Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA 19104, USA.
Ann Intern Med. 2010 Feb 2;152(3):144-51. doi: 10.7326/0003-4819-152-3-201002020-00005.
Tobacco dependence is a chronic, relapsing condition that may require extended treatment.
To assess whether extended-duration transdermal nicotine therapy increases abstinence from tobacco more than standard-duration therapy in adult smokers.
Parallel randomized, placebo-controlled trial from September 2004 to February 2008. Participants and all research personnel except the database manager were blinded to randomization. (ClinicalTrials.gov registration number: NCT00364156)
Academic center.
568 adult smokers.
In an unstratified small block-randomization scheme, participants were randomly assigned to standard therapy (Nicoderm CQ [GlaxoSmithKline, Research Triangle Park, North Carolina], 21 mg, for 8 weeks and placebo for 16 weeks) or extended therapy (Nicoderm CQ, 21 mg, for 24 weeks).
The primary outcome was biochemically confirmed point-prevalence abstinence at weeks 24 and 52. Secondary outcomes were continuous and prolonged abstinence, lapse and recovery events, cost per additional quitter, and side effects and adherence.
At week 24, extended therapy produced higher rates of point-prevalence abstinence (31.6% vs. 20.3%; odds ratio, 1.81 [95% CI, 1.23 to 2.66]; P = 0.002), prolonged abstinence (41.5% vs. 26.9%; odds ratio, 1.97 [CI, 1.38 to 2.82]; P = 0.001), and continuous abstinence (19.2% vs. 12.6%; odds ratio, 1.64 [CI, 1.04 to 2.60]; P = 0.032) versus standard therapy. Extended therapy reduced the risk for lapse (hazard ratio, 0.77 [CI, 0.63 to 0.95]; P = 0.013) and increased the chances of recovery from lapses (hazard ratio, 1.47 [CI, 1.17 to 1.84]; P = 0.001). Time to relapse was slower with extended versus standard therapy (hazard ratio, 0.50 [CI, 0.35 to 0.73]; P < 0.001). At week 52, extended therapy produced higher quit rates for prolonged abstinence only (P = 0.027). No differences in side effects and adverse events between groups were found at the extended-treatment assessment.
The generalizability of the findings may be limited because participants were smokers without medical comorbid conditions who were seeking treatment, and differences in adherence across treatment groups were detected.
Transdermal nicotine for 24 weeks increased biochemically confirmed point-prevalence abstinence and continuous abstinence at week 24, reduced the risk for smoking lapses, and increased the likelihood of recovery to abstinence after a lapse compared with 8 weeks of transdermal nicotine therapy.
National Institutes of Health.
烟草依赖是一种慢性、复发性疾病，可能需要长期治疗。
评估延长持续时间的透皮尼古丁治疗是否比标准持续时间的治疗更能增加成年吸烟者的戒烟率。
2004 年 9 月至 2008 年 2 月进行的平行随机、安慰剂对照试验。参与者和除数据库管理员外的所有研究人员对随机分组均不知情。（临床试验.gov 注册号：NCT00364156）
学术中心。
568 名成年吸烟者。
在非分层小区块随机分组方案中，参与者被随机分配至标准治疗组（Nicoderm CQ [葛兰素史克，三角研究园，北卡罗来纳州]，21mg，治疗 8 周，安慰剂治疗 16 周）或延长治疗组（Nicoderm CQ，21mg，治疗 24 周）。
主要结局是 24 周和 52 周时生物化学确证的点患病率戒烟率。次要结局是连续和长期戒烟、复发和恢复事件、每增加一个戒烟者的成本，以及副作用和依从性。
在第 24 周时，延长治疗组的点患病率戒烟率更高（31.6%对 20.3%；优势比，1.81 [95%置信区间，1.23 至 2.66]；P = 0.002）、长期戒烟率更高（41.5%对 26.9%；优势比，1.97 [置信区间，1.38 至 2.82]；P = 0.001）和连续戒烟率更高（19.2%对 12.6%；优势比，1.64 [置信区间，1.04 至 2.60]；P = 0.032），而标准治疗组则更低。延长治疗降低了复发的风险（风险比，0.77 [置信区间，0.63 至 0.95]；P = 0.013），并增加了从复发中恢复的可能性（风险比，1.47 [置信区间，1.17 至 1.84]；P = 0.001）。与标准治疗相比，延长治疗组的复发时间更慢（风险比，0.50 [置信区间，0.35 至 0.73]；P < 0.001）。在第 52 周时，延长治疗组的长期戒烟率更高（P = 0.027）。在延长治疗评估时，两组之间未发现副作用和不良事件的差异。
研究结果的推广性可能受到限制，因为参与者是寻求治疗的没有合并症的吸烟者，而且在治疗组之间检测到了依从性的差异。
与 8 周透皮尼古丁治疗相比，24 周的透皮尼古丁治疗可在第 24 周时增加生物化学确证的点患病率戒烟率和连续戒烟率，降低吸烟复发的风险，并增加复发后恢复到戒烟状态的可能性。
美国国立卫生研究院。
