近六年中成药防治原发性高血压病的临床研究证据图分析  

Evidence mapping of clinical research on prevention and treatment of essential hypertension with Chinese patent medicines in recent six years

作　　者：乔利杰 李彬[2] 王永霞[2] 朱明军[2] QIAO Li-jie;LI Bin;WANG Yong-xia;ZHU Ming-jun(Henan University of Chinese Medicine,Zhengzhou 450000,China;the First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450000,China)

机构地区：[1]河南中医药大学,河南郑州450000 [2]河南中医药大学第一附属医院,河南郑州450000

出　　处：《中国中药杂志》2022年第19期5375-5382,共8页China Journal of Chinese Materia Medica

基　　金：国家重点研发计划“中医药现代化研究”重点专项(2019YFC1710000,2019YFC1710003);国家中医药管理局中医药循证能力建设项目(2019XZZX-XXG003);河南省中医药科学研究专项(2019JDZX2098);河南省中原千人计划-中原名医项目(豫财行[2020]140);河南省高校科技创新团队支持计划项目(13IRTSTHN012)。

摘　　要：该研究运用证据图,系统检索并梳理近六年中成药防治原发性高血压病的临床研究,了解该领域证据分布情况。通过检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、Cochrane Library数据库里中成药治疗原发性高血压病的相关文献,检索日期为2016年1月至2021年12月。采用图表结合文字的方式分析并呈现证据分布特征。最终纳入文献263篇,包括238篇干预性研究、17篇系统评价/Meta分析、8篇观察性研究。对纳入文献进行分析,共获得72种中成药,以松龄血脉康胶囊使用频次最高;国内对中成药治疗原发性高血压病关注不足,近年来发文量呈下降趋势,文献质量普遍较低;临床用药存在超说明书使用与未经辨证论治用药的情况;对于结局指标方面,未能体现中医特色,存在忽视终点结局指标的问题;系统评价/Meta分析整体质量较低,且大多数文献难以给出确定有效的结论。未来需进一步规范临床用药选择,提高随机对照试验(RCT)研究质量,以便形成高质量的循证医学证据,为中成药防治原发性高血压病的有效性与安全性提供支持。In this study,the evidence mapping was employed to systematically analyze the clinical research literature and learn the distribution of evidence on the prevention and treatment of essential hypertension with Chinese patent medicines in recent six years.CNKI,Wanfang,VIP,SinoMed,PubMed,and Cochrane Library were searched for the relevant literature published from January 2016 to December 2021.The distribution characteristics of evidence were analyzed and presented in charts combined with words.A total of 263 studies were selected,including 238 intervention studies,17 systematic reviews/Meta-analysis,and 8 observation studies.A total of 72 Chinese patent medicines were involved,among which Songling Xuemaikang Capsules had the highest frequency.In China,the attention to the treatment of essential hypertension with Chinese patent medicines was insufficient,as manifested by the declining number of published literature and the low quality of studies.There were cases of off-label use and medication without syndrome differentiation in clinical practice.Some outcome indicators failed to embody the characteristics of traditional Chinese medicine and there were cases ignoring the end-point outcome indicators.The overall quality of systematic reviews/Meta-analysis was low,and a variety of studies failed to draw valid conclusions.In the future,it is necessary to standardize the clinical medication and improve the quality of randomized controlled trial(RCT),so as to produce high-quality evidence-based medical evidence and provide strong support for the efficacy and safety of Chinese patent medicines in the prevention and treatment of essential hypertension.

关 键 词：中成药 原发性高血压病 临床研究 证据图 方法学 

分 类 号：R259[医药卫生—中西医结合]