参芪益心汤治疗慢性心力衰竭疗效和安全性的系统评价

Systematic Review on the Efficacy and Safety of Shenqi Yixin Decoction(参芪益心汤)in the Treatment of Chronic Heart Failure

目的:系统评价参芪益心汤治疗慢性心力衰竭(CHF)的有效性及安全性。方法:检索中国知网数据库(CNKI)、万方数据库(WanFang Data)、中国科技期刊数据库(VIP),PubMed、Web Of Science、Cochrane Library和Embase数据库,以参芪益心汤治疗CHF的临床随机对照试验(RCT)为对象,收集自建库至2021年7月1日所有相关RCT。由2名数据员独立筛选整理文献、提取数据并对纳入研究进行质量评价,Meta分析工具采用Review Manager 5.4软件。结果:共纳入19项RCT,1804例CHF患者。Meta分析结果表明,在常规西药治疗的基础上加用参芪益心汤可明显提高CHF患者临床有效率[RR=1.23,95%CI(1.18,1.29),P<0.00001]、6 min步行距离[MD=104.02,95%CI(83.15,124.89),P<0.00001]、左心室射血分数[MD=7.63,95%CI(5.93,9.33),P<0.00001]、左室端轴缩短率[MD=6.54,95%CI=(5.81,7.27),P<0.00001]、舒张早期及晚期充盈度[MD=0.16,95%CI(0.13,0.19),P<0.00001],改善CHF患者心率变异性:全部窦性心博RR间期的标准差(SDNN)[MD=12.62,95%CI(10.27,14.97),P<0.00001]、RR间期平均值标准差(SDANN)[MD=10.01,95%CI(7.39,12.62),P<0.00001]、相邻RR间期差值的均方根(RMSSD)[MD=7.55,95%CI=(6.22,8.89),P<0.00001],改善CHF患者匹兹堡睡眠质量指数[MD=-3.44,95%CI(-4.57,-2.30),P<0.00001]。结论:参芪益心汤联合西医常规治疗可明显提高CHF患者临床疗效、心功能指标及运动耐量,增强射血分数及心脏收缩舒张功能,改善CHF患者心率变异性及睡眠质量。

Objective:To systematically evaluate the efficacy and safety of Shenqi Yixin Decoction in the treatment of chronic heart failure(CHF).Methods:CNKI,WanFang,VIP,PubMed,Web Of Science,Embase and Cochrane Library databases were electronically searched to collect all randomized controlled trials(RCT)of Shenqi Yixin Decoction in the treatment of CHF from the establishment of the database to July 1st,2021.Two reviewers independently screened literature,extracted data and evaluated the quality of included studies.Meta-analysis tool was Review Manager 5.4 software.Results:According to the inclusion criteria,19 RCTs were included,including1804 CHF patients.Meta-analysis results showed that compared with routine western medicine treatment,Shenqi Yixin Decoction can significantly improve the clinical effective rate of CHF patients[RR=1.23,95%CI(1.18,1.29),P<0.00001],6-minute walking distance[MD=104.02,95%CI(83.15,124.89),P<0.00001],left ventricular ejection fraction[MD=7.63,95%CI(5.93,9.33),P<0.00001],shortening rate of left ventricular end axis[MD=6.54,95%CI=(5.81,7.27),P<0.00001],early and late diastolic filling[MD=0.16,95%CI(0.13,0.19),P<0.00001],improve heart rate variability,including SDNN[MD=12.62,95%CI(10.27,14.97),P<0.00001],SDANN[MD=10.01,95%CI(7.39,12.62),P<0.00001]and RMSSD[MD=7.55,95%CI(6.22,8.89),P<0.00001],and improve Pittsburgh Sleep quality Index[MD=-3.44,95%CI(-4.57,-2.30),P<0.00001].Conclusion:Shenqi Yixin Decoction combined with routine western medicine treatment can improve the clinical curative effect and cardiac function index,increase exercise tolerance,enhance ejection fraction and cardiac systolic and diastolic function,and improve heart rate variability and sleep quality of CHF patients.