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

Abstract

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 evaluation of safety, the total drug adverse event, 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.

Key words: Fixed-dose combination, Pulmonary tuberculosis, Meta-analysis

CLC Number:

R311
R521

MA Jing-jing, ZHOU Ze-wen, YAN Tao, WU Xian, WANG Run-hua, YI Jing. Meta-analysis on efficacy and safety of fixed-dose combination (FDC) in treatment of pulmonary tuberculosis[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2012, 17(10): 1143-1150.

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