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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。
Alcohol abuse is a serious public health problem worldwide. The current treatment of alcohol drugs less and curative effect is limited, the urgent need to develop new therapies and medicines. The United States Food and Drug Administration (FDA) released in February 2015 the guiding principles (draft) on the clinical research on the treatment of alcohol abuse drugs, which mainly introduced the general requirements for the clinical research on such drugs and the requirements on the pharmacodynamics research. The trial, which lasted for 6 months, took the primary endpoint as the proportion of patients who did not drink any alcohol during the observation period (percentage of days without alcoholism). The main content of the guiding principle is introduced, and it is hoped that it will be helpful for the research and registration review of such drugs in our country.