瓦伦尼克林的有效性和安全性在场试验
Jennifer Pearson1, Mitchell A Nides2, Alana Cataldo3
1Department of Health Behavior, Policy, and Administration Sciences, University of Nevada-Reno, Reno, Nevada, USA.
概括
瓦伦尼克林是一种帮助人们戒烟的药物,作为非处方药 (OTC) 选择,显示出了希望. 较高剂量的瓦雷尼克林 (1毫克) 与安慰剂和较低剂量相比,增加了戒断的几率.
科学领域:
- 药理学 药理学是指药理学的学科.
- 公共卫生 公共卫生
- 临床试验 临床试验
背景情况:
- 瓦伦尼克林是一种处方药,已被证明是戒烟的有效药物,与安慰剂相比,戒烟率大约翻了一番.
- 目前,瓦雷尼克林在美国没有处方药 (OTC),这限制了试图戒烟的人的可用性.
研究的目的:
- 评估非处方药 (OTC) 瓦伦尼克林1毫克和0.5毫克剂量用于戒烟的安全性和有效性.
- 在一个随机,双盲,安慰剂对照的研究中,比较OTC瓦伦尼克林与安慰剂的有效性.
主要方法:
- 一项随机,双盲,安慰剂控制的研究,涉及313名参与者在两个美国临床场所.
- 参与者接受了1毫克瓦伦尼克林,0.5毫克瓦伦尼克林或安慰剂12周.
- 通过使用气息一氧化碳和尿液中丁氨酸水平,生物确认戒烟,在COVID-19大流行期间进行了远程参与.
主要成果:
- 从第8周到第12周的持续戒断率之间没有显著差异.
- 与安慰剂 (或3.39) 和0.5毫克瓦雷尼克林 (或2.37) 相比,1毫克瓦雷尼克林在第12周显著增加了点患病率禁欲的几率.
- 副作用通常是轻微的,与已知的副作用一致,包括生动的梦想和恶心.
结论:
- 瓦伦尼克林在1毫克的剂量似乎是安全和有效的戒烟,当作为一个非处方药 (OTC) 药物.
- 这些发现表明,OTC瓦伦尼克林可能是一个可行的选择,可以提高试图戒烟的人的可访问性.
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