Davidson M, Epstein M, Burt R, Schaefer C, Whitworth G, McDonald A
Chicago Center for Clinical Research, Ill 60610-4324, USA.
Arch Fam Med. 1998 Nov-Dec;7(6):569-74. doi: 10.1001/archfami.7.6.569.
To evaluate the efficacy and safety of a transdermal nicotine patch as an aid for smoking cessation in an over-the-counter setting.
Multicenter, double-blind, randomized, placebo-controlled trial of 6-week duration with 18 weeks of follow-up.
Four shopping mall precincts.
The randomized sample consisted of 802 adults (mean age, 39 years) and was 89% white and 54% female. A smoking history of at least 20 cigarettes per day for 1 year and a score of 5 (on a 10-point scale) on a motivational assessment questionnaire were required for enrollment. Poststudy follow-up was limited to those who had quit smoking at the end of 6 weeks.
Nicotine patches were provided at the shopping mall. Guidance consisted only of package instructions and a smoking cessation self-help booklet.
Quit rates were defined as total abstinence from smoking for 4 consecutive weeks (treatment weeks 3-6), point prevalence smoking status at week 6, or nonsmoker at week 6 and week 24 (6-month postquit date). Smoking status was assessed by diaries, and verification for the first 2 quit rates was obtained by confirmation of carbon monoxide of 8 ppm or less in expired breath. Safety was evaluated by self-reported adverse events.
Quit rate was 12% for the active treatment group and 5.5% for the placebo group, based on total abstinence for 4 consecutive weeks (P = .001) compared with quit rates of 19.5% and 7.5% for active treatment and placebo groups, respectively, based on point prevalence data at week 6. At 24 weeks, 8.2% of nonsmokers in the active treatment group and 4.0% in the placebo group remained nonsmokers. At least 1 adverse event was reported by 57% receiving the nicotine patch and 39% receiving placebo (P<.001).
When the nicotine patch was used in an over-the-counter setting, quit rates were comparable to those reported for medical settings. A 2:1 quit rate advantage was achieved at week 6 and was maintained at 24 weeks.
评估非处方环境下经皮尼古丁贴片辅助戒烟的有效性和安全性。
为期6周、随访18周的多中心、双盲、随机、安慰剂对照试验。
四个购物中心区域。
随机样本包括802名成年人（平均年龄39岁），其中89%为白人，54%为女性。入组要求有每天至少吸20支烟达1年的吸烟史，且在动机评估问卷上的得分（满分10分）为5分。研究后的随访仅限于在6周结束时已戒烟的人。
在购物中心提供尼古丁贴片。指导仅包括包装说明和一本戒烟自助手册。
戒烟率定义为连续4周完全戒烟（治疗第3 - 6周）、第6周的时点患病率吸烟状态，或第6周和第24周（戒烟后6个月日期）为非吸烟者。吸烟状态通过日记评估，前两个戒烟率的验证通过确认呼出气体中一氧化碳含量在8 ppm或以下来获得。安全性通过自我报告的不良事件进行评估。
基于连续4周完全戒烟，活性治疗组的戒烟率为12%，安慰剂组为5.5%（P = 0.001）；基于第6周的时点患病率数据，活性治疗组和安慰剂组的戒烟率分别为19.5%和7.5%。在24周时，活性治疗组8.2%的非吸烟者和安慰剂组4.0%的非吸烟者仍为非吸烟者。接受尼古丁贴片的人中57%报告了至少1次不良事件，接受安慰剂的人中这一比例为39%（P<0.001）。
当在非处方环境下使用尼古丁贴片时，戒烟率与医疗环境中报告的戒烟率相当。在第6周时实现了2:1的戒烟率优势，并在24周时得以维持。
