Fiore M C, Smith S S, Jorenby D E, Baker T B
Center for Tobacco Research and Intervention, University of Wisconsin Medical School, Madison 53706-1532.
JAMA. 1994;271(24):1940-7.
To estimate the overall efficacy and optimal use of the nicotine patch for treating tobacco dependence.
Nicotine patch efficacy studies published through September 1993, identified through MEDLINE, Psychological Abstracts, and Food and Drug Administration new drug applications.
Double-blind, placebo-controlled nicotine patch studies of 4 weeks or longer with random assignment of subjects, biochemical confirmation of abstinence, and subjects not selected on the basis of specific diseases (eg, coronary artery disease).
Pooled abstinence rates and combined odds ratios (ORs) at end of treatment and 6-month follow-up were examined overall and in terms of patch type (16-hour vs 24-hour), patch treatment duration, dosage reduction (weaning), counseling format (individual vs group), and intensity of adjuvant behavioral counseling.
Across 17 studies (n = 5098 patients) meeting inclusion criteria, overall abstinence rates for the active patch were 27% (vs 13% for placebo) at the end of treatment and 22% (vs 9% for placebo) at 6 months. The combined ORs for efficacy of active patch vs placebo patch were 2.6 at the end of treatment and 3.0 at 6 months. The active patch was superior to the placebo patch regardless of patch type (16-hour vs 24-hour), patch treatment duration, weaning, counseling format, or counseling intensity. The 16-hour and 24-hour patches appeared equally efficacious, and extending treatment beyond 8 weeks did not appear to increase efficacy. The pooled abstinence data showed that intensive behavioral counseling had a reliable but modest positive impact on quit rates.
The nicotine patch is an effective aid to quitting smoking across different patch-use strategies. Active patch subjects were more than twice as likely to quit smoking as individuals wearing a placebo patch, and this effect was present at both high and low intensities of counseling. The nicotine patch is an effective smoking cessation aid and has the potential to improve public health significantly.
评估尼古丁贴片治疗烟草依赖的总体疗效及最佳使用方法。
通过MEDLINE、《心理学文摘》以及美国食品药品管理局的新药申请识别出的截至1993年9月发表的尼古丁贴片疗效研究。
为期4周或更长时间的双盲、安慰剂对照尼古丁贴片研究,受试者随机分组,有禁欲的生化确认,且受试者不是基于特定疾病(如冠状动脉疾病)选择的。
在治疗结束时和6个月随访时,总体及按贴片类型(16小时与24小时)、贴片治疗持续时间、剂量减少(逐渐停用)、咨询形式(个体与团体)以及辅助行为咨询强度来检查汇总的禁欲率和合并比值比(OR)。
在符合纳入标准的17项研究(n = 5098例患者)中,治疗结束时活性贴片的总体禁欲率为27%(安慰剂为13%),6个月时为22%(安慰剂为9%)。活性贴片与安慰剂贴片疗效的合并OR在治疗结束时为2.6,6个月时为3.0。无论贴片类型(16小时与24小时)、贴片治疗持续时间、逐渐停用、咨询形式或咨询强度如何,活性贴片均优于安慰剂贴片。16小时和24小时贴片似乎疗效相同,且治疗超过8周似乎并未提高疗效。汇总的禁欲数据表明,强化行为咨询对戒烟率有可靠但适度的积极影响。
尼古丁贴片在不同的贴片使用策略中都是戒烟的有效辅助手段。使用活性贴片的受试者戒烟的可能性是佩戴安慰剂贴片者的两倍多,且这种效果在咨询强度高和低时均存在。尼古丁贴片是一种有效的戒烟辅助手段,有显著改善公众健康的潜力。