摘要
为系统评价养心定悸胶囊治疗心律失常的有效性和安全性,计算机检索PubMed、EMbase、Cochrane Library、中国知网(CNKI)、维普(VIP)、中国生物医学文献数据库(CBM)、万方(Wanfang),搜集养心定悸胶囊治疗心律失常的随机对照试验(randomized control trial,RCT),检索时限均从建库至2020年10月20日。由2名评价人员独立筛选文献,录入数据,并对纳入研究进行文献质量评估,采用RevMan 5.3软件进行Meta分析。共检索到文献127篇,筛选后纳入文献15篇,包括1371例受试者,其中治疗组685例,对照组686例,干预措施为养心定悸胶囊联合常规抗心律失常西药治疗,对照措施为常规抗心律失常西药治疗。Meta分析结果显示,在常规抗心律失常西药治疗的基础上加用养心定悸胶囊,可显著提高患者的临床有效率(RR=1.23,95%CI[1.17,1.30],P<0.00001)、左室射血分数(MD=4.31,95%CI[3.10,5.52],P<0.00001),降低心率(MD=-3.79,95%CI[-7.42,-0.15],P=0.04)、左室舒张末期内径(MD=-7.06,95%CI[-11.91,-2.21],P=0.004)、左室收缩末期内径(MD=-4.78,95%CI[-6.63,-2.93],P<0.00001)、氨基末端B型利钠肽前体(MD=-200.51,95%CI[-254.52,-146.51],P<0.00001)、超敏C反应蛋白(MD=-1.74,95%CI[-3.23,-0.24],P=0.02),差异均具有统计学意义。与对照组相比,养心定悸胶囊的不良反应较少(RR=0.53,95%CI[0.36,0.79],P=0.002)。当前研究证据表明,养心定悸胶囊对于心律失常患者具有一定的作用,且相对安全。但受纳入研究样本量、结局指标、质量等限制,该结论有待更多高质量研究进行验证。
To systematically review the efficacy and safety of Yangxin Dingji Capsules in the treatment of arrhythmia.PubMed,EMbase,Cochrane Library,CNKI,VIP,CBM and Wanfang databases were electronically retrieved to collect randomized controlled trial(RCT)on the efficacy of Yangxin Dingji Capsules in the treatment of arrhythmia from the time of database establishment to October 20th,2020.Two reviewers independently screened out the literatures,input the data,and evaluated the literature quality of the included studies.RevMan 5.3 software was used for Meta-analysis.A total of 127 studies were retrieved,and 15 articles were included after screening,involving 1371 cases,with 685 cases in the treatment group and 686 cases in the control group.Yangxin Dingji Capsules combined with anti-arrhythmia western medicine was adopted for intervention in the treatment group,while the patients in the control group were treated with the anti-arrhythmia western medicine alone.Meta-analysis results showed that in arrhythmia patients,the combination of Yangxin Dingji Capsules and conventional western medicine significantly increased the clinical efficacy(RR=1.23,95%CI[1.17,1.30],P<0.00001)and left ventricular ejection fraction(MD=4.31,95%CI[3.10,5.52],P<0.00001),reduced heart rate(MD=-3.79,95%CI[-7.42,-0.15],P=0.04),left ventricular end-diastolic diameter(MD=-7.06,95%CI[-11.91,-2.21],P=0.004),left ventricular end-systolic diameter(MD=-4.78,95%CI[-6.63,-2.93],P<0.00001),N-terminal B-type natriuretic peptide precursor(MD=-200.51,95%CI[-254.52,-146.51],P<0.00001)and high-sensitivity C-reactive protein(MD=-1.74,95%CI[-3.23,-0.24],P=0.02),all with statistically significant differences.Compared with the control group,Yangxin Dingji Capsules had fewer adverse reactions(RR=0.53,95%CI[0.36,0.79],P=0.002).The existing evidences showed that Yangxin Dingji Capsules had certain effect in the treatment of arrhythmia,with a safety.However,due to the limitation in sample size,outcome measures and quality of the included studies,more high-quality studies are required to verify the above conclusion.
作者
王晓宇
胡海殷
季昭臣
翟静波
刘春香
张俊华
WANG Xiao-yu;HU Hai-yin;JI Zhao-chen;ZHAI Jing-bo;LIU Chun-xiang;ZHANG Jun-hua(Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;Evidence-based Medicine Center,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2021年第20期5418-5427,共10页
China Journal of Chinese Materia Medica
基金
天津市人才发展特殊支持计划——青年拔尖人才项目(201504)。
关键词
中成药
养心定悸胶囊
心律失常
系统评价
META分析
随机对照试验
Chinese patent medicine
Yangxin Dingji Capsules
arrhythmia
systematic review
Meta-analysis
randomized controlled trial
作者简介
王晓宇,硕士研究生,E-mail:278572261@qq.com;通信作者:张俊华,博士生导师,主要从事中医药临床评价和循证中医药研究,E-mail:zjhtcm@foxmail.com。
