养心定悸胶囊联合常规西药对心律失常患者心功能指标有效性及安全性的Meta分析

Effect and safety of Yangxin Dingji Capsule combined with Western medicine for cardiac function indexes among patients with arrhythmia:a Meta-analysis

关键词:  养心定悸胶囊  心律失常  系统评价  Meta分析  随机对照临床试验

Key words:  Yangxin Dingji Capsule  arrhythmias  systematic review  Meta-analysis  randomized controlled trial

摘要:

[目的] 系统评价养心定悸胶囊联合西药常规改善心律失常患者心功能指标的疗效优势及安全性。[方法] 计算机检索中国知网（CNKI）、万方数据库（WanFang Data）、维普（VIP）、中国生物医学文献数据库（SinoMed）、PubMed、Cochrane Library、Embase和Web of Science数据库，搜集关于养心定悸胶囊联合西药常规治疗心律失常的随机对照试验（RCT），检索时限从建库至2021年11月31日。由两位评价员独立筛选文献、提取资料，如有分歧，讨论解决，采用RevMan 5.3软件进行数据分析。[结果] 共检索到文献242篇，最终纳入27篇，样本量2 665例。Meta分析结果提示，相较于单纯西药常规治疗，养心定悸胶囊联合西药常规治疗在改善以下临床指标方面具有显著优势，包括临床总有效率[OR=3.04，95%CI（2.45，3.76），P<0.000 01]，室性期前收缩[MD=-1.49，95%CI（-2.00，-0.99），P<0.000 01]、房性期前收缩[MD=-1.19，95%CI（-1.60，-0.77），P<0.000 01]及阵发性房颤[MD=-40.98，95%CI（-51.34，-30.63），P<0.000 01]发作频次，心率变异指标正常RR间期标准差（SDNN）[MD=9.96，95%CI（4.22，15.70），P=0.000 7]、RR间期平均值标准差（SDANN）[MD=10.44，95%CI（4.56，16.31），P=0.000 5]和相邻RR间期差值的均方根（RMSSD）[MD=4.34，95%CI（0.96，7.71），P=0.01]，心脏多普勒超声指标左室射血分数（LVEF）[MD=4.56，95%CI（3.25，5.86），P<0.000 01]、左室舒张末期内径（LVEDD）[MD=-6.91，95%CI（-11.95，-1.86），P=0.007]和左室收缩末期内径（LVESD）[MD=-4.34，95%CI（-5.79，-2.88），P<0.000 01]。此外，养心定悸胶囊联合西药常规治疗患者不良事件发生低于西药常规对照[OR=0.49，95%CI（0.36，0.66），P<0.000 01]。[结论] 当前证据支持养心定悸胶囊联合西药常规治疗在改善心律失常患者心功能指标、提高临床疗效方面具有优势，且安全性较好。但由于文献数量及质量限制，仍需更多随机对照、多中心、大样本临床试验提供高质量证据。

Abstract:

[Objective] To systematically evaluate the therapeutic advantages and safety of Yangxin Dingji Capsules combined with conventional Western medicine in improving cardiac function indexes and safety among patients with arrhythmia.[Methods] CNKI,WanFang Data,VIP,SinoMed,PubMed,Cochrane Library,Embase and Web of Science were searched to collect randomized controlled trials (RCTs) of Yangxin Dingji Capsules combined with conventional Western medicine for arrhythmia from the establishment of the database to November 31,2021.Two reviewers independently screened the literature and extracted data.Any disagreements were resolved through discussion,and RevMan 5.3 software was used for data analysis.[Results] A total of 242 literatures were retrieved,and 27 articles were finally included,including 2 665 patients.According to the results of meta-analysis,compared with conventional Western medicine alone,Yangxin Dingji Capsules combined with conventional Western medicine showed significant advantages in improving the following clinical indicators,including the total clinical effective rate[OR=3.04,95%CI(2.45,3.76),P<0.000 01],frequency of premature ventricular contraction[MD=-1.49,95%CI(-2.00,-0.99),P<0.000 01],premature atrial contraction[MD=-1.19,95%CI(-1.60,-0.77),P<0.000 01]and the paroxysmal atrial fibrillation[MD=-40.98,95%CI(-51.34,-30.63),P<0.000 01],heart rate variability index including SDNN[MD=9.96,95%CI(4.22,15.70),P=0.000 7],SDANN[MD=10.44,95%CI(4.56,16.31),P=0.000 5]and RMSSD[MD=4.34,95%CI(0.96,7.71),P=0.01],Cardiac Doppler ultrasound index including LVEF[MD=4.56,95%CI(3.25,5.86),P<0.000 01],LVEDD[MD=-6.91,95%CI(-11.95,-1.86),P=0.007]and LVESD[MD=-4.34,95%CI(-5.79,-2.88),P<0.000 01].In addition,the incidence of adverse events in Yangxin Dingji Capsule combined with conventional Western medicine treatment was lower than that in conventional Western medicine control[OR=0.49,95%CI(0.36,0.66),P<0.000 01].[Conclusion] Current evidence supports that Yangxin Dingji Capsules combined with conventional Western medicine has advantages in improving cardiac function indexes and clinical efficacy in patients with arrhythmia,with good safety.However,due to the limited quantity and quality of literature,more randomized controlled,multicenter,large-sample clinical trials are still needed to provide high-quality evidence.