Abstract: Surrogate endpoints are frequently used to substitute for target outcomes in randomized controlled trials to shorter trial duration，reduced sample size and etc. But some surrogate endpoints would increase uncertainty of the intervention's true effect and unreliable in revealing intervention harms. We do need better reporting of trials that rely on surrogate endpoints. The SPIRIT-Surrogate and CONSORT- Surrogate provides the minimum reporting requirements for trials that use surrogate endpoints.Those extension checklists help to improve transparency，usefulness of trial findings，and ultimately reduce research waste.We interpreted these two guidelines with the aim of providing reference for practitioners and drawing their attention to surrogate endpoints.

Key words: Randomized controlled trial, Surrogate endpoints, Surrogate indicators, Primary outcomes, Clinical study

摘要： 随机对照试验正在越来越广泛地使用替代终点作为主要结局的评价指标，虽然其具有加快试验进程、减少样本量等诸多优势，但是，并非所有的替代终点都能很好的预测干预效果。因此，使用替代终点作为主要结局指标的规范性和后续验证问题受到人们的重视和思考。近期发布的《基于SPIRIT和CONSORT标准的替代终点扩展指南》对使用替代终点的随机对照试验制订了最低参照标准，旨在提高这些试验方案或报告的科学性及规范性。两个扩展指南的制订符合国际指南编写流程，这些条目在优化试验方案/报告质量的同时也有助于减少临床资源的浪费。本文将两个扩展指南一同对比解读，以期为广大研究者提供参考，引起相关从业者对替代终点及其背后诸多问题的关注。

关键词: 随机对照试验, 替代终点, 替代指标, 主要结局, 临床研究