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用于尼古丁依赖的2毫克和4毫克尼古丁口香糖。在行为矫正支持项目内进行的双盲安慰剂对照试验。

Nicotine gum, 2 and 4 mg, for nicotine dependence. A double-blind placebo-controlled trial within a behavior modification support program.

作者信息

Herrera N, Franco R, Herrera L, Partidas A, Rolando R, Fagerström K O

机构信息

Smoking Cessation Clinic, Centro Medico Docente La Trinidad, Caracas, Venezuela.

出版信息

Chest. 1995 Aug;108(2):447-51. doi: 10.1378/chest.108.2.447.

DOI:10.1378/chest.108.2.447
PMID:7634882
Abstract

The effectiveness of nicotine gum in combination with a behavior modification program was studied. The nicotine dependence of participating smokers (N = 322) was assessed. One hundred sixty-eight smokers were labeled as high nicotine dependent and 154 as moderate to low dependent. In a randomized double-blind procedure, the high-dependent smokers were given gum containing 4 mg of nicotine (87) or 2 mg of nicotine (81) and the smokers with medium or low dependence were given gum containing 2 mg (76) or a placebo gum (78). The smokers were also randomized to familiarizing themselves with the medication a week before quit day (112) or to regular use, that is starting gum use on the quit day (122). In the high-dependent group, sustained and chemically verified nonsmoking rates at 6 weeks, 1 year, and 2 years were, respectively, 60%, 39%, and 34% in the subjects given the 4-mg dose compared with 41%, 16%, and 16% for those using the 2-mg dose. In the group with medium or low dependence, the success rates at the same time periods were 70%, 49%, and 39% for the subjects given the 2-mg dose and 38%, 22%, and 17% for those given placebo gum. The differences in success rates were significant at least at the p < 0.02% level for all comparisons. Familiarizing with the gum as compared with regular use gave fewer reports of side effects, 15% vs 34%, p < 0.001. A trend toward better success rates at 6 weeks, although not statistically significant, was observed for the familiarization group, 61% vs 52%. The study shows that high nicotine-dependent smokers need higher doses of nicotine replacement, in this case the 4-mg dose rather than the 2-mg dose, whereas 2 mg is superior to placebo among less dependent smokers. These results compare favorably with those reported from the more recent nicotine patch therapy.

摘要

研究了尼古丁口香糖与行为矫正计划相结合的有效性。评估了参与研究的吸烟者(N = 322)的尼古丁依赖性。168名吸烟者被标记为高尼古丁依赖性,154名吸烟者被标记为中度至低度依赖性。在随机双盲程序中,高依赖性吸烟者被给予含4毫克尼古丁的口香糖(87人)或含2毫克尼古丁的口香糖(81人),中度或低度依赖性吸烟者被给予含2毫克尼古丁的口香糖(76人)或安慰剂口香糖(78人)。吸烟者还被随机分为在戒烟日前提早一周熟悉药物(112人)或常规使用,即在戒烟日开始使用口香糖(122人)。在高依赖性组中,接受4毫克剂量的受试者在6周、1年和2年时经化学验证的持续戒烟率分别为60%、39%和34%,而使用2毫克剂量的受试者的相应戒烟率分别为41%、16%和16%。在中度或低度依赖性组中,在相同时间段内,接受2毫克剂量的受试者的成功率分别为70%、49%和39%,而接受安慰剂口香糖的受试者的成功率分别为38%、22%和17%。所有比较的成功率差异至少在p < 0.02%水平上具有统计学意义。与常规使用相比,熟悉口香糖的副作用报告较少,分别为15%和34%,p < 0.001。熟悉组在6周时的成功率有升高趋势,尽管无统计学意义,分别为61%和52%。该研究表明,高尼古丁依赖性吸烟者需要更高剂量的尼古丁替代物,在本研究中为4毫克剂量而非2毫克剂量,而在依赖性较低的吸烟者中,2毫克剂量优于安慰剂。这些结果与最近报道的尼古丁贴片疗法的结果相比更具优势。

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