Rose J E, Behm F M, Westman E C, Levin E D, Stein R M, Ripka G V
Veterans Affairs Medical Center, Durham, NC 27705.
Clin Pharmacol Ther. 1994 Jul;56(1):86-99. doi: 10.1038/clpt.1994.105.
To evaluate concurrent administration of mecamylamine (nicotine antagonist) with nicotine skin patch treatment for smoking cessation.
This was a randomized, double-blind, placebo-controlled trial. Forty-eight healthy smokers who smoked at least one pack per day were studied at an outpatient smoking cessation research clinic. The subjects ranged in age from 20 to 40 years. Intervention with the nicotine skin patch (6 to 8 weeks) plus oral mecamylamine (2.5 to 5 mg twice a day for 5 weeks) was compared to nicotine patch plus placebo. Mecamylamine treatment began 2 weeks before smoking cessation. The primary outcome was continuous abstinence through 7 weeks after cessation (1 week after treatment), confirmed by expired air carbon monoxide measurements. Secondary measures included point abstinence at 7 weeks, continuous abstinence at 6- and 12-month follow-up, and self-reported withdrawal symptoms.
The continuous abstinence rate at 7 weeks was three times higher in the mecamylamine condition: 50% versus 16.7%, p = 0.015. Point abstinence at 7 weeks was 58% for mecamylamine versus 29% for placebo, p = 0.044. At follow-up, continuous abstinence remained higher for mecamylamine: 37.5% versus 12.5% at 6 months (p = 0.046) and 37.5% versus 4.2% at 12 months (p = 0.004). Mecamylamine also significantly reduced craving for cigarettes, negative affect, and appetite.
Agonist-antagonist therapy, consisting of the nicotine patch with oral mecamylamine, may substantially improve current smoking cessation treatment.
评估美加明(尼古丁拮抗剂)与尼古丁透皮贴剂联合使用对戒烟的治疗效果。
这是一项随机、双盲、安慰剂对照试验。48名每天至少吸一包烟的健康吸烟者在一家门诊戒烟研究诊所接受研究。受试者年龄在20至40岁之间。将尼古丁透皮贴剂(6至8周)加口服美加明(每天两次,每次2.5至5毫克,共5周)的干预措施与尼古丁贴剂加安慰剂进行比较。美加明治疗在戒烟前2周开始。主要结局是戒烟后7周(治疗后1周)持续戒烟,通过呼出气体一氧化碳测量来确认。次要指标包括7周时的点戒烟率、6个月和12个月随访时的持续戒烟率以及自我报告的戒断症状。
美加明组7周时的持续戒烟率高出三倍:分别为50%和16.7%,p = 0.015。美加明组7周时的点戒烟率为58%,安慰剂组为29%,p = 0.044。在随访中,美加明组的持续戒烟率仍然较高:6个月时分别为37.5%和12.5%(p = 0.046),12个月时分别为37.5%和4.2%(p = 0.004)。美加明还显著降低了对香烟的渴望、负面情绪和食欲。
由尼古丁贴剂与口服美加明组成的激动剂 - 拮抗剂疗法可能会显著改善当前的戒烟治疗。