在药物临床前研究中，动物毒理试验获得的结果可以指导临床研究，为临床试验中可能出现的毒性反应提供预测。由于不同种属间存在一定差异，所以不是所有毒性反应都可以推论到人。简述了大鼠中不可推论到人的5种毒性病理改变：肝细胞肥大协同甲状腺腺泡细胞肥大或增生、α2u-球蛋白肾病、胰岛纤维化、苯巴比妥诱导的肝脏肿瘤、睾丸间质细胞肿瘤，为临床前安全性评价毒性病理改变的解释及对临床试验毒性反应的预测提供参考。

The results of pre-clinical study can be guidance of the clinical study and applied for adverse predicting. But not all the results can be translated to human due to the spices differences. Here we introduce five rat-specific histo-toxicologic findings, such as: hypertrophy of hepacyte associated with hypertrophy or hyperplasia of thyroid follicle cells, α2u-globulin nephropathy, fiborsis of pancreas islet, liver tumor induced by phenobarbital, Leydig cell tumor of testis, which can not be translated to human and for providing reference for explanation of histo-toxicologic finding and the prediction of the clinical study.

R944.5

国家科技重大专项重大新药创制（2018ZX09721004-001-003）