药物性肝损伤相关生物学标志物的研究进展

Research progress in biomarkers of drug-induced liver injury

药物性肝损伤(DILI)是导致上市药物撤市和药物临床试验失败的主要原因之一。潜在肝损伤的检测对临床管理及临床前药物安全研究是一个挑战。目前,ALT、AST是评估肝损伤的金标准。然而,这些评估指标特异性差且不敏感,经常导致假阳性。因此,人们一直致力于寻找敏感性、特异性高的DILI相关生物学标志物。综述了近期DILI相关生物学标志物的研究进展,以便更好地预测、诊断DILI。

Drug- induced liver injury（ DILI） is a major reason for the recall of marketed drugs and the failure of clinical trials. Detection of potential liver injury remains a challenge for clinical management and preclinical drug safety studies. Currently,serum levels of alanine aminotransferase and aspartate aminotransferase are the gold standards for evaluating liver injury. However,these biomarkers are nonspecific and insensitive,and often result in false- positive results. Therefore,researchers have never stopped searching for the biomarkers of DILI with high sensitivity and specificity. This review summarizes recent research progress in the biomarkers of DILI to better predict and diagnose DILI.