzumab）已知风险，妊娠风险主要来自细胞因子释放和感染，致畸风险低
o监管机构立场：FDA 认可按 ICH S6(R1) 的 WoE 方法评估，主要生殖风险为母体和新生儿 B 细胞耗竭及感染风险，引用 obinutuzumab 穿过胎盘、乳汁分泌及婴儿 B 细胞完全耗竭等数据
· 监管结论：FDA 接受。USPI 含胚胎-胎儿毒性 Warning/Precaution；基于半衰期（6.1 天）将避孕和停止哺乳时间定为末次给药后 1 个月（FDA 曾将申请人提出的 2 个月缩短为 1 个月）
42、Cyramza
· 商品名/通用名：Cyramza / ramucirumab
· 药物类型：生物药（人 IgG1 单克隆抗体，VEGFR2 拮抗剂）
· 适应症：晚期胃癌/胃食管交界处腺癌（单药及联合紫杉醇二线治疗）
· 生殖毒性研究：未开展（生育力/EFD/围产期均未提交；遗传毒性和致癌性亦未提交）
· 未开展的理由：
o申请人立场/监管讨论：依据 ICH S9，适应症为晚期胃癌，故未开展生殖发育毒性研究。
o风险评估依据：基于作用机制和文献推定 VEGF 信号抑制可损害生育力、胎盘发育、胎儿及出生后发育；另 39 周猴毒性研究中见雌性生殖器官毒性——卵巢和子宫重量降低
· 监管结论：EMA/CHMP 接受。生殖发育毒性列入 RMP"重要潜在风险"，风险最小化措施为 SmPC 4.6 措辞（妊娠期不推荐、避孕至末次给药后 3 个月、哺乳期停药至少 3 个月），PRAC 认为措施充分
43、Blenrep
· 商品名/通用名：BLENREP / belantamab mafodotin（GSK2857914）
· 药物类型：生物药——抗体偶联药物（ADC）：抗 BCMA（B 细胞成熟抗原）人源化 IgG1 单抗，连接子-载荷为 cys-mcMMAF（微管抑制剂 MMAF）
· 适应症：复发/难治多发性骨髓瘤（既往接受过≥4 线治疗，含抗 CD38、蛋白酶体抑制剂、免疫调节剂）
· 生殖毒性研究：未开展（生育力/EFD/PPND 均未开展）
· 未开展的理由：
o申请人立场： Belantamab mafodotin 为针对快速分裂细胞的细胞毒（遗传毒性）药物，预期具有胚胎/胎仔毒性和致畸性，无需开展 DART 研究，符合 ICH S9（抗肿瘤药非临床评价）指导原则
o补充依据：体外人淋巴细胞微核筛查试验阳性，与 cys-mcMMAF 结合微管蛋白、破坏微管（影响快速分裂的胚胎组织）的药理作用一致
o虽未开展专门的生育力研究，重复给药毒性研究（大鼠/猴）显示雄性睾丸生精小管变性（不可逆）和雌性卵巢黄素化非排卵卵泡等生殖器官毒性，
· 监管结论：FDA 接受。标签含胚胎-胎仔毒性警告及避孕建议（女性治疗后 4 个月、男性 6 个月，哺乳避让 3 个月，依据 FDA 肿瘤药生殖毒性指导原则）
44、Bizengri
· 商品名/通用名：BIZENGRI / zenocutuzumab（MCLA-128）
· 药物类型：生物药——双特异性 IgG1 抗体（依赖性抑制 Format），同时靶向 HER2 与 HER3，阻断 NRG1-HER3 信号（首个 NRG1 融合靶向药）
· 适应症：携带 NRG1 基因融合的晚期不可切除或转移性 NSCLC 或胰腺腺癌（PDAC），既往系统治疗后进展（加速批准）
· 生殖毒性研究：未开展（生育力/EFD/PPND 均未开展，代之以文献权重证据 WOE 评估）
· 未开展的理由：
o申请人依据该药物的作用机制，采用基于文献的WOE对MCLA‑128潜在生殖毒性开展评估；该评估方式与美国FDA行业指南《肿瘤药物：生殖毒性试验及说明书标签建议》中所述的替代研究方法相一致
o鉴于MCLA‑128的靶点特异性，NHP被认为是开展生殖毒性研究唯一具有药理学相关性的物种。公开文献数据表明，靶向HER2和/或HER3的抗体可产生胚胎毒性；同时结合FDA最新发布的指南《缓解新冠疫情导致非人灵长类动物供应受限的非临床研究考量》，无需采用非人灵长类动物获取MCLA‑128生殖毒性的补充数据，且该类研究也不符合伦理要求
o补充：食蟹猴重复给药毒性研究（5 周与 13 周，最高 100 mg/kg）中生殖器官与组织未见不良影响；HER2/HER3 对胚胎心脏、血管、神经元发育至关重要（基因敲除小鼠孕中期死亡等文献证据）
· 监管结论：FDA 接受；FDA 要求在标签中增加胚胎-胎仔毒性黑框警告，并建议有生育潜能女性治疗期间及末次给药后 2 个月内有效避孕
45、Beyfortus
· 商品名/通用名：Beyfortus / nirsevimab（尼塞韦单抗），AstraZeneca/Sanofi
· 药物类型：生物药——重组人源化 IgG1κ 单克隆抗体，靶向 RSV 融合前 F 蛋白（外源性靶点）
· 适应症：预防新生儿及婴儿首个 RSV 季节的 RSV 下呼吸道疾病；以及至 24 月龄仍易患重症 RSV 疾病儿童的第二个 RSV 季节
· 生殖毒性研究：未开展（无生育力、EFD、PPND/ePPND 研究）
o未开展的理由：根据 ICH S6 (R1) 指导原则，作用于外源性靶点的生物制品通常无需开展 DART 研究。此外，食蟹猴 4 周重复给药毒性研究中未观察到雄性或雌性生殖毒性。组织交叉反应研究未见脱靶结合现象。最后，nirsevimab的适应症不涵盖具有生育潜能的女性人群
· 监管结论：FDA 接受
46、Beovu
· 商品名/通用名：Beovu / brolucizumab（布罗卢西单抗），Novartis
· 药物类型：生物药——抗 VEGF-A 单链抗体片段（scFv，约 26 kDa），玻璃体内注射
· 适应症：新生血管性（湿性）年龄相关性黄斑变性（nAMD）
· 生殖毒性研究：未开展（无生育力研究、EFD、PPND/ePPND；生育力仅以重复给药毒性研究中的生殖道组织病理学间接评估）
· 未开展的理由：
o申请人依据患者人群为 ≥50 岁 AMD 患者、玻璃体内给药后全身暴露极低——引用 Phase 2 临床 PK 数据、以及抗 VEGF 作用机制的风险评估来替代 DART 研究；相关讨论在 2016-01-15 的 Type C 会议中进行
o依据 ICH S6 (R1) 指导原则：“当非人灵长类动物（NHP）为唯一相关物种时，可通过重复给药毒性试验中对生殖系统（脏器重量及组织病理学检查）的评价，评估药物对雌雄动物生育力的潜在影响”。组织学检查未发现与给药相关的异常改变，睾丸及卵巢重量亦未见异常变化
核心豁免逻辑：适应症人群（老年人）+ 极低全身暴露 + 机制明确的获益-风险考量
· 监管结论：FDA（P/T）接受，非临床研究足以支持AMD适应症，但明确指出若为全新作用机制的 NME，该非临床研究并不充分；标签 8.1 基于抗 VEGF 机制警示胚胎发育风险，要求育龄女性治疗期间及末次给药后 1 个月内有效避孕
47、Bavencio
· 商品名/通用名：Bavencio / avelumab（阿维鲁单抗），Merck Serono（EMD Serono）/Pfizer
· 药物类型：生物药——人 IgG1 单克隆抗体，抗 PD-L1（具有 ADCC 活性）
· 适应症：成人转移性梅克尔细胞癌（mMCC）单药治疗（孤儿药，附条件上市）
· 生殖毒性研究：未开展（无生育力研究、EFD、PPND/ePPND）
· 未开展的理由：
o申请人/监管共识立场：晚期癌症适应症按 ICH S9 免除 DART 研究；已知 PD-L1 阻断在小鼠妊娠模型中致胎仔丢失，直接构成胚胎-胎儿毒性风险警示，无需再以动物实验证明
o生育力：尚未开展avelumab的生育力研究。猴 1 个月及 3 个月重复给药毒性试验中，雌性生殖器官未观察到明显异常。本研究所用雄性猴多数尚未性成熟，因此无法就药物对雄性生殖器官的影响得出明确结论
· 监管结论：EMA（CHMP）接受；"Embryo-foetal toxicity"列入 RMP 重要潜在风险，通过 SmPC 4.6/5.3 警示管理（建议治疗期及末次给药后至少 1 个月有效避孕、哺乳期禁用）
· 备注：本品属"未开展生殖毒性研究"的典型抗肿瘤免疫检查点抑制剂案例，理由为 ICH S9（晚期癌症）+ 机制已知风险（PD-L1 维持母胎耐受）+ 以标签警示和 RMP 风险管理替代
48、Anktiva
· 商品名/通用名：Anktiva / N-803/ALT-803，ImmunityBio
· 药物类型：生物药——IL-15 超级激动剂融合蛋白（IL-15 突变体与可溶性 IL-15Rα sushi 结构域/IgG1 Fc 融合），膀胱内灌注给药
· 适应症：与 BCG 联用治疗 BCG 无应答的非肌层浸润性膀胱癌（NMIBC）伴原位癌（CIS）
· 生殖毒性研究：未开展（无生育力研究、EFD、PPND/ePPND；以WOE书面评估替代）
· 未开展的理由：
o申请人立场：膀胱解剖屏障+高分子量/低等电点+临床 PK 证实无全身吸收（低于定量限），故无需动物 DART 研究；同时以文献证据提示 IL-15 升高对生育/胚胎植入/妊娠维持的潜在风险
o监管立场：FDA 认可本品无显著全身暴露（低于定量限）。但基于其作用机制，若发生全身暴露，妊娠期女性使用 Anktiva 可能会对胎儿造成伤害
o事前沟通确认：FDA 书面回复确认，基于膀胱内给药途径、有限的药物暴露以及目标受试人群（NMIBC），采用WOE书面评估方式开展EFD风险评估是妥当的。（2020-09-29 Type B 非临床会议）
· 监管结论：FDA 接受 WOE 替代方案并批准；标签基于 IL-15 机制警示"若发生全身暴露可能致胎儿伤害"，建议育龄女性有效避孕
· 备注：本品是"以证据权重书面评估替代 DART 研究"并事先获得 FDA 书面确认的典型案例，核心理由为膀胱内给药无全身暴露 + 肿瘤适应症（ICH S9）
49、Alhemo
· 商品名/通用名：Alhemo（concizumab-mtci，BLA 761315）
· 药物类型：生物药——人源化 IgG4 单克隆抗体（TFPI 拮抗剂）
· 适应症：血友病 A/B（伴抑制物）的常规预防出血
· 生殖毒性研究：部分开展——未开展专门的 DART 研究（无 EFD/PPND）；但生育力评估被纳入 26 周食蟹猴慢性毒性研究（性成熟雌雄猴，剂量达 9 mg/kg/day SC），生殖器官组织病理学评估纳入 4/13/26/52 周重复给药毒性研究
· 未开展的理由：血友病为 X 连锁隐性遗传，约 99% 患者为男性，临床开发仅在男性中进行，故未开展专门生殖发育毒性研究。文献资料显示，小鼠 TFPI 基因失活可致胚胎致死，但小鼠与人类器官形成期 IgG 胎盘转运不同，临床相关性未知；TFPI 对维持人类正常妊娠可能关键（复发性流产关联）。生育力终点（月经周期、睾丸指标、精子计数/活力/形态）均未见明显影响
· 监管结论：FDA 接受。标签基于作用机制加 IgG 可通过胎盘的一般知识。未要求补充 DART 研究
50、Xolremdi
· 商品名/通用名：XOLREMDI / mavorixafor（X4P-001）
· 药物类型：化药；小分子 CXCR4（C-X-C 趋化因子受体4）拮抗剂，阻断 CXCR4-CXCL12 相互作用
· 适应症：≥12 岁 WHIM 综合征（疣-低丙种球蛋白血症-感染-骨髓滞留综合征）患者，增加循环成熟中性粒细胞和淋巴细胞
· 生殖毒性研究：未开展（正式的生育力与早期胚胎发育研究、确证性 EFD 研究、PPND 研究均未开展；仅有一项低暴露的大鼠初步生殖毒性研究，未见胎仔发育毒性证据；雄性生育力风险由 39 周犬重复给药毒性研究中的睾丸毒性代替支持）
· 未开展的理由：申请人立场（WOE评估）：CXCR4/SDF-1信号对哺乳动物胚胎-胎仔发育至关重要（基因敲除小鼠胚胎致死、造血/心血管/神经系统严重畸形），故任何该机制药物均可推定存在显著发育风险，开展体内生殖毒性研究不会提供额外有用信息
· 监管结论：FDA 接受，未要求补做生殖毒性研究；风险通过说明书管理（基于机制可致胎害，避孕至末次给药后 3 周；未开展生育力研究但犬在临床暴露下见睾丸曲细精管变性/萎缩）
· 备注：本项目未开展 DART 研究的核心逻辑——机制推定+罕见病高未满足需求 + 文献证据权重评估
51、Rapiblyk
· 商品名/通用名：RAPIBLYK（landiolol hydrochloride，盐酸兰地洛尔，ONO-1101），NDA 217202，申请人 AOP Orphan Pharmaceuticals
· 药物类型：小分子化药——超短效选择性 β1 肾上腺素受体阻滞剂，静脉注射
· 适应症：室上性心动过速（含房颤、房扑）成人患者的短期心室率控制
· 生殖毒性研究：部分开展/引用文献替代（申请人自身未开展任何新的 DART 研究；引用已发表文献：大鼠 FEED 生育力研究、大鼠及兔 EFD 研究、大鼠围产期/哺乳期研究，均来自日本 Onoact（ONO-1101）产品）
· 未开展的理由：505(b)(2) 依赖已上市参比产品（日本 Onoact）的公开非临床数据，DART 毒性依据已发表文献评价，未自行开展；此做法事先获得 FDA 审评部门同意
· 监管结论：FDA 接受。推荐的输液剂量下临床生殖毒性风险极小，不要求额外上市后非临床研究
52、Qfitlia
· 商品名/通用名：QFITLIA（fitusiran），NDA 219019，申请人 Alnylam（赛诺菲合作开发）
· 药物类型：非传统小分子——GalNAc 偶联的 siRNA 寡核苷酸药物，靶向抗凝血酶（antithrombin, AT）mRNA，皮下注射（按任务分类为化药，实际为寡核苷酸类药物）
· 适应症：血友病 A/B（含抑制剂型）成人和≥12 岁儿童患者的出血预防治疗
· 生殖毒性研究：部分开展（仅雄性生育力及早期胚胎发育研究：雄性大鼠给药 16 周后与未给药雌鼠交配，作为 26 周重复给药毒性研究 AT3-NCD14-009 的一部分；未开展雌性动物 EFD、PPND 及雌性生育力研究）
· 未开展的理由：申请人立场认为目标人群几乎全为男性。因血友病为 X 连锁隐性遗传、99% 患者为男性，有生育能力女性接受本药的可能性极低，故仅在雄性动物中评估生育力
· 监管结论：FDA 接受
53、POSLUMA
· 商品名/通用名：POSLUMA（flotufolastat F 18，rhPSMA-7.3），NDA 216023，申请人 Blue Earth Diagnostics
· 药物类型：放射性诊断药物（microdose radiopharmaceutical，18F 标记的 radiohybrid PSMA 靶向配体），PET 显像用；非传统治疗性小分子
· 适应症：疑似转移的前列腺癌男性患者的 PSMA 阳性病灶 PET 显像（定位原发灶/复发灶）
· 生殖毒性研究：未开展（申请豁免并获得 FDA 批准；无 FEED/EFD/PPND）
· 未开展的理由：申请人主动请求豁免，监管机构认可，放射性诊断药单次亚药理剂量给药，且放射性药物对胎儿的固有辐射风险已在说明书中充分描述，豁免合理。本品的豁免逻辑：基于单次使用适应症、目标人群为老年男性及微剂量）
· 监管结论：FDA 接受并正式授予豁免；非临床仅需一项扩展单次给药毒性研究（NOAEL 10 mg/kg，约 971 倍临床剂量安全系数）
· 备注：本品为"放射性诊断药物（微剂量）DART 豁免"的典型案例；理由三要素：微剂量（NMT 100 µg）、单次给药、辐射风险已由说明书覆盖
54、ORSERDU
· 商品名/通用名：ORSERDU / Elacestrant（RAD1901）
· 药物类型：化药，口服选择性雌激素受体降解剂（oral SERD，ER 拮抗剂）
· 适应症：绝经后女性或成年男性 ER+/HER2-、ESR1 突变的晚期/转移性乳腺癌（既往内分泌治疗进展后）
· 生殖毒性研究：部分开展（仅大鼠 EFD 研究；生育力/早期胚胎发育 FEED 与围产期发育 PPND 均未开展）
· 未开展的理由：依据 ICH S9，晚期癌适应症无需专门的生育力和围产期研究；生育力损害可由机制（ERα 通路）及重复给药毒性研究中雌雄生殖器官病变（Leydig 细胞减少、睾丸生精小管变性萎缩、卵巢/子宫阴道萎缩）推知
· 监管结论：FDA 接受
· 备注：大鼠 EFD 显示 elacestrant 具胚胎致死性和致畸性（≥3 mg/kg/天胚胎死亡，≥10 mg/kg/天畸形，约 0.1 倍人 AUC），据此说明书含胚胎-胎仔毒性 Warning 及避孕建议（治疗期间及末次给药后 1 周）
55、Ojemda
· 商品名/通用名：OJEMDA / Tovorafenib（DAY101）
· 药物类型：化药，口服泛 RAF 激酶抑制剂（II 型 RAF 抑制剂，靶向 BRAF 融合/重排及 BRAF V600 突变）
· 适应症：6 个月及以上复发/难治性儿童低级别胶质瘤（LGG），含 BRAF 融合/重排或 BRAF V600 突变
· 生殖毒性研究：部分开展（大鼠剂量范围摸索性 EFD 研究，非正式确证性研究；大鼠雌雄生育力及早期胚胎发育 FEED 研究）；未开展确证性 EFD 及 PPND 研究
· 未开展的理由：大鼠剂量范围摸索性 EFD 中所有剂量组（≥37.5 mg/kg/天，约 0.8 倍人体暴露）均出现 100% 着床后丢失/整窝吸收，胚胎毒性信号明确，故无需进一步研究。FDA 明确认可不需确证性 EFD/PPND（依据 ICH S9 抗癌药原则）
· 监管结论：FDA 接受。胚胎-胎仔毒性已作为 Warning 写入说明书
· 备注：FEED：雄鼠至 150 mg/kg/天对交配、生育力、精子无影响；雌鼠各剂量（≥37.5 mg/kg/天）妊娠数、黄体、着床、活胚数减少，着床后丢失增加，雌性生殖 NOAEL <37.5 mg/kg/天。FDA 建议有生殖潜能女性使用非激素避孕（治疗期间及停药后 28 天，因 t1/2 约 48 小时且为 CYP3A 诱导剂可削弱激素避孕药效），男性治疗期间及停药后 2 周避孕
56、Lumisight
· 商品名/通用名：LUMISIGHT / Pegulicianine（代码 LUM015）
· 药物类型：化药——光学荧光显像剂（Optical Imaging Agent）：近红外荧光花菁染料（Cy5）+ 淬灭基团（QSY21）+ PEG（20 kDa）构成的蛋白酶激活探针，非治疗性小分子诊断药物
· 适应症：成人乳腺癌患者乳房肿瘤切除术（lumpectomy）中，配合 Lumicell DVS 荧光成像系统辅助术中检测术腔内癌组织
· 生殖毒性研究：未开展（生育力、EFD、PPND 等均未开展，文献中也无相关研究）
· 未开展的理由：申请人主动申请豁免 DART 研究；FDA 认为理由充分——单次/偶发给药、半衰期短（5–7 小时）、目标人群 70–80% 已过生育年龄、一般毒理研究中未见生殖器官毒性，且相对于已知辅助化疗的胚胎-胎仔毒性风险，本品对生殖健康/胎儿的风险极小。（申请人申请豁免 + 监管机构认可豁免理由，双方立场一致）
· 监管结论：FDA 接受豁免申请并批准上市
57、Komzifti
· 商品名/通用名：KOMZIFTI / Ziftomenib（代码 KO-539）
· 药物类型：化药——Menin-KMT2A（menin-MLL）相互作用抑制剂，表观遗传调节剂，抗肿瘤药
· 适应症：伴 NPM1 突变的复发/难治性急性髓系白血病（AML）成人患者（600 mg 每日一次）
· 生殖毒性研究：部分开展——仅小鼠 EFD（剂量范围摸索 KO-TOX-0017 + 正式研究 KO-TOX-0018）；未开展生育力研究、未开展 PPND、未开展幼龄动物研究、未开展第二种属（兔）确证试验
· 未开展的理由：抗癌药适用 ICH S9，生育力/PPND/幼龄动物研究均无必要；正式 EFD 已阳性（致畸），无需第二种属确证；13 周犬毒理中生殖器官毒性已足以支持生育力警示
· 监管结论：FDA 完全接受申请人立场；基于 EFD 阳性结果和作用机制在说明书加入胚胎-胎仔毒性警示（黑框风险范畴），并因犬生殖器官不可逆病变建议男性停药后继续避孕 3 个月（FDA 提议）
· 关键结果：小鼠 EFD 中 60 mg/kg/天见腭裂等外观畸形及肋骨/颅骨/椎骨畸形，各剂量组均有骨骼畸形，最低剂量暴露约为人 600 mg QD 的 0.3 倍，判定为致畸剂（3 倍人暴露水平即见不良发育结局）
58、IZERVAY
· 商品名/通用名：Izervay / avacincaptad pegol sodium（ARC1905，Zimura）
· 药物类型：化药（PEG 化 2'-氟代 RNA 适配体/寡核苷酸，合成核酸适配体，非生物药）；补体 C5 抑制剂，玻璃体内（IVT）注射
· 适应症：治疗年龄相关性黄斑变性（AMD）继发的地图样萎缩（GA）
· 生殖毒性研究：部分开展
o生育力与早期胚胎发育（FEED）：未开展（豁免）
o胚胎-胎仔发育（EFD）：已开展（大鼠+ 兔，IV 给药，NOAEL 均为 1.2 mg/kg/day）
o围产期发育（PPND）：未开展（豁免）
· 未开展的理由：包括①目标人群（GA/AMD，多 ≥50 岁）基本无生殖能力；②IVT 给药全身暴露极低，预计不分布到生殖组织；③慢性毒性研究未见生殖器官不良影响；④EFD 研究阴性；⑤同类 C5 抑制剂/适配体上市产品无生殖发育毒性证据。该豁免在 2021-09-08 Type C 会议上与 FDA 讨论并获得同意后正式提交豁免申请
· 监管结论：FDA 接受豁免
59、Hyrnuo
· 商品名/通用名：HYRNUO / sevabertinib（BAY 2927088）
· 药物类型：化药小分子；HER2 靶向酪氨酸激酶抑制剂（对 HER2 外显子 20 插入突变及激活点突变高效抑制，口服抗肿瘤药）
· 适应症：成人不可切除或转移性 NSCLC（伴 HER2 外显子 20 插入突变等）——2025-08-08 加速批准
· 生殖毒性研究：部分开展（已开展：大鼠 EFD 预试验+确证性研究、ReproTracker 体外 hiPSC 分化试验；未开展：专门的生育力/早期胚胎发育研究、兔 EFD、PPND）
· 未开展的理由：
o生育力研究：ICH S9，治疗晚期肿瘤的药物，专门生育力研究无需开展；以重复给药毒性研究中生殖器官的称重/病理检查替代
o兔 EFD：兔无法达到有效暴露量，不适用作 EFD 第二种属；以大鼠 EFD + ReproTracker 体外试验补充，符合 FDA 肿瘤药生殖毒性试验指南
oPPND：同 ICH S9，晚期肿瘤药不要求 PPND）
· 监管结论：FDA 接受，加速批准；标签含胚胎-胎仔毒性警告
· 备注：大鼠 EFD 未见致畸（NOAEL 3 mg/kg/天，仅母体及胎仔体重轻度下降）；但 ReproTracker 体外试验将 sevabertinib 判为致畸原（干扰心肌/肝细胞分化，MYH6 0.2-1 µM 起抑制）；FDA 评估了其对口服避孕药的 CYP 诱导影响
60、Hernexeos
· 商品名/通用名：HERNEXEOS / zongertinib（佐仑替尼，BI 1810631）
· 药物类型：化药小分子；HER2（ERBB2）酪氨酸激酶域突变选择性激酶抑制剂（口服抗肿瘤药；非造影剂/放射性药物）
· 适应症：成人不可切除或转移性非鳞状 NSCLC，肿瘤伴 HER2 激活突变（既往系统治疗后）
· 生殖毒性研究：部分开展（已开展：大鼠和兔 EFD——各含非 GLP 剂量探索 + GLP 确证研究；未开展：专门生育力/早期胚胎发育研究、PPND）
· 未开展的理由：
o生育：治疗晚期肿瘤药物按 ICH S9 不需要专门生育力研究；以 91 天大鼠一般毒理研究中生殖器官病理发现替代，并在标签注明可能损害男性生育力
oPPND：同属晚期肿瘤药按 ICH S9 惯例未要求
· 监管结论：FDA 接受，建议批准；标签含胚胎-胎仔毒性警告及避孕 2 周建议（按 5 个半衰期）
· 备注：大鼠 EFD 60 mg/kg（约 19X 人体暴露）见泌尿系统发育迟缓、肾积水，FDA 将 NOAEL 定为 30 mg/kg（与申请人认定的 60 mg/kg 有分歧）；≥90 mg/kg 着床后丢失增加、100% 胎仔死亡（270 mg/kg）；兔 EFD 至 120 mg/kg（2.4X）无胚胎-胎仔不良发现，因母体毒性无法提高剂量；一般毒理见睾丸空泡化（≥10 mg/kg，恢复期不可逆）等生殖器官改变
61、Gomekli
· 商品名/通用名：GOMEKLI / mirdametinib（PD-0325901）
· 药物类型：化药小分子；MEK1/MEK2 激酶抑制剂（口服抗肿瘤药）
· 适应症：≥2 岁儿童及成人 1 型神经纤维瘤病（NF1）伴无法完全切除的症状性丛状神经纤维瘤（PN）
· 生殖毒性研究：部分开展（已开展：大鼠雌雄生育力与早期胚胎发育 GLP 确证研究、大鼠和兔 EFD 剂量探索研究；未开展：确证性 EFD、PPND）
· 未开展的理由：申请人立场，且经 FDA 事先同意。鉴于剂量探索研究中已见显著胚胎-胎仔毒性，且 MEK 为胚胎发育所必需，确证性 EFD 和 PPND 研究无需开展
· 监管结论：FDA 接受，建议批准；标签含胚胎-胎仔毒性警告，女性避孕 6 周、男性避孕 3 个月（半衰期 28 小时，药物具胚胎致死及致非整倍体性）
· 备注：生育力研究 NOAEL 1 mg/kg/天（交配、生育、妊娠指标无影响）；兔 EFD 低至 0.3 mg/kg（约等于临床剂量 2 mg/m²，BSA 折算）即见着床后丢失和胎仔体重下降；大鼠一般毒理 1 mg/kg 起见雌性生殖器官改变，标签 13.1 注明可能损害生育力
62、Grafapex
· 商品名/通用名：GRAFAPEx / treosulfan（曲奥舒凡）
· 药物类型：化药小分子；双功能烷化剂（细胞毒性抗肿瘤药，为 DNA 烷化/交联剂）
· 适应症：联合氟达拉滨作为 ≥1 岁儿童及成人 AML 或 MDS 异基因造血干细胞移植（allo-HSCT）前的预处理方案
· 生殖毒性研究：未开展（专门生育力研究、EFD 研究、PPND 均未开展；以一般毒理学和幼年动物毒理学中生殖器官发现替代）
· 未开展的理由：ICH S9 原则，治疗晚期肿瘤患者的药物不需要专门生育力研究。基于其烷化剂/基因毒性机制及同类药物已知生殖毒性，标签直接列入胚胎-胎仔毒性警告，无需动物 EFD 研究证实；FDA 曾要求提交体外 DNA 烷化/断裂研究以表征其基因毒性及潜在的生殖发育毒性风险
· 监管结论：FDA 接受，建议批准（Approval）
· 备注：treosulfan 为基因毒性物质（洋葱根尖染色体畸变试验阳性，环氧化物代谢物活性更强）；一般毒理见生殖器官毒性（睾丸/附睾增大且不可逆、卵巢剂量依赖性萎缩），7 个月 Wistar 大鼠研究见剂量依赖性雌雄生育力损害（精子发生停滞、黄体和卵泡缺失）；幼年大鼠见雄性生殖器官缩小、阴道开口延迟 1.8 天；标签为胚胎-胎仔毒性警告
63、FRUZAQLA
· 商品名/通用名：FRUZAQLA / fruquintinib（HMPL-013）
· 药物类型：化药——小分子激酶抑制剂（选择性 VEGFR-1/-2/-3 抑制剂，VEGFR2 IC50 约 0.5-35 nM）
· 适应症：成人转移性结直肠癌（mCRC），既往经氟尿嘧啶/奥沙利铂/伊立替康、抗 VEGF 及（RAS 野生型时）抗 EGFR 治疗后
· 生殖毒性研究：部分开展——仅开展大鼠 EFD 研究（Study 8449387，GD6-17，0/0.025/0.1/0.25 mg/kg）；未开展生育力（FEED）与围产期（PPND）研究，未开展兔 EFD
· 未开展的理由：晚期肿瘤适应症按 ICH S9 可免生育力、PPND；EFD 结果阳性：≥0.1 mg/kg 约 0.5×临床剂量出现血管/骨骼畸形，据此以避孕和禁哺乳替代进一步 DART 研究。标签建议育龄女性治疗中及末次给药后 2 周内有效避孕、哺乳期避免哺乳（基于 42 小时半衰期与毒性特征）
· 监管结论：FDA 接受。
64、DEFENCATH
· 商品名/通用名：DEFENCATH（taurolidine 1.35% + 肝素 5,000 USP Units/5 mL 导管锁溶液，CorMedix）
· 药物类型：化药组合（药械组合产品）；taurolidine 为广谱抗菌的抗感染剂（其抗菌活性源于甲醛前体代谢物），肝素为抗凝成分；属导管局部使用、非全身给药
· 适应症：降低经中心静脉导管接受长期血液透析的肾衰竭患者导管相关血流感染（CRBSI）的发生率（经 LPAD 有限人群抗菌药物路径批准）
· 生殖毒性研究：未开展（全部豁免：生育力、EFD、PPND 均未开展）
· 未开展的理由：该产品为导管锁溶液，透析后注入导管腔内并于下次透析前抽出，不用于全身给药，按说明书使用时各组分临床暴露量可忽略，因此 FDA 豁免了全部生殖与发育毒性研究
· 监管结论：FDA 接受
· 备注：这是"因局部用药/无全身暴露而完全豁免 DART"的典型案例（与 ICH S3A/S5 局部用药原则一致），理由由监管机构在审评中明确认可
65、Dawnzera
· 商品名/通用名：DAWNZERA（donidalorsen，研发代号 ISIS 721744；Ionis Pharmaceuticals）
· 药物类型：化药（按 NDA 申报的小分子类）；GalNAc 偶联反义寡核苷酸（ASO），靶向血浆前激肽释放酶（PKK）mRNA，经 RNase H1 介导降解 PKK mRNA 从而减少 PK 蛋白生成
· 适应症：预防性治疗遗传性血管性水肿（HAE）发作
· 生殖毒性研究：①小鼠联合生育力与胚胎-胎仔发育研究——donidalorsen（1/4/10 mg/kg/周 SC）及小鼠药理学替代物 ISIS 722059（4 mg/kg/周）；②小鼠联合生育力与发育毒性研究——未偶联母体化合物 ISIS 546254 及其小鼠替代物 ISIS 482584；③兔 EFD 研究——使用母体化合物 ISIS 546254（与 donidalorsen 序列相同）；④小鼠 PPND 研究（donidalorsen + 替代物 ISIS 722059）。所有研究均未见生殖/发育不良影响
· 未开展的理由（部分豁免）：兔 EFD 未使用 donidalorsen 本品开展，因母体化合物（未偶联 ASO，序列与本品一致）已有兔 EFD 数据，FDA 在 EOP2 会议上同意豁免 donidalorsen 本品的兔 EFD。另因小鼠 PKK 基因序列与本品不完全匹配（非药理学相关种属），生育力/发育研究采用小鼠替代物 ISIS 722059 开展
· 监管结论：FDA 接受
· 备注：属于已开展完整 DART（部分以替代物/母体化合物桥接）案例；未开展部分（本品兔 EFD）的豁免系 FDA 在 EOP2 会上主动同意，理由为序列相同的母体化合物已有数据
药理毒理开发1-7群已满，想进8群的加微信，目前已300多人，备注姓名+企业名称+专长领域。比如王**+A企业+注册或毒理。名额有限，已经在1-7群的朋友就不要跨群了。
另外，新建了GLP毒理专题负责人交流群，只有同时满足GLP机构+专题负责人两个条件的，方可入群。目前300多人，还有名额。
抗体药物偶联物临床结果
2026-07-17
点击蓝字 关注我们
作者
吴琪 段少峰 岑娟*
抗病毒性传染病创新药物全国重点实验室，河南省天然药物创新与转化重点实验室，河南大学药学院，开封 475004
摘要
摘要：新冠肺炎作为近年来全球范围内严重的公共卫生危机之一，是一种新型急性呼吸道传染病。新冠病毒对所有年龄段的人群普遍易感，感染症状多样，其中以无症状感染者为主要传染源，病毒常与宿主细胞的ACE2受体结合从而入侵人体并引发多种炎症反应。研究者们常以直接靶向病毒和靶向宿主作为药物研发的两大策略，制备了多种抗新冠病毒药物。然而，感染新冠肺炎容易引发多器官炎症和神经损伤等各种慢性病症，现有药物仅能够缓解症状但无法对其并发症及长期影响等进行全程干预。本综述从新冠病毒对机体影响的机制出发，对相应药物及研发现状进行了归纳，并结合本实验室的最新研究进展对相关药物研发趋势进行了展望，相关研究将为开发全程抗病毒药物、治疗新冠肺炎的急慢性并发症及后遗症提供重要参考。
关键词：新冠病毒；并发症；长期预后；全程干预治疗；血管紧张素转化酶2
Research progress of anti-COVID-19 drugs and the strategy prospect of the whole course of intervention
therapy
Abstract COVID-19, one of the most severe global public health crises, is a new acute respiratory infectious disease. The SARS-CoV-2 virus exhibits universal susceptibility across all age groups, with diverse clinical manifestations, wherein asymptomatic carriers serve as the primary transmission source. The virus typically invades host cells by binding to the ACE2 receptor, thus triggering various inflammatory responses. There were two major drug development strategies, including direct viral targeting therapy and host targeting therapy, which have led to the development of multiple anti-SARS-CoV-2 drugs. However, COVID-19 infection also induces chronic complications such as multi-organ inflammation and neurological damage, while current drugs can only alleviate symptoms to a certain extent but cannot provide comprehensive intervention for complications and long-term symptoms. Based on the pathogenesis of SARS-CoV-2, this review systematically summarized the research progress of existing drugs.Furthermore, by integrating the latest findings of our laboratory, the predictions regarding future trends were studied in drug development. This study might offer meaningful references for developing whole-course antiviral drugs,which could be capable of dealing with not only acute and chronic complications but also sequelae associated with COVID-19.
Key words COVID-19; Complication; Long-term prognosis; Whole process intervention treatment;Angiotensin converting enzyme 2
新冠病毒全称新型冠状病毒(severe acute respiratory syndrome coronavirus 2，SARS-CoV-2)，它主要与宿主细胞表面受体血管紧张素转化酶2(Angiotensin-converting enzyme 2，ACE2)结合而进入宿主细胞[1]，从而引发新型冠状病毒感染。临床上针对新型冠状病毒肺炎(COVID-19)的治疗方法主要为抗病毒治疗、免疫治疗和中医药治疗等[2]，治疗药物包括莫诺拉韦、瑞德西韦等[3]。然而，相关研究表明，尽管现有药物能在一定程度上抑制病毒复制并缓解急性症状[4]，但仍存在如下局限性：病毒的高突变性导致药物有效性降低；中枢神经系统并发症等未能有效干预[5]；治疗窗口期狭窄，延迟用药导致药效丧失[6]等。更值得注意的是，约10%~30%的康复者出现持续性后遗症，包括嗅觉障碍、认知功能下降及呼吸系统损伤等[7]，而相关抗病毒药物均难以解决。本文就目前的抗新冠病毒研究及相关问题进行综述，并基于课题组近年的研究工作对全程抗病毒药物的设计进行了思考和展望。从病毒感染、复制和其急慢性症状、并发症及长期后遗症方面提取创新靶点，为全程抗病毒药物设计策略及新药研发提供参考。
1 新冠病毒概述
1.1 新冠病毒生物学特征
新型冠状病毒属于β属冠状病毒[3]，其基因组为单股正链RNA，病毒颗粒中包含刺突蛋白(spike，S)、包膜蛋白(envelope，E)、膜蛋白(membrane，M)和核壳蛋白(nucleocapsid，N)4种结构蛋白[2]以及非结构蛋白等。其中，S蛋白的功能性受体为血管紧张素转化酶2(angiotensin-converting enzyme 2，ACE2)，因其分布决定了受累组织及相应并发症，导致新冠病毒感染会攻击人体多种脏器[8]。同时，新冠病毒作为RNA病毒，其复制过程依赖于低保真性RNA聚合酶，导致病毒的不断变异[9]。此外，S蛋白的氨基酸替换或剪切位点突变影响病毒与宿主细胞受体ACE2的结合，从而改变病毒的传播力、致病性和免疫逃逸能力[10]。目前全球主要流行的奥密克戎亚型包括BA.5、XBB.1.5和BQ.1.1等，这些亚型在感染力、抗原逃逸和免疫反应方面表现出动态变化[11]。因此依赖病毒结构特征的疫苗或治疗药物的迭代速度永远难以跟进病毒的突变速度。
1.2 新冠病毒感染机制
新冠病毒通过飞沫、接触和气溶胶传播[12]。入侵呼吸道后，病毒表面的S蛋白上的受体结合域(receptor binding domain,RBD)识别宿主细胞受体ACE2[2]，并与之结合实现感染，也以胞吞和膜融合方式进入其他靶细胞[13]。此外，其他受体如二肽基肽酶-4(dipeptidyl peptidase-4，DPP4)和氨肽酶N(aminopeptidase，APN)也参与作用[1]。感染会激活维甲酸诱导基因I样受体(retinoic acid-induciblegene I，RIG-1)、黑色素瘤分化相关蛋白5(melanoma differentiation-associated protein 5，MDA5)、Toll样受体(Toll-like receptors，TLRs)和NOD样受体家族吡啶结构域蛋白3(NOD-like receptor family pyrindomain containing 3，NLRP3)等信号通路，进一步级联干扰素(interferons，IFNs)、细胞因子(如Il-6、IL-10)和趋化因子的产生，导致巨噬、中性粒等免疫细胞募集至感染部位进一步促进大量炎症因子、细胞因子以及趋化因子的释放，加剧炎症反应[14-15](图1)。
1.3 感染症状
新冠病毒感染临床发热的发病率最高(88.5%)，其次是咳嗽(68.6%)、肌痛乏力(35.8%)和咳痰(28.2%)，腹泻的发病率较低(4.8%)，其他症状还包括呼吸困难、恶心呕吐以及头痛等[16]。严重的肺泡空洞出血导致急性呼吸窘迫综合征(acute respiratory distress syndrome,ARDS)[17]。同时，由于炎症反应剧烈，并发症可能涉及心脏、肾脏、循环系统等多方面功能障碍[17-18]。此外，“新冠后综合征”或“长新冠综合征”也引发较大关注，主要涉及病毒感染后持续超过12周仍存在的、不能用其他诊断解释的健康问题[19]。典型症状包括失眠、脑雾、注意力不集中、记忆力减退、认知障碍、味觉和嗅觉丧失等[18,20]，大脑中也存在ACE2受体的表达，因此推测是病毒通过血液循环感染神经元所致[21]。
2 现有治疗策略及药物研发现状
2.1 抗感染策略及相关药物
2.1.1 抗感染机制
病毒表面的S蛋白能与宿主细胞表面受体ACE2结合，从而进入细胞完成复制、组装和释放等过程，阻断病毒进入宿主细胞或抑制病毒复制能够有效治疗新冠肺炎。目前临床上使用的典型抗新冠病毒药物有瑞德西韦[3]、莫努匹韦和阿兹夫定片[22]。瑞德西韦通过抑制RNA聚合酶活性从而干扰病毒RNA的合成或复制过程，阻止病毒在宿主细胞内的增殖[3]；洛匹那韦/利托那韦[23]和法匹拉韦[24]通过抑制病毒蛋白酶(如3CLpro)的活性，阻止病毒颗粒的组装和释放。重组ACE2蛋白可以竞争性抑制病毒与宿主细胞表面受体ACE2的结合发挥作用[25]。同时，针对新冠宿主细胞靶点的机制研究也取得了一定进展，例如新型α-葡萄糖苷酶抑制剂DNJ-黄酮偶联物，可通过靶向内质网质量控制依赖的糖蛋白而发挥作用[26]；宿主细胞产生的BRD2通过调节ACE2受体阻断感染[27]。以上机制为抗新冠病毒感染类药物研发提供了多种选择。
2.1.2 此类药物研发情况
目前，上述多种药物已成功上市用于治疗新冠肺炎，代表药物如瑞德西韦由美国FDA批准于2020年10月22日上市，用于治疗12岁及以上、体重至少40kg的COVID-19住院患者；托珠单抗(施瑞立和安维泰)接连于2023年1月16日和18日获批上市，被纳入《新型冠状病毒感染诊疗方案(试行第十版)》和《新型冠状病毒感染重症病例诊疗方案(试行第四版)》，用于治疗重症患者，尤其是实验室监测白介素6水平明显升高的患者；Paxlovid由中国国家药品监督管理局于2022年2月11日附条件批准进口注册，用于治疗成人伴有进展为重症高风险因素的轻至中度新冠病毒感染患者；阿兹夫定于2022年7月25日获得中国国家药品监督管理局的附条件批准，用于治疗普通型新型冠状病毒感染成年患者。此外，还有多种药物如奥格特韦纳正处于临床研究阶段[28]，重组ACE2蛋白[25]、青蒿素和槲皮素[29]等多种药物已被证实有一定的抗新冠病毒潜力，但其疗效和安全性仍需更多真实世界数据和大规模随机对照试验来进一步验证。老药新用中，以地尔硫卓为代表的部分药物也进入了临床前研究，但因缺乏人体试验数据，其安全性和有效性仍需进一步验证[30]。
2.2 免疫调节策略及相关药物
免疫系统是机体抵御病原微生物入侵的关键防线，过度免疫激活是炎症损伤的关键因素。通过合理的免疫调节平衡抗病毒感染并减轻炎症损伤是新冠治疗的重要策略。免疫调节药物如托珠单抗(tocilizumab)或其它白介素6(IL-6)抑制剂，通过阻断IL-6信号传导，从而减少炎症风暴，已在临床中取得显著效果[31]。糖皮质激素类药物如地塞米松、氢化可的松等可通过全身治疗的方式发挥抗炎作用，尤其适用于重症及病程进展迅速的患者[32]。此外，使用康复者血浆中的抗体可通过增强机体免疫力或直接中和病毒发挥抗炎作用[33]。其中，AZD7442采用抗体鸡尾酒疗法(替沙格韦单抗/西加韦单抗)以协同作用实现长效中和，兼具预防与治疗价值[34]。针对奥密克戎变异株，尽管多数中和抗体(如REGN10933组合)因氨基末端结构域(N-terminal domain，NTD)或RBD突变而效力下降，但SA55、LY-CoV1404等仍保持广谱中和能力[35]。这些抗体作用机制的研究可为开发新一代广谱抗病毒药物提供关键指导，以应对持续变异的SARS-CoV-2。除中和抗体外，研究表明，干扰素也能有效抑制新冠肺炎的感染，减少其对呼吸道上皮细胞的侵袭性、减轻炎症反应[36]。
2.3 多靶点调控策略及相关中药
中医中药在治疗新冠肺炎中发挥了重要作用。根据辨证论治原则，结合病因、病机及临床表现，新冠感染轻症属于湿毒郁肺证或湿热蕴肺证，宣肺败毒方、连花清瘟胶囊适用；感染重症为疫毒闭肺证，清肺排毒汤等适用；危重者为内闭外脱证，参附注射液、安宫牛黄丸适用；甚至对于恢复期的患者针对其气阴两虚证，生脉散、六君子汤、参苓白术散等都有疗效。此外，针灸、艾灸、熏蒸等多管齐下，个体化动态诊疗助力，均表现出较好的综合疗效[3]。上述中药制剂具有抗病毒、抗炎、免疫调节等多重功效，有效地改善了患者症状，缩短病程，并降低了重症率和死亡率[37]。以上3类药物汇总如表1所示。
2.4 新兴治疗策略及药物设计
2.4.1 改变细胞内的环境
冠状病毒通过S蛋白与ACE2结合，并在低pH环境下触发S蛋白构相变化，促进病毒进入宿主细胞[48]。同时，酸性环境可以激活CTSL等蛋白水解酶并促进其在细胞凋亡和炎症反应中的作用[49]。酸性环境还能促进病毒吸附、加速病毒释放以及提供病毒复制所需的糖类和氨基酸等资源[50]。因此，调节细胞内pH值可以干扰病毒的内吞过程和后续复制机制，为治疗新冠肺炎提供潜在策略。例如氯喹作为弱碱性物质，能够破坏需要低pH值才能复制的多种病毒的酶，展现出潜在抗病毒效果[51]。
2.4.2 干细胞疗法
干细胞疗法在治疗新冠病毒方面显示出一定的潜力和前景。研究表明，间充质干细胞MSCs具有免疫调节、抗炎、组织修复等特性，能够改善COVID-19患者的病情，尤其是重症患者[52]。与此同时，多项临床试验也正在探索不同类型的干细胞疗法，例如尝试采用人脐带间充质干细胞治疗冠状病毒病患者[53]。干细胞疗法潜在降低COVID-19患者死亡率和发病率的可能性，但目前仍需进一步大规模研究以验证干细胞疗法的安全性和有效性[54]。
2.4.3 复合治疗策略
复合治疗通常比单一手段治疗效果更甚，为此，研究者们也采用了多药联用、中医多样化治疗、中西医结合等多种综合治疗策略以增效减毒。例如对于重症患者，可结合人工肝血液净化疗法、低分子肝素抗凝治疗等方法，以减轻炎症和改善病情[55-56]。此外中医对治疗期和康复期制定了不同的干预和管理策略[57]，为新冠后综合征的治疗提供参考。对症治疗、物理治疗和心理支持等多学科综合管理策略也为新冠治疗提供了新的尝试[58]。
上述疗法的作用机制见图2所示，代表性药物如图3所示。综上，现有药物在新冠病毒感染早期具有一定的治疗作用，但对重症及其他病程干预效果有限。此外，大量药物存在胃肠道反应、肝肾功能损害[59]、过敏反应[60]、神经系统反应[61]、心血管问题[62]或其他严重副作用。更为重要的是，新冠后综合征，特别是各种精神症状(即焦虑、抑郁、睡眠紊乱)和神经症状(即注意力集中或思维困难、头晕、头痛、认知障碍)[21]，目前进展有限。
3 全程干预策略及药物设计展望
3.1 长新冠治疗研究进展
3.1.1 长新冠感染的共性机制
新冠感染可能出现多种后遗症和并发症，其原因与炎症机制关系密切。病毒感染后，机体启动免疫防御，释放CCL-2、IL-6等炎症因子，招募免疫细胞形成炎症反馈环路[63]。早期、有限度的免疫激活及炎症响应是机体的正常保护机制，有助于自体免疫系统的抗病毒作用；然而病毒通过“顿挫感染”触发免疫过度激活，导致细胞因子风暴，并产生NSP14蛋白加剧炎症[64]。同时，病毒与ACE2结合以及激活TLR/NF-κB信号通路进一步促进了炎症反应[64]。新冠病毒感染后在人体内可持续存在数月或数年，造成以慢性肺部病变为主的慢性疾病[65]，肺泡上皮持续损伤后成纤维细胞活化，胶原过度沉积，而机械通气等治疗可能加重纤维化[66]。病毒不仅可以直接通过ACE2受体感染神经细胞，外周炎症因子也会经血脑屏障或神经元逆行途径侵袭中枢神经系统，进一步加剧神经系统的损害，引发脑雾、认知障碍等神经症状，是长新冠的典型表现[67]。除了神经元损伤外，血管内皮的损伤使炎症介质释放增强，激活凝血级联反应，引发高凝状态和微血栓，导致心、脑器官缺血、肺泡损伤及肺纤维化风险增加[68]。部分患者出现的嗅觉障碍，可能是因病毒通过嗅觉受体侵入神经所致，甚至扩散至脑干及全脑[69-70]。
基于上述研究，发现各新冠后综合征共性机制均与炎症相关。新冠病毒入侵宿主导致炎症风暴，作用于肺部、大脑等组织从而引发相应慢性疾病。即便肺部症状消失，其慢性炎症对各处组织造成的损伤仍然存在，且存在持续感染的风险[71]。在基础病及其他特定条件下，全身炎症反应综合征(system icinflammatory response syndrome,SIRS)占主导地位，进而引发持久的压倒性和代偿性抗炎反应综合征(compensatory anti-inflammatory response syndrome,CARS)。CARS反应是免疫稳态的重要保障，与SIRS反应微妙平衡，最终决定了COVID-19的长期结局[72]。
3.1.2 长新冠治疗研究进展
以抗炎机制为导向的长新冠药物的研究已有初步进展。有研究使用低剂量纳曲酮(low-dose naltrexone,LDN)通过调节阿片受体和免疫通路，增强病毒清除率并抑制炎症反应、促进组织修复[73]；靶向木瓜蛋白酶样蛋白酶(papain-like protease，PLpro)的新型抑制剂WEHI-P8因其有效抑制病毒并显著减少炎症，兼具治疗急性感染和预防长新冠的潜力[74]；此外，二甲双胍也通过阻断哺乳动物雷帕霉素靶蛋白通路(mammalian target of rapamycin，mTOR)降低急慢性期组织损伤[75]。这些药物为长新冠提供了多种治疗的可能性，但具体疗效还有待进一步临床研究确证。
此外，新型递送策略也为长新冠治疗提供了较大助益。例如，基于可离子化脂质的LNP递送平台，能高效包裹mRNA疫苗，有效改善其热稳定性和生物相容性[76]。仿生递送系统如巨噬细胞膜修饰的纳米粒、纳米海绵等通过细胞因子中和/吸附病毒，展现出新冠肺炎后遗症的治疗优势[77]。外泌体雾化作为一种创新的治疗方式，运用间充质干细胞来源的外泌体精准递送抗炎分子至靶器官，显著改善了肺损伤并呈现出良好的安全性[78]。进一步研究发现，改造的益生菌外膜囊泡能高效递送多抗原，为疫苗研发提供新的可能性[79]。然而，上述递送技术仅对肺组织进行了相应研究，但对其余组织和器官疗效有限。因此全程干预策略对中枢神经系统及其他重要组织的保护作用仍有待探索。
3.2 全程干预策略的多器官保护药物研发展望
现有药物无法满足COVID-19感染治疗临床期望，其主要原因是感染受体ACE2广泛表达于人体多个组织和器官，包括肺部、心脏、肾脏、肠道、大脑等，使新冠病毒感染后导致多器官损伤，并发症和复杂后遗症[8]包括心脑血管疾病、神经系统疾病、主要脏器疾病等，幸存者也可能伴有长期神经和精神症状，其他各种疾病的发病率风险也有显著增加。因此，目前仅针对感染或炎症等某一个环节进行干预疗效有限。
考虑到炎症为新冠病毒感染后各组织脏器病理学改变的核心机制，本课题组研究认为在炎症调控通路中寻找新冠病毒并发症及后遗症中的可干预靶点或为开发新的安全、高效的全程抗病毒药物提供创新思路。在各种疾病造成的神经系统损伤的病理环境中，均发现了大量被激活成M1表型的小胶质细胞，可分泌促炎性物质如TNF-α、IL-6导致严重的血管炎症[80]，而ACE2可通过大量降解AngII产生Ang1-7，驱动小神经胶质细胞从M1型转化为M2型，抑制促炎性物质的分泌，从而抑制神经炎症、促进血管生成[81-83]。此外，在心力衰竭、高血压等心血管疾病[84]中，ACE/AngII过度激活会导致炎症因子释放、氧化应激增加等炎症反应，而ACE2/Ang1-7可有效对抗其作用，抑制炎症和减少氧化应激，从而减轻心肌纤维化和改善心脏功能[85]；急性肺损伤中，ACE2的表达通常下调，而AngII水平升高，导致ACE/ACE2失衡，因此激活ACE2可通过激活Ang1-7/Mas受体途径保护肺部免受损伤[86]；在糖尿病肾病中，由于高血糖和氧化应激等因素，ACE活性增加，导致AngII水平升高，而ACE2活性降低，从而减少了Ang1-7的生成。AngII通过激活AT1受体，促进炎症因子的释放，加剧肾脏炎症和纤维化[87]。相比之下，Ang1-7通过Mas受体发挥抗炎作用，能够抑制NF-κB信号通路，减少促炎因子的表达[88]。除上述疾病外，ACE/AngII过度激活还会导致糖尿病视网膜[89]、其他器官功能障碍[90]等，利用Ang1-7类物质可以抑制氧化应激并促进血管内皮细胞的修复功能[89]，展现出降压、抗炎、抗血栓和抗增殖/凋亡活性[90]。综上可知，ACE2/Ang1-7不仅是新冠病毒感染的可干预靶点，还可作为新冠感染后并发症及后遗症的干预靶点，用于全程干预治疗。
根据以上ACE2靶点的特性，本团队针对其设计研发了一种基于芦丁的三重靶向自组装药物递送系统(SS-31-透明质酸-芦丁，命名为SHR)，以期在抗新冠病毒感染的同时，有效改善新冠肺炎的并发症及中长期后遗症，拟全过程干预病毒致病性，进一步提高新冠肺炎治疗效果。现有研究已揭示了SHR可有效对抗神经系统炎症，对急性期及中长期神经系统损伤有强效治疗作用[91]，其作用机制如图4所示。其中，SS-31(S)是一种具有抗氧化作用的小肽，可带领药物体系穿透血脑屏障等各种屏障体系[92-93]；透明质酸(hyaluronic acid,H)为功能药物的连接组分，不仅发挥了不同组分药物结构的连接功能，更有效改善了整个药物体系的水溶性、生物利用度、靶向性和控释性等成药特征；芦丁(rutin，R)为ACE2的底物，对细胞膜上的ACE2受体有高亲和力，可竞争性抑制病毒的S蛋白与ACE2结合从而发挥抗感染作用[94]。更重要的是，SHR通过激活ACE2靶点，介导ACE2/Ang1-7/Mas信号通路对抗ACE/AngII信号通路抑制炎症反应，降低促炎因子IL-6等的表达并增加抗炎因子ARG1和IL-10的水平，全面优化受损脑区的神经血管单元，显著逆转神经炎症，促进受损脑区的血管生成和血管正常化[95]。该药体系可有效改善新冠病毒的感染过程和急慢性神经症状。后续研究将针对其他新冠并发症及后遗症进行研究，以验证其全程干预效果，为新药研发提供参考。
4 结语
新冠病毒危机似乎已经过去，但随着病毒变异的不断迭代，未来是否出现新的公共卫生挑战尚未可知。更重要的是，新冠感染导致的多系统损伤使原有基础性疾病恶化、并发症增加，以及神经后遗症等长期存在，仍是当前医药工作者面临的难题。兼顾抗感染与抗炎、兼顾短期急性损伤与长期预后影响的全程抗病毒药物研发策略或为解决上述问题提供新的契机。
利益冲突 所有作者均声明不存在利益冲突
参考文献（略）
引用格式：吴琪, 段少峰, 岑娟. 抗新冠病毒药物研究进展及全程干预治疗策略展望[J]. 中国抗生素杂志, 2026, 51(6): 693-704.
长按并识别下方二维码查看本期全文
▼
点击下方“阅读原文”下载全文
↓↓↓
2026-06-24
Journal of Antimicrobial Chemotherapy Volume 81, Issue 1抗菌化疗杂志81卷 1期
https://academic.oup.com/jac/issue
50th Anniversary Collection（50周年纪念合集）
Review（综述）
1
Artificial intelligence for improving decision-making in bacterial infection management: a narrative review
人工智能在改善细菌感染治疗决策中的应用：一项叙述性综述
Anisia Talianu and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf470, https://doi.org/10.1093/jac/dkaf470
Reviews（综述）
2
Evolving landscape of methicillin-resistant Staphylococcus pseudintermedius: the emergence of new epidemic waves across Europe, Asia and North America
耐甲氧西林中间型葡萄球菌的演变格局：欧洲、亚洲和北美洲新流行浪潮的出现
Lillian Rose Giarratana and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf340, https://doi.org/10.1093/jac/dkaf340
3
Azithromycin resistance in non-typhoidal Salmonella: a review
非伤寒沙门氏菌对阿奇霉素的耐药性：综述
Zhe Zhu and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf341, https://doi.org/10.1093/jac/dkaf341
4
Antibiotic pharmacodynamics: from MIC to advanced metrics and their applications
抗生素药效动力学：从最低抑菌浓度到高级指标及其应用
Malin Andersson and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf374, https://doi.org/10.1093/jac/dkaf374
5
Progress in the study of drug resistance mechanism of Bacillus cereus
蜡样芽孢杆菌耐药机制研究进展
Yuhang Zhang and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf399, https://doi.org/10.1093/jac/dkaf399
6
The curious constraints on clofazimine
氯法齐明的奇特限制
Maple Goh and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf430, https://doi.org/10.1093/jac/dkaf430
7
Antiplasmid systems: a novel strategy to combat antibiotic resistance
抗质粒系统：对抗抗生素耐药性的新策略
Mohd Asim and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf472, https://doi.org/10.1093/jac/dkaf472
Systematic Review（系统综述）
8
Coccidioidomycosis in Europe: a systematic literature review of epidemiology, treatment and outcomes
欧洲球孢子菌病：流行病学、治疗和预后的系统文献综述
Priya Shastri and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf407, https://doi.org/10.1093/jac/dkaf407
9
Systematic review of antimicrobial pharmacokinetic/pharmacodynamic indices in murine thigh and hollow fibre dose fractionation studies analysed with a standard method
用标准方法分析小鼠大腿和空心纤维剂量分次研究中的抗菌药物药代动力学/药效动力学指数的系统综述
Najla Alabdulkarim and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf446, https://doi.org/10.1093/jac/dkaf446
Virtual Roundtable（虚拟圆桌会议）
10
Procalcitonin in the management of lower respiratory tract infection and sepsis
降钙素原在下呼吸道感染和败血症治疗中的应用
Ramy H Elshaboury and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf298, https://doi.org/10.1093/jac/dkaf298
Original Research（论著）
11
Model-based assessment of letermovir pharmacokinetics in allogeneic haematopoietic stem cell transplant recipients
来特莫韦在异基因造血干细胞移植受者中药代动力学的基于模型的评估
Chrisoula Tahtsidou and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf427, https://doi.org/10.1093/jac/dkaf427
12
In vitro exebacase (CF-301) activity against methicillin-susceptible or methicillin-resistant Staphylococcus aureus and coagulase-negative staphylococci strains isolated from patients with infective endocarditis
体外试验评估依拉环素（CF-301）对甲氧西林敏感或甲氧西林耐药金黄色葡萄球菌及凝固酶阴性葡萄球菌（从感染性心内膜炎患者中分离）的活性
María-Alexandra Cañas and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf435, https://doi.org/10.1093/jac/dkaf435
13
Evaluation of subcutaneous amoxicillin/clavulanic acid pharmacokinetics as an alternative to the intravenous route in older patients—the PhASAge Study
评估皮下注射阿莫西林/克拉维酸药代动力学作为老年患者静脉给药替代方案——PhASAge研究
Nicolas Grégoire and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf381, https://doi.org/10.1093/jac/dkaf381
14
Real-life use of isavuconazole in Spanish children and adolescents
西班牙儿童和青少年中艾沙康唑的实际使用情况
Natalia Mendoza-Palomar and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf394, https://doi.org/10.1093/jac/dkaf394
15
No pharmacovigilance signal of intracranial hypertension associated with glycylcyclines: a FAERS-based disproportionality analysis
基于FAERS数据库的不成比例性分析：未发现甘氨酰环素类与颅内高压相关的药物警戒信号
Slobodan M Jankovic and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf395, https://doi.org/10.1093/jac/dkaf395
16
Posaconazole enteral tube administration in adults: pharmacokinetic target attainment of oral suspension compared with crushed delayed-release tablet
成人经肠内营养管给予泊沙康唑：口服混悬液与碾碎的缓释片的药代动力学目标达成情况比较
Nirjan Bhattarai and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf396, https://doi.org/10.1093/jac/dkaf396
17
Characterizing CYP3A4-mediated drug interactions: a fixed-sequence pharmacokinetic Chinese study of posaconazole and ruxolitinib in haematological malignancies
CYP3A4介导的药物相互作用特征：一项关于泊沙康唑和鲁索替尼在血液系统恶性肿瘤中的固定序列药代动力学中国研究
Beibei Liang and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf398, https://doi.org/10.1093/jac/dkaf398
18
Differences in prescription for impetigo and cellulitis across years in three European countries
三个欧洲国家不同年份脓疱病和蜂窝织炎的处方差异
Thomas Bettuzzi and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf400, https://doi.org/10.1093/jac/dkaf400
19
β-Lactam concentrations monitored in the early phase of community-acquired sepsis in the intensive care unit
重症监护室社区获得性脓毒症早期阶段监测的β-内酰胺浓度
Karolina Liljedahl Prytz and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf401, https://doi.org/10.1093/jac/dkaf401
20
Enhanced antimycobacterial efficacy of simulated inhaled clofazimine versus oral clofazimine in combination with azithromycin and ethambutol in a hollow-fiber system
在空心纤维系统中，模拟吸入氯法齐明与口服氯法齐明联合阿奇霉素和乙胺丁醇的抗结核分枝杆菌疗效增强比较
Jelmer Raaijmakers and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf402, https://doi.org/10.1093/jac/dkaf402
21
Identification of antimicrobial resistance genes in Escherichia coli through network diffusion
通过网络扩散法鉴定大肠杆菌中的抗生素耐药基因
Anis Mansouri and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf404, https://doi.org/10.1093/jac/dkaf404
22
Preclinical evaluation of epetraborole in the hollow fibre system model of Mycobacterium abscessus lung disease
依培硼罗在脓肿分枝杆菌肺病空心纤维系统模型中的临床前评估
Sanjay Singh and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf405, https://doi.org/10.1093/jac/dkaf405
23
The β-lactamase inhibitor concentration-dependent minimum inhibitory concentration (MICcBLI) as methodology to assess the pharmacokinetic/pharmacodynamic relationship of piperacillin/tazobactam for dosing optimization
β-内酰胺酶抑制剂浓度依赖性最低抑菌浓度（MICcBLI）作为评估哌拉西林/他唑巴坦药代动力学/药效动力学关系以优化给药的方法
Malin Andersson and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf406, https://doi.org/10.1093/jac/dkaf406
24
Unravelling the triad of penicillin-binding proteins, β-lactamase activity, and mRNA dynamics in Pseudomonas aeruginosa AmpC induction
解析铜绿假单胞菌AmpC诱导过程中青霉素结合蛋白、β-内酰胺酶活性和mRNA动态的三元关系
Maria Montaner and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf408, https://doi.org/10.1093/jac/dkaf408
25
Unnoticed spread of linear VanA-plasmids in vancomycin-variable Enterococcus faecium strains across different regions: a diagnostics challenge
不同地区万古霉素可变型粪肠球菌菌株中线性VanA质粒的未被察觉的传播：一项诊断挑战
Ana C Almeida-Santos and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf409, https://doi.org/10.1093/jac/dkaf409
26
Switching from etravirine to doravirine in virologically suppressed people with HIV: results from the French multicentre SWEED observational study
在病毒学抑制的HIV感染者中从依曲韦林切换至多拉韦林：法国多中心SWEED观察性研究的结果
Romain Palich and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf410, https://doi.org/10.1093/jac/dkaf410
27
HIV-1 drug resistance among pregnant and breastfeeding mothers and its association with paediatric HIV infections in the Dolutegravir era in Uganda
乌干达多替拉韦时代孕产妇及哺乳期母亲中HIV-1耐药情况及其与儿童HIV感染的关联
Anne Kapaata and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf411, https://doi.org/10.1093/jac/dkaf411
28
Outpatient antibiotic prescribing for medically attended respiratory syncytial virus, influenza, or human metapneumovirus illness among high-risk adults in rural Wisconsin, United States
美国威斯康星州农村地区高风险成人因呼吸道合胞病毒、流感或人偏肺病毒感染就诊时的门诊抗生素处方情况
Sarah C J Jorgensen and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf412, https://doi.org/10.1093/jac/dkaf412
29
Omadacycline as a drug candidate for Mycobacterium avium infections: in vitro insights on single and combination therapies
奥马环素作为鸟分枝杆菌感染候选药物：单药及联合治疗的体外研究
Saskia E Mudde and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf413, https://doi.org/10.1093/jac/dkaf413
30
Post-pandemic trends in Streptococcus pneumoniae serotype epidemiology and antibiotic susceptibility in adults with invasive and non-invasive pneumococcal disease in the USA (2022–2023)
后疫情时代美国成人侵袭性与非侵袭性肺炎链球菌病血清型流行病学及抗生素敏感性趋势（2022-2023）
Mekki F Bensaci and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf414, https://doi.org/10.1093/jac/dkaf414
31
Benznidazole pharmacokinetics in patients with chronic Chagas disease: association with demographic factors and adverse drug reactions
慢性恰加斯病患者苯芴醇药代动力学：与人口统计学因素及药物不良反应的关联
Gabriel P E Silveira and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf416, https://doi.org/10.1093/jac/dkaf416
32
Acquired antimicrobial resistance genes in Bordetella Species: a global genomic analysis
博德特氏菌属中获得的抗菌药物耐药基因：全球基因组分析
Biao Tang and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf418, https://doi.org/10.1093/jac/dkaf418
33
Machine learning for personalized antimicrobial susceptibility breakpoints: (Adaptive clinical breakpoint interpretation)
基于机器学习的个性化抗菌药物敏感性折点制定（自适应临床折点解释）
Yinzheng Zhong and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf419, https://doi.org/10.1093/jac/dkaf419
34
Multicentre investigation of Wickerhamomyces anomalus fungemia in India: emerging resistance and mechanistic insights
印度异常威克汉姆酵母菌血症的多中心研究：新发耐药性及机制洞察
Shristi Verma and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf420, https://doi.org/10.1093/jac/dkaf420
35
Reducing aztreonam/avibactam waste: insights from Monte Carlo simulations
减少氨曲南/阿维巴坦浪费：蒙特卡洛模拟的启示
Yeleen Fromage and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf421, https://doi.org/10.1093/jac/dkaf421
36
Nanoparticle-based co-delivery of ciprofloxacin and meropenem enhances synergistic activity against multidrug-resistant hypervirulent Klebsiella pneumoniae clinical isolates
基于纳米颗粒的环丙沙星与美罗培南共递送可增强对多重耐药高毒力肺炎克雷伯菌临床分离株的协同活性
Reham Mostafa and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf422, https://doi.org/10.1093/jac/dkaf422
37
Development of population pharmacokinetic models of total and free piperacillin in critically ill children and young adults for Monte Carlo simulations and model-informed precision dosing
危重症儿童及青年总游离哌拉西林群体药代动力学模型开发：用于蒙特卡洛模拟及模型引导的精准给药
Sonya Tang Girdwood and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf423, https://doi.org/10.1093/jac/dkaf423
38
Reaching the target: time and dose required to achieve target vancomycin plasma concentrations in admitted patients
达标分析：住院患者达到目标万古霉素血浆浓度所需的时间与剂量
W Töpfer and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf424, https://doi.org/10.1093/jac/dkaf424
39
Notable transmitted HIV drug resistance among people who inject drugs in Pakistan
巴基斯坦注射毒品人群中显著传播的HIV耐药性
Stephanie Melnychuk and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf425, https://doi.org/10.1093/jac/dkaf425
40
Synergistic but clinically unattainable: amoxicillin/ceftriaxone combination against ampicillin-susceptible Enterococcus faecium
协同但临床难以实现：阿莫西林/头孢曲松联合对氨苄西林敏感粪肠球菌的体外活性
Ahmed Ashrin and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf426, https://doi.org/10.1093/jac/dkaf426
41
Pharmacodynamic studies of taniborbactam (VNRX-5133) combined with cefepime against β-lactamase–producing Gram-negative bacteria in a neutropenic murine thigh infection model
中性粒细胞减少小鼠大腿感染模型中他尼硼巴坦（VNRX-5133）联合头孢吡肟对产β-内酰胺酶革兰氏阴性菌的药效动力学研究
Panagiota-Christina Georgiou and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf431, https://doi.org/10.1093/jac/dkaf431
42
Epidemiology and treatment of endocarditis secondary to Enterobacterales other than Serratia spp.
非塞拉蒂亚属肠杆菌目细菌所致心内膜炎的流行病学及治疗
Clayton F Hausberger and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf432, https://doi.org/10.1093/jac/dkaf432
43
Enhanced activity of apramycin and apramycin-based combinations against Mycobacteroides abscessus
阿普拉霉素及其组合对脓肿分枝杆菌的增强活性
Yanqin Huang and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf433, https://doi.org/10.1093/jac/dkaf433
44
Efflux-mediated multidrug resistance mechanism in Trichophyton indotineae and Trichophyton rubrum; role of ABC transporters and MFS gene
印度毛癣菌与红色毛癣菌中由ABC转运蛋白和MFS基因介导的流出泵型多重耐药机制
Dipika Shaw and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf434, https://doi.org/10.1093/jac/dkaf434
45
Sphingobacterium spp. as intrinsic producers of SPI Ambler class B metallo-β-lactamases
鞘氨醇杆菌属作为SPI Ambler B类金属β-内酰胺酶的固有产生者
Delphine Girlich and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf436, https://doi.org/10.1093/jac/dkaf436
46
Global phylogeography and genomic characterization of blaNDM-1-positive carbapenem-resistant Acinetobacter soli
blaNDM-1阳性碳青霉烯耐药溶胶阿卡净菌的全球系统发育地理学及基因组特征
Pengpeng Min and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf437, https://doi.org/10.1093/jac/dkaf437
47
Pharmacokinetics and tolerability of one-month daily rifapentine for latent tuberculosis treatment in haemodialysis patients
血液透析患者潜伏性结核治疗中每月一次每日利福喷丁的药代动力学及耐受性
Thornthun Ueaphongsukkit and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf439, https://doi.org/10.1093/jac/dkaf439
48
In vitro susceptibility of cefepime-enmetazobactam, cefepime-taniborbactam and cefepime-zidebactam towards carbapenemase-producing Enterobacterales
头孢吡肟-恩美他唑巴坦、头孢吡肟-他尼硼巴坦及头孢吡肟-齐德巴坦对产碳青霉烯酶肠杆菌目的体外敏感性
Marion Dutkiewicz and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf440, https://doi.org/10.1093/jac/dkaf440
49
In vitro efficacy of sulbactam/durlobactam combined with β-lactam antibiotics in Australian Mycobacterium abscessus isolates
舒巴坦/杜洛巴坦联合β-内酰胺类抗生素对澳大利亚脓肿分枝杆菌分离株的体外疗效
Kirby Patterson-Fahy and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf441, https://doi.org/10.1093/jac/dkaf441
50
Harnessing CRISPR–Cas9 and CRISPRi systems to reverse antibiotic resistance in a clinical multidrug-resistant Escherichia coli isolate
利用CRISPR-Cas9及CRISPRi系统逆转临床多重耐药大肠杆菌分离株的抗生素耐药性
Ruonan Zhao and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf442, https://doi.org/10.1093/jac/dkaf442
51
Cotrimoxazole in the intensive care unit: an impossible task for the fixed association in real life?
重症监护室中复方磺胺甲噁唑的应用：固定组合在现实中的不可行性？
Manon Launay and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf443, https://doi.org/10.1093/jac/dkaf443
52
National representative survey of pretreatment HIV drug resistance in Colombia: analysis of antiretroviral resistance-associated mutations using next-generation sequencing
哥伦比亚全国代表性调查：基于下一代测序的抗逆转录病毒耐药相关突变分析
Ernesto Martínez-Buitrago and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf444, https://doi.org/10.1093/jac/dkaf444
53
A model-based comparison of dose reduction strategies for fixed-dose dolutegravir-containing regimens
基于模型的含固定剂量多替拉韦方案减量策略比较
Laura Dickinson and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf445, https://doi.org/10.1093/jac/dkaf445
54
Therapeutic drug monitoring and target attainment of unbound flucloxacillin in hospitalized patients with measured MICs (FLUTE)
住院患者中游离氟氯西林的治疗药物监测及目标达成情况（基于实测最低抑菌浓度的FLUTE研究）
Pjotr P Temme and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf447, https://doi.org/10.1093/jac/dkaf447
55
Nirmatrelvir-ritonavir addition to acute care formulary: a retrospective, multi-centre evaluation of quantitative economic and qualitative clinical outcomes
奈玛特韦/利托那韦纳入急症治疗目录：一项多中心回顾性评估定量经济与定性临床结果的研究
Jose Valdes Ledesma and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf448, https://doi.org/10.1093/jac/dkaf448
56
Local antibiotic resistance surveillance in nursing homes using lot quality assurance sampling: a feasibility study
采用批量质量保证抽样法对养老院进行本地抗生素耐药性监测的可行性研究
Sacha Kuil and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf451, https://doi.org/10.1093/jac/dkaf451
57
High in vitro activity of the novel antimicrobial gepotidacin against Neisseria gonorrhoeae isolates in eight WHO Enhanced Gonococcal Antimicrobial Surveillance Programme countries in three WHO regions, 2021–24
2021-2024年，在世卫组织三个区域的八个世卫组织增强淋球菌抗菌药物监测计划国家中，新型抗菌药物吉皮达星对淋病奈瑟菌分离株的体外活性较高
Josefine Ahlstrand and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf452, https://doi.org/10.1093/jac/dkaf452
58
Despite increasing use of integrase inhibitors to treat HIV infection, resistance to this class remains stable
尽管整合酶抑制剂用于治疗HIV感染的使用量不断增加，但此类药物的耐药性仍保持稳定
Cathia Soulie and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf454, https://doi.org/10.1093/jac/dkaf454
59
Fine-needle aspiration in infected necrotizing pancreatitis in the delayed intervention era: a post hoc analysis of safety, microbiological yield and therapeutic implications
延迟干预时代感染性坏死性胰腺炎的细针穿刺抽吸术：安全性、微生物学检出率及治疗意义的事后分析
Hannah S Pauw and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf455, https://doi.org/10.1093/jac/dkaf455
60
β-Lactam dosing in critically ill children: predictors for target non-attainment
危重症儿童β-内酰胺类药物给药：未达目标浓度的预测因素
Stef Schouwenburg and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf457, https://doi.org/10.1093/jac/dkaf457
61
Co-administration of triazoles with calcineurin or mammalian target of rapamycin inhibitors in solid organ transplant patients hospitalized with invasive aspergillosis
实体器官移植患者合并侵袭性曲霉病住院时三唑类药物与钙调磷酸酶抑制剂或哺乳动物雷帕霉素靶蛋白抑制剂的联合用药情况
Barbara Alexander and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf461, https://doi.org/10.1093/jac/dkaf461
62
In vitro selection of cefiderocol-resistant mutants in Acinetobacter baumannii harbouring the most common carbapenemase genes
携带最常见碳青霉烯酶基因的鲍曼不动杆菌中头孢地尔耐药突变体的体外筛选
Otávio Hallal Ferreira Raro and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf462, https://doi.org/10.1093/jac/dkaf462
63
Preventing resistance development in infections by OXA β-lactamase-producing Pseudomonas aeruginosa: correlating clinical outcomes with hollow-fibre model input
预防产OXA β-内酰胺酶铜绿假单胞菌感染耐药性的产生：将临床结局与中空纤维模型输入相关联
María M Montero and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf464, https://doi.org/10.1093/jac/dkaf464
64
A national pilot community pharmacy–led urinary tract infection service: clinical and patient-reported outcomes from 9077 consultations
全国社区药房主导的尿路感染服务试点项目：9077次咨询的临床结局和患者报告结局
Efi Mantzourani and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf466, https://doi.org/10.1093/jac/dkaf466
65
Towards enhanced translational value: preclinical drug activity testing against actively multiplying, nutrient-starved and pellicle biofilm-embedded Mycobacterium abscessus
提高转化价值：针对活跃增殖、营养匮乏和生物膜包裹的脓肿分枝杆菌进行临床前药物活性测试
Henriëtte M Meliefste and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf468, https://doi.org/10.1093/jac/dkaf468
Research Letters（研究快报）
66
Novel multiresistance transposon Tn7731 in bovine Pasteurella multocida from Germany
德国牛源多杀性巴氏杆菌中新型多重耐药转座子Tn7731
Henrike Krüger-Haker and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf336, https://doi.org/10.1093/jac/dkaf336
67
Efficacy of eravacycline in difficult-to-treat (DTR) Acinetobacter baumannii bacteraemia in ICU: a case report
厄他培南治疗重症监护病房难治性鲍曼不动杆菌菌血症的疗效：一例病例报告
Monica Melchio and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf347, https://doi.org/10.1093/jac/dkaf347
68
Possible increased risk of Epstein–Barr virus (EBV) infection and post-transplant lymphoproliferative disease (PTLD) in letermovir-exposed haematopoietic cell transplantation recipients
来特莫韦暴露的造血细胞移植受者中EB病毒感染和移植后淋巴增殖性疾病风险可能增加
Jose F Camargo and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf348, https://doi.org/10.1093/jac/dkaf348
69
Dalbavancin dosing in a severely underweight woman with prosthetic valve endocarditis: the critical role of proactive therapeutic drug monitoring
达巴万星在严重体重不足人工瓣膜心内膜炎女性患者中的给药：主动治疗药物监测的关键作用
Ambra Barco and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf365, https://doi.org/10.1093/jac/dkaf365
70
Cefazolin-induced seizures in a haemodialysis patient with elevated serum and cerebrospinal fluid concentrations: a case report
血液透析患者头孢唑林血清和脑脊液浓度升高诱发癫痫：一例病例报告
Kohei Hasegawa and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf373, https://doi.org/10.1093/jac/dkaf373
71
Retrospective analysis of pharmacological therapeutic monitoring of caspofungin in patients undergoing continuous renal replacement therapy using polyacrylonitrile membranes
使用聚丙烯腈膜进行连续性肾脏替代治疗的患者中卡泊芬净药代动力学治疗监测的回顾性分析
Antoine Hérault and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf390, https://doi.org/10.1093/jac/dkaf390
72
Diffusion of OXA-48- and NDM-5-producing Klebsiella pneumoniae ST383 clone in Central Italy
产OXA-48和NDM-5的肺炎克雷伯菌ST383克隆在意大利中部的传播
Gloria D’Achille and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf397, https://doi.org/10.1093/jac/dkaf397
73
Durability of lenacapavir in viremic heavily treatment-experienced people with HIV: real-world data from the PRESTIGIO Registry
来那卡帕韦在病毒载量阳性且接受过大量抗逆转录病毒治疗的HIV感染者中的持久性：来自PRESTIGIO登记处的现实数据
Tommaso Clemente and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf415, https://doi.org/10.1093/jac/dkaf415
74
Co-carriage of the oxazolidinone resistance genes cfr and optrA in a linezolid-resistant Staphylococcus rostri isolate from a pig-farm worker
猪场工人利奈唑胺耐药猪鼻支原体分离株中噁唑烷酮类耐药基因cfr和optrA的共携带情况
Gi Yong Lee and Soo-Jin Yang
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf428, https://doi.org/10.1093/jac/dkaf428
75
Importance of reviewing the package insert from gradient strip manufacturers
梯度扩散法药敏纸片生产商说明书审阅的重要性
Mandy Wootton and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf429, https://doi.org/10.1093/jac/dkaf429
76
One resistance gene, many transposons: repeated formation of compound and pseudo-compound transposons carrying the aphA1 kanamycin and neomycin resistance gene
一个耐药基因，多个转座子：携带aphA1卡那霉素和新霉素耐药基因的复合及假复合转座子的重复形成
Christopher J Harmer and Ruth M Hall
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf450, https://doi.org/10.1093/jac/dkaf450
77
Absence of lymphogranuloma venereum among men who have sex with men on PrEP receiving doxycycline postexposure prophylaxis
接受暴露后多西环素预防性治疗的暴露前预防用药男男性行为者中未发现性病淋巴肉芽肿
Cristina Gómez-Ayerbe and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf456, https://doi.org/10.1093/jac/dkaf456
78
In vitro activity of gepotidacin against Chlamydia trachomatis
吉皮达星对沙眼衣原体的体外活性
Arabella Touati and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 1, January 2026, dkaf460, https://doi.org/10.1093/jac/dkaf460
Journal of Antimicrobial Chemotherapy Volume 81, Issue 2抗菌化疗杂志 81卷 2期
https://academic.oup.com/jac/issue
Viewpoints（观点）
1
Long-acting glycopeptides: what are the barriers to access in patients who need them most, and how can they be overcome?
长效糖肽类：最需要它们的患者获取药物的障碍有哪些，如何克服？
Aleece MacPhail and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf471, https://doi.org/10.1093/jac/dkaf471
2
Redefining antifungal prophylaxis in acute leukaemia in the era of targeted therapies
靶向治疗时代急性白血病抗真菌预防的重新定义
Marcio Nucci and Johan Maertens
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag010, https://doi.org/10.1093/jac/dkag010
Reviews（综述）
3
Research progress on resistance mechanisms and clinical efficacy of tigecycline against Klebsiella pneumoniae
替加环素对肺炎克雷伯菌的耐药机制及临床疗效研究进展
Meilin Wu and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf504, https://doi.org/10.1093/jac/dkaf504
4
Liposomal amphotericin B and renal safety: review of the evidence and clinical considerations
两性霉素B脂质体与肾脏安全性：证据回顾及临床考量
Johan Maertens and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf473, https://doi.org/10.1093/jac/dkaf473
5
Strategies for mitigating severe COVID-19 in patients with haematological malignancy during the omicron era
奥密克戎时代减轻血液系统恶性肿瘤患者严重新冠肺炎的策略
Keiji Okinaka and Joshua T Schiffer
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf489, https://doi.org/10.1093/jac/dkaf489
Systematic Reviews（系统综述）
6
Safety and efficacy of gepotidacin in urinary tract infection: a GRADE-assessed systematic review and meta-analysis
吉泊替达辛治疗尿路感染的安全性和有效性：一项基于GRADE评估的系统综述和荟萃分析
Taha Ibrahim and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf469, https://doi.org/10.1093/jac/dkaf469
7
The emerging clinical relevance and antimicrobial resistance of Pluralibacter gergoviae: a systematic review
产吲哚金黄杆菌日益凸显的临床相关性和抗菌药物耐药性：一项系统综述
Bruna Abdul Ahad Saad and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf476, https://doi.org/10.1093/jac/dkaf476
8
A comprehensive analysis of the mutational landscape determining polymyxin resistance in Klebsiella pneumoniae
决定肺炎克雷伯菌多粘菌素耐药性的突变谱综合分析
Sambit Kumar Dwibedy and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf503, https://doi.org/10.1093/jac/dkaf503
9
Factors promoting or hindering self-administered outpatient parenteral antimicrobial therapy: a systematic literature review
促进或阻碍自我给药门诊静脉注射抗菌药物治疗的因素：一项系统文献综述
Hester H Stoorvogel and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf490, https://doi.org/10.1093/jac/dkaf490
Original Research（论著）
10
Cefepime/enmetazobactam for Gram-negative periprosthetic joint infections? A randomized porcine study on target tissue pharmacokinetics
头孢吡肟/恩美唑巴坦治疗革兰氏阴性假体周围关节感染？一项关于猪的靶组织药代动力学的随机研究
M B D Nielsen and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf487, https://doi.org/10.1093/jac/dkaf487
11
Impact of extracorporeal membrane oxygenation modes on voriconazole exposure in critically ill patients
体外膜肺氧合模式对危重患者伏立康唑暴露的影响
Xinrui Wang and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf501, https://doi.org/10.1093/jac/dkaf501
12
Model-based assessment of VRC07-523LS dosing in infants through population pharmacokinetic -pharmacodynamic modelling in adults and infants
基于模型通过成人和婴儿群体药代动力学-药效学模型评估VRC07-523LS在婴儿中的给药方案
Dustin Huynh and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf449, https://doi.org/10.1093/jac/dkaf449
13
Antibiotic resistance of Pseudomonas aeruginosa strains—intracellular metabolomics analysis
铜绿假单胞菌菌株的抗生素耐药性——细胞内代谢组学分析
Karolina Anna Mielko-Niziałek and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf453, https://doi.org/10.1093/jac/dkaf453
14
In vitro activity of cefepime/zidebactam against sulbactam/durlobactam-susceptible and -resistant Acinetobacter baumannii clinical isolates
头孢吡肟/齐多巴坦对舒巴坦/杜洛巴坦敏感和耐药鲍曼不动杆菌临床分离株的体外活性
Carlo Tascini and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf467, https://doi.org/10.1093/jac/dkaf467
15
Prevalence of macrolide resistance in Mycoplasma pneumoniae in The Netherlands
荷兰肺炎支原体大环内酯类抗生素耐药性的流行情况
Patrick D J Sturm and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf475, https://doi.org/10.1093/jac/dkaf475
16
Simulated lung exposure in pneumonia patients to evaluate the antibacterial capacity and resistance suppression of clinical tigecycline regimens against carbapenem-resistant
Acinetobacter baumannii
模拟肺炎患者肺部暴露情况以评估临床替加环素方案对碳青霉烯类耐药鲍曼不动杆菌的抗菌能力和耐药抑制作用
Xiaonan Zhang and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf477, https://doi.org/10.1093/jac/dkaf477
17
Enterococcus faecium harbouring vanA, optrA and cfr(D) on a linear plasmid in Canada: a CANWARD surveillance case
加拿大发现携带vanA、optrA和cfr(D)的粪肠球菌线性质粒：一项CANWARD监测病例
Melissa McCracken and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf478, https://doi.org/10.1093/jac/dkaf478
18
The effect of intrauterine exposure to aminoglycosides on neonatal hearing
宫内暴露于氨基糖苷类抗生素对新生儿听力的影响
Daniel Leshin-Carmel and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf483, https://doi.org/10.1093/jac/dkaf483
19
Ceftazidime/avibactam: a potent arsenal against multidrug-resistant Pseudomonas aeruginosa-unveiling in vitro and in vivo strategies
头孢他啶/阿维巴坦：对抗多重耐药铜绿假单胞菌的有力武器——揭示体内外策略
Jiaju Zhuo and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf495, https://doi.org/10.1093/jac/dkaf495
20
Comparison of disk diffusion, MIC test strip and broth microdilution for eravacycline susceptibility testing of 422 Staphylococcus aureus isolates using ChinaCAST breakpoints
采用中国CAST折点，比较422株金黄色葡萄球菌对依拉环素的纸片扩散法、最低抑菌浓度测试条法和肉汤微量稀释法的敏感性测试结果
Xinying Wang and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf502, https://doi.org/10.1093/jac/dkaf502
21
Penetration of daptomycin in cerebrospinal fluid during pneumococcal meningitis
肺炎链球菌性脑膜炎期间达托霉素在脑脊液中的渗透情况
Pascal Chavanet and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf474, https://doi.org/10.1093/jac/dkaf474
22
Rapid molecular diagnostics for detection of extensively drug-resistant Salmonella Typhi
用于检测广泛耐药伤寒沙门菌的快速分子诊断技术
Emma L Sweeney and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf481, https://doi.org/10.1093/jac/dkaf481
23
Gender inequality and antibiotic consumption: analysis of pharmaceutical sales data from 70 countries, 2000–22
性别不平等与抗生素消费：基于2000 - 2022年70个国家药品销售数据的分析
Deepshikha Batheja and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag002, https://doi.org/10.1093/jac/dkag002
24
Real-world evaluation of isavuconazole in children with cancer
伊沙康唑在儿童癌症患者中的现实应用评估
Janine Nijhuis and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf485, https://doi.org/10.1093/jac/dkaf485
25
Assessing antimicrobial susceptibility testing guideline adherence by laboratories providing bacteriology services in Ghana: a pilot study
加纳提供细菌学服务的实验室对抗菌药物敏感性试验指南依从性的评估：一项试点研究
Joseph Elikem Efui Acolatse and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag003, https://doi.org/10.1093/jac/dkag003
26
Resistance to second-generation integrase inhibitors in people with HIV following treatment failure on dolutegravir- or bictegravir-based ART in Taiwan
台湾地区基于多替拉韦或比克替拉韦的抗逆转录病毒治疗失败后，HIV感染者对第二代整合酶抑制剂的耐药性
Guan-Jhou Chen and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf488, https://doi.org/10.1093/jac/dkaf488
27
In vitro activity of gepotidacin against a challenging panel of multidrug-resistant Neisseria gonorrhoeae isolates
吉泊西汀对一组具有挑战性的多重耐药淋病奈瑟菌分离株的体外活性
Michelle Jayne Cole and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag001, https://doi.org/10.1093/jac/dkag001
28
A disproportionality analysis of adverse events associated with omadacycline based on the FDA adverse event reporting system database
基于美国食品药品监督管理局（FDA）不良事件报告系统数据库的奥马环素相关不良事件比例失衡分析
Ye-Lei Zhao and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag006, https://doi.org/10.1093/jac/dkag006
29
Weight-band-based simplification of oral allometric miltefosine dosing in paediatric patients with visceral leishmaniasis
基于体重范围的口服异速缩放米替福新给药方案在儿童内脏利什曼病患者中的简化应用
Andres Mazariegos Herrera and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag014, https://doi.org/10.1093/jac/dkag014
30
evelopment of a capability framework for antimicrobial stewardship specialist health professionals working in the NHS in England: utilizing Delphi methodology
运用德尔菲法为在英国国家医疗服务体系（NHS）中工作的抗菌药物管理专业人员制定能力框架
Ryan A Hamilton and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf438, https://doi.org/10.1093/jac/dkaf438
31
First characterization of insertions in the HIV-1 integrase-coding region from people with HIV
首次对来自艾滋病病毒感染者的HIV-1整合酶编码区插入情况进行特征分析
Nhat Quang Tu and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf491, https://doi.org/10.1093/jac/dkaf491
32
Development of an impedance-based fast antimicrobial susceptibility test for Neisseria gonorrhoeae
开发一种基于阻抗的淋病奈瑟菌快速抗菌药物敏感性检测方法
Caitlin N Daniels and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf493, https://doi.org/10.1093/jac/dkaf493
33
Juvenile toxicity and developmental safety of Zintrodiazine, a novel antimalarial candidate, in Wistar rats
新型抗疟候选药物Zintrodiazine在Wistar大鼠中的幼年毒性和发育安全性研究
Hitesh A Kadu and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag008, https://doi.org/10.1093/jac/dkag008
34
Do the redefined EUCAST susceptibility categories warrant adjustment of paediatric antibiotic dosages? Pragmatic physiologically based pharmacokinetic modelling of four commonly used agents
欧洲抗微生物药物敏感性试验委员会（EUCAST）重新定义的敏感性分类是否需要调整儿童抗生素剂量？——对四种常用药物的实用生理药代动力学建模研究
Marika A de Hoop-Sommen and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf463, https://doi.org/10.1093/jac/dkaf463
35
Exploring the opportunity for therapeutic drug monitoring (TDM) and precision dose antimicrobials in an outpatient antimicrobial therapy (OPAT) service: a prospective observational study
门诊抗菌治疗（OPAT）服务中开展治疗药物监测（TDM）和精准剂量抗菌治疗的机遇：一项前瞻性观察研究
R C Wilson and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf484, https://doi.org/10.1093/jac/dkaf484
36
Impact of sex, age and body composition on rilpivirine and cabotegravir trough concentrations in people with HIV receiving long-acting injectable antiretroviral therapy
性别、年龄和身体成分对接受长效注射用抗逆转录病毒治疗的HIV感染者利匹韦林和卡博特韦谷浓度的影响
Maria Vittoria Cossu and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag024, https://doi.org/10.1093/jac/dkag024
37
Pharmacokinetics of cefiderocol during prolonged intermittent kidney replacement therapy in two patients with septic shock
头孢地尔在两例感染性休克患者长时间间歇性肾脏替代治疗期间的药代动力学
Julius J Schmidt and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf496, https://doi.org/10.1093/jac/dkaf496
38
Understanding mechanisms of reduced cefiderocol susceptibility in pvdS and fecI mutants of Pseudomonas aeruginosa
了解铜绿假单胞菌pvdS和fecI突变体对头孢地尔敏感性降低的机制
Yoshinori Yamano and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag004, https://doi.org/10.1093/jac/dkag004
39
Biomarker-informed PBPK modelling of meropenem in paediatric severe pneumonia: implications for target-site PK/PD
基于生物标志物的美罗培南在儿童重症肺炎中的生理药动学模型构建：对靶部位药代动力学/药效学的影响
Yao Liu and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf500, https://doi.org/10.1093/jac/dkaf500
40
Evaluating hypoalbuminaemia thresholds associated with delayed blood sterilization among patients receiving cefazolin or antistaphylococcal penicillins for MSSA bacteraemia
评估接受头孢唑林或抗葡萄球菌青霉素治疗甲氧西林敏感金黄色葡萄球菌（MSSA）菌血症患者中，与血液延迟灭菌相关的低白蛋白血症阈值
Sunish Shah and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf498, https://doi.org/10.1093/jac/dkaf498
Research Letters（研究快讯）
41
False-negative result in fourth-generation HIV screening tests after weak detection of p24 antigen in the context of inappropriate post-exposure prophylaxis use: a case report
不当使用暴露后预防用药导致第四代HIV筛查试验p24抗原弱检出后出现假阴性结果：一例病例报告
J Kimmerlin and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf459, https://doi.org/10.1093/jac/dkaf459
42
Proposal for the nomenclature of tmexCD-toprJ-like gene clusters
关于tmexCD-toprJ样基因簇命名的建议
Chengzhen Wang and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf482, https://doi.org/10.1093/jac/dkaf482
43
IS26-mediated chromosomal integration of virulence plasmid fragments in ST2237 carbapenem-resistant Klebsiella pneumoniae
IS26介导的毒力质粒片段在ST2237型碳青霉烯耐药肺炎克雷伯菌染色体中的整合
Yan Li and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag018, https://doi.org/10.1093/jac/dkag018
Letter to the Editor（致编辑的信）
44
Comment on: Retrospective analysis of pharmacological therapeutic monitoring of caspofungin in patients undergoing continuous renal replacement therapy using polyacrylonitrile membranes
对“采用聚丙烯腈膜对接受连续性肾脏替代治疗的患者进行卡泊芬净药代动力学监测的回顾性分析”的评论
Gwénola Marais and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf465, https://doi.org/10.1093/jac/dkaf465
45
Antimicrobial use for the treatment of bacterial sexually transmitted infections among doxycycline post-exposure prophylaxis (DoxyPEP) users in Milan, Italy-right-to-reply
意大利米兰地区使用多西环素暴露后预防（DoxyPEP）人群中，用于治疗细菌性传播感染的抗菌药物使用情况——回应说明
Angelo Roberto Raccagni and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkag027, https://doi.org/10.1093/jac/dkag027
ACKNOWLEDGEMENT OF REFEREES（鸣谢审稿专家）
46
Acknowledgement of Referees
鸣谢审稿专家
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf417, https://doi.org/10.1093/jac/dkaf417
CORRECTION（更正）
47
Correction to: Comment on: Antiviral effect of Evusheld in COVID-19 hospitalized patients infected with pre-Omicron or Omicron variants: a modelling analysis of the randomized DisCoVeRy trial
更正：关于Evusheld在感染奥密克戎变异株前或奥密克戎变异株的新冠住院患者中的抗病毒效果：对随机DisCoVeRy试验的建模分析的评论
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 2, February 2026, dkaf492, https://doi.org/10.1093/jac/dkaf492
Journal of Antimicrobial Chemotherapy Volume 81, Issue 3抗菌化疗杂志 81卷 3期
https://academic.oup.com/jac/issue
REVIEW（综述）
1
Closing the PrEP access gap in Europe: a strategic framework for equity and innovation among difficult-to-reach populations
缩小欧洲暴露前预防获取差距：面向难以触及（PrEP）人群的公平与创新战略框架
Josep M Llibre and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag052, https://doi.org/10.1093/jac/dkag052
2
Precision dosing of systemic antifungals in adults: therapeutic drug monitoring, empiric dose optimization and barriers to implementation
成人全身性抗真菌药物的精准给药：治疗药物监测、经验性剂量优化及实施障碍
Daniel B Chastain and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag055, https://doi.org/10.1093/jac/dkag055
3
Bacterial DNA topoisomerase IV and DNA gyrase inhibitors: history of the quinolones, their clinical usage and potential alternatives for the future
细菌DNA拓扑异构酶IV和DNA旋转酶抑制剂：喹诺酮类药物的历史、临床应用及未来潜在替代方案
Daisuke Fukuda and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag054, https://doi.org/10.1093/jac/dkag054
4
Combating multidrug-resistant Klebsiella pneumoniae: current therapeutic regimens and future directions
应对多重耐药肺炎克雷伯菌：当前治疗方案与未来方向
Robiul Islam and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag064, https://doi.org/10.1093/jac/dkag064
SYSTEMATIC REVIEW（系统综述）
5
Global and regional prevalence of metallo-β-lactamases in carbapenem-resistant Acinetobacter baumannii: a systematic review and meta-analysis
耐碳青霉烯类鲍曼不动杆菌中金属β-内酰胺酶的全球和区域流行情况：一项系统综述和荟萃分析
Stamatis Karakonstantis and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag037, https://doi.org/10.1093/jac/dkag037
Original Research（论著）
6
The effect of oral ciprofloxacin at conventional doses on the QT interval in a tertiary outpatient setting
三级门诊常规剂量口服环丙沙星对患者QT间期的影响
Weber Liu and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag020, https://doi.org/10.1093/jac/dkag020
7
Bictegravir concentrations in breastmilk of healthy, lactating women without HIV
未感染人类免疫缺陷病毒（HIV）的健康哺乳期女性乳汁中的比克替拉韦浓度
L C van der Wekken-Pas and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag022, https://doi.org/10.1093/jac/dkag022
8
Management and outcomes of Stenotrophomonas maltophilia recovered from deep-site clinical specimens: a bicentric retrospective cohort study
从深部部位临床标本中分离出的嗜麦芽窄食单胞菌的治疗及转归：一项双中心回顾性队列研究
Anastasia Saade and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag021, https://doi.org/10.1093/jac/dkag021
9
Development of a risk prediction model for vancomycin-associated acute kidney injury: a multicentre retrospective study
万古霉素相关急性肾损伤风险预测模型的建立：一项多中心回顾性研究
Tomoyuki Ishigo and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag012, https://doi.org/10.1093/jac/dkag012
10
Cooperation between HIV-1 integrase natural polymorphism K156N and 3′PPT mutations in dolutegravir monotherapy failure
HIV-1 整合酶天然多态性 K156N 与 3′PPT 突变在多替拉韦单药治疗失败中的协同作用
Jolieke A T van Osch and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag033, https://doi.org/10.1093/jac/dkag033
11
Impact of body mass index and serum albumin levels on isavuconazole plasma concentrations in patients with haematological malignancies
体重指数和血清白蛋白水平对血液系统恶性肿瘤患者艾沙康唑血浆浓度的影响
Jie Gao and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag032, https://doi.org/10.1093/jac/dkag032
12
Pharmacokinetics of cefotaxime and its metabolite desacetyl-cefotaxime to optimize dosing in critically ill children and children with sickle cell disease
用以优化危重症儿童和镰状细胞病儿童给药剂量的头孢噻肟及其代谢产物去乙酰头孢噻肟的药代动力学研究
Seef Abdalla and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag019, https://doi.org/10.1093/jac/dkag019
13
Summary of ceftriaxone-resistant Neisseria gonorrhoeae in Canada, 2017–24
2017 - 2024年加拿大头孢曲松耐药淋病奈瑟菌情况汇总
Robyn Thorington and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag007, https://doi.org/10.1093/jac/dkag007
14
Improving perioperative prophylactic antibiotic prescribing using a novel decision-support tool
使用新型决策支持工具改进围手术期预防性抗生素处方
Mark Mcintyre and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag015, https://doi.org/10.1093/jac/dkag015
15
Comparative activity of established versus new-generation β-lactams against AmpC-hyperproducing clinical isolates of Enterobacter cloacae complex and Klebsiella aerogenes: a multicentre study
针对产超广谱AmpC酶的阴沟肠杆菌复合群和产气克雷伯菌临床分离株，比较已上市与新一代β-内酰胺类抗生素的抗菌活性：一项多中心研究
Ángel Rodríguez-Villodres and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag034, https://doi.org/10.1093/jac/dkag034
16
Impact of eravacycline on fibrinogen
依拉环素对纤维蛋白原的影响
Emily Stevenson and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag030, https://doi.org/10.1093/jac/dkag030
17
Biliary pharmacokinetic/pharmacodynamic analysis of continuous infusion ceftazidime–avibactam in a case series of orthotopic liver transplant recipients
原位肝移植受者连续输注头孢他啶-阿维巴坦的药代动力学/药效学胆系分析：一项病例系列研究
Milo Gatti and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag009, https://doi.org/10.1093/jac/dkag009
18
Autoaggregation-associated carbapenem tolerance mediated by mrkH inactivation identified from a cohort of Klebsiella pneumoniae species complex clinical isolates
从肺炎克雷伯菌复合群临床分离株队列中鉴定出由mrkH失活介导的与自动聚集相关的碳青霉烯耐受性
Natsuki Yamanaka and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag017, https://doi.org/10.1093/jac/dkag017
19
In vitro activity of double and triple antimicrobial combinations against carbapenem-resistant Pseudomonas aeruginosa biofilm
双联和三联抗菌药物组合对碳青霉烯耐药铜绿假单胞菌生物膜的体外活性研究
Si-Ho Kim and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag031, https://doi.org/10.1093/jac/dkag031
20
LYSC98 as a novel vancomycin-derived agent effective against antibiotic-resistant pathogens in tolerant state
LYSC98作为一种新型万古霉素衍生物，对耐受状态下的耐药病原体有效
Xing Xia and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag036, https://doi.org/10.1093/jac/dkag036
21
HBV status modulates transaminase decrease after switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV
HIV感染者从富马酸替诺福韦二吡呋酯切换为丙酚替诺福韦后，HBV状态对转氨酶下降的调节作用
Giuseppe Lapadula and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag045, https://doi.org/10.1093/jac/dkag045
22
Pharmacokinetics of colistin in adult critically ill patients in South Africa
南非成人危重症患者中多黏菌素的药代动力学研究
Veshni Pillay-Fuentes Lorente and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag011, https://doi.org/10.1093/jac/dkag011
23
Antifungal susceptibility surveillance of clinical moulds to olorofim, manogepix, amphotericin B, triazoles and echinocandins at 10 tertiary hospitals in China (2019–24)
2019 - 2024年中国10家三级医院临床霉菌对奥罗芬净、马诺盖匹克斯、两性霉素B、三唑类和棘白菌素类抗真菌药的敏感性监测
Su Chen and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag016, https://doi.org/10.1093/jac/dkag016
24
Short-cycle three-day-per-week efavirenz/emtricitabine/tenofovir disoproxil fumarate therapy: a seven-year extension study
短周期每周三日依非韦伦/恩曲他滨/富马酸替诺福韦二吡呋酯疗法：一项为期七年的延长研究
Beatriz Borjabad and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag040, https://doi.org/10.1093/jac/dkag040
25
Risk of hypertension in people with HIV in the USA initiating modern antiretroviral regimens: pooled analysis of blood pressure data from five clinical trials
美国感染HIV者启动现代抗逆转录病毒治疗方案后患高血压的风险：五项临床试验血压数据汇总分析
Priscilla Y Hsue and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag005, https://doi.org/10.1093/jac/dkag005
26
Real-world drug monitoring of dalbavancin using a three-dose regimen of 1500mg at days 1, 15 and 43 in bone and joint or cardiovascular infection
采用第1、15和43天各1500毫克的三剂量方案对达巴万星（Dalbavancin）在骨关节或心血管感染治疗中的实际药物监测研究
Thomas Lin and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag039, https://doi.org/10.1093/jac/dkag039
27
Nationwide patterns of HIV drug resistance and high viral load in Sub-Saharan African countries
撒哈拉以南非洲国家全国范围内的HIV耐药及高病毒载量模式
Abubaker Ibrahim Elbur and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkaf497, https://doi.org/10.1093/jac/dkaf497
28
Risk factors for suboptimal target attainment of commonly used ß-lactam antibiotics in older adults: a prospective cohort study
老年人常用β-内酰胺类抗生素未达最佳治疗目标的风险因素：一项前瞻性队列研究
Arnaud De Clercq and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag048, https://doi.org/10.1093/jac/dkag048
29
Physiologically based pharmacokinetic modelling to optimize dosing regimen of biapenem in renal impairment and elderly populations
基于生理的药代动力学模型优化肾功能不全及老年人群比阿培南给药方案
Wenyan Li and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkaf499, https://doi.org/10.1093/jac/dkaf499
30
Early targeted therapy guided by rapid phenotypic antimicrobial susceptibility testing in critically ill patients with Gram-negative bacterial bloodstream infections: a retrospective cohort study
快速表型抗菌药物敏感性试验指导下的早期目标性治疗对革兰氏阴性菌血流感染危重患者的效果：一项回顾性队列研究
Salvatore Rotundo and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag056, https://doi.org/10.1093/jac/dkag056
31
Impact of COVID-19-related healthcare changes on antibiotic resistance in clinical Escherichia coli isolates: interrupted time series analyses in Scotland, UK
与新冠肺炎相关的医疗变化对英国苏格兰地区临床大肠杆菌分离株抗生素耐药性的影响：中断时间序列分析
Laura Ciaccio and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag049, https://doi.org/10.1093/jac/dkag049
32
Multicentre evaluation of teicoplanin prescribing and monitoring in the UK and Ireland: the TUcK–SHOP study
英国和爱尔兰替考拉宁处方与监测的多中心评估：TUcK–SHOP研究
Stephen Hughes and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag038, https://doi.org/10.1093/jac/dkag038
33
Diabetes and risk of significant fibrosis in adults with HIV and metabolic dysfunction-associated steatotic liver disease: a prospective cohort study
糖尿病与HIV合并代谢功能障碍相关脂肪性肝病成人患者发生显著肝纤维化的风险：一项前瞻性队列研究
Win Min Han and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag053, https://doi.org/10.1093/jac/dkag053
34
A pharmacovigilance analysis of carbapenem-related utilizing the FDA adverse event reporting system (FAERS) database from 2013 to 2025
基于美国食品药品监督管理局不良事件报告系统（FAERS）数据库2013 - 2025年数据的碳青霉烯类相关药物警戒分析
Connor Frey and Parham Elmi
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag060, https://doi.org/10.1093/jac/dkag060
35
Effects of extracorporeal membrane oxygenation on the pharmacokinetics and tissue penetration rates of vancomycin and linezolid: data from Landrace pigs
体外膜肺氧合对万古霉素和利奈唑胺药代动力学及组织穿透率的影响：来自长白猪的数据
Huifang Zhang and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag063, https://doi.org/10.1093/jac/dkag063
36
Switching to bictegravir/emtricitabine/tenofovir alafenamide in people with HIV and prior resistance mutations. Data from the Italian ARCA cohort: the BIC-BARRIER study. B/F/TAF switch: mutations and outcomes
在既往存在耐药突变的人类免疫缺陷病毒（HIV）感染者中换用比克替拉韦/恩曲他滨/丙酚替诺福韦治疗。来自意大利ARCA队列的数据：BIC-BARRIER研究。比克替拉韦/恩曲他滨/丙酚替诺福韦（B/F/TAF）换药方案：耐药突变与治疗结果
Laura Pezzati and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag035, https://doi.org/10.1093/jac/dkag035
37
A two-stage diagnostic model for discriminating and assessing risk of meropenem heteroresistance in Pseudomonas aeruginosa
用于鉴别和评估铜绿假单胞菌对美罗培南异质性耐药风险的二阶段诊断模型
Yali Fan and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag061, https://doi.org/10.1093/jac/dkag061
38
Microdialysis assessment of gentamicin for second-line antimicrobial prophylaxis in abdominal surgery
微透析评估庆大霉素在腹部手术中作为二线抗菌预防药物的效果
Quentin Saint-Genis and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag071, https://doi.org/10.1093/jac/dkag071
39
Genetic and clinical predictors of voriconazole pharmacokinetics and hepatotoxicity: focused on CYP2C19 normal and intermediate metabolizers
伏立康唑药代动力学及肝毒性的遗传和临床预测因素：聚焦于CYP2C19正常代谢型和中间代谢型
Hui Li and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag065, https://doi.org/10.1093/jac/dkag065
40
Stakeholder perspectives on the offer and acceptance of self-administration of outpatient parenteral antimicrobial therapy: a qualitative study
利益相关者对提供和接受门诊患者自行注射抗菌药物治疗的看法：一项定性研究
Hester H Stoorvogel and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag068, https://doi.org/10.1093/jac/dkag068
41
Is current guidance for cloxacillin prophylaxis dosages in hip and knee arthroplasty adequate? Evidence from a prospective Swedish cohort
当前髋关节和膝关节置换术中氯唑西林预防性用药剂量指南是否充分？来自一项前瞻性瑞典队列研究的证据
Katja Wallander and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag067, https://doi.org/10.1093/jac/dkag067
42
Effect of pretreatment HIV drug resistance on mortality, attrition and viral suppression in patients initiating antiretroviral therapy and genetic transmission network: an observational cohort study in Southwest China
治疗前HIV药物耐药性对开始接受抗逆转录病毒治疗患者的死亡率、失访率和病毒抑制率的影响以及遗传传播网络：中国西南地区一项观察性队列研究
Litai Qin and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag073, https://doi.org/10.1093/jac/dkag073
RESEARCH LETTER（研究快讯）
43
Varicella and varicella zoster virus meningoencephalitis in a diffuse large B-cell lymphoma patient after chimeric antigen receptor-T-cell therapy
嵌合抗原受体T细胞疗法后，弥漫性大B细胞淋巴瘤患者发生水痘及水痘-带状疱疹病毒脑膜脑炎
Yan Feng and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag041, https://doi.org/10.1093/jac/dkag041
44
The ‘double hit’ on dalbavancin pharmacokinetics: hypertriglyceridaemia and augmented renal clearance in a child with glycogen storage disease type Ib
糖原累积病Ib型患儿中，高甘油三酯血症和肾清除率增加对达巴万星药代动力学的“双重打击”
Bianca Monti and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag028, https://doi.org/10.1093/jac/dkag028
45
Tn7860, a novel chromosomal pseudo-compound transposon carrying the OptrA gene in Enterococcus faecalis
Tn7860，粪肠球菌中携带OptrA基因的一种新型染色体假复合转座子
Francesca Romana Massacci and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag046, https://doi.org/10.1093/jac/dkag046
46
HBV reactivation after switching to cabotegravir plus rilpivirine therapy among people living with HIV: do not forget the reservoir
HIV感染者换用卡博特韦（cabotegravir）联合利匹韦林（rilpivirine）治疗后乙肝病毒再激活：切勿忽视病毒储存库
Rémi Rouget and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag050, https://doi.org/10.1093/jac/dkag050
47
An inoperable mediastinal infection involving vascular graft treated with weekly oritavancin as chronic suppressive therapy. A case report with pharmacokinetic data
一例涉及血管移植物的无法手术的纵隔感染，采用每周一次的奥利万星作为慢性抑制疗法。附药代动力学数据的病例报告
Pierangelo Chinello and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag013, https://doi.org/10.1093/jac/dkag013
48
Evaluation of the Carbapenemase Detection Kit (Colloidal Gold; Macro & Micro Test): a new immunochromatographic assay for rapid detection of carbapenemases in Enterobacterales
碳青霉烯酶检测试剂盒（胶体金法；宏基因与微基因检测法）评估：一种用于快速检测肠杆菌目细菌中碳青霉烯酶的新型免疫层析法
Hippolyte De Swardt and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag066, https://doi.org/10.1093/jac/dkag066
49
Cefalexin use in UK acute pyelonephritis practice: unaddressed challenges in dosing, breakpoints and clinical evidence
头孢氨苄在英国急性肾盂肾炎治疗中的应用：给药、断点和临床证据方面尚未解决的挑战
Stephen Hughes and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag051, https://doi.org/10.1093/jac/dkag051
LETTERS TO THE EDITOR（致编辑的信）
50
Comment on: Antimicrobial use for the treatment of bacterial sexually transmitted infections among doxycycline post-exposure prophylaxis (DoxyPEP) users in Milan, Italy
评论：意大利米兰多西环素暴露后预防（DoxyPEP）使用者中用于治疗细菌性性传播感染的抗菌药物使用情况
Chris Kenyon
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag025, https://doi.org/10.1093/jac/dkag025
51
Possible increased risk of Epstein–Barr virus (EBV) infection and post-transplant lymphoproliferative disease (PTLD) in letermovir-exposed haematopoietic cell transplantation recipients: right-to-reply
来特莫韦暴露的造血细胞移植受者发生EB病毒（EBV）感染和移植后淋巴增殖性疾病（PTLD）的风险可能增加：答复权
Jose F Camargo and Anthony D Anderson
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag043, https://doi.org/10.1093/jac/dkag043
52
Antimicrobial use for the treatment of bacterial sexually transmitted infections among doxycycline post-exposure prophylaxis (DoxyPEP) users in Milan, Italy—right-to-reply
意大利米兰市使用多西环素暴露后预防（DoxyPEP）人群中，用于治疗细菌性性传播感染的抗菌药物使用情况——答复权声明
Angelo Roberto Raccagni and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag026, https://doi.org/10.1093/jac/dkag026
53
Comment on: Artificial intelligence for improving decision-making in bacterial infection management
述评：人工智能在细菌感染管理决策中的优化作用
Daniele Roberto Giacobbe
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag078, https://doi.org/10.1093/jac/dkag078
CORRECTION（更正）
54
Correction to: Bayesian estimation of the prevalence of antimicrobial resistance: a mathematical modelling study
更正：抗菌药物耐药性流行率的贝叶斯估计：一项数学建模研究
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkaf494, https://doi.org/10.1093/jac/dkaf494
55
Correction to: National representative survey of pretreatment HIV drug resistance in Colombia: analysis of antiretroviral resistance-associated mutations using next-generation sequencing
更正：哥伦比亚具有全国代表性的治疗前HIV耐药性调查：使用下一代测序技术分析抗逆转录病毒耐药相关突变
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 3, March 2026, dkag057, https://doi.org/10.1093/jac/dkag057
Journal of Antimicrobial Chemotherapy Volume 81, Issue 4抗菌化疗杂志81卷 4期
https://academic.oup.com/jac/issue
50TH ANNIVERSARY COLLECTION（50周年纪念合集）
GARROD LECTURE（加罗德讲座）
1
Garrod lecture: achieving the UNGA AMR mortality reduction goals
加罗德讲座：实现联合国大会抗菌药物耐药性死亡率降低目标
Ramanan Laxminarayan
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag082, https://doi.org/10.1093/jac/dkag082
REVIEW（综述）
2
25 years of improvement in mortality in invasive aspergillosis in haematology patients: will it be sustained or is it under threat?
侵袭性曲霉病血液病患者25年死亡率改善情况：这种改善能否持续，还是正受到威胁？
Johan A Maertens and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag077, https://doi.org/10.1093/jac/dkag077
3
A strategic discovery roadmap towards high-quality leads and drug development candidates for kinetoplastid diseases. Part 2: from molecule to confirmed hit
针对锥虫病的从高质量潜在客户和药物开发候选者出发的战略发现路线图。第二部分：从分子到确证活性分子
Sarah Hendrickx and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag110, https://doi.org/10.1093/jac/dkag110
VIRTUAL ROUNDTABLE（虚拟圆桌会议）
4
Diagnosis and risk factors for invasive mould disease—a round table discussion on directing antifungal therapy according to the available evidence
侵袭性霉菌病的诊断与危险因素——根据现有证据指导抗真菌治疗的圆桌讨论
Ana Alastruey-Izqueirdo and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag062, https://doi.org/10.1093/jac/dkag062
EDITORIALS, MESSAGES FROM THE OUTGOING AND INCOMING EDITORS-IN-CHIEF（社论、离任与就任主编寄语）
5
Message from the incoming Editor-in-Chief of JAC
《抗菌化疗杂志》就任主编寄语
Monica A Slavin
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkaf479, https://doi.org/10.1093/jac/dkaf479
6
Message from the outgoing Editor-in-Chief
离任主编寄语
J Peter Donnelly
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkaf480, https://doi.org/10.1093/jac/dkaf480
REVIEW（综述）
7
Experimental biofilm models for pharmacokinetic and pharmacodynamic investigations: bridging in vitro, ex vivo and in vivo systems
用于药代动力学和药效学研究的实验性生物膜模型：连接体外、离体和体内系统
Stephanie Supparitsch and Markus Zeitlinger
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag091, https://doi.org/10.1093/jac/dkag091
8
Antimicrobial therapy for infected necrotizing pancreatitis: microbiology, antimicrobial resistance and pharmacokinetics
感染性坏死性胰腺炎的抗菌治疗：微生物学、抗菌药物耐药性及药代动力学
Hannah S Pauw and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag092, https://doi.org/10.1093/jac/dkag092
9
Continuous linezolid infusion: the new way to dose, the old risks to fear
持续输注利奈唑胺：新的给药方式，仍需警惕旧有风险
Daniel Muñoz-Pichuante and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag100, https://doi.org/10.1093/jac/dkag100
10
Alignment of national standard treatment guidelines with WHO AWaRe recommendations for adult primary care infectious diseases: implications for antimicrobial stewardship
将国家标准治疗指南与世卫组织（WHO）针对成人初级保健传染病的“慎用、监测、备用”（AWaRe）推荐意见相统一：对抗菌药物管理的影响
Huda Arooj and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag099, https://doi.org/10.1093/jac/dkag099
SYSTEMATIC REVIEW（系统综述）
11
Healthcare providers’ experiences in caring for MDRO carriers with a focus on the moral dimensions of care: a systematic review
医疗服务提供者护理多重耐药菌（MDRO）携带者的经历——聚焦护理中的道德维度：一项系统综述
Carlijn Damsté and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag059, https://doi.org/10.1093/jac/dkag059
12
Extrapolation of oritavancin PK/PD targets to inform therapeutic drug monitoring: a systematic review
奥利他万星药代动力学/药效学目标的外推用以指导治疗药物监测：一项系统综述
Giammarco Baiardi and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag117, https://doi.org/10.1093/jac/dkag117
ORIGINAL RESEARCH（论著）
13
Beyond plasma: defining the translation value of epithelial lining fluid exposure profiles for the treatment of pneumonia
超越血浆：明确上皮衬里液暴露谱对肺炎治疗的转化价值
Yakun Fu and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkaf458, https://doi.org/10.1093/jac/dkaf458
14
Impact of loading dose β-lactam therapy on outcomes of KPC-producing Klebsiella pneumoniae bloodstream infections in non-ICU patients: a real world study
负荷剂量β-内酰胺类药物治疗非重症监护病房患者产KPC肺炎克雷伯菌血流感染的疗效影响：一项现实研究
Luisa Frallonardo and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag087, https://doi.org/10.1093/jac/dkag087
15
Rezafungin exhibits anti-biofilm properties against fungal biofilms in vitro
雷扎芬净在体外对真菌生物膜表现出抗生物膜特性
Hafsa Abduljalil and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag058, https://doi.org/10.1093/jac/dkag058
16
Vancomycin resistance predicts increased mortality in patients with Enterococcus faecium bloodstream infections: a six-year experience at a large tertiary care Italian hospital
万古霉素耐药性可预测屎肠球菌血流感染患者死亡率增加：意大利一家大型三级医院六年来的经验
Lucia Graziani and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag069, https://doi.org/10.1093/jac/dkag069
17
Fluoroquinolones and the risk of panic attacks: a systematic review and disproportionality analysis using individual case safety reports from the FDA Adverse Event Reporting System (FAERS) database
氟喹诺酮类药物与惊恐发作风险：基于美国食品药品监督管理局不良事件报告系统（FAERS）数据库中个体病例安全报告的系统综述和比例失衡分析
Keeirah Hiertika Raguram and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag083, https://doi.org/10.1093/jac/dkag083
18
Cefuroxime concentrations in facial artery musculomucosal flap, buccal submucosa, subcutaneous tissue, and plasma following bolus or continuous infusion in patients undergoing oral cancer resection: a randomized clinical microdialysis study
在接受口腔癌切除术的患者中，采用随机临床微透析研究，探究头孢呋辛在面动脉肌黏膜瓣、颊黏膜下层、皮下组织和血浆中的浓度（团注或持续输注后）
Johanne Ravn Hansen and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag085, https://doi.org/10.1093/jac/dkag085
19
Infection point of care tests bridge the experience gap of antibiotic STOP decisions: clinicians versus students
感染即时检测可弥补抗生素停药决策方面的经验差距：临床医生与学生对比
Archit Singhal and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkaf486, https://doi.org/10.1093/jac/dkaf486
20
Functional analysis of a novel macrolide–lincosamide resistance gene erm(57) in Cutibacterium avidum
痤疮丙酸杆菌中一种新型大环内酯 - 林可酰胺类耐药基因erm(57)的功能分析
Juri Koizumi and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag029, https://doi.org/10.1093/jac/dkag029
21
HIV drug resistance amongst children and adolescents with viraemia in Lesotho and Tanzania: a nested analysis in the GIVE MOVE trial
莱索托和坦桑尼亚病毒血症儿童及青少年中的HIV耐药性：GIVE MOVE试验的嵌套分析
Christof Manuel Schönenberger and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag070, https://doi.org/10.1093/jac/dkag070
22
Identification and assessment of paediatric cefepime-induced neurotoxicity in a retrospective cohort of paediatric intensive care patients
在儿科重症监护患者回顾性队列中识别和评估儿科头孢吡肟诱导的神经毒性
Kathryn Pavia and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag075, https://doi.org/10.1093/jac/dkag075
23
Prioritization of adverse events related to integrase inhibitors and NNRTIs: a disproportionality analysis using data from the FAERS database
整合酶抑制剂和非核苷类逆转录酶抑制剂相关不良事件的优先级排序：基于FAERS数据库数据的比例失衡分析
Gao-yang Wang and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag074, https://doi.org/10.1093/jac/dkag074
24
Clinical and immunovirological status in children, adolescents and young adults with early-life-acquired HIV: a Spanish multi-cohort analysis since 2020
自2020年以来西班牙多队列分析中，儿童、青少年及青年时期感染HIV者的临床及免疫病毒学状态
Laura Tarancon-Diez and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag079, https://doi.org/10.1093/jac/dkag079
25
Population pharmacokinetics of meropenem in critically ill adult patients receiving extracorporeal membrane oxygenation—an ASAP ECMO study
接受体外膜肺氧合治疗的危重成年患者美罗培南的群体药代动力学——一项ASAP ECMO研究
Mohd H Abdul–Aziz and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag090, https://doi.org/10.1093/jac/dkag090
26
Evaluation of HIV-1 transmitted drug-resistance among subtypes circulating from 2022 to 2024 in Italy: a refined analysis through next-generation sequencing
2022年至2024年意大利流行HIV-1亚型间传播耐药性的评估：通过下一代测序技术进行的精细分析
Daniele Armenia and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag084, https://doi.org/10.1093/jac/dkag084
27
Characterization of efflux pump channel of florfenicol for resistance-enhancing variant RE-CmeABC in Campylobacter
耐药增强型变异体RE-CmeABC中氟苯尼考外排泵通道在弯曲菌中的特性研究
Hong Yao and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag047, https://doi.org/10.1093/jac/dkag047
28
Genomic characterization of colistin heteroresistance in Acinetobacter baumannii: Evidence for lpxD deletion and collateral sensitivity
鲍曼不动杆菌中黏菌素异质性耐药的基因组特征：lpxD缺失及附带敏感性的证据
Banu Sancak and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag076, https://doi.org/10.1093/jac/dkag076
29
Sustaining stewardship: longitudinal evaluation of an integrated antimicrobial programme in the ICU
持续管理：重症监护室（ICU）综合抗菌药物管理项目的纵向评估
Ashmitha Thomas and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag086, https://doi.org/10.1093/jac/dkag086
30
Global dissemination of optrA-mediated linezolid resistance in enterococci
利奈唑胺耐药性基因optrA介导的肠球菌在全球的传播
Jia Qi Beh and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag089, https://doi.org/10.1093/jac/dkag089
31
Predicting oral cephalosporin susceptibility in Escherichia coli blood isolates using parenteral cephalosporin susceptibility testing
利用肠外头孢菌素敏感性试验预测大肠杆菌血培养分离株对口服头孢菌素的敏感性
Tho H Pham and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag093, https://doi.org/10.1093/jac/dkag093
32
The pharmacodynamics of polymyxin B in Acinetobacter baumannii in murine thigh and lung infection models
在小鼠大腿和肺部感染模型中多粘菌素B对鲍曼不动杆菌的药效动力学研究
Sanne van den Berg and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag097, https://doi.org/10.1093/jac/dkag097
33
Genomic insights into the tmexCD-toprJ: plasmid-mediated evolution, dissemination and diversity in bacterial populations
关于tmexCD-toprJ的基因组见解：质粒介导的细菌群体进化、传播与多样性
Lilan Wan and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag107, https://doi.org/10.1093/jac/dkag107
34
Baseline resistance mutations and virological response to dolutegravir in treatment-naïve patients: a multicentre NGS study
初治患者基线耐药突变与多替拉韦病毒学应答：一项多中心下一代测序（NGS）研究
Alexy Inciarte and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag080, https://doi.org/10.1093/jac/dkag080
35
Novel integrase mutations linked to genotypic DTG resistance in African non-B HIV-1 strains: the DTG RESIST study
非洲非B型HIV-1毒株中与多替拉韦（DTG）基因型耐药相关的新型整合酶突变：DTG耐药研究
Nuri Han and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag088, https://doi.org/10.1093/jac/dkag088
36
Pharmacological evaluation of an ex vivo cervicovaginal HIV prevention model
体外宫颈阴道HIV预防模型的药理学评估
Lindsey B Collins and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag103, https://doi.org/10.1093/jac/dkag103
37
The magnitude of the pharmacodynamic index for NOSO-502: pathogen clearance, emergence of resistance and human dose predictions
NOSO-502药效学指数的幅度：病原体清除、耐药性出现和人体剂量预测
Sanne van den Berg and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag106, https://doi.org/10.1093/jac/dkag106
38
Temocillin: a therapeutic alternative in bone and joint infections due to third generation cephalosporin-resistant Enterobacterales?
替莫西林：治疗第三代头孢菌素耐药肠杆菌目引起的骨关节感染的一种替代疗法？
Louise Piquart and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag105, https://doi.org/10.1093/jac/dkag105
39
Metallo-β-lactamase–producing Enterobacterales: cyanide-containing efflux pump inhibitors as potential dual-activity inhibitors
产金属β-内酰胺酶的肠杆菌科细菌：含氰化物的外排泵抑制剂作为潜在的双活性抑制剂
Otávio Hallal Ferreira Raro and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag122, https://doi.org/10.1093/jac/dkag122
40
Outer membrane vesicles transmit blaNDM-5 and package metallo-β-lactamases to promote antibiotic resistance in Escherichia coli
外膜囊泡传递blaNDM-5并包装金属β-内酰胺酶以促进大肠杆菌的抗生素耐药性
Ting-Yin Lu and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag123, https://doi.org/10.1093/jac/dkag123
41
Characterization of a ST412-K57 colistin-resistant hypervirulent Klebsiella pneumoniae strain of chicken origin
一株鸡源ST412-K57多粘菌素耐药高毒力肺炎克雷伯菌的特征分析
Qiu Xu and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag114, https://doi.org/10.1093/jac/dkag114
42
Olorofim in combination with azole antifungals: results from the Phase 2 salvage therapy study
奥罗芬明与唑类抗真菌药联合使用：2期挽救治疗研究结果
Johan Maertens and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag118, https://doi.org/10.1093/jac/dkag118
RESEARCH LETTER（研究快讯）
43
Infant HIV transmission despite maternal viral suppression: a case of post-weaning seroconversion
母体病毒得到抑制，婴儿仍发生HIV传播：一例断奶后血清转阳病例
Shadia Nakalema and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag072, https://doi.org/10.1093/jac/dkag072
44
Urinary antigen–negative Legionella pneumonia in critically ill patients: value of systematic molecular testing for optimal antimicrobial therapy
危重患者中尿抗原阴性军团菌肺炎：系统分子检测在优化抗菌治疗中的价值
Livia Foglia Manzillo and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag101, https://doi.org/10.1093/jac/dkag101
45
Contribution of SHV-1 overexpression to carbapenem resistance in a Klebsiella pneumoniae clinical isolate
SHV-1过表达对某株肺炎克雷伯菌临床分离株碳青霉烯类抗生素耐药性的影响
Céline Plainvert and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag108, https://doi.org/10.1093/jac/dkag108
LETTER TO THE EDITOR（致编辑的信）
46
Comment on: Possible increased risk of Epstein–Barr virus (EBV) infection and posttransplant lymphoproliferative disease (PTLD) in letermovir-exposed haematopoietic cell transplantation recipients
评论：接受莱特莫韦治疗的造血细胞移植受者中，EB病毒（EBV）感染和移植后淋巴增殖性疾病（PTLD）的风险可能增加
Jan Styczynski
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag042, https://doi.org/10.1093/jac/dkag042
47
Comment on: Antimicrobial use for the treatment of bacterial sexually transmitted infections among doxycycline post-exposure prophylaxis users in Milan, Italy
评论：意大利米兰地区使用多西环素暴露后预防措施人群中针对细菌性性传播感染的抗菌药物使用情况
Luca Bortolani and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag023, https://doi.org/10.1093/jac/dkag023
48
Retrospective analysis of pharmacological therapeutic monitoring of caspofungin in patients undergoing continuous renal replacement therapy using polyacrylonitrile membranes—right to reply
使用聚丙烯腈膜进行连续肾脏替代治疗的患者中卡泊芬净药物治疗监测的回顾性分析——答复权
Antoine Hérault and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag095, https://doi.org/10.1093/jac/dkag095
49
Comment on: Temocillin versus other intravenous beta-lactams for urinary tract infections caused by third-generation cephalosporin-resistant Enterobacterales: a multicentre retrospective matched-cohort study
评论：替莫西林与其他静脉注射β-内酰胺类抗生素治疗第三代头孢菌素耐药肠杆菌目引起的尿路感染：一项多中心回顾性匹配队列研究
Shanshan Ru and Yingzhe Zhang
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag096, https://doi.org/10.1093/jac/dkag096
50
Comment on: Long-acting glycopeptides: what are the barriers to access in patients who need them most, and how can they be overcome?
评论：长效糖肽类抗生素：对于最需要它们的患者，获取的障碍是什么，如何克服？
Marco Bongiovanni
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag102, https://doi.org/10.1093/jac/dkag102
51
Comment on ‘Retrospective analysis of pharmacological therapeutic monitoring of caspofungin in patients undergoing continuous renal replacement therapy using polyacrylonitrile membranes’
评论：“对使用聚丙烯腈膜进行连续肾脏替代治疗的患者中卡泊芬净的药理学治疗监测的回顾性分析”
Julien Massol and Frédéric Baud
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag094, https://doi.org/10.1093/jac/dkag094
52
Comment on: ‘Epidemiology and treatment of endocarditis secondary to Enterobacterales other than Serratia spp’
对“除塞拉蒂亚属（Serratia spp）外肠杆菌目所致心内膜炎的流行病学和治疗”的评论
Gianpiero Tebano and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag098, https://doi.org/10.1093/jac/dkag098
53
‘Comparing serotype coverage of pneumococcal vaccines with PCV21 (V116), a new 21-valent conjugate pneumococcal vaccine, and the epidemiology of its eight unique Streptococcus pneumoniae serotypes (15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B) causing invasive pneumococcal disease in adult patients in Canada: SAVE study, 2018–2021-right-to-reply’
“比较肺炎球菌疫苗的血清型覆盖率——PCV21（V116，一种新型21价结合肺炎球菌疫苗）与加拿大成人患者中导致侵袭性肺炎球菌疾病的其8种独特肺炎链球菌血清型（15A、15C、16F、23A、23B、24F、31和35B）的流行病学：SAVE研究，2018 - 2021年——回应”
John J Schellenberg and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag126, https://doi.org/10.1093/jac/dkag126
54
Comment on: Antagonistic in vitro interaction between olorofim and voriconazole against Aspergillus fumigatus
评论：奥罗芬明与伏立康唑对烟曲霉的体外拮抗作用
Corinne Pinder and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag119, https://doi.org/10.1093/jac/dkag119
55
Epidemiology and treatment of endocarditis secondary to Enterobacterales other than Serratia spp.: right-to-reply
除塞氏杆菌属外肠杆菌科细菌所致心内膜炎的流行病学和治疗：回应
Sunish Shah and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 4, April 2026, dkag121, https://doi.org/10.1093/jac/dkag121
Journal of Antimicrobial Chemotherapy Volume 81, Issue 5抗菌化疗杂志81卷 5期
https://academic.oup.com/jac/issue
50TH ANNIVERSARY COLLECTION（50周年纪念合集）
REVIEW（综述）
1
A strategic discovery roadmap towards high-quality leads and drug development candidates for kinetoplastid diseases. Part 1: setting the stage
针对动基体病的高质量先导化合物及药物开发候选物的战略发现路线图。第一部分：背景介绍
Sarah Hendrickx and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag109, https://doi.org/10.1093/jac/dkag109
REVIEW（综述）
2
Pathophysiology, risk factors and clinical management for polymyxin-associated acute kidney injury
多粘菌素相关急性肾损伤的病理生理学、危险因素及临床治疗
Simiao Zhao and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag132, https://doi.org/10.1093/jac/dkag132
SYSTEMATIC REVIEW（系统综述）
3
Definitions and rates of treatment failure in females with uncomplicated urinary tract infection: a systematic literature review
女性单纯性尿路感染治疗失败的定义及发生率：一项系统文献综述
Meghan E Luck and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag112, https://doi.org/10.1093/jac/dkag112
4
Therapeutic drug monitoring and the role of pharmacokinetics/pharmacodynamics in optimizing beta-lactam antibiotic dosing for deep-seated infections: a systematic review
在针对深部感染的β-内酰胺类抗生素优化给药方案中治疗药物监测以及药代动力学/药效学的作用：一项系统综述
Cassandra Vale and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag142, https://doi.org/10.1093/jac/dkag142
ORIGINAL RESEARCH（论著）
5
Optimizing cloxacillin prophylaxis in hip and knee arthroplasty based on population pharmacokinetics of unbound plasma concentrations
基于游离血浆浓度群体药代动力学优化髋关节和膝关节置换术中的氯唑西林预防用药方案
Gustaf Beijer and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag116, https://doi.org/10.1093/jac/dkag116
6
The tissue distribution and pharmacokinetics of [14C]-olorofim following intravenous dosing in the rat
大鼠静脉注射[14C]奥洛罗芬后的组织分布及药代动力学研究
Derek Law and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag120, https://doi.org/10.1093/jac/dkag120
7
Insights from the WHO Tricycle-aligned Fleming Fund EQASIA External Quality Assessment (EQA) programme detecting ESBL-, AmpC- and carbapenemase-producing Escherichia coli in South and South-East Asia
世界卫生组织三轮车项目（Tricycle）协同的弗莱明基金南亚和东南亚地区外部质量评估（EQASIA EQA）计划在检测南亚和东南亚地区产超广谱β-内酰胺酶（ESBL）、AmpC酶和碳青霉烯酶的大肠埃希菌方面的见解
Hiba Al-Mir and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag129, https://doi.org/10.1093/jac/dkag129
8
The plasma and intracellular exposure of intramuscularly administered long-acting cabotegravir and rilpivirine in people with HIV
HIV感染者肌内注射长效卡博特韦和利匹韦林后的血浆及细胞内暴露情况
Micol Ferrara and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag113, https://doi.org/10.1093/jac/dkag113
9
In vitro synergistic activity of minocycline and biapenem against cefiderocol-resistant New Delhi metallo-β-lactamase-producing Enterobacterales
米诺环素与比阿培南在体外对产新德里金属β-内酰胺酶且对头孢地尔耐药的肠杆菌科细菌的协同作用
Takashi Okanda and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag128, https://doi.org/10.1093/jac/dkag128
10
Mortality risk of ESBL producers in Escherichia coli bacteraemia: a comprehensive analysis using the PROBAC cohort
产超广谱β-内酰胺酶大肠埃希菌菌血症的死亡风险：基于PROBAC队列的综合分析
Paula Olivares-Navarro and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag130, https://doi.org/10.1093/jac/dkag130
11
Molecular mechanism of envZ regulating β-lactam antibiotic resistance and virulence in Escherichia coli
EnvZ调控大肠埃希菌β-内酰胺类抗生素耐药性及毒力的分子机制
Kun Yang and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag104, https://doi.org/10.1093/jac/dkag104
12
In vitro activity of amoxicillin combined with oral cephalosporins against endocarditis-associated E. faecalis clinical isolates
阿莫西林联合口服头孢菌素针对心内膜炎相关粪肠球菌临床分离株的体外活性
David Luque Paz and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag127, https://doi.org/10.1093/jac/dkag127
13
Genome-wide association studies builds a predictive model and reveals novel resistance features for macrolide-resistant Bordetella pertussis
全基因组关联研究构建预测模型并揭示大环内酯类耐药百日咳鲍特菌的新耐药特征
Jialiang Chen and Guowei Liang
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag131, https://doi.org/10.1093/jac/dkag131
14
Real-world validation of a reduced-dose continuous infusion cefepime regimen: pharmacodynamic target attainment, efficacy and neurotoxicity
减量持续静脉输注头孢吡肟方案的实际应用验证：药效学目标达成情况、疗效及神经毒性
Kieffer Korvin and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag138, https://doi.org/10.1093/jac/dkag138
15
Cross-species and cross-border spread of aph(3′)-ia-mediated neomycin resistance in Escherichia coli from animals: a genomic perspective
从基因组角度研究动物源大肠杆菌中aph(3′)-ia介导的新霉素耐药性的跨物种和跨国传播
Mattia Pirolo and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag143, https://doi.org/10.1093/jac/dkag143
16
Prevalence of cyp51A variants in a US collection of Aspergillus fumigatus clinical isolates and comparative analysis of their contribution to triazole antifungal resistance
美国烟曲霉临床分离株集合中cyp51A变异体的流行情况及其对三唑类抗真菌药物耐药性作用的比较分析
Luisa Fernanda Gómez Londoño and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag124, https://doi.org/10.1093/jac/dkag124
17
In vitro and in vivo activity of daptomycin plus ceftaroline for the treatment of experimental endocarditis due to Enterococcus faecalis with and without high-level aminoglycoside resistance
达托霉素联合头孢洛林对高水平氨基糖苷类耐药及非耐药粪肠球菌所致实验性心内膜炎的体内外疗效研究
María-Alexandra Cañas and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag136, https://doi.org/10.1093/jac/dkag136
18
Pharmacokinetics of a three-dose regimen of intramuscular benzathine penicillin G in pregnant women with syphilis
三剂苄星青霉素G肌内注射方案在妊娠期梅毒患者中的药代动力学研究
Eshetie Melese Birru and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag145, https://doi.org/10.1093/jac/dkag145
19
Cefiderocol resistance mediated by mutation of the miniconductance mechanosensitive channel MscM in Klebsiella oxytoca
由产气克雷伯菌中微小电导机械敏感通道MscM发生突变所介导的头孢地尔耐药性
Pia Turowski and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag147, https://doi.org/10.1093/jac/dkag147
20
The veterinary clinic backyard lawn used for relief walks of hospitalized dogs is a hotspot for OXA-type carbapenemases in multiple Enterobacterales
兽医诊所后院供住院犬只散步的草坪是多种肠杆菌科细菌中OXA型碳青霉烯酶的传播热点区域
Yvonne Spahr and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag144, https://doi.org/10.1093/jac/dkag144
21
Pharmacokinetics of cefazolin in bariatric surgery patients: a preoperative perspective
头孢唑林在减肥手术患者中的药代动力学：术前视角
Alexandra Porlier and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag150, https://doi.org/10.1093/jac/dkag150
RESEARCH LETTERS（研究快讯）
22
Plasmid-encoded FRI-10 carbapenemase harboured by non-Enterobacter species isolated from a wastewater sample in Tokyo, Japan
从日本东京废水样本中分离出的非肠杆菌科物种携带质粒编码的FRI-10碳青霉烯酶
Kou Murakami and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag133, https://doi.org/10.1093/jac/dkag133
23
Synergistic activity of cefepime/enmetazobactam with meropenem, piperacillin, piperacillin/tazobactam, cefiderocol and fosfomycin against Klebsiella pneumoniae carrying blaKPC allelic variants
头孢吡肟/恩美唑巴坦与美罗培南、哌拉西林、哌拉西林/他唑巴坦、西他沙星和磷霉素针对携带blaKPC等位基因变体的肺炎克雷伯菌的协同作用
Alice Crema and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag141, https://doi.org/10.1093/jac/dkag141
24
MRSA and carbapenem-resistant Acinetobacter baumannii on the fall: successful infection prevention and control in Chilean ICUs
耐甲氧西林金黄色葡萄球菌和耐碳青霉烯类鲍曼不动杆菌数量下降：智利重症监护病房感染预防与控制的成功案例
Patricio Ross and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag146, https://doi.org/10.1093/jac/dkag146
LETTER TO THE EDITOR（致编辑的信）
25
Comment on: Model-based assessment of VRC07-523LS dosing in infants through population pharmacokinetic–pharmacodynamic modelling in adults and infants
评论：基于模型的评估VRC07-523LS在婴儿中的给药剂量——基于成人和婴儿群体药代动力学-药效学模型
Wanhua Qiu
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag139, https://doi.org/10.1093/jac/dkag139
26
Comment on: Comparing serotype coverage of pneumococcal vaccines with PCV21 (V116), a new 21-valent conjugate pneumococcal vaccine, and the epidemiology of its eight unique Streptococcus pneumoniae serotypes (15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B) causing invasive pneumococcal disease in adult patients in Canada: SAVE study, 2018–21
评论：比较含21种血清型的肺炎球菌疫苗PCV21（V116）（一种新型21价结合肺炎球菌疫苗）的血清型覆盖范围，以及2018 - 2021年SAVE研究中导致加拿大成年患者侵袭性肺炎球菌疾病的8种独特肺炎链球菌血清型（15A、15C、16F、23A、23B、24F、31和35B）的流行病学情况
Gokul Raj Pullagura and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag125, https://doi.org/10.1093/jac/dkag125
27
Comment on: Distinct population structure and genomic context of NarAB between broiler and human clinical Enterococcus isolates
评论：肉鸡源和人临床来源肠球菌分离株中NarAB的不同种群结构和基因组背景
Alex Wong
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag134, https://doi.org/10.1093/jac/dkag134
28
Distinct population structure and genomic context of narAB between broiler and human clinical Enterococcus isolates—authors’ response
肉鸡源和人临床来源肠球菌分离株中narAB的不同种群结构和基因组背景——作者回复
Jayanth Balakuntla and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 5, May 2026, dkag135, https://doi.org/10.1093/jac/dkag135
Journal of Antimicrobial Chemotherapy Volume 81, Issue 6抗菌化疗杂志81卷 6期
https://academic.oup.com/jac/issue
50TH ANNIVERSARY COLLECTION（50周年纪念合集）
REVIEW（综述）
1
A strategic discovery roadmap towards high-quality leads and drug development candidates for kinetoplastid diseases. Part 3: from lead towards a drug development candidate
针对动基体疾病高质量先导化合物和药物开发候选物的战略发现路线图。第三部分：从先导化合物到药物开发候选物
Sarah Hendrickx and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag111, https://doi.org/10.1093/jac/dkag111
ORIGINAL RESEARCH（原创研究）
2
Population pharmacokinetics and probability of target attainment of tigecycline in critically ill children
危重患儿中替加环素（Tigecycline）的群体药代动力学及目标达成概率研究
Wenjuan Hu and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag156, https://doi.org/10.1093/jac/dkag156
3
Phenotypic and genotypic characterization of HMB-3, a metallo-beta-lactamase from Pseudomonas asiatica
假单胞菌属亚洲种（Pseudomonas asiatica）中金属β-内酰胺酶HMB-3的表型和基因型特征
Jacqueline Findlay and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag148, https://doi.org/10.1093/jac/dkag148
4
Early adequate linezolid concentrations and clinical outcomes in confirmed Gram-positive infections: the role of therapeutic drug monitoring
确诊的革兰氏阳性菌感染中早期达到适宜利奈唑胺浓度与临床预后的关系：治疗药物监测的作用
Daniel Fresán and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag137, https://doi.org/10.1093/jac/dkag137
5
Monte Carlo simulations identify suboptimal PK/PD target attainment with standard maribavir dosing
蒙特卡洛模拟表明标准剂量马立巴韦的药动学/药效学靶标达成情况欠佳
Yeleen Fromage and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag153, https://doi.org/10.1093/jac/dkag153
6
Exploring the pharmacokinetic mechanisms that affect bictegravir exposure during pregnancy
探究妊娠期间影响比克替拉韦暴露的药代动力学机制
L van der Wekken-Pas and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag159, https://doi.org/10.1093/jac/dkag159
7
Artificial intelligence for analysing antibiotic use: an exploratory study in a tertiary care paediatric hospital in Italy
人工智能用于分析抗生素使用情况：意大利一家三级儿科医院的探索性研究
Elio Castagnola and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag162, https://doi.org/10.1093/jac/dkag162
8
Antimicrobial activity of aztreonam–avibactam against KPC variant-producing Klebsiella pneumoniae with ceftazidime–avibactam resistance
氨曲南-阿维巴坦对产KPC变异体且对头孢他啶-阿维巴坦耐药的肺炎克雷伯菌的抗菌活性
Jingchun Kong and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag152, https://doi.org/10.1093/jac/dkag152
9
Highly transformable Haemophilus influenzae as a potential amplifier of quinolone resistance dissemination
高转化型流感嗜血杆菌作为喹诺酮耐药性传播的潜在放大器
Takeaki Wajima and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag160, https://doi.org/10.1093/jac/dkag160
10
Comparative nephrotoxicity of polymyxin B versus colistin: evidence from ensemble learning and propensity score matching
多黏菌素B与黏菌素的肾毒性比较：来自集成学习和倾向评分匹配的证据
Murat Özdede and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag044, https://doi.org/10.1093/jac/dkag044
11
Emulating a target trial of early compared with late initiation of appropriate antibiotic therapy for hospital-acquired monobacterial Gram-negative bloodstream infections
模拟医院获得性单菌革兰氏阴性菌血流感染早期与晚期开始恰当抗生素治疗的对照试验
Abdullah T Aslan and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag161, https://doi.org/10.1093/jac/dkag161
12
Flufenamic acid resensitizes MRSA to gentamicin through synergistic ion modulation
氟苯尼考通过协同离子调节使MRSA对庆大霉素重新敏感
Xiaomin Ren and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag154, https://doi.org/10.1093/jac/dkag154
13
Description of OXA-244 carbapenemase-producing Escherichia coli in farm animals in The Netherlands, 2024
2024年荷兰农场动物中OXA-244碳青霉烯酶产大肠杆菌的描述
K T Veldman and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag155, https://doi.org/10.1093/jac/dkag155
14
Clinical outcomes of beta-bactam monotherapy versus beta-lactam plus azithromycin in hospitalized patients with community-acquired pneumoniae
β-内酰胺类单药治疗与β-内酰胺类联合阿奇霉素治疗社区获得性肺炎住院患者的临床预后比较
Ilona Zhygalova Zhygalova and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag158, https://doi.org/10.1093/jac/dkag158
15
‘Leaving no stones unturned’: up to 10 years results on the effectiveness, tolerability and metabolic safety of dolutegravir+lamivudine (DTG+3TC) as a switch regimen in the ODOACRE cohort
"不遗余力"：ODOACRE队列中多替拉韦+拉米夫定（DTG+3TC）作为转换方案长达10年的有效性、耐受性及代谢安全性结果
Arturo Ciccullo and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag172, https://doi.org/10.1093/jac/dkag172
16
Evaluation of a novel lateral flow immunochromatographic assay, Certest ResisCheck® Carbapenemases, for the rapid detection and differentiation of carbapenemase in Gram-negative bacteria from bacterial culture
新型侧向流免疫层析检测试剂Certest ResisCheck® Carbapenemases用于革兰氏阴性菌培养物中碳青霉烯酶快速检测与鉴别的评估
Laura Monge-Olivares and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag149, https://doi.org/10.1093/jac/dkag149
17
Temocillin efficacy and emergence of resistance in Enterobacter cloacae Complex in a murine peritonitis model
替莫西林对产气肠杆菌复合群的疗效及耐药性演变：小鼠腹膜炎模型研究
N Alanbari and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag151, https://doi.org/10.1093/jac/dkag151
18
Temporal association between aerosolized colistin use and colistin resistance in the ICU: a time-series analysis
ICU中雾化粘菌素使用与粘菌素耐药之间的时间关联：一项时间序列分析
Weechang Kang and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag169, https://doi.org/10.1093/jac/dkag169
19
Can antimicrobial stewardship programmes be implemented during an armed conflict? A retrospective interventional cohort study
武装冲突期间能否实施抗菌药物管理计划？一项回顾性干预性队列研究
Hailie D Uren and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag115, https://doi.org/10.1093/jac/dkag115
20
Voriconazole therapy and CYP2C19 phenotype: identifying patients who may need alternative antifungal therapy
伏立康唑治疗与CYP2C19表型：识别可能需要替代抗真菌治疗的患者
Eman Wehbe and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag168, https://doi.org/10.1093/jac/dkag168
21
Impact of cardiopulmonary bypass on cefuroxime plasma and interstitial tissue concentrations in patients undergoing cardiac bypass surgery—a prospective controlled clinical trial
体外循环对心脏旁路手术患者头孢呋辛血浆及组织间质浓度的影响——一项前瞻性对照临床试验
Stefanie Nothofer and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag171, https://doi.org/10.1093/jac/dkag171
22
Population pharmacokinetic analysis and dosing regimen optimization of eravacycline in critically ill patients with carbapenem-resistant Acinetobacter baumannii pneumonia
对碳青霉烯耐药鲍曼不动杆菌肺炎危重患者中埃拉环素的药代动力学分析及给药方案优化
Luqi Lou and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag178, https://doi.org/10.1093/jac/dkag178
23
Durability and mechanistic performance of aztreonam/avibactam versus aztreonam plus ceftazidime/avibactam against Stenotrophomonas maltophilia complex
氨曲南/阿维巴坦与氨曲南联合头孢他啶/阿维巴坦对抗嗜麦芽窄食单胞菌复合群的耐久性和机制性能比较
Ashlan J Kunz Coyne and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag177, https://doi.org/10.1093/jac/dkag177
24
High-dose daptomycin for the treatment of invasive infections due to Enterococcus faecalis isolates with intermediate susceptibility
高剂量达托霉素治疗粪肠球菌中介敏感株所致侵袭性感染的疗效
Sidney Drake and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag179, https://doi.org/10.1093/jac/dkag179
25
Updated mapping of Plasmodium falciparum kelch13 gene polymorphisms in Madagascar, 2024
2024年马达加斯加恶性疟原虫kelch13基因多态性的最新图谱更新
Camille Roesch and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag181, https://doi.org/10.1093/jac/dkag181
26
Efficacy of ceftazidime/avibactam against 10 clinical isolates of Pseudomonas aeruginosa in icodextrin-based peritoneal dialysis solution and patient-derived dialysate
头孢他啶/阿维巴坦针对icodextrin基腹膜透析液及患者来源透析液中10株铜绿假单胞菌临床分离株的抗菌活性
Stephanie Supparitsch and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag185, https://doi.org/10.1093/jac/dkag185
27
Cefiderocol activity against multidrug-resistant isolates from the PERSEUS study: relationship between cefiderocol minimum inhibitory concentration and clinical outcomes
头孢德罗对PERSEUS研究中多重耐药分离株的抗菌活性：头孢德罗最低抑菌浓度与临床预后之间的关系
Rafael Cantón and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag164, https://doi.org/10.1093/jac/dkag164
28
Class 1 DISARM system in restriction of conjugative carbapenemase-encoding plasmids in Klebsiella pneumoniae sequence type 23
1类DISARM系统对肺炎克雷伯菌ST23中接合型碳青霉烯酶编码质粒的限制作用
Qingqing Du and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag167, https://doi.org/10.1093/jac/dkag167
29
Acute kidney injury following amikacin therapy: a retrospective cohort study
阿米卡星治疗后急性肾损伤：一项回顾性队列研究
Iris Zohar and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag188, https://doi.org/10.1093/jac/dkag188
30
Performance of EUCAST disc diffusion and supplementary methods to detect reduced susceptibility to linezolid in enterococci— the NordicAST LRE-study
EUCAST纸片扩散法及补充方法检测肠球菌利奈唑胺低敏感性的表现——NordicAST LRE研究
Bjørg Christina Haldorsen and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag174, https://doi.org/10.1093/jac/dkag174
31
In vitro exposure to non-antipseudomonal antibiotics (NAPA) induces Pseudomonas aeruginosa resistance to antipseudomonal antibiotics (APA)
体外暴露于非抗假单胞菌抗生素（NAPA）可诱导铜绿假单胞菌对抗假单胞菌抗生素（APA）产生耐药性
David Lasry and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag182, https://doi.org/10.1093/jac/dkag182
32
Sub-inhibitory polyether ionophores enhance resistance plasmid transfer and transiently perturb the broiler gut resistome
亚抑制浓度的聚醚离子载体可促进耐药质粒转移并暂时扰乱肉鸡肠道耐药组
Jingyue Yang and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag190, https://doi.org/10.1093/jac/dkag190
33
Influence of a putative TonB-dependent receptor on cefiderocol susceptibility in clinical Enterobacter hormaechei isolates
推测的TonB依赖性受体对临床肠杆菌hormaechei分离株中头孢地尔敏感性的影响
Pia Turowski and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag193, https://doi.org/10.1093/jac/dkag193
RESEARCH LETTERS（研究快报）
34
Early bictegravir failure and emergence of R263K-mediated class-wide HIV integrase inhibitors resistance linked to over-the-counter supplement use
比克替拉韦早期治疗失败与R263K介导的与非处方补充剂使用相关的全类HIV整合酶抑制剂耐药的出现
Elisa Minacori and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag157, https://doi.org/10.1093/jac/dkag157
35
Environmental benefits of switching from intravenous to oral administration of ciprofloxacin
环丙沙星从静脉给药转换为口服给药的环境效益
Nicolas De Jaegher and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag163, https://doi.org/10.1093/jac/dkag163
36
Macrolide resistance via 23S rRNA gene mutation in Corynebacterium ulcerans
白喉棒状杆菌通过23S rRNA基因突变介导的大环内酯类耐药
Chiara Crestani and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag166, https://doi.org/10.1093/jac/dkag166
37
Prosthesis-associated Burkholderia cepacia complex infection managed with sequential directed therapy including ceftolozane/tazobactam
采用包括头孢妥仑/他唑巴坦在内的序贯导向疗法治疗假体相关洋葱伯克霍尔德菌复合感染
Elia Asensi-Díaz and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag165, https://doi.org/10.1093/jac/dkag165
38
Drug interactions and kidney safety of bictegravir/emtricitabine/tenofovir alafenamide in kidney transplant recipients with HIV: an interventional pilot study
比克替拉韦/恩曲他滨/丙酚替诺福韦在合并HIV的肾移植受者中的药物相互作用及肾脏安全性：一项干预性 pilot 研究
Thomas Stehlé and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag176, https://doi.org/10.1093/jac/dkag176
39
Harmonizing antimicrobial susceptibility testing: a comparison of CLSI and EUCAST categorizations
抗菌药物敏感性试验的协调：CLSI与EUCAST分类法的比较
Eric Farfour and Marie Lavollay
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag081, https://doi.org/10.1093/jac/dkag081
LETTER TO THE EDITOR（致编辑的信）
40
Comment on: Impact of loading dose β-lactam therapy on outcomes of KPC-producing Klebsiella pneumoniae bloodstream infections in non-ICU patients: a real world study
对"负荷剂量β-内酰胺类治疗对非ICU患者产KPC肺炎克雷伯菌血流感染结局的影响：一项现实研究"的评论
Xuefeng Yu
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag173, https://doi.org/10.1093/jac/dkag173
41
Comment on: ‘Cooperation between HIV-1 integrase natural polymorphism K156N and 3′PPT mutations in dolutegravir monotherapy failure’
评论："HIV-1整合酶天然多态性K156N与3′PPT突变在多替拉韦单药治疗失败中的协同作用"
Muhammad Ifham Hanif and Mentari Maratus Sholihah
Journal of Antimicrobial Chemotherapy, Volume 81, Issue 6, June 2026, dkag175, https://doi.org/10.1093/jac/dkag175
Journal of Antimicrobial Chemotherapy Volume 81, Issue Supplement_1抗菌化疗杂志81卷 增刊1期
https://academic.oup.com/jac/issue/81/Supplement_1?login=false
SUPPLEMENT（增刊）
Breaking Evidence and Insights into Effective Utilization and Implementation of Procalcitonin
降钙素原有效利用与实施的突破性证据与见解
VIRTUAL ROUNDTABLE（线上圆桌论坛）
1
Procalcitonin in the management of lower respiratory tract infection and sepsis
降钙素原在下呼吸道感染和脓毒症治疗中的应用
Ramy H Elshaboury and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue Supplement_1, June 2026, Pages i1–i5, https://doi.org/10.1093/jac/dkaf298
VIEWPOINT（观点）
2
Beyond the algorithm: reframing biomarker-guided antibiotic stewardship with behavioural insights
超越算法：以行为学见解重构生物标志物导向的抗菌药物管理
Patrycja Sleboda and others
Journal of Antimicrobial Chemotherapy, Volume 81, Issue Supplement_1, June 2026, Pages i6–i8, https://doi.org/10.1093/jac/dkag140
CORRECTION（更正）
3
Correction to: Procalcitonin in the management of lower respiratory tract infection and sepsis
更正：降钙素原在下呼吸道感染和脓毒症治疗中的应用
Journal of Antimicrobial Chemotherapy, Volume 81, Issue Supplement_1, June 2026, Page i9, https://doi.org/10.1093/jac/dkag170
100 项与 西加韦单抗/替沙格韦单抗 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 新型冠状病毒感染 | 美国 | 2021-12-08 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 冠状病毒感染 | 临床1期 | 美国 | 2021-11-30 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床1期 | - | 60 | 遞餘廠顧壓構壓獵鹽蓋(齋願觸淵獵廠醖範網選) = 衊鹹選網壓窪鑰選遞齋 製範艱蓋壓選簾顧遞淵 (壓齋鏇夢壓鏇壓遞壓鑰 ) 更多 | 积极 | 2025-11-01 | ||
Placebo | 遞餘廠顧壓構壓獵鹽蓋(齋願觸淵獵廠醖範網選) = 製襯蓋憲簾醖襯艱簾窪 製範艱蓋壓選簾顧遞淵 (壓齋鏇夢壓鏇壓遞壓鑰 ) | ||||||
临床1期 | 46 | AZD7442+AZD8895+AZD1061 (Cohort 1) | 繭鏇衊糧壓製餘齋築構(淵鬱鹹夢繭積觸積壓鏇) = 醖襯艱網獵餘衊醖選選 鏇窪膚艱憲衊衊淵夢選 (範齋壓夢淵鹹願襯齋廠, 72.72) 更多 | - | 2025-04-18 | ||
AZD7442+AZD8895+AZD1061 (Cohort 2) | 選顧廠窪鑰醖構觸廠淵(衊壓築糧夢憲窪鹽壓製) = 壓築選選憲遞齋廠壓齋 觸鏇顧鹹壓淵築鏇襯窪 (構範觸鑰遞艱鬱製衊獵, NA) 更多 | ||||||
临床1期 | 224 | 選製醖艱築鏇艱蓋繭選(夢積衊觸積繭選製襯衊) = 獵鏇糧選衊構簾鏇顧鑰 顧築淵鏇艱獵憲艱簾膚 (築構鏇積繭獵範獵繭餘, 43.12) 更多 | - | 2024-11-25 | |||
選製醖艱築鏇艱蓋繭選(夢積衊觸積繭選製襯衊) = 壓夢衊製獵網積鏇遞鏇 顧築淵鏇艱獵憲艱簾膚 (築構鏇積繭獵範獵繭餘, 38.96) 更多 | |||||||
临床2期 | 272 | (AZD7442) | 膚繭壓襯淵醖遞網顧蓋 = 繭窪鑰製網範衊獵網繭 積願遞網夢積廠蓋構鹹 (積獵鬱壓窪醖構觸鑰網, 艱願淵壓廠憲齋獵艱遞 ~ 廠壓鬱壓獵積鑰築窪構) 更多 | - | 2024-11-21 | ||
600mg placebo IV (Placebo) | 膚繭壓襯淵醖遞網顧蓋 = 鏇積觸鏇鏇鑰淵窪鹽繭 積願遞網夢積廠蓋構鹹 (積獵鬱壓窪醖構觸鑰網, 艱鏇積膚膚餘觸製繭鑰 ~ 蓋範醖鹽獵鑰窪醖齋觸) 更多 | ||||||
临床2期 | 251 | (AZD7442: 600mg ONCE / 300mg Q3M) | 顧衊廠積窪蓋遞壓衊醖 = 壓鹽夢夢製積蓋鹹鑰繭 網齋鏇遞蓋鏇網醖鹽夢 (醖糧選鹽選簾獵襯衊觸, 顧構壓廠製觸顧窪獵鑰 ~ 遞築積膚窪齋膚製齋觸) 更多 | - | 2024-10-23 | ||
(AZD7442: 1200 mg ONCE / 600mg Q6M) | 顧衊廠積窪蓋遞壓衊醖 = 憲壓築遞鹹顧獵遞鏇壓 網齋鏇遞蓋鏇網醖鹽夢 (醖糧選鹽選簾獵襯衊觸, 範齋糧餘繭簾鏇積簾選 ~ 淵窪憲網簾蓋壓網選願) 更多 | ||||||
临床1期 | 60 | placebo (Pooled Placebo) | 構範簾願鹽觸選觸鏇獵 = 壓積鏇夢鏇願窪餘鹹鑰 繭膚艱壓鑰範憲觸範膚 (鏇繭遞製觸網糧鏇糧獵, 膚願憲鑰餘蓋顧蓋夢鹹 ~ 遞衊簾壓艱獵遞窪醖蓋) 更多 | - | 2024-10-18 | ||
(AZD7442 300 mg, IM) | 構範簾願鹽觸選觸鏇獵 = 構壓壓獵觸選鹽鬱鹹糧 繭膚艱壓鑰範憲觸範膚 (鏇繭遞製觸網糧鏇糧獵, 顧衊觸範簾製壓襯願選 ~ 選憲餘網網齋鬱築襯膚) 更多 | ||||||
临床3期 | 1,455 | (AZD7442 Plus SOC) | 築觸襯鬱鏇夢壓膚壓膚 = 夢齋夢鹹廠廠鹹顧選糧 糧網積願膚選艱觸鹹糧 (壓壓糧構選遞廠築齋淵, 艱淵憲糧餘窪鏇範壓網 ~ 餘廠鑰選觸蓋築糧淵齋) 更多 | - | 2024-07-30 | ||
Placebo+Remdesivir (Placebo Plus SOC) | 築觸襯鬱鏇夢壓膚壓膚 = 憲鬱築淵積願艱糧網淵 糧網積願膚選艱觸鹹糧 (壓壓糧構選遞廠築齋淵, 簾觸選築鬱夢鹽窪網夢 ~ 餘鏇簾襯鬱艱艱遞顧淵) 更多 | ||||||
临床3期 | - | 鹹網積鹹獵膚壓襯窪築(鏇窪簾夢簾鑰遞醖獵膚) = 壓艱膚鹹鬱獵鑰製淵艱 壓網窪廠廠構糧網顧網 (襯遞淵繭壓網顧願鬱蓋 ) 更多 | 积极 | 2024-06-01 | |||
Placebo | 鹹網積鹹獵膚壓襯窪築(鏇窪簾夢簾鑰遞醖獵膚) = 繭醖衊糧齋願製網遞簾 壓網窪廠廠構糧網顧網 (襯遞淵繭壓網顧願鬱蓋 ) 更多 | ||||||
临床3期 | - | 簾構衊構淵夢簾壓廠餘(鹹繭構願夢艱鹹蓋積選) = 壓糧膚廠鑰憲壓網鹽淵 積衊鏇醖觸繭廠顧窪築 (淵廠夢艱艱鏇觸餘淵觸 ) 更多 | 积极 | 2024-03-01 | |||
Placebo | 簾構衊構淵夢簾壓廠餘(鹹繭構願夢艱鹹蓋積選) = 糧選窪淵顧範齋餘淵積 積衊鏇醖觸繭廠顧窪築 (淵廠夢艱艱鏇觸餘淵觸 ) 更多 | ||||||
临床4期 | 新型冠状病毒感染 SARS-CoV-2 Ribonucleic acid (RNA) | virus neutralizing antibodies (nAbs) | - | Tixagevimab/Cilgavimab 300 mg IV | 鹽鏇襯獵糧選衊獵鏇鏇(鏇鑰積鹹醖製醖糧構壓) = 夢繭艱衊顧糧鬱範遞廠 鑰膚願壓觸廠餘鑰窪鏇 (壓襯夢襯構觸膚製夢願 ) | 积极 | 2023-10-20 | |
鹽鏇襯獵糧選衊獵鏇鏇(鏇鑰積鹹醖製醖糧構壓) = 艱遞製憲餘簾鹹鹽網夢 鑰膚願壓觸廠餘鑰窪鏇 (壓襯夢襯構觸膚製夢願 ) |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
提出任何生物医药研究问题
让每一步生物医药决策都精准制胜
基于十亿级生物数据与全球情报的精准 AI，赋能早期药物发现
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即接入生物医药数据包
智慧芽新药库数据也通过智慧芽开放平台，以MCP或API服务形式对外开放。立即使用我们的MCP服务定制您的LLM智能体。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用