Effectiveness of extended-duration transdermal nicotine therapy: a randomized trial.
Effectiveness of extended-duration transdermal nicotine therapy: a randomized trial.
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DOI：
10.7326/0003-4819-152-3-201002020-00005
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发表时间：
2010-02-02
影响因子：
39.2
通讯作者：
Lerman C
中科院分区：
文献类型：
--
作者：
Schnoll RA;Patterson F;Wileyto EP;Heitjan DF;Shields AE;Asch DA;Lerman C
背景：烟草依赖是一种慢性、复发性疾病，可能需要长期治疗。目的：评估延长透皮尼古丁治疗是否比标准持续时间治疗更能提高成年吸烟者的戒烟效果。设计：2004 年 9 月至 2008 年 2 月的平行随机安慰剂对照试验（小组随机方案，未分层）。研究参与者和除数据库管理员外的所有研究人员均对随机化不知情。 (NCT00364156) 设置：学术中心。参与者：568 名成年吸烟者。干预：参与者被随机分为：标准治疗（8 周 21mg Nicoderm CQ，16 周安慰剂）或延长治疗（24 周 21mg Nicoderm CQ）。测量：主要结局是第 24 周和第 52 周经生化验证的点戒烟率。次要结局是持续和长期戒烟、戒烟和恢复事件、成本/额外戒烟以及副作用和依从性。结果：在 24 周时，延长治疗产生更高的点流行率戒断率（31.6% 对比 20.3%；比值比 [OR] = 1.81 [1.23-2.66]，p = 0.002）、延长戒断率（41.5% 对比 26.9%；OR = 1.97 [1.38-2.82] p = 0.001）和持续戒断率戒断（19.2% vs 12.6%；OR = 1.64 [1.04-2.60] p = 0.032）与标准治疗相比。延长治疗降低了失误风险（风险比 [HR] = 0.77 [0.63-0.95]，p = 0.013）并增加了从失误中恢复的机会（HR = 1.47 [1.17-1.84]，p = 0.001）。与标准治疗相比，延长治疗的复发时间更慢（HR = 0.50 [0.35-0.73]，p < 0.001）。在第 52 周，延长治疗仅对长期戒烟产生较高的戒烟率 (p = 0.027)。在延长治疗阶段评估中，副作用和不良事件没有组间差异。局限性：研究结果的普遍性可能有限，因为参与者是寻求治疗的吸烟者，没有合并症，并且检测到治疗组之间的依从性存在差异。结论：与 8 周的透皮尼古丁治疗相比，24 周的透皮尼古丁治疗提高了第 24 周经生化确认的点戒烟率和持续戒烟率，降低了戒烟风险，并增加了戒烟后恢复的可能性。
Background: Tobacco dependence is a chronic, relapsing condition that may require extended treatment. Objective: To assess whether extended transdermal nicotine therapy increases abstinence from tobacco more than standard duration therapy in adult smokers. Design: Parallel randomized placebo-controlled trial from September 2004 to February 2008 (small block randomization scheme, not stratified). Study participants and all research personnel except for the database manager were blinded to randomization. (NCT00364156) Setting: Academic center. Participants: 568 adult smokers. Intervention: Participants were randomized to: standard (8 weeks 21mg Nicoderm CQ, 16 weeks placebo) or extended (24 weeks 21mg Nicoderm CQ) therapy. Measurements: The primary outcome was biochemically-verified point prevalence abstinence at weeks 24 and 52. Secondary outcomes were continuous and prolonged abstinence, lapse and recovery events, cost/additional quitter, and side effects and adherence. Results: At 24 weeks, extended therapy produced higher rates of point prevalence abstinence (31.6% versus 20.3%; Odds Ratio [OR] = 1.81 [1.23-2.66], p = 0.002), prolonged abstinence (41.5% versus 26.9%; OR = 1.97 [1.38-2.82] p = 0.001), and continuous abstinence (19.2% versus 12.6%; OR = 1.64 [1.04-2.60] p = 0.032), versus standard therapy. Extended therapy reduced the risk for a lapse (Hazard Ratio [HR] = 0.77 [0.63-0.95], p = 0.013) and increased the chances of recovery from lapses (HR = 1.47 [1.17-1.84], p = 0.001). Time to relapse was slower with extended versus standard therapy (HR = 0.50 [0.35-0.73], p < 0.001). At week 52, extended therapy produced higher quit rates for prolonged abstinence only (p = 0.027). There were no group differences in side effects and adverse events at the extended treatment phase assessment. Limitations: The generalizability of the findings may be limited because participants were treatment-seeking smokers without medical comorbidity and differences in adherence across treatment arms were detected. Conclusion: Compared to 8 weeks of transdermal nicotine, 24 weeks of transdermal nicotine increased biochemically-confirmed point prevalence abstinence and continuous abstinence at week 24, reduced the risk of smoking lapses, and increased the likelihood of post-lapse recovery to abstinence.
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影响因子：
39.2
作者：
Lerman, C;Kaufmann, V;Benowitz, N
通讯作者：
Benowitz, N
影响因子：
4.4
作者：
Kozlowski, Lynn T.;Glovino, Gary A.;Ahern, Frank
通讯作者：
Ahern, Frank
影响因子：
--
作者：
RUSSELL, MAH;STAPLETON, JA;CONNOR, P
通讯作者：
CONNOR, P
影响因子：
4.7
作者：
Rose, Jed E.;Herskovic, Joseph E.;Westman, Eric C.
通讯作者：
Westman, Eric C.
影响因子：
5.9
作者：
Shiffman, S;Scharf, DA;Clark, DB
通讯作者：
Clark, DB