长期低剂量丹塞的安全性和合规性,用于治疗酒精使用障碍
Giovanni Addolorato1, Hannu Alho2, Paula Bresciani M De Andrade3
1Department of Medical and Surgical Sciences, Università Cattolica di Roma, Rome, Italy; Internal Medicine and Alcohol Related Disease Unit, Columbus-Gemelli Hospital, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
低剂量丹塞 (AD04) 在酒精使用障碍 (AUD) 患者中没有显示出任何不良肝脏影响. 这表明AD04可能是AUD和与酒精有关的肝病 (ALD) 的安全治疗选择.
科学领域:
- 肝病学 肝病学是一种肝病学.
- 药理学 药理学是指药理学的学科.
- 精神病学是一个精神病学.
背景情况:
- 酒精使用障碍 (AUD) 和与酒精相关的肝病 (ALD) 的患病率不断增加,需要有效的管理策略.
- 低剂量的丹塞 (AD04),一种5-HT3抗剂,在特定的基因型特征中显示出AUD的前景.
- 在AUD患者中,AD04的肝脏安全性尚未先前确立.
研究的目的:
- 在患有AUD的受试者中,与安慰剂相比,评估低剂量AD04的肝脏安全性.
- 评估AD04对AUD患者肝脏主要生物化学参数的影响.
主要方法:
- 第三阶段随机对照试验涉及具有5标志物遗传特征的AUD受试者.
- 低剂量AD04 (0.33毫克每天两次) 或安慰剂的使用,以及心理咨询.
- 肝酶 (ALT,AST,GGT),胆红素,MCV和前列血在基线和第12和第24周的评估.
主要成果:
- 低剂量的AD04并没有显著改变肝损伤标志物,如ALT,AST和血清胆红素.
- 在AUD患者中,高GGT水平仍然不受AD04治疗的影响.
- 在口服低剂量AD04中没有报告显著的不良反应.
结论:
- 低剂量AD04在AUD患者中显示出有利的肝脏安全概况.
- AD04有可能成为AUD和ALD同时发生的个体的安全治疗选择.
- 进一步的随机对照试验 (RCT) 是有必要的,以确认AUD和ALD组合的疗效和指导精确治疗.
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