烟碱与野靛碱用于戒烟的效果比较。

Cytisine versus nicotine for smoking cessation.

机构信息

From the National Institute for Health Innovation (N.W., C.H., V.P., C.B.), the Centre for Tobacco Control Research, Department of Social and Community Health (M.G.), the Department of Pacific Health (V.N.) and the School of Population Health and the School of Pharmacy (J.B.), University of Auckland, Auckland, and the Quit Group, Wellington (B.B.) - all in New Zealand; and Queen Mary University of London, Wolfson Institute of Preventive Medicine, and UK Centre for Tobacco and Alcohol Studies, Barts and the London School of Medicine and Dentistry - all in London (H.M.).

出版信息

N Engl J Med. 2014 Dec 18;371(25):2353-62. doi: 10.1056/NEJMoa1407764.

DOI:10.1056/NEJMoa1407764

PMID:25517706

Abstract

BACKGROUND

Placebo-controlled trials indicate that cytisine, a partial agonist that binds the nicotinic acetylcholine receptor and is used for smoking cessation, almost doubles the chances of quitting at 6 months. We investigated whether cytisine was at least as effective as nicotine-replacement therapy in helping smokers to quit.

METHODS

We conducted a pragmatic, open-label, noninferiority trial in New Zealand in which 1310 adult daily smokers who were motivated to quit and called the national quitline were randomly assigned in a 1:1 ratio to receive cytisine for 25 days or nicotine-replacement therapy for 8 weeks. Cytisine was provided by mail, free of charge, and nicotine-replacement therapy was provided through vouchers for low-cost patches along with gum or lozenges. Low-intensity, telephone-delivered behavioral support was provided to both groups through the quitline. The primary outcome was self-reported continuous abstinence at 1 month.

RESULTS

At 1 month, continuous abstinence from smoking was reported for 40% of participants receiving cytisine (264 of 655) and 31% of participants receiving nicotine-replacement therapy (203 of 655), for a difference of 9.3 percentage points (95% confidence interval, 4.2 to 14.5). The effectiveness of cytisine for continuous abstinence was superior to that of nicotine-replacement therapy at 1 week, 2 months, and 6 months. In a prespecified subgroup analysis of the primary outcome, cytisine was superior to nicotine-replacement therapy among women and noninferior among men. Self-reported adverse events over 6 months occurred more frequently in the cytisine group (288 events among 204 participants) than in the group receiving nicotine-replacement therapy (174 events among 134 participants); adverse events were primarily nausea and vomiting and sleep disorders.

CONCLUSIONS

When combined with brief behavioral support, cytisine was found to be superior to nicotine-replacement therapy in helping smokers quit smoking, but it was associated with a higher frequency of self-reported adverse events. (Funded by the Health Research Council of New Zealand; Australian New Zealand Clinical Trials Registry number, ACTRN12610000590066.).

摘要

背景

安慰剂对照试验表明，烟碱乙酰胆碱受体部分激动剂 cytisine 可用于戒烟，能将戒烟者在 6 个月时的戒烟成功率提高近一倍。我们研究了 cytisine 是否在帮助吸烟者戒烟方面至少与尼古丁替代疗法一样有效。

方法

我们在新西兰开展了一项实用、开放标签、非劣效性试验，共纳入 1310 名有戒烟意愿并拨打全国戒烟热线的成年每日吸烟者，将他们以 1:1 的比例随机分配，接受 cytisine 治疗 25 天或尼古丁替代疗法治疗 8 周。cytisine 通过邮件免费提供，尼古丁替代疗法通过提供低成本贴片的代金券以及口香糖或含片提供。两组均通过戒烟热线获得低强度的电话式行为支持。主要结局是 1 个月时自我报告的持续戒烟。

结果

在 1 个月时，接受 cytisine 治疗的参与者中有 40%（655 例中有 264 例）和接受尼古丁替代疗法治疗的参与者中有 31%（655 例中有 203 例）报告持续戒烟，差异为 9.3 个百分点（95%置信区间，4.2 至 14.5）。cytisine 在第 1 周、第 2 个月和第 6 个月时的持续戒烟效果均优于尼古丁替代疗法。在主要结局的预先指定亚组分析中，cytisine 在女性中的疗效优于尼古丁替代疗法，而在男性中的疗效则不劣于尼古丁替代疗法。在 cytisine 组（204 名参与者中有 288 例）中，6 个月时报告的自我报告不良事件比在接受尼古丁替代疗法组（134 名参与者中有 174 例）更常见；不良事件主要为恶心和呕吐以及睡眠障碍。