Mehta Ravindra L, Awdishu Linda, Davenport Andrew, Murray Patrick T, Macedo Etienne, Cerda Jorge, Chakaravarthi Raj, Holden Arthur L, Goldstein Stuart L
University of California San Diego School of Medicine, La Jolla, California, USA.
University of California San Diego Skaggs School of Pharmacy, La Jolla, California, USA.
Kidney Int. 2015 Aug;88(2):226-34. doi: 10.1038/ki.2015.115. Epub 2015 Apr 8.
Drug-induced kidney disease is a frequent cause of renal dysfunction; however, there are no standards to identify and characterize the spectrum of these disorders. We convened a panel of international, adult and pediatric, nephrologists and pharmacists to develop standardized phenotypes for drug-induced kidney disease as part of the phenotype standardization project initiated by the International Serious Adverse Events Consortium. We propose four phenotypes of drug-induced kidney disease based on clinical presentation: acute kidney injury, glomerular, tubular, and nephrolithiasis, along with the primary and secondary clinical criteria to support the phenotype definition, and a time course based on the KDIGO/AKIN definitions of acute kidney injury, acute kidney disease, and chronic kidney disease. Establishing causality in drug-induced kidney disease is challenging and requires knowledge of the biological plausibility for the specific drug, mechanism of injury, time course, and assessment of competing risk factors. These phenotypes provide a consistent framework for clinicians, investigators, industry, and regulatory agencies to evaluate drug nephrotoxicity across various settings. We believe that this is the first step to recognizing drug-induced kidney disease and developing strategies to prevent and manage this condition.
药物性肾病是肾功能不全的常见原因；然而，目前尚无识别和描述这些疾病谱的标准。我们召集了一个由国际成人及儿科肾脏病学家和药剂师组成的小组，作为国际严重不良事件联盟发起的表型标准化项目的一部分，制定药物性肾病的标准化表型。我们根据临床表现提出了药物性肾病的四种表型：急性肾损伤、肾小球、肾小管和肾结石，以及支持表型定义的主要和次要临床标准，以及基于KDIGO/AKIN急性肾损伤、急性肾病和慢性肾病定义的时间进程。确定药物性肾病的因果关系具有挑战性，需要了解特定药物的生物学合理性、损伤机制、时间进程以及对竞争风险因素的评估。这些表型为临床医生、研究人员、行业和监管机构在各种情况下评估药物肾毒性提供了一个一致的框架。我们认为，这是认识药物性肾病并制定预防和管理该疾病策略的第一步。
