替代指标在临床试验中的应用与局限性  

Use and limitation of surrogate outcomes in clinical trials

作　　者：徐小国[1] 蒋萌[1] 

机构地区：[1]南京中医药大学附属医院临床药理科

出　　处：《中国临床药理学与治疗学》2006年第10期1194-1197,共4页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：本文依据国内外临床试验中结局指标选择的现状,论述了替代指标与终点指标的概念及其关系,以及在临床试验中结局指标选择基本方法及其当前存在的问题。强调只有对患者有直接影响的终点指标才能够证实干预措施的真正疗效,而以实验室为主的生物学指标和患者的临床症状或体征等替代指标,只有被证实与真正临床结局具有因果关系且能客观反映临床措施对临床结局净效应的情况下,才能够作为代替终点指标的评价指标使用。According to the status quo of choosing outcome indexes in Chinese and other countries＇ clinical trials, propose the concepts of points and correlation between methods and present problems surrogate outcomes and end them, discuss the general of choosing true endpoints It is emphasized that only the primary outcomes which affect the patients directly can prove the real effectiveness of the interventions. Only when the surrogate ones, such as biological indexes from laboratory and the patients＇ symp toms or signs, which are proved to have a correlate of the true clinical outcome and fully capture the net effect of treatment on the clinical outcome, can the latter be the substitute for the former.

关 键 词：替代指标 终点指标 临床试验 应用 局限性 

分 类 号：R969[医药卫生—药理学]