Targeted Versus Standard Peri-operative Antibiotic Prophylaxis in Patients Colonized With Carbapenemase-producing Enterobacterales Undergoing Liver Transplantation: a Stepped Wedge Cluster Randomization Trial

This is a multicenter stepped-wedge cluster randomized trial, conducted over a 2-year period at three hospitals. The trial is structured into four phases, each lasting six months. During phase 1 (pre-rollout), all hospitals will use standard antibiotic prophylaxis for all patients. In each of phases 2 to 4, one hospital will switch to targeted antibiotic prophylaxis, so that by phase 4 all hospitals will be using it. The order in which hospitals switch is determined by computer-generated randomization performed centrally by an independent statistician, ensuring each hospital has an equal chance of switching at any given phase and minimizing selection bias.
The goal of this clinical trial is to learn whether targeted antibiotic prophylaxis works better than standard antibiotic prophylaxis at preventing infections in liver transplant patients who carry resistant bacteria called CPE (carbapenemase-producing Enterobacterales). It will also learn about the effects of these antibiotics on gut bacteria.
The main questions it aims to answer are:
* Does targeted antibiotic prophylaxis reduce the number of CPE infections occurring in the first two weeks after liver transplant, compared to standard prophylaxis?
* How do targeted and standard antibiotic prophylaxis affect the gut microbiome after transplant?
* Is there a link between achieving optimal antibiotic blood levels and the risk of developing an infection after transplant?
Researchers will compare targeted antibiotic prophylaxis (chosen based on the specific bacteria each patient carries) to standard antibiotic prophylaxis (used routinely at each hospital) to see which approach better prevents infection.
This study does not involve the administration of any drugs or instrumental examinations beyond those already part of standard clinical care at each center. However, additional blood tests will be performed by collecting one extra blood sample (and a bile sample, if the patient has a Kehr's tube, which is a drain placed in the bile duct after surgery) during blood draws already scheduled as part of routine clinical practice, in order to measure drug levels in the blood. Stool samples will also be collected specifically for the study to investigate the gut microbiome.

开始日期2026-10-01

申办/合作机构

IRCCS Azienda Ospedaliero-Universitaria di Bologna

CTIS2024-516232-10-00

/ Recruiting临床4期IIT

Defining Antibiotic Levels in Intensive care patients (DALI-2) protocol - A multi-national pharmacokinetic/pharmacodynamic cohort study to determine whether contemporary antibiotic dosing for critically ill patients achieves therapeutic exposures.

开始日期2026-07-31

申办/合作机构

Centre Hospitalier Universitaire de Nimes

NCT07431307

/ Not yet recruiting临床2期

A Two-part Phase IIb Randomized, Multicenter, Open-label Comparative Study to Firstly Evaluate the Safety and Efficacy Trial of BV100 in Combination With Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol Versus Best Available Therapy in Patients With Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia and Bloodstream Infection, Suspected or Confirmed to be Due to Carbapenem-resistant Acinetobacter Baumannii Calcoaceticus Complex (CRABC), and Secondly to Evaluate the Pharmacokinetics of BV100 in Combination With Low Dose Polymyxin B Plus Cefideroc

This Phase IIb study aims to evaluate the safety and efficacy of BV100 in combination with low dose polymyxin B plus ceftazidime/avibactam or cefiderocol in patients with suspected or confirmed CRABC infections. The study is divided into two parts (Part A and Part B), recruiting in parallel. Approximately 10 subjects will be recruited in Part B, with enrollment ending once Part A enrollment is complete (at least 30 patients randomized to all of the three groups). Eligible patients, who have given informed consent, will be enrolled, and pre-treatment microbiology samples submitted to a local laboratory.

开始日期2026-07-01

申办/合作机构

BioVersys AG

100 项与硫酸甲苯磺酸头孢德罗相关的临床结果

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100 项与硫酸甲苯磺酸头孢德罗相关的转化医学

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100 项与硫酸甲苯磺酸头孢德罗相关的专利（医药）

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1,173

项与硫酸甲苯磺酸头孢德罗相关的文献（医药）

2026-12-01·MEDICAL MICROBIOLOGY AND IMMUNOLOGY

Human ex vivo comparison of Escherichia coli and Pseudomonas aeruginosa lipopolysaccharide–induced immune responses and cefiderocol effects in whole blood

Article

作者: Pracher, Lena ; Eberl, Sabine ; Zeitlinger, Markus ; Weber, Maria ; Jorda, Anselm

Abstract:

Immune dysregulation is central in bacterial sepsis with lipopolysaccharide (LPS) of gram-negative bacteria acting as a key component in innate immune activation. Modulation of the host response by potential immunomodulatory agents may confer benefits. This ex vivo study compared cytokine responses induced by E. coli and P. aeruginosa LPS and evaluated the impact of cefiderocol on LPS-induced immune activation in human whole blood. Whole blood from ten healthy volunteers was stimulated ex vivo with E. coli or P. aeruginosa LPS in the presence or absence of cefiderocol and incubated for 4 h at 37 °C. Plasma concentrations of TNF-α, IL-1β, IL-6, IL-10, IFN-α, IFN-γ, and IL-8 were quantified at 0 h, 2 h, and 4 h using a multiplex immunoassay. Cytokine release was significantly higher after E. coli LPS stimulation than with P. aeruginosa LPS across all analytes. Mean TNF-α area under the curve (AUC₀–₄) was 2379 pg*h/mL with cefiderocol vs 1936 pg*h/mL without (percent difference 18.2% [95% CI, 5.9–31.4]) after E. coli LPS stimulation, and 278 pg/mL vs 242 pg*h/mL (12.9% [4.3–21.5]) after P. aeruginosa LPS stimulation. For IL-6, cefiderocol slightly increased AUC₀–₄ following E. coli LPS stimulation (4584 vs 3635 pg*h/mL; 20.7% [8.3–33.0]) but not with P. aeruginosa LPS (184 vs 201 pg*h/mL; − 9.3% [− 53.7–35.2]). IL-1β, IL-10, IFN-α, IFN-γ, and IL-8 levels were mostly unaffected by cefiderocol. Cefiderocol did not suppress cytokine release in human whole blood. In this study, E. coli LPS elicited a stronger immune response than P. aeruginosa LPS.

2026-11-01·INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS

Molecular and epidemiological characteristics of cefiderocol-resistant Klebsiella pneumoniae: Insights from genomic analysis

Review

作者: Li, Yi ; Li, Chunhua ; Jia, Xun ; Li, Dan ; Zhang, Jie ; Long, Shanshan ; Mao, Huinan ; Yang, Jing

OBJECTIVE:

To characterize reported cefiderocol (FDC)-resistant Klebsiella pneumoniae through a systematic review and reanalysis of available whole-genome sequencing (WGS) data.

METHODS:

PubMed, Embase, and Web of Science were searched for original reports of FDC-resistant K. pneumoniae. Epidemiological, susceptibility, molecular, and available WGS data were extracted and reanalysed. Iron-related disruptive events were compared between high- and lower-minimum inhibitory concentration (MIC) groups among eligible non-outbreak isolates.

RESULTS:

Seventy-five studies reported 779 FDC-resistant K. pneumoniae isolates from 24 countries or regions. Forty-four studies provided WGS data, yielding 145 non-duplicate genomes. The WGS subset comprised 31 sequence types (STs), most commonly ST147, ST16, ST512, and ST307. Carbapenemase genes were detected in 143 genomes, most frequently blaNDM (71/145, 49.0%), blaKPC (65/145, 44.8%), and blaOXA-48-like (31/145, 21.4%); 31 genomes (21.4%) carried carbapenemase genes from two groups. Iron uptake- or regulation-related disruptive events were identified in 59 isolates (40.7%). Among 71 non-outbreak isolates with MIC data, these events were more frequent in the high-MIC group than in the lower-MIC group (78.3% vs. 22.9%; odds ratio = 12.1, 95% confidence interval 3.82-36.18; P < 0.0001), and disruption involving two or more iron-related genes was observed only in the high-MIC group. Among isolates with available data, resistance to ceftazidime-avibactam (105/129, 81.4%) and ceftolozane-tazobactam (75/75, 100%) was frequent, whereas aztreonam-avibactam resistance was detected in 4 of 60 isolates (6.7%).

CONCLUSIONS:

Available WGS data indicate that reported FDC-resistant K. pneumoniae isolates are genetically diverse, commonly carry complex β-lactamase backgrounds, and harbour candidate iron-related genomic alterations associated with higher FDC MICs.

2026-10-01·INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS

Comment on "A multicenter, randomized, double-blind, imipenem/cilastatin-controlled clinical study of cefiderocol for the treatment of complicated urinary tract infections caused by gram-negative pathogens in Chinese adults"

Letter

作者: Li, Qiuqiong ; Luo, Hong ; Chai, Liying

309

项与硫酸甲苯磺酸头孢德罗相关的新闻（医药）

2026-09-14

·药学进展

独家原创 | 2018 年版《国家基本药物目录》与 2025 年版 WHO 《基本药物标准清单》中抗菌药物的比较与分析

“ 点击蓝字关注我们 2018 年版《国家基本药物目录》与 2025 年版 WHO 《基本药物标准清单》中抗菌药物的比较与分析 PPS 任鸣睿，颜建周 * (中国药科大学国家药物政策与医药产业经济研究中心，江苏南京 211198) 颜建周社会与管理药学博士、兴药研究员、博士生导师。中国药科大学伦理委员会委员、浙江大学临床药学研究中心学术委员会委员、国家药物政策与医药产业经济研究中心 (NDPE) 青年研究员、中国医疗保险研究会药物经济专业委员会常务委员、中国医疗保险研究会制度体系与法治建设专业委员会常务委员、中国医疗保险研究会商业健康险专委会委员、中国卫生经济学会药物经济学专委会副主任委员、中国药理学会药源性疾病学专委会委员、中国人体健康科技促进会药物政策研究工作委员会委员、《健康发展与政策研究》《世界临床药物杂志》《中国药科大学学报》等编委 / 青年编委。主持科研项目 60 余项，其中国家自然科学基金面上项目，教育部人文社会科学基金，国家卫健委、国家医保局、国家药监局等部委委托课题多项。以第一作者 / 通信作者在 Value Health,Health Res Policy Sy,PATIENT 等杂志发表论文 40 余篇。 [摘要] 目的比较 2018 年版《国家基本药物目录》(简称 “基药目录”) 与 2025 年版世界卫生组织《基本药物标准清单》(简称 “清单”) 中抗菌药物异同，为进一步完善我国基药目录提供参考。方法采用描述性分析方法对比两版目录中抗菌药物在品种、AwaRe 分类、数量等方面的差异。结果与清单相比，我国基药目录收录的抗菌药物品种数量少，核心抗菌药物选择具有较高一致性，但在多重耐药菌治疗药物、新型抗菌药物纳入方面存在不足，且储备类药物纳入较少，特殊人群适宜剂型不足，规格覆盖范围较窄。结论我国基药目录的抗菌药物部分在应对耐药挑战和满足特殊人群需求方面有待加强，尤其在保障临床有效性、提升用药安全性及优化长期经济性方面存在优化空间。建议参考 WHO 清单，优化品种结构，增加耐药治疗和新型抗菌药物，补充适宜剂型与规格，以提升临床用药的合理性、安全性与可及性。基本药物 (essential medicines) 的概念由世界卫生组织 (World Health Organization,WHO) 于 1975 年世界卫生大会首次提出，并于 1977 年在第 615 号技术报告中正式提出，基本药物是指适应基本医疗卫生需求、剂型适宜、价格合理，能够保障供应，且由国家负责遴选、公众可公平获得的药物 [1‑2]。《世界卫生组织基本药物标准清单》(WHO Model List of Essential Medicines,EML, 简称 “清单”) 每两年更新发布一次，其遴选以药品的安全性、有效性和经济性为核心原则，旨在为各国制定本土基本药物目录提供参考指南，进而提高药物可及性，促进合理用药，降低医疗成本。在现代医学领域，抗菌药物广泛应用于感染性疾病的治疗，其合理用药与可及性直接关系到全民健康保障水平。然而，由于抗菌药物的滥用与误用，抗菌药耐药性问题持续加剧，并已发展为全球性公共卫生挑战 [3]。据统计，仅 2019 年，抗菌药耐药性直接导致全球约 127 万人死亡，间接导致约 495 万人死亡 [4]。在此背景下，WHO 于 2017 年制定了抗菌药物 AWaRe 分类体系，作为支持地方、国家及全球层面开展抗菌药物管理工作的工具，助力遏制耐药性的发展。该体系将抗菌药物分为 3 类：获取类 (access)、慎用类 (watch) 和储备类 (reserve), 旨在考量不同类别及品种抗菌药物对耐药性的影响程度，强调临床合理用药的重要性 [5]。我国《国家基本药物目录》(List of National Essential Medicines,NEML, 简称 “基药目录”) 是各级医疗卫生机构配备和使用药品的基础，2018 年版目录在 2012 年版目录的基础上进行了显著优化与扩充，品种数量由 520 种增至 685 种，增幅达 31.73%[6], 旨在高质量满足人民群众疾病防治基本用药需求。此次目录的调整确立了动态更新机制，原则上调整周期不超过 3 年，但自 2018 年以来，NEML 已 7 年未进行更新。鉴于当前细菌耐药形势的快速演变、新型抗菌药物的研发进展及国际治疗指南的持续更新，对现行目录内抗菌药物开展周期性、基于国际标准对照的评估显得尤为迫切。基于此，本文对 2025 年版 EML 和 2018 年版 NEML 中的抗菌药物目录进行比较分析，从品种、数量、剂型、规格到 AWaRe 分类管理结构等多维度展开剖析，并重点结合基本药物遴选原则 (安全性、有效性和经济性) 评估两者间差异，旨在为我国基本药物目录的修订与完善提供参考。 1 资料与方法 1.1 资料本研究纳入 WHO 发布的 2025 年版 EML [7] 和国家卫生健康委员会公布的 2018 年版 NEML [8]。 1.2 方法对比上述 2 个目录中的抗菌药物内容，包括品种、数量、剂型、规格等，采用 Excel 软件进行汇总与分析，比较 2025 年版 EML 和 2018 年版 NEML 的异同。 2025 年版 EML 采用解剖‑治疗‑化学 (anatomical therapeutic chemical,ATC) 分类法进行分类，并在抗生素部分采用了 AWaRe 分类体系，旨在为监测抗生素使用情况提供标准化工具 [5]。 2018 年版 NEML 则基于药品结构或药理作用机制进行分类。本研究中涉及的抗菌药为 2025 年版 EML 中抗感染药物 (6.0)‑抗菌药物 (6.2)(不包括抗麻风药物和抗结核药物) 和抗真菌药物 (6.3) 项下的药物目录；2018 年版 NEML 中抗微生物药物 (不包括抗结核病药、抗麻风病药、抗病毒药) 项下的药物目录。 2 结果与分析 2.1 抗菌药物的品种与数目比较 2025 年版 EML 共收录抗菌药物 50 个品种，覆盖 14 个药理类别；2018 年版 NEML 收录抗菌药物 36 个品种，覆盖 11 个药理类别。两个目录重合品种数为 24 个，总体重合率为 67%, 表明两个目录在核心抗菌药物的遴选上具有较高的一致性 (见表 1)。基于我国感染性疾病的流行病学特征，碳青霉烯类耐药革兰阴性菌 (carbapenem‑resistant Enterobacteriaceae,CRE) 检出率持续上升、耐甲氧西林金黄色葡萄球菌 (methicillin‑resistant Staphylococcus aureus,MRSA) 感染负担仍较重 [9], 然而 EML 中收录的用于治疗多重耐药革兰阳性菌感染的糖肽类药物 (万古霉素) 和针对泛耐药革兰阴性菌的多肽类药物 (多黏菌素 B) 等关键药物，尚未被 2018 年版 NEML 收录。这些药物是美国感染病学会 (Infectious Diseases Society of America, IDSA) 发布的《2024 抗微生物耐药革兰阴性菌治疗指引》[10] 中推荐用于治疗 MRSA、CRE 等耐药菌感染的 “最后防线” 药物，其在医保目录中缺失，直接削弱了临床应对泛耐药菌感染的诊疗有效性。值得注意的是，2025 年版 EML 在药品遴选上更加顺应新研发药物和耐药性的发展，纳入了针对多重耐药菌感染的新型药物，如头孢他啶阿维巴坦、头孢洛生他唑巴坦钠、美罗培南法硼巴坦、头孢地罗酚等，此类药物具有较好的长期经济性优势。相比之下，受限于 2018 年版 NEML 未及时更新，我国当前抗菌药目录仍以传统一线药物为主，对新型抗菌药物及便于督导治疗的复方制剂纳入不足。建议我国抗菌药物目录的调整应更加重视与疾病负担的精准匹配，优先补充治疗多重耐药菌感染的关键药物，同时加强对新型抗菌药物临床价值与长期经济性的综合评估，推动其适时纳入目录。 2.2 抗菌药物的构成分类比较 2018 年版 NEML 与 2025 年版 EML 在 AwaRe 分类框架下重合率较高，达 66% (见表 2)。WHO 建立的 AWaRe 分类框架，其理想目标是确保至少 60% 的抗菌药物消耗来自获取类，同时严格控制慎用类和储备类药物的使用 [11]。2025 年版 EML 中抗菌药物的 AWaRe 分类构成比为获取类∶慎用类∶ 储备类 = 20∶11∶9 (50.0%∶27.5%∶22.5%), 整体以获取类药物为基础，慎用类与储备类药物合理配比，形成 “金字塔形” 构成。为促进临床合理应用抗菌药物，控制细菌耐药发展，我国于 2012 年发布了《抗菌药物临床应用管理办法》[12], 将抗菌药物分为非限制使用级、限制使用级与特殊使用级 3 个管理层级，该分级体系与 WHO 的 AWaRe 分类框架相对应。此后，各地区依据该办法并结合本地抗菌药物使用实际情况，制定了相应的抗菌药物临床应用分级管理目录。本研究参照《京津冀医疗机构抗菌药物临床应用分级管理目录 (2024 年版)》[13] 对 2018 年版 NEML 内抗菌药物进行分级梳理，结果显示其构成比为非限制使用级∶ 限制使用级：特殊使用级 =79.5 %: 15.4 %: 5.1 % （见图1），该目录整体以非限制使用级药物为主，限制使用级与特殊使用级为辅，分级结构与 WHO 的 AWaRe 分类框架理想目标相符。具体来看，2018 年版 NEML 中非限制使用级药物 (79.5%) 占比高于 2025 年版 EML 中的获取类药物 (50%), 限制使用级 / 特殊使用级药物 (20.5%) 占比远低于慎用类 / 储备类药物 (50%), 显示出我国目录对保障基础药物可及性与安全性的重视。2018 年版 NEML 所收录的储备类药物虽与 2025 年版 EML 的重合度达 100%, 但具体品种数量相差较大。特别是多黏菌素 E、多黏菌素 B 及新型药物头孢地尔等关键品种的缺失，限制了临床对 MRSA、CRE 和碳青霉烯类耐药鲍曼不动杆菌 (carbapenem‑resistant Acinetobacter baumannii, CRAB) 等泛耐药菌感染治疗的有效性。基于此，建议我国在进行目录调整时适当参考 AWaRe 框架，补充储备类药物、优化品种结构，并加强分级管理在临床实践中的落实，以促进抗菌药物合理使用，控制耐药性发展。 2.3 抗菌药物的剂型比较在抗菌药物剂型方面，2018 年版 NEML 中传统口服剂型 (如片剂、胶囊) 覆盖面较广，同一药品常同时收录片剂、胶囊及颗粒剂，临床实际应用时短缺风险较低（见表3）。然而，2018 年版 NEML 中干混悬剂、散剂、口服液等剂型收录数量较少；2025 年版 EML 在口服液用粉末 (13 种)、口服液 (10 种) 和分散片 (4 种) 等剂型的收录数量明显高于 2018 年版 NEML，且涵盖了阿莫西林‑克拉维酸、头孢呋辛等临床高频使用品种。上述剂型更便于儿童、老年人等吞咽困难患者服用，能够显著提高此类患者的用药依从性。相关研究显示，分散片可在水中崩解为混悬液后服用，能使 6 岁以下患儿整片吞服失败率从 40% 显著降低至 10% 以下 [14]。我国现有目录中分散片收录数量较少，不利于儿童等吞咽困难患者服用。此外，我国药品目录已纳入干混悬剂等儿童适宜剂型，以改善儿童用药可及性，但可供临床选择的口服液体制剂的品种和规格仍显不足，临床中仍依赖片剂分割使用，易导致切割不准确、药物稳定性下降、生物利用度受影响等问题 [15]，既影响治疗有效性，也带来安全隐患。在给药途径多样性方面，2025 年版 EML 考量更为全面，该目录新增收录了栓剂 (甲硝唑)，此类剂型经直肠黏膜直接吸收，无需经过胃腔，可有效避免口服甲硝唑引起的上消化道不适，为无法口服给药的患者 (如术后或严重呕吐者) 提供了有效、便捷的替代治疗方案，保障了药物治疗的连续性和可及性，而 2018 年版 NEML 中未收录此类抗菌药物剂型。此外，2025 年版 EML 中还纳入了注射用油性悬浮液 (氯霉素)，与普通注射液、注射用粉末相比，注射用油性悬浮液可在肌肉注射部位形成药物贮库，借助组织液与油相间的缓慢扩散及药物再溶解过程，实现 ≥21 d 的药物持续释放，从而满足疾病暴发期单剂给药的替代需求 [16]，进一步提升患者用药依从性。综上所述，建议在我国基药目录的修订过程中，进一步重视剂型与临床需求的匹配，尤其要加强对儿童、老年人等特殊人群适宜剂型的纳入，保障其用药安全性与有效性，同时应丰富抗菌药物的给药途径，增加临床用药选择，提升合理用药水平。 2.4 抗菌药物的规格比较由于 2018 年版 NEML 与 2025 年版 EML 中抗菌药物的规格数量较多，为全面覆盖不同类别和剂型、系统反映规格纳入的差异，本研究最终筛选出 6 种具有代表性的抗菌药物进行对比分析（见表4）。与 2018 年版 NEML 相比，2025 年版 EML 纳入的规格跨度更广，以左氧氟沙星为例，2025 年版 EML 收录了 0.1 ~ 0.75 g 等多种口服规格，便于临床医师根据患者感染严重程度 (如复杂性尿路感染可能需要更高剂量) 和肾功能情况进行个体化剂量调整，有助于提高临床治疗效果并降低不良反应发生风险，体现了对个性化治疗有效性和用药安全性的考量。相比之下，2018 年版 NEML 仅收录 0.2 g 与 0.5 g 两种固定规格，与 2025 年版 EML 差异显著，这可能与我国执行 “一品两规” 制度有关，选择适宜规格纳入基药目录具有重要的现实意义。2025 年版 EML 与 2018 年版 NEML 均纳入了抗菌药物复方制剂，但两版目录对复方制剂规格的描述上存在较大差异。以阿莫西林克拉维酸钾为例，2025 年版 EML 主要纳入了 5∶1 (注射) 和 4∶1/7∶1 (口服) 等标准化配比，2018 年版 NEML 目录同时列有 2∶1、4∶1、5∶1、7∶1 等多种比例。此外，2025 年版 EML 在注射用粉末规格中明确标注了 “以钠计算”，确保了不同厂家、不同批次药品间剂量的准确换算与一致性，避免了因盐基不同造成的剂量偏差，进而保障临床给药安全。2018 年版 NEML 仅对药物质量进行规定，并未对盐基进行明确说明。综上，建议我国基药目录调整时，系统增补国内上市药品的主流规格，根据临床实际应用情况对部分规格进行优化调整，且明确标注注射用粉末的盐基，从而提升给药的灵活性与安全性。 3 讨论与建议我国 2018 年版 NEML 与 2025 年版 EML 在核心抗菌药物的遴选上具有较高一致性，但在药物的品种数量、品种结构合理性、剂型适宜性和规格覆盖范围等方面仍存在一定差异。未来，在我国基药目录的调整与管理中，应在安全性、有效性、经济性基本原则的基础上，构建融合药物流行病学、临床药学与药物经济学等多维度评估框架，2025 年版 EML 可作为我国目录优化提供借鉴与参考。 3.1 基于遴选原则的品种优化 3.1.1 有效性为核心，补充关键治疗药物 2018 年版 NEML 在抗菌药物的品种覆盖上仍以传统一线药物 (青霉素类、头孢菌素类、喹诺酮类等) 为主，而针对碳青霉烯类耐药革兰阴性菌和耐药革兰阳性菌等感染的部分关键治疗药物纳入不足。WHO 监测数据显示，2018—2023 年全球范围内所监测的病原体‑抗生素组合中，超过 40% 的受监测抗生素耐药性呈上升趋势，年均增幅达 5% ~ 15%[17]，面对多重耐药菌感染日益严峻的防控挑战，2025 年版 EML 纳入了能有效治疗多重耐药革兰阴性菌和阳性菌感染的糖肽类、多肽类、环肽类等关键药物。鉴于我国 2018 年版 NEML 尚未收录此类用于治疗多重耐药菌的药物，建议在我国基药目录调整中，优先考虑将其补充纳入，同时加快评估并纳入经循证医学证实可有效应对耐药性的抗菌药物。此外，2025 年版 EML 纳入了头孢他啶阿维巴坦、头孢洛生他唑巴坦钠、头孢地罗酚等新型抗菌药物，此类药物作用机制独特，能有效应对耐药菌感染。以头孢他啶阿维巴坦为例，2025 年一项前瞻性真实世界研究结果显示，该药在治疗由多重耐药革兰阴性菌 (如铜绿假单胞菌、肺炎克雷伯菌) 引起的各类感染时，总体治疗成功率达 79.0%，28 d 死亡率为 20.2%，同时严重不良事件发生率较低 (6.2%)[18]，充分体现出其在应对此类复杂耐药感染时兼具疗效与安全性的临床价值。凭借卓越的临床疗效，上述药物还被纳入了《IDSA 2022 年关于广谱 β 内酰胺酶产生的肠杆菌、耐碳青霉烯的肠杆菌和难治性铜绿假单胞菌的治疗指南》[19] 和《2021 ESCMID 指南：多重耐药革兰阴性杆菌感染的治疗》[20] 等多个国际权威指南。其次，该类新型抗菌药物的临床应用能显著节省医疗费用，展现出显著的经济性优势。同样以头孢他啶阿维巴坦为例，在感染治疗早期引入该药物，可通过提高疗效和缩短住院时间等途径，在 10 年周期内实现医疗成本的大幅节约与质量调整生命年的有效增加 [21]。考虑到当前我国细菌耐药形势依然严峻，因此建议考虑将此类高品质新型抗菌药物纳入相关目录。在纳入评估时，需综合考量其临床有效性、安全性数据以及基于我国国情的药物经济学评价结果，以期更好地满足我国患者的治疗需求，提升治疗保障水平。此外，我国目录内部分药品 (如替硝唑、磺胺嘧啶等) 虽未直接列入 WHO 标准清单的 “抗菌药” 分类下，但均被收录于目录的其他章节 (如抗原虫药、抗感染药等)，这表明我国基药目录与 WHO 标准清单在品种覆盖上保持了高度一致。 3.1.2 优化品种结构，平衡安全性与经济性剂型的适宜性是保障用药安全性与有效性的基础，也直接影响治疗的整体经济性。当前，我国基药目录中收录的抗菌药物品种以非限制使用级药物为主，限制使用级与特殊使用级为辅，整体结构与 WHO 建立的 AWaRe 分类框架理想目标相符，但在非限制使用级和储备类药物的纳入方面仍存在优化空间。目前，我国基药目录中非限制使用级药物占比达 79.5%，而 AWaRe 分类中获取类药物占比为 56.3%，两者存在一定差异；我国基药目录 36 个抗菌药物品种中仅有 1 个储备类药物，极大限制了临床应对多重耐药菌的用药选择。AWaRe 分类框架作为全球抗菌药物管理的核心工具，其设计已涵盖了遏制耐药性的目标，我国基药目录中限制使用级与特殊使用级占比较低，可能不利于实现遏制广泛耐药菌传播的安全性目标。从长期经济性角度看，适当增加储备类药物品种并严格规范化管理，能够有效延缓耐药发生、保护现有抗菌药物有效性，其可避免的未来 “无药可用” 产生的巨额防治成本，将远高于当前所投入的药品采购费用。近年来，我国在抗菌药物管理体系与耐药防控方面采取了系列行动。国家层面发布了《遏制微生物耐药国家行动计划 (2022—2025 年)》[22]，并以《抗菌药物临床应用管理办法》为核心，通过实施抗菌药物分级管理、建立抗菌药物临床应用监测网和细菌耐药监测网，全面加强抗菌药物的合理使用。鉴于当前抗菌药物处于严格管控体系之下，在目录中适当纳入更多高级别抗菌药物，预计不会加剧临床滥用问题，反而能提升此类药品的可及性。综上，建议我国基药目录调整过程中，统筹参考 AWaRe 分类框架和《抗菌药物临床应用分级管理目录》，进一步优化抗菌药物品种结构，在适度增加储备类药物的同时，依托我国现有抗菌药物临床应用监测网和分级管理制度，严格落实临床使用监管，切实保障用药安全并合理控制费用。 3.2 补充药物剂型，提升特殊人群用药安全性与依从性药物剂型不仅直接关系到用药的安全性与有效性，也间接影响药物治疗的经济性。我国现行基药目录中，口服剂型覆盖面较广，占所有剂型的 67%，但针对儿童、老年患者及吞咽困难患者等特殊用药人群的适宜剂型相对较少。以吞咽困难患者为例，非固体剂型更有助于其用药，但在我国基药目录收录的 36 种抗菌药物中，仅 10 种药物包含适合吞咽困难患者使用的剂型 (如分散片、散剂、颗粒剂、干混悬剂)，占比仅 27.8%；在 53 个口服制剂中，适宜吞咽困难患者使用的剂型仅占 22.6%，难以充分满足该类患者的用药需求。以儿童患者为例，口服液、颗粒剂、栓剂等为临床常用适宜剂型，其中口服液制剂具有剂量灵活和服用方便的特点，但我国基药目录中抗菌药物部分尚未纳入该种剂型，临床面对儿童患者时仍普遍采用 “片剂掰半” 等方式拆分给药，易造成剂量偏差较大，不仅降低治疗效果，还会增加用药安全风险 [23]。建议在未来基药目录调整中，更加关注特殊人群的用药特点与实际需求，优先纳入分散片、口服液、栓剂、口服液用粉末等可显著提升特殊群体用药安全性与依从性的药物剂型，以满足我国儿童、老年患者等特殊群体的临床用药需求。 3.3 提升规格覆盖范围，保障精准治疗与用药安全 2025 年版 EML 在规格设计上更加注重临床使用的灵活性，以左氧氟沙星口服规格为例，2025 年版 EML 涵盖了 0.1g、0.25g、0.5g、0.75g 共 4 种规格，而 2018 年版 NEML 仅收录 0.2g 和 0.5g 2 种规格，一定程度上影响了临床上不同剂量精细化调整的便利性与准确性。《处方管理办法》[24] 和《抗菌药物临床应用管理办法》要求医疗机构同一通用名称的抗菌药物品种，注射剂型和口服剂型各不得超过 2 种，这恰恰要求国家基药目录本身应提供更丰富、更科学的规格选择，以便于医疗机构采购最符合临床需求的药品规格，进而优化药品资源配置、减少药品浪费。从临床实际应用来看，小规格药品的纳入便于医生根据患者的肾功能状况、感染类型及严重程度等进行更精准的剂量调整 [25]，而大规格药品不仅能满足重症感染的高剂量需求，还可减少单次服药片数，有助于减轻患者的用药负担与心理抗拒感，从而提高患者的治疗依从性 [26]。在复方制剂规格方面，两版目录存在一定差异，以阿莫西林克拉维酸钾为例，2018 年版 NEML 纳入了阿莫西林克拉维酸钾的多种规格比例，2025 年版 EML 遵循循证医学的理念与方法，将其规格比例标准化为 4∶1、7∶1 等，进一步提升了规格选择的科学性与规范性。此外，2025 年版 EML 在注射用粉末规格中标明 “以钠计算”“以钾计算”，确保了剂量给药的准确性，而 2018 年版 NEML 对此未作明确要求，存在潜在的剂量偏差风险。综上所述，为进一步提升我国基药目录的临床应用价值与科学性，建议在后续目录调整中适当增补国内已上市药品的主流规格，结合临床实践需求优化现有规格设置，不断完善药品评估遴选机制，并明确注射用粉末制剂的盐基信息，通过上述措施扩大临床用药选择范围，在确保用药安全有效的基础上，进一步提升药品使用的经济性与合理性。我国基药目录与《WHO 基本药物标准清单》在满足基础抗感染治疗需求的抗菌药物核心品种方面具有较高共识度，但面对当前我国细菌耐药形势严峻、特殊人群用药需求增长等现实问题，现行目录在应对耐药挑战的临床疗效保障、提升特殊人群用药安全性及优化整体卫生资源配置的经济性方面，仍存在显著优化空间。具体而言，在品种方面，重点补充关键耐药菌治疗药物，优化抗菌药物品种结构；在剂型方面，增加特殊人群适宜剂型，提升用药依从性；在规格方面，拓展市场主流规格和临床所需规格，同时规范注射用粉末的盐基标注，以增强治疗灵活性与剂量准确性。通过上述系统化完善，可进一步提升目录的科学性与实用性，为抗菌药物的供应保障、临床合理用药提供决策依据，助力我国有效应对细菌耐药挑战，推进健康中国战略目标的实现。参考文献: [1] 薛慧颖，李娟。解读 2018 年版《国家基本药物目录》[J]. 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Infectious diseases society of America guidance on the treatment of extended‑spectrum β‑lactamase producing enterobacterales (ESBL‑E), Carbapenem‑resistant enterobacterales (CRE), and Pseudomonas aeruginosa with difficult‑to‑treat resistance (DTR‑P. aeruginosa) [J]. Clin Infect Dis, 2021, 72 (7): 1109‑1116. [20] Paul M, Carrara E, Retamar P, et al. European Society of Clinical Microbiology and Infectious Diseases (ESCMID) guidelines for the treatment of infections caused by multidrug‑resistant Gram‑negative bacilli (endorsed by European society of intensive care medicine)[J]. Clin Microbiol Infect, 2022, 28 (4): 521‑547. [21] Yang W, Zhen X, Sun X, et al. Estimating the value of new antibiotic treatment strategies in Zhejiang Province, China: cost‑effectiveness analysis based on a validated dynamic model [J]. BMJ Open, 2024, 14 (8): e086039. [22] 国家卫生健康委员会. 《关于印发遏制微生物耐药国家行动计划 (2022‑2025 年) 的通知》[EB/OL]. (2022‑10‑28)[2022‑10‑28]. https://www.nhc.gov.cn/yzygj/c100068/202210/280d6d 0c875e453aac606f9c215323bb.shtml. [23] Brustugun J, Notaker N, Paetz L H, et al. Adjusting the dose in paediatric care by dispersing fragments of four different aspirin tablets [J]. Acta Paediatr, 2020, 109 (11): 2394‑2401. [24] 国务院卫生部. 《处方管理办法》[EB/OL]. (2007‑02‑14)[2007‑02‑14]. https://www. nhc. gov. cn/wjw/c100068/202201/ 6a4ee53e4a3a407fbd9f520e1e2662c5.shtml. [25] 中国医药信息查询平台。左氧氟沙星 [EB/OL]. (2019‑11‑11) [2019‑11‑18]. https://www.dayi.org.cn/drug/1151912.html. [26] Osterberg L, Blaschke T. Adherence to medication[J]. N Engl J Med, 2005, 353(5): 487‑497. 本文引文格式：任鸣睿,颜建周.2018年版《国家基本药物目录》与2025年版WHO《基本药物标准清单》中抗菌药物的比较与分析[J].药学进展,2026,50(6):543-550. 美编排版：金霆辉感谢您阅读《药学进展》微信平台原创好文，也欢迎各位读者转载、引用。本文选自《药学进展》2026年第 6 期。《药学进展》杂志由教育部主管、中国药科大学主办，中国科技核心期刊（中国科技论文统计源期刊）。刊物以反映药学科研领域的新方法、新成果、新进展、新趋势为宗旨，以综述、评述、行业发展报告为特色，以药学学科进展、技术进展、新药研发各环节技术信息为重点，是一本专注于医药科技前沿与产业动态的专业媒体。《药学进展》注重内容策划、加强组稿约稿、深度挖掘、分析药学信息资源、在药学学科进展、科研思路方法、靶点机制探讨、新药研发报告、临床用药分析、国际医药前沿等方面初具特色；特别是医药信息内容以科学前沿与国家战略需求相合，更加突出前瞻性、权威性、时效性、新颖性、系统性、实战性。根据最新统计数据，刊物篇均下载率连续三年蝉联我国医药期刊榜首，复合影响因子1.311，具有较高的影响力。《药学进展》编委会由国家重大专项化学药总师陈凯先院士担任主编，编委由新药研发技术链政府监管部门、高校科研院所、制药企业、临床医院、CRO、金融资本及知识产权相关机构近两百位极具影响力的专家组成。联系《药学进展》↓↓↓ 编辑部官网：pps.cpu.edu.cn；邮箱：yxjz@163.com；电话：025-83271227。欢迎投稿、订阅！往期推荐聚焦“第七届药学前沿学术论坛暨《药学进展》编委会会议” 聚力前沿赛道，共启学术新程：第七届药学前沿学术论坛在南京隆重启幕承学术匠心，启时代新章：《药学进展》第七届编委会、第三届青年编委会成立大会在宁召开聚焦“兴药为民·2023生物医药创新融合发展大会”“兴药为民·2023生物医药创新融合发展大会”盛大启幕！院士专家齐聚杭城，绘就生物医药前沿赛道新蓝图“兴药强刊”青年学者论坛暨《药学进展》第二届青年编委会议成功召开“兴药为民·2023生物医药创新融合发展大会”路演专场圆满收官！校企合作新旅程已启航我知道你在看哟

2026-09-14

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柳叶刀·传染病学26卷 7-9期

THE LANCET Infectious Diseases. Volume 26Number 7 柳叶刀·传染病学26卷 7期 https://www.thelancet.com/journals/laninf/issue/current Editorial（社论） 1 Key facts about the Bundibugyo virus outbreak 本迪布焦病毒暴发核心事实 The Lancet Infectious Diseases The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：p651 Comment（述评） 2 Treatment of multidrug-resistant Gram-negative infections: a stewardship imperative 多重耐药革兰阴性菌感染治疗：抗菌药物管理势在必行 Sarah Kabbani,L Clifford McDonald The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：p652 3 Meningococcal disease, meningococcal vaccines, and the recent meningococcal outbreak in Kent, UK 脑膜炎球菌病、脑膜炎球菌疫苗与英国肯特郡近期脑膜炎球菌暴发 Shamez N Ladhani,Caroline Trotter,Ray Borrow,Gayatri Amirthalingam,Mary E Ramsay The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：p653 Correspondence（读者来信） 4 Actionable sexual health education for HIV and STI prevention among LGBTQ+ youth in the USA 面向美国性少数青年、可落地实施的艾滋病与性传播疾病预防性健康教育 Jonah Segil,Matthew J Mimiaga The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e268 5 Effectiveness of the BNT162b2 LP.8.1-adapted SARS-CoV-2 vaccine against COVID-19-associated hospitalisation and death: a Danish nationwide cohort study 适配LP.8.1变异株的BNT162b2新冠疫苗预防新冠相关住院与死亡的有效性：丹麦全国队列研究 Christian Holm Hansen,Bolette Soborg,Morten Rasmussen,Ida Rask Moustsen-Helms,Palle Valentiner-Branth The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e269 6 Andes virus on a cruise ship: person-to-person transmission and an empty pipeline 游轮安第斯病毒疫情：人传人传播与药物储备空白 Oriol Mitjà The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e271 7 Bundibugyo Ebola: why preparedness still fails at the point of detection 本迪布焦埃博拉病毒：为何疫情初筛阶段防控体系仍存在短板 Thirumalaisamy P Velavan,Peter G Kremsner,Francine Ntoumi The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e273 8 Cross-border transmission of Ebola virus disease caused by Bundibugyo virus into Uganda, 2026 2026年本迪布焦埃博拉病毒病跨境传入乌干达疫情 Henry Kyobe Bosa,Misaki Wayengera,Atek Kagirita,Bernard Lubwama,Allan Muruta,Susan Nabadda,Andrew Nsawotebba,Charles Olaro,Diana Atwine,Jane Ruth Aceng The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e275 9 Bundibugyo virus disease outbreak in DR Congo: current trajectory and potential risk for a Pandemic Emergency 刚果民主共和国本迪布焦病毒病暴发：当前流行态势及构成国际关注突发公共卫生事件潜在风险 Marie Roseline Belizaire,Dick Chamla,Mohamed Janabi The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e277 10 Estimation of the Ebola outbreak size in the Democratic Republic of the Congo 刚果民主共和国埃博拉疫情规模估算 Ruth McCabe,Lennox Ebbarnezh,Solome Okware,Richard Fotsing,Etien Koua,Paul Mbaka,Adelard Lofungola,Dav M Ebengo,Placide K Mbala,Tania T Bishola,Christian M Ibolobolo,Herman M Matondo,Jean-Clement M Sibo,Sabine L van Elsland,Martina McMenamin,Neil M Ferguson,Olivier le Polain de Waroux,Anne Cori The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e279 Corrections（勘误） 11 Correction to Lancet Infect Dis 2020; 20: 1204–14 《柳叶刀·传染病》2020年；20卷：1204–14页勘误 The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e281 12 Correction to Lancet Infect Dis 2023; 23: 1370–82 《柳叶刀·传染病》2023年；23卷：1370–82页勘误 The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e281 13 Correction to Lancet Infect Dis 2024; 24: 775–82 《柳叶刀·传染病》2024年；24卷：775–82页勘误 The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e281 14 Correction to Lancet Infect Dis 2026; 26: 343–61 《柳叶刀·传染病》2026年；26卷：343–61页勘误 The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e281 15 Correction to Lancet Infect Dis 2025; published online March 18. https://doi.org/10.1016/S1473-3099(26)00059-9 《柳叶刀·传染病》2025年在线发表勘误，2025年3月18日 The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e281 16 Correction to Lancet Infect Dis 2026; published online March 23. https://doi.org/10.1016/S1473-3099(26)00058-7 《柳叶刀·传染病》2026年在线发表勘误，2026年3月23日 The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e281 17 Correction to Lancet Infect Dis 2026; published online March 31. https://doi.org/10.1016/S1473-3099(26)00063-0 《柳叶刀·传染病》2026年在线发表勘误，2026年3月31日 The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e281 18 Correction to Lancet Infect Dis 2026; published online April 17. https://doi.org/10.1016/S1473-3099(26)00144-1 《柳叶刀·传染病》2026年在线发表勘误，2026年4月17日 The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e282 19 Correction to Lancet Infect Dis 2026; published online April 28. https://doi.org/10.1016/S1473-3099(26)00137-4 《柳叶刀·传染病》2026年在线发表勘误，2026年4月28日 The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e282 Newsdesk（新闻瞭望） 20 Hantavirus outbreak on cruise ship kills three 游轮汉坦病毒疫情致3人死亡 Tony Kirby The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e283 21 New WHO prequalifications signal hope for malaria 世卫组织新增预认证药品为疟疾防治带来希望 Sanjeet Bagcchi The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e284 22 New partnership to support TB vaccine implementation 全新合作项目助力结核病疫苗落地推广 Manjulika Das The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e285 23 Updated Global Action Plan on Antimicrobial Resistance 新版全球抗微生物药物耐药性行动计划 Timothy Jesudason The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e286 24 Update on the Ebola virus outbreak in DR Congo 刚果民主共和国埃博拉病毒疫情最新进展 Talha Burki The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e287 25 Research in brief 研究简报 Priya Venkatesan The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e288 Obituary（讣告） 26 Dame Bridget Ogilvie 布里吉特·奥格尔维女爵士 Udani Samarasekera The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：p656 Profile（人物专访） 27 Sabiha Essack—helping Africa lead the fight against AMR 萨比哈·埃萨克——助力非洲主导抗微生物耐药性攻坚 Tony Kirby The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：p657 Media Watch（媒体观察） Film（影视） 28 Challenging the stigma around leprosy 消除麻风病相关社会污名 Sanjeet Bagcchi The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：p658 Articles（论著） 29 Survival trends in patients with difficult-to-treat, antibiotic-resistant, Gram-negative infections in the era of next-generation antibiotics in the USA: a retrospective cohort study 新一代抗生素时代美国难治性耐药革兰阴性菌感染患者生存趋势：一项回顾性队列研究 Morgan K Walker,Christina Yek,Sadia Sarzynski,Sarah Warner,Anthony D Harris,Jonathan D Baghdadi,Katherine E Goodman,John H Powers III,Michael Klompas,Chanu Rhee,Bruce Swihart,Sameer S Kadrifor the NIH Antimicrobial Resistance Outcomes Research Initiative (NIH-ARORI) The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：p659 30 Development and validation of the AURIS score for predicting candidaemia in Candidozyma auris-colonised patients in the intensive care unit: a bicentric retrospective cohort study 重症监护室耳念珠菌定植患者念珠菌血症预测AURIS评分构建与验证：双中心回顾队列研究 Victor Garcia-Bustos,Francesc Puchades,Fernando Alonso-Ecenarro,Marta Dafne Cabanero-Navalon,Alba Ruiz-Gaitán,Javier Pemán,Miguel Salavert,María Tasias,Eva Calabuig,Remedio Guna,Carolina Ferrer-Gómez,María Pilar Ortega-García,Vicente Abril The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：p671 31 Double-dose azithromycin mass drug administration, facial cleanliness, and fly control measures for trachoma control in Oromia, Ethiopia (Stronger SAFE): a cluster-randomised controlled trial 埃塞俄比亚奥罗米亚地区双倍剂量阿奇霉素群体给药、面部清洁与灭蝇综合沙眼防控方案（强化SAFE策略）：整群随机对照试验 Anna Last,Oumer Shafi Abdurahman,Katie Greenland,Ailie Robinson,Edao Sinba Etu,Robert Butcher,Meseret Guye,Demitu Legesse,Kedir Temam Nuri,Gemeda Shuka,Munira Haji-Mohammed Yusuf,Gaddisa Dheressa,Gebeyehu Dumessa,Haile Abera,Mesfin Bekele,Melese Akalu,Mesfin Tadesse,Dereje Adugna Kumsa,Fikre Seife Gebretsadik,Claire Collin,Alexandra Czerniewska,Bart Versteeg,Esmael Habtamu,Sarity Dodson,Aida Abashawl,Wondu Alemayehu,Anthony W Solomon,Helen A Weiss,James G Logan,David Macleod,Matthew J Burton The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：p680 32 Na-GST-1 adsorbed on Alhydrogel co-administered with different Toll-like receptor agonists in hookworm-naive adults using a controlled human infection model in the USA: a phase 2, double-blind, randomised controlled trial 无钩虫感染健康成人接种吸附于氢氧化铝佐剂的Na-GST-1疫苗联合不同Toll样受体激动剂的人体可控感染模型Ⅱ期双盲随机对照试验（美国） Caroline K DiRosato,Elissa M Malkin,Sean M Lee,Guacyara Erwin,Lara Hoeweler,Larissa Scholte,Maria Elena Bottazzi,David I Pritchard,Peter J Hotez,Jeffrey M Bethony,David J Diemert The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：p692 33 Post-discharge sequelae of Lassa fever survivors in Nigeria: an analysis of the LASCOPE prospective cohort 尼日利亚拉沙热幸存者出院后远期后遗症分析：LASCOPE前瞻性队列研究 Eva Guichard,Sylvain Juchet,Ijeoma Chukwudumebi Etafo,Béatrice Serra,Delphine Gabillard,Chukwuyem Abejegah,Abiodun Tolani Abidoye,Bimpe Oyegunle,Benjamin Séri,Alexandre Duvignaud,Jackson Katembo Vihundira,Denis Malvy,Marion Bérerd-Camara,Nelson Akinola Adedosu,Ayeni Olufunke Gbenga,Liasu Adeagbo Ahmed,Oladele Oluwafemi Ayodeji,Marie Jaspard The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：p705 34 Evaluating dengue transmission dynamics in an endemic urban setting in Viet Nam: an index-household contact cohort study 越南登革热流行城区传播动力学评估：索引病例-家庭接触者队列研究 Lucy Masdin,James Ashall,Mai Kim Huynh,Joseph Biggs,Jody Phelan,Sonal Shah,Lien Thuy Le,Trieu Bao Nguyen,Hung Thai Do,Hien Anh Thi Nguyen,Thuy Thi Thu Nguyen,Duc Anh Dang,Chihiro Iwasaki,Michiko Toizumi,Marnix Van Loock,Guillermo Herrera-Taracena,Leen Vijgen,Freya Rasschaert,Liesbeth Van Wesenbeeck,Julius Clemence Hafalla,Oliver J Brady,Lay-Myint Yoshida,Stéphane Hué,Martin L Hibberd The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：p714 35 Optimising DTwP-containing vaccine infant immunisation schedules in Uganda and Nepal (OptImms): two open-label, non-inferiority, randomised controlled trials 乌干达、尼泊尔含无细胞百日咳疫苗婴儿免疫程序优化研究（OptImms）：两项开放标签非劣效随机对照试验 Sanjeev M Bijukchhe,Natalie G Marchevsky,Freddie Kibengo,Arun K Sharma,Ruby Basi,Liberty Cantrell,Sachi Chuke,Benjamin Curtis,Dimitri A Diavatopoulos,Agnes Eordogh,Madhav C Gautam,Meeru Gurung,Gerco den Hartog,Hari P Kattel,Samir KC,Dominic Kelly,Sarah Kelly,Grace Li,Pratistha Maskey,Ella Morey,Yama F Mujadidi,Dora J Mulondo,Tryphena Nareeba,Mary Nyantaro,Anil R Ojha,Bhishma Pokhrel,Shristy Rajkarnikar,Andrew Roberts,Sonu Shrestha,Gaby Smits,Surya B Thapa,Fiona Van der Klis,Merryn Voysey,Sudha Basnet,Alison M Elliott,Xinxue Liu,Shrijana Shrestha,Andrew J Pollardon behalf of the OptImms Nepal and Uganda teams The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：p726 36 Safety, tolerability, and immunogenicity of a 31-valent pneumococcal conjugate vaccine (VAX-31) in healthy adults aged 50 years and older from the USA: a phase 1/2, double-blinded, active-controlled, parallel-group, dose-finding randomised clinical trial 美国50岁及以上健康成人31价肺炎球菌结合疫苗（VAX-31）安全性、耐受性与免疫原性Ⅰ/Ⅱ期双盲阳性对照平行分组剂量爬坡随机临床试验 James Wassil,Jeff Fairman,Carlos A Fierro,James Clark,Sean Bennett,Derek Johnson,Qin Jiang,Thi-Sau Migone,Alexandra Paschenko,Jakub K Simon,Steve Lamola,Maggie Sisti The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：p739 Review（综述） 37 Accelerating research and development of new vaccines against tuberculosis: 5-year progress on the global roadmap 加速新型结核病疫苗研发：全球路线图五年进展总结 Elly van Riet,Björn Corleis,Birgitte K Giersing,Mark Hatherill,Erlina Burhan,Waasila Jassat,Richard G White,David Lewinsohn,Frank Cobelens The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e289 38 Best practice guidelines for viral hepatitis service delivery in prisons 监狱病毒性肝炎规范化诊疗最佳实践指南 Yumi Sheehan,Akhil Garg,Julia Sheehan,Nonso Maduka,Frederick L Altice,Filipa Alves da Costa,Sean Cox,Ahmed M Elsharkawy,Ehab Salah,Mark Stoové,Lara Tavoschi,Alexander J Thompson,Karla Thornton,Andrew R Lloyd,Joaquín Cabezas,Matthew J Akiyama,Nadine Kronfli The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e302 Personal View（个人观点） 39 Post-tuberculosis lung disease: a case definition for use in research studies 结核后肺病：适用于科研的病例定义标准 Gregory P Bisson,Brian Allwood,Anthony Byrne,Gunar Günther,Celso Khosa,Neelima Navuluri,Rebecca Nightingale,Ingrid Schoeman,Marieke M van der Zalm,Jamilah Meghji,Sara Auld The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e315 Grand Round（大查房） 40 Management of critical illness in an adolescent caused by highly pathogenic avian influenza A(H5N1) virus infection in British Columbia, Canada 加拿大不列颠哥伦比亚省高致病性甲型H5N1禽流感病毒感染青少年危重症诊疗 Elspeth MacBain,Ashraf Znait,Linda Edwards,Agatha Jassem,Vilte E Barakauskas,Kevin C Harris,Sarah Lohrenz,Sareh Zahedieh,Nathalie Bastien,Charlene Ranadheera,Cherry Mammen,Roxana Azma,Audi Setiadi,Jonathan H Rayment,Nicolas Mourad,Ryaan El-Andari,Timothy M Uyeki,Lynne Li,Ashley Roberts,Muhieldin A Muhieldin,David M Goldfarb The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e326 Clinical Picture（临床图鉴） 41 Disseminated herpes zoster with hepatic necrosis in a patient with newly diagnosed HIV 初诊艾滋病患者播散性带状疱疹合并肝坏死 Shinya Hasegawa,Frida Teran-Garza,Jeffery L Meier The Lancet Infectious Diseases. Jul 2026，Vol 26(7)：e335 THE LANCET Infectious Diseases. Volume 26Number 8 柳叶刀·传染病学26卷 8期 https://www.thelancet.com/journals/laninf/issue/current Editorial（社论） 1 Our twenty-five year journey 二十五载发展历程 The Lancet Infectious Diseases The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：p751 Comment（述评） 2 Sense and susceptibility: predicting influenza dynamics from immune landscapes 感知与易感性：基于免疫图谱预测流感流行动态 C Jessica E Metcalf,Wakinyan Benhamou,Oliver G Spacey,Jasmine Wang The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：p752 3 New chapter in rabies vaccine development 狂犬病疫苗研发迈入新阶段 Leo G Visser The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：p753 4 Clinical trial priorities, adaptive strategies, and equitable partnerships for the Bundibugyo Ebola outbreak 本迪布焦埃博拉疫情的临床试验重点、适应性策略与公平合作模式 Jean B Nachega,Olivier Tshiani Mbaya,Sabue Mulangu,Morenike Oluwatoyin Folayan,Nicaise Ndembi,Francine Ntoumi,Edward J Mills,Salim S Abdool Karim,Alimuddin Zumla,Jean-Jacques Muyembe-Tamfum The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：p755 5 Bundibugyo Ebola in DR Congo and Uganda: community-centred response must be operational, not rhetorical 刚果民主共和国与乌干达本迪布焦埃博拉疫情：以社区为核心的防控重在落地而非空谈 Placide Mbala-Kingebeni,Yap Boum,Mosoka P Fallah,Barthalomew Wilson,Marie-Roseline Belizaire,Nicole A Hoff,Armand Sprecher,Lisa E Hensley,Jason Kindrachuk,Anne W Rimoin The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：p757 6 The Bundibugyo virus disease outbreak: a warning signal for risks to health workers 本迪布焦病毒病暴发：医护人员职业暴露风险预警 Nebiyu Dereje,Yap Boum,Kyeng Mercy,Marie-Roseline Belizaire,Tolbert Nyenswah,Justus Nsio,Pierre Zalagile Akilimali,Atek Kagirita,Ngashi Ngongo,Jean Kaseya The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：p759 Correspondence（读者来信） 7 Rapid recruitment for a remote long COVID clinical trial 远程长新冠临床试验受试者快速招募 Julia Moore Vogel The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e268 8 Tuberculosis treatment with early detection 早筛导向的肺结核治疗 Aparna Prakash The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e269 9 The limb-saving power of bedside Gram staining 床旁革兰氏染色的保肢价值 Samadhi Patamatamkul The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e270 10 Keep antibiotics habitable: stewardship as climate mitigation 守护抗生素生态：抗菌药物管理助力环境风险缓解 Giovanni Mori The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e271 11 25 years of antibiotics: from desperate access to precision safety 抗生素应用25年：从迫切可及迈向精准安全 Jinlin Guo,Xinfeng Cai,Mi Zhou The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e272 12 The optimism in front of us 前路可期 Victor Naestholt Dahl The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e273 13 The importance of study volunteers in saving future lives 研究志愿者对守护大众健康的重要意义 Chuen-Yen Lau The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e274 14 Crossing the regulatory and clinical operational valley in antimicrobial resistance: from a start-up's perspective 跨越抗菌耐药领域监管与临床落地鸿沟：初创企业视角 Venu Gopal Jonnalagadda The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e275 15 A new era of hope: the impact of long-acting injectables for individuals ageing with childhood HIV 希望新时代：长效注射药物对儿童期感染HIV老龄患者的作用 Hayley T Berry,Jordan Jones,Richard Lueking,Stephanie E Kirk The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e276 16 A defining clinical moment during the COVID-19 pandemic in Nigeria 尼日利亚新冠疫情中标志性临床事件 Chizaram Onyeaghala The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e277 Corrections（勘误） 17 Correction to Lancet Infect Dis 2026; published online June 2. https://doi.org/10.1016/S1473-3099(26)00194-5 《柳叶刀·传染病》2026年6月2日在线刊发文章勘误，文献doi：10.1016/S1473-3099(26)00194-5 The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e278 18 Correction to Lancet Infect Dis 2026; published online June 3. https://doi.org/10.1016/S1473-3099(26)00285-9 《柳叶刀·传染病》2026年6月3日在线刊发文章勘误，文献doi：10.1016/S1473-3099(26)00285-9 The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e278 Newsdesk（新闻资讯） 19 Indigenous Australians see surge in diphtheria cases 澳大利亚原住民白喉病例激增 Tony Kirby The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e279 20 Trials of medical countermeasures to begin in DR Congo 刚果民主共和国启动医学应对手段临床试验 Esther Nakkazi The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e280 21 Rollout of lenacapavir begins in South Africa 南非正式推广莱那卡韦 Ed Holt The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e281 22 Cold-chain vehicles to support vaccination in Ecuador 冷链运输车辆助力厄瓜多尔疫苗接种工作 Sanjeet Bagcchi The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e282 23 2026 High-Level Meeting on HIV/AIDS 2026年艾滋病高级别会议 Talha Burki The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e283 24 Research in brief 科研快讯 Priya Venkatesan The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e284 Obituary（讣告） 25 Edward Pesanti 爱德华·佩桑蒂 Udani Samarasekera The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：p762 Profile（人物专访） 26 Krutika Kuppalli—containing infectious disease outbreaks 克鲁蒂卡·库帕利：防控传染病疫情 Udana Samarasekera The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：p763 27 Troy Grennan—getting anal cancer the attention it deserves 特洛伊·格伦南：推动肛门癌获得应有重视 Tony Kirby The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：p764 Media Watch（媒体瞭望） Book（书评） 28 The market for pox remedies 天花治疗药物市场 Talha Burki The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：p765 Articles（论著） 29 Measuring population immunity against influenza using individual antibody titres: a multicountry, retrospective observational study 基于个体抗体滴度评估人群流感免疫水平：多国回顾性观察研究 Weijia Xiong,Xiaotong Huang,Tran Thi Nhu Thao,Nguyen Thi Le Thanh,Liping Peng,Ranawaka A P M Perera,Vicky J Fang,Bingyi Yang,Sook-San Wong,Nancy H L Leung,Sheena G Sullivan,Dennis K M Ip,Malik Peiris,Ted M Ross,Maciej F Boni,Benjamin J Cowling,Tim K Tsang The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：p766 30 Immunogenicity of high-dose recombinant influenza vaccine versus standard-dose egg-grown and cell-grown vaccines among frequently and infrequently vaccinated young adults in Singapore: a randomised, controlled, double-blind, single-centre, phase 4 clinical trial 新加坡高频、低频接种青年人群中，高剂量重组流感疫苗对比标准剂量鸡胚培养、细胞培养流感疫苗的免疫原性：单中心随机对照双盲4期临床试验 Sheena G Sullivan,Xuan Ying Poh,Stephany Sanchez-Ovando,A Jessica Hadiprodjo,Louise Carolan,Yi Qing Chin,Suma Rao,Stephanie Sutjipto,Joseph Lim,Desiree Anthony,Sapna P Sadarangani,Ian G Barr,Barnaby Young,Annette Fox The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：p778 31 Immunogenicity, reactogenicity, and safety of a reduced-interval 4CMenB primary immunisation schedule in UK infants: a multicentre, open-label, assessor-blinded, phase 4 randomised controlled trial 英国婴儿缩短间隔4CMenB基础免疫程序的免疫原性、不良反应与安全性：多中心开放标签、评估者盲法4期随机对照试验 Natasha Thorn,Zsofia Danos,Nick J Andrews,Natalina Sutton,Katrina Cathie,Daniel Owens,Dominic Kelly,Fiona Shackley,Tim Scorrer,Charlotte Lea,Andrew Collinson,Thahmena Miah,Jonathan Lewis-Bridgeman,Jennifer Pearce,Ray Borrow,Jennifer Louth,Abigail Bell,Shamez N Ladhani,Paul T Heath The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：p793 32 Real-world effectiveness of 20-valent pneumococcal conjugate vaccine against all-cause outcomes among Medicare beneficiaries aged 65 years and older in the USA: a retrospective cohort study 美国65岁及以上医保参保人群中20价肺炎球菌结合疫苗针对全因结局在现实中的保护效力：回顾性队列研究 Amanda C Miles,Jelena Vojicic,Paula Peyrani,Summer Rosenstock,Huihua Li,Jeffrey T Vietri,Qi Yan,Alison E Randall,Xin Zhao,Wencheng Zhu,Bobby Zhao,Anan Zhou,Luis Jodar,Bradford D Gessner,Christian Theilacker,Jennifer C Moïsi,Paul Balmer,Lindsay R Grant,Alejandro Cane The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：p807 33 Durability of doxycycline effectiveness against gonorrhoea after implementation of post-exposure prophylaxis in southern California, USA: a retrospective, test-negative, observational study 美国南加州开展暴露后预防后多西环素抗淋病疗效的持续性：回顾性病例阴性观察研究 Matan Yechezkel,David Helekal,Banshri Kapadia,Vennis Hong,Magdalena E Pomichowski,Iris Anne C Reyes,Gregg S Davis,Nicola F Müller,Yonatan H Grad,Sara Y Tartof,Joseph A Lewnard The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：p819 34 Duration and association with protection of NANP-repeat-specific and C-terminus-specific anti-circumsporozoite protein IgG responses following RTS,S/AS01E vaccination: an observational ancillary immunological study of a phase 3 clinical trial 接种RTS,S/AS01E疫苗后，环子孢子蛋白NANP重复序列、C端特异性IgG应答持续时间及其与保护力的关联：3期临床试验配套免疫观察研究 Maria Lara-Escandell,Lina Sánchez,Dídac Macià,Chenjerai Jairoce,Maxmillian Mpina,Hermann Sorgho,Selidji Todagbe Agnandji,David Dosoo,Ben Gyan,Marta Vidal,Alfons Jiménez,Robert Andrew Mitchell,Daniel Medina-Expósito,Laura Puyol,Rebeca Santano,Sheetij Dutta,Seth Owusu-Agyei,Kwaku Poku Asante,Halidou Tinto,Pedro Aide,Augusto Nhabomba,Benjamin Mordmüeller,Claudia Daubenberger,Ruth Aguilar,John Waitumbi,Gemma Moncunill,Carlota Dobaño The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：p832 35 Safety and immunogenicity of a single-dose adenovirus-vectored rabies vaccine over 1 year in adults and children in Tanzania: interim data from an ongoing, partly randomised, controlled, phase 1b/2 trial 坦桑尼亚成人与儿童单次腺病毒载体狂犬病疫苗接种1年期安全性及免疫原性：一项正在开展的部分随机对照1b/2期临床试验中期结果 Adam J Ritchie,Omary Hassan,Nsiande Urasa,Paschal A Apanga,Rinter Kimathi,Wilmina F Kalinga,Ivanny M Mtaka,Reward G Lyimo,Moshi Moshi Shabani,Francisco Orliacq,Adam Berg,ZhiQuan Xiang,Saumu Ahmed,Thabit Athuman,Hildegund C J Ertl,Ally Olotu,Alexander D Douglason behalf of the RAB002 study team The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：p843 36 Diagnostic and prognostic accuracy of the Mycobacterium tuberculosis host response 3-gene cartridge among tuberculosis household contacts in Mozambique, Tanzania, and Zimbabwe: a prospective, longitudinal, diagnostic and prognostic accuracy cohort study 莫桑比克、坦桑尼亚、津巴布韦结核家庭密切接触者中结核宿主应答三基因检测试剂盒的诊断与预后效能：前瞻性纵向诊断预后队列研究 Leyla Larsson,Ioana Diana Olaru,Anna-Lisa Behnke,Edson T Marambire,Martha Chipinduro,Claire J Calderwood,Denise Banze,Alfred Mfinanga,Celina Nhamuave,Harieth L Mwambola,Kathrin Held,Rishi K Gupta,Lillian T Minja,Celso Khosa,Norbert Heinrich,Katharina Kranzeron behalf of the ERASE-TB consortium The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：p858 Review（综述） 37 Methodological quality assessment tool for observational studies comparing treatment effectiveness in infectious diseases: a Delphi consensus and application to studies on bloodstream infections due to carbapenem-resistant Enterobacterales 传染病疗效对比观察性研究方法学质量评价工具：德尔菲共识构建及耐碳青霉烯肠杆菌科菌血流感染研究应用 Giulia Zumbo,Martina Beltrami,Jose M Bravo-Ferrer,Belén Gutiérrez-Gutiérrez,Jesús Rodríguez-Bañothe ASSURE-ID group The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e285 38 Leptospirosis—clinical review and updates on therapeutics 钩端螺旋体病临床综述与治疗新进展 Nathaniel Lee,Takeshi Tanaka,Nobuo Koizumi,Charles Coughlan,Ana Ria Sayo,Koya Ariyoshi,Tansy Edwards,Chris Smith,Robin Bailey The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e294 Personal View（个人观点） 39 Transitioning to people-centred antimicrobial resistance surveillance 向以人为本的抗菌药物耐药监测模式转型 Direk Limmathurotsakul,Raheelah Ahmad,Elizabeth A Ashley,Rifat Atun,Rogier H van Doorn,Jyoti Joshi,Souha S Kanj,Janet Midega,Mirfin Mpundu,Paul Turner,Kamini Walia,Sharon J Peacock,Nicholas A Feaseyand the Surveillance and Epidemiology of Drug Resistant Infections Consortium (SEDRIC) The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e308 40 The looming crisis of bedaquiline-resistant tuberculosis and a promising way forward 贝达喹啉耐药肺结核危机迫近与可行解决路径 Pauline Howell,Jonathan Stillo,Anja Reuter,Tendai Nkomo,Carole D Mitnick,Lorenzo Guglielmetti,Kelly Curran,Richard E Chaisson,Jennifer Furin The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e314 Clinical Picture（临床图鉴） 41 Ignatzschineria larvae and Staphylococcus aureus bacteraemia secondary to cutaneous myiasis of the face 面部皮肤蝇蛆病继发伊格纳茨菌幼虫与金黄色葡萄球菌菌血症 Clive Martin Rodrigues,Jonathan Youngs,Anjaneya Bapat,Callan Strydom The Lancet Infectious Diseases. Aug 2026，Vol 26(8)：e319 THE LANCET Infectious Diseases. Volume 26Number 9 柳叶刀·传染病学 26卷 9期 https://www.thelancet.com/journals/laninf/issue/current Editorial（社论） 1 Oral carbapenem—a double‑edged sword? 口服碳青霉烯类药物：一把双刃剑？ The Lancet Infectious Diseases The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：p871 Comment（述评） 2 Non‑sputum testing: an incomplete bridge across the tuberculosis diagnostic gap 非痰标本检测：弥合结核病诊断缺口尚不完美的桥梁 Adrienne E Shapiro The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：p872 3 Beyond vaccines: closing the critical gap in diagnostics and therapeutics for outbreak response 疫苗之外：补齐疫情应对中诊断与治疗领域的关键短板 Tedros Adhanom Ghebreyesus,Jean Kaseya,Chikwe Ihekweazu,Vasee Moorthy,Mosoka Fallah,Shanelle Hall,Sylvie Briand The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：p873 4 Reconsidering the rVSVΔG‑ZEBOV‑GP vaccine during the 2026 Bundibugyo virus outbreak 2026年本迪布焦病毒暴发期间对rVSVΔG‑ZEBOV‑GP疫苗的再思考 Krutika Kuppalli,Richard Lokudu,Andrew S Azman,Armand Sprecher,Gaston Musemakweli Komanda,Iza Ciglenecki,Manuel Albela,Deby Mukendi,Yap Boum,Jean B Nachega,Placide Mbala,Jean‑Jacques Muyembe‑Tamfum The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：p875 Correspondence（通信） 5 Seasonal influenza versus COVID‑19 hospitalisation risk during the 2025–26 influenza season 2025‑2026流感季季节性流感与新型冠状病毒感染住院风险对比 Yan Xie,Taeyoung Choi,Ziyad Al‑Aly The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e321 6 Cefiderocol heteroresistance in NDM Enterobacterales NDM阳性肠杆菌目细菌对头孢地尔的异质性耐药 Tugba Ozturk,Sarah Lohsen,Sarah W Satola,David S Weiss The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e323 7 Diagnostic performance of RADIONE for diagnosis of BDBV RADIONE检测用于本迪布焦病毒的诊断效能 Tony Wawina‑Bokalanga,Adrienne Amuri‑Aziza,Koen Vercauteren,Daniel Mukadi‑Bamuleka,Christian Ngandu,Jason Kindrachuk,Pierre Akilimali,Jean‑Jacques Muyembe‑Tamfum,Placide Mbala‑Kingebenithe Ebola Research and Response Team The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e324 8 Real‑time epidemic intelligence in a public health emergency: the 2026 Bundibugyo virus outbreak 突发公共卫生事件下的实时疫情情报：2026年本迪布焦病毒暴发 Onesime Mbulayi,Pierre Akilimali,Ciara Judge,Bernardo Gutierrez,Patrick Mulu,Chistian M Ibolobolo,Jean‑Clement Sibo,Rossy Nkwele wa Nkwele,Matondo M Hermann,Leader Lawanga Ontshick,Daniel Mukadi,Benjamin Kanku,Eric Katanga,Kyeng Mercy,Joel Kosianza,Brian Ajong,Michel Muteba,Tania Bishola Tshitenge,Eddy Lusamaki,Romain Goldenberg,Linus Bengtsson,Ellie Bourgikos,Joseph L‑H Tsui,Cathal Mills,Moritz U G Kraemer,Samuel V Scarpino,Christian Ngandu,Dieudonne Mwamba Kazadi,Etien Koua,Olivier le Polain de Waroux,Placide Mbala‑Kingebeni,Dav M Ebengo The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e326 9 SARS‑CoV‑2 BA.3.2.2 is more evasive of neutralisation by plasma from young children 新冠病毒BA.3.2.2变异株更易逃逸幼儿血浆的中和作用 Madeline Wu,Hsiang Hong,Yicheng Guo,Kristin Daniel,Ryan Hisner,Marc C Johnson,Aubree Gordon,David D Ho,Ian A Mellis The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e328 10 Pseudovirus‑based analysis of host cell entry and vaccine‑induced neutralisation of Bundibugyo virus 基于假病毒分析本迪布焦病毒的宿主细胞入侵及疫苗诱导的中和效应 Markus Hoffmann,Aparna Shandheep,Andreas Pavlou,Katharina Rahmel‑Stein,My Linh Ly,Nianzhen Chen,Nicole Moor,Anna‑Sophie Moldenhauer,Christian Drosten,Ulrich Kalinke,Marylyn Martina Addo,Stefan Pöhlmann The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e330 11 Congolese hospital staff cohort admitted with infectious symptoms in the setting of the Bundibugyo virus outbreak, April and May 2026, Bunia, DR Congo 2026年4‑5月刚果（金）布尼亚，本迪布焦病毒暴发期间因感染症状入院的刚果医护人员队列 Patrick LaRochelle,Melinda McKnight,Ufoymungo Ucama Patrick,Musungufu Ambitapio Davin The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e332 Corrections（勘误） 12 Correction to Lancet Infect Dis 2020; 20: 37–59 勘误：Lancet Infect Dis 2020; 20: 37‑59 The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e335 13 Correction to Lancet Infect Dis 2020; 20: 60–79 勘误：Lancet Infect Dis 2020; 20: 60‑79 The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e335 14 Correction to Lancet Infect Dis 2026; published online June 30. https://doi.org/10.1016/S1473‑3099(26)00256‑2 勘误：Lancet Infect Dis 2026，6月30日在线发表。https://doi.org/10.1016/S1473‑3099(26)00256‑2 The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e335 Newsdesk（新闻） 15 Sri Lanka battles major dengue outbreak 斯里兰卡应对登革热大规模暴发 Samaan Lateef The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e336 16 USA to end support of South Africa's HIV programmes 美国将终止对南非艾滋病项目的资助 Ed Holt The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e337 17 First rapid nucleic acid test for Bundibugyo virus 首款本迪布焦病毒快速核酸检测问世 Priya Venkatesan The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e338 18 New UN resolution links NTDs to human rights 联合国新决议将被忽视的热带病与人权相关联 Timothy Jesudason The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e339 19 Enrolment begins in the EBO‑PEP trial in DRC 刚果（金）EBO‑PEP临床试验启动受试者入组 Talha Burki The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e340 20 Research in brief 研究简报 Priya Venkatesan The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e341 Obituary（讣告） 21 Clarence James Peters 克拉伦斯·詹姆斯·彼得斯 Udani Samarasekera The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：p878 Profile（人物专访） 22 Aalisha Sahukhan—strengthening public health responses 阿丽莎·萨胡坎——强化公共卫生应急处置能力 Tony Kirby The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：p879 Media Watch（媒体观察） Theatre（书评·戏剧） 23 Pride and solidarity 自豪与团结 Marco De Ambrogi The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：p880 Articles（论著） 24 Expanding Xpert MTB/RIF Ultra and lateral flow urine lipoarabinomannan testing for diagnosis of tuberculosis among adults living with HIV admitted to hospitals in Tanzania and Mozambique (EXULTANT): a randomised controlled trial 在坦桑尼亚与莫桑比克住院HIV感染成人中推广Xpert MTB/RIF Ultra及尿脂阿拉伯甘露聚糖侧流检测用于结核病诊断（EXULTANT）：一项随机对照试验 Marta Cossa,Robert Ndege,Bindiya Meggi,Chacha Mangu,Vinzeigh Leukes,Issa Sabi,Celso Khosa,Bernard Kivuma,Dinis Nguenha,Friedrich Riess,Carlos Fernández‑Escobar,Laura de la Torre‑Perez,Patricia Manjate,Maja Weisser,Antonio Machiana,Craysophy Zachariah,Elisa Tagliani,Joanna Ehrlich,Julia Buech,Claudia Schacht,Sergi Sanz,Sunita Singh,Dorcas Mnzava,Samuel G Schumacher,Helen Cox,Leslie Scott,Nyanda Ntinginya,Katharina Kranzer,Morten Ruhwald,Adam Penn‑Nicholson,Alberto L Garcia‑Basteiroon behalf of the TB‑CAPT Consortium The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：p881 25 Post‑mortem characterisation of pathogen‑specific causes of infection‑related deaths in African and south Asian neonates: a prospective, observational, multicentre study 非洲与南亚新生儿感染相关死亡的病原体特异性死因尸检分析：一项前瞻性、观察性多中心研究 Muntasir Alam,Kyu Han Lee,Vicky Baillie,Sana Mahtab,Afruna Rahman,Atique Iqbal Chowdhury,Julius Ojulong,Nega Assefa,Lola Madrid,Fentabil Getnet,Ayantu Mekonnen,Dickens Onyango,Victor Akelo,Florence Murila,Magdalene Kuria,Aggrey Igunza,Samba O Sow,Karen L Kotloff,Milagritos D Tapia,Adama Mamby Keita,Jane Juma,Inacio Mandomando,Marcelino Garrine,Rosauro Varo,Milton Kincardett,Ikechukwu Ogbuanu,Kazi Munisul Islam,Sulaiman Sannoh,Ima‑Abasi Bassey,Ejikeme Chukwuka Oham,Nelesh P Govender,Sithembiso Velaphi,Anthony Scott,Portia Mutevedzi,Beth Tippett Barr,Shams El Arifeen,Emily S Gurley,Quique Bassat,Cynthia G Whitney,Shabir A Madhithe CHAMPS Consortium The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：p894 26 Performance of five mpox antigen‑based rapid diagnostic tests tested on lesion swabs from patients with suspected mpox from the Kinshasa province of DR Congo: a diagnostic accuracy study 5项猴痘抗原快速检测用于刚果（金）金沙萨省疑似猴痘患者皮损拭子样本的诊断效能：一项诊断准确性研究 Hugo Kavunga‑Membo,Hanesh Fru Chi,Devy M Emperador,Hugues Mirimo,Elie Ishara‑Nshombo,Marithe Mukoka,Raphael Lumembe,Michael Otieno,Mireille Muloki,Jean‑Claude Makangara‑Cigolo,Eddy Kinganda‑Lusamaki,Tony Wawina‑Bokalanga,Camille Escadafal,Kenneth Adea,Ana Hoxha,Rosamund F Lewis,Nicksy Gumede,Olga Ntumba‑Tshitenge,Richard Fotsing,Isabella Eckerle,Daniel Mukadi‑Bamuleka,Placide Mbala‑Kigenbeni,Emmanuel Agogo,Lorenzo Subissi The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：p906 27 Immunogenicity and safety of a dose‑sparing inactivated poliovirus vaccine in infants in India: a phase 2/3, double‑blind, randomised controlled trial 印度婴儿减量接种灭活脊髓灰质炎疫苗的免疫原性与安全性：一项2/3期双盲随机对照试验 Prasad S Kulkarni,Sajjad A Desai,Suman Kanungo,Shanta Dutta,Madhu Gupta,Bheemisetty Srinivasa Chakravarthy,Sonali Palkar,Sushma Save,Renuka Munshi,Pradeep Nanjappa,Vijai Anand Babu Bangi,Sandeep Kumar Panigrahi,Sandesh Bharati,Parikshit Tyagi,Sunil Gairola,Jagdish K Zade,Sambhaji S Pisal,Rajeev M Dhere,Cyrus S Poonawalla,Anirudha Vyankatesh Poteyon behalf of the IPV‑01 Study Group The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：p915 28 Sustained and indirect effects of PCV10 reduced‑dose schedules on pneumococcal carriage in Viet Nam: a long‑term follow‑up of a cluster‑randomised controlled trial 越南PCV10减量免疫程序对肺炎链球菌携带的持续及间接效应：一项整群随机对照试验的长期随访 Billy J Quilty,Michiko Toizumi,Hien Anh Thi Nguyen,Lien Thuy Le,Hoang Huy Le,Chihiro Iwasaki,Mizuki Takegata,Noriko Kitamura,Mohammad Monir Shah,Monica L Nation,Jason Hinds,Kevin van Zandvoort,Belinda D Ortika,Eileen M Dunne,Catherine Satzke,Hung Thai Do,Kim Mulholland,Duc‑Anh Dang,Stefan Flasche,Lay‑Myint Yoshida The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：p925 29 Global and regional molecular epidemiology of HIV‑1 during 1990–2024: systematic review, global survey, and analysis of prevalence 1990‑2024年全球及区域HIV‑1分子流行病学：系统综述、全球调研与流行率分析 Ayisha Khalid,Lucy Gettins,Lauren Scullion,Xin Liu,Lily Li Lin Wei,Abednego N Masai,Philippe J Guerin,Kasim Allel,Joris HemelaarGlobal HIV Molecular Epidemiology Collaboration The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：p939 30 Maribavir for clinically significant cytomegalovirus infection in haematopoietic cell transplant recipients in Europe: a real‑world multicentre retrospective registry study 马立巴韦治疗欧洲造血细胞移植受者临床意义明确的巨细胞病毒感染：一项多中心真实世界回顾性登记研究 Annalisa Paviglianiti,Per Ljungman,Rafael de la Camara,Gloria Tridello,Juana Schwartz,Nina Knelange,Arancha Bermudez Rodriguez,María Suárez‑Lledó,Johan Maertens,Maria Stamouli,Francis Ayuk,Candela Ceballos,Maria Huguet,Felipe Peña Muñoz,Pablo Granados,Alienor Xhaard,Jurgen Kuball,Chiara Nozzoli,Jan Styczynski,Dina Averbuchon behalf of the Infectious Diseases Working Party of the EBMT The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：p956 31 Dihydroartemisinin–piperaquine versus chloroquine for the treatment of uncomplicated Plasmodium vivax malaria with concurrent or delayed high‑dose primaquine in Brazil (Curavivax): an open‑label, single‑centre, randomised clinical trial 巴西伯氨喹同步或延迟大剂量给药前提下，双氢青蒿素哌喹对比氯喹治疗非复杂性间日疟（Curavivax）：开放标签单中心随机临床试验 Djane C Baía‑da‑Silva,Kim Vinícius AmaralC Machado,Amanda Lia RebêloC Rabelo,Antônio AlcirleyC da Silva Balieiro,Antônio S LC Barbosa,Mônica Regina FariasC Costa,Vanderson S Sampaio,Gisely C Melo,Marcia A A Alexandre,Aline C C Alencar,Cristiana T Nascimento,Christiane Maria Prado Jerônimo,Mariana Souza Marcovski,Laila Rowena Albuquerque Barbosa,Cristiane Siqueira Valle,Thaís Alves Amaral Carrilho,JoséLuiz Fernandes Vieira,Marly Marques de Melo,Kelry Mazurega Oliveira Dinelly,Aretha Gomes Omena,José Diego Brito‑Sousa,Gilce Alves Barreiros,Yasmin Vieira Rocha,Aristóteles Comte Alencar Filho,Quique Bassat,Maria das Graças C Alecrim,André M Siqueira,Marcus V G Lacerda The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：p965 Review（综述） 32 The impact of clinical metagenomic testing on patient management: facts versus fantasy 临床宏基因组检测对患者诊疗的影响：现实与展望 Julianne R Brown,Charles Y Chiu,F Xavier López‑Labrador,Jutte J C de Vries The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e342 33 Artemisinin partial resistance at a crossroads: evidence for continental variation in Plasmodium falciparum clearance phenotypes 青蒿素部分耐药来到十字路口：恶性疟原虫虫体清除表型存在洲际差异的证据 Varun Hosangadi,David A Fidock The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e355 Personal View（个人观点） 34 Time to re‑evaluate combination antifungal therapy for invasive aspergillosis and other invasive mycoses 需重新评估侵袭性曲霉病及其他侵袭性真菌病的抗真菌联合治疗方案 Thomas S Harrison,Thomas J Walsh The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e366 Grand Round（临床病例研讨） 35 Intravenous immunoglobulin treatment for long COVID: a case report of clinical and immunological findings 静脉注射免疫球蛋白治疗长新冠：1例临床及免疫学结果病例报告 Marta Camici,Eva Piano Mortari,Giulia Del Duca,Eleonora Cimini,Valentina Mazzotta,Chiara De Ponte,Ilaria Mastrorosa,Stefania Mazzotta,Carmela Pinnetti,Stefania Notari,Veronica Bordoni,Simona Gili,Giusi Prencipe,Fabrizio Maggi,Rita Carsetti,Enrico Girardi,Andrea Antinori,Chiara Agrati The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e373 Clinical Picture（临床图鉴） 36 Tularaemia after deer exposure in a vehicular collision 车辆碰撞接触鹿后罹患土拉菌病 Henning Gruell,Benedict Steffens,Daniela Jacob,Thorsten Wille,Leonard Poluschkin,Clara Lehmann,Philipp Schommers The Lancet Infectious Diseases. Sep 2026，Vol 26(9)：e385

2026-09-10

·shionogi.com

Approval for Cefiderocol in Australia

OSAKA, Japan, September 7 2026 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced today that it has received marketing authorization from the Therapeutic Goods Administration (TGA) in Australia for cefiderocol, a siderophore cephalosporin developed by Shionogi for the treatment of carbapenem-resistant Gram-negative bacterial infections. This marketing authorization is based on the results of three global clinical trials of cefiderocol conducted to date: the Phase 2 APEKS-cUTI study in patients with complicated urinary tract infections (cUTI), the Phase 3 CREDIBLE-CR study in patients with carbapenem-resistant Gram-negative bacterial infections, and the Phase 3 APEKS-NP study in patients with hospital-acquired pneumonia.1-3 The TGA has approved cefiderocol for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia due to proven or strongly suspected carbapenem-resistant aerobic Gram-negative organisms in adults with limited treatment options. Shionogi has entered into a license agreement with Link Medical Products Pty Ltd (Head Office: New South Wales, Australia; hereafter “Link”) for the development and commercialization of cefiderocol in Australia and New Zealand.4 Following the marketing authorization in Australia, Shionogi will work with Link to improve access to this novel antibacterial agent for patients who need it. Antimicrobial resistance (AMR), often referred to as a “silent pandemic,” is one of the major global public health threats facing humanity and is an urgent global challenge that requires immediate action. In 2021, AMR was estimated to have been directly responsible for 1.14 million deaths worldwide, and it is projected that more than 39 million people could die from AMR by 2050 unless action is taken through international collaboration.5-7 At the same time, treatment options remain limited, making AMR one of the areas with a significant unmet medical need. Cefiderocol is active against Gram-negative bacteria, including a range of multidrug-resistant bacteria that have become difficult to treat due to the acquisition of antimicrobial resistance, and the marketing authorization is expected to provide a new treatment option for patients with these infections. Shionogi has identified “Protect People from the Threat of Infectious Diseases” as one of its material issues and is advancing initiatives toward realizing total care for infectious diseases. To contribute to the successful global response to AMR, Shionogi will continue its efforts to deliver anti-infective medicines needed to protect people’s health to patients around the world. For more information on Shionogi’s initiatives to address AMR, please visit Address the problem of antimicrobial resistance (AMR). About Cefiderocol Cefiderocol is an antibacterial agent that effectively penetrates the outer membrane of Gram-negative bacteria, including multidrug-resistant bacteria, to exert its antibacterial activity. The APEKS-cUTI is a global, double-blind, parallel-group Phase 2 study, the CREDIBLE-CR is a global, open-label, parallel-group phase 3 study, the APEKS-NP is a global, double-blind, parallel-group Phase 3 study. Cefiderocol is marketed in multiple countries and regions, including the United States, Japan, Europe, Taiwan, and South Korea. Cefiderocol is included in the World Health Organization (WHO) Model List of Essential Medicines and plays an important role globally as a treatment option for infections caused by antimicrobial-resistant bacteria. To improve access to this novel antibacterial agent for patients in need across many low- and middle-income countries, Shionogi is also advancing initiatives through a tripartite agreement with the Global Antibiotic Research and Development Partnership (GARDP) and the Clinton Health Access Initiative (CHAI).8 The application for marketing authorization in Australia was accepted by the Australian authorities in December 2024.9 Cefiderocol is not currently listed on the Pharmaceutical Benefits Scheme. For more information about cefiderocol in Australia, healthcare professionals and consumers should consult the Consumer Medicine Information. Cefiderocol is included in the Black Triangle Scheme and subject to additional monitoring. Healthcare professionals are asked to report suspected adverse events to the TGA.10 It is recommended that cefiderocol should be used after consultation with a physician with appropriate experience in the management of infectious diseases. About Link Medical Products Pty Ltd For over 30 years, LINK Healthcare, part of Clinigen, has been a trusted partner to healthcare professionals, hospitals, pharmaceutical and biotechnology companies across Australia and New Zealand. Providing specialised services across the product lifecycle, from clinical development through to commercialisation, LINK enables ethical and compliant access to registered and unregistered medicines. Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. References: 1. Press release on January 12, 2017 2. Press release on October 2, 2019 3. Press release on November 15, 2019 4. Press release on April 2, 2025 5. GBD 2021 Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance 1990-2021: a systematic analysis with forecasts to 2050. Lancet. 2024 Sep 28;404(10459):1199-1226. doi: 10.1016/S0140-6736(24)01867-1. Epub 2024 Sep 16. PMID: 39299261. 6. World Health Organization (WHO), “Antimicrobial resistance,” 16 July 2026. 7. Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet 2022; 399: 629–55. 8. Press release on June 15, 2022 9. Press release on December 3, 2024 10. Report an adverse event or safety problem | Therapeutic Goods Administration (TGA) For Further Information: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html

临床3期引进/卖出上市批准

100 项与硫酸甲苯磺酸头孢德罗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11013	硫酸甲苯磺酸头孢德罗	J01D	DB14879

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
医院获得性细菌性肺炎	澳大利亚	Link Medical Products Pty Ltd.	2026-08-14
呼吸机相关细菌性肺炎	澳大利亚	Link Medical Products Pty Ltd.	2026-08-14
复杂的尿路感染	韩国	Jeil Pharmaceutical Co., Ltd.	2025-02-18
感染	日本	Shionogi Pharma, Inc.	2023-11-30
医院获得性肺炎	美国	Shionogi, Inc.	2020-09-25
医院获得性肺炎	美国	Shionogi & Co., Ltd.	2020-09-25
克雷伯菌感染	美国	Shionogi & Co., Ltd.	2020-09-25
克雷伯菌感染	美国	Shionogi, Inc.	2020-09-25
呼吸机相关性肺炎	美国	Shionogi, Inc.	2020-09-25
呼吸机相关性肺炎	美国	Shionogi & Co., Ltd.	2020-09-25
沙雷菌感染	美国	Shionogi & Co., Ltd.	2020-09-25
沙雷菌感染	美国	Shionogi, Inc.	2020-09-25
革兰氏阴性菌感染	欧盟	Qualicaps Netherlands BV	2020-04-23
革兰氏阴性菌感染	冰岛	Qualicaps Netherlands BV	2020-04-23
革兰氏阴性菌感染	列支敦士登	Qualicaps Netherlands BV	2020-04-23
革兰氏阴性菌感染	挪威	Qualicaps Netherlands BV	2020-04-23
肾盂肾炎	美国	Shionogi & Co., Ltd.	2019-11-14
肾盂肾炎	美国	Shionogi, Inc.	2019-11-14
泌尿道感染	美国	Shionogi, Inc.	2019-11-14
泌尿道感染	美国	Shionogi & Co., Ltd.	2019-11-14

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
复杂腹腔感染	临床3期	中国	盐野义有限公司	2022-11-21
耐碳青霉烯类细菌感染	临床3期	中国	盐野义有限公司	2022-09-16
脓毒症	临床3期	美国	Shionogi, Inc.	2016-09-07
脓毒症	临床3期	日本	Shionogi, Inc.	2016-09-07
脓毒症	临床3期	巴西	Shionogi, Inc.	2016-09-07
脓毒症	临床3期	克罗地亚	Shionogi, Inc.	2016-09-07
脓毒症	临床3期	法国	Shionogi, Inc.	2016-09-07
脓毒症	临床3期	德国	Shionogi, Inc.	2016-09-07
脓毒症	临床3期	希腊	Shionogi, Inc.	2016-09-07
脓毒症	临床3期	危地马拉	Shionogi, Inc.	2016-09-07

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临床结果

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分期

评价

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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


NCT04335539 (PEDI-CEFI, CTgov)	临床2期	革兰氏阴性菌感染 \| 复杂腹腔感染 \| 呼吸机相关性肺炎 ... 更多	53	cefiderocol (Single-Dose Phase: Cohort 1 (12 to <18 Years))	築窪鹽簾憲遞網廠鏇艱 = 鹽廠範壓憲積鬱鹽觸夢襯鹹觸衊蓋膚窪廠顧醖 (廠蓋簾構膚範鑰衊夢顧, 齋齋廠願鑰製鏇範鏇醖 ~ 艱鹹築鹽簾簾遞齋鹽鹹) 更多	-	2026-02-27
				cefiderocol (Single-Dose Phase: Cohort 2 (6 to <12 Years))	築窪鹽簾憲遞網廠鏇艱 = 鹽鏇窪襯鹹鏇簾蓋窪積襯鹹觸衊蓋膚窪廠顧醖 (廠蓋簾構膚範鑰衊夢顧, 夢艱糧鬱壓顧餘窪鑰壓 ~ 廠齋築繭顧鬱衊獵艱膚) 更多
NCT05789199 (PERSEUS study, Pubmed \| Eur J Clin Microbiol Infect Dis)	N/A	革兰氏阴性菌感染	261	Cefiderocol	壓顧繭醖鬱鏇齋願艱簾(鑰網遞壓廠齋糧顧醖鏇) = 遞窪獵製蓋鬱願夢壓廠積獵壓衊廠顧簾鏇壓鑰 (齋築艱遞壓襯繭醖選憲 ) 更多	积极	2025-03-25
NCT05789199 (PERSEUS study, Pubmed \| Eur J Clin Microbiol Infect Dis)	N/A	慢性肾病 Gram-negative bacteria	-	Cefiderocol (Stenotrophomonas maltophilia)	鹽膚膚壓簾壓鹽範築選(簾鹽艱鏇齋餘繭淵顧鹹) = 醖鹹醖選鹹蓋膚繭膚鏇膚糧範製齋壓鹹願簾願 (壓壓築蓋選繭範廠襯壓 )	积极	2025-03-24
				Cefiderocol (Burkholderia cepacia complex)	鹽膚膚壓簾壓鹽範築選(簾鹽艱鏇齋餘繭淵顧鹹) = 鬱獵構襯鬱糧繭觸願齋膚糧範製齋壓鹹願簾願 (壓壓築蓋選繭範廠襯壓 )
NCT05395104 (CTgov)	临床1期	-	14	Cefiderocol+Midazolam	憲憲繭窪艱憲簾夢艱餘(壓艱膚鏇餘範淵鏇願獵) = 遞鏇範鏇壓蓋淵衊夢簾願鑰壓願願糧願顧鬱衊 (構衊觸簾鹹繭齋鹽構觸, 45.3) 更多	-	2023-12-14
NCT03032380 (APEKS-NP, Pubmed \| Eur J Clin Microbiol) 人工标引	临床3期	医疗保健相关性肺炎	-	Linezolid+Cefiderocol	夢夢糧餘襯憲觸鑰憲襯(範築艱鑰製蓋繭遞齋鏇) = 製簾願鑰蓋鹽鬱蓋鬱餘網鏇觸獵鹽獵獵選鬱構 (願願糧鬱夢顧簾鹹網繭 ) 更多	非劣	2022-01-13
				Linezolid+meropenem	夢夢糧餘襯憲觸鑰憲襯(範築艱鑰製蓋繭遞齋鏇) = 鏇蓋鑰憲衊憲顧範夢糧網鏇觸獵鹽獵獵選鬱構 (願願糧鬱夢顧簾鹹網繭 ) 更多
NCT02714595 (CREDIBLE-CR, Pubmed \| Lancet Infect Dis) 人工标引	临床3期	感染	152	cefiderocol	觸襯構範鏇積蓋繭鏇鏇(壓觸積鏇糧廠觸鏇網範) = 膚窪壓廠夢願顧蓋糧憲遞鹽艱鬱鏇齋窪積淵襯 (憲衊構範鑰餘遞顧繭構, 23.2 ~ 65.5) 更多	相似	2021-02-01
				best available therapy	觸襯構範鏇積蓋繭鏇鏇(壓觸積鏇糧廠觸鏇網範) = 夢獵繭網製遞膚醖淵鹹遞鹽艱鬱鏇齋窪積淵襯 (憲衊構範鑰餘遞顧繭構, 17.7 ~ 71.1) 更多
NCT02321800 (APEKS-cUTI, Pubmed)	临床2期	复杂下尿路感染	371	Cefiderocol	範鑰構願繭鬱餘構糧繭(壓醖築範遞簾膚襯築鑰) = 廠顧觸齋鏇窪鑰憲鏇窪憲艱餘淵築範顧衊鹽廠 (醖廠網夢糧獵膚膚願鹹 )	-	2021-01-01
				Imipenem-cilastatin	範鑰構願繭鬱餘構糧繭(壓醖築範遞簾膚襯築鑰) = 製築齋餘廠憲鑰醖構鏇憲艱餘淵築範顧衊鹽廠 (醖廠網夢糧獵膚膚願鹹 )
NCT03032380 (APEKS-NP, CTgov)	临床3期	医院获得性细菌性肺炎 \| 呼吸机相关细菌性肺炎	300	Cefiderocol+Linezolid (Cefiderocol)	範鏇鬱願夢簾淵壓餘繭 = 憲選憲觸蓋網構夢鑰襯窪簾繭窪網鏇鏇夢鹽膚 (鏇範範簾鏇顧鬱繭廠窪, 蓋製鏇選鬱襯艱憲艱膚 ~ 鹽鹽選糧製構艱網壓鑰) 更多	-	2020-11-13
				Meropenem+Linezolid (Meropenem)	範鏇鬱願夢簾淵壓餘繭 = 積糧鏇鏇醖醖廠餘繭獵窪簾繭窪網鏇鏇夢鹽膚 (鏇範範簾鏇顧鬱繭廠窪, 遞積鑰艱艱餘蓋艱鹹網 ~ 蓋鏇鏇憲製夢壓餘鹽製) 更多
NCT03862040 (CTgov)	临床1期	细菌性肺炎	7	Standard of Care Antibiotic+Cefiderocol	齋廠顧築構選衊淵鏇淵(願憲簾襯製膚觸糧衊繭) = 獵繭範衊範憲築衊製醖繭憲遞艱構窪衊選築積 (壓廠鬱衊窪築觸鬱顧齋, 選觸衊窪觸壓憲壓窪壓 ~ 夢憲壓簾簾遞獵築鬱鏇) 更多	-	2020-11-05
NCT02321800 (Pubmed) 人工标引	临床2期	泌尿道感染 Gram-negative	452	Cefiderocol	鹽壓膚鬱蓋淵憲選蓋憲(築繭膚築艱構糧築廠壓) = 鬱鑰襯鏇願遞齋憲襯醖獵範觸蓋鹹願廠製齋餘 (遞艱齋餘鑰鏇衊糧獵糧 ) 更多	积极	2018-12-01
				imipenem-cilastatin	鹽壓膚鬱蓋淵憲選蓋憲(築繭膚築艱構糧築廠壓) = 鏇夢齋膚簾糧製積鏇艱獵範觸蓋鹹願廠製齋餘 (遞艱齋餘鑰鏇衊糧獵糧 ) 更多