延长释放纳尔德与布普伦诺芬-纳洛在阿片类药物复发预防方面的比较有效性 (X:BOT):多中心,开放,随机对照试验
Joshua D Lee1, Edward V Nunes2, Patricia Novo3
1Department of Population Health, New York University School of Medicine, New York, NY, USA.
Lancet (London, England)
|November 19, 2017
概括
一旦开始使用,延长释放纳尔德 (XR-NTX) 和布诺芬-纳洛 (BUP-NX) 的安全性和有效性相似. 然而,与BUP-NX相比,XR-NTX的复发率更高,因为患者在治疗开始时遇到困难.
科学领域:
- 药物成
- 药理学
- 比较有效性研究
背景情况:
- 延长释放纳尔德 (XR-NTX) 和布诺芬-纳洛 (BUP-NX) 是不同的阿片类药物预防复发的药物.
- 治疗阿片类药物使用障碍 (OUD) 的目的是减少复发并改善患者的治疗结果.
研究的目的:
- 在OUD患者中比较XR-NTX和BUP-NX的无阿片类复发生存期.
- 评估这两种药物治疗在预防阿片类药物复发方面的有效性和安全性.
主要方法:
- 这是一项为期24周的随机对照试验,涉及570名OUD患者.
- 参与者被随机分配 (1:1) 每月接受XR- NTX注射或每天接受BUP- NX注射.
- 主要结局是没有阿片类药物复发的生存期,而复发是根据阿片类药物使用的特定标准定义的.
主要成果:
- 与BUP-NX (94%) 相比,较少的参与者开始使用XR-NTX (72%) (p<0.0001).
- 在预期治疗群体中,XR- NTX的复发率高于BUP- NX (57%) (HR为1. 36).
- 一旦开始使用,这两种药物的复发率,安全性和有效性在每项方案的人群中都相似.
结论:
- 对XR-NTX的启动挑战对治疗意向群体的整体复发率产生了负面影响.
- 一旦启动,XR-NTX和BUP-NX都是安全和有效的,而BUP-NX在易于启动方面具有优势.
- 未来的研究应该集中在改善XR-NTX诱导和治疗保留的两种药物.
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