王亦菲;郭丽君;高风;张智博;任高灿;马晓昌;
WANG Yi-fei;GUO Li-jun;GAO Feng;ZHANG Zhi-bo;REN Gao-can;MA Xiao-chang;Graduate School of Beijing University of Chinese Medicine;National Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences;Xiyuan Hospital, China Academy of Chinese Medical Sciences;

• 1:北京中医药大学研究生院
• 2:中国中医科学院西苑医院国家中医心血管病临床医学研究中心
• 3:中国中医科学院西苑医院

摘要(Abstract)：

该研究应用证据图梳理和总结了中成药治疗高血压病的临床研究证据，了解相关研究的证据分布。查找《国家基本医疗保险、工伤保险和生育保险药品目录》(2021年版)和《中国药典》(2020年版)中收录的明确提到能治疗高血压病的中成药，通过Cochrane Library、PubMed、Web of Science、中国知网(CNKI)、万方(Wanfang)、维普(VIP)和中国生物医学文献服务系统(SinoMed)检索自2016年1月1日至2022年2月14日发表的相关文献，采用文字描述结合表格、气泡图的形式分析证据分布特征。共检索到31种中成药，最终纳入中成药20种、相关文献111篇。对比分析了20种中成药的基本信息、发文量、研究人群的高血压病分级和中医证型、研究规模、干预方案及结局指标。结果表明，目前临床研究以平肝息风类中成药为主，以单中心、小样本、短周期的随机对照试验居多；临床研究未突显中医药治疗的关键和优势；在结局指标选择方面，种类较多，除血压外多关注替代性结局指标和复合结局指标，对卫生经济学指标、生活质量评价及血管、心脏等靶器官损害的关注略显不足。
In this study, evidence mapping was employed to sort out and summarise the evidence from clinical studies of Chinese patent medicines for hypertension and to understand the evidence distribution in related studies. Chinese patent medicines for hypertension were searched from Medicine Catalogue for National Basic Medical Insurance, Employment Injury Insurance, and Maternity Insu-rance(2021) and Chinese Pharmacopoeia(2020). Relevant articles(published from January 1, 2016 to February 14, 2022) were retrieved from Cochrane Library, PubMed, Web of Science, CNKI, Wanfang, VIP, and SinoMed. Then, the evidence distribution was analysed based on description, tables, and bubble charts. A total of 31 Chinese patent medicines were identified and 20 were finally included, involving 111 articles. The basic information of the 20 Chinese patent medicines, the number of related articles, the hypertension staging and traditional Chinese medicine(TCM) syndrome types of the subjects, sample size, interventions, and outcome indicators were compared. The results showed Chinese patent medicines with the function of pacifying liver and eliminating wind were frequently studied, and most of them were single-center, small-sample, short-period randomized controlled trials. They failed to highlight the key and advantages of TCM. A wide variety of outcome indicators were involved, and in addition to blood pressure, surrogate outcome indicators and composite outcome indicators were emphasized. However, health economic indicators, quality of life, and damage to target organs such as blood vessels and heart, were rarely used.

关键词(KeyWords)： 中成药;高血压病;证据图;循证医学
Chinese patent medicine;hypertension;evidence mapping;evidence-based medicine

Abstract:

Keywords:

基金项目(Foundation):

作者(Authors): 王亦菲;郭丽君;高风;张智博;任高灿;马晓昌;
WANG Yi-fei;GUO Li-jun;GAO Feng;ZHANG Zhi-bo;REN Gao-can;MA Xiao-chang;Graduate School of Beijing University of Chinese Medicine;National Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences;Xiyuan Hospital, China Academy of Chinese Medical Sciences;

DOI: 10.19540/j.cnki.cjcmm.20220602.501

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