针对耐多药细菌引进新抗生素:障碍与前进之路。

IF 10.9 1区 医学 Q1 INFECTIOUS DISEASES Clinical Microbiology and Infection Pub Date : 2024-10-05 DOI:10.1016/j.cmi.2024.09.025
Thomas Tängdén, Elena Carrara, Mona Mustafa Hellou, Dafna Yahav, Mical Paul
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引用次数: 0

摘要

背景:在大力重振干抗生素研发管道之后,最近批准了几种备受期待的具有抗耐多药(MDR)细菌活性的抗生素:目的:我们旨在强调新抗生素在获得批准时所产生的证据方面的差距,并审查优先 MDR 细菌治疗指南因此而受到的限制。我们还报告了新抗生素的可用性、允许医院使用这些抗生素的报销策略以及抗生素监管工作:我们在 PubMed 上搜索了 2013-2023 年间获批用于抗 MDR 细菌的 3 期随机对照试验。其他来源包括有关新抗生素报销和使用政策的政府和专业文件:内容:本文介绍了有关新型抗生素的现有证据中存在的几个缺陷,涉及试验的目标人群、比较对象、试验中的管理算法、非劣效假设以及研究中的耐药性发展评估。我们强调了现行指南有可能会增加新抗生素的使用,从而加速耐药性的产生。对抗生素可用性的最新调查显示,在获得新抗生素方面存在严重的不平等。最后,欧洲各国为提供新抗生素而采取的策略没有得到抗生素监管工作的充分平衡,无法合理使用新抗生素:抗生素耐药性是一个迫在眉睫的威胁。本综述强调了需要在不同国家和地理区域采取更加系统和统一的策略,以改进新型广谱抗生素的证据、供应和使用的领域。
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Introducing new antibiotics for multidrug-resistant bacteria: obstacles and the way forward.

Background: Following intense efforts to revive the dry antibiotic research and development pipeline, a few highly awaited antibiotics with activity against multidrug-resistant (MDR) bacteria were recently approved.

Objectives: We aim to highlight gaps in the evidence generated for new antibiotics by the time of their approval and to review the consequent limitations of treatment guidelines for priority MDR bacteria. We also report on the availability of the new antibiotics, reimbursement strategies allowing the use of these antibiotics in hospitals, and antibiotic stewardship efforts.

Sources: We searched PubMed for phase 3 randomized controlled trials, guidelines, and publications on access, usage, regulatory aspects and antimicrobial stewardship of antibiotics approved for use against MDR bacteria between 2013 and 2023. Other sources included governmental and professional documents regarding policies for reimbursement and use of the new antibiotics.

Content: Several gaps in the evidence available regarding the new antibiotics are described related to the trials' target populations, comparators, management algorithm within the trial, non-inferiority hypotheses, and assessment of resistance development within the studies. We highlight the risk of current guidelines to increase the usage of new antibiotics and consequently accelerate resistance development. Updated mapping of antibiotic availability reveals critical inequality in access to the new antibiotics. Finally, strategies used nationally in Europe to provide access to the new antibiotics are not sufficiently balanced by antibiotic stewardship efforts to calibrate the judicious use of the new antibiotics.

Implications: Antibiotic resistance is an immediate threat. The present review highlights areas where more systematic and uniform strategies across countries and geographical regions are warranted to improve evidence, availability, and use of new broad-spectrum antibiotics.

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来源期刊
CiteScore
25.30
自引率
2.10%
发文量
441
审稿时长
2-4 weeks
期刊介绍: Clinical Microbiology and Infection (CMI) is a monthly journal published by the European Society of Clinical Microbiology and Infectious Diseases. It focuses on peer-reviewed papers covering basic and applied research in microbiology, infectious diseases, virology, parasitology, immunology, and epidemiology as they relate to therapy and diagnostics.
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