DOSE EFFECTS AND PREDICTORS OF OUTCOME IN A RANDOMIZED TRIAL OF TRANSDERMAL NICOTINE PATCHES IN GENERAL-PRACTICE
DOSE EFFECTS AND PREDICTORS OF OUTCOME IN A RANDOMIZED TRIAL OF TRANSDERMAL NICOTINE PATCHES IN GENERAL-PRACTICE
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DOI：
10.1046/j.1360-0443.1995.901316.x
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发表时间：
1995-01-01
期刊：
影响因子：
6
通讯作者：
WISEMAN, D
中科院分区：
文献类型：
--
作者：
STAPLETON, JA;RUSSELL, MAH;WISEMAN, D
经皮尼古丁贴剂已被证明可以有效帮助戒烟。易于确保良好的依从性使其比尼古丁口香糖具有潜在优势，作为在初级保健机构中提供简短建议和支持的辅助手段，在初级保健机构中获得了重大的公共卫生影响。在一项随机安慰剂对照试验的一半样本的初步报告中，我们表明该贴片在一般实践环境中是有效的。我们在此报告完整样本的明确结果，包括剂量效应、结果预测因素以及其他理论和实际利益问题。总共 1200 名重度吸烟者（每天大于或等于 15 支）在英国 15 个县参加了 30 次全科诊所，接受了简短的全科医生建议、一本小册子和每天 16 小时的贴片治疗，为期 18 周。剂量增加以及突然与逐渐减少贴剂剂量也被随机化，并在第 1、3、6、12、26 和 52 周进行随访。结果是通过自我报告的第 3 周至第 52 周的完全戒断来衡量的，并在所有随访点进行生化验证。尼古丁贴片治疗使持续戒烟率增加一倍（尼古丁 9.6%，安慰剂 4.8%，p < 0.01）；它很可能是通过减少戒断症状来起作用的。它在第一周增强了戒烟效果，并在第二周减少了复发。第一周后剂量增加并没有导致戒烟持续增加。逐渐减少剂量在预防复发方面并不比第 12 周后突然撤除贴剂更好。尚未测试在第 3 周至第 12 周之间的某个时间点结束治疗是否会增加复发。尽管治疗前对香烟的依赖是失败的预兆，但贴片对高度依赖和不太依赖的吸烟者同样有帮助。贴片对于治疗前有亚临床心境恶劣症状的吸烟者特别有帮助。在该研究中，除了一名最终实现长期戒烟的 96 名受试者外，其他所有人都在戒烟的第一周内戒烟。
The transdermal nicotine patch has proved an effective aid to smoking cessation. The ease of securing good compliance gives it a potential advantage over nicotine gum as an adjunct to brief advice and support in primary care settings where the major public health impact is obtained. In a preliminary report of half the sample of a randomized placebo controlled trial, we showed the patch to be effective in a general practice setting. We report here the definitive results of the full sample, including dose effects, predictors of outcome and other issues of theoretical and practical interest. A total of 1200 heavy smokers (greater-than-or-equal-to 15 per day), attending 30 general practices in 15 English counties received brief GP advice, a booklet and 16 hours per day patch treatment for 18 weeks. Dose increase and abrupt vs. gradual reduction of patch dosage were also randomized and follow-ups conducted at 1, 3, 6, 12, 26 and 52 weeks. Outcome was measured by self-reported complete abstinence from week 3 to 52 with biochemical validation at all follow-up points. Nicotine patch treatment doubled the rate of continuous abstinence up to 1 year (nicotine 9.6%, placebo 4.8%, p < 0.01); it most likely worked by reducing withdrawal symptoms. It enhanced cessation during the first week and reduced relapse during the second week. The dose increase after week 1 produced no sustained increase in cessation. Gradual reduction was no better at preventing relapse than abrupt withdrawal of patches after week 12. Whether relapse would have increased by ending treatment at some point between weeks 3 and 12 was not tested. Although pre-treatment dependence on cigarettes was prognostic of failure, the patches were equally helpful to both highly and less dependent smokers. Patches were particularly helpful to smokers with pre-treatment subclinical dysthymic symptoms. All but one of the 96 subjects eventually achieving long-term abstinence in the study quit during the first week of cessation.