麝香保心丸联合曲美他嗪治疗冠心病合并心力衰竭疗效与安全性的系统评价

Evaluation of the Efficacy and Safety of Shexiang Baoxin Pill Combined with Trimexazidine in the Treatment of Coronary Heart Disease Complicated with Heart Failure

目的:系统评价麝香保心丸联合曲美他嗪治疗冠心病合并心力衰竭的临床疗效与安全性。方法:计算机检索EMbase、the Cochrane Library、PubMed、维普中文期刊服务平台、万方数据库、中国知网、中国生物医学文献数据库,检索时限为建库至2022年3月11日,检索有关麝香保心丸联合曲美他嗪治疗冠心病合并心力衰竭的临床随机对照试验(RCT)。由2名研究者筛选获得符合要求文献后提取有效数据,采用RevMan 5.3软件进行Meta分析。采用Cochrane评价手册中的风险偏倚评估工具进行文献质量评估。结果:共纳入文献13篇,涉及病人1 366例,其中试验组683例,对照组683例。Meta分析结果显示,试验组临床有效率高于对照组[RR=1.22,95%CI(1.15,1.28),P<0.000 01],试验组治疗后B型钠尿肽水平低于对照组[SMD=-5.06,95%CI(-7.07,-3.05),P<0.000 01],左室射血分数高于对照组[SMD=1.70,95%CI(1.36,2.04),P<0.000 01],左室舒张末期内径[SMD=-1.31,95%CI(-1.74,-0.87),P<0.000 01]和左室收缩末期内径[SMD=-1.91,95%CI(-2.32,-1.51),P<0.000 01]小于对照组,6 min步行试验距离较对照组增加[MD=48.29,95%CI(37.06,59.52),P<0.000 01],且不良反应发生率低于对照组[RR=0.33,95%CI(0.18,0.61),P=0.000 3]。结论:现有证据表明,麝香保心丸联合曲美他嗪治疗冠心病合并心力衰竭有协同增效作用,能改善病人心功能,提高临床疗效,且可有效降低不良反应发生率。

Objective:To evaluate the clinical efficacy and safety of Shexiang Baoxin Pill combined with trimetazidine for the treatment of coronary heart disease complicated with heart failure.Methods:Computer search EMbase,the Cochrane Library,PubMed,Chinese Science and Technology Journal Database(VIP)Chinese journal service platform,Wanfang Data,China National Knowledge Infrastructure(CNKI),China Biomedical Literature Database.The retrieval time was from the establishment of the database to March 11,2022.Randomized controlled trials(RCT)of Shexiang Baoxin Pill combined with trimetazidine for the treatment of coronary heart disease complicated with heart failure were searched.The qualified literatures were screened by two researchers.Meta-analysis was performed using RevMan 5.3 software.The risk bias evaluation tool in the Cochrane review manual was used to evaluate the quality of the literature.Results:A total of 13 articles were included,involving 1366 patients,including 683 patients in the experimental group and 683 patients in the control group.The results of Meta-analysis showed that the clinical effective rate of the experimental group was higher than that of the control group(RR=1.22,95%CI 1.15-1.28,P<0.00001).After treatment,brain natriuretic peptide level in experimental group was lower than that in control groups(SMD=-5.06,95%CI-7.07--3.05,P<0.00001),and left ventricular ejection fraction was higher than that in control groups(SMD=1.70,95%CI 1.36-2.04,P<0.00001),left ventricular end-diastolic diameter(SMD=-1.31,95%CI-1.74--0.87,P<0.00001)and left ventricular end-systolic diameter(SMD=-1.91,95%CI-2.32--1.51,P<0.00001)were smaller than those of control group,the 6 min walking distance was higher than that of the control group(MD=48.29,95%CI 37.06-59.52,P<0.00001),and the adverse reaction rate was lower than that of the control group(RR=0.33,95%CI 0.18-0.61,P=0.0003).Conclusion:Available evidence shows that Shexiang Baoxin Pill and trimetazidine show synergistic effect for the treatment of CHD complicated with heart failure,they can improve the cardiac function of patients,improve clinical efficacy,and effectively reduce the incidence of adverse reactions.