头孢哌酮/舒巴坦治疗临床感染的有效性和安全性：系统综述和荟萃分析

摘要: 目的 系统评价注射用头孢哌酮钠/舒巴坦钠(商品名：舒普深)在中国治疗临床感染的有效性和安全性。 方法 系 统检索万方、中国知网、维普、SinoMed、PubMed和Cochrane Library数据库，收集1978年至2019年7月4日公开发表的关于头孢 哌酮/舒巴坦在中国治疗临床感染方面的文献，按照纳入排除标准进行筛选，使用Stata 15.0和SAS 9.4软件进行荟萃(Meta)分析。 主要结局指标包括临床有效率与痊愈率，次要结局指标包括细菌清除率(株)与不良事件发生率。 结果 最终纳入110篇文献，其 中有82篇、87篇分别纳入有效率和痊愈率的Meta分析。结果显示，头孢哌酮/舒巴坦治疗临床感染的总有效率为80.3% 95%置信 区间(CI): 77.4%~83.0%]，痊愈率为50.1% (95%CI: 45.1%~55.1%)。共38项研究报告了细菌清除率，结果显示细菌清除率为81.1% (95%CI: 76.9%~84.9%)。62篇文献报告治疗中发生的不良事件例数，合计不良事件的发生率为7.4% (95%CI: 6.1%~8.9%)，包括 血液系统不良事件、胃肠道不良事件、肝肾功能损害及皮肤不良事件等。与其他对照药物相比，头孢哌酮/舒巴坦治疗临床感染 的有效性和安全性良好。 结论 头孢哌酮/舒巴坦的临床应用效果较为可观，对治疗临床感染具有较高的价值，安全性好。但 临床应注意合理用药，加强对头孢哌酮/舒巴坦的不良事件监测，减少不良事件。

Effectiveness and safety of cefoperazone/sulbactam in the treatment of clinical infections: A systematic review and meta-analysis

Abstract Objective To systematically evaluate the effectiveness and safety of cefoperazone/sulbactam (Sulperazon®) in the treatment of clinical infections in China. Methods The literature on the clinical application of cefoperazone/sulbactam in China published before July 4, 2019 was searched in the databases of WanFang, CNKI, VIP, SinoMed, PubMed, and Cochrane Library. The literature was screened according to the inclusion and exclusion criteria, and the meta-analysis was performed using Stata 15.0 and SAS 9.4. The primary outcomes included the effective rate and the cure rate in clinical effectiveness, and the secondary outcomes included the bacterial clearance rate and the incidence of adverse reactions. Results A total of 110 articles were included, and 82 articles were included in the effective rate and 87 were included in the cure rate. The total effective rate was 80.3% (95%CI: 77.4%~83.0%) and the cure rate was 50.1% (95%CI: 45.1%~55.1%). The bacterial clearance rate was 81.1% (95%CI: 76.9%~84.9%) which was reported in 38 studies. The total incidence of adverse events was 7.4% (95%CI: 6.1%~8.9%)reported in 62 articles, including blood system, gastrointestinal tract, liver function, kidney function, and skin adverse events. The effectiveness and safety of cefoperazone/sulbactam were compared to other antimicrobial agents in the treatment of clinical infections. Conclusion The clinical effectiveness of cefoperazone/sulbactam is considerable and the overall safety is good. However, clinical attentions should be paid and the monitoring of adverse events of cefoperazone/sulbactam should be strengthened.