固定剂量复合剂(FDC)治疗肺结核的疗效和安全性的Meta分析

目的: 评价抗结核固定剂量复合剂治疗肺结核的疗效和安全性。方法: 通过计算机检索和参考文献追溯相结合的方法,收集和整理国内外公开发表的固定剂量复合剂治疗初治涂阳肺结核的疗效或安全性的临床随机对照试验(RCTs)和临床对照试验(CCTs)的文献。结果: 通过筛选纳入22个研究。疗效评价,固定剂量复合剂(FDC)与单药组合治疗初治肺结核在2月末痰菌阴转率、6月末痰菌阴转率比较RR值及其95%CI分别为 1.02(1.01,1.03)、1.01(1.00,1.02),P<0.05;复发率比较RR值及其95%CI为 1.72(0.98,3.02),P>0.05。安全性评价,两组在副反应总发生率、皮肤副反应发生率、胃肠道副反应发生率、肝胆副反应发生率及副反应停药率比较差异均无统计学意义(P>0.05)。经敏感性分析,胃肠道副反应发生率和肝胆副反应发生率的结果不稳定。结论: 固定剂量复合剂治疗肺结核疗效较单药组合好,安全性评价的结果不稳定,需要更多可靠证据。

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

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.