A randomized, placebo-controlled trial of varenicline, a selective α4β2 nicotinic acetylcholine receptor partial agonist, as a new therapy for smoking cessation in Asian smokers
A randomized, placebo-controlled trial of varenicline, a selective α4β2 nicotinic acetylcholine receptor partial agonist, as a new therapy for smoking cessation in Asian smokers
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DOI：
10.1016/j.clinthera.2007.06.011
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发表时间：
2007-06-01
影响因子：
3.2
通讯作者：
Williams, Kathryn E.
中科院分区：
文献类型：
--
作者：
Tsai, Shih-Tzu;Cho, Hong-Jun;Williams, Kathryn E.
背景：东亚男性的吸烟率从35%到60%不等，女性和年轻人的吸烟率正在上升。目的：本研究评估1mg BID varenicline(一种新型α （4) β(2)烟碱受体部分激动剂）对台湾和韩国吸烟者戒烟的疗效和耐受性。方法：随机、双盲、安慰剂对照，在韩国和台湾各5个试验点进行12周治疗和12周随访试验。符合条件的受试者，吸烟>= 10支/d，接受简短的戒烟咨询，并按1:1的比例随机分配到varenicline 1mg BID（在第一周滴定）或安慰剂。通过自我报告确定吸烟状况，并在临床就诊时通过呼气末一氧化碳= 5%（伐尼克兰组为43.7%，安慰剂组为11.3%）、失眠（15.1%，安慰剂组为13.7%）、食欲增加（7.9%，安慰剂组为6.5%）、便秘（7.1%，安慰剂组为2.4%）、焦虑（5.6%，安慰剂组为2.4%）和异常梦（5.6%，安慰剂组为0.8%）证实吸烟状况。不良事件导致
Background: Rates of smoking in East Asian men range from >35% to >60%, and are increasing in women and the young.Objective: This study evaluated the efficacy and tolerability of 1 mg BID varenicline, a novel alpha(4)beta(2) nicotinic acetylcholine receptor partial agonist, for smoking cessation in smokers in Taiwan and Korea.Methods: A randomized, double-blind, placebo-controlled, 12-week treatment, 12-week follow-up trial was conducted at 5 sites each in Korea and Taiwan. Eligible subjects, smoking >= 10 cigarettes/d, received brief smoking-cessation counseling and were randomly assigned in a 1:1 ratio to varenicline 1 mg BID (titrated during the first week) or placebo. Smoking status was established by self-report and confirmed at clinic visits by end-expiratory carbon monoxide = 5% for varenicline were nausea (43.7% for varenicline vs 11.3% placebo), insomnia (15.1% vs 13.7%), increased appetite (7.9% vs 6.5%), constipation (7.1% vs 2.4%), anxiety (5.6% vs 2.4%), and abnormal dreams (5.6% vs 0.8%). Adverse events resulted in