Dale Lowell C, Ebbert Jon O, Glover Elbert D, Croghan Ivana T, Schroeder Darrell R, Severson Herbert H, Hurt Richard D
Mayo Clinic College of Medicine, Rochester, MN 55905, USA.
Drug Alcohol Depend. 2007 Sep 6;90(1):56-63. doi: 10.1016/j.drugalcdep.2007.02.008. Epub 2007 Mar 13.
No pharmacotherapies have been shown to increase long-term (> or = 6 months) tobacco abstinence rates among smokeless tobacco (ST) users. Bupropion SR has demonstrated potential efficacy for ST users in pilot studies. We conducted a multicenter, randomized, double-blind, placebo-controlled, clinical trial to assess the efficacy and safety of bupropion SR for tobacco abstinence among ST users.
Adult ST users were randomized to bupropion SR titrated to 150 mg twice daily (N=113) or placebo (N=112) for 12 weeks plus behavioral intervention. The primary endpoint was the 7-day point-prevalence tobacco abstinence rate at week 12. Secondary outcomes included prolonged and continuous tobacco abstinence rates, craving and nicotine withdrawal, and weight gain.
The 7-day point-prevalence tobacco abstinence rates did not differ between bupropion SR and placebo at the end treatment (53.1% versus 46.4%; odds ratio (OR) 1.3; p=0.301). The 7-day point-prevalence abstinence did not differ at weeks 24 and 52. The prolonged and continuous tobacco abstinence rates did not differ at weeks 12, 24, and 52. A time-by-treatment interaction was observed in craving over time with greater decreases in the bupropion SR group. At 12 weeks, the mean (+/-S.D.) weight change from baseline among abstinent subjects was an increase of 1.7 (+/-2.9)kg for the bupropion SR group compared to 3.2 (+/-2.7)kg for placebo (p=0.005).
Bupropion SR did not significantly increase tobacco abstinence rates among ST users, but it significantly decreased craving and weight gain over the treatment period.
尚无药物疗法被证实可提高无烟烟草（ST）使用者的长期（≥6个月）戒烟率。在前期研究中，安非他酮缓释片已显示出对ST使用者具有潜在疗效。我们开展了一项多中心、随机、双盲、安慰剂对照临床试验，以评估安非他酮缓释片帮助ST使用者戒烟的疗效和安全性。
成年ST使用者被随机分为两组，一组接受逐渐滴定至每日两次、每次150毫克的安非他酮缓释片治疗（N = 113），另一组接受安慰剂治疗（N = 112），为期12周，并接受行为干预。主要终点是第12周时7天时间点患病率的戒烟率。次要结局包括延长和持续的戒烟率、渴望和尼古丁戒断反应，以及体重增加。
治疗结束时，安非他酮缓释片组和安慰剂组的7天时间点患病率戒烟率无差异（53.1%对46.4%；优势比（OR）1.3；p = 0.301）。在第24周和第52周时，7天时间点患病率戒烟率也无差异。在第12周、24周和52周时，延长和持续的戒烟率也无差异。随着时间推移，在渴望方面观察到治疗与时间的交互作用，安非他酮缓释片组的下降幅度更大。在第12周时，成功戒烟的受试者中，安非他酮缓释片组自基线起的平均（±标准差）体重变化为增加1.7（±2.9）千克，而安慰剂组为3.2（±2.7）千克（p = 0.005）。
安非他酮缓释片未显著提高ST使用者的戒烟率，但在治疗期间显著降低了渴望程度和体重增加。
