系统性喹诺酮类药物和急性肝衰竭的风险II:临床试验的系统回顾

Taher Mohamed Kadry, Habsah Mohamed, Bjerre Lise, M. Franco, M. Donald, Krewski Daniel
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引用次数: 1

摘要

背景:喹诺酮类药物是一类具有四代合成抗生素,具有作用机制独特、广谱、药理作用强、安全性合理等特点。它们在全球和日益普及的同时,抗菌素耐药性的出现和意外不良反应的发生也在增加。尽管如此,医生继续开这些药的规模越来越大,而不考虑其他治疗方案的可用性。目的:系统回顾所有喹诺酮类抗生素与其他药物或药物组合进行比较的临床试验,以寻找喹诺酮类抗生素与ALF风险相关的证据。方法:我们检索了4个主要的文献数据库、8个临床试验注册库和主要的灰色文献来源,包括国际会议论文集、药物审评网络和制药公司数据库,以获取正在进行或未发表的研究。我们还检查了入选我们综述的其他相关研究的出版物的参考书目。普洛斯彼罗注册号:CRD42020148742。结果:我们确定了1974年至2020年间在全球许多国家进行的1264项原始临床试验,招募了几乎所有种族、背景、年龄组和不同合并症负担的男性和女性。一项试验报告了一例使用吉氟沙星的ALF病例,另一项试验报告了另一例使用莫西沙星的ALF病例。结论:临床试验没有足够的证据表明喹诺酮类抗生素是急性肝衰竭的原因。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Systemic Quinolones and Risk of Acute Liver Failure II: Systematic Review of Clinical Trials
Background: Quinolones are a class with four generations of synthetic antibiotics characterized by a unique mechanism of action, broad spectrum, potent pharmacologic properties and reasonable safety profile. Their global and growing popularity has been accompanied by an increase in the emergence of antimicrobial resistance and occurrence of unexpected adverse reactions. Nevertheless, physicians continue to prescribe these drugs on an increasing scale, irrespective of the availability of other treatment alternatives. Objective: To systematically review all clinical trials where a quinolone antibiotic was tested or used as a comparator to other drugs or drug combinations, for evidence on quinolones’ association with ALF risk. Methods: We examined 4 major bibliographic databases, 8 clinical trial registries, and major grey literature sources including international conference proceedings, drug review networks and databases of pharmaceutical companies for ongoing or unpublished studies. We also examined the bibliographies of publications selected for inclusion in our review for other relevant studies. PROSPERO registration number: CRD42020148742. Results: We identified 1,264 original clinical trials conducted between 1974 and 2020, in many countries around the world, enlisting men and women from almost all ethnicities, backgrounds, age groups and with different comorbidity burdens. One trial reported a single ALF case with gemifloxacin and the other reported another case with moxifloxacin. Conclusion: There is inadequate evidence from clinical trials to implicate quinolone antibiotics as a cause of acute liver failure.
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