抗阿尔茨海默病药物非临床药效学评价体系的探索  

Exploration of nonclinical pharmacodynamics evaluation system of Alzheimer’s disease

作　　者：黄龙舰 赵春阳 冯新红[3] 兰嘉琦[1] 唐婧姝 王庆利 彭英[1] HUANG Long-jian;ZHAO Chun-yang;FENG Xin-hong;LAN Jia-qi;TANG Jing-shu;WANG Qing-li;PENG Ying(Institute of Materia Medica,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100050,China;Center for Drug Evaluation,National Medical Product Administration,Beijing 100022,China;Department of Neurology,Beijing Tsinghua Changgung Hospital,Beijing 102218,China)

机构地区：[1]中国医学科学院、北京协和医学院药物研究所,北京100050 [2]国家药品监督管理局药品审评中心,北京100022 [3]清华大学附属北京清华长庚医院神经内科,北京102218

出　　处：《药学学报》2020年第5期789-805,共17页Acta Pharmaceutica Sinica

基　　金：国家自然科学基金资助项目(81673420);国家“重大新药创制”科技重大专项(2018ZX09711001-003-005,2018ZX09711001-003-009);北京市医院管理局青苗计划专项经费资助(QML20170902);中国医学科学院医学与健康科技创新工程(2017-I2M-2-004)。

摘　　要：阿尔茨海默病(Alzheimer’s disease, AD)是引发老年人痴呆的最常见的神经退行性疾病。目前, AD的发病机制尚不明确,已上市的药物全部为对症治疗药物,无法延缓或逆转疾病的进程,同时在研药物面临严峻的临床转化难题。因此,围绕AD展开新药研发,解决未被满足的临床需求具有重大的社会意义和经济价值。本文结合了近年来国内外抗AD药物的研发进展,主要从动物模型和药效评价指标两个方面对抗AD药物非临床药效学评价体系进行归纳总结,以期为抗AD药物的非临床开发提供参考。Alzheimer’s disease(AD) is the most common neurodegenerative disease that causes dementia among elderly people. The pathogenesis of AD is still unclear, and currently approved drugs only provide symptomatic benefits and do not prevent or delay progressive neurodegeneration. Meanwhile, potential drugs in development are facing great challenges in clinical translation. Therefore, finding effective treatment for the unmet clinical needs of AD is of great economic value and social significance. In this review, we will summarize the current models and pharmacodynamics evaluation methods of anti-AD drug based on the recent studies at home and abroad, and provide reference for drug development in AD at nonclinical stage.

关 键 词：阿尔茨海默病 动物模型 行为学检测 非临床药效学评价体系 新药研发 

分 类 号：R966[医药卫生—药理学]