Nature Reviews Gastroenterology & Hepatology ( IF 45.9 ) Pub Date : 2024-06-07 , DOI: 10.1038/s41575-024-00936-x Brian P Lee 1 , Katie Witkiewitz 2 , Jessica Mellinger 3 , Frank A Anania 4 , Ramon Bataller 5 , Thomas G Cotter 6 , Brenda Curtis 7 , Srinivasan Dasarathy 8 , Kelly S DeMartini 9 , Ivan Diamond 10 , Nancy Diazgranados 11 , Andrea F DiMartini 12 , Daniel E Falk 13 , Anne C Fernandez 14 , Margarita N German 15 , Patrick S Kamath 16 , Kelley M Kidwell 17 , Lorenzo Leggio 18 , Raye Litten 19 , Alexandre Louvet 20, 21 , Michael R Lucey 15 , Mary E McCaul 22 , Arun J Sanyal 23 , Ashwani K Singal 24, 25 , Norman L Sussman 26, 27 , Norah A Terrault 1 , Mark R Thursz 28 , Elizabeth C Verna 29 , Svetlana Radaeva 30 , Laura E Nagy 31 , Mack C Mitchell 32
Most patients with alcohol-associated liver disease (ALD) engage in heavy drinking defined as 4 or more drinks per day (56 g) or 8 (112 g) or more drinks per week for women and 5 or more drinks per day (70 g) or 15 (210 g) or more drinks per week for men. Although abstinence from alcohol after diagnosis of ALD improves life expectancy and reduces the risk of decompensation of liver disease, few studies have evaluated whether treatment of alcohol use disorders will reduce progression of liver disease and improve liver-related outcomes. In November 2021, the National Institute of Alcohol Abuse and Alcoholism commissioned a task force that included hepatologists, addiction medicine specialists, statisticians, clinical trialists and members of regulatory agencies to develop recommendations for the design and conduct of clinical trials to evaluate the effect of alcohol use, particularly treatment to reduce or eliminate alcohol use in patients with ALD. The task force conducted extensive reviews of relevant literature on alcohol use disorders and ALD. Findings were presented at one in-person meeting and discussed over the next 16 months to develop the final recommendations. As few clinical trials directly address this topic, the 28 recommendations approved by all members of the task force represent a consensus of expert opinions.
中文翻译:
设计临床试验以解决酒精使用和酒精相关性肝病:专家组共识声明
大多数酒精相关性肝病 (ALD) 患者酗酒,定义为女性每天 4 杯或更多(56 克)或 8 杯(112 克)或更多,男性每天 5 杯或更多(70 克)或 15 杯(210 克)或更多。尽管诊断为 ALD 后戒酒可延长预期寿命并降低肝病失代偿的风险,但很少有研究评估酒精使用障碍的治疗是否会减少肝病进展并改善肝脏相关结局。2021 年 11 月,美国国家酒精滥用和酒精中毒研究所委托了一个工作组,该工作组包括肝病学家、成瘾医学专家、统计学家、临床试验人员和监管机构成员,为设计和实施临床试验提出建议,以评估酒精使用的效果,特别是减少或消除酒精性酒精中毒患者饮酒的治疗。该工作组对有关酒精使用障碍和 ALD 的相关文献进行了广泛的审查。调查结果在一次面对面会议上提出,并在接下来的 16 个月内进行讨论,以制定最终建议。由于很少有临床试验直接涉及该主题,因此工作组所有成员批准的 28 条建议代表了专家意见的共识。