Kornitzer M, Boutsen M, Dramaix M, Thijs J, Gustavsson G
Laboratory of Epidemiology and Social Medicine, Free University Brussels, Belgium.
Prev Med. 1995 Jan;24(1):41-7. doi: 10.1006/pmed.1995.1006.
Smoking is considered as an addiction to nicotine for most subjects consuming 10 cigarettes or more per day. Hence, nicotine replacement therapy by way of gum, patch, or spray has been advocated. The rationale of this study is to evaluate the possible beneficial effects of adding nicotine gum to the routine of subjects using the nicotine patch. The effect of the nicotine patch against the placebo, both groups receiving placebo nicotine gum, has also been assessed.
Healthy subjects (374) were randomized at their work-setting in a 1-year double-blind placebo-controlled trial: 149 subjects to active nicotine patch + active gum (group 1), 150 to active nicotine patch + placebo gum (group 2), and 75 to placebo patch + gum (group 3). Treatment duration was 12 weeks with a 16-hr transdermal patch of 15 mg, followed by a 6 + 6-weeks weaning period on respectively 10 and 5 mg patches. Gum use was not restricted during the first 6 months, with recommendations to use at least four pieces a day. A strict definition of smoking abstinence was used in this study, which did not allow smoking any cigarette after Week 1. Nonsmoking status at each visit, as reported by the subjects, was verified by CO below 10 ppm in expired air.
Abstinence rates in group 1 against group 2 were 34.2 and 22.7% (P = 0.027) at 12 weeks, 27.5 and 15.3% (P = 0.010) at 24 weeks, and 18.1 and 12.7% (P = 0.191) at 52 weeks. In group 3, abstinence rates were 17.3, 14.7, and 13.3% respectively at 12, 24, and 52 weeks. Using logistic regression with adjustment for six baseline covariates, odds ratios for abstinence (with 95% CI) were computed. For group 1/group 2, OR at 12, 24, and 52 weeks were 1.72 (1.03-2.94) (P = 0.039), 2.04 (1.14-3.57) (P = 0.018), and 1.47 (0.76-2.76) (P = 0.125). No significant differences in OR were observed when comparing groups 2 and 3. Time to relapse is significantly longer in group 1 as compared to that of group 2 (P = 0.041), whereas no significant differences between groups 2 and 3 were observed. No significant differences between the three groups in systemic and local adverse drug events were observed.
Adding active gum use to active patch use in subjects smoking 10 cigarettes or more a day increased abstinence rates, which are statistically significant up to 24 weeks.
对于大多数每天吸食10支或更多香烟的人来说，吸烟被认为是对尼古丁上瘾。因此，有人提倡通过口香糖、贴片或喷雾剂进行尼古丁替代疗法。本研究的目的是评估在使用尼古丁贴片的受试者日常治疗中添加尼古丁口香糖可能产生的有益效果。同时也评估了尼古丁贴片与安慰剂（两组均接受安慰剂尼古丁口香糖）相比的效果。
374名健康受试者在工作场所被随机分配到一项为期1年的双盲安慰剂对照试验中：149名受试者接受活性尼古丁贴片+活性口香糖（第1组），150名接受活性尼古丁贴片+安慰剂口香糖（第2组），75名接受安慰剂贴片+口香糖（第3组）。治疗持续12周，使用15毫克的经皮贴片16小时，随后分别在10毫克和5毫克贴片上进行6+6周的戒断期。在前6个月内，口香糖的使用不受限制，建议每天至少使用4片。本研究采用了严格的戒烟定义，即第1周后不允许吸食任何香烟。受试者报告的每次就诊时的非吸烟状态，通过呼出气体中一氧化碳低于10 ppm进行验证。
第1组与第2组的戒烟率在12周时分别为34.2%和22.7%（P=0.027），24周时为27.5%和15.3%（P=0.010），52周时为18.1%和12.7%（P=0.191）。在第3组中，12周、24周和52周的戒烟率分别为17.3%、14.7%和13.3%。使用逻辑回归并对六个基线协变量进行调整后，计算出戒烟的优势比（及其95%置信区间）。对于第1组/第2组，12周、24周和52周的OR分别为1.72（1.03-2.94）（P=0.039）、2.04（1.14-3.57）（P=0.018）和1.47（0.76-2.76）（P=0.125）。比较第2组和第3组时，未观察到OR有显著差异。与第2组相比，第1组的复发时间明显更长（P=0.041），而第2组和第3组之间未观察到显著差异。三组在全身和局部药物不良事件方面未观察到显著差异。
对于每天吸食10支或更多香烟的受试者，在使用活性贴片的基础上增加活性口香糖的使用可提高戒烟率，在24周内具有统计学意义。
