国产替罗非班对中国人群非ST段抬高急性冠脉综合征有效性与安全性的Meta分析

Effectiveness and Safety of Domestic Tirofiban for Chinese Population with Non-ST-elevation Acute Coronary Syndrome: A Meta-analysis

目的系统评价国产替罗非班在治疗非ST段抬高急性冠脉综合征(NSTE-ACS)患者非介入治疗中应用的有效性与安全性。方法计算机检索The Cochrane Library(2013年第11期)、Pub Med、EMbase、CBM、CNKI、VIP及Wan Fang Data,查找国产替罗非班治疗NSTE-ACS患者非介入治疗的随机对照试验(RCT),检索时限均为从1994年至2014年。由2位评价者按照纳入与排除标准独立筛选文献、提取资料和评价纳入研究的方法学质量后,采用Rev Man 5.2软件进行Meta分析。结果共纳入23个RCT,包括2 425例患者。Meta分析结果显示:1试验组治疗NSTE-ACS的疗效优于对照组[OR=3.62,95%CI(2.33,5.63),P<0.000 01];2试验组的ST段压低改善情况优于对照组[WMD=0.39,95%CI(0.30,0.49),P<0.000 01];3试验组的血小板聚集率改善情况优于对照组[WMD=27.89,95%CI(25.45,30.34),P<0.000 01];4试验组的复合终点心血管事件发生率低于对照组[住院期间36 h内:OR=0.20,95%CI(0.12,0.31),P<0.000 01;30天后:OR=0.31,95%CI(0.23,0.42),P<0.000 01];5试验组的出血发生率高于对照组[OR=1.53,95%CI(1.09,2.15),P=0.02]。结论与单用常规药物相比,替罗非班加用常规药物对中国人群NSTE-ACS非冠脉介入治疗疗效更好,但其出血发生率相对较高。

Objective To systematically review the effectiveness and safety of domestic tirofiban for Chinese population with non ST-elevation acute coronary syndromes （NSTE-ACS） in non-interventional therapy. Methods We searched databases including The Cochrane Library （Issue 11, 2013）, PubMed, EMbase, CBM, CNKI, VIP and WanFang Data from 1994 to 2014 to collect randomized controlled trials （RCTs） about domestic tirofiban for NSTE-ACS patients in non-interventional therapy. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed methodological quality of included studies. Meta-analysis was then conducted using RevMan 5.2 software. Results A total of 23 RCTs were enrolled involving 2 425 patients. The results of meta- analysis showed that： a） the effectiveness of tirofiban in the trial group was significantly better than that in the control group （OR=3.62, 95%CI 2.33 to 5.63, P〈0.000 01）; b） ST segment down improvement in the trial group was better than that in the control group （WMD=0.39, 95%CI 0.30 to 0.49, P〈0.000 01）; c） improvement of platelet aggregation in the trial group was better than that in the control group （WMD=27.89, 95%CI 25.45 to 30.34, P〈0.000 01）; d） the incidences of cardiovascular events of composite endpoints in the trial group were lower than that in the control group （during 36 h： OR=0.20, 95%CI 0.12 to 0.31, P〈0.000 01; and after 30 days： OR=0.31, 95%CI 0.23 to 0.42, P〈0.000 01）; and e） the incidence rate of bleeding in the trial group was higher than that in the control group （OR=1.53, 95%CI 1.09 to 2.15, P=0.02）. Conclusion Compared with routine drugs used alone, tirofiban has better therapeutic effects in noninterventional therapy for Chinese population with NSTE-ACS, but the incidence of bleeding is relatively high.