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.
Tianjin University of Traditional Chinese Medicine Tianjin 301617, China Evidence-based Medicine Center,Tianjin University of Traditional Chinese Medicine Tianjin 301617, China.
Zhongguo Zhong Yao Za Zhi. 2021 Oct;46(20):5418-5427. doi: 10.19540/j.cnki.cjcmm.20210409.502.
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.
系统评价养心定悸胶囊治疗心律失常的有效性和安全性。通过电子检索PubMed、EMbase、Cochrane图书馆、中国知网、维普、中国生物医学文献数据库和万方数据库,收集从各数据库建库至2020年10月20日关于养心定悸胶囊治疗心律失常有效性的随机对照试验(RCT)。由两名研究者独立筛选文献、录入数据并评价纳入研究的文献质量。采用RevMan 5.3软件进行Meta分析。共检索到127篇研究,筛选后纳入15篇文献,涉及1371例患者,治疗组685例,对照组686例。治疗组采用养心定悸胶囊联合抗心律失常西药进行干预,对照组仅采用抗心律失常西药治疗。Meta分析结果显示,在心律失常患者中,养心定悸胶囊联合传统西药显著提高了临床疗效(RR=1.23,95%CI[1.17,1.30],P<0.000 01)和左心室射血分数(MD=4.31,9CI[3.10,5.52],P<0.000 01),降低了心率(MD=-3.79,95%CI[-7.42,-0.15],P=0.04)、左心室舒张末期内径(MD=-7.06,95%CI[-11.91,-2.21],P=0.004)、左心室收缩末期内径(MD=-4.78,95%CI[-6.63,-2.93],P<0.000 01)、N末端B型利钠肽前体(MD=-200.51,95%CI[-254.52,-146.51],P<0.000 01)和高敏C反应蛋白(MD=-1.74,95%CI[-3.23,-0.24],P=0.02),差异均有统计学意义。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)。现有证据表明,养心定悸胶囊治疗心律失常有一定疗效,且安全性较好。然而,由于纳入研究的样本量、结局指标和质量存在局限性,需要更多高质量研究来验证上述结论。