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国产头孢哌酮/舒巴坦与商品头孢哌酮/舒巴坦治疗细菌感染的疗效和安全性:系统评价和荟萃分析。

Efficacy and safety of generic cefoperazone/sulbactam versus branded cefoperazone/sulbactam in the treatment of bacterial infections: a systematic review and meta-analysis.

机构信息

Yunnan Provincial Key Laboratory of Entomological Biopharmaceutical R&D, Dali University, Dali, Yunnan Province, China.

Department of Pharmacy, The Affiliated Anning First People's Hospital of Kunming University of Science and Technology, Kunming, China.

出版信息

J Chemother. 2024 Dec;36(8):698-708. doi: 10.1080/1120009X.2024.2343961. Epub 2024 Apr 21.

Abstract

This study aim to assess the clinical efficacy and safety of generic cefoperazone/sulbactam compared to the branded cefoperazone/sulbactam (Sulperazon) in treating bacterial infections through a meta-analysis. Searches were conducted across PubMed, Embase, Cochrane Library, CNKI, WanFang, VIP databases, and Clinical Trials database, resulting in the inclusion of 11 studies comprising 7 randomized controlled trials (RCTs) and 4 retrospective cohort studies (RCSs). Meta-analysis of the RCTs indicated no statistical differences in clinical success rates, clinical cure rates, microbiological eradication rates, and incidence of adverse reactions between the generic cefoperazone/sulbactam and the branded version. Findings from the RCSs aligned with those from the RCTs, demonstrating that generic versions of cefoperazone/sulbactam are equivalent in efficacy and safety to their branded counterparts in treating bacterial infections.

摘要

本研究旨在通过荟萃分析评估与品牌头孢哌酮/舒巴坦(Sulperazon)相比,通用头孢哌酮/舒巴坦治疗细菌感染的临床疗效和安全性。通过对 PubMed、Embase、Cochrane 图书馆、CNKI、万方、VIP 数据库和临床试验数据库进行检索,纳入了 11 项研究,包括 7 项随机对照试验(RCT)和 4 项回顾性队列研究(RCS)。对 RCT 的荟萃分析表明,在临床成功率、临床治愈率、微生物清除率以及不良反应发生率方面,通用头孢哌酮/舒巴坦与品牌药物之间没有统计学差异。RCS 的结果与 RCT 的结果一致,表明通用头孢哌酮/舒巴坦在治疗细菌感染方面的疗效和安全性与品牌药物相当。

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