尋找能早期、靈敏、特異地診斷腎毒性的新型生物標志物已成為目前藥物臨床前研究的熱點。大量研究發(fā)現(xiàn)尿液中性粒細胞明膠酶相關(guān)脂質(zhì)運載蛋白（NGAL）對腎損傷的診斷效能優(yōu)于傳統(tǒng)生物標志物血清肌酐和尿素氮。2018年尿液NGAL獲得了美國食品藥品監(jiān)督管理局的批準，可用于I期臨床試驗中藥物對腎小管損傷作用的監(jiān)測，但其在臨床前試驗中的應(yīng)用和推廣仍有待進一步研究。就NGAL特性、作為藥物誘導(dǎo)急性腎損傷生物標志物研究進展及其應(yīng)用面臨的挑戰(zhàn)進行綜述，以期為NGAL在我國新藥研發(fā)中對急性腎毒性評價的應(yīng)用奠定基礎(chǔ)。

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.

國家自然科學(xué)基金項目（81603210）；國家“重大新藥創(chuàng)制”科技重大專項（2018ZX09201017-001）