瓦雷尼克林和布洛普里昂SR组合用于吸烟者的烟草依赖治疗:一项随机试验
Jon O Ebbert1, Dorothy K Hatsukami2, Ivana T Croghan1
1Nicotine Dependence Center, Mayo Clinic, Rochester, Minnesota.
JAMA
|January 9, 2014
概括
与单独使用瓦雷尼克林相比,联合使用瓦雷尼克林和布罗 (组合疗法) 在12周和26周改善了长期戒烟. 然而,这种组合疗法在任何时间点都没有显著增加7天禁欲的流行率.
科学领域:
- 药理学和成医学 药理学和成医学
- 临床试验研究 临床试验研究
- 烟草依赖治疗 烟草依赖治疗
背景情况:
- 结合药物治疗来治疗烟草成是一种增加戒烟率的潜在策略.
- 瓦伦尼克林和布洛普持续释放 (SR) 是常用的戒烟辅助剂.
研究的目的:
- 为了评估瓦雷尼克林与布普罗SR结合的疗效和安全性,而不是瓦雷尼克林单疗法,用于成人吸烟者戒烟.
- 为了比较长期和7天点流行吸烟戒断率在组合治疗和瓦雷尼克林单一治疗之间.
主要方法:
- 一个随机的,盲目的,安慰剂控制的多中心临床试验,涉及506名成年吸烟者.
- 参与者接受了为期12周的瓦伦尼克林加布罗SR或瓦伦尼克林加安慰剂.
- 主要结局包括生物化学证实长期和7天的点流行性禁欲率在12周,随访52周.
主要成果:
- 在12周后,组合疗法显示较长时间的戒断 (53.0%对43.2%,P=.03) 较高,但与瓦伦尼克林单独治疗相比,没有7天点流行率 (56.2%对48.6%,P=.09).
- 在26周观察到类似的趋势,在组合治疗中长期戒断显著增加 (36.6%对27.6%,P=.03).
- 在52周,在长期或7天的点患病率禁欲中没有发现群体之间的显著差异. 组合疗法与焦虑和抑郁症状的增加有关.
结论:
- 与瓦雷尼克林和布洛普里昂SR的联合治疗与瓦雷尼克林单独治疗相比,在12周和26周增加了长期戒烟.
- 组合疗法在12周或26周没有显著改善7天的禁欲流行点,在52周也没有显著差异.
- 需要进一步的研究来确定组合治疗在长期戒烟中的作用,考虑到不良心理症状的潜在增加.
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