参麦注射液治疗急性心肌梗死的Meta分析

目的:系统评价参麦注射液治疗急性心肌梗死(acute myocardial infarction,AMI)的有效性和安全性。方法:检索Cochrane图书馆,Medline,EMbase,CBM,CNKI,万方和VIP,全面收集参麦注射液治疗AMI所有类型的临床研究。其中有效性分析纳入随机对照试验(randomized controlled trials,RCT)或半随机对照试验(quasi-RCTs),并对其进行质量评价,采用Rev-Man 5.1软件进行统计分析。结果:①有效性分析共纳入15个研究,仅1个研究采用恰当的随机分配方法。所有研究均未提及分配隐藏、盲法及失访。Meta分析结果显示常规治疗的基础上加用参麦组在住院期间病死率(OR=0.43,95%CI[0.31～0.60])、心衰发生率(OR=0.49,95%CI[0.34～0.70])、休克发生率(OR=0.53,95%CI[0.30～0.93])及再梗发生率(OR=0.16,95%CI[0.03～0.77])方面均低于单独常规治疗组,但在冠脉再通率方面未显示明显效果(OR=1.24,95%CI[0.90～1.71])。②安全性分析纳入参麦治疗AMI所有类型的临床研究,结果未发现严重的不良反应/不良事件(ADR/AE)。结论:现有研究表明,在常规治疗基础上加用参麦注射液可降低AMI患者的住院期间病死率,心衰、休克及再梗发生率,而在冠脉再通率方面未显示明显效果。但由于本系统评价纳入研究样本量小且质量较低,上述结论尚需高质量RCTs予以证实。该系统评价虽尚未发现参麦注射液治疗AMI严重的ADR/AE,参麦注射液上市后安全性评价问题仍需进一步重视与开展。

Meta-analysis of Shenmai injection treatment for acute myocardial infarction

Objective: To assess the efficacy and safety of Shenmai injection for acute myocardial infarction(AMI).Method: All clinical studies of Shenmai for AMI were searched from Cochrane library,Medline,EMbase,CBM,CNKI,Wanfang and VIP.For efficacy analysis of Shenmai,randomized controlled trials(RCTs) and quasi-RCTs were included and the Cochrane Collaboration′s RevMan 5.1 was used for data analysis.Result: ①Fifty studies were included for efficacy analysis,in which,only 1 study was true RCT,all of studies did not mention allocation concealment,blind and information of loss to follow-up.The fatality rate during hospitalization(OR 0.43,95% CI[0.31-0.60]),incidence of heart failure(OR 0.49,95% CI[0.34-0.70]),incidence of shock(OR 0.53,95% CI[0.30-0.93]) and incidence of re-infarction(OR 0.16,95% CI[0.03-0.77]) in Shenmai injection plus conventional treatment group was lower than that in the conventional treatment group,while the rate of recanalization(OR 1.24,95% CI[0.90-1.71]) was similar between the two groups.②For safety analysis,we did not found serious adverse drug reaction/adverse events(ADR/AE) of Shenmai injection for AMI.Conclusion: The currently available evidence showed that Shenmai injection plus conventional treatment group may decrease the fatality rate during hospitalization,the incidence of cardiac failure,shock and re-infarction.However,these findings should be carefully interpreted due to the low methodological quality and small sample size of trials.Although serious ADR/AE was did not report of Shenmai injection,the post-marketing safety evaluation is need to be performed.