Ohta Etsuko
Global Drug Safety, Eisai Co., Ltd., 5-1-3 Tokodai, Tsukuba-shi, Ibaraki 300-2635, Japan.
J Toxicol Pathol. 2023 Apr;36(2):95-122. doi: 10.1293/tox.2022-0089. Epub 2023 Feb 13.
Nonhuman primates (NHPs), which have many advantages in scientific research and are often the only relevant animals to use in assessing the safety profiles and biological or pharmacological effects of drug candidates, including biologics. In scientific or developmental experiments, the immune systems of animals can be spontaneously compromised possibly due to background infection, experimental procedure-associated stress, poor physical condition, or intended or unintended mechanisms of action of test articles. Under these circumstances, background, incidental, or opportunistic infections can seriously can significantly complicate the interpretation of research results and findings and consequently affect experimental conclusions. Pathologists and toxicologists must understand the clinical manifestations and pathologic features of infectious diseases and the effects of these diseases on animal physiology and experimental results in addition to the spectrum of infectious diseases in healthy NHP colonies. This review provides an overview of the clinical and pathologic characteristics of common viral, bacterial, fungal, and parasitic infectious diseases in NHPs, especially macaque monkeys, as well as methods for definitive diagnosis of these diseases. Opportunistic infections that can occur in the laboratory setting have also been addressed in this review with examples of cases of infection disease manifestation that was observed or influenced during safety assessment studies or under experimental conditions.
非人灵长类动物(NHPs)在科学研究中有许多优势,并且通常是评估候选药物(包括生物制品)的安全性概况以及生物学或药理学效应时唯一适用的相关动物。在科学或开发实验中,动物的免疫系统可能会由于背景感染、实验程序相关的应激、身体状况不佳或受试物有意或无意的作用机制而自发受损。在这些情况下,背景感染、偶发感染或机会性感染会严重使研究结果和发现的解读复杂化,进而影响实验结论。病理学家和毒理学家除了要了解健康非人灵长类动物群体中的传染病谱外,还必须了解传染病的临床表现和病理特征以及这些疾病对动物生理学和实验结果的影响。本综述概述了非人灵长类动物,尤其是猕猴常见的病毒、细菌、真菌和寄生虫感染性疾病的临床和病理特征,以及这些疾病的确切诊断方法。本综述还讨论了在实验室环境中可能发生的机会性感染,并列举了在安全性评估研究或实验条件下观察到或受到影响的感染性疾病表现的案例。