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中成药治疗缓慢性心律失常临床随机对照试验的网状Meta分析
引用本文:胡海殷,季昭臣,于丹丹,杨丰文,王辉,郑文科,张俊华.中成药治疗缓慢性心律失常临床随机对照试验的网状Meta分析[J].中国中药杂志,2020(5):1149-1158.
作者姓名:胡海殷  季昭臣  于丹丹  杨丰文  王辉  郑文科  张俊华
作者单位:天津中医药大学循证医学中心;中国中医科学院中医临床基础医学研究所
基金项目:津教委“十三五”创新团队培养计划项目(TD13-5047)。
摘    要:采用网状Meta分析方法比较治疗缓慢性心律失常中成药的有效性和安全性。计算机检索中国期刊全文数据库(CNKI)、万方数据库(WanFang)、维普数据库(VIP)、SinoMed数据库、PubMed、Cochrane Library,检索时间均为建库至2019年2月。按预先制定的纳入与排除标准进行文献筛选和资料提取。Cochrane系统评价员手册5.3推荐的偏倚风险评估工具对纳入的RCTs进行质量评价。采用WinBUGS软件进行数据分析,STATA软件进行绘图。最终纳入46个中成药治疗缓慢性心律失常的随机对照试验(RCT),涉及4种中成药,3306例患者。网状Meta分析结果显示,心律失常症状改善总有效率共产生7个直接比较和3个间接比较,其中,参仙升脉口服液、参松养心胶囊、心宝丸、宁心宝胶囊联合常规治疗的临床疗效均优于单纯常规治疗,且差异具有统计学意义;中成药疗效排序依次为:参仙升脉口服液>参松养心胶囊>心宝丸>宁心宝胶囊。平均心率监测共产生7个直接比较和3个间接比较,参仙升脉口服液、参松养心胶囊联合常规治疗的疗效均优于单纯常规治疗,且差异具有统计学意义;中成药疗效排序依次为:参仙升脉口服液>参松养心胶囊>心宝丸>宁心宝胶囊。在常规治疗基础上,联用中成药可提高缓慢性心律失常的临床治疗效果。不同的中成药由于纳入的研究数量及质量存在差异,中成药排序结果有待进一步验证。

关 键 词:中成药  缓慢性心律失常  网状Meta分析  随机对照试验

Network Meta-analysis of randomized controlled trials of Chinese patent medicine for bradyarrhythmia
HU Hai-yin,JI Zhao-chen,YU Dan-dan,YANG Feng-wen,WANG Hui,ZHENG Wen-ke,ZHANG Jun-hua.Network Meta-analysis of randomized controlled trials of Chinese patent medicine for bradyarrhythmia[J].China Journal of Chinese Materia Medica,2020(5):1149-1158.
Authors:HU Hai-yin  JI Zhao-chen  YU Dan-dan  YANG Feng-wen  WANG Hui  ZHENG Wen-ke  ZHANG Jun-hua
Institution:(Evidence Based Medicine Center,Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China;Institue of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100049,China)
Abstract:To assess the clinical efficacy of Chinese patent medicine for bradyarrhythmia(BA)by using network Meta-analysis method.Relevant randomized controlled trials(RCTs)of Chinese patent medicine for BA were retrieved from China National Knowledge Infrastructure(CNKI),WanFang Database,VIP database,SinoMed,PubMed and Cochrane Library.The retrieval time ranged from the commencement of each database to February 2019.We completed the literature screening and data extraction according to the pre-determined inclusion and exclusion criteria.The quality of inclusion studies was assessed using the bias risk assessment tool recommended by the Cochrane Handbook of Systematic Review 5.3.The data were analyzed by WinBUGS,and STATA software was used for plotting.Finally,46 RCTs were included,involving 4 Chinese patent medicines and 3306 patients.According to the network Meta-analysis,the total effective rate in alleviating BA symptoms had 7 direct comparisons and 3 indirect comparisons.The efficacy of the 4 Chinese patent medicines combined with routine therapy was superior to that of routine therapy,with statistically significant differences.The order of the four Chinese patent medicines by efficacy was as follows:Shenxian Shengmai Oral Liquid>Shensong Yangxin Capsules>Xinbao Pills>Ningxinbao Capsules.The average heart rate had 7 direct comparisons and 3 indirect comparisons.The efficacy of Shenxian Shengmai Oral Liquid and Shensong Yangxin Capsules combined with routine therapy was superior to that of routine therapy,with statistically significant differences.The order of the four Chinese patent medicines by efficacy was as follows:Shenxian Shengmai Oral Liquid>Shensong Yangxin Capsules>Xinbao Pills>Ningxinbao Capsules.The results showed that the Chinese patent medicines combined with routine therapy were effective in the treatment of BA.Due to the differences in the quantity and quality of the included studies on different Chinese patent medicines,the sequencing results of Chinese patent medicines need to be further verified.
Keywords:Chinese patent medicine  bradyarrhythmia  network Meta-analysis  randomized controlled trials
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