[Meta-analysis on efficacy and safety of Shenmai injection in treatment of coronary heart disease].

OBJECTIVE

To evaluate the efficacy and safety of Shenmai injection in the treatment of coronary heart disease (CHD).

METHODS

CNKI (1979 to December 2011), VIP (1989 to December 2011), and Wanfang Data (1987 to December 2011) were retrieved for literatures concerning randomized controlled trials of Shenmai injection in the treatment of coronary heart disease. Their quality was assessed by the Jadad scale. Review Manager 5.0 and Stata 12 software were adopted for data analysis.

RESULTS

Altogether 18 randomized clinical trials were included in the Meta-analysis. According to the findings, compared with routine therapy alone, the combination of Shenmai injection and routine therapy increased the overall effective rate by clinical symptoms by 22% [RD = 0.22, 95% CI (0.17, 0.26), P<0.000 01], with the relative risk ratio of [RR = 1.31, 95% CI (1.20, 1.43), P<0.000 1] and the efficacy by electrocardiogram by 25% [RD = 0.25, 95% CI (0.19, 0.31), P<0.000 01], with the relative risk ratio of [RR = 1.46, 95% CI (1.32, 1.62), P<0.000 1]. It also improved New York heart association classification (NYHA) by 33% [RD = 0.33, 95% CI (0.16, 0.49), P<0.000 01], with the relative risk ratio of [RR = 1.79, 95% CI (1.28, 2.51), P = 0.000 6] and left ventricular ejection fraction [WMD 7.55, 95% CI (2.28, 12.83)]. Additionally, studies reported that Shenmai injection could increase left ventricular stroke volume, decrease left ventricular end systolic diameter, improved hemodynamic indexes, reduced NT-pro-BNP, DMA, cytokines, TNF-alpha, IL-6 and serum enzyme, mitigated infarction-related revascularization IRA indexes and shortened the symptom improvement time and electrocardiogram recovery time. Three studies had reported adverse events, mainly dizziness, palpitation, mild abdominal distension, nausea, metal excitement and flushed face, with no serious adverse effect.

CONCLUSIONS

Clinical evidences prove that Shenmai injection has certain effect in treating CHD and remains to be improved in the overall effective rate. The essay, despite of some shortcomings, provides certain reference for clinical application. It is suggested holding more multicenter randomized controlled trials with rational design, strict implementation, large sample size and sufficient following-up time to further verify its efficacy and safety.