小分子血小板糖蛋白Ⅱb/Ⅲa受体拮抗剂用于急性冠脉综合征的经皮介入治疗Meta分析

Small-molecule glycoprotein Ⅱb/Ⅲa inhibitors in percutaneous coronary intervention for acute coronary syndrome:a Meta-analysis of randomized trials

目的系统评价小分子血小板糖蛋白Ⅱb/Ⅲa受体拮抗剂(glycoproteinⅡb/Ⅲa inhibitors,GPI)用于急性冠脉综合征(acute coronary syndrome,ACS)经皮介入治疗(percutaneous coronary intervention,PCI)的疗效和安全性。方法计算机检索PubMed、EMBASE、OVID、CBM、CNKI、VIP等数据库,检索2012年7月31日前小分子GPI与安慰剂对ACS患者PCI疗效影响的所有随机对照试验(randomized controlled trials,RCTs),并同时追索纳入研究的参考文献。由2名评价者独立对纳入研究的质量进行评价和资料提取后,采用RevMan5.1软件进行Meta分析。结果共纳入10个RCTs共计9 518例进行PCI治疗的ACS患者。Meta分析结果显示,①与安慰剂相比,小分子GPI能降低7、30 d及6个月的主要不良心脏事件(major adverse cardiovascular event,MACE)发生率[7 d:RR=0.71,95%CI(0.55,0.94),P<0.05;30 d:RR=0.85,95%CI(0.73,0.98),P<0.05;6个月:RR=0.73,95%CI(0.55,0.99),P<0.05];降低30 d血运重建(target vesselrevascularization,TVR)发生率[RR=0.75,95%CI(0.58,0.96),P<0.05]及6个月的再次心肌梗死(myocardial infarction,MI)发生率[RR=0.67,95%CI(0.53,0.83),P<0.01]。但对于30 d死亡率﹑6个月死亡率、30 d MI及6个月血TVR,2组差异无统计学意义[30 d死亡率:RR=0.65,95%CI(0.41,1.04),P>0.05;6个月死亡率:RR=0.87,95%CI(0.58,1.32),P>0.05;30 d MI:RR=0.80,95%CI(0.65,1.00),P=0.05;6个月血TVR:RR=0.90,95%CI(0.79,1.02),P>0.05]。②与安慰剂相比,小分子GPI伴随更多的轻微出血[RR=1.60,95%CI(1.24,2.07),P<0.01]及严重出血事件[RR=1.44,95%CI(1.09,1.89),P<0.05]。但血小板减少症的发生率并没有统计学差异[RR=1.16,95%CI(0.63,2.14),P>0.05]。结论小分子GPI对于降低接受PCI治疗的ACS患者MACE发生率具有一定疗效,但也伴随更多出血事件的发生。

Objective To systematically evaluate the efficacy and safety of small-molecule glycoprotein Ⅱb/Ⅲa inhibitors（GPI） in percutaneous coronary intervention（PCI） for acute coronary syndrome（ACS）.Methods A search was conducted in PubMed,EMBASE,OVID,CBM,CNKI and VIP for the randomized controlled trials（RCTs） of small-molecule GPI versus placebos in PCI for ACS from the date of their establishment to July 31,2012,and the bibliographies of the included studies were also searched.According to the criteria of the Cochrane Handbook,two reviewers evaluated the quality of the included RCTs and extracted data independently,and then the extracted data were analyzed by using RevMan 5.1 software.Results Ten RCTs involving 9 518 ACS patients treated with PCI were included.The results of Meta-analysis showed that：（1） Compared with placebos,small-molecule GPI decreased major adverse cardiovascular events（MACE） in 7 and 30 d,and 6 months [RR=0.71,95%CI（0.55,0.94）,P0.05;RR=0.85,95%CI（0.73,0.98）,P0.05;RR=0.73,95%CI（0.55,0.99）,P0.05].The incidences of target vessel revascularization（TVR） in 30 d and re-myocardial infarction（MI） in 6 months also decreased [RR=0.75,95%CI（0.58,0.96）,P0.05;RR=0.67,95%CI（0.53,0.83）,P0.01].But for the mortality in 30 d and 6 months,the re-MI in 30 d and the TVR in 6 months showed no significant differences between the 2 groups [RR=0.65,95%CI（0.41,1.04）,P0.05;RR=0.87,95%CI（0.58,1.32）,P0.05;RR=0.80,95%CI（0.65,1.00）,P=0.05;RR=0.90,95%CI（0.79,1.02）,P0.05].（2） Compared with placebos,small-molecule GPI were associated with high risk of minor and major bleeding complications [RR=1.60,95%CI（1.24,2.07）,P0.01;RR=1.44,95%CI（1.09,1.89）,P0.05].However,the incidence of thrombocytopenia was not significantly different between the 2 groups [RR=1.16,95%CI（0.63,2.14）,P0.05].Conclusion Small-molecule GPI have positive effect in PCI for ACS,but they are associated with high risk of bleeding complications.