首页|基于中医复杂性、动态性的干预特点构建中医随机对照试验新型复杂干预模式

基于中医复杂性、动态性的干预特点构建中医随机对照试验新型复杂干预模式

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依据干预措施特点现有中医随机对照试验(RCT)设计可分为两大类:以固定处方为代表的解释性RCT设计和以辨证用药为代表的实用性RCT设计.在实现中医药特色与RCT有机结合方面,两类干预措施均存在一定缺陷.解释性RCT严格标准化设计以牺牲部分中医药疗效为代价保证试验的内部真实性,但中医辨证论治及个体化诊疗特色体现不足.实用性RCT设计体现中医诊疗特色却调低干预措施的标准化程度,牺牲设计的严密性促进了方案的实施.文章提出一种中医RCT新型复杂干预模式,以期为中医药临床研究提供思路.
Construction of a new complex intervention mode of traditional Chinese medicine randomized controlled trial based on the complex and dynamic intervention characteristics of traditional Chinese medicine
According to the characteristics of interventions,the existing randomized controlled trial(RCT)design of traditional Chinese medicine(TCM)can be divided into two categories,the explanatory RCT design represented by a fixed prescription and the practical RCT design represented by dialectical medication.Both types of interventions have certain defects in realizing the organic combination of TCM characteristics and RCT.The strictly standardized design of explanatory RCTs guarantees the internal authenticity of the test at the expense of the therapeutic effects of some TCM,but the characteristics of dialectical treatment and personalized diagnosis and treatment of TCM are insufficient.The practical RCT design reflects the characteristics of TCM diagnosis and treatment,but reduces the degree of standardization of interventions,sacrificing the rigor of the design to promote the implementation of the solution.This paper proposes a new type of complex intervention model of TCM RCT with a view to providing ideas for clinical research of TCM.

Traditional Chinese medicineRandomized controlled trial(RCT)Trial designBody of evidenceComplex intervention

王悦、陈红、张根明

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北京中医药大学第一临床医学院,北京 100700

北京中医药大学东直门医院,北京 100700

中医药 随机对照试验 试验设计 证据体 复杂干预

国家重点研发计划

2019YFC1712000

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(3)
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