■伐尼克兰是戒烟最有效的唯一药物疗法。如果与尼古丁替代疗法(NRT)联合使用,戒烟率可能会进一步提高,但联合用药的疗效和安全性尚需评估.
■研究与单纯使用伐尼克林治疗的住院吸烟者相比,使用伐尼克林和NRT锭剂治疗的住院吸烟者是否获得了更高的长期戒烟率。
■双盲,安慰剂对照随机对照临床试验是在5家澳大利亚公立医院的成人内科或外科住院患者中进行的,这些患者有每天吸烟10支或更多的历史,有兴趣退出,并可在2019年5月1日至2021年5月1日期间进行12个月的随访(2022年5月的最终12个月数据收集)。数据分析于2023年6月1日至8月30日进行。
■所有参与者在住院期间以标准剂量开始了为期12周的伐尼克兰方案。如果有吸烟的冲动,参与者被随机分配使用NRT(2mg)或安慰剂锭剂。向所有参与者提供行为支持(Quitline)。
■主要结果是在6个月时经过生化验证的持续禁欲。次要结果包括自我报告的长时间禁欲,7天点患病率禁欲(3、6和12个月),和药物相关的不良事件。
■总共320名参与者(平均[SD]年龄,52.5[12.1]岁;183[57.2%]男性)被随机分组。生化验证的进行受到COVID-19限制的影响;因此,干预措施与对照组的生化验证禁欲(18[11.4%]对16[10.1%];比值比[OR],1.14;95%CI,0.56-2.33)不支持联合治疗。干预措施与对照组的次要结局为6个月时7天点的禁欲(54[34.2%]vs37[23.4%];或,1.71;95%CI,1.04-2.80),12个月时长期禁欲(47[29.9%]对30[19.1%];或,1.77;95%CI,1.05-3.00),和12个月时的7天点患病率禁欲(48[30.6%]vs31[19.7%];或,1.79;95%CI,1.07-2.99)在联合治疗下显着改善。自我报告的6个月延长禁欲(61[38.6%]对47[29.7%];或,1.49;95%CI,0.93-2.39)支持联合治疗,但无统计学意义。两组药物相关不良事件相似(干预组102例[74.5%],对照组86例[68.3%])。
■在这项针对住院成年每日吸烟者的伐尼克林和NRT锭剂组合的随机临床试验中,与单用伐尼克兰相比,联合治疗改善了自我报告的禁欲,在不损害安全的情况下,但它并没有改善生物化学验证的禁欲。
■anzctr.org.AU标识符:ACTRN12618001792213。
UNASSIGNED: Varenicline is the most effective sole pharmacotherapy for smoking cessation. If used in combination with nicotine replacement therapy (NRT), cessation rates may be further improved, but the efficacy and safety of the combination need to be evaluated.
UNASSIGNED: To examine whether hospitalized smokers treated with varenicline and NRT lozenges achieve higher prolonged smoking abstinence rates compared with those treated with varenicline alone.
UNASSIGNED: A double-blind, placebo-controlled randomized clinical trial was conducted in adult medical or surgical inpatients of 5 Australian public hospitals with a history of smoking 10 cigarettes or more per day, interested in quitting, and available for 12-month follow-up between May 1, 2019, and May 1, 2021 (final 12-month data collection in May 2022). Data analysis was performed from June 1 to August 30, 2023.
UNASSIGNED: A 12-week varenicline regimen was initiated during hospitalization at standard doses in all participants. Participants were randomized to additionally use NRT (2 mg) or placebo lozenges if there was an urge to smoke. Behavioral support (Quitline) was offered to all participants.
UNASSIGNED: The primary outcome was biochemically verified sustained abstinence at 6 months. Secondary outcomes included self-reported prolonged abstinence, 7-day point prevalence abstinence (3, 6, and 12 months), and medicine-related adverse events.
UNASSIGNED: A total of 320 participants (mean [SD] age, 52.5 [12.1] years; 183 [57.2%] male) were randomized. The conduct of biochemical verification was affected by COVID-19 restrictions; consequently, the biochemically verified abstinence in the intervention vs control arms (18 [11.4%] vs 16 [10.1%]; odds ratio [OR], 1.14; 95% CI, 0.56-2.33) did not support the combination therapy. The secondary outcomes in the intervention vs control arms of 7-day point prevalence abstinence at 6 months (54 [34.2%] vs 37 [23.4%]; OR, 1.71; 95% CI, 1.04-2.80), prolonged abstinence at 12 months (47 [29.9%] vs 30 [19.1%]; OR, 1.77; 95% CI, 1.05-3.00), and 7-day point prevalence abstinence at 12-months (48 [30.6%] vs 31 [19.7%]; OR, 1.79; 95% CI, 1.07-2.99) significantly improved with the combination therapy. The self-reported 6-month prolonged abstinence (61 [38.6%] vs 47 [29.7%]; OR, 1.49; 95% CI, 0.93-2.39) favored the combination therapy but was not statistically significant. Medicine-related adverse events were similar in the 2 groups (102 [74.5%] in the intervention group vs 86 [68.3%] in the control group).
UNASSIGNED: In this randomized clinical trial of the combination of varenicline and NRT lozenges in hospitalized adult daily smokers, the combination treatment improved self-reported abstinence compared with varenicline alone, without compromising safety, but it did not improve biochemically validated abstinence.
UNASSIGNED: anzctr.org.au Identifier: ACTRN12618001792213.