注射用头孢曲松钠不良反应的Meta分析

摘要/Abstract

摘要： 目的初步评价注射用头孢曲松钠临床用药安全性。方法检索Medline、EBsco、Cochrane图书馆和中国生物医学文献数据库、中国知网数据库、维普全文期刊数据库,纳入有关头孢曲松钠临床研究。采用Rev Man 5.3软件对纳入文献进行Meta分析。根据PRISMA指南,对不同国别、不同适应证、不同剂量的药品不良反应（ADR）发生率进行亚组分析。结果共纳入21个随机对照试验（RCT）,涉及临床病例5 417例。Meta分析结果,本品ADR发生率高于对照组[OR=1.18,95% CI（1.02,1.35）,Z=2.26,P=0.002],多个研究的异质性有统计学意义。亚组分析显示国外多项研究数据的异质性有统计学意义[OR=1.20,95% CI（1.03,1.41）,Z=2.33,P=0.02],本品常规剂量ADR发生率数据异质性有统计学意义（Z=2.17,P=0.03）,常规剂量组ADR发生率高于对照组。结论注射用头孢曲松钠不良反应发生率高于对照组。受纳入研究方法学限制,该结论有待大样本、高质量的随机对照试验进一步验证。

关键词: 注射用头孢曲松钠, 药品不良反应, Meta分析, 亚组分析

Abstract: Objective To preliminarily evaluate the safety of ceftriaxone sodium for injection in clinical practice. Methods Medline, EBsco, Cochrane Library and Chinese Biomedical Literature Database, China National Knowledge Database, VIP database were retrieved, and randomized controlled trials (RCTs) related to ceftriaxone were included. Meta-analysis for adverse drug reaction (ADR) rates of ceftriaxone sodium was performed by RevMan 5.1. In addition, subgroup analyses including different countries, different indications and different doses were performed according to PRISAM guidelines. Results A total of 21 RCTs were included, involving 5417 cases. The result of Meta-analysis showed that the rate of adverse reactions in ceftriaxone sodium for injection group was significantly higher than that in the control group [OR=1.18, 95% CI (1.02, 1.35), Z=2.26, P=0.002]. Heterogeneity of several studies was statistically significant. Subgroup analyses showed that heterogeneity of several studies in foreign group was statistically significant [OR=1.20, 95% CI (1.03, 1.41), Z = 2.33, P=0.02]. The ADR incidence of the conventional dose group was higher than that in the control group, and its heterogeneity was statistically significant (Z=2.17, P=0.03). Conclusion Treatment with ceftriaxone sodium for injection has higher adverse reaction incidence than other treatments. The Results need more high-quality randomized controlled trials to testify.

Key words: ceftriaxone sodium for injection, adverse drug reaction, Meta-analysis, subgroup analysis

中图分类号:

R978.11

魏芬芳, 孙怡园, 杨悦. 注射用头孢曲松钠不良反应的Meta分析[J]. 中国药物警戒, 2016, 13(6): 351-358.

WEI Fen-fang, SUN Yi-Yuan, YANG Yue. Meta-analysis of Adverse Drug Reactions of Ceftriaxone Sodium for Injection[J]. Chinese Journal of Pharmacovigilance, 2016, 13(6): 351-358.

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