免疫系统是一个复杂的、涉及多个器官的系统，自身易受年龄、性别、环境等多个因素的影响，其正常的生理变异较大，因此在临床前安全性研究中评估药物所致的免疫毒性是一个巨大的挑战。目前，免疫系统的组织形态学评价是确定免疫毒性公认的基石。就免疫系统病理学评价相关的指导原则，以及胸腺、脾脏、淋巴结等重要免疫器官的病理学评价进行简要论述，以帮助毒性病理学家准确和一致性评价免疫系统中预期的或意外的药物所致的毒性改变。

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.

国家科技重大专项（2015ZX09501007）；重大新药创制（2015ZX09501004-002）