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中成药治疗心房颤动临床研究证据图分析

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背景 中成药是中医治疗心房颤动的重要手段,然而目前尚缺乏对该领域临床研究证据的全面把握。目的运用证据图的研究方法对中成药治疗心房颤动的临床研究进行梳理和总结,以了解该领域的证据现状与存在问题。方法 计算机检索中国知网、万方、维普、中国生物医学文献数据库、PubMed、Embase和The Cochrane Library数据库收录的有关中成药治疗心房颤动的临床研究,检索时限为2013年1月—2022年9月。由2名研究员独立筛选文献、提取资料,以文字描述和图表结合的形式展示证据分布特征。结果 最终纳入文献355篇,包括干预性研究323篇、观察性研究8篇、系统综述24篇。总体发文量比较稳定,近2年有下降趋势。纳入文献对老年、心力衰竭、高血压合并心房颤动的关注度较高,共涉及36种中成药,以稳心颗粒和参松养心胶囊占比最多。干预疗程以4~12周为主。结局指标对疗效和安全性指标关注度较高,对预后/终点、中医、生活质量、经济学、心理状况指标关注度不足。随机对照试验的偏倚风险大多判断为"未知偏倚风险",仅1篇文献进行了研究方案的注册,存在设盲不足相关问题。Meta分析/系统评价的方法学质量测量工具(Assessment of Multiple Systematic Reviews,AMSTAR)评分在3~9分之间,多数研究只能得出"潜在有效"的结论。结论 中成药治疗房颤已经开展了大量小样本、短周期研究,但是文献质量偏低,关注人群局限、干预疗程较短、结局指标选择不规范,临床选择应当谨慎,未来应做好顶层设计,以提高研究的影响力。
Evidence Mapping of Clinical Research on Chinese Patent Medicines for Atrial Fibrillation
Background Chinese patent medicine(CPM)has become an important means to treat atrial fibrillation(AF).However,the overall clinical evidence for different CPM in the treatment of AF is still unclear.Objective This study aimed to a-dopt the evidence-mapping method and integrate the evidence from various researches on this topic to depict the whole picture of CPM for AF.Methods PubMed,Embase,The Cochrane Library,CNKI,Wanfang Data,VIP and CBM were electronically searched to collect studies on CPM for AF from January 2013 to September 2022.Two independent reviewers screened the literature,ex-tracted information of all included studies to provide an intuitive overview of the evidence.Results A total of 355 articles invol-ving 323 intervention studies,8 observational studies and 24 systematic reviews were included.The number of trials were relative-ly stable.However,the number was a downward trend in the last two years.A total of 36 CPM were identified and Wenxin Gran-ule(稳心颗粒)and Shensong Yangxin Capsule(参松养心胶囊)accounted for the most.The elderly,heart failure and hyper-tension complicated with AF were highly concerned.The course of intervention was mainly 4 to 12 weeks.The outcome indicators paid more attention to the efficacy and safety,but pay less attention to prognosis,endpoint,traditional Chinese medicine,quality of life,economics and psychological status.The bias risk of randomized controlled trials were mostly judged as"unclear".Only one study registered a protocol,and there was a problem of insufficient blinding.The systematic reviews of AMSTAR scored between 3 and 9 points,and most studies can only reach the conclusion of"potential effectiveness".Conclusion A large number of small-sample and short-period studies have been carried out on AF treated with CPM.However,the quality of the study is low,the focus on the population is limited,the intervention course is short and the selection of outcome indicators is not standard-ized.The clinical selection should be cautious,and the top-level design should be done well in the future to improve the influ-ence of the study.

atrial fibrillationChinese patent medicineevidence mapmethodology

孙阳、乔利杰、彭广操、李彬、朱明军

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河南中医药大学第一附属医院,河南郑州 450000

河南省中医药循证医学中心,河南郑州 450000

心房颤动 中成药 证据图 方法学

国家重点研发计划"中医药现代化研究"重点专项国家重点研发计划"中医药现代化研究"重点专项国家自然科学基金项目国家中医药管理局中医药循证能力建设项目

2019YFC17100002019YFC1710003820742262019XZZX-XXG003

2024

中华中医药学刊
中华中医药学会 ,辽宁中医药大学

中华中医药学刊

CSTPCD北大核心
影响因子:1.007
ISSN:1673-7717
年,卷(期):2024.42(2)
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