参附强心丸治疗慢性心力衰竭的证据概述

目的系统评价参附强心丸联合西药常规治疗慢性心力衰竭的临床疗效及安全性,并进行证据评价。方法计算机检索中国期刊全文数据库、中文科技期刊全文数据库、万方数据库、中国生物医学文献数据库、EMbase、PubMed、the Cochrane Library,检索时间从数据库建库至2019年3月,搜集参附强心丸联合西药常规与西药常规治疗慢性心力衰竭的随机对照试验研究,按照纳入与排除标准筛选及纳入文献,提取病人一般资料、干预措施、观察指标及不良反应等信息,采用RevMan 5.3软件进行Meta分析,并采用GRADE系统对证据质量进行评估。结果共纳入5项研究,涉及421例病人。Meta分析结果显示,参附强心丸联合西药常规治疗心力衰竭可提高左室射血分数WMD=4.39,95%CI(2.80,5.98),P<0.00001]、降低左室舒张末期内径WMD=-2.79,95%CI(-3.67,-1.92),P<0.00001]、降低B型利钠肽(P<0.05)、提高6 min步行距离WMD=40.62,95%CI(6.98,74.25),P=0.02]、改善明尼苏达心力衰竭生活质量量表积分WMD=-6.83,95%CI(-8.76,-4.90),P<0.00001]、改善中医证候RR=1.40,95%CI(1.18,1.66),P=0.0001],疗效均优于西药常规治疗,证据评级为低质量;可降低N末端B型脑钠肽前体SMD=-0.71,95%CI(-0.92,-0.50),P<0.00001],疗效优于西药常规治疗,证据评级为中等质量。结论现有证据表明,参附强心丸联合西药常规治疗慢性心力衰竭可进一步改善病人症状和心功能,提高临床疗效,但临床证据质量偏低。

Review of Evidence of Shenfu Qiangxin Pill for Chronic Heart Failure

Objective To systematically evaluate the clinical effects and safety of Shenfu Qiangxin pills combined with conventional western medicine for chronic heart failure.Methods China journal full-text database,Chinese technical journal full-text database,WanFang database,Chinese biomedical literature database,EMbase,PubMed,and the Cochrane Library were searched from inception to March 2019 to collect the randomized controlled trial(RCT)of Shenfu Qiangxin pills combined with conventional western medicine in the treatment of heart failure.The RCTs were screened according to the predefined inclusion and exclusion criteria,then the general information,intervention measures,observation indexes,and adverse reactions were extracted.RevMan5.3 software was used for Meta analysis.The evidence quality was evaluated by GRADE system.Results Five RCTs were included,including 421 patients.The Meta-analysis results showed that Shenfu Qiangxin pills combined with routine western medicine in the treatment of chronic heart failure could increase left ventricular ejection fractionWMD=4.39,95%CI(2.80,5.98),P<0.00001],lower left ventricular end-diastolic diameterWMD=-2.79,95%CI(-3.67,-1.92),P<0.00001],lower brain natriuretic peptide(P<0.05),increase 6-minute walk distanceWMD=40.62,95%CI(6.98,74.25),P=0.02],improve the quality of lifeWMD=-6.83,95%CI(-8.76,-4.90),P<0.0001],improve TCM syndromeRR=1.40,95%CI(1.18,1.66),P=0.0001],the curative effect were superior to conventional western medicine alone.The evidence quality was low.And Shenfu Qiangxin pills combined with routine western medicine treatment could lower N-terminal B-type natriuretic peptideSMD=-0.71,95%CI(-0.92,-0.50),P<0.00001],the evidence quality was medium.Conclusion The current evidence shows that,Shenfu Qiangxin pills combined with conventional western medicine can improve symptoms,cardiac function,and clinical effects in the treatment of chronic heart failure.However,the quality of clinical evidence was low.