[关键词]
[摘要]
酗酒是世界范围内严重的公共卫生问题。目前治疗酗酒药物少而且疗效有限,亟待开发新的疗法与药品。美国食品药品管理局(FDA)于2015 年2 月发布了有关治疗酗酒药物临床研究的指导原则(草案),主要介绍了对这类药物临床研究的一般要求和对药效学研究的要求,建议采取持续6 个月的试验,并以在观察期间没有任何酗酒天数患者的比例(无酗酒天数的百分率)为主要终点。介绍该指导原则的主要内容,希望对我国这类药物的研究和注册审评有所帮助。
[Key word]
[Abstract]
Alcoholism is a major public health problem in the world. The drug for the treatment of alcoholism is little, the efficacy is limited at present, and the development is urgent. FDA issued Alcoholism: Developing Drugs for Treatment Guidance for Industry (Draft) in February 2015. The general considerations and specific efficacy trial considerations for development program are described. FDA's current recommendation is for trials of 6 months, with a primary endpoint of the proportion of patients who do not have any heavy drinking days during the observation period (percent no heavy drinking days). This paper introduces the main contents of this guidance. It is hoped to be helpful for the research and the evaluation for registration of this kind of drug in our country.
[中图分类号]
[基金项目]