原研和仿制氯吡格雷治疗不稳定型心绞痛有效性和安全性的Meta分析

Meta-analysis of Clinical Efficacy and Safety of Original and Generic Clopidogrel Treating Unstable Angina

目的:系统评价原研和仿制氯吡格雷治疗不稳定型心绞痛(unstable augina,UA)的有效性和安全性。方法:计算机检索CNKI、WanFang Data、VIP数据库,搜集关于原研和仿制氯吡格雷治疗UA临床疗效的随机对照试验(RCTs),检索时限为CNKI 1915年1月1日~2018年5月31日,VIP 1989年1月1日~2018年5月31日,WanFang Data 1990年1月1日~2018年5月31日。由两位研究者独立筛选文献、提取数据和评价纳入研究的偏倚风险,采用RevMan 5.1软件进行Meta分析。结果:共纳入10个RCTs,共1 197例患者,其中仿制氯吡格雷(泰嘉)组588例,原研氯吡格雷(波立维)组609例。Meta分析结果显示:仿制氯吡格雷组和原研氯吡格雷组在治疗UA时,临床疗效总有效率、心电图改善疗效总有效率、血小板计数、心血管不良事件发生率、药品不良反应发生率的差异均无统计学意义。结论:仿制氯吡格雷和原研氯吡格雷在治疗UA时的有效性和安全性差异无统计学意义,临床上可推荐仿制氯吡格雷替代原研氯吡格雷治疗UA。

Objective:To systematically assess the clinical efficacy and safety of original and generic clopidogrel in the treatment of unstable angina via a meta analysis.Methods:The randomized controlled trials about the clinical efficacy and safety of original and generic clopidogrel in the treatment of unstable angina were searched in the full-text database such as CNKI from January 1,1915 to May 31,2018;VIP from January 1,1989 to May 31,2018;WanFang Data from January 1,1990 to May 31,2018.Two reviewers independently screened studies according to the inclusion and exclusion criteria,extracted data and evaluated the risk of bias of the included studies.Then meta-analysis was performed using the RevMan 5.1 software.Results:According to the inclusion and exclusion criterion,10 RCTs involved 1 197 patients in which 588 patients treated with generic clopidogrel and 609 patients treated with original clopidogrel.Results of Meta-analysis:there was no significant statistical difference between generic clopidogrel group and original clopidogrel group for the treatment of unstable angina,in the aspect of the clinical efficacy,the improvement of electrocardiogram,platelet count,the incidence of adverse events and the incidence of adverse reaction.Conclusion:There was no significant difference between generic clopidogrel and original clopidogrel by comparing the clinical efficacy and safety.Our results provided some evidences for the antiplatelet therapy and suggested that generic clopidogrel can take the place of original clopidogrel in the treatment of unstable angina.