国产替罗非班对中国人群急性ST段抬高型心肌梗死介入治疗系统评价

Systematic evaluation of effects of domestic tirofiban for interventional therapy in Chinese patients with acute ST-segment elevation myocardial infarction

目的:评价国产替罗非班在治疗急性ST段抬高心肌梗死介入治疗中的有效性及安全性。方法:计算机检索至2011年6月Cochrane图书馆临床对照试验资料库(CCTR)、Pubmed、Embase、万方数据库、中国学术期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、维普数据库(VIP),收集国产替罗非班治疗心肌梗死介入治疗的随机对照试验(RCT),共纳入21项文献,2332例患者,其中替罗非班组1149例,常规治疗对照组1183例。使用RevMan 5.0软件进行Meta分析。结果:替罗非班治疗(1)ST段抬高心肌梗死的疗效:显著优于常规治疗对照组[OR=2.47,95%CI(1.81,3.37),P<0.00001];(2)住院期间24h,30d后复合终点心血管事件的发生:显著低于常规治疗对照组[OR=0.24,95%CI(0.16,0.35),OR=0.22,95%CI(0.15,0.32),P均<0.00001];(3)出血发生率:显著高于常规治疗对照组[OR=1.77,95%CI(1.30,2.43),P=0.0003],但无严重出血病例及血小板减少症。结论:现有临床研究证据显示:国产替罗非班对中国人群急性ST段抬高心肌梗死介入治疗疗效显著,且不良反应发生率较低。

Objective： To evaluate efficacy and safety of domestic tirofiban for interventional therapy of acute STsegment elevation myocardial infarction （STEMI）. Methods： Randomized controlled trials on interventional therapy of myocardial infarction with domestic tirofiban up to Jun 2011 were collected from Cochrane Controlled Trial Register （CCTR）, Pubmed, Embase, Wanfang database, China national knowledge infrastructure （CNKI）, Chinese bio-medical （CBM） literature database and VIP database （VIP）. A total of 21 studies were enrolled, including 2 332 patients, in which tirofiban group contained 1 149 cases, routine therapy group contained 1 183 cases. RevMan 5.0 software was used for Meta analysis. Results.. （1） Therapeutic effects of tirofiban on STEMI were signifi- cantly better than those of control group [OR = 2.47, 95%CI （1.81, 3.37）, P〈0. 00001] ; （2） Incidence of car- diovascular events of composite end point within 24h, after 30 d during admission in tirofiban group was significantly lower than that of control group [OR= 0.24, 95%CI （0.16, 0.35）, OR = 0.22, 95%CI （0.15, 0.32）, P〈 0. 00001 all] ; （3） Incidence rate of bleeding in tirofiban group was significantly higher than that of control group EOR= 1.77, 95%CI （1.30, 2.43）, P = 0. 0003], but there were no severe bleeding and thrombopenia.Conelusion.. Existing clinical studies indicate that domestic tirofiban has significant therapeutic effects on interventional therapy of acute ST-segment elevation myocardial infarction in Chinese population and incidence rates of adverse reactions are low.