熊苗 朱斌

    [摘要] 肾脏病严重危害人类健康，但目前防治的临床证据不够充足，这可能与肾脏病临床“硬”终点达到的时间太长、相关的高质量肾脏病临床试验较少等原因有关。肾脏病临床试验终点的选择设置十分重要，影响研究的可行性和完成质量，选择合适的终点事件可能会有事半功倍的作用。本文就目前慢性肾脏病及急性肾损伤临床试验终点事件的相关研究进行阐述讨论，包括临床终点、可取的生物标记物替代终点、急性肾损伤试验的复合终点等，以期能在开展肾脏病临床试验时提供参考。

    [关键词] 肾疾病;临床研究;慢性肾疾病;急性肾损伤;终点事件

    [中图分类号] R544.1? ? ? ? ? [文献标识码] A? ? ? ? ? [文章编号] 1673-9701(2021)36-0184-05

    Research progress of endpoint events of kidney disease in clinical research

    XIONG Miao1， 2? ?ZHU Bin1

    1.Department of Nephrology， Guangxing Hospital Affiliated to Zhejiang Chinese Medical University，Hangzhou? ?310007，China; 2.The Third Clinical Medical College， Zhejiang Chinese Medical University，Hangzhou? ?310053，China

    [Abstract] Kidney disease seriously endangers human health，but the clinical evidence for prevention and treatment is not sufficient currently，which may be related to the long time to reach the clinical “hard” endpoint of kidney disease and the few related high-quality clinical trials of kidney disease.The selection and setting of endpoints in clinical trials of kidney disease are of great importance， which affects the feasibility and completion quality of the study.Selecting the appropriate endpoint event may get twice the result with half the effort. In this article ......