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去甲替林联合经皮尼古丁用于戒烟的随机试验。

A randomized trial of nortriptyline combined with transdermal nicotine for smoking cessation.

作者信息

Prochazka Allan V, Kick Steven, Steinbrunn Connie, Miyoshi Thomas, Fryer George E

机构信息

Division of General Internal Medicine, University of Colorado Health Sciences Center, Denver, USA.

出版信息

Arch Intern Med. 2004 Nov 8;164(20):2229-33. doi: 10.1001/archinte.164.20.2229.

DOI:10.1001/archinte.164.20.2229
PMID:15534159
Abstract

BACKGROUND

Smoking cessation rates with current therapy are suboptimal. Tricyclic antidepressants improve cessation rates. We hypothesized that addition of nortriptyline hydrochloride to transdermal nicotine would enhance cessation rates.

METHODS

We conducted a randomized, double-blind, placebo-controlled trial at a Department of Veterans Affairs medical center. Subjects were aged 18 to 65 years, smoked 10 or more cigarettes per day, and did not have current major depression. Nortriptyline hydrochloride or matched placebo was started at 25 mg 14 days before quit day, titrated to 75 mg/d as tolerated, and continued for 12 weeks after quit day. Transdermal nicotine (21 mg/d) was started on quit day and continued for 8 weeks. The behavioral intervention consisted of 12 brief, individual visits. Withdrawal symptoms were measured by means of a daily diary, and smoking cessation was defined as self-reported abstinence, expired carbon monoxide level of 9 ppm or less, and a 6-month urine cotinine level less than 50 ng/mL (284 nmol/L).

RESULTS

A total of 158 patients were randomized (79 to nortriptyline and 79 to placebo). There was no significant reduction in withdrawal symptoms. The cessation rates at 6 months were 23% (18/79) and 10% (8/79), respectively (absolute difference, 13%; 95% confidence interval, 1.3%-24.5%; P = .052). Nortriptyline caused frequent side effects, including dry mouth (38%) and sedation (20%).

CONCLUSIONS

Nortriptyline combined with transdermal nicotine resulted in an increased cessation rate with little effect on withdrawal symptoms. This combination may represent an option for smokers in whom standard therapy has failed.

摘要

背景

目前的戒烟治疗方法的戒烟成功率并不理想。三环类抗抑郁药可提高戒烟成功率。我们推测,在经皮尼古丁治疗中添加盐酸去甲替林会提高戒烟成功率。

方法

我们在一家退伍军人事务部医疗中心进行了一项随机、双盲、安慰剂对照试验。受试者年龄在18至65岁之间,每天吸烟10支或更多,且目前没有重度抑郁症。盐酸去甲替林或匹配的安慰剂在戒烟日之前14天开始服用,剂量为25毫克,根据耐受情况滴定至75毫克/天,并在戒烟日之后持续服用12周。经皮尼古丁(21毫克/天)在戒烟日开始使用,并持续8周。行为干预包括12次简短的个人就诊。通过每日日记测量戒断症状,戒烟定义为自我报告的戒烟、呼出一氧化碳水平在9 ppm或以下,以及6个月尿液可替宁水平低于50 ng/mL(284 nmol/L)。

结果

共有158名患者被随机分组(79人接受去甲替林治疗,79人接受安慰剂治疗)。戒断症状没有显著减轻。6个月时的戒烟成功率分别为23%(18/79)和10%(8/79)(绝对差异为13%;95%置信区间为1.3%-24.5%;P = 0.052)。去甲替林引起频繁的副作用,包括口干(38%)和镇静(20%)。

结论

去甲替林与经皮尼古丁联合使用可提高戒烟成功率,对戒断症状影响较小。这种联合治疗可能是标准治疗失败的吸烟者的一种选择。

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