复合终点在临床研究中的应用与挑战  

Application and challenge of composite endpoints in clinical research

作　　者：王心怡 龙囿霖 方可 杨健岚 李瑶 蒋梓轩 张娜[2] 王鑫瑶 万兴丽[5] 郭琼 黄进[3] 李正赤[7] 杜亮[2,3] WANG Xinyi;LONG Youlin;FANG Ke;YANG Jianlan;LI Yao;JIANG Zixuan;ZHANG Na;WANG Xinyao;WAN Xingli;GUO Qiong;HUANG Jin;LIZhengchi;DU Liang(General Practice Medical Center,West China Hospital,Sichuan University,Chengdu 610041,P.R.China;Chinese Evidence-based Medicine Center,West China Hospital,Sichuan University,Chengdu 610041,P.R.China;Medical Device Regulatory Research and Evaluation Center,West China Hospital,Sichuan University,Chengdu 610041,P.R.China;West China School of Public Health,Sichuan University,Chengdu 610041,P.R.China;Nursing Department,West China Second University Hospital,Sichuan University/Key Laboratory of Birth Defects and Related Diseases of Women and Children(Sichuan University),Ministry of Education,Chengdu 610041,P.R.China;West China Medical Publishers,West China Hospital,Sichuan University,Chengdu 610041,P.R.China;CPC Committee Ofice,West China Hospital,Sichuan University,Chengdu 610041,P.R.China)

机构地区：[1]四川大学华西医院全科医学中心,成都610041 [2]四川大学华西医院中国循证医学中心,成都610041 [3]四川大学华西医院医疗器械监管研究与评价中心,成都610041 [4]四川大学华西公共卫生学院,成都610041 [5]四川大学华西第二医院护理部/出生缺陷与相关妇儿疾病教育部重点实验室,成都610041 [6]四川大学华西医院华西期刊社,成都610041 [7]四川大学华西医院党委办公室,成都610041

出　　处：《中国循证医学杂志》2023年第12期1465-1471,共7页Chinese Journal of Evidence-based Medicine

基　　金：国家自然科学基金项目(编号:72074161、81873197)。

摘　　要：复合终点在临床研究中的广泛应用为研究者提供了更为全面的视角,使其能够更深入地理解复杂医学问题,同时有效提升研究的效能和效率,进而降低整体研究的经济成本。理解复合终点的优势和局限性对于正确应用复合终点及合理解读结果至关重要。本文旨在介绍复合终点在临床试验中的应用进展,讨论其优势和局限性,总结复合终点的使用建议,以期为帮助研究者认识和处理复合终点提供指导。The widespread application of composite endpoints in clinical research has afforded researchers a more comprehensive perspective,enabling a deeper understanding of intricate medical issues.Simultaneously,it effectively enhances the efficiency and efficacy of studies,thereby reducing the overall economic costs of research.A profound comprehension of the strengths and limitations of composite endpoints is crucial for their correct application and the accurate interpretation of results.This paper aims to introduce the recent advancements in the application of composite endpoints in clinical trials,discussing their advantages and limitations,and providing practical recommendations for their use.The intention is to offer guidance to researchers in understanding and managing composite endpoints effectively.

关 键 词：复合终点 临床试验 优势 挑战 

分 类 号：R-3[医药卫生]