摘要
目的:系统评价参松养心胶囊治疗快速性心律失常的疗效及安全性.方法:计算机检索PubMed、Web of Science、the Cochrane library、Embase、CBM、中国知网、万方、维普数据库中参松养心胶囊治疗快速性心律失常的随机对照试验,时限为建库至2022年9月.由2名研究员独立筛选文献、提取数据并根据Cochrane手册对纳入研究的偏倚风险进行评价.采用RevMan 5.3软件进行数据分析,并绘制漏斗图对纳入研究的发表偏倚进行评价.结果:共纳入 42 项随机对照试验,包含 3 867 例受试患者,参松养心胶囊联合常规西药治疗患者 1 952 例,单纯常规西药治疗患者 1 915 例.Meta分析结果显示:与单纯常规西药治疗相比,联用参松养心胶囊可明显改善临床总有效率(RR = 1.18,95%CI =[1.13,1.22],P＜0.000 01)、心率(MD =-8.29,95%CI=[-12.29,-4.29],P＜0.000 1)、左心室射血分数(MD = 4.90,95%CI=[3.48,6.33],P＜0.000 01)、左心舒张末期内径(MD =-6.94,95%CI=[-8.50,-5.38],P＜0.000 01)、左心收缩末期内径(MD =-4.62,95%CI=[-4.93,-4.31],P＜0.000 01)、6分钟步行试验(MD=72.36,95%CI=[27.39,117.34],P=0.002)、不良反应发生率(RR=0.65,95%CI=[0.49,0.86],P=0.002).结论:当前证据显示,参松养心胶囊联合常规西药治疗快速性心律失常在改善临床总有效率、心率、左心室射血分数、左心舒张末期内径、左心收缩末期内径、6分钟步行试验疗效显著,且不良反应发生率低.但受纳入研究质量及数量的限制,今后仍需要开展能体现中医病证结合、辨证论治诊疗特色的大样本、多中心、随机、双盲、安慰剂平行对照试验进一步验证结论.
Abstract
Objective:To systematically evaluate the efficacy and safety of the Shensong Yangxin capsules(参松养心胶囊)on tachyarrhythmia.Methods:The RCTs of the Shensong Yangxin capsules on tachyarrhythmias were retrieved from PubMed,Web of Science,the Cochrane library,Embase,CBM,CNKI,Wanfang,VIP,and the time limit was to build the database until September 2022.Two researchers independently screened the literature,extracted data and evaluated the quality of the included studies according to the Cochrane handbook.Data analysis by RevMan 5.3 software.Funnel plots were drawn to evaluate the publication bias of the included studies.Results:A total of 42 RCTs involving 3 867 patients were included,patients of the Shensong Yangxin capsules combined with conventional western medicine treatment are 1 952,patients of conventional western medicine treatment are 1 915.The results of Meta-analysis showed that compared with conventional western medicine treatment,the Shensong Yangxin capsules combined with conventional western medicine were effective on clinical total effective(RR=1.18,95%CI=[1.13,1.22],P<0.000 01),heart rate(HR)(MD=-8.29,95%CI=[-12.29,-4.29],P<0.000 1),left ventricular ejection fraction(LVEF)(MD=4.90,95%CI=[3.48,6.33],P<0.000 01),left ventricular end-diastolic diameter(LVEDD)(MD=-6.94,95%CI=[-8.50,-5.38],P<0.000 01),left ventricular end-systolic diameter(LVESD)(MD=-4.62,95%CI=[-4.93,-4.31],P<0.000 01),6-minute walk test(6MWT)(MD=72.36,95%CI=[27.39,117.34],P=0.002)and adverse reaction(RR=0.65,95%CI=[0.49,0.86],P=0.002).Conclusion:The current evidence shows that the Shensong Yangxin capsules combined with conventional western medicine in the treatment of tachyarrhythmia have significant curative effects on the total clinical effective rate,HR,LVEF,LVEDD,LVESD,6MWT,and the incidence of adverse reactions is low.However,due to the limitations of the quality and quantity of included studies.In the future,it is still necessary to carry out large-sample,multi-center,randomized,double-blind,placebo-controlled trials that can reflect the principles of TCM diagnosis and treatment to further verify the conclusions.
基金项目
国家重点研发计划项目(2019YFC1710401)
维普
万方数据