OBJECTIVETo assess the efficacy and safety of Shenmai injection for acute myocardial infarction (AMI).

METHODAll 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.

RESULT1) Fifty 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. 2) For safety analysis, we did not found serious adverse drug reaction/adverse events (ADR/AE) of Shenmai injection for AMI.

CONCLUSIONThe 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.