尿液NGAL作为药物诱导急性肾毒性生物标志物的研究进展  

Research progress on urinary NGAL as biomarker of drug-induced acute nephrotoxicity

作　　者：王超[1] 白玉杰 周晓冰[1] 李波[1] WANG Chao;BAI Yujie;ZHOU Xiaobing;LI Bo(National Center for Safety Evaluation of Drugs,National Institutes for Food and Drug Control,Beijing 100176,China;Weifang Xiashan Jingwei Biotechnology Co.Ltd.,Weifang 262600,China)

机构地区：[1]中国食品药品检定研究院国家药物安全评价监测中心,药物非临床安全评价研究北京市重点实验室,北京100176 [2]潍坊峡山荆卫生物科技有限公司,山东潍坊262600

出　　处：《药物评价研究》2021年第8期1806-1810,共5页Drug Evaluation Research

基　　金：国家自然科学基金项目(81603210);国家“重大新药创制”科技重大专项(2018ZX09201017-001)。

摘　　要：寻找能早期、灵敏、特异地诊断肾毒性的新型生物标志物已成为目前药物临床前研究的热点。大量研究发现尿液中性粒细胞明胶酶相关脂质运载蛋白(NGAL)对肾损伤的诊断效能优于传统生物标志物血清肌酐和尿素氮。2018年尿液NGAL获得了美国食品药品监督管理局的批准,可用于I期临床试验中药物对肾小管损伤作用的监测,但其在临床前试验中的应用和推广仍有待进一步研究。就NGAL特性、作为药物诱导急性肾损伤生物标志物研究进展及其应用面临的挑战进行综述,以期为NGAL在我国新药研发中对急性肾毒性评价的应用奠定基础。Finding new biomarkers that can diagnose nephrotoxicity early,sensitively and specifically has become a hot spot in drug preclinical research.A large number of studies domonstrated that urinary neutrophil gelatinase-associated lipocalin(NGAL)is better than the traditional biomarkers BUN and CRE in the diagnosis of renal injury.In 2018,urinary NGAL approved by FDA,can be used for monitoring renal tubular damage in I clinical trials of drugs.However,further study should be performed for the application and promotion of NGAL in preclinical trials.This article reviews the characteristics of NGAL,its research progress as a biomarker of drug-induced acute kidney injury and the challenge of NGAL application,which will offer the foundation of the NGAL application for acute renal toxicity assessment in new drug preclinical research in China.

关 键 词：中性粒细胞明胶酶相关脂质运载蛋白 急性肾损伤 生物标志物 临床前研究 

分 类 号：R965.3[医药卫生—药理学]