参附养心汤用于慢性心力衰竭的有效性和安全性的Meta分析  

Meta-Analysis on Efficacy and Safety of Shenfu Yangxin Decoction in the Treatment of Chronic Heart Failure

作　　者：王慧琳 卫军营[1] WANG Huilin;WEI Junying(Institute of Traditional Chinese Medicine,Chinese Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]中国中医科学院中药研究所,北京100700

出　　处：《中国医院用药评价与分析》2025年第4期448-452,457,共6页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：北京市科学技术委员会资助项目(No.Z231100007223009)。

摘　　要：目的:系统评价参附养心汤用于慢性心力衰竭(CHF)的有效性与安全性。方法:对中国知网、维普数据库、万方数据库、中国生物医学文献服务系统、PubMed、the Cochrane Library和Embase等7个数据库进行检索,收集建库至2024年11月关于参附养心汤治疗CHF的随机对照试验(对照组为西药常规治疗,观察组单用参附养心汤或在对照组的基础上联合应用参附养心汤)。文献质量参照Cochrane标准评价,数据系统评价使用RevMan 5.4和Stata/MP 18软件,证据质量依据GRADE标准评估。结果:共纳入13篇随机对照试验文献,包含1232例患者。Meta分析结果表明,观察组患者的临床总有效率显著高于对照组,差异有统计学意义(RR=1.23,95%CI=1.16~1.30,P<0.00001);观察组方案在提高左心室射血分数(LVEF)、降钙素基因相关肽(CGRP)水平,降低左心室收缩末期内径(LVESD)、左心室舒张末期内径(LVEDD)、肿瘤坏死因子α(TNF-α)和内皮素(ET)水平方面优于对照组;证据尚不足以证明观察组与对照组患者的不良反应发生率有差异(RR=1.05,95%CI=0.49~2.25,P=0.89)。GRADE系统评价显示,临床总有效率、CGRP、ET评价为中质量证据,LVESD、TNF-α为低质量证据,LVEF、LVEDD为极低质量证据。结论:基于本研究结果,参附养心汤可提高CHF患者的临床总有效率,改善心功能、血管内皮功能和炎症反应指标水平,且无增加不良反应发生的风险。OBJECTIVE:To systematically evaluate the efficacy and safety of Shenfu Yangxin decoction in the treatment of chronic heart failure(CHF).METHODS:Seven databases including CNKI,VIP,Wanfang Data,SinoMed,PubMed,the Cochrane Library,and Embase were retrieved to collect randomized controlled trials(RCT)of Shenfu Yangxin decoction in the treatment of CHF(the control group was treated with conventional Western medicine,while the observation group used ginseng Yangxin soup alone or used Shenfu Yangxin decoction together on the basis of the control group)up to Nov.2024.The quality of the literature was evaluated according to the Cochrane standards,the data were systematically reviewed by using RevMan 5.4 and Stata/MP 18 software,and the quality of evidence was assessed according to GRADE criteria.RESULTS:A total of 13 RCT were enrolled,including 1232 patients.Meta-analysis showed that the total clinical effective rate of observation group was higher than that in control group,the difference was statistically significant(RR=1.23,95%CI=1.16-1.30,P<0.00001).The observation group was superior to the control group in improving left ventricular ejection fraction(LVEF),calcitonin gene-related peptide(CGRP),and reducing left ventricular end-systolic diameter(LVESD),left ventricular end-diastolic diameter(LVEDD),tumor necrosis factorα(TNF-α),and endothelin(ET)levels.The evidence was not sufficient to prove that there was statistically significant difference in the incidence of adverse drug reactions between two groups(RR=1.05,95%CI=0.49-2.25,P=0.89).GRADE system evaluation showed that the overall clinical efficacy,CGRP,and ET were evaluated as moderate quality evidence,LVESD and TNF-αwere evaluated as low quality evidence,and LVEF and LVEDD were evaluated as very low quality evidence.CONCLUSIONS:Based on the results,Shenfu Yangxin decoction can improve the total effective rate of CHF patients,improve the level of cardiac function,vascular endothelial function and inflammatory response indicators,without increasing the risk of ad

关 键 词：参附养心汤 慢性心力衰竭 随机对照试验 META分析 

分 类 号：R972[医药卫生—药品] R932[医药卫生—药学]