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作 者:张菀桐 易丹辉[3,4] 赵阳[1,2] 杨晓晨[3,4] 普心怡 高蕊 ZHANG Wan-tong;YI Dan-hui;ZHAO Yang;YANG Xiao-chen;PU Xin-yi;GAO Rui(GCP Center,Xiyuan Hospital,China Academy of Chinese Medical Sciences,100091;Institute of Clinical Pharmacology,China Academy of Chinese Medical Sciences,Beijing,100091;School of Statistics,Renmin University of China,Beijing,100872;Center for Applied Statistics,Renmin University of China,Beijing,100872)
机构地区:[1]中国中医科学院西苑医院GCP中心,北京100091 [2]中国中医科学院临床药理研究所,北京100091 [3]中国人民大学统计学院,北京100872 [4]中国人民大学应用统计中心,北京100872
出 处:《中国中西医结合杂志》2022年第2期223-227,共5页Chinese Journal of Integrated Traditional and Western Medicine
基 金:国家重点研发计划(No.2019YFC1709304)。
摘 要:如何根据患者的整体获益确定最佳疗程,一直是中医临床实践的难点,本研究根据用药后多次随访形成的纵向数据结果,探索中医药干预治疗最佳疗程确定的模型和方法,挖掘中医治疗特色与优势。本文以中药新药治疗稳定型劳累性冠心病心绞痛临床试验数据为例,以心绞痛疼痛发作次数为因变量,药物分组、访视时间及药物和时间的交互效应为自变量构建广义估计方程,根据QIC准则选择重复观测间的相关结构,通过与对照药比较,反应出试验药最优的起效时间。通过广义估计模型理论分析、实例分析和模拟研究,为后续药物疗程的确定提供适当依据。In the process of syndrome differentiation and treatment of Chinese medicine(CM), it is often necessary to carry out a follow-up on subjects to obtain a longitudinal data group fused by each visiting point and time series. Determining the best course of treatment of CM according to the evaluation results of longitudinal data has become a key problem to explore the advantages of CM. This paper takes the clinical trial data of new CM in the treatment of stable exertional coronary heart disease and angina pectoris as an example. A generalized estimation equation is constructed by taking the number of angina pectoris took as dependent variables, drug grouping, visiting time, and the interaction between drugs and time as independent variables. Selection of correlation structure between repeated observations is according to QIC criterion the article provides an appropriate method for determination of the course of CM via theory analysis and simulation study of generalized estimation model.
分 类 号:R24[医药卫生—中医临床基础]
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