TARGETING HEAVY SMOKERS IN GENERAL-PRACTICE - RANDOMIZED CONTROLLED TRIAL OF TRANSDERMAL NICOTINE PATCHES
TARGETING HEAVY SMOKERS IN GENERAL-PRACTICE - RANDOMIZED CONTROLLED TRIAL OF TRANSDERMAL NICOTINE PATCHES
复制标题
DOI：
10.1136/bmj.306.6888.1308
复制
发表时间：
1993-05-15
影响因子：
--
通讯作者：
CONNOR, P
中科院分区：
文献类型：
--
作者：
RUSSELL, MAH;STAPLETON, JA;CONNOR, P
目的-（a）评价尼古丁透皮贴剂在一般实践环境中作为简短建议和支持的辅助手段时辅助戒烟的疗效;（B）观察尼古丁贴片剂量的增加是否能提高初始戒烟率。设计-随机双盲安慰剂对照平行组研究，随访一年。英国15个郡的30个普通诊所。受试者-600名依赖性重度吸烟者干预措施-简要的全科医生的意见，小册子，每天16小时的贴片治疗18周，简短的支持和后续行动，在一，三，主要结果测量-自我报告的完全戒烟长达一年，在所有随访点进行生化验证。结果-尼古丁贴片在戒断的第一周降低了烟瘾和不良情绪变化的严重程度，并在第3周使初始戒烟率增加了一倍（尼古丁组36%（144/400），安慰剂组16.5%（33/200））和持续戒烟一年（尼古丁组9.3%（37），安慰剂组5.0%（10））。在戒烟困难的患者中，第1周增加剂量可增加第3周达到戒烟的比例。有没有不良全身效应归因于尼古丁，但中度或重度局部刺激或瘙痒的发生率在补丁网站为16.4%（63例），与3.8%（7）与安慰剂conclusion-透皮尼古丁贴片作为一种辅助手段，以简短的建议和支持，在一般的做法设置是一种有效的援助长期戒烟的高度依赖的吸烟者。
Objectives-(a) To evaluate the efficacy of transdermal nicotine patches as an aid to stopping smoking when used as an adjunct to brief advice and support in a general practice setting; (b) to see whether an increase in nicotine patch dosage enhances the rate of initial cessation.Design-Randomised double blind placebo controlled parallel group study with one year of follow up.Setting-30 general practices in 15 English counties.Subjects-600 dependent heavy smokers (greater-than-or-equal-to 15 cigarettes daily) who were well motivated to give up.Interventions-Brief general practitioner advice, booklet, and 16 hours per day patch treatment for 18 weeks with brief support and follow up at one, three, six, 12, 26, and 52 weeks.Main outcome measures-Self reported complete abstinence for up to one year with biochemical validation at all follow up points.Results-Nicotine patches reduced the severity of craving and adverse mood changes in the first weeks of withdrawal and doubled the rate of initial cessation at week 3 (nicotine group 36% of patients (144/400), placebo group 16.5% of patients (33/200)) and of continuous abstinence throughout one year (nicotine group 9.3% (37), placebo group 5.0% (10)). A dose increase at week 1 among patients experiencing difficulty in quitting increased the proportion who achieved abstinence at week 3. There were no adverse systemic effects attributable to nicotine, but the incidence of moderate or severe local irritation or itching at the patch site was 16.4% (63 patients), compared with 3.8% (seven) with placebo.Conclusion-Transdermal nicotine patches used as an adjunct to brief advice and support in a general practice setting are an effective aid to long term cessation of smoking in highly dependent smokers.