生脉注射液治疗慢性心力衰竭有效性的系统评价

Efficacy of Shengmai Injection in theTreatment of Chronic Heart Failure:Systematic Review

目的系统评价生脉注射液治疗慢性心力衰竭的有效性。方法计算机检索中国知网、万方数据库、维普数据库、中国生物医学文献数据库(SinoMed)、PubMed及Cochrane数据库,检索期限均从建库至2018年5月。检索生脉注射液治疗慢性心力衰竭的随机对照试验(RCT),采用Cochrane系统评价手册推荐的偏倚风险评估工具对纳入研究进行质量评价,并对生脉注射液的有效性和安全性进行系统评价。结果检索得到1397条文献题录,最终纳入17篇RCT,共1198例患者。17项研究病例数据均完整,但均未提分配隐藏,且均未提及结果评价盲法,其中15项研究仅提及“随机”但并未描述具体分组方法,并有15项研究在结果部分进行了完整报告。Meta分析结果:12项研究报告了左心射血分数(LVEF),提示生脉注射液与西药联用临床疗效优于单纯西药[MD=6.37,95%CI(置信区间)(3.91,8.83),P<0.00001],组间比较差异有统计学意义;16项研究报告了心功能分级(NYHA)的总有效率,提示生脉注射液与西药联用临床疗效优于单纯西药[RR=1.25,95%CI(1.18,1.32),P<0.00001],组间比较差异有统计学意义;2项研究报告了血浆脑钠肽(BNP),提示生脉注射液与西药联用临床疗效虽优于单纯西药[MD=-168.64,95%CI(-345.78,8.49),P=0.06],差异无统计学意义。结论在常规治疗基础上,加用生脉注射液可提高慢性心力衰竭临床疗效,但由于纳入文献的数量和质量等问题,研究结论尚需开展更多高质量的RCT研究予以验证。

Objective This systematic review aims to systematically evaluate the efficacy of Shengmai Injection on the treatment of Chronic heart failure.Methods We searched CNKI,WanFang,VIP,SinoMed,PubMed and the Cochrane Library from the inception to May 2018,to collect randomized controlled trials(RCTs)of Shengmai Injection in treating Chronic heart failure.The quality of inclusion studies was assessed using the bias risk assessment tool recommended by the Cochrane Handbook of Systematic Review,and evaluated the efficacy and safety of Shengmai Injection.Results Seventeen RCTs were screened according to the inclusion criteria,and 1198 patients were included in this study.The results of the meta-analysis showed that:12 studies reported left ventricular ejection fraction(LVEF),compared with the Western medicine group,Shengmai Injection combined with Western medicine agents could significantly improve the clinical efficacy[MD=6.37,95%CI(3.91,8.83)],the difference between the groups is statistically significant;16 studies reported the total effective rate of NYHA cardiac function classification,compared with the Western medicine group,Shengmai Injection combined with Western medicine agents could significantly improve the clinical efficacy[RR=1.25,95%CI(1.18,1.32)],the difference between the groups is statistically significant;2 studies reported plasma brain natriuretic peptide(BNP),compared with the Western medicine group,Shengmai Injection combined with Western medicine agents could significantly improve the clinical efficacy[MD=-168.64,95%CI(-345.78,8.49)],no statistical significance.Conclusions The data analysis suggested that Shengmai Injection combined with Western medicine agents can improve the clinical treatment of chronic heart failure.Due to the quality and quantity of included studies,the conclusion need to be verified with more and high quality RCTS.