成年人使用尼古丁电子烟停止吸烟:ORCA-V1随机临床试验
Nancy A Rigotti1, Neal L Benowitz2, Judith J Prochaska3
1Tobacco Research and Treatment Center, Division of General Internal Medicine and the Mongan Institute, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston.
西尼西林有效地帮助成年人戒烟尼古丁,与安慰剂相比,禁欲率更高. 这种基于植物的治疗方法耐受性很好,为尼古丁电子烟戒烟提供了一个有前途的选择.
科学领域:
- 药理学 药理学是指药理学的学科.
- 成 药物 药物 药物 药物
- 临床试验 临床试验
背景情况:
- 美国成年人,特别是年轻人中电子烟使用率不断上升.
- 很难戒掉尼古丁vaping尽管愿意这样做.
- 通过尼古丁酸乙胆受体向,在戒烟方面证明了赛西尼基林的有效性.
研究的目的:
- 评估cytisinicline与安慰剂的疗效和安全性,以实现成年人从电子烟使用中戒断.
- 确定cytisinicline作为一种潜在的药物疗法,用于戒烟.
主要方法:
- 双盲,安慰剂控制的随机临床试验.
- 160名成年人每天吸食尼古丁,并寻求戒烟被随机分配 (2:1) 给cytisinicline (3 mg TID) 或安慰剂12周.
- 提供每周的行为支持;对16周的随访;主要结局:生物化学验证的持续戒断 (9-12周).
主要成果:
- 与安慰剂 (15.1%) 相比,在治疗结束时 (第9-12周,OR,2.64;P=.04周) 中,cytisinicline组实现了显著更高的戒断率 (31.8%).
- 二次结局 (第9至16周) 显示,使用西西尼西克林的禁欲趋势较高 (23.4%对13.2%;P=.15).
- 西尼基林耐受性良好;只有3.8%的患者因不良事件而停止服用.
结论:
- 锡提西尼克林证明了有效性,并且可以很好地容忍帮助成年人在12周内停止使用电子烟,并提供行为支持.
- 为尼古丁电子烟依赖提供了潜在的药物治疗方法.
- 需要在更大规模的试验中进一步证实,随访时间更长.
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