在藥物臨床前研究中，動物毒理試驗獲得的結果可以指導臨床研究，為臨床試驗中可能出現(xiàn)的毒性反應提供預測。由于不同種屬間存在一定差異，所以不是所有毒性反應都可以推論到人。簡述了大鼠中不可推論到人的5種毒性病理改變：肝細胞肥大協(xié)同甲狀腺腺泡細胞肥大或增生、α2u-球蛋白腎病、胰島纖維化、苯巴比妥誘導的肝臟腫瘤、睪丸間質細胞腫瘤，為臨床前安全性評價毒性病理改變的解釋及對臨床試驗毒性反應的預測提供參考。

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

國家科技重大專項重大新藥創(chuàng)制（2018ZX09721004-001-003）