采用尼古丁口香糖阶梯戒烟：随机对照试验
2009/05/20
背景：许多吸烟者想通过逐渐减少吸烟量达到完全戒烟的目的。本试验研究尼古丁口香糖在阶梯戒烟中的作用。
设计：本研究为多中心、安慰剂对照，双盲的随机对照研究，采用2和4 mg尼古丁口香糖和安慰剂作为受试药物。
受试人群：对阶梯戒烟感兴趣的3297名吸烟者。
干预：在最长为8周的戒烟期内，受试对象被要求通过增加口香糖的使用来逐渐降低吸烟量。一旦获得初始戒烟（24小时未吸烟），根据FDA批准的戒烟指导给予口香糖。研究在非处方条件下完成，不提供咨询。28天和6个月后对持续性戒烟进行评价。同时评价吸烟量下降的次级指标。对研究的分析在1999～2000年和2007～2008年进行。
检测主要结果：使用含尼古丁口香糖吸烟者更有可能获得初始戒烟（2 mg: OR=1.42; 4 mg: OR=1.90），持续28天的戒烟（2 mg: OR=2.01; 4 mg: OR=4.66）和持续6个月的戒烟（2 mg: OR=1.80; 4 mg: OR=5.96）。在吸烟减少阶段，含尼古丁口香糖能辅助减少吸烟，吸烟减少的参与者更有可能获得戒烟。
结论：上述研究结果显示，想要通过阶梯戒烟的吸烟者可借助尼古丁口香糖减少吸烟和戒烟。
（林江涛 审校）
Shiffman S, et al. Am J Prev Med. 2009 Feb;36(2):96-104.e1
Quitting by gradual smoking reduction using nicotine gum: a randomized controlled trial.
BACKGROUND: Many smokers express a desire to quit smoking by gradually reducing the number of cigarettes they smoke until they stop completely. This study tested the efficacy of nicotine gum in facilitating cessation through gradual reduction.
DESIGN: This was a multi-center, placebo-controlled, double-blind RCT of 2- and 4-mg nicotine gum versus placebo.
SETTING/PARTICIPANTS: 3297 smokers who were interested in quitting gradually.
INTERVENTION: Subjects were instructed to gradually reduce their smoking while increasing their gum use over the course of up to 8 weeks. Once they had achieved initial abstinence (no smoking for 24 hours), gum was to be used in accordance with the current FDA-approved directions for cessation. The study was conducted under over-the-counter conditions, with no counseling provided. Continuous abstinence was assessed after 28 days and 6 months. Secondary measures of smoking reduction were also assessed. Analyses were conducted in 1999-2000 and 2007-2008.
MAIN OUTCOME MEASURES: Smokers on active gum were significantly more likely to achieve initial cessation (2 mg: OR=1.42; 4 mg: OR=1.90); 28-day continuous abstinence (2 mg: OR=2.01; 4 mg: OR=4.66); and continuous abstinence at 6 months (2 mg: OR=1.80; 4 mg: OR=5.96). During the reduction phase, active gum aided smoking reduction, and participants who reduced their smoking were more likely to achieve abstinence.
CONCLUSIONS: These findings demonstrate that smokers who wish to quit smoking by gradual reduction can increase their success by using nicotine gum to facilitate reduction and cessation.
