Division of Nephrology, Stanford University School of Medicine, Palo Alto, CA.
Division of Nephrology, Stanford University School of Medicine, Palo Alto, CA.
Am J Kidney Dis. 2020 Apr;75(4):508-512. doi: 10.1053/j.ajkd.2019.11.010. Epub 2020 Feb 7.
Acute kidney injury (AKI) is a common outcome evaluated in clinical studies, often as a safety end point in a variety of cardiovascular, kidney disease, and other clinical trials. AKI end points that include modest increases in serum creatinine levels from baseline may not associate with patient-centered outcomes such as initiation of dialysis, sustained decline in kidney function, or death. Surprisingly, data from several randomized controlled trials have suggested that in certain settings, the development of AKI may be associated with favorable outcomes. AKI safety end points that are nonspecific and may not associate with patient-centered outcomes could result in beneficial therapies being inappropriately withheld or never developed for commercial use. We review several issues related to commonly used AKI definitions and suggest that future work in AKI use more patient-centered AKI end points such as major adverse kidney events at 30 days or other later time points.
急性肾损伤 (AKI) 是临床研究中评估的常见结果，通常作为心血管、肾脏疾病和其他临床试验中各种安全性终点。包含血清肌酐水平从基线适度升高的 AKI 终点可能与以患者为中心的结局（如开始透析、肾功能持续下降或死亡）无关。令人惊讶的是，几项随机对照试验的数据表明，在某些情况下，AKI 的发展可能与有利的结局相关。非特异性且可能与以患者为中心的结局无关的 AKI 安全性终点可能导致有益的治疗方法被不适当地拒绝或从未开发用于商业用途。我们回顾了与常用 AKI 定义相关的几个问题，并建议未来的 AKI 研究使用更多以患者为中心的 AKI 终点，例如 30 天或其他更晚时间点的主要不良肾脏事件。
