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中医药队列研究中永恒时间偏倚的识别与控制策略OA

Identification and Control Strategies for Immortal Time Bias in Traditional Chinese Medicine Cohort Studies

中文摘要英文摘要

系统梳理中医药队列研究中永恒时间偏倚的常见类型及其原因,认为永恒时间偏倚主要包括错误分类与错误排除两类,其产生的原因是研究对象从入组到接受干预的时间间隔内产生了结局事件,这类患者被错误地归入某组或被错误地排除出结局观察.基于上述分析,阐述了控制永恒时间偏倚的具体方法,如研究设计方面,可采用巢式病例对照研究和目标试验模拟;统计学方法方面,时间依赖的COX回归模型、Poisson回归模型、敏感性分析、界标分析可较为有效地监测和控制永恒时间偏倚;硬件技术方面,新的检测技术以及智能手环等可穿戴设备、植入式芯片等连续生物传感器、移动健康应用程序等新技术手段可从根本上缩短永恒时间,减少永恒时间偏倚.通过以上方式,可为永恒时间偏倚的良好控制和中医药高水平临床研究的开展提供方法学借鉴.

This article systematically reviewed the common types and causes of immortal time bias in traditional Chinese medicine(TCM)cohort studies.It is suggested that immortal time bias mainly includes misclassification and erroneous exclusion,which occur when outcome events happen during the time interval between participant enroll-ment and receiving the intervention.These patients are incorrectly assigned to a group or erroneously excluded from outcome observation.Based on the above analysis,specific methods for controlling immortal time bias are discussed.In terms of study design,nested case-control studies and target trial simulations can be used.Regarding statistical methods,time-dependent Cox regression models,Poisson regression models,sensitivity analysis,and landmark ana-lysis can effectively monitor and control immortal time bias.In terms of hardware technology,new detection technolo-gies and wearable devices such as smart wristbands,continuous biosensors like implantable chips,and mobile health applications can fundamentally shorten immortal time and reduce immortal time bias.By using the above-mentioned methods,it will provide methodological references for the effective control of immortal time bias and the development of high-quality clinical research in TCM.

陈俞含;李润庭;袁滋艺;魏书闻;刘凯;文雅倩;刘建平;刘兆兰

北京中医药大学循证医学中心,北京市朝阳区北三环东路11号,100029南京财经大学管理科学与工程学院北京中医药大学针灸推拿学院北京中医药大学针灸推拿学院北京中医药大学循证医学中心,北京市朝阳区北三环东路11号,100029北京中医药大学循证医学中心,北京市朝阳区北三环东路11号,100029北京中医药大学循证医学中心,北京市朝阳区北三环东路11号,100029||成都中医药大学附属医院循证医学中心北京中医药大学循证医学中心,北京市朝阳区北三环东路11号,100029

永恒时间偏倚队列研究真实世界研究中医药临床试验

immortal time biascohort studyreal-world studytraditional Chinese medicine clinical trials

《中医杂志》 2026 (8)

838-844,7

国家自然科学基金(82374298)北京中医药大学后备学科带头人资助项目(90010960920033)

10.13288/j.11-2166/r.2026.08.006

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