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生脉注射液治疗缓慢性心律失常有效性和安全性的Meta分析 被引量:12

Meta-analysis on the Efficacy and Safety of Shengmai Injection in the Treatment of Chronic Arrhythmias
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摘要 目的:评价生脉注射液治疗缓慢性心律失常的有效性和安全性。方法:计算机检索中国知网数据库(CNKI)、万方数据库、重庆维普中文科技期刊数据库(VIP)。从建立数据库到2018年3月初进行文件检索,搜索语言为中文。搜索生脉注射液治疗缓慢性心律失常的RCT文献。两名研究者独立严格进行纳入文献的资料提取和质量评估,使用Cochrane系统评价手册的偏倚风险评估标准进行评估,采用RevMan5.3软件进行Meta分析。结果:共纳入18项研究,共1332名缓慢性心律失常的患者,试验的方法学质量普遍偏低。生脉注射液加常规西药治疗组(治疗组)与基础治疗组(对照组)比较显示:总有效率治疗组优于对照组(OR=4.06,95%CI,3.11~5.31,P<0.00001);治疗组24h平均心率高于对照组(MD=11.02,95%CI,10.05~11.99,P<0.00001)。七项研究显示治疗前后有不良反应。结论:生脉注射液治疗缓慢性心律失常具有一定的疗效,可以减轻患者的症状,显著提升患者的24h平均心率。但现有的文献质量评价不高,且临床研究数量不多,需要更多高质量、多中心的RCT来完善其适应症、主要功用和不良反应。 Objective:There have been several randomized controlled trials (RCT)in China for the treatment of chronic arrhythmias with shengmai injection,but most of them have not received high quality evaluation.No metaanalysis has been conducted on the treatment of chronic arrhythmias with shengmai injection.Objective:To evaluate the efficacy and safety of shengmai injection in the treatment of bradycardia.Methods:The databases of CNKI,wanfang and VIP were searched by computer.From the establishment of the database to the beginning of March 2018for file retrieval,the search language is Chinese.Search the RCT literature of shengmai injection in the treatment of chronic arrhythmia.The two researchers independently and strictly carried out the data extraction and quality assessment of the included literature,and used the bias risk assessment standard of the Cochrane system evaluation manual for evaluation,and the RevManS.3software for meta-analysis.Results:A total of 1332patients with chronic arrhythmia were included in 18 studies,and the methodological quality of the test was generally low.Comparison between Shengmai injection and conventional western medicine treatment group(treatment group)and basic treatment group (control group)showed that the total effective treatment group was superior to the control group (OR=4.06,95%CI,3.11-5.31, P<0.00001).The 24-hour average heart rate of the treatment group was higher than that of the control group (MD=11.02, 95%CI,10.05-11.99,P<0.00001).Seven studies have shown adverse reactions before and after treatment.Conclusion:Shengmai injection has certain curative effect on chronic arrhythmias,which can reduce the symptoms of patients and significantly increase the average heart rate of patients in 24hours.However,the quality evaluation of the existing literature is not high,and the number of clinical studies is not large,so more high-quality and multi-center RCT is needed to improve its indications,main functions and adverse reactions.
作者 董佰冰 季康寿 侯平 DONG Baibing;JI Kangshou;HOU Ping(Liaoning University of Traditional Chinese Medicine,Liaoning Shenyang 110032,China;Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Liaoning Shenyang 110032,China)
出处 《中医药临床杂志》 2018年第11期2055-2060,共6页 Clinical Journal of Traditional Chinese Medicine
基金 国家中医临床研究基地业务建设项目(项目编号:JDZX2015032)
关键词 生脉注射液 缓慢性心律失常 随机对照试验 META分析 Shengmai injection Chronic arrhythmia Randomized controlled trial Meta analysis
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