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: 1) 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. 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.
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: 1) 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. 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.