风疹病毒减毒活疫苗猴体神经毒力试验  

Neurovirulence test of attenuated live rubella vaccine in rhesus

作　　者：葛鹏[1] 兰天龙[1] 石慧颖 李小唤 胡雷[1] 周博宇[1] 徐德璐 刘艳菊[1] 任红梅 GE Peng LAN Tian-long SHI Hui-yingz LI Xiao-huan HU Lei ZHOU Bo-yu XU De-lul LIU Yan-ju REN Hong-mei(Tianjin Institute of Pharmaceutical Research New Drug Evaluation Co. Ltd., Tianjin 300301, China Bioroc Pharmaceutical ＆ Biotech Co. Ltd., Tianjin 300308, China)

机构地区：[1]天津药物研究院新药评价有限公司,天津300301 [2]天津百若克医药生物技术有限责任公司,天津300308

出　　处：《药物评价研究》2016年第5期781-785,共5页Drug Evaluation Research

基　　金：天津创新药物安全评价技术平台基金资助项目(2013ZX09302301)

摘　　要：目的评价风疹病毒减毒活疫苗的潜在神经毒力。方法普通级恒河猴随机分为2组,风疹病毒减毒活疫苗组10只,对照组2只,采用猴脑定位的方法将风疹病毒减毒活疫苗接种于猴两侧丘脑,对照组接种等体积生理盐水;检测血清抗体效价;并观察动物是否产生抽搐、癫痫、共济失调、震颤等神经毒力症状,以及风疹病毒减毒活疫苗对一般体征、饮食、体温的影响;风疹病毒减毒活疫苗组疫苗接种后20 d、对照组接种后31 d进行脑部及脊髓大体解剖和组织病理学检查,以评价该疫苗的神经毒力。结果猴丘脑注射疫苗后,风疹病毒减毒活疫苗组动物血清抗体效价呈阳性,免疫应答较好,对照组均呈阴性;动物未出现情绪激怒、呕吐、颈强直、抽风惊厥等神经毒力症状;动物外观、行为活动、饮食情况、体温等各方面均未见明显异常;组织病理学检查未见药物引起脑及脊髓的明显病理学改变。结论风疹病毒减毒活疫苗在猴体中不具有神经毒力。Objective To evaluate the potential neurovirulence of attenuated live rubella vaccine. Methods Rhesus were randomly divided into two groups, 10 in rubella virus vaccine group, 2 in the control group. Rhesus bilateral thalamus were inoculated with attenuated live rubella vaccine via brain localization operation, rhesus in control group were inoculated with the same volume of normal saline. Neurovirulence symptoms, such as convulsion, epilepsy, incoordination, tremor, and general physical signs, food consumption, temperature were observed, and the antibody levels of them were detected. Animals were sacrificed for gross anatomy and histopathology of brain and spinal cord. Results Serum antibody titer was positive in vaccine treated group with a well immune response and negative in control group. Abnormal change of neurotoxic symptoms such as emotion infuriation, vomiting, neck stiffness, convulsion and physical appearance, behavior, food consumption, temperature and gross anatomy, histopathology of brain and spinal cord were not observed. Conclusion Attenuated live rubella vaccine has no neurovirulence on rhesus.

关 键 词：风疹病毒减毒活疫苗 猴 神经毒力 丘脑给药 组织病理学 

分 类 号：R965[医药卫生—药理学]