亚群疗效模式图(STEPP)法在临床试验中的应用  

Application of the subpopulation treatment effect pattern plot(STEPP)method in clinical trials

作　　者：李宇飞 刘建平[1] 梁士兵 程红杰 张巧妍 张颖[1] LI Yufei;LIU Jianping;LIANG Shibing;CHENG Hongjie;ZHANG Qiaoyan;ZHANG Ying(Centre for Evidence-Based Chinese Medicine,Beijing University of Chinese Medicine,Beijing 100029,P.R.China;Clinical Research Center,Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Jinan 250013,P.R.China;Fangshan Hospital Beijing University of Chinese Medicine,Beijing 102401,P.R.China)

机构地区：[1]北京中医药大学循证医学中心,北京100029 [2]山东中医药大学附属医院临床研究中心,济南250013 [3]北京中医药大学房山医院,北京102401

出　　处：《中国循证医学杂志》2024年第8期980-985,共6页Chinese Journal of Evidence-based Medicine

基　　金：国家重点研发计划项目(编号:2022YFC0868300);国家中医药管理高水平中医药重点学科建设项目(编号:zyyzdxk-2023249)。

摘　　要：亚群疗效模式图(subpopulation treatment effect pattern plot,STEPP)法是一种通过制作STEPP,反映研究治疗效应与连续协变量之间关系的方法,其特征为将研究人群根据连续协变量值划分为多个重叠的亚群进行分析。STEPP法与传统亚组分析目的不同,在探究治疗效应与连续协变量的关系上STEPP法有着明显优势。本研究对STEPP法的概念、优势以及亚群划分方法进行了介绍,并以实例介绍了采用R语言的STEPP包进行STEPP法分析的具体操作过程和结果解读方法。Subpopulation treatment effect pattern plot(STEPP)method is a method for examining the relationship between treatment effects and continuous covariates and is characterized by dividing the study population into multiple overlapping subpopulations to be analyzed based on continuous covariate values.STEPP method has a different purpose than traditional subgroup analyses,and STEPP has a clear advantage in exploring the relationship between treatment effects and continuous covariates.In this study,the concepts,advantages,and subpopulation delineation methods of the STEPP method are introduced,and the specific operation process and result interpretation methods of STEPP method analysis using the STEPP package in R language are presented with examples.

关 键 词：亚群疗效模式图法 亚组分析 交互作用 R语言 随机对照试验 

分 类 号：R-03[医药卫生]