在藥物臨床前研究中，動物毒理試驗(yàn)獲得的結(jié)果可以指導(dǎo)臨床研究，為臨床試驗(yàn)中可能出現(xiàn)的毒性反應(yīng)提供預(yù)測。由于不同種屬間存在一定差異，所以不是所有毒性反應(yīng)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(xì)胞肥大協(xié)同甲狀腺腺泡細(xì)胞肥大或增生、α2u-球蛋白腎病、胰島纖維化、苯巴比妥誘導(dǎo)的肝臟腫瘤、睪丸間質(zhì)細(xì)胞腫瘤，為臨床前安全性評價(jià)毒性病理改變的解釋及對臨床試驗(yàn)毒性反應(yīng)的預(yù)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(xiàng)重大新藥創(chuàng)制（2018ZX09721004-001-003）