益气通脉汤联合常规西药对冠心病慢性心力衰竭的疗效及安全性的Meta分析

Meta-analysis on the Efficacy and Safety of Yiqi Tongmai Decoction Combined with Conventional Western Medicine in Treating Chronic Heart Failure with Coronary Heart Disease

目的以Meta分析方法对益气通脉汤与常规西药联合治疗冠状动脉粥样硬化性心脏病所致慢性心力衰竭临床疗效和安全性进行评价。方法计算机检索CBM、VIP、WanFang、CNKI及PubMed数据库2014年1月1日至2024年1月1日,益气通脉汤治疗冠心病慢性心力衰竭的随机对照试验。筛选文献,提取相应数据,采用RevMan5.4及Stata16.0对得到的数据进行统计分析。最后,利用TSA 0.9.5.10 Beta软件对临床总有效率试验序贯分析。结果21项研究中观察组933例患者,对照组933例患者,合计1866例。研究结果提示:相对于单纯常规西药治疗而言,联合益气通脉汤可显著提高临床总有效率[OR=5.61,95%CI(3.92,8.03),Z=9.43,P<0.00001]、延长6 min步行距离[MD=56.45,95%CI(49.87,63.03),Z=16.82,P<0.00001]、降低N末端B型利钠肽原水平[MD=-286.47,95%CI(-312.57,-260.36),Z=21.51,P<0.00001],改善心功能指标的左心室射血分数[MD=7.25,95%CI(6.77,7.72),Z=29.95,P<0.00001]、左室收缩末期内径[MD=-4.87,95%CI(-6.46,-3.29),Z=6.03,P<0.00001]及左室舒张末期内径[MD=-4.47,95%CI(-5.20,-3.74),Z=12.04,P<0.00001]。中药与西药联合治疗安全性良好。试验序贯分析进一步提高了益气通脉汤加用常规西药治疗冠心病慢性心力衰竭患者临床疗效的循证证据。结论益气通脉汤与常规西药合用治疗冠心病慢性心力衰竭患者疗效明显优于常规西药,安全性好。期待更加优质、大样本、多中心随机对照试验为益气通脉汤治疗冠心病慢性心力衰竭提供新的循证证据。

Objective:To evaluate the clinical efficacy and safety of the combination of Yiqi Tongmai Decoction and conventional western medicine in the treatment of chronic heart failure due to coronary atherosclerotic heart disease by meta-analysis.Methods:Computer searches of the CBM,VIP,Wangfang and CNKI databases were conducted from January 1,2014 to January 1,2024 for randomized controlled trials of Yiqi Tongmai Decoction for chronic heart failure due to coronary heart disease.Lu Wei and Shao Xupeng independently screened the literature according to inclusion and exclusion criteria,extracted the corresponding data,and performed statistical analysis using RevMan 5.4 and Stata 16.0.Finally,Trial Sequential Analysis(TSA)software version 0.9.5.10 Beta was used to conduct a sequential analysis of the overall clinical effectiveness.Results:In 21 studies,there were 933 patients in the observation group and 933 patients in the control group,totaling 1866 cases.The results suggested that compared with monotherapy with conventional western medicine,the addition of Yiqi Tongmai Decoction significantly improved the overall clinical efficacy rate[0R=5.61,95%CI(3.92,8.03),Z=9.43,P<0.00001],increased the 6-minute walking distance[MD=56.45,95%CI(49.87,63.03),Z=16.82,P<0.00001],and reduced the levels of N-terminal pro-B-type natriuretic peptide(NT-proBNP)[MD=-286.47,95%CI(-312.57,-260.36),Z=21.51,P<0.00001].It also improved left ventricular ejection fraction(LVEF)[MD=7.25,95%CI(6.77,7.72),Z=29.95,P<0.00001],end-systolic left ventricular diameter[MD=-4.87,95%CI(-6.46,-3.29),Z=6.03,P<0.00001],and end-diastolic left ventricular diameter[MD=-4.47,95%CI(-5.20,-3.74),Z=12.04,P<0.000 O1].The combination therapy of TCM and western medicine demonstrated good safety.TSA further strengthened the evidence for the clinical efficacy of adding Yiqi Tongmai Decoction to conventional western medicine in patients with chronic heart failure due to coronary heart disease.Conclusion:The combination of Yiqi Tongmai Decoction and conventional western medicine shows significantly better efficacy in treating patients with chronic heart failure due to coronary heart disease and good safety.More high-quality,large-sample,multicenter randomized controlled trials are needed to provide richer evidence for the application of Yiqi Tongmai Decoction in chronic heart failure due to coronary heart disease.