美国威斯康星大学麦迪逊分校Michael C. Fiore团队研究了伐仑克林联合尼古丁贴片和延长治疗时间对戒烟的影响。相关论文发表在2021年10月19日出版的《美国医学会杂志》上。

戒烟药物通常用于医疗保健。研究表明，将伐伦克林与尼古丁贴片联合使用，延长伐伦克林治疗的时间，或两者同时使用，可能会提高戒烟效果。

为了比较伐伦克林加尼古丁贴片或安慰剂，以及联合用药12周（标准用药期）或24周（延长用药期）的戒烟效果，2017年11月11日至2020年7月9日，研究组在威斯康星州麦迪逊市的1个研究诊所和威斯康星州密尔沃基市的1个诊所进行了一项双盲、2 × 2 析因随机临床试验。

在参与研究的5836名成年人中，1251名每天吸烟5支及以上的人接受随机分配，在接受戒烟咨询后随机分为4个药物组，其中315例接受伐伦克林单药治疗12周，314例接受伐伦克林加尼古丁贴片治疗12周，311例接受伐伦克林单药治疗24周，311例接受伐伦克林加尼古丁贴片治疗24周。主要结局为52周时一氧化碳-自我报告的7天点戒断率。

1251例患者的平均年龄为49.1岁，其中675例（54.0%）为女性，751例（60.0%）完成了治疗，881例（70.4%）进行了最终随访。在主要结局方面，用药类型与用药持续时间这两个治疗因素之间无显著交互作用。对于随机分为24周和12周治疗时间的患者，主要结局发生率分别为24.8%和24.3%，差异不显著。对于随机接受伐伦克林联合治疗和伐伦克林单药治疗的患者，主要结局发生率分别为24.3%和24.8%，差异亦不显著。恶心发生率为24.0-30.9%，失眠发生率为24.4-30.5%。

研究结果表明，在每天吸5支烟及以上的成年人中，使用伐伦克林联合尼古丁贴片治疗与使用单独伐伦克林治疗相比，或治疗24周与12周相比，在52周的7天点戒断率方面没有显著差异。这些发现不支持使用联合治疗或延长治疗时间。

附：英文原文

Title: Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial

Author: Timothy B. Baker, Megan E. Piper, Stevens S. Smith, Daniel M. Bolt, James H. Stein, Michael C. Fiore

Issue&Volume: 2021/10/19

Abstract: Importance  Smoking cessation medications are routinely used in health care. Research suggests that combining varenicline with the nicotine patch, extending the duration of varenicline treatment, or both, may increase cessation effectiveness.

Objective  To compare combinations of varenicline plus the nicotine or placebo patch vs combinations used for either 12 weeks (standard duration) or 24 weeks (extended duration).

Design, Settings, and Participants  Double-blind, 2×2 factorial randomized clinical trial conducted from November 11, 2017, to July 9, 2020, at 1 research clinic in Madison, Wisconsin, and at 1 clinic in Milwaukee, Wisconsin. Of the 5836 adults asked to participate in the study, 1251 who smoked 5 cigarettes/d or more were randomized.

Interventions  All participants received cessation counseling and were randomized to 1 of 4 medication groups: varenicline monotherapy for 12 weeks (n=315), varenicline plus nicotine patch for 12 weeks (n=314), varenicline monotherapy for 24 weeks (n=311), or varenicline plus nicotine patch for 24 weeks (n=311).

Main Outcomes and Measures  The primary outcome was carbon monoxide–confirmed self-reported 7-day point prevalence abstinence at 52 weeks.

Results  Among 1251 patients who were randomized (mean [SD] age, 49.1 [11.9] years; 675 [54.0%] women), 751 (60.0%) completed treatment and 881 (70.4%) provided final follow-up. For the primary outcome, there was no significant interaction between the 2 treatment factors of medication type and medication duration (odds ratio [OR], 1.03 [95% CI, 0.91 to 1.17]; P=.66). For patients randomized to 24-week vs 12-week treatment duration, the primary outcome occurred in 24.8% (154/622) vs 24.3% (153/629), respectively (risk difference, 0.4% [95% CI, 5.2% to 4.3%]; OR, 1.01 [95% CI, 0.89 to 1.15]). For patients randomized to varenicline combination therapy vs varenicline monotherapy, the primary outcome occurred in 24.3% (152/625) vs 24.8% (155/626), respectively (risk difference, 0.4% [95% CI, 4.3% to 5.2%]; OR, 0.99 [95% CI, 0.87 to 1.12]). Nausea occurrence ranged from 24.0% to 30.9% and insomnia occurrence ranged from 24.4% to 30.5% across the 4 groups.

Conclusions and Relevance  Among adults smoking 5 cigarettes/d or more, there were no significant differences in 7-day point prevalence abstinence at 52 weeks among those treated with combined varenicline plus nicotine patch therapy vs varenicline monotherapy, or among those treated for 24 weeks vs 12 weeks. These findings do not support the use of combined therapy or of extended treatment duration.

DOI: 10.1001/jama.2021.15333

Source: https://jamanetwork.com/journals/jama/article-abstract/2785264