免疫系統(tǒng)是一個復(fù)雜的、涉及多個器官的系統(tǒng)，自身易受年齡、性別、環(huán)境等多個因素的影響，其正常的生理變異較大，因此在臨床前安全性研究中評估藥物所致的免疫毒性是一個巨大的挑戰(zhàn)。目前，免疫系統(tǒng)的組織形態(tài)學(xué)評價是確定免疫毒性公認(rèn)的基石。就免疫系統(tǒng)病理學(xué)評價相關(guān)的指導(dǎo)原則，以及胸腺、脾臟、淋巴結(jié)等重要免疫器官的病理學(xué)評價進(jìn)行簡要論述，以幫助毒性病理學(xué)家準(zhǔn)確和一致性評價免疫系統(tǒng)中預(yù)期的或意外的藥物所致的毒性改變。

The immune system is a complex system involving multiple organs, and it is vulnerable to age, gender, environment and other factors. For a variation normal physiological range, it is a great challenge to evaluate drug-induced immunotoxicity in preclinical safety study. Histomorphologic assessment of the immune system is a recognized cornerstone in the identification of immunotoxicity at present. In this paper, the principles of pathological evaluation for immune system, and pathological evaluation for important immune organs including thymus, spleen, lymph nodes are discussed briefly, so that it is intended to assist toxicity pathologists in the accurate and consistent characterization of intended and unintended drug-induced alterations of the immune system.

國家科技重大專項(xiàng)（2015ZX09501007）；重大新藥創(chuàng)制（2015ZX09501004-002）