首页|队列多重随机对照设计应用于中医药专病专证研究的建议

队列多重随机对照设计应用于中医药专病专证研究的建议

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随机对照试验作为验证医学干预措施效果存在与否及其效应大小的"金标准",是"讲清楚、说明白"中医药疗效过程中不可避免的关键一环.然而,基于中医辨证施治原则指导下的中医药治疗措施形式多样、内容复杂,使得采用经典的随机对照设计开展相关临床研究时面临着诸多现实障碍,如缺乏标准化干预方案、难以实施双盲、安慰剂对照难以获取患者知情同意等.文章在总结当前中医药随机对照研究困境的基础上,引入并详细介绍了队列多重随机对照这一复合型研究设计的开展流程、相关特性及应用现状,分析了其在中医药专病专证研究中的适用性,并提供了参考示例,以期为未来中医药随机对照研究应用此设计提供思路与借鉴.
Proposal on cohort multiple randomised controlled trial for research on specific condition-syndrome of traditional Chinese medicine
Randomised controlled trial(RCT),as the'gold standard'for verifying the existence or otherwise of the effects of medical interventions and their effect size,is an unavoidable and crucial part of the process of'clarifying and explaining'the efficacy of traditional Chinese medicine(TCM).However,based on the principle of syndrome differentiation,the treatments of TCM are diverse in form and complex in content,which makes the use of classic randomised controlled design to carry out relevant clinical research face many practical obstacles,such as the lack of standardized intervention programs,the difficulty of implementing double-blind,and the difficulty of obtaining patients'informed consent for placebo control.On the basis of summarizing the current dilemma of RCT in TCM,this paper introduced in detail the procedure,characteristics and application of the'cohort multiple randomized controlled trial'design,and analyzed its applicability in clinical research of TCM as well as examples attached,aiming to provide reference for the application of this design in specific condition-syndrome research of TCM in the future.

Cohort multiple randomised controlled trialPragmatic trialCohort of specific condition-syndromeMethodologyTraditional Chinese medicine

景城阳、刘建平、廖星

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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

北京中医药大学循证医学中心,北京 100029

队列多重随机对照试验 实效性试验 专病专证队列 方法学 中医药

中国中医科学院科技创新工程项目中国中医科学院科技创新工程项目国家自然科学基金项目中国中医药循证医学中心业务研究室主任专项

CI2021A05503CI2021A00701-3821742392020YJSZX-2

2024

中华中医药杂志
中华中医药学会

中华中医药杂志

CSTPCD北大核心
影响因子：1.135
ISSN：1673-1727
年,卷(期)：2024.39(10)