Sustained-release bupropion for pharmacologic relapse prevention after smoking cessation - A randomized, controlled trial
Sustained-release bupropion for pharmacologic relapse prevention after smoking cessation - A randomized, controlled trial
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DOI：
10.7326/0003-4819-135-6-200109180-00011
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发表时间：
2001-09-18
影响因子：
39.2
通讯作者：
White, JD
中科院分区：
文献类型：
--
作者：
Hays, JT;Hurt, RD;White, JD
背景：戒烟药物治疗成功后，吸烟复发是常见的。没有以前的研究已经检查了长期的药物治疗明确用于预防吸烟复发。目的：为了评估安非他酮的疗效，以防止吸烟复发。设计：随机，安慰剂对照试验。参与者：784名健康的社区志愿者，他们有戒烟的动机，每天至少吸烟15支。干预：参与者接受开放标签，缓释安非他酮，300 mg/d，持续7周。在开放标签治疗的第7周期间禁欲的参与者被随机分配接受安非他酮，300 mg/d或安慰剂45周，随后在药物治疗阶段结束后再随访一年。在所有后续访问中，参与者都得到了简短的咨询。在开放标签安非他酮治疗结束时，784名参与者中有461名（58.8%）戒烟。测量：自我报告的戒烟是通过呼气中一氧化碳浓度为百万分之十或更低来证实的。在药物治疗结束时（第52周），安非他酮组戒烟率显著高于安慰剂组（分别为55.1% vs. 42.3%; P = 0.008）和第78周（47.7% vs. 37.7%; P = 0.034），但在最终（第104周）随访访视时无差异（41.6% vs. 40.0%）。安非他酮接受者的中位复发时间显著大于安慰剂接受者（156天vs. 65天; P = 0.021）。在研究第24周（随机化后17周），安非他酮组的持续戒断率高于安慰剂组（52.3% vs. 42.3%; P = 0.037），但在第24周后两组间无差异。在研究的第52周，安非他酮组的体重增加明显少于安慰剂组（3.8 kg vs 5.6 kg; P = 0.002）和104（4.1 kg vs. 5.4 kg; P = 0.016）。在用安非他酮治疗7周而戒烟的人中，持续释放安非他酮12个月延迟吸烟复发，并导致体重增加较少。
Background: Smoking relapse is common after successful pharmacologic treatment for smoking cessation. No previous studies have examined long-term drug therapy used expressly for prevention of smoking relapse.Objective: To evaluate the efficacy of bupropion to prevent smoking relapse.Design: Randomized, placebo-controlled trial.Participants: 784 healthy community volunteers who were motivated to quit smoking and who smoked at least 15 cigarettes per day.Intervention: The participants received open-label, sustained-release bupropion, 300 mg/d, for 7 weeks. Participants who were abstinent throughout week 7 of open-label treatment were randomly assigned to receive bupropion, 300 mg/d, or placebo for 45 weeks and were subsequently followed for an additional year after the conclusion of the medication phase. Participants were briefly counseled at all follow-up visits. At the end of open-label bupropion treatment, 461 of 784 participants (58.8%) were abstinent from smoking.Measurement: Self-reported abstinence was confirmed by an expired air carbon monoxide concentration of 10 parts per million or less.Results: The point prevalence of smoking abstinence was significantly higher in the bupropion group than in the placebo group at the end (week 52) of drug therapy (55.1% vs. 42.3%, respectively; P = 0.008) and at week 78 (47.7% vs. 37.7%; P = 0.034) but did not differ at the final (week 104) follow-up visit (41.6% vs. 40.0%). The median time to relapse was significantly greater for bupropion recipients than for placebo recipients (156 days vs. 65 days; P = 0.021). The continuous abstinence rate was higher in the bupropion group than in the placebo group at study week 24 (17 weeks after randomization) (52.3% vs. 42.3%; P = 0.037) but did not differ between groups after week 24. Weight gain was significantly less in the bupropion group than in the placebo group at study weeks 52 (3.8 kg vs. 5.6 kg; P = 0.002) and 104 (4.1 kg vs. 5.4 kg; P = 0.016).Conclusions: in persons who stopped smoking with 7 weeks of bupropion treatment, sustained-release bupropion for 12 months delayed smoking relapse and resulted in less weight gain.