随机对照试验中替代终点的报告规范SPIRITSurrogate与CONSORT-Surrogate解读  

Interpretation of SPIRIT-Surrogate and CONSORT-Surrogate reporting guidelines for surrogate endpoints in randomized controlled trials

作　　者：陈嘉慧 王子怡 李洁韵 张强[4] 王海博 邓秀秀 王治达[1] 卢存存 CHEN Jiahui;WANG Ziyi;LI Jieyun;ZHANG Qiang;WANG Haibo;DENG Xiuxiu;WANG Zhida;LU Cuncun(The First Hospital of Lanzhou University,Clinical Skills Training Center,Lanzhou 730000,P.R.China;Evidence-Based Social Science Research Center,School of Public Health,Lanzhou University,Lanzhou 730000,P.R.China;School of Basic Medical Sciences,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,P.R.China;The First Affiliated Hospital of Henan University of CM,Zhengzhou 450000,P.R.China;Department of Critical Care Medicine,Affiliated Hospital of Gansu University of Chinese Medicine,Lanzhou 730000,P.R.China;Central Laboratory,Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu 610075,P.R.China;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,P.R.China)

机构地区：[1]兰州大学第一医院临床技能培训中心,兰州730000 [2]兰州大学公共卫生学院循证社会科学研究中心,兰州730000 [3]上海中医药大学基础医学院,上海201203 [4]河南中医药大学第一附属医院,郑州450000 [5]甘肃中医药大学附属医院重症医学科,兰州730000 [6]成都中医药大学附属医院中心实验室,成都610075 [7]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《中国循证医学杂志》2025年第2期214-224,共11页Chinese Journal of Evidence-based Medicine

基　　金：兰州大学医学本科教育教学水平提升培育项目(编号:lzuyxcx-2022-69)。

摘　　要：替代终点是临床试验中用于代替最终目标结局的生物标志物或中间结局指标,近年来其在临床试验和药械加速审批中越来越常见。为了规范替代终点在临床试验方案及其研究中的应用和报告,有关学者在BMJ于2024年7月发表了SPIRIT-Surrogate和CONSORT-Surrogate报告规范。本文结合案例对上述规范进行解读,旨在为国内研究人员提供借鉴,提高相关临床试验的整体质量,最终促进国内医疗卫生水平的提升。Surrogate endpoints,defined as biomarkers or intermediate outcomes utilized in clinical trials to replace the ultimate targeted outcomes,have witnessed a growing prevalence in both clinical trials and drug-device approvals in recent years.To standardize the application and reporting of surrogate endpoints in clinical trial protocols and associated studies,relevant scholars published the SPIRIT-Surrogate and CONSORT-Surrogate reporting guidelines in the BMJ in July 2024.This article provides an interpretation of these guidelines in conjunction with published case studies,with the aim of offering references for domestic researchers,elevating the overall quality of related clinical trials,and eventually facilitating the enhancement of domestic healthcare level.

关 键 词：替代结局 随机对照试验 SPIRIT-Surrogate CONSORT-Surrogate 报告规范 

分 类 号：R-03[医药卫生]