设计临床试验以解决酒精使用和酒精相关的肝病:专家小组 协商一致声明
Brian P Lee1, Katie Witkiewitz2, Jessica Mellinger3
1Division of Gastroenterology and Liver Diseases, University of Southern California Keck School of Medicine and Institute for Addiction Science, University of Southern California, Los Angeles, CA, USA.
Nature reviews. Gastroenterology & hepatology
|June 7, 2024
概括
在患有酒精相关性肝病 (ALD) 的患者中,治疗酒精使用障碍至关重要. 专家建议侧重于临床试验设计,以评估减少酒精摄入量是否改善肝脏结果.
科学领域:
- 肝病学 肝病学是一种肝病学.
- 成 药物 药物 药物 药物
- 临床试验设计 临床试验设计
背景情况:
- 与酒精相关的肝病 (ALD) 影响了许多有大量饮酒模式的患者.
- 虽然戒酒改善了结果,但酒精使用障碍 (AUD) 治疗对肝病进展的影响还未得到充分研究.
- 强度饮酒是由男性和女性的具体每日和每周消费门来定义的.
研究的目的:
- 为临床试验制定建议,评估减少或消除ALD患者饮酒的效果.
- 引导研究AUD治疗对肝病进展和结果的影响.
主要方法:
- 一个由专家 (肝病学家,成专家,统计学家,试验人员,监管机构) 组成的特别工作组于2021年11月由国家酒精滥用和酒研究所召开.
- 对AUD和ALD进行了广泛的文献审查.
- 调查结果在16个月内进行了讨论,最终形成了基于共识的建议.
主要成果:
- 该工作组为设计和进行ALD临床试验制定了28项建议.
- 这些建议涉及评估减少饮酒对肝病进展的影响.
- 由于有限的直接临床试验数据,这些建议代表了专家意见的共识.
结论:
- 需要进行强大的临床试验,以调查AUD治疗ALD的好处.
- 开发的建议为这个关键领域的未来研究提供了一个框架.
- 专家的共识强调了解决酒精使用在ALD管理中的重要性.
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