Jorenby D E, Smith S S, Fiore M C, Hurt R D, Offord K P, Croghan I T, Hays J T, Lewis S F, Baker T B
Center for Tobacco Research and Intervention, University of Wisconsin-Madison, USA.
JAMA. 1995 Nov 1;274(17):1347-52.
To compare the efficacy and safety of 22-mg and 44-mg doses of transdermal nicotine therapy when it is paired with minimal, individual, or group counseling to improve smoking cessation rates.
An 8-week clinical trial (4 weeks double-blind followed by 4 weeks open label) using random assignment of participants to both dose (22 or 44 mg) and counseling (minimal, individual, or group) conditions.
Daily cigarette smokers (> or = 15 cigarettes per day for at least 1 year) who volunteered to participate in a study of smoking cessation treatment. A total of 504 participants were enrolled at two sites.
Four weeks of 22- or 44-mg transdermal nicotine therapy followed by 4 weeks of dosage reduction (2 weeks of 22 mg followed by 2 weeks of 11 mg). Counseling consisted of a self-help pamphlet (minimal); a self-help pamphlet, a brief physician motivational message, and three brief (< 15 minutes) follow-up visits with a nurse (individual); or the pamphlet, the motivational message, and eight weekly 1-hour group smoking cessation counseling visits (group). All participants returned weekly to turn in questionnaires and for assessment of their smoking status.
Abstinence from smoking was based on self-report, confirmed by an expired carbon monoxide concentration lower than 10 ppm. Withdrawal severity was assessed by means of an eight-item self-report questionnaire completed daily.
Smoking cessation rates for the two nicotine patch doses and three levels of counseling did not differ significantly at either 8 weeks or 26 weeks following the quit date. Among those receiving minimal contact, the 44-mg dose produced greater abstinence at 4 weeks than did the 22-mg dose (68% vs 45%; P < .01). Participants receiving minimal-contact adjuvant treatment were less likely to be abstinent at the end of 4 weeks than those receiving individual or group counseling (56% vs 67%; P < .05). The 44-mg dose decreased desire to smoke more than the 22-mg dose, but this effect was not related to success in quitting smoking. Transdermal nicotine therapy at doses of 44 mg produced a significantly greater frequency of nausea (28%), vomiting (10%), and erythema with edema at the patch site (30%) than did a 22-mg dose (10%, 2%, and 13%, respectively; P < .01 for each adverse effect). Three serious adverse events occurred during use of the 44-mg patch dose.
There does not appear to be any general, sustained benefit of initiating transdermal nicotine therapy with a 44-mg patch dose or of providing intense adjuvant smoking cessation treatment. The two doses and all adjuvant treatments produced equivalent effects at the 26-week follow-up, and the higher patch dose produced more adverse effects. Higher-dose (44-mg) nicotine replacement does not appear to be indicated for general clinical populations, although it may provide short-term benefit to some smokers attempting to quit with minimal adjuvant treatment.
比较22毫克和44毫克剂量的经皮尼古丁疗法与最少、个体化或团体咨询相结合时，提高戒烟率的疗效和安全性。
一项为期8周的临床试验（4周双盲，随后4周开放标签），将参与者随机分配至剂量（22或44毫克）和咨询（最少、个体化或团体）条件。
每天吸烟的人（每天至少吸15支烟，至少持续1年），自愿参加戒烟治疗研究。在两个地点共招募了504名参与者。
4周的22毫克或44毫克经皮尼古丁疗法，随后4周减量（2周22毫克，随后2周11毫克）。咨询包括一本自助手册（最少）；一本自助手册、医生简短的激励信息以及与护士进行三次简短（<15分钟）的随访（个体化）；或手册、激励信息以及八次每周1小时的团体戒烟咨询（团体）。所有参与者每周返回提交问卷并接受吸烟状况评估。
戒烟基于自我报告，通过呼出一氧化碳浓度低于10 ppm来确认。戒断严重程度通过每天完成的一份八项自我报告问卷进行评估。
在戒烟日期后的8周或26周，两种尼古丁贴片剂量和三种咨询水平的戒烟率无显著差异。在接受最少接触的人群中，44毫克剂量在4周时的戒烟率高于22毫克剂量（68%对45%；P<.01）。接受最少接触辅助治疗的参与者在4周结束时戒烟的可能性低于接受个体化或团体咨询的参与者（56%对67%；P<.05）。44毫克剂量比22毫克剂量更能降低吸烟欲望，但这种效果与戒烟成功与否无关。44毫克剂量的经皮尼古丁疗法产生恶心（28%）、呕吐（10%）和贴片部位红斑伴水肿（30%）的频率显著高于22毫克剂量（分别为10%、2%和13%；每种不良反应P<.01）。在使用44毫克贴片剂量期间发生了三起严重不良事件。
开始使用44毫克贴片剂量的经皮尼古丁疗法或提供强化辅助戒烟治疗似乎没有任何普遍、持续的益处。两种剂量和所有辅助治疗在26周随访时产生的效果相当，且较高贴片剂量产生的不良反应更多。高剂量（44毫克）尼古丁替代疗法似乎不适用于一般临床人群，尽管它可能对一些在最少辅助治疗下试图戒烟的吸烟者有短期益处。
