国产与进口氯吡格雷治疗PCI患者的Meta分析

Meta Analysis on Curative Effect and Safety of Domestic-Made Clopidogrel in Treatment of Percutaneous Coronary Interventions

目的 系统评价国产氯吡格雷与进口氯吡格雷在PCI患者中的疗效和安全性.方法 计算机检索Cochrane图书馆、PubMed、EMbase、VIP、CNKI、CBM和WanFang Data中关于国产氯吡格雷与进口氯吡格雷在PCI患者中比较治疗的随机对照试验(RCT),检索时限截止至2018年6月24日.由2位评价者按照纳入与排除标准独立筛选文献,提取资料并严格评价纳入研究的方法学质量,采用Rev-Man5.3软件进行Meta分析.结果 共纳入29个RCT,共收集7880例患者的资料.Meta分析显示,国产氯吡格雷与进口氯吡格雷治疗PCI患者的主要不良心血管事件[RR=0.86,95%CI(0.74,0.99),P=0.04]、心血管源性死亡[RR=0.89,95%CI(0.58,1.36),P=0.59]、心肌梗死[RR=0.99,95%CI(0.67,1.47),P=0.95]、脑卒中[RR=1.14,95%CI(0.46,2.79),P=0.78]、靶血管血运再次重建[RR=0.81,95%CI(0.58,1.12),P=0.19]、出血事件[RR=0.88,95%CI(0.70,1.12),P=0.31]、不良反应[RR=1.09,95%CI(0.89,1.35),P=0.39]的发生率差异均无统计学意义.结论 国产氯吡格雷与进口氯吡格雷治疗PCI患者的疗效和安全性相当.

Objective To systematically evaluate the efficacy and safety of domestic and imported clopidogrel for percutaneous coronary interventions.Methods Such databases as The Cochrane library,PubMed,EMbase,VIP,CNKI,CBM and WanFang Data were searched from the inception to June 24,2018 to collect the randomized controlled trials(RCTs)about domestic and imported clopidogrel for percutaneous coronary interventions,and the references of the included literature were also retrieved.Two reviewers independently screened the literature according to the inclusion and exclusion criteria,extracted the data,and evaluated and cross-checked the methodological quality.Then meta-analysis was conducted using RevMan 5.3 soft ware.Results A total of 29 RCTs involving 7880 patients were included.The analyses showed that:There was no statistical difference between domestic and imported clopidogrel in PCI postoperative treatment which showed by the following indicators:Major adverse cardiac events[RR=0.86,95%CI(0.74,0.99),P=0.04],cardiogenic death[RR=0.89,95%CI(0.58,1.36),P=0.59),myocardial infarction[RR=0.99,95%CI(0.67,1.47),P=0.95),stroke(RR=1.14,95%CI(0.46,2.79),P=0.78),target vessel revascularization[RR=0.81,95%CI(0.58,1.12),P=0.19],bleeding events[RR=0.88,95%CI(0.70,1.12),P=0.31],adverse reactions[RR=1.09,95%CI(0.89,1.35),P=0.39].Conclusion The efficacy and safety of domestic clopidogrel and imported clopidogrel in treating PCI patients are similar.However,the conclusion need to be further proved by large-sample,multi-centre,randomized,double-blind and control trials.