口服中成药治疗心律失常临床研究证据的概况性综述  

Clinical Evidence of Oral Chinese Patent Medicines in Treatment of Cardiac Arrhythmia:A Scoping Review

作　　者：王特 常天瀛 崔英子[2] 樊春晖 刘欢 黄永生[2] 廖星[3] WANG Te;CHANG Tianying;CUI Yingzi;FAN Chunhui;LIU Huan;HUANG Yongsheng;LIAO Xing(Changchun University of Chinese Medicine,Changchun 130117,China;Affiliated Hospital of Changchun University of Chinese Medicine,Changchun 130021,China;Center for Evidence-based Chinese Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]长春中医药大学,长春130117 [2]长春中医药大学附属医院,长春130021 [3]中国中医科学院,中医临床基础医学研究所循证医学基础研究室,北京100700

出　　处：《中国实验方剂学杂志》2023年第6期157-166,共10页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：中国中医科学院科技创新工程项目(CI2021A00701-3);中国中医科学院基本科研业务费优秀青年科技人才(创新类)培养专项(ZZ13-YQ-075);中国中医药循证医学中心“业务研究室主任专项”(2020YJSZX-2);长春中医药大学附属医院基本中医药循证能力建设项目。

摘　　要：目的:采用概况性综述的方法对口服中成药治疗心律失常的药品信息和临床研究现状进行梳理分析,明确当前研究存在的问题,为后续开展研究提供参考。方法:以心律失常为检索词在2020年版《中华人民共和国药典》、2018年版《中国基本药物目录》、2020年版《国家基本医疗保险、工伤保险和生育保险药品目录》三大目录、药智网和相关指南检索出治疗心律失常的中成药,再通过药智网查阅已纳入中成药的说明书,并提取详细信息。在中国知网(CNKI)、万方数据库(Wanfang Data)、维普(VIP)、Pubmed、Embase五大数据库检索纳入中成药的相关文献,提取符合纳排标准的文献信息,统计分析后用文字描述和图表的形式展示。结果:该研究共纳入65种口服中成药,药物功效以活血化瘀为主;药品的日平均价格为8.17元,日平均价格10元以下的药品有42种,药品价格相对适中。中成药文献共纳入351篇,包括随机对照试验259篇,非随机对照试验16篇,非对照试验8篇,系统评价62篇,指南、专家共识各2篇。涉及18种中成药,临床研究已在全国28个省市自治区直辖市开展;药品研究文献量最多的是稳心颗粒和参松养心胶囊(75.21%);所纳入的研究中,中成药联合西药与西药的对照类型最多(64.25%)。结局评价以临床疗效、症状疗效、心律失常疗效、不良反应、心率变化为主。结论:治疗心律失常的口服中成药临床研究数量差异较大,实际应用缺乏中医辨证思维;临床研究不规范,文献质量普遍偏低,后期需要进一步改进完善。Objective:To review the drug information and research progress on oral Chinese patent medicines in the treatment of cardiac arrhythmia to identify existing problems and provide references for followup research.Method:Chinese patent medicines against cardiac arrhythmia were retrieved from the three major drug catalogues,Yaozh.com,and relevant guidelines with arrhythmia as the retrieval term.The instructions for included Chinese patent medicines were retrieved through Yaozh.com and specific information was extracted.The research articles on Chinese patent medicines included were retrieved from the five databases,and the information meeting the inclusion and exclusion criteria was extracted and displayed in the form of text description and graphs after statistical analysis.Result:Sixty-five oral Chinese patent medicines were included in this study,with the main functions of activating the blood and resolving stasis.The average daily cost of medicines was 8.17 yuan,and there were 42 medicines with an average daily cost of less than 10 yuan,showing a moderate medicine cost.A total of 351 research articles on Chinese patent medicines were screened out,including 259 randomized controlled trials(RCTs),16 non-RCTs,eight non-controlled trials,62 systematic reviews,two guidelines,and two expert consensuses.Eighteen types of Chinese patent medicines were involved,whose clinical trials had been conducted in 28 provinces,cities,autonomous regions,and municipalities in China.Wenxin granules and Shensong Yangxin capsules were the top medicines under investigation,accounting for 75.21%of all research articles.Among the included studies,the most common comparison design was Chinese patent medicine combined with western medicine vs western medicine(64.25%).The outcome evaluation was mainly based on clinical efficacy,symptom efficacy,arrhythmia efficacy,adverse reactions,and heart rate changes.Conclusion:The number of clinical studies of oral Chinese patent medicines against cardiac arrhythmia varies greatly,but traditional Chinese

关 键 词：心律失常 口服中成药 临床研究证据 概况性综述 

分 类 号：R242[医药卫生—中医临床基础] R2-031[医药卫生—中医学] R932R541.7R972.2R256.21