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延长释放布普伦诺芬剂量治疗高风险阿片类药物使用的比较:一项随机临床试验
Rajinder Shiwach1, Bernard Le Foll2, Hannu Alho3
1Adams Clinical Research, Desoto, Texas.
JAMA network open
|December 17, 2025
概括
较高剂量的延长释放布伦诺芬 (300毫克) 可能会改善高风险阿片类药物使用患者的治疗结果,特别是那些使用芬太尼的患者. 无论是100毫克还是300毫克的剂量都有效且耐受良好.
科学领域:
- 成 药物 药物 药物 药物
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 高风险的阿片类药物使用,特别是涉及芬太尼,需要有效的治疗策略.
- 延长释放布伦诺芬 (XR-BUP) 是阿片类药物使用障碍 (OUD) 的关键治疗方法.
- 优化XR-BUP剂量对于最大限度地提高治疗疗效和患者留守至关重要.
研究的目的:
- 在高风险OUD患者 (包括芬太尼使用者) 中,比较100毫克对300毫克XR-BUP每月维护剂的疗效和安全性.
- 确定可能受益于更高XR-BUP剂量的潜在子组.
主要方法:
- 一个多中心的,随机的,双盲的临床试验,涉及436名参与者中度至重度OUD.
- 在初始治疗后的8个月内,参与者每月接受100毫克或300毫克的XR-BUP注射.
- 主要终点:参与者在20-38周内实现≥80%阿片类药物戒断的比例.
主要成果:
- 在100毫克 (20.2%) 和300毫克 (23.2%) XR-BUP组之间,整体反应率没有显著差异.
- 在每天使用芬太尼尔 (11.1%的差异) 或频繁使用芬太尼尔 (≥14次/周,12.2%的差异) 的参与者中,300mg剂量显示出明显更好的结果.
- 这两种剂量都耐受良好;注射部位反应在300mg剂量时更频繁.
结论:
- 100mg和300mg的XR-BUP维护剂量对高风险的OUD有效且耐受良好.
- 300毫克的剂量可能为大量使用芬太尼的人提供更好的益处.
- 鉴于强大的合成阿片类药物如芬太尼在北美起,这些发现至关重要.
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