尋找能早期、靈敏、特異地診斷腎毒性的新型生物標(biāo)志物已成為目前藥物臨床前研究的熱點(diǎn)。大量研究發(fā)現(xiàn)尿液中性粒細(xì)胞明膠酶相關(guān)脂質(zhì)運(yùn)載蛋白（NGAL）對(duì)腎損傷的診斷效能優(yōu)于傳統(tǒng)生物標(biāo)志物血清肌酐和尿素氮。2018年尿液NGAL獲得了美國(guó)食品藥品監(jiān)督管理局的批準(zhǔn)，可用于I期臨床試驗(yàn)中藥物對(duì)腎小管損傷作用的監(jiān)測(cè)，但其在臨床前試驗(yàn)中的應(yīng)用和推廣仍有待進(jìn)一步研究。就NGAL特性、作為藥物誘導(dǎo)急性腎損傷生物標(biāo)志物研究進(jìn)展及其應(yīng)用面臨的挑戰(zhàn)進(jìn)行綜述，以期為NGAL在我國(guó)新藥研發(fā)中對(duì)急性腎毒性評(píng)價(jià)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(guó)家自然科學(xué)基金項(xiàng)目（81603210）；國(guó)家“重大新藥創(chuàng)制”科技重大專(zhuān)項(xiàng)（2018ZX09201017-001）