模拟目标试验及其在中医药研究中应用的可行性分析  

Target Trial Emulation and Feasibility in Traditional Chinese Medicine Researches

作　　者：王禹毅[1,2] 马文欣 王雪惠 卜志军 刘建平[1] 刘兆兰[1] WANG Yuyi;MA Wenxin;WANG Xuehui;BU Zhijun;LIU Jianping;LIU Zhaolan(Center for Evidence-Based Medicine,Beijing University of Chinese Medicine,Beijing 100029;Chongqing Hospital of Traditional Chinese Medicine)

机构地区：[1]北京中医药大学循证医学中心,北京市100029 [2]重庆市中医院

出　　处：《中医杂志》2023年第19期1969-1974,共6页Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金(82374298);北京市朝阳区科技计划(CYSF2205)。

摘　　要：模拟目标试验是指采用观察性研究数据模拟实施随机对照试验,即将随机对照试验的研究设计原则应用于旨在评估干预效果的观察性研究。模拟目标试验的优势是当不适合开展随机对照试验时,利用观察性数据模拟实施随机对照试验,同时控制观察性研究自身设计引起的偏倚,提高观察性数据因果推断的效能。从入组标准、治疗措施、治疗措施的分配程序、指定宽限期、结局指标、随访、效果比较、统计分析计划等方面介绍模拟目标试验的方法学要点。阐释模拟目标试验应用于中医药研究中的可行性和必要性,并提出其在中医药研究中实施面临的研究人员专业性、数据收集与整合、混杂因素控制等挑战。Target trial emulation,using observational data to emulate a target trial,applies the study design principles of randomized controlled trials to observational studies that aim to estimate the effect of an intervention.The advantage of target trial emulation is that observational data is used to emulate a target trial when it is not appropriate to conduct randomized controlled trials.Target trial emulation can control bias caused by the design of observational studies,and improve the effectiveness of causal inference from observational data.This paper introduced the methodological framework and key points in terms of eligibility criteria,treatment strategies,assignment procedures,grace period,outcomes,follow-up period,effect contrasts,and statistical plan for implementing target trial emulation.This article elucidated the feasibility and necessity of applying target trail emulation in the realm of traditional Chinese medicine researches,and highlighted the challenges encountered in its implementation,such as the need for specialized personnel,data collection and integration,and the control of confounding factors.

关 键 词：模拟目标试验 观察性研究 随机对照试验 方法学 

分 类 号：R2-0[医药卫生—中医学]