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

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。

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.