预约演示
更新于：2026-02-27
Miltefosine
米替福新
更新于：2026-02-27
概要
基本信息
原研机构- |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)临床前 |
特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟) |
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结构/序列
分子式C21H46NO4P |
InChIKeyPQLXHQMOHUQAKB-UHFFFAOYSA-N |
CAS号58066-85-6 |
关联
57
项与 米替福新 相关的临床试验NCT07149753
Pilot Study: Safety and Therapeutic Dose of a Miltefosine Gel (G-MTF) in Patients With Uncomplicated Cutaneous Leishmaniasis (NCCL)
The goal of this clinical trial is to learn if the drug MILTEFOSINE, used topically in a hydrogel, works to treat non-complicated cutaneous leishmaniasis (CL) in adults. It will also learn about the safety of the drug MILTEFOSINE used topically. The main questions it aims to answer are:
* Is topical treatment with MILTEFOSINE hydrogel effective in patients with CL, thus justifying its continuation in the clinical phases (II and III) of development?
* What skin problems do participants have when using miltefosine hydrogels over CL lesions? Researchers will evaluate the safety and effectiveness of various concentrations of MILTEFOSINE hydrogel: 0.5%, 1.0%, and 1.5%.
Participants will:
* Apply the MILTEFOSINE hydrogel to the affected lesions daily for 28 consecutive days.
* Visit the Center at least two days prior to the study. This initial visit will include diagnostic tests, interviews, study information, informed consent, and the administration of the first doses. After this, patients are required to return to the clinic on day 28 and again three months later for additional check-ups and tests.
* Take a photo once a week for checkups, and keep a note of their symptoms
* Is topical treatment with MILTEFOSINE hydrogel effective in patients with CL, thus justifying its continuation in the clinical phases (II and III) of development?
* What skin problems do participants have when using miltefosine hydrogels over CL lesions? Researchers will evaluate the safety and effectiveness of various concentrations of MILTEFOSINE hydrogel: 0.5%, 1.0%, and 1.5%.
Participants will:
* Apply the MILTEFOSINE hydrogel to the affected lesions daily for 28 consecutive days.
* Visit the Center at least two days prior to the study. This initial visit will include diagnostic tests, interviews, study information, informed consent, and the administration of the first doses. After this, patients are required to return to the clinic on day 28 and again three months later for additional check-ups and tests.
* Take a photo once a week for checkups, and keep a note of their symptoms
开始日期2026-01-01 |
ACTRN12626000038392
Comparative efficacy of intramuscular meglumine antimoniate and miltefosine in the management of cutaneous leishmaniasis in patients aged 18 - 60 years old.
开始日期2025-10-01 |
申办/合作机构- |
NCT06550609
Treatment of Bolivian L Braziliensis Mucosal Leishmaniasis with Inhaled Pentamidine Plus Oral Miltefosine
This is a phase 2 study of the combination of inhaled-pentamidine plus oral miltefosine for Bolivian mucosal leishmaniasis.
开始日期2025-02-04 |
申办/合作机构- |
100 项与 米替福新 相关的临床结果
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100 项与 米替福新 相关的转化医学
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100 项与 米替福新 相关的专利（医药）
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2,658
项与 米替福新 相关的文献（医药）2026-12-01·PARASITOLOGY RESEARCH
Multidrug-resistant Acanthamoeba keratitis caused by the T4 Genotype: A case report
Article
作者: Kazemirad, Elham ; Atighehchian, Mehrnaz ; Zarei-Ghanavati, Mehran ; Kasiri, Maryam ; Latifi, Alireza
This report describes the case of a 28-year-old woman, who presented with a two-week history of severe ocular pain and photophobia in her right eye. She was a soft contact lens wearer with no history of ocular trauma or systemic illness. Ophthalmic examination revealed conjunctival hyperemia, epithelial irregularities, and a developing ring-shaped stromal infiltrate. In vivo confocal microscopy demonstrated double-walled hyperreflective cysts, and culture followed by PCR and sequencing confirmed the presence of Acanthamoeba T4 genotype. Despite intensive treatment with topical polyhexamethylene biguanide, chlorhexidine, propamidine, and voriconazole, as well as oral miltefosine, the infection progressed, leading to stromal necrosis. The patient underwent two therapeutic penetrating keratoplasties; however, the disease continued to advance, eventually resulting in phthisis bulbi and permanent vision loss. This case highlights the potential for aggressive, clinically refractory Acanthamoeba keratitis caused by the T4 genotype, emphasizing the importance of early diagnosis, vigilant monitoring, and timely surgical intervention in resistant cases.
2026-06-01·BIOORGANIC CHEMISTRY
Synthesis and antiprotozoal activity of β-carboline-(piperazinyl)-1,3,5-triazine hybrids
Article
作者: Fortuna, Caroline ; Baldoqui, Debora Cristina ; Gonçalves, Débora Laís ; Nakamura, Celso Vataru ; Baréa, Paula ; Cecatto, Ana Julia ; Balbinot, Rodolfo Bento ; Sarragiotto, Maria Helena
Neglected tropical diseases, such as leishmaniasis and Chagas disease cause over 50,000 deaths annually and affect millions worldwide. Current drugs are limited due to their toxicity, prolonged treatment, and drug resistance. The β-carboline scaffold has emerged as a privileged nucleus in the search for novel antiprotozoal derivatives. Our previous studies demonstrated the antileishmanial activity of β-carboline-1,3,5-triazine hybrids containing a N-aminoethyl group as linker connecting the nucleus, as well as the antiprotozoal activity of β-carboline-piperazinyl derivatives. Based on these findings, and in literature reports on the potential of piperazine heterocycle, in this work we synthesized novel β-carboline-(piperazinyl)-1,3,5-triazine hybrids (4a-g), and evaluated their activity, and of its precursors (1a-g), against Leishmania amazonensis and Trypanosoma cruzi. The β-carboline-3-carboxylic acids 1a-e were weakly active for L. amazonensis promastigotes, with IC50 values in the range of 55.9 to 159.7 μM. For amastigotes, the compounds exhibited moderate activity, with IC50 values in the range of 18.2 to 62.6 μM. The hybrids 4a, 4c and 4d showed potent activity for L. amazonensis promastigotes, with IC50 values in the range of 8.3 to 9.5 μM, and displayed higher activity and selectivity index (SI in the range of 5.40 to 17.3) than the reference drug miltefosine (IC50pro = 22.71 μM, SI = 2.4). A moderated activity was observed towards L. amazonensis amastigotes (IC50 in the range of 15.1 to 34.9 μM). The β-carboline carboxylic acids (1a-g) and β-carboline-(piperazinyl)-1,3,5-triazines (4a-g) showed no significant activity against T. cruzi epimastigotes.
2026-04-01·DRUG DEVELOPMENT RESEARCH
Novel Imidazoquinoline Based TLR7 Agonist Induces Antileishmanial Efficacy‐An In Vitro Study
Article
作者: Thakur, Shivani ; Kaur, Sandeep ; Salunke, Deepak B. ; Kumar, Kushvinder ; Sanjana ; Kaur, Sukhbir ; Sihag, Binita
ABSTRACT:
Leishmaniasis elimination and control remain challenging due to the lack of successful treatment and possible prevention. A suitable anti‐leishmanial medication that is acceptable in terms of price and safety is currently being researched. In light of this, the current study examined the effectiveness of imidazoquinoline based selective Toll‐like receptor (TLR)‐7 agonists as anti‐leishmanial agents. A library of TLR7 agonists was evaluated for anti‐leishmanial efficacy against experimental visceral leishmaniasis (VL). Among all the agonists, 2‐butyl‐1‐(3,4‐dimethoxybenzyl)‐1
H
‐imidazo[4,5‐
c
]quinolin‐4‐amine (
7
) and its niosomal formulation
18
exhibited better activity than Miltefosine. These were then further studied against
Leishmania donovani
for their ability to arrest the parasites at sub G
0
/G
1
phase of cell cycle. The selected TLR7 agonists depicted their ability to arrest higher percentage of parasites in comparison to the standard antileishmanial drugs. Similar observations were seen in case of reactive oxygen species (ROS) generation where parasites treated with the lead TLR7 agonist produced higher ROS than the untreated parasites. These results suggest that TLR7 agonist
7
and its niosomal formulation
18
could be the promising hits for development of a novel drug treating VL. However additional in‐vivo studies could aid in their future advancement.
24
项与 米替福新 相关的新闻（医药）2026-02-06
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
临床结果临床1期
2026-02-03
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
临床结果临床1期
2026-01-26
康心药物临床试验
2026/1/26
康心药物临床试验
【食管癌】
患者招募
patient enrolment for drug clinical trials
康心药物临床试验患者招募中心：依托于国家疾病防治中心，为各类癌症肿瘤疾病患者、血液疾病患者、慢性疾病患者、传染病疾病患者、罕见病等患者，提供专业国内外药物临床试验免费治疗项目的咨询、药物查询，项目报名、匹配、筛选、对接、入组、帮扶等服务。为患者创造出一条崭新的出路和新的选择。
01
癌症肿瘤项目
【食管癌】
注射用血卟啉醚酯III期临床试验招募（姑息治疗重度梗阻食管癌）
【基本信息】
登记号：CTR20161062
相关登记号：CTR20161060
药物名称：注射用血卟啉醚酯 曾用名：无
药物类型：化学药物
临床申请受理号：企业选择不公示
适应症：重度梗阻食管癌（用于姑息治疗，适用于拒绝/无法耐受常规治疗、常规治疗无效或复发者）
试验专业题目：注射用血卟啉醚酯姑息治疗重度梗阻食管癌的多中心、开放性、单臂临床试验
试验通俗题目：注射用血卟啉醚酯单臂临床试验
试验方案编号：ZXYF201201 方案最新版本号：无 版本日期：无
试验分类：安全性和有效性（含药代动力学研究）
试验分期：III期
设计类型：单臂试验
随机化：非随机化
盲法：开放
试验范围：国内试验
方案是否为联合用药：企业选择不公示
受试者信息：年龄18岁(最小年龄)至无上限(最大年龄)；其中药代动力学试验受试者年龄18岁（含）-70岁（含），男女不限 健康受试者：无
【入选标准】
1. 自愿签署书面知情同意书，对研究内容充分了解，依从性良好，愿意遵循研究方案及相关访视、检查要求；
2. 年龄≥18周岁，男女不限；药代动力学试验受试者年龄需在18-70周岁（含）范围内，男女皆有；预期生存期＞3个月；
3. 经病理诊断证实为原发性食管癌，且为重度梗阻食管癌，吞咽困难分级≥3级，同时符合以下任一条件：①拒绝或无法耐受常规治疗（手术、放疗、化疗）；②放疗、化疗无效或复发；
4. 治疗光纤可顺利通过梗阻部位最狭窄处，能耐受光动力治疗及内窥镜检查；
5. 既往接受过放疗、化疗、生物治疗或其他研究药品者，需停药≥4周，且已从之前手术、抗肿瘤治疗的毒性反应中完全恢复；
6. 血液学检查达标：白细胞计数（WBC）≥3.5×10⁹/L，血小板计数（PLT）≥90×10⁹/L。
【排除标准】
1. 经检查确诊为非原发性食管癌患者；
2. 已知对注射用血卟啉醚酯、相关产品过敏，或患有卟啉症者；
3. HIV抗体阳性，或患有乙肝、丙肝、梅毒者；
4. 经超声胃镜等检查证实存在食管气管瘘、食管纵隔瘘，或肿瘤侵及周围大血管，出血风险高者；
5. 食管肿瘤病灶长度＞10cm，或处于恶液质状态，研究者评估无法耐受光动力治疗者；
6. 肝肾功能不全：①血清肌酐＞1.5×ULN；②无肝转移时ALT、AST＞2.5×ULN，有肝转移时ALT、AST＞5×ULN；③血清胆红素＞1.5×ULN；
7. 患有严重/未控制的心血管疾病及肺部疾病：包括心肌梗死、NYHA III-IV级心衰、心功能不全、≥2级心脏传导阻滞、严重心律失常、高室性心律失常风险心脏病；哮喘发作期、呼吸功能衰竭无法平卧、肺功能差致血氧饱和度＜90%等；
8. 存在急性炎症（尤其腐蚀性炎症）、明显活动性感染，或有活动性出血、凝血机制异常（出血体质）者；
9. 妊娠期、哺乳期女性，或育龄期受试者（含男性）拒绝在研究期间采取适当避孕措施者；
10. 研究期间计划进行或正在接受其他抗肿瘤伴随治疗者；
11. 入组前3个月内参加过其他临床试验者；
12. 患有严重躯体/精神疾病，研究者判定可能影响治疗、评估，或对研究方案依从性差者。
【试验分组】
试验药1（注射用血卟啉醚酯）：中文通用名：注射用血卟啉醚酯；英文通用名：Hematoporphyrin Ether Ester for Injection；商品名称：NA；剂型：冻干粉针剂；规格：75mg/瓶；用法用量：按体重计算，剂量2.0mg/kg，用5%葡萄糖注射液溶解，5分钟内缓慢静脉注射或30分钟内静脉滴注完成；用药时程：整个临床试验仅给药一次；
试验药2（注射用血卟啉醚酯）：中文通用名、英文通用名、商品名称、剂型、规格、用法用量、用药时程同上；
对照药：无
【患者权益】
1. 免费体检及相关试验流程检查（血常规、肝肾功能、内窥镜、影像学、传染病筛查等，含药代动力学相关检测）；
2. 有一定的交通补助及随访补贴；
3. 免费用药治疗（注射用血卟啉醚酯）及相关光动力治疗操作；
4. 就诊多中心合作知名三甲医院，全程由食管癌专科专家团队跟踪诊疗及健康管理。
【需要资料】
肿瘤项目需要的资料（通用）
① 详细记录病情、既往治疗经过（手术、放化疗史）及吞咽困难分级的最新出院记录；
② 最近两次复查的CT、超声胃镜等影像学报告（明确病灶长度、梗阻情况）；
③ 确诊时的病理报告（明确原发性食管癌）；
④ 血常规、血生化、肝肾功能、出凝血功能、肿瘤标志物、传染病（乙肝、丙肝、艾滋、梅毒）报告；
⑤ 既往用药史、过敏史、手术史记录；育龄期女性需提供妊娠试验报告。
【研究中心所在地区】
河北、山西、黑龙江、吉林、辽宁、江苏、浙江、安徽、福建、江西、山东、河南、湖北、湖南、广东、海南、四川、贵州、云南、陕西、甘肃、青海、北京、上海、天津、重庆等，上百个城市均设有项目中心。
全国百家三甲医院负责主治，根据患者实际病情和项目匹配筛选安排。招募重度梗阻食管癌患者（拒绝/无法耐受常规治疗、常规治疗无效或复发），您可直接联系我们进行匹配筛选。
官方渠道：线上扫码加微信详细咨询报名
02
癌症肿瘤项目
【食管癌】
晚期实体瘤优替德隆胶囊Ⅱ期临床试验招募
【基本信息】
登记号：CTR20244187
相关登记号：CTR20230508、CTR20252556
药物名称：优替德隆胶囊 曾用名：无
药物类型：化学药物
临床申请受理号：企业选择不公示
适应症：晚期实体瘤（含胃癌、卵巢癌、胆管癌、食管癌、肝癌、结直肠癌、宫颈癌等）
试验专业题目：优替德隆胶囊治疗晚期实体瘤患者的Ⅱ期临床试验
试验通俗题目：优替德隆胶囊治疗晚期实体瘤患者的Ⅱ期临床试验
试验方案编号：BG02-2403 方案最新版本号：V2.0 版本日期：2024-10-25
试验分类：有效性、安全性、药代动力学特征
试验分期：II期
设计类型：单臂试验
随机化：非随机化
盲法：开放
试验范围：国内试验
方案是否为联合用药：否
受试者信息：年龄18岁(最小年龄)至70岁(最大年龄) 性别：男+女 健康受试者：无
【入选标准】
1. 自愿签署书面知情同意书，充分理解研究内容，依从性良好，愿意遵循研究方案及相关访视、检查要求；
2. 年龄18≤年龄≤70周岁，男女不限；东部肿瘤协作组（ECOG）体力状态评分0-1分，预期生存期＞12周；
3. 分瘤种确诊要求：①胃癌组：经组织学/细胞学确诊为不可切除HER2阴性局部晚期/复发/转移性胃腺癌或胃食管交界处腺癌（2019版WHO分类）；②胆管癌组：经组织学/细胞学确诊为手术不可切除晚期/转移性胆管癌；③卵巢癌组：经组织学/病理学确诊为高级别浆液性卵巢癌，且为铂耐药复发性卵巢癌（末次铂化疗后6个月内进展，2020版WHO分类）；④其他瘤种：食管癌为局部晚期复发/转移性食管鳞癌；肝癌为不可手术切除/转移性肝细胞癌（2024版《原发性肝癌诊疗指南》），Child-Pugh评分≤7分；结直肠癌为不可切除晚期/转移性结直肠癌；宫颈癌为复发/转移性鳞癌、腺癌或腺鳞癌，不可根治性手术/放化疗；
4. 按RECIST v1.1标准，至少有1个非放射治疗野的可测量靶病灶（CT/MRI最长径≥10mm，淋巴结短径≥15mm，扫描层厚≤5mm）；
5. 至少接受过1种标准系统治疗，既往系统抗肿瘤治疗线数≤4线（新辅助、辅助化疗不视为既往治疗，除非治疗期间/末次化疗后6个月内进展）；
6. 骨髓功能达标（入组前1周内检查，入组前14天内未使用rhG-CSF、输血/EPO等药物）：白细胞计数（WBC）≥3.5×10⁹/L，中性粒细胞计数（ANC）≥1.5×10⁹/L，血小板计数（PLT）≥100×10⁹/L，血红蛋白≥9.0g/dL；
7. 肝肾功能达标（入组前1周内检查）：总胆红素（TBIL）≤1.5×ULN；无肝转移者ALT、AST≤3×ULN，有肝转移者≤5×ULN；肌酐清除率（Ccr）≥60ml/min（Cockcroft-Gault公式计算）；
8. 凝血功能充分：INR或PT≤1.5×ULN，正在接受抗凝治疗者PT在拟定范围内即可；
9. 有生育能力的受试者（含伴侣），需在试验期间及末次用药后至少3个月内采取可靠避孕措施；育龄期女性入组前血/尿妊娠试验需为阴性。
【排除标准】
1. 分瘤种排除要求：①胃癌组：HER2阳性患者；②卵巢癌组：透明细胞/粘液性/肉瘤组织学、混合性肿瘤、低级别/交界性卵巢癌，或铂难治卵巢癌（末次铂治疗后1个月内进展）；
2. 入组前5年内患有其他恶性肿瘤（治愈的皮肤基底细胞癌、宫颈原位癌、甲状腺乳头状癌除外）；
3. 既往使用过优替德隆注射液，或对优替德隆胶囊及辅料过敏者；
4. 首次给药前用药/治疗限制：6周内接受过亚硝基脲/丝裂霉素C；4周内/药物5个半衰期内（取较短者）接受过化疗、放疗、靶向/免疫治疗等抗肿瘤治疗；2周内/药物5个半衰期内（取较短者）接受过口服氟尿嘧啶类、小分子靶向药、内分泌治疗，或有抗肿瘤适应症的中药/中成药；
5. 首次给药前4周内接受过主要脏器手术（穿刺活检除外）、发生显著外伤，或试验期间需接受择期手术；
6. 周围神经病变（CTCAE 5.0）≥2级，或既往抗肿瘤治疗不良反应（脱发等无安全风险毒性除外）未恢复至≤1级；
7. 入组前6个月内有胃肠道出血、活动性消化道溃疡、胃肠道梗阻（含麻痹性）、胃肠穿孔/瘘、腹腔内脓肿；存在吞咽困难、影响药物口服吸收，或需肠外营养者；
8. 有症状临床活动性脑部转移、脊髓压迫、软脑膜癌扩散，或放疗/局部治疗后2个月内脑转移病变进展者；
9. 有临床症状需穿刺引流的癌性胸/腹/心包积液，或首次给药前30天内接受过积液引流；
10. 肿瘤侵犯重要血管，经研究者判定治疗期间有极高致命大出血风险；
11. 严重心脑血管疾病：入组前6个月内发生急性冠脉综合征、充血性心力衰竭、主动脉夹层、脑卒中或≥3级心血管事件；需干预的室性心律失常、Ⅱ-Ⅲ度房室传导阻滞；静息心电图QTcF男性＞450ms/女性＞470ms；临床无法控制的高血压；
12. 入组前3个月内未控制的糖尿病，或有活动性感染需系统性抗感染治疗者；
13. 活动性乙肝/丙肝（HBsAg+/HbcAb+且HBV DNA阳性，或抗-HCV+且HCV RNA阳性）、HIV抗体阳性、梅毒螺旋体特异性抗体阳性；
14. 入组前2年内患有活动性自身免疫性疾病，需全身治疗（生理性皮质类固醇替代疗法除外）；
15. 妊娠期、哺乳期女性，或计划在研究期间妊娠者；
16. 有精神障碍、依从性差，或同时参与另一项干预性临床试验、使用其他研究性治疗者；
17. 研究者判定存在严重系统性疾病史或其他不宜入组的情况。
【试验分组】
试验药1（优替德隆胶囊）：中文通用名：优替德隆胶囊；英文通用名：Utidron Capsules；商品名称：NA；剂型：胶囊；规格：15mg/粒；用法用量：按体表面积（BSA）调整剂量，60mg/m²/d组：BSA≤1.5m²服6粒/天，1.5＜BSA＜1.9m²服7粒/天，BSA≥1.9m²服8粒/天；75mg/m²/d组：BSA≤1.5m²服7粒/天，1.5＜BSA＜1.9m²服8粒/天，BSA≥1.9m²服9粒/天；用药时程：连续给药5天，21天为一个治疗周期，持续给药至疾病进展或退出；
试验药2（优替德隆胶囊）：中文通用名、英文通用名、商品名称、剂型、规格、用法用量、用药时程同上；
对照药：无
【患者权益】
1. 免费体检及相关试验流程检查（血常规、肝肾功能、影像学、凝血功能、肿瘤标志物、传染病筛查、药代动力学相关检测等）；
2. 有一定的交通补助及随访补贴；
3. 免费用药治疗（优替德隆胶囊）；
4. 就诊多中心合作知名三甲医院，全程由实体瘤专科专家团队跟踪诊疗及健康管理。
【需要资料】
肿瘤项目需要的资料（通用）
① 详细记录病情、既往治疗经过（手术、放化疗、靶向/免疫治疗史）的最新出院记录；
② 最近两次复查的CT或核磁报告（明确可测量病灶，符合RECIST v1.1标准）；
③ 确诊时的病理报告，分瘤种补充资料：胃癌需HER2检测报告，卵巢癌需铂化疗史记录，肝癌需Child-Pugh评分报告，基因检测报告（未做可不提供）；
④ 血常规、血生化、肝肾功能、出凝血功能、肿瘤标志物、传染病（乙肝、丙肝、艾滋、梅毒）报告；
⑤ 既往用药史、过敏史、手术史记录；育龄期女性需提供妊娠试验报告。
【研究中心所在地区】
河北、山西、黑龙江、吉林、辽宁、江苏、浙江、安徽、福建、江西、山东、河南、湖北、湖南、广东、海南、四川、贵州、云南、陕西、甘肃、青海、北京、上海、天津、重庆等，上百个城市均设有项目中心。
全国百家三甲医院负责主治，根据患者实际病情和项目匹配筛选安排。招募多类晚期实体瘤患者（胃癌、卵巢癌、胆管癌等），您可直接联系我们进行匹配筛选。
官方渠道：线上扫码加微信详细咨询报名
03
癌症肿瘤项目
【胃食管癌】
注射用sacituzumab tirumotecan III期临床试验招募
【基本信息】
登记号：CTR20242332
相关登记号：无
药物名称：注射用sacituzumab tirumotecan 曾用名：无
药物类型：生物制品
临床申请受理号：企业选择不公示
适应症：3L+晚期/转移性胃食管癌（含胃腺癌、胃食管结合部腺癌、食管腺癌）
试验专业题目：一项在3L+晚期/转移性胃食管腺癌（胃腺癌、胃食管结合部腺癌和食管腺癌）患者中比较MK-2870与医生选择的治疗的有效性和安全性的III期、多中心、开放标签、随机研究
试验通俗题目：在晚期/转移性胃食管腺癌患者中评估MK-2870的III期研究
试验方案编号：MK-2870-015 方案最新版本号：09 版本日期：2025-10-07
试验分类：安全性和有效性
试验分期：III期
设计类型：平行分组
随机化：随机化
盲法：开放
试验范围：国际多中心试验
方案是否为联合用药：否
受试者信息：年龄18岁(最小年龄)至无上限(最大年龄) 性别：男+女 健康受试者：无
【入选标准】
1. 自愿签署书面知情同意书，充分理解研究内容，依从性良好，愿意遵循研究方案及相关访视、检查要求；
2. 年龄≥18周岁，男女不限；随机分组前3天内东部肿瘤协作组（ECOG）体能状态评分为0-1分；
3. 经组织学或细胞学确诊为晚期、不可切除或转移性胃腺癌、胃食管结合部腺癌或食管腺癌；
4. 既往接受过至少2种针对晚期/不可切除/转移性胃食管癌的化疗和/或免疫治疗，且已发生疾病进展；
5. 可纳入任何HER2状态受试者：HER2状态未知者需按当地标准确定是否检测；HER2阳性受试者既往需接受过曲妥珠单抗治疗（如可及/适用）；
6. 按RECIST 1.1标准，经当地研究者/影像科医师评估存在可测量病灶；
7. 器官功能充足，可耐受研究治疗；已提供存档肿瘤组织样本，或最近一次获得的（既往未接受放疗）肿瘤病灶粗针、切取/切除活检样本；
8. 既往抗肿瘤治疗导致的不良事件（AE）需恢复至≤1级或基线水平；内分泌相关AE经激素替代治疗控制充分者可纳入；
9. 需接受曲氟尿苷-替匹嘧啶治疗的受试者，必须具备正常吞咽口服药物的能力；
10. 病毒感染相关要求：HBsAg阳性受试者需在随机分组前接受至少4周HBV抗病毒治疗，且HBV病毒载量不可检出；有HCV感染史者筛选时HCV病毒载量需不可检出。
【排除标准】
1. 有重度干眼症、重度睑板腺疾病/睑缘炎病史，或妨碍/延缓角膜愈合的重度角膜疾病史；
2. 存在≥2级周围神经病变，或有需要类固醇治疗的（非感染性）肺部炎症/ILD病史、当前患有肺部炎症/ILD；
3. 患有需要免疫抑制药物治疗的活动性炎症性肠病，或有克罗恩病、溃疡性结肠炎、慢性腹泻等炎症性肠病既往史；
4. 研究干预首次给药前6个月内，患有未受控的重大心血管疾病或脑血管疾病；
5. 既往接受过TROP2靶向ADC、含拓扑异构酶1抑制剂的ADC及化疗，或对研究干预、其辅料及其他生物疗法有≥3级重度超敏反应；
6. 过去3年内患有需要积极治疗的已知其他恶性肿瘤（正在进展者亦排除）；
7. 存在活动性乙型肝炎（HBsAg阳性和/或可检出HBV DNA）、丙型肝炎（抗HCVAb阳性且可检出HCV RNA）感染；
8. 研究干预首次给药前30天内接种过活疫苗或减毒活疫苗；
9. 目前正在接受强效CYP3A4诱导剂/抑制剂治疗，且研究期间无法停用；
10. 已知存在活动性中枢神经系统（CNS）转移和/或癌性脑膜炎。
【试验分组】
试验药：
1（注射用sacituzumab tirumotecan）：中文通用名：注射用sacituzumab tirumotecan；英文通用名：Sacituzumab Tirumotecan for Injection；商品名称：NA；剂型：注射剂；规格：200mg/瓶；用法用量：4mg/kg，每两周用药一次，静脉输注；用药时程：每42天为一个周期，每个周期第1、15、29天给药一次；
2（注射用sacituzumab tirumotecan）：中文通用名、英文通用名、商品名称、剂型、规格、用法用量、用药时程同上；
对照药：
1（盐酸伊立替康注射液）：中文通用名：盐酸伊立替康注射液；英文通用名：Irinotecan Hydrochloride Injection；商品名称：开普拓/Campto；剂型：注射剂；规格：100mg/5ml；用法用量：150mg/m²，静脉给药；用药时程：每28天为一个周期，每个周期第1、15天给药；
2（多西他赛注射液）：中文通用名：多西他赛注射液；英文通用名：Docetaxel Injection；商品名称：泰索帝/TAXOTERE；剂型：注射剂；规格：0.5ml:20mg；用法用量：75mg/m²，静脉给药；用药时程：每21天为一个周期，每个周期第1天给药；
3（紫杉醇注射液）：中文通用名：紫杉醇注射液；英文通用名：Paclitaxel Injection；商品名称：安泰素；剂型：注射剂；规格：5ml:30mg；用法用量：80mg/m²，静脉给药；用药时程：每28天为一个周期，每个周期第1、8、15天给药；
4（曲氟尿苷替匹嘧啶片）：中文通用名：曲氟尿苷替匹嘧啶片；英文通用名：Trifluridine and Tipiracil Hydrochloride Tablets；商品名称：朗斯弗；剂型：片剂；规格：15mg/20mg；用法用量：35mg/m²，口服，每日两次；用药时程：每28天为一个周期，每个周期第1-5天、第8-12天给药；
【患者权益】
1. 免费体检及相关试验流程检查（血常规、肝肾功能、影像学、肿瘤标志物、传染病筛查、肿瘤组织样本检测等）；
2. 有一定的交通补助及随访补贴；
3. 免费用药治疗（试验药注射用sacituzumab tirumotecan或对照药）及相关给药操作；
4. 就诊国际多中心合作知名三甲医院，全程由胃食管癌专科专家团队跟踪诊疗及健康管理。
【需要资料】
肿瘤项目需要的资料（通用）
① 详细记录病情、既往治疗经过（化疗、免疫治疗、曲妥珠单抗用药史）的最新出院记录；
② 最近两次复查的CT或核磁报告（明确可测量病灶，符合RECIST 1.1标准）；
③ 确诊时的病理报告、HER2检测报告，及存档肿瘤组织样本/近期未放疗部位肿瘤活检样本相关资料；
④ 血常规、血生化、肝肾功能、肿瘤标志物、传染病（乙肝、丙肝、艾滋、梅毒）及病毒载量检测报告；
⑤ 既往用药史、过敏史、治疗相关不良事件恢复情况记录。
【研究中心所在地区】
国内覆盖河北、山西、黑龙江、吉林、辽宁、江苏、浙江、安徽、福建、江西、山东、河南、湖北、湖南、广东、海南、四川、贵州、云南、陕西、甘肃、青海、北京、上海、天津、重庆等上百个城市，同时包含国际多中心研究站点。
国内外多中心合作知名三甲医院负责主治，根据患者实际病情和项目匹配筛选安排。招募3L+晚期/转移性胃食管癌患者，您可直接联系我们进行匹配筛选
#扫码加微信详细咨询报名或致电咨询：
0799-6888661/186 7998 8528
04
癌症肿瘤项目
【食管癌】
多队列实体瘤注射用多西他赛聚合物胶束II期临床试验招募
【基本信息】
登记号：CTR20213207
相关登记号：CTR20192730
药物名称：注射用多西他赛聚合物胶束 曾用名：无
药物类型：化学药物
临床申请受理号：CXHL1700105
适应症：晚期实体瘤（剂量确认阶段及队列1：食管癌；队列2：头颈部鳞癌（非鼻咽癌）；队列3：胆道恶性肿瘤，含肝内胆管、肝外胆管及胆囊恶性肿瘤）
试验专业题目：评估注射用多西他赛聚合物胶束在晚期恶性实体瘤患者中有效性和安全性的开放性、多队列II期临床研究
试验通俗题目：多西他赛胶束实体瘤II期
试验方案编号：B02B00903-DTAX-201 方案最新版本号：V1.1 版本日期：2022-02-26
试验分类：安全性和有效性
试验分期：II期
设计类型：平行分组
随机化：随机化
盲法：开放
试验范围：国内试验
方案是否为联合用药：否
受试者信息：年龄18岁(最小年龄)至75岁(最大年龄) 性别：男+女 健康受试者：无
【入选标准】
1. 自愿签署书面知情同意书，依从性良好，可配合随访，自愿遵守研究各项规定；
2. 年龄18周岁（含）-75周岁（含），男女不限；东部肿瘤协作组（ECOG）体能状态评分0-1分，预计生存期不少于12周；
3. 经组织病理学或细胞学证实为晚期或转移性实体瘤，既往标准治疗失败或不适合接受标准治疗，具体瘤种对应：剂量确认阶段及队列1为食管癌，队列2为头颈部鳞癌，队列3为胆道恶性肿瘤；
4. 按RECIST 1.1标准存在可测量肿瘤病灶（既往放疗或局部治疗区域的病灶，除非明确进展，否则不作为可测量病灶）；
5. 骨髓功能达标：血红蛋白（HB）≥90g/L，中性粒细胞计数（ANC）≥1.5×10⁹/L，血小板（PLT）≥80×10⁹/L，且14天内未输血、7天内未使用集落刺激因子治疗；
6. 肝肾功能达标：总胆红素≤1.0×ULN（肝转移患者≤1.5×ULN），ALT、AST≤1.5×ULN（肝转移患者≤2.5×ULN），碱性磷酸酶＜2.5×ULN；血肌酐≤1.5×ULN或肌酐清除率（/肾小球滤过率）＞50ml/min；
7. 有生育能力的受试者（男女），需在试验期间及末次用药后至少90天内与伴侣共同采取可靠避孕措施（激素、屏障法或禁欲）；育龄期女性首次给药前7天内血妊娠试验需为阴性。
【排除标准】
1. 既往用过多西他赛姑息性化疗失败（治疗中/结束后6个月内疾病进展），或辅助治疗使用多西他赛且末次用药后6个月内复发者；
2. 对紫杉类药物有≥3级过敏史（CTCAE 5.0标准），或已知有酒精、药物依赖者；
3. 首次给药前4周内接受过化疗、放疗、生物治疗、内分泌治疗、免疫治疗等抗肿瘤治疗；小分子靶向药物需停药2周或5个半衰期（取较长者），有抗肿瘤适应症的中药需停药2周；
4. 首次给药前4周内接受过其他未上市临床研究药物治疗，或接受过主要脏器外科手术（穿刺活检除外）、发生显著外伤，或试验期间需接受择期手术；
5. 首次给药前7天内使用过，或研究期间需使用CYP3A4强效抑制剂/诱导剂；
6. 既往抗肿瘤治疗不良反应（脱发等无安全风险毒性除外）未恢复至CTCAE 5.0≤1级；
7. 有临床症状的中枢神经系统转移/脑膜转移，或病灶未控制经研究者判断不适合入组；
8. 存在未控制的活动性感染，需系统性抗感染治疗；或有免疫缺陷病史（HIV抗体阳性）；
9. 活动性乙型肝炎（HBsAg阳性且HBV DNA＞ULN）、丙型肝炎（HCV抗体阳性且HCV RNA＞ULN）；
10. 严重心血管疾病：首次给药前6个月内发生急性冠脉综合征、充血性心力衰竭、脑卒中或≥3级心血管事件；需干预的室性心律失常、Ⅱ-Ⅲ度房室传导阻滞；NYHA心功能分级≥II级、LVEF＜50%或高风险结构性心脏病；药物干预后收缩压仍≥150mmHg和/或舒张压≥100mmHg的不可控高血压；
11. 临床无法控制的第三间隙积液，经研究者判断不适合入组；
12. 妊娠期、哺乳期女性，或有精神障碍、依从性差者；
13. 2年内或同时患有其他恶性肿瘤（已治愈的原位癌除外）；
14. 研究者判定存在其他不适合参加本研究的情况。
【试验分组】
试验药1（注射用多西他赛聚合物胶束）：中文通用名：注射用多西他赛聚合物胶束（HT001）；英文通用名：Docetaxel Polymeric Micelles for Injection；商品名称：NA；剂型：冻干粉针剂；规格：20mg/瓶；用法用量：静脉滴注；用药时程：按方案规定使用；
试验药2（注射用多西他赛聚合物胶束）：中文通用名、英文通用名、商品名称、剂型、规格、用法用量、用药时程同上；
对照药：无
【患者权益】
1. 免费体检及相关试验流程检查（血常规、肝肾功能、影像学、肿瘤标志物、传染病筛查等）；
2. 有一定的交通补助及随访补贴；
3. 免费用药治疗（注射用多西他赛聚合物胶束）及相关给药操作；
4. 就诊国内多中心合作知名三甲医院，全程由实体瘤专科专家团队跟踪诊疗及健康管理。
【需要资料】
肿瘤项目需要的资料（通用）
① 详细记录病情、既往治疗经过（含多西他赛用药史、放化疗及靶向/免疫治疗史）的最新出院记录；
② 最近两次复查的CT或核磁报告（明确可测量病灶，符合RECIST 1.1标准）；
③ 确诊时的病理报告（明确瘤种及病理类型），基因检测报告（未做可不提供）；
④ 血常规、血生化、肝肾功能、出凝血功能、肿瘤标志物、传染病（乙肝、丙肝、艾滋）及病毒载量检测报告；
⑤ 既往用药史、过敏史、手术史记录；育龄期女性需提供妊娠试验报告。
【研究中心所在地区】
河北、山西、黑龙江、吉林、辽宁、江苏、浙江、安徽、福建、江西、山东、河南、湖北、湖南、广东、海南、四川、贵州、云南、陕西、甘肃、青海、北京、上海、天津、重庆等，上百个城市均设有项目中心。
全国百家三甲医院负责主治，根据患者实际病情和项目队列匹配筛选安排。招募晚期食管癌、头颈部鳞癌、胆道恶性肿瘤患者，您可直接联系我们进行匹配筛选。
官方渠道：线上扫码加微信详细咨询报名
05
癌症肿瘤项目
【食管癌】
AN0025联合放化疗Ib期临床试验招募
【基本信息】
登记号：CTR20212952
相关登记号：无
药物名称：AN0025 曾用名：无
药物类型：化学药物
临床申请受理号：企业选择不公示
适应症：局部晚期或局部复发食管癌、食管胃结合部癌
试验专业题目：AN0025联合放化疗治疗局部晚期或局部复发食管癌的开放、多中心Ib临床研究
试验通俗题目：AN0025联合放化疗治疗局部晚期或局部复发食管癌Ib期研究
试验方案编号：AN0025S0104 方案最新版本号：3.0 版本日期：2024-11-08
试验分类：安全性
试验分期：Ib期（I期）
设计类型：单臂试验
随机化：非随机化
盲法：开放
试验范围：国内试验
方案是否为联合用药：是（联合术前新辅助放化疗或根治性放化疗）
受试者信息：年龄18岁(最小年龄)至无上限(最大年龄) 性别：男+女 健康受试者：无
【入选标准】
1. 自愿签署书面知情同意书，依从性良好，愿意遵循试验治疗方案及访视计划，配合完成研究相关评估；
2. 年龄≥18周岁（签署知情同意书当天），男女不限，无年龄上限；
3. 预期生存期≥12周，体力状况评分ECOG≤1分，可耐受联合放化疗治疗；
4. 经组织病理学和/或细胞学明确确诊为局部晚期或局部复发食管癌、食管胃结合部癌；
5. 按实体瘤疗效评价标准（RECIST 1.1），存在至少一个可测量的肿瘤靶病灶（既往放疗或局部治疗区域病灶，除非明确进展，否则不作为可测量病灶）；
6. 器官功能基本达标：无明确严重肝肾功能、造血功能异常，经研究者评估无联合治疗禁忌；
7. 首次给药前，既往治疗毒性效应（除“脱发”等无安全风险情况外）恢复至CTCAE ≤1级，或研究者判定无安全性风险；
8. 育龄期女性首次给药前3天内妊娠试验阴性，受试者及其育龄期伴侣需在研究期间及末次给药后6个月内采取高效避孕措施。
【排除标准】
1. 既往或同时患有其他恶性肿瘤（已根治的皮肤基底细胞癌、浅表膀胱癌等除外）；
2. 病毒感染阳性者：乙肝表面抗原(HBsAg)阳性且乙肝病毒载量(HBV-DNA)高于实验室检测下限；丙肝抗体（HepC Ab）阳性且丙肝病毒载量（HCV-RNA）高于实验室检测下限；HIV-1/2抗体阳性；梅毒螺旋体抗体阳性；
3. 首次用药前4周内接受过大手术（诊断性活检除外）或发生严重外伤，且相关主要副作用尚未恢复；
4. 首次用药前4周内（或药物5个半衰期内，取较长者）接受过全身性抗肿瘤治疗，包括化疗、靶向治疗、免疫治疗、抗肿瘤中药及其他未上市临床研究药物；进入前一临床研究随访期且距末次用药≥4周者除外；
5. 当前入组其他临床研究器械、假体植入研究，或距此类研究停用时间≤4周；
6. 存在无法控制的癌痛，经对症治疗后仍无法缓解，影响研究治疗及评估；
7. 首次用药前1周内使用过，或研究期间需使用强效CYP450抑制剂/诱导剂，经研究者判断可能干扰药物代谢；
8. 有症状内脏播散性病变，或首次给药前3周内因胸/腹/心包积液接受穿刺引流者；
9. 筛选期电解质紊乱，或经治疗未控制稳定的系统性疾病（如糖尿病、不可控高血压等）；
10. 精神、家庭或社会等因素可能影响对研究方案的依从性，或干扰研究指标评估；
11. 其他严重急性或慢性疾病、严重实验室检查异常，经研究者判断可能增加研究相关风险，或干扰研究结果判断；
12. 妊娠期、哺乳期女性，或对AN0025、放化疗药物成分有明确过敏史者。
【试验分组】
试验药（AN0025）：中文通用名：AN0025；英文通用名：AN0025；商品名称：无；剂型：片剂；规格：250mg；用法用量：口服，一日一次，剂量为250mg或500mg（按剂量探索方案调整）；用药时程：一日一次，最长给药时长1-2年，联合放化疗使用，最终按试验方案确定；
对照药：无
【患者权益】
1. 免费体检及相关试验流程检查（血常规、肝肾功能、影像学、肿瘤标志物、传染病筛查等）；
2. 有一定的交通补助及随访补贴；
3. 免费用药治疗（AN0025）及联合放化疗相关治疗、给药操作；
4. 就诊国内多中心合作知名三甲医院，全程由食管癌专科专家团队跟踪诊疗及健康管理，动态监测治疗效果与安全性。
【需要资料】
肿瘤项目需要的资料（通用）
① 详细记录病情、既往治疗经过（含手术史、放化疗史、靶向/免疫治疗史）的最新出院记录；
② 最近两次复查的CT或核磁报告（明确可测量病灶，符合RECIST 1.1标准）；
③ 确诊时的病理报告（明确食管癌/食管胃结合部癌病理类型），基因检测报告（未做可不提供）；
④ 血常规、血生化、肝肾功能、出凝血功能、肿瘤标志物、传染病（乙肝、丙肝、艾滋、梅毒）及病毒载量检测报告；
⑤ 既往用药史、过敏史、疼痛控制情况记录；育龄期女性需提供妊娠试验报告。
【研究中心所在地区】
河北、山西、黑龙江、吉林、辽宁、江苏、浙江、安徽、福建、江西、山东、河南、湖北、湖南、广东、海南、四川、贵州、云南、陕西、甘肃、青海、北京、上海、天津、重庆等，上百个城市均设有项目中心。
全国百家三甲医院负责主治，根据患者实际病情（局部晚期/局部复发）及治疗耐受情况匹配筛选。招募拟接受新辅助或根治性放化疗的食管癌、食管胃结合部癌患者，您可直接联系我们进行匹配筛选。
官方渠道：线上扫码加微信详细咨询报名
06
癌症肿瘤项目
【食管癌】
晚期实体瘤T3011疱疹病毒注射液I/IIa期临床试验招募
【基本信息】
登记号：CTR20192464
相关登记号：无
药物名称：T3011疱疹病毒注射液 曾用名：无
药物类型：生物制品
临床申请受理号：企业选择不公示
适应症：晚期实体瘤，包括但不限于浅表性肿瘤、乳腺癌、头颈部肿瘤、食管癌、肉瘤、黑色素瘤（标准治疗无效或不耐受，无后续有效标准治疗）
试验专业题目：评估T3011疱疹病毒注射液在晚期实体瘤患者中的安全性、耐受性、生物分布特征和生物效应的I/IIa期临床研究
试验通俗题目：T3011疱疹病毒注射液Ⅰ/Ⅱa期临床研究
试验方案编号：TG1819ONC 方案最新版本号：5.1 版本日期：2023-05-09
试验分类：安全性和有效性
试验分期：I/IIa期
设计类型：单臂试验
随机化：非随机化
盲法：开放
试验范围：国内试验
方案是否为联合用药：企业选择不公示
受试者信息：Part I 18-70岁（含），Part II、III 18岁及以上（无上限）；性别：男+女；健康受试者：无
【入选标准】
1. 自愿签署书面知情同意书，理解研究内容，依从性良好，能遵守所有试验要求；
2. 年龄要求：Part I 18-70岁（含），Part II、III 18岁及以上，男女不限；ECOG体能状态评分0-1分，预期生存期≥12周；
3. 经组织学/细胞学确诊为晚期实体瘤，标准治疗后进展或不耐受，无后续有效标准治疗；Part III 限定瘤种：肉瘤、头颈部鳞癌（非鼻咽癌）、乳腺癌、黑色素瘤，且各瘤种需符合对应病理及治疗史要求；
4. 按RECIST v1.1标准有可测量病灶（基线最长径≥10mm，淋巴结短轴≥15mm），且病灶未放疗（放疗后明确进展除外）、筛选期无额外活检，可准确重复测量；
5. 有可注射病灶（直接注射或影像辅助注射），单个病灶最长径≥10mm或多个病灶最长径之和≥10mm；
6. 器官和骨髓功能达标（采血前2周无造血生长因子治疗或输血等）：①血液学：ANC≥1.5×10⁹/L，血小板≥75×10⁹/L，血红蛋白≥9g/dL；②肾功能：血清肌酐≤1.5×ULN或肌酐清除率≥50ml/min；③肝功能：总胆红素≤1.5×ULN，AST/ALT≤2.5×ULN（肝转移者≤5×ULN），白蛋白≥2.8g/dL；④凝血功能：INR/PT、aPTT≤1.5×ULN（皮肤/皮下注射病灶者，抗凝药物导致指标延长可由研究者判定）；个别指标不达标可复筛一次；
7. 育龄期女性首次给药前7天内血清妊娠试验阴性；有生育能力的受试者（含伴侣），需在签署知情同意后至末次给药后6个月内采取有效避孕措施。
【排除标准】
1. 首次给药前4周内接受过抗肿瘤治疗，或距上次治疗未达5个半衰期（取较短者）；Part III 需排除4周内接受过抗肿瘤治疗者；
2. 既往局部放疗结束距首次给药＜1周，或大面积放疗/超过30%骨髓照射结束＜4周；
3. 既往接受过溶瘤病毒、其他基因治疗（Part I仅接受T3011治疗者除外），或IL-12联合PD-1/PD-L1抗体治疗（Part I仅接受T3011治疗者除外）；
4. 仍在本项目Part I组未出组，或未完成DLT观察及安全随访者；
5. 头颈部鳞癌患者：肿瘤侵犯/包裹主要血管/气管/食管，或颈动脉照射野接受过重复放疗；
6. 首次给药前28天内接受过非诊断性大手术、有未愈合伤口/溃疡/骨折（病灶破溃者需研究者与申办方共同评估）；
7. 既往抗癌治疗毒性反应（脱发除外）未恢复至CTCAE v5.0 0-1级；
8. Part I、II排除原发性脑肿瘤或脑转移者；Part III排除颅内病灶3个月内进展者；
9. Part III排除有症状、需频繁处理（≥每月1次）的大量胸/腹水或心包积液者；
10. 首次给药前12个月内有癫痫发作史，或处于口唇疱疹发作期；
11. 合并不可控疾病：如症状性心衰、不稳定性心绞痛、室性心律不齐等；
12. 存在活动性感染：活动性肺结核、HIV抗体阳性、HBsAg/HBcAb阳性（HBV DNA≥10⁴copies/ml或≥2000IU/mL者排除）、HCV抗体及RNA阳性；
13. 对HSV-1、IL-12、抗PD-1抗体或T3011处方组分有过敏史；
14. 患有活动性自身免疫疾病、原发性/继发性免疫缺陷病；
15. 首次给药前4周内使用过全身免疫抑制药物（＞10mg/天泼尼松或同等剂量），吸入/外用及≤10mg/天泼尼松替代治疗者除外（无活动性自身免疫病）；
16. 非肉瘤患者远处转移病灶＞3个或最大转移灶直径＞3cm，肉瘤患者最大转移灶直径＞5cm（计划注射的可注射病灶不计入）；
17. 既往免疫治疗中出现过非感染性肺炎/间质性肺炎、≥3级免疫相关不良反应，或不良反应未恢复至≤1级者；
18. 首次给药前5年内患过本研究瘤种以外的其他恶性肿瘤（研究者与申办方确认已治愈、无转移风险者除外）；
19. 研究期间需使用全身抗HSV药物（局部应用除外），或计划接受其他抗肿瘤治疗（含抗肿瘤中草药）；
20. 有精神疾病、药物/酒精滥用史（近1年内），或处于妊娠期、哺乳期、计划本试验期间生育；
21. 正在参加其他临床研究，或计划1个月内加入其他临床试验；
22. 肿瘤位于不适合瘤内注射部位（如包围颈动脉、邻近重要神经血管/气道/食管，注射风险高），或研究者判定存在其他不适合入组的因素。
【试验分组】
试验药（T3011疱疹病毒注射液）：中文通用名：T3011疱疹病毒注射液；英文通用名：Herpes Virus T3011 Injection；商品名称：NA；剂型：注射剂；规格：0.25mL/支、0.5mL/支（1×10⁸ PFU/mL）；用法用量：稀释后瘤内注射，病毒滴度为2.5×10⁵-1.0×10⁸ pfu/mL，注射体积由研究者根据肿瘤大小确定；用药时程：Part I为1个周期，Part II、III为12个周期；
对照药：无
【患者权益】
1. 免费体检及相关试验流程检查（血常规、肝肾功能、影像学、肿瘤标志物、传染病筛查、病毒载量检测等）；
2. 有一定的交通补助及随访补贴；
3. 免费用药治疗（T3011疱疹病毒注射液）及相关给药、检测操作；
4. 就诊国内多中心合作知名三甲医院，全程由实体瘤专科专家团队跟踪诊疗及健康管理。
【需要资料】
肿瘤项目需要的资料（通用）
① 详细记录病情、既往治疗经过（含放化疗、免疫治疗、溶瘤病毒/基因治疗史）的最新出院记录；
② 最近两次复查的CT或核磁报告（明确可测量病灶，符合RECIST v1.1标准）；
③ 确诊时的病理报告（肉瘤患者需明确病理类型，可提供组织切片或配合活检复核），基因检测报告（未做可不提供）；
④ 血常规、血生化、肝肾功能、出凝血功能、肿瘤标志物、传染病（乙肝、丙肝、艾滋、梅毒）及病毒载量检测报告；
⑤ 既往用药史、过敏史、手术史、放疗史及治疗相关不良反应恢复情况记录；育龄期女性需提供妊娠试验报告。
【研究中心所在地区】
河北、山西、黑龙江、吉林、辽宁、江苏、浙江、安徽、福建、江西、山东、河南、湖北、湖南、广东、海南、四川、贵州、云南、陕西、甘肃、青海、北京、上海、天津、重庆等，上百个城市均设有项目中心。
全国百家三甲医院负责主治，根据患者实际病情、瘤种类型及试验分组要求匹配筛选。招募晚期实体瘤（肉瘤、头颈部鳞癌、乳腺癌、黑色素瘤、食管癌等）患者，您可直接联系我们进行匹配筛选。
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临床3期临床结果
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研发状态
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 皮肤利什曼病 | 美国 | 2014-03-19 | |
| 粘膜皮肤利什曼病 | 美国 | 2014-03-19 | |
| 内脏利什曼病 | 美国 | 2014-03-19 |
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 肿瘤 | 临床前 | 中国 | 2024-12-09 |
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床2期 | - | 艱製觸積鏇夢襯顧鏇淵(觸鬱選獵積蓋繭選繭蓋) = 艱鹹夢鬱製鹹醖構範鬱 構遞齋繭觸繭顧範鏇範 (艱襯衊廠鬱鏇遞鏇遞淵 ) | 积极 | 2024-07-15 | |||
艱製觸積鏇夢襯顧鏇淵(觸鬱選獵積蓋繭選繭蓋) = 淵網簾網顧鹽願壓壓簾 構遞齋繭觸繭顧範鏇範 (艱襯衊廠鬱鏇遞鏇遞淵 ) | |||||||
临床2期 | 110 | Paromomycin/Miltefosine | 糧繭蓋糧願憲齋鹹鏇憲(憲網獵鹹憲憲觸糧膚遞) = 觸鑰鏇願遞鹹糧構鬱壓 製鹽齋夢淵繭積鏇繭網 (鬱襯築夢繭獵醖顧醖網, 90.3 ~ 100) | 积极 | 2023-11-21 | ||
Liposomal Amphotericin B/Miltefosine | 糧繭蓋糧願憲齋鹹鏇憲(憲網獵鹹憲憲觸糧膚遞) = 鏇蓋簾網顧淵醖遞簾製 製鹽齋夢淵繭積鏇繭網 (鬱襯築夢繭獵醖顧醖網, 70.2 ~ 91.9) | ||||||
N/A | 6 | 積醖範觸憲餘蓋願齋壓(鏇網壓獵鹽壓鬱夢範蓋) = 網構壓憲糧獵憲遞遞選 積簾壓製鬱願夢衊餘夢 (網窪膚糧窪鹹鑰膚蓋糧 ) 更多 | 积极 | 2023-07-03 | |||
临床2期 | 130 | Thermotherapy | 範鏇鏇醖簾鹹艱鑰選願(獵範夢醖膚選範築窪糧) = The presence of vesicles at the site of heat application was the most common adverse event reported associated with the use of TT; while vomiting (31.8%) and elevation of liver enzymes (28.8%) were the most frequent adverse events reported associated with the use of MLT. 製艱鏇顧憲夢製夢繭範 (製廠網遞觸製憲衊鹽壓 ) | 积极 | 2022-03-07 | ||
Thermotherapy + Miltefosine | |||||||
N/A | 94 | 鏇網顧鏇築糧顧蓋鹽鹽(夢衊製獵窪鏇鹹憲餘憲) = 積壓艱夢觸餘壓鏇蓋鹹 鹹簾壓繭鑰壓鏇獵鹹鏇 (廠網衊鬱簾淵觸範鹽獵 ) 更多 | - | 2021-05-28 | |||
临床3期 | 150 | Topical GM-CSF + Miltefosine | 淵選簾獵廠顧糧襯鑰選(繭鑰淵簾觸積膚憲繭選) = One patient (group MA) stopped treatment after presenting with fever, exanthema, and severe arthralgia 簾壓遞願遞獵顧夢簾廠 (獵窪憲構鏇憲鏇構繭窪 ) 更多 | - | 2021-02-01 | ||
Placebo + Miltefosine | |||||||
临床2期 | 4 | 簾願艱壓窪衊鑰鹹願蓋 = 網餘範窪餘夢顧壓衊獵 範襯艱築糧蓋衊襯蓋壓 (繭衊鬱糧鬱鏇願遞壓衊, 艱簾醖遞膚廠製構齋壓 ~ 顧廠鹹壓簾積構艱窪醖) 更多 | - | 2020-09-30 | |||
临床3期 | 133 | Miltefosine + topical GM-CSF | 鏇鹹艱淵淵獵蓋鏇築鹹(觸窪廠範鹹鑰鬱夢獵願) = 獵夢憲壓鑰襯蓋積艱夢 淵憲壓憲遞衊簾製廠餘 (糧齋鏇糧壓鏇餘蓋蓋膚 ) 更多 | 积极 | 2020-09-07 | ||
Miltefosine + placebo | 鏇鹹艱淵淵獵蓋鏇築鹹(觸窪廠範鹹鑰鬱夢獵願) = 繭積鏇顧願衊簾構簾壓 淵憲壓憲遞衊簾製廠餘 (糧齋鏇糧壓鏇餘蓋蓋膚 ) 更多 | ||||||
临床2期 | 30 | 遞夢遞鑰顧齋憲壓壓夢(窪艱顧衊餘鹹築夢鑰製) = There were 2 serious AEs: both were unrelated to treatment and both patients were fully recovered 鏇糧餘願廠顧顧膚願選 (願鹽夢獵糧醖積願蓋蓋 ) 更多 | - | 2019-04-24 | |||
临床3期 | 601 | 繭醖夢積簾鏇齋窪獵鑰(餘簾淵範蓋積窪糧繭艱) = There were 12 serious adverse events in the study in 11 patients that included 3 non-study drug related deaths. There were no relapses or PKDL up to 6 months follow-up. All treatments were well tolerated with no unexpected side effects. Adverse events were most frequent during treatment with miltefosine + paromomycin, three serious adverse events related to the treatment occurred in this arm, all of which resolved. 簾遞遞廠鏇構製醖襯壓 (齋構醖鑰餘構糧網顧廠 ) | - | 2017-05-01 | |||
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