对AUD的药物开发:对临床试验方法的系统审查
S Donato1, L R Meredith1, S J Nieto1
1Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA.
Alcohol (Fayetteville, N.Y.)
|July 7, 2024
概括
这一系统性审查审查了40年的酒精使用障碍 (AUD) 药物的临床试验. 方法实践得到了改进,随着时间的推移,女性入学率增加,数据报告更好.
科学领域:
- 临床药理学 临床药理学
- 精神病学是一个精神病学.
- 生物统计学 生物统计学
背景情况:
- 临床试验方法显著影响酒精使用障碍 (AUD) 的治疗疗效.
- 标准化实践对于最大限度地提高随机临床试验 (RCT) 的效率至关重要.
- 了解AUD临床试验的方法趋势对于未来的研究和治疗开发至关重要.
研究的目的:
- 在过去的40年中,系统地审查和描述酒精使用障碍 (AUD) 药物临床试验的方法实践.
- 为了确定研究设计的趋势,参与者人口统计,治疗持续时间,随访期和结果报告.
- 提供关于AUD临床试验的当前文献的全面摘要.
主要方法:
- 使用PubMed对2018年7月至2023年4月期间发表的AUD药物的RCT进行了系统的文献搜索,并与1985年至2018年的之前搜索相结合.
- 包括标准包括:随机对照试验,双盲或单盲,安慰剂或活性对照,使用酒精作为主要终点,治疗持续时间为4周以上,随访时间为12周以上.
- 从代表19种药物的139个RCT中提取和总结了方法数据.
主要成果:
- 纳尔特雷克松 (42项试验),阿坎普罗沙特 (24项试验) 和巴克洛芬 (11项试验) 是研究的最常见药物.
- 参与者主要是男性 (74%),随机化前的每月酒精消费量为226杯.
- 平均治疗持续时间为12周,平均随访时间为12.5周. 大多数研究 (63%) 报告了戒酒和大量饮酒的结果.
结论:
- 在过去的四十年中,AUD的临床试验报告得到了改进,特别是在女性入学和种族/种族数据方面.
- 需要试验前禁欲的研究减少了.
- 本综述综合了关键的方法特征和效果大小,为AUD临床试验研究的演变提供了见解.
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