Sulopenem

International Journal of Antimicrobial Agents Volume 67, Issue 7 国际抗微生物制剂杂志 67卷 7期 https://www.sciencedirect.com/journal/international-journal-of-antimicrobial-agents/vol/67/issue/7 International Society of Antimicrobial Chemotherapy (ISAC) News and Information Page（国际抗菌化疗学会（ISAC）新闻与信息页） 1.  International Society of Antimicrobial Chemotherapy (ISAC) News and Information Page 国际抗菌化疗学会（ISAC）新闻与信息页 Article 107845 Full Length Articles（长篇论著） 2.  Targeting the human protein disulfide isomerase A3 as a broad-spectrum antiviral approach against human respiratory viruses 以人蛋白二硫键异构酶A3为靶点，开发针对人类呼吸道病毒的广谱抗病毒方法 Giulia Sibille, Arianna Maggiora, Giorgia Cimato, Anna Luganini, Giorgio Gribaudo Article 107802 3.  Comparative outcomes of daptomycin and linezolid in vancomycin-resistant enterococcal intra-abdominal infections with bacteraemia 达托霉素与利奈唑胺治疗耐万古霉素肠球菌所致伴菌血症的腹腔内感染的疗效比较 Tsung-Yu Tsai, Yu-Chung Chuang, Jia-Ling Yang, Chi-Ying Lin, ... Shan-Chwen Chang Article 107792 4.  Synthetic quinolone-tethered aminoguanidine derivatives exhibit potent anti-plasmodial activity 合成的喹诺酮连接氨基胍衍生物表现出强效的抗疟原虫活性 Nanang R. Ariefta, Richard M. Beteck, Lesetja J. Legoabe, Yoshifumi Nishikawa Article 107797 5.  Association between antimicrobial resistance and in-hospital mortality in adults with bacterial infective endocarditis: A nationwide cohort study 抗菌药物耐药性与成人细菌性感染性心内膜炎住院死亡率之间的关联：一项全国性队列研究 Iván Oterino-Moreira, Francisco Javier Candel-González, Montserrat Pérez-Encinas, Susana Lorenzo-Martínez Article 107805 6.  Machine learning-based prediction of multi-level anti-microbial resistance in Klebsiella pneumoniae using whole-genome sequencing data 基于全基因组测序数据，利用机器学习预测肺炎克雷伯菌的多层级抗菌药物耐药性 Xinmiao Jia, Jingjia Zhang, Jing Chen, Jun Wang, ... Qiwen Yang Article 107807 7.  Investigating the role of novel alphatectiviruses in reducing carriage and transfer of antimicrobial resistance plasmids 新型α干扰病毒在减少耐药质粒携带和转移中的作用研究 Mattis Kreins-Irle, Michael Berger, Ágnes Solti-Hodován, Krishnendu Mukherjee, ... Ulrich Dobrindt Article 107806 8.  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 关于头孢地尔治疗中国成人由革兰氏阴性菌引起的复杂性尿路感染的多中心、随机、双盲、以亚胺培南/西司他丁为对照的临床研究 Jinyi Yuan, Deyong Fan, Henglan Wu, Bei Jia, ... Yingyuan Zhang Article 107812 9.  Multidrug-Resistant Acinetobacter baumannii Pneumonia in Clinical Therapy: A Systematic Review and Network Meta-analysis on Effectiveness and Safety of Different Antibiotic Combination Regimens 多重耐药鲍曼不动杆菌肺炎的临床治疗：不同抗生素联合用药方案有效性和安全性的系统综述与网络荟萃分析 Shao-Yuan Hao, Hau-Yu Lin, Po-I Yeh, Hui-Chuan Hsiao, ... Po-Liang Lu Article 107815 10.   Population pharmacokinetics of polymyxin B in critically ill patients with multi–drug-resistant (MDR) Acinetobacter baumannii and Pseudomonas aeruginosa infections 多药耐药（MDR）鲍曼不动杆菌和铜绿假单胞菌感染危重患者中多粘菌素B的群体药代动力学 Puteri Juanita Zamri, Saskia A. Wölky, Maria P. Hernandez-Mitre, Xin Liu, ... Mohd Hafiz Abdul-Aziz Article 107816 Short Communications（短讯） 11.   Model-informed cefepime dosing in paediatric patients receiving continuous renal replacement therapy 接受连续性肾脏替代治疗的儿科患者的头孢吡肟模型指导给药 Ronaldo Morales Junior, Shannon Reinert, Emily Diseroad, Erin Schuler, ... H. Rhodes Hambrick Article 107809 12.   Aggressive joint pharmacokinetic/pharmacodynamic target attainment of TDM-guided continuous infusion meropenem-vaborbactam monotherapy: A valuable strategy for maximizing the microbiological outcome of documented KPC-producing Enterobacterales infections? TDM指导下美罗培南-韦博巴坦持续输注单药治疗的积极联合药代动力学/药效学目标达标：一种最大化KPC产肠杆菌科细菌感染微生物学结局的有价值策略？ Milo Gatti, Cecilia Bonazzetti, Benedetta Secci, Beatrice Giorgi, ... Federico Pea Article 107811 13.   Efficacy and pharmacokinetics of a stepwise isolated phage cocktail against carbapenem-resistant Klebsiella pneumoniae in a murine pneumonia model 逐步分离噬菌体鸡尾酒疗法对抗碳青霉烯耐药肺炎克雷伯菌的疗效和药代动力学：小鼠肺炎模型研究 Xin Yin, Huan Luo, Yu Feng, Qingqing Fang, Zhiyong Zong Article 107810 14.   In vivo emergence of cross-resistance to ceftazidime/avibactam and cefiderocol through selection of KPC variants in Klebsiella pneumoniae clinical isolates 肺炎克雷伯菌临床分离株通过选择KPC变异株，在体内对头孢他啶/阿维巴坦和头孢地尔产生交叉耐药性 Gabriele Bianco, Jacqueline Findlay, Sara Comini, Cristina Costa, ... Matteo Boattini Article 107808 Letters to the Editor（致编辑的信） 15.   In reply to the letter to the editor regarding “Antibiotic class comparisons for the treatment of pyelonephritis and complicated urinary tract infections: A systematic review and meta-analysis” 回复致编辑关于“治疗肾盂肾炎和复杂性尿路感染的抗生素类别比较：一项系统综述和荟萃分析”的来信 Itay Zahavi, Digbijay Kunwar, Judit Olchowski, Hagar Dallasheh, Mical Paul Article 107800 16.   Comment on “Enhancing meropenem therapy in critical care: A retrospective study of PK/PD target attainment and therapeutic drug monitoring” 对“加强重症监护病房美罗培南治疗：一项关于药代动力学/药效学目标达成情况和治疗药物监测的回顾性研究”的评论 Xuefeng Yu Article 107804 17.   Analytical feasibility of linezolid quantification by LC–MS/MS using dried plasma spot microsampling 采用干血浆斑微量采样法通过液相色谱-串联质谱（LC–MS/MS）技术定量测定利奈唑胺的分析可行性研究 Anisa Bardhi, Bochra Mansour, Dimitri Schlemmer, Pascal Robidou, ... Noël Zahr Article 107799 18.   Beyond parasite clearance: Three unresolved methodological challenges in cross-regional PKDL trials 突破寄生虫清除：跨区域皮肤型黑热病（PKDL）试验中三个尚未解决的方法学挑战 Ciyu Zhao, Shanshan Yuan Article 107798 19.   Comment on “Nanomedicine for phage therapy: Encapsulation strategies for enhanced antimicrobial efficacy” 对"噬菌体治疗的纳米医学：增强抗菌疗效的包封策略"的评论 Wenhao Wang, Ziyu Zhao, Zhengwei Huang Article 107814 20.   Comment on “ESBL-producing Escherichia coli bacteremic urinary tract infections: Clinical and economic burden and antimicrobial stewardship opportunities in a retrospective cohort study” 对"产ESBL大肠埃希菌血源性尿路感染：一项回顾性队列研究中的临床和经济负担及抗菌药物管理机会"的评论 Neeraj Singh, Monika Srivastav Article 107820 International Journal of Antimicrobial Agents Volume 67, Issue 8 国际抗微生物制剂杂志 67卷 8期 https://www.sciencedirect.com/journal/international-journal-of-antimicrobial-agents/vol/67/issue/8 Reviews（综述） 1.  Comparative efficacy and safety of antifungal prophylactic agents in allogeneic hematopoietic stem cell transplantation: A systematic review and network meta-analysis 异基因造血干细胞移植中抗真菌预防药物的疗效和安全性比较：系统综述与网络荟萃分析 Xinyi Li, Ruonan Shao, Tingting Zhang, Yuping Fan, ... Sizhou Feng Article 107826 2.   Revisiting fluoroquinolone prophylaxis in haematological malignancies and hematopoietic cell transplantation: A decade of evidence and gaps in understanding the impact of gut colonization with fluoroquinolone-resistant Enterobacterales 重新审视血液系统恶性肿瘤和造血干细胞移植中氟喹诺酮类药物的预防应用：十年证据及对氟喹诺酮耐药肠杆菌目细菌肠道定植影响的认知空白 Hilal Abdessamad, Dania Abdallah, Rana Attieh, Shadi Eid, ... Rima Moghnieh Article 107824 Full Length Articles（长篇论著） 3.  Multi-target modulation of the AKT/NF-κB signalling axis by quercetin attenuates Stenotrophomonas maltophilia-induced pneumonia 槲皮素对AKT/NF-κB信号轴的多靶点调节可减轻嗜麦芽寡养单胞菌诱导的肺炎 Hanzhao Zhang, Yang Li, Fuming You, Jiang Li, ... Luomeng Chao Article 107823 4.  Risk factors and serum concentration thresholds associated with tigecycline-induced hepatotoxicity in critically ill patients 危重患者替加环素诱导肝毒性的相关风险因素和血清浓度阈值 Mengxue Li, Jie He, Gaoqiu Dong, Hua Shao, Linlin Hu Article 107822 5.  Population Pharmacokinetics of Total and Free Ceftriaxone in Critically Ill and Non-Critically Ill Hospitalised Adult Patients 危重与非危重住院成年患者中总头孢曲松和游离头孢曲松的群体药代动力学 Eko Setiawan, Alvaro Gonzalez, Saskia A. Wölky, Menino Osbert Cotta, ... Mohd H. Abdul-Aziz Article 107817 6.  Stepwise within-host evolution of a blaCTX-M-27-positive Klebsiella pneumoniae clone under changing antimicrobial pressures leading to enhancement of β-lactam resistance 在不断变化的抗菌压力下，blaCTX-M-27阳性肺炎克雷伯菌克隆的宿主体内逐步进化及其β-内酰胺耐药性增强 Masamune Aihara, Yasuhiro Gotoh, Keiji Nakamura, Tomoko Kimura-Hyoda, ... Tetsuya Hayashi Article 107840 7.  Integrated prediction of ceftriaxone resistance in major Salmonella serotypes using MALDI-TOF MS data with balanced datasets and machine learning 利用MALDI-TOF MS数据结合平衡数据集与机器学习对主要沙门菌血清型头孢曲松耐药性的整合预测 Jun Ren, Jintao Xia, Mengyu Zhang, Chunhong Liu, ... Wenjun Cao Article 107832 8.  The ATP-binding cassette transporter CstA as a novel therapeutic target for treating carbapenem-resistant Enterobacteriaceae bacteria ATP结合盒转运蛋白CstA作为治疗碳青霉烯耐药肠杆菌科细菌的新型治疗靶点 Jiafang Fu, Rong Wang, Yayu Liu, Gongli Zong, ... Guangxiang Cao Article 107837 9.  Characterization and host range associating factors of Staphylococcus aureus bacteriophage PBSA08; Using Australian MRSA reference set 葡萄球菌噬菌体PBSA08的特征及宿主范围相关因子分析：基于澳大利亚MRSA参考菌株集 Shinwon Lee, Stephanie Lynch, Clare Fisher, Nouri Ben Zakour, ... Jonathan R. Iredell Article 107838 10.   In vivo evolution of tigecycline resistance in ST540 carbapenem-resistant Acinetobacter baumannii: Mechanisms and global epidemiological perspective ST540碳青霉烯耐药鲍曼不动杆菌体内替加环素耐药性进化：机制与全球流行病学视角 Jintao He, Hanqi Zhang, Haiyang Liu, Wanxun Lin, ... Chuanxin Yang Article 107841 Short Communications（短讯） 11.   The need for systematic therapeutic drug monitoring of isoniazid in tuberculosis: A real-world study. 结核病中异烟肼的系统性治疗药物监测需求：一项现实研究。 Marine Chancel, Youssef Bennis, Sandra Bodeau, Anne-Sophie Lemaire-Hurtel, ... Claire Andréjak Article 107827 12.   Multidrug-resistant Enterobacterales in United States hospitals: Frequency and susceptibility to newer β-lactamase inhibitor combinations (2020–2024) 美国医院中多重耐药肠杆菌目细菌的发生频率及对新型β-内酰胺酶抑制剂复合制剂的敏感性（2020–2024） Helio S. Sader, Rodrigo E. Mendes, John H. Kimbrough, Marisa L. Winkler, Mariana Castanheira Article 107835 13.   Environmental surveillance in Chile reveals a multidrug-resistant Salmonella Amager from an emerging blaCTX-M-65/pESI-positive lineage 智利环境监测发现来源于新兴blaCTX-M-65/pESI阳性谱系的多重耐药阿马格沙门菌 Josefina Miranda-Riveros, Daniel Tichy-Navarro, María José Navarrete, Angélica Reyes-Jara, ... Alejandro Piña-Iturbe Article 107831 Letters to the Editor（致编辑的信） 14.   Comment on: New-generation antibiotics and nonantibiotic strategies against carbapenemase-producing Enterobacterales: More focus on metallo-β-lactamase producers 评论：新一代抗生素及非抗生素策略对抗产碳青霉烯酶肠杆菌目细菌：重点关注金属β-内酰胺酶生产者 Xiaopei Yang, Wen Zhou, Xisong Ke Article 107833 15.   Comment on “Present trajectories to forecasted future: A longitudinal analysis of hospital antibiotic use in China from 2013 to 2024 and projections to 2030” 评论"当前轨迹与未来预测：中国医院抗生素使用的纵向分析（2013–2024）及至2030年的预测" Jiaxin Luo Article 107821 16.   In reply to the letter to editor regarding ``Enhancing meropenem therapy in critical care: A retrospective study of PK/PD target attainment and therapeutic drug monitoring'' 关于"增强重症监护中美罗培南治疗：PK/PD靶标达成率与治疗药物监测的回顾性研究"致编辑信的回复 Jingli Liao, Chao Li, Jingxian Liu, Wei Wu, ... Lixia Li Article 107830 17.   Reply to the letter to the editor regarding “Beneficial effects of a compound probiotic in Helicobacter pylori-infected patients aged over 40 years: An open-label randomised clinical trial” 关于"复合益生菌对40岁以上幽门螺杆菌感染患者的有益作用：一项开放标签随机临床试验"致编辑信的回复 Chenghai Yang, Jie Cheng, Meng Zhang, Wenyi Zhang, Ye Chen Article 107836 18.   Comment on “Disrupting bacterial metabolism by targeting LDH reverses aminoglycoside resistance in Streptococcus suis”: Methodological and translational considerations 评论"通过靶向LDH干扰细菌代谢可逆转猪链球菌氨基糖苷类耐药性"：方法学与转化方面的考量 Jiehua Han Article 107834 19.   Targeted use of sulopenem in multidrug-resistant uncomplicated urinary tract infections sulopenem在多重耐药非复杂性尿路感染中的靶向应用 Areej Riaz, Raana Riaz Article 107828

当地时间 12 月 11 日，葛兰素史克（GSK）宣布，美国 FDA 已批准口服疗法 Gepotidacin 的补充新药申请，用于治疗 12 岁及以上（体重≥45 kg）单纯性泌尿生殖系统淋病患者。该申请此前已获 FDA 优先审查资格。 根据新闻稿，这是三十多年来首个获批用于治疗淋病的新型抗生素。 Gepotidacin 是一款 first-in-class 新型口服抗生素，具有独特的药物特性与作用机制，其结构属于三氮杂苊烯类，不同于现有喹诺酮类抗生素。和喹诺酮类仅单一抑制拓扑异构酶 II（Top II）或拓扑异构酶 IV（Top IV）不同，Gepotidacin 可选择性且均衡抑制细菌 DNA 回旋酶（Top II 的亚型）与 Top IV，通过双重作用阻断细菌 DNA 复制。 今年 3 月 25 日，Gepotidacin（商品名 Blujepa）首次获 FDA 批准，用于治疗单纯性尿路感染（uUTI）的成人女性患者（≥40 kg）及 12 岁以上青少年患者（≥40 kg），这也是 30 多年来首个获批治疗 uUTI 的新型口服抗生素。 Gepotidacin 本次新适应症的获批是基于 EAGLE-1 III 期临床试验的数据，该试验（NCT04010539）是 Gepotidacin 针对成人及青少年的全球性 III 期综合临床试验项目组成部分，结果已于 2025 年 4 月发表于《柳叶刀》。在这项纳入约 600 名单纯性泌尿生殖系统淋病患者的非劣效性试验中，研究人员对比了 Gepotidacin（口服两剂，每次 3000 毫克）与肌内注射头孢曲松（500 毫克）联合口服阿奇霉素（1000 毫克）的疗效与安全性。 数据显示，Gepotidacin 组泌尿生殖部位治疗成功率达 92.6%（187/202，95% CI：88.0-95.8），头孢曲松联合阿奇霉素组成功率为 91.2%（186/204，95% CI：86.4-94.7），证实 Gepotidacin 的疗效达到非劣效标准。此外，两组治疗中均未出现因淋球菌持续感染导致的泌尿生殖部位治疗失败案例。 Gepotidacin 的安全性和耐受性与此前临床试验结果一致，治疗组与对照组均未观察到药物相关的严重不良事件，最常见的不良反应为轻至中度胃肠道反应，整体安全性与耐受性良好。 淋病是由淋球菌引发的性传播感染，已成为公共卫生领域的重要挑战。根据美国疾病控制与预防中心（CDC）数据，2023 年美国报告的淋病病例超 60 万例，位列该国性传播感染报告数量第二位。目前美国尚无获批的淋病预防疫苗，临床标准治疗方案以注射疗法为主，临床对口服治疗选择的需求迫切。Gepotidacin 的获批恰好填补了这一空白，为患者提供了更便捷的治疗新选项。 目前，淋病治疗领域正在研发中的新药，还有Zoliflodacin（Entasis Therapeutics）、Sulopenem（Iterum Therapeutics）、呋喃妥因（ Fabbrica Italiana Sintetici）等。 参考：Insight 数据库 加入读者交流群： —精彩回顾— 我国启动全球最大规模尿液HPV筛查研究 针对红斑狼疮！阿斯利康首创生物制剂 III 期成功 恒瑞乙肝「突破性疗法」来袭 ADC之后，ABC来了 全球首例！中国医生体内CAR-T成功治疗狼疮 商  务  合  作  ：  杨小雨 15210041717