用于标示外治疗适应症的头孢哌酮的安全性和有效性:系统综述。

Riyan Babidhan, Abigale Lewis, Cailin Atkins, Nicolas J Jozefczyk, Branden D Nemecek, Courtney A Montepara, Michael R Gionfriddo, David E Zimmerman, Jordan R Covvey, Anthony J Guarascio
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引用次数: 3

摘要

目的:头孢羟氨苄是一种嗜苷头孢菌素,最近被美国食品和药物管理局批准用于治疗医院和呼吸机获得性细菌性肺炎以及复杂性尿路感染。不过,头孢羟氨苄还有可能用于治疗其他各种感染。本系统性综述的目的是找出研究头孢羟氨苄用于标签外适应症的安全性和有效性的文献:方法:采用 PRISMA 指南进行报告。检索的数据库包括 PubMed、Scopus 和 Embase,检索时间从开始到 2021 年 9 月。纳入了描述头孢羟氨苄在临床环境中标示外使用的稿件。排除标准包括侧重于标签适应症的研究、动物研究、药效学/药代动力学研究、体外或实验室研究,以及非英语或阿拉伯语的稿件。每个阶段的审查均由两名独立研究人员进行,并解决冲突和进行批判性评估。研究人员提取了有关发病情况、临床过程和感染特征的数据,并进行了描述性分析:搜索共发现了 985 条记录,最后筛选出 27 项研究。其中包括 18 项(66.7%)病例报告、8 项(29.6%)系列病例和 1 项(3.7%)3 期临床试验。在总共 76 例纳入研究的患者中,有 51 例(67.1%)患者在标示外使用头孢羟氨苄治疗菌血症/败血症,无论有无明确病源。在有数据的病例系列/报告中,53 名患者中有 43 名(81.1%)接受了联合抗生素治疗。最常见的病原体包括多重/广泛耐药的铜绿假单胞菌和/或鲍曼不动杆菌。有 18 项(66.7%)研究报告了各种临床终点,而微生物终点则有报告。与头孢羟氨苄相关的副作用并不常见,而且很少限制使用:本系统综述描述了标签外头孢羟氨苄的相对临床疗效,最常用于铜绿假单胞菌和鲍曼不动杆菌感染的联合抗生素治疗。需要进一步研究以阐明头孢羟氨苄在更多患者和适应症中的安全性和有效性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safety and efficacy of cefiderocol for off-label treatment indications: A systematic review.

Purpose: Cefiderocol is a siderophore cephalosporin recently approved by the United States Food and Drug Administration for the treatment of hospital- and ventilator-acquired bacterial pneumonia and complicated urinary tract infections. However, there is potential for cefiderocol utility for a variety of other infections. The purpose of this systematic review was to identify literature examining the safety and efficacy of cefiderocol for off-label indications.

Methods: The PRISMA guidelines were utilized for reporting. Databases searched included PubMed, Scopus, and Embase, from inception to September 2021. Manuscripts describing cefiderocol off-label use in clinical settings were included. Exclusion criteria were studies focused on labeled indications, animal studies, pharmacodynamic/pharmacokinetic studies, in vitro or laboratory studies, and manuscripts in languages other than English or Arabic. Each stage of review utilized two independent investigators, with conflicts resolved and critical appraisal performed. Data regarding presentation, clinical course, and infection characteristics were extracted and descriptively analyzed.

Results: The search identified a total of 985 records, narrowed to a final set of 27 studies. Among studies included were 18 (66.7%) case reports, 8 (29.6%) case series, and 1 (3.7%) phase 3 clinical trial. Cefiderocol was most frequently used off-label for bacteremia/sepsis with or without an identified source in 51 (67.1%) out of a total of 76 included patients. Among case series/reports with available data, 43 of 53 patients (81.1%) received combination antibiotic therapy. The most common pathogens identified included multi/extensively drug-resistant Pseudomonas aeruginosa and/or Acinetobacter baumannii. Various clinical end points were reported, while microbiological end points were reported in 18 (66.7%) studies. Cefiderocol-related side effects were uncommon and rarely use-limiting.

Conclusions: This systematic review depicts relative clinical effectiveness of off-label cefiderocol, most commonly for P. aeruginosa and A. baumannii infections as combination antibiotic therapy. Further study is needed to elucidate the safety and efficacy of cefiderocol across an expanded set of patients and indications.

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