酗酒是世界范圍內(nèi)嚴(yán)重的公共衛(wèi)生問題。目前治療酗酒藥物少而且療效有限,亟待開發(fā)新的療法與藥品。美國(guó)食品藥品管理局(FDA)于2015 年2 月發(fā)布了有關(guān)治療酗酒藥物臨床研究的指導(dǎo)原則(草案),主要介紹了對(duì)這類藥物臨床研究的一般要求和對(duì)藥效學(xué)研究的要求,建議采取持續(xù)6 個(gè)月的試驗(yàn),并以在觀察期間沒有任何酗酒天數(shù)患者的比例(無(wú)酗酒天數(shù)的百分率)為主要終點(diǎn)。介紹該指導(dǎo)原則的主要內(nèi)容,希望對(duì)我國(guó)這類藥物的研究和注冊(cè)審評(píng)有所幫助。

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.