参附强心丸联合化学药常规治疗用于慢性心力衰竭有效性与安全性的Meta分析

Efficacy and Safety of Shenfu Qiangxin Pills Combined with Chemical Medicine Conventional Therapy in the Treatment of Chronic Heart Failure:A Meta-analysis

目的:系统评价参附强心丸联合化学药常规治疗用于慢性心力衰竭的有效性和安全性,为临床用药提供循证参考。方法:计算机检索中国知网、万方数据、维普网、谷歌学术、PubMed、Cochrane图书馆、Embase等数据库,收集参附强心丸联合化学药常规治疗(试验组)对比化学药常规治疗(对照组)的随机对照试验(RCT),检索时限均为各数据库建库起至2020年5月12日。筛选文献、提取数据后,采用Cochrane系统评价员手册推荐的5.1.0偏倚风险评估工具对纳入文献质量进行评价。采用Stata 14.0软件进行Meta分析、敏感性分析。结果:共纳入7项RCT,共计596例患者。Meta分析结果显示,试验组患者的总有效率显著高于对照组[OR=4.14,95%CI(2.15,7.97),P<0.00001];按疗效判定标准不同进行的亚组分析结果显示,试验组患者以Lee式积分法、心功能分级法判定的总有效率均显著高于对照组(P<0.05)。试验组患者治疗后N末端B型利钠肽原(NT-proBNP)水平显著低于对照组[SMD=-1.33,95%CI(-1.55,-1.11),P<0.00001];按心力衰竭类型不同进行的亚组分析结果显示,试验组慢性心力衰竭患者治疗后NT-proBNP水平均显著低于对照组(P<0.001)。试验组患者治疗后左心室射血分数(LVEF)水平[WMD=5.76,95%CI(5.05,6.47),P<0.00001]显著高于对照组,治疗后B型利钠肽水平[SMD=-1.61,95%CI(-2.58,-0.54),P<0.00001]、左心室舒张末期内径(LVEDD)水平[WMD=-6.06,95%CI(-6.84,-5.27),P<0.00001]、左心室收缩末期内径水平[WMD=-5.02,95%CI(-5.70,-4.33),P<0.00001]均显著低于对照组。两组患者不良反应发生率比较,差异无统计学意义(P>0.05)。敏感性分析结果显示,以治疗后NT-proBNP、LVEF水平、LVEDD水平为指标时,剔除异质性来源后的分析结果与剔除前比较无显著性差异。结论:参附强心丸联合化学药常规治疗慢性心力衰竭的疗效与安全性均较好。

OBJECTIVE:To systematically evaluate the effectiveness and safety of Shenfu qiangxin pills combined with chemical medicine conventional therapy in the treatment of chronic heart failure,and to provide evidence-based reference for clinical drug use.METHODS:Retrieved from CNKI,Wanfang database,VIP,Google Scholar,PubMed,the Cochrane Library and Embase database,RCTs about Shengfu qiangxin pills combined with chemical medicine conventional therapy(trial group)versus chemical medicine conventional treatment(control group)were collected during the inception to May 12 th,2020.After literature screening and data extraction,the quality of the literatures was evaluated with risk bias assessment tool recommended by Cochrane 5.1.0 system evaluator manual.Meta-analysis and sensitivity analysis were performed by using Stata 14.0 software.RESULTS:A total of 7 RCTs were included,involving 596 patients.Meta-analysis results showed that the total response rate of trial group was significantly higher than that of control group[OR=4.14,95%CI(2.15,7.97),P<0.00001];the results of sub-group analysis according to the different criteria for determining the efficacy showed that the total response rates of trial group determined by Lee integral method and cardiac function grading method were significantly higher than that of the control group(P<0.05).After treatment,N-terminal pro-B-type natriuretic peptide(NT-pro BNP)level of trial group was significantly lower than that of control group[OR=-1.33,95%CI(-1.55,-1.11),P<0.00001].Results of sub-group analysis according to cardiac failure type showed that NT-pro BNP level of patients with chronic heart failure in trial group was lower than control group(P<0.001).The level of left ventricular ejection fraction(LVEF)in trial group after treatment[WMD=5.76,95%CI(5.05,6.47),P<0.00001]was significantly higher than control group;after treatment,the level of B-type natriuretic peptide[SMD=-1.61,95%CI(-2.58,-0.54),P<0.00001],left ventricular end-diastolic diameter(LVEDD)level[WMD=-6.06,95%CI(-6.84,-5.27),P<0.00001],left ventricular end-systolic diameter level[WMD=-0.52,95%CI(-5.70,-4.33),P<0.00001]were significantly lower than control group.There was no statistically significant difference in the incidence of ADR between 2 groups(P>0.05).Results of sensitivity analysis showed that when NT-pro BNP,LVEF level,LVEDD level after treatment were used as indicators,there was no significant difference in the analysis results after eliminating heterogeneity source,compared with before elimination.CONCLUSIONS:Shenfu qiangxin pills combined with chemical medicine conventional treatment has good efficacy and safety.