生物胺系统抗抑郁药物依赖性评价研究进展

doi:10.19803/j.1672-8629.2022.01.26

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (1): 113-116.
DOI: 10.19803/j.1672-8629.2022.01.26

• 综述 • 上一篇

生物胺系统抗抑郁药物依赖性评价研究进展

陈瑛^1,2, 李亮^3,△, 吉文岳^1,2, 吴纯启⁴, 董延生^1,2,*

¹北京赛赋医药研究院有限公司,北京 101102;
²国科赛赋河北医药技术有限公司,河北廊坊 065500;
³解放军总医院第六医学中心麻醉科,北京 100036;
⁴国家北京药物安全评价研究中心,北京100850

收稿日期:2020-11-04 出版日期:2022-01-15 发布日期:2022-01-20
通讯作者: ^*董延生,男,博士,副研究员,新药安全评价。E-mail：dongyansheng@safeglp.com
作者简介:陈瑛,女,硕士,实验师,新药非临床依赖性评价。^△为并列第一作者。
基金资助:
重大新药创制国家科技重大专项2018年度（2018ZX09201017-003）

Research progress in dependence potential evaluation of antidepressants of biogenic amines

CHEN Ying^1,2, LI Liang^3,△, JI Wenyue^1,2, Wu Chunqi⁴, Dong Yansheng^1,2,*

¹Beijing Safe Medical Research Institute Co., Ltd., Beijing 101102, China;
²Safe Medical Technology Co., Ltd., Langfang Hebei 065500, China;
³Department of Anesthesiology, the Sixth Medical Center of PLA General Hospital, Beijing 100036, China;
⁴National Beijing Center for Drug Safety Evaluation and Research, Beijing 100850, China

Received:2020-11-04 Online:2022-01-15 Published:2022-01-20

摘要/Abstract

摘要： 生物胺系统抗抑郁药物呈现出良好的经济效益和开发前景,近年来针对5-羟色胺（5-HT）/去甲肾上腺素（NE）/多巴胺（DA）三重靶点再摄取抑制作用的抗抑郁药物研发得到快速发展,但其可能伴随的副作用─滥用与成瘾,已成为世界公共卫生领域的严重问题。美国食品药品监督管理局（FDA）、欧洲药品管理局（EMA）和我国国家药品监督管理局（NMPA）发布的药物依赖性评价指导原则均要求对此类药物进行非临床依赖性评价,旨在对药物的依赖性潜力进行有效评估,指导临床合理安全用药。本文通过文献研究,讨论了生物胺系统抗抑郁药物及其依赖性评价的研究现状、存在问题以及前景展望。建议借鉴FDA及EMA经验,加强我国对生物胺系统抗抑郁药物非临床依赖性评价平台的投入及相关政策法规体系的建设。

关键词: 生物胺, 抗抑郁药物, 依赖性评价

Abstract: Antidepressants of biogenic amines promised good economic benefits and prospects of development. In recent years, the research and development of antidepressants targeting the reuptake inhibitory effect of the 5-HT/NE/DA triple targets has been accelerated. However, abuse and addiction as possible side effects have become a public health concern globally. Drug dependence evaluation guidelines issued by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and China's National Medical Products Administration (NMPA) all require non-clinical dependence potential evaluation of such drugs for the purpose of evaluating the dependence potential of these drugs effectively and guide clinical use. Through literature research, the status quo, existing problems and prospects of research on antidepressants of biogenic amines and evaluation of their dependence potential were studied. It is recommended that China learn from the experience of FDA and EMA to step up investment in the non-clinical dependence evaluation platform of antidepressants of biogenic amines and update related policies and regulations.

Key words: biogenic amines, antidepressant, dependence potential evaluation

中图分类号:

R964

陈瑛, 李亮, 吉文岳, 吴纯启, 董延生. 生物胺系统抗抑郁药物依赖性评价研究进展[J]. 中国药物警戒, 2022, 19(1): 113-116.

CHEN Ying, LI Liang, JI Wenyue, Wu Chunqi, Dong Yansheng. Research progress in dependence potential evaluation of antidepressants of biogenic amines[J]. Chinese Journal of Pharmacovigilance, 2022, 19(1): 113-116.

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生物胺系统抗抑郁药物依赖性评价研究进展

Research progress in dependence potential evaluation of antidepressants of biogenic amines

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