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固定剂量复合剂(FDC)治疗肺结核的疗效和安全性的Meta分析

马婧婧 周泽文 颜陶 伍翔 王润华 易静

中国临床药理学与治疗学2012,Vol.17Issue(10):1143-1150,8.
中国临床药理学与治疗学2012,Vol.17Issue(10):1143-1150,8.

固定剂量复合剂(FDC)治疗肺结核的疗效和安全性的Meta分析

Meta-analysis on efficacy and safety of fixed-dose combination (FDC) in treatment of pulmonary tuberculosis

马婧婧 1周泽文 1颜陶 2伍翔 1王润华 1易静1

作者信息

  • 1. 重庆医科大学公共卫生与管理学院,卫生统计学教研室,重庆400016
  • 2. 重庆医科大学药学院,药理学教研室,重庆400016
  • 折叠

摘要

Abstract

AIM: To evaluate the efficacy and safety of fixed-dose combination for the treatment of pulmonary tuberculosis. METHODS: The studies related to the efficacy and safety of FDC in the treatment of newly diagnosed smear-positive pulmonary tuberculosis, and randomized clinical controlled trials (RCTs) or clinical controlled trials (CCTs) published in the openly journals either in Chinese or English were searched by computer, then searched references of included studies additionally. RESULTS: 22 studies were included. In the aspect of efficacy, Risk Ratio and its 95% CI of 2-month sputum negative conversion rate were 1. 02 (1. 01,1. 03) in FDC regimen, 6-month sputum negative conversion rate were 1. 01 (1. 00,1. 02) in FDC regimen, P<0. 05; relapse rate were 1.72 (0.98, 3. 02) in FDC regimen, P>0. 05. As for the e- valuation of safety, the total drug adverse e-vent, adverse events of skin , gastrointestinal adverse events, liver and biliary and discontinuation of medication were all no significant differences between FDC regimen and free-drug component regimen (P>0. 05). However, adverse events of gastrointestinal and discontinuation, liver and biliary of medication were unsteadiness by sensitivity analysis. CONCLUSION: The efficacy of FDC regimen was better than free-drug component regimen. The result of safety evaluation was unsteadiness, required more credibility evidences.

关键词

固定剂量复合剂/肺结核/Meta分析

Key words

Fixed-dose combination/ Pulmonary tuberculosis/ Meta-analysis

分类

医药卫生

引用本文复制引用

马婧婧,周泽文,颜陶,伍翔,王润华,易静..固定剂量复合剂(FDC)治疗肺结核的疗效和安全性的Meta分析[J].中国临床药理学与治疗学,2012,17(10):1143-1150,8.

基金项目

国家自然科学基金"基于人工神经网络的结核病疫情预测研究及软件实现"资助项目(30872160) (30872160)

重庆市科委自然科学基金计划资助项目(CSTC,2009BB5415) (CSTC,2009BB5415)

中国临床药理学与治疗学

OACSCDCSTPCD

1009-2501

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