麝香通心滴丸治疗慢性心力衰竭的Meta分析和试验序贯分析

Meta-analysis and Trial Sequential Analysis of Shexiang Tongxin Dripping Pills(麝香通心滴丸)in Treatment of Chronic Heart Failure

目的系统评价麝香通心滴丸治疗慢性心力衰竭的疗效与安全性。方法综合检索PubMed、the Cochrane Li-brary、Embase、中国知网(CNKI)、维普(VIP)、万方(Wanfang)、中国生物医学文献库(SinoMed)等国内外数据库,收集建库至2021年4月有关麝香通心滴丸治疗慢性心力衰竭的随机对照试验。2名评价者进行文献的筛选和信息提取,并采用RevMan5.3软件进行Meta分析评价,使用采用TSA 0.9.5.10 Beta软件进行试验序贯分析(TSA)。结果最终纳入符合标准研究11项,涉及患者1403例,试验组700例,对照组703例。Meta分析结果显示,与对照组相比,试验组能显著提高患者心功能临床有效率[RR=1.20,95%CI(1.13,1.27),P<0.00001]、左室射血分数[MD=5.98,95%CI(1.71,10.25),P=0.006]、六分钟步行试验水平[MD=80.95,95%CI(76.77,85.13),P<0.00001];降低N末端B型利钠肽原[SMD=-4.30,95%CI(-5.80,2.80),P<0.00001]、左心室舒张末期内径[MD=-2.58,95%CI(-3.76,-1.41),P<0.0001]、高敏C-反应蛋白[MD=-0.75,95%CI(-1.22,-0.29),P=0.002],且试验组未发生明显不良反应。亚组分析表明,不同的干预用药疗程可能是研究间异质性的原因,TSA结果肯定了麝香通心滴丸治疗慢性心力衰竭的心功能临床有效率,但也提示结果存在假阳性可能。结论麝香通心滴丸可进一步提高慢性心力衰竭的临床疗效,且安全性良好,但受研究质量和数量的限制,本研究的结果仍需进一步验证。

Objective To comprehensively assess the safety and efficacy of Shexiang Tongxin dripping pills(麝香通心滴丸)in treatment of chronic heart failure,and to provide evidence-based basis for clinical practice.Methods The databases of CNKI,SinoMed,VIP,Wan Fang,PubMed,the Cochrane Library,and Embase were searched comprehensively to collect relevant ran-domized controlled studies from April 2021.Two evaluators independently completed the literature screening and information ex-traction,used RevMan5.3 software for Meta-analysis and TSA 0.9.5.10 Beta software for test sequential analysis.Results 11 eligible studies were finally included,involving a total of 1403 samples,including 700 in the treatment group and 703 in the con-trol group.The overall quality of the included studies was general.The results of meta-analysis showed that compared with the control group,the experimental group could significantly improve the clinical efficiency of cardiac function[RR=1.20,95%CI;1.13,1.27),P<0.00001],left ventricular ejection fraction[MD=5.98,95%CI(1.71,10.25),P=0.006],and six minute walk test level[MD=80.95,95%CI(76.77,85.13),P<0.00001].In addition,the experimental group could reduce N-ter-minal B-type natriuretic peptide[SMD=-4.30,95%CI(-5.80,2.80),P<0.00001],left ventricular end diastolic Di-mension[MD=-2.58,95%CI(-3.76,-1.41),P<0.0001],and high sensitivity C-reactive protein[MD=-0.75,95%CI(-1.22,-0.29),P=0.002].No obvious adverse reactions occurred in the experimental group.Subgroup analysis showed that different duration of intervention medication might be the reason for the heterogeneity among the studies.TSA results con-firmed the clinical effectiveness of Shexiang Tongxin dropping pills in the treatment of chronic heart failure,but also indicated false positive results.Conclusions Shexiang Tongxin dropping pills can further increase the clinical efficacy of chronic heart fail-ure,and the safety is good.However,due to the limitation of research quality and quantity,the results of this research still need to be further confirmed.