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每日尼古丁贴片使用依从性与治疗效果之间的关系:一项为期10周的模拟成人吸烟者非处方使用的随机、双盲、安慰剂对照临床试验的二次分析。

Relationship between adherence to daily nicotine patch use and treatment efficacy: secondary analysis of a 10-week randomized, double-blind, placebo-controlled clinical trial simulating over-the-counter use in adult smokers.

作者信息

Shiffman Saul, Sweeney Christine T, Ferguson Stuart G, Sembower Mark A, Gitchell Joseph G

机构信息

PinneyAssociates, Inc., Pittsburgh, Pennsylvania 15213, USA.

出版信息

Clin Ther. 2008 Oct;30(10):1852-8. doi: 10.1016/j.clinthera.2008.09.016.

DOI:10.1016/j.clinthera.2008.09.016
PMID:19014840
Abstract

BACKGROUND

It has been reported that the efficacy of acute forms of nicotine replacement therapy, such as nicotine gum and lozenges, improves when sufficient quantities of medication are used.

OBJECTIVE

This analysis examined whether adherence with daily nicotine patch wear was associated with improved rates of smoking abstinence.

METHODS

This was a secondary analysis of data from a double-blind study in which subjects were randomized to receive either an active nicotine patch or a placebo patch under simulated over-the-counter conditions. Subjects were asked to complete a daily diary on their patch use and smoking. Logistic regression, controlling for smoking in the first 3 weeks of treatment, was used to evaluate the likelihood of abstinence at 6 weeks as a function of treatment assignment (active vs placebo) and adherence (ie, patch wear for >or=20 of the first 21 days of treatment). The relationship between reported adverse events and adherence was also examined.

RESULTS

This analysis involved data from 371 subjects, 204 using the active patch and 167 using the placebo patch. The study population was mainly white (87.3%), had a mean age of 42.8 years, a mean weight of 77.3 kg, had been smoking for a mean of 24.4 years, and smoked a mean of 25.2 cigarettes per day. Two hundred fifty-three subjects were classified as adherent. Rates of adherence did not differ significantly between the active and placebo groups (139 [68.1%] and 114 [68.3%], respectively). The likelihood of experiencing an adverse event did not differ significantly between adherent and nonadherent subjects in either group. Among active patch users, 61.5% of nonadherent subjects experienced an adverse event, compared with 59.7% of adherent subjects; among placebo patch users, the corresponding proportions were 41.5% and 43.9%. Among active patch users, the odds of abstinence at 6 weeks were more than 3 times greater for adherent versus nonadherent subjects (53.2% vs 21.5%, respectively; adjusted odds ratio [OR] = 3.25; 95% CI, 1.30-8.09; P = 0.011); no benefit of adherence over nonadherence was seen among users of the placebo patch (16.7% vs 15.1%; adjusted OR = 0.60; 95% CI, 0.16-2.31). The interaction between treatment group and adherence was statistically significant (P = 0.022).

CONCLUSION

Under conditions simulating over-the-counter use, adherence to daily nicotine patch wear within the first 3 weeks of treatment was associated with an improved likelihood of achieving smoking abstinence at 6 weeks.

摘要

背景

据报道,当使用足够剂量的药物时,尼古丁口香糖和含片等急性形式的尼古丁替代疗法的疗效会提高。

目的

本分析旨在研究每日坚持使用尼古丁贴片是否与戒烟成功率提高相关。

方法

这是一项对双盲研究数据的二次分析,在模拟非处方条件下,受试者被随机分配接受活性尼古丁贴片或安慰剂贴片。受试者被要求完成一份关于贴片使用和吸烟情况的每日日记。使用逻辑回归分析,控制治疗前3周的吸烟情况,以评估6周时戒烟的可能性,该可能性是治疗分配(活性贴片与安慰剂贴片)和依从性(即治疗的前21天中贴片使用天数≥20天)的函数。同时还研究了报告的不良事件与依从性之间的关系。

结果

本分析涉及371名受试者的数据,其中204人使用活性贴片,167人使用安慰剂贴片。研究人群主要为白人(87.3%),平均年龄42.8岁,平均体重77.3千克,平均吸烟史24.4年,平均每日吸烟25.2支。253名受试者被归类为依从者。活性组和安慰剂组的依从率无显著差异(分别为139人[68.1%]和114人[68.3%])。两组中依从和不依从的受试者发生不良事件的可能性无显著差异。在使用活性贴片的受试者中,不依从者发生不良事件的比例为61.5%,依从者为59.7%;在使用安慰剂贴片的受试者中,相应比例分别为41.5%和43.9%。在使用活性贴片的受试者中,6周时依从者戒烟的几率是不依从者的3倍多(分别为53.2%和21.5%;调整后的优势比[OR]=3.25;95%可信区间[CI],1.30 - 8.09;P = 0.011);在使用安慰剂贴片的受试者中,未观察到依从者比不依从者有优势(分别为16.7%和15.1%;调整后的OR = 0.60;95%CI,0.16 - 2.31)。治疗组与依从性之间的交互作用具有统计学意义(P = 0.022)。

结论

在模拟非处方使用的条件下,治疗前3周内每日坚持使用尼古丁贴片与6周时戒烟可能性的提高相关。

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