美国和欧盟老年群体药物临床研究支持策略的研究  

Strategies to support drug clinical research in older population in the United States and European Union

作　　者：张伊楠 李新辰[1] 吴汀溪 赵志刚[1,2] ZHANG Yi-nan;Li Xin-chen;WU Ting-xi;ZHAO Zhi-gang(Department of Pharmacy,Beijing Tiantan Hospital,Capital Medical University,Beijing 100070,China;Department of Clinical Pharmacy,School of Pharmaceutical Science,Capital Medical University,Beijing 100069,China)

机构地区：[1]首都医科大学附属北京天坛医院药学部,北京100070 [2]首都医科大学药学院临床药学系,北京100069

出　　处：《中国新药杂志》2025年第1期1-5,共5页Chinese Journal of New Drugs

基　　金：中国药品监督管理研究会立项课题资助项目(2023-Y-Y-018)。

摘　　要：我国已进入老龄化社会,老年人口规模日益庞大。老年人的药动学和药效学特征可能与年轻成年人群存在差异,在药物临床研究中获取基于老年群体的证据是老年人合理用药的重要基础。某些发达国家/地区因较早步入老龄化,对老年患者药物临床研究不足的问题关注较早。查阅美国、欧盟药品监督管理部门网站发现,美国和欧盟已形成了一系列指南与报告为老年患者药物临床研究提供建议,要求进入临床试验的患者应该能够合理代表随后将接受该药物治疗的人群。目前我国尚无针对老年群体临床研究的指导原则,可以借鉴其他国家/地区的经验,通过法规、指南等鼓励上市前临床试验纳入老年群体,同时规范加强上市后老年群体研究,以便更好地进行获益-风险评估,促进老年群体合理用药。China has entered an aging society,with an increasingly large elderly population.The pharmacokinetics and pharmacodynamics in older population may differ from those in younger adults.It is a critical foundation for rational drug use in the elderly to obtain evidence based on the older population in drug clinical research.Some developed countries have entered the aging phase earlier,thus have long been attentive to the insufficiencies in drug clinical research for geriatrics.Upon scrutinizing the websites of drug regulatory authorities in the United States and Europe,it appears that these regions have developed a series of guidelines and reports providing recommendations for drug clinical research in older population.They required that patients entering clinical trials should be reasonably representative of the population that will be later treated by the drug.Currently,China lacks specific guidance on clinical research of older population.We could learn from other countries'experience,which involves encouraging pre-marketing clinical trials to include the older population through regulations and guidelines,as well as standardize and strengthen post-marketing studies,so as to better evaluate the drug benefit-risk and promote rational drug use in the geriatric population.

关 键 词：老年人 药物临床研究 支持策略 老龄化 

分 类 号：R95[医药卫生—药学]