中国中药杂志

2021, v.46(20) 5418-5427

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养心定悸胶囊治疗心律失常的疗效及安全性系统评价及Meta分析
Systematic review and Meta-analysis of efficacy and safety of Yangxin Dingji Capsules in treatment of arrhythmia

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;Evidence-based Medicine Center,Tianjin University of Traditional Chinese Medicine;

摘要(Abstract):

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1 371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<0.000 01)、左室射血分数(MD=4.31,95%CI[3.10,5.52],P<0.000 01),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<0.000 01)、氨基末端B型利钠肽前体(MD=-200.51,95%CI[-254.52,-146.51],P<0.000 01)、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 20 th, 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 1 371 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<0.000 01)and left ventricular ejection fraction(MD=4.31, 95%CI[3.10, 5.52], P<0.000 01), 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<0.000 01), N-terminal B-type natriuretic peptide precursor(MD=-200.51, 95%CI[-254.52,-146.51], P<0.000 01)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.

关键词(KeyWords): 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

Abstract:

Keywords:

基金项目(Foundation): 天津市人才发展特殊支持计划——青年拔尖人才项目(201504)

作者(Author): 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;Evidence-based Medicine Center,Tianjin University of Traditional Chinese Medicine;

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