生物技術(shù)藥物的免疫原性在臨床前藥物安全性評(píng)價(jià)中表現(xiàn)為實(shí)驗(yàn)動(dòng)物的超敏反應(yīng)以及腎損傷，但其誘導(dǎo)免疫復(fù)合物形成的機(jī)制尚未完全明確。目前國(guó)內(nèi)外主要通過(guò)檢測(cè)動(dòng)物體內(nèi)循環(huán)態(tài)和沉積態(tài)的免疫復(fù)合物，來(lái)綜合判斷生物技術(shù)藥物是否對(duì)動(dòng)物造成免疫復(fù)合物性腎損傷。簡(jiǎn)述了臨床前生物技術(shù)藥物誘導(dǎo)免疫復(fù)合物的形成、清除、沉積、毒性反應(yīng)以及檢測(cè)方法的研究進(jìn)展，以期為建立早期、簡(jiǎn)便、靈敏的生物技術(shù)藥物免疫復(fù)合物性腎損傷的檢測(cè)技術(shù)提供一定參考。

The immunogenicity of biopharmaceutical drugs is manifested as renal injuries as well as hypersensitivity reactions in experimental animals in preclinical safety evaluation of drugs. However, the mechanism of biopharmaceutical drug-induced immune complexes in experimental animals is still unclear. The immune complex-based injuries to the kidney of biopharmaceutical drugs have been mainly determined comprehensively by detecting the immune complexes of circulating and deposited states. In this paper, we briefly summarize that the formation, clearance, deposition, toxicological reactions, and detection of immune complexes induced by preclinical biopharmaceutical drugs in experimental animals, in the hope of providing some references for the establishment of early, simple, and sensitive detection methods of renal injuries caused by biopharmaceutical drug-induced immune complexes.

R965.3

江蘇省新藥一站式高效非臨床評(píng)價(jià)公共服務(wù)平臺(tái)建設(shè)項(xiàng)目（BM2021002）