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， the related researches on endpoint events in clinical trials of chronic kidney disease and acute kidney injury were reviewed and discussed， including clinical endpoint， desirable biomarker replacement endpoint， compound endpoint of acute kidney injury test， etc.，hoping to provide a reference for clinical trials of kidney disease.

[Key word] Kidney disease; Clinical research; Chronic kidney disease; Acute kidney injury; Endpoint event

腎脏病越来越受到全球医疗卫生事业研究的关注，但目前肾病相关高质量临床试验研究数量不多，各种肾病的临床证据不足，这可能与实现肾脏病临床终点及结局事件运行时间太长、成本高、样本量大等因素有关。在临床研究的设计、执行和完成中，既要实现高质量，又要兼顾经济和可行性，终点事件的选择和管理至关重要[1]。随着生物技术的快速发展，临床试验出现了越来越多的临床指标，但哪些指标可以作为肾脏病研究中的终点事件以及如何选择终点事件，这是一个宽泛而复杂的问题。

慢性肾脏病（Chronic kidney diseases，CKD）世界范围内患病率约为10%～16%[2];急性肾损伤（Acute kidney injury，AKI）作为住院患者常见严重并发症之一，发病率及死亡率越来越高，发展为CKD、肾衰竭的风险显著[3]。……