3. Joint Sino-Italian Laboratory of Traditional Chinese Medicine,Italian National Institute of Health,Rome,Italy
4. 天津中医药大学,天津;现代中医药海河实验室,天津
折叠
摘要
本研究旨在对2022年发布的中成药和中医经典名方的临床随机对照试验(RCT)进行全面的概述和方法学质量分析,以提供临床研究、政策制定和指南修订的循证依据.研究数据来源于中医药临床循证评价证据库系统(EVDS)中成药临床试验数据库,并辅以中国知网(CNKI)、万方数据库、维普资讯、中国生物医学文献服务系统(SinoMed)、Cochrane Library、PubMed、以及Web of Science数据库的补充检索,检索时间范围限定为2022年1月1日至2022年12月31日.本研究纳入了中成药和中医经典名方的RCTs作为临床证据来源,对其发表信息、样本量、干预与对照措施、治疗周期及方法学质量等方面进行了细致的分析与评价.经过筛选,共纳入中成药RCTs研究1464篇,覆盖中成药种类达667种.在干预与对照设置方面,“中成药联合西药对比单纯西药”的模式最为常见,涉及417篇RCTs,占总文献量的28.48％.同时,纳入中医经典名方的RCTs研究245篇,涉及经典名方55种,其中“汤剂联合常规治疗对比单纯常规治疗”的设置最为频繁,涉及87篇RCTs,占总文献量的35.51％.分析结果显示,已发表的中成药和经典名方RCTs在设计和执行方面存在若干不足,多数研究在分配隐藏和受试者盲法方面被评为中高风险;关键研究环节如试验注册和伦理审批的报告也不够充分.尽管如此,本年度的RCT研究数量虽有所下降,但研究质量和影响力却有所提升.为进一步提高临床试验的设计、执行和报告水平,建议在试验设计阶段引入方法学专家的专业技术指导,并在研究执行过程中注重过程质量控制,尤其是随机化执行的规范性,需要不断优化和完善.
Abstract
Objective:The paper is to comprehensively summarize and analyze the basic situation and methodological quality of clinical randomized controlled trials(RCTs)of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions published in 2022,to provide evidence and reasonable suggestions for the advancement of clinical research and the formulation of policies and guidelines.Methods:The Evidence Database System of clinical evidence-based evaluation of traditional Chinese medicine was searched,and data from China National Knowledge Infrastructure(CNKI),PubMed,and other databases were supplemented.The search duration was from January 1,2022,to December 31,2022.RCTs of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were included as the source of clinical evidence,and published information,sample size,intervention,control measures,treatment course,methodological quality,and key link report were analyzed and evaluated.Results:A total of 1,464 RCTs of traditional Chinese patent medicines were included,which comprised 667 types of traditional Chinese patent medicines;"traditional Chinese patent medicines+Western medicine vs.Western medicine"was the most widely used intervention and control setting,involving 417 RCTs(28.48％).A total of 245 RCTs of traditional Chinese classic famous prescriptions were included,comprising 55 types of traditional Chinese classic famous prescriptions."Decoction+conventional treatment vs.conventional treatment"was the most widely used intervention and control setting,with 87 RCTs(35.51％).Published RCTs on traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were limited by the study design and implementation.Most"allocation concealment"and"blinding of patients and personnel"were rated as medium to high risk.There are insufficient reports on key research links such as experimental registration and ethical approval.Conclusions:The number of RCTs on traditional Chinese patent medicines has decreased in 2022,but there has been a slight improvement in the research quality and impact.There are relatively few studies on traditional Chinese classic famous prescriptions.Measures must be taken to improve clinical trial design,implementation,and reporting.Methodological experts should be invited to provide professional technical guidance on the trial design.In the research implementation process,attention should be paid to quality control,particularly the standardization of the randomized execution.
关键词
中成药/经典名方/随机对照试验/循证医学
Key words
Chinese patent medicine/Evidence-based medicine/Randomized controlled trials/Traditional Chinese classic famous prescriptions
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基金项目
Tianjin Science and Technology Bureau-Outstanding youth program-Methodological research on Intelligent Transformation of evicenc(20JCJQJC00120)
Traditional Chinese Medicine Innovation Team and Talent Support Program National Traditional Chinese Medicine Multidisciplinary (ZYYCXTD-D-202204)
万方数据