Li Fu-Dong, Shen Yi
Department of Epidemiology and Health Statistics, School of Public Health, Zhejiang University, Hangzhou 310058, China.
Zhongguo Zhong Yao Za Zhi. 2012 Dec;37(23):3651-8.
To evaluate the efficacy and safety of Shenmai injection in the treatment of coronary heart disease (CHD).
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.
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.
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.
评价参麦注射液治疗冠心病（CHD）的有效性和安全性。
检索中国知网（1979年至2011年12月）、维普资讯（1989年至2011年12月）和万方数据（1987年至2011年12月）中有关参麦注射液治疗冠心病的随机对照试验文献。采用Jadad量表评估文献质量。采用Review Manager 5.0和Stata 12软件进行数据分析。
Meta分析共纳入18项随机临床试验。结果显示，与单纯常规治疗相比，参麦注射液联合常规治疗使临床症状总有效率提高了22%[RD = 0.22，95%CI（0.17，0.26），P<0.000 01]，相对危险度比值为[RR = 1.31，95%CI（1.20，1.43），P<0.000 1]；心电图疗效提高了25%[RD = 0.25，95%CI（0.19，0.31），P<0.000 01]，相对危险度比值为[RR = 1.46，95%CI（1.32，1.62），P<0.000 1]。还使纽约心脏协会心功能分级（NYHA）改善了33%[RD = 0.33，95%CI（0.16，0.49），P<0.000 01]，相对危险度比值为[RR = 1.79，95%CI（1.28，2.51），P = 0.000 6]，左心室射血分数[加权均数差7.55，95%CI（2.28，12.83）]。此外，研究报道参麦注射液可增加左心室每搏输出量，减小左心室收缩末期内径，改善血流动力学指标，降低NT - pro - BNP、DMA、细胞因子、肿瘤坏死因子 -α、白细胞介素 - 6和血清酶，减轻梗死相关血管重建（IRA）指标，缩短症状改善时间和心电图恢复时间。3项研究报告了不良事件，主要为头晕、心悸、轻度腹胀、恶心、金属样兴奋和面部潮红，无严重不良反应。
临床证据表明参麦注射液治疗冠心病有一定疗效，总有效率仍有待提高。本文虽有一定不足，但为临床应用提供了一定参考。建议开展更多设计合理、实施严格、样本量大、随访时间充足的多中心随机对照试验，进一步验证其有效性和安全性。
