Covey Lirio S, Glassman Alexander H, Jiang Huiping, Fried Jane, Masmela Jenny, LoDuca Catherine, Petkova Eva, Rodriguez Kristina
Smoking Cessation Program, New York State Psychiatric Institute, Columbia University Medical Center, New York, NY 10032, USA.
Addiction. 2007 Aug;102(8):1292-302. doi: 10.1111/j.1360-0443.2007.01887.x.
To investigate the efficacy of maintenance treatment with bupropion and/or nicotine gum for reducing smoking relapse.
DESIGN, SETTING AND PARTICIPANTS: A 48-week study was conducted at a university-based smoking cessation clinic between February 2001 and October 2005. A total of 588 smokers received bupropion and nicotine patch in 8 weeks of open-label treatment (OLT); 289 abstainers during the last 4 weeks of OLT were randomized in double-blind placebo-controlled fashion to one of four arms for 16 weeks of maintenance treatment (MT) followed by 24 weeks of non-treatment follow-up (NTFU).
Bupropion (300 mg/day) and 2 mg nicotine gum, used alone or combined, and comparable placebo pill and placebo gum. Behavioral counseling at all visits.
Time to relapse (TTR) from randomization. Relapse is defined as the first 7 consecutive days of smoking. Abstinence verified by carbon monoxide <or= 8 parts per million.
TTR was longer with extended active treatments compared to placebo (median days to relapse: bupropion + placebo = 136, nicotine + placebo = 98, bupropion + nicotine = 90, double placebo = 71). Hazard ratios (HR) for relapse were statistically significant for bupropion + placebo versus double placebo during MT (HR = 0.59, 95% CI = 0.37-0.92) and to the end of NTFU (HR = 0.66, 95% CI = 0.42-0.96). However, bupropion's advantage dissipated upon stopping the drug. Gum use was low, preventing a valid assessment; but analysis restricted to gum users suggested a weak effect of extended nicotine gum.
Maintenance treatment with bupropion exerted a modest benefit for preventing smoking relapse; the optimum duration of bupropion treatment was unclear. Further research is needed to ascertain the merits of extended use of nicotine gum, other nicotine replacement agents and other treatments known to aid smokers for preventing relapse once abstinence is achieved.
研究安非他酮和/或尼古丁口香糖维持治疗对减少吸烟复发的疗效。
设计、地点和参与者：2001年2月至2005年10月在一家大学戒烟诊所进行了一项为期48周的研究。共有588名吸烟者在8周的开放标签治疗（OLT）中接受了安非他酮和尼古丁贴片；在OLT的最后4周内，289名戒烟者被随机分为四个组之一，以双盲安慰剂对照方式进行16周的维持治疗（MT），随后进行24周的非治疗随访（NTFU）。
安非他酮（300毫克/天）和2毫克尼古丁口香糖，单独使用或联合使用，以及类似的安慰剂药丸和安慰剂口香糖。每次就诊时进行行为咨询。
从随机分组开始到复发的时间（TTR）。复发定义为连续7天首次吸烟。通过一氧化碳≤8 ppm来验证戒烟情况。
与安慰剂相比，延长活性治疗的TTR更长（复发的中位天数：安非他酮+安慰剂=136天，尼古丁+安慰剂=98天，安非他酮+尼古丁=90天，双安慰剂=71天）。在MT期间，安非他酮+安慰剂与双安慰剂相比，复发的风险比（HR）具有统计学意义（HR = 0.59，95%CI = 0.37 - 0.92），到NTFU结束时也是如此（HR = 0.66，95%CI = 0.42 - 0.96）。然而，停止使用安非他酮后其优势消失。口香糖的使用率较低，无法进行有效评估；但仅限于口香糖使用者的分析表明，延长使用尼古丁口香糖的效果较弱。
安非他酮维持治疗对预防吸烟复发有一定益处；安非他酮治疗的最佳持续时间尚不清楚。需要进一步研究以确定延长使用尼古丁口香糖、其他尼古丁替代药物以及其他已知有助于吸烟者在戒烟后预防复发的治疗方法的优点。
