Shiffman Saul, Rolf Clyde N, Hellebusch Stephen J, Gorsline Jane, Gorodetzky Charles W, Chiang Yu-Kun, Schleusener Debra S, Di Marino Michael E
Pinney Associates, Inc, Pittsburgh, PA 15213, USA.
Addiction. 2002 May;97(5):505-16. doi: 10.1046/j.1360-0443.2002.00141.x.
To assess smoking cessation rates achieved with nicotine gum and patch in simulated over-the-counter (OTC) and actual prescription (Rx) settings.
Separate open-label studies with gum and patch in OTC and Rx settings.
There were multiple samples: OTC gum: 2981 smokers; OTC patch: 2367; Rx gum: 324; Rx patch: 669.
All smokers received active nicotine replacement. In the OTC setting, smokers self-selected doses of nicotine gum (2 or 4 mg Nicorette) or patch (21, 14 or 7 mg NicoDerm CQ). No intervention was provided. In the Rx setting, smokers were prescribed gum or patch by their physician.
Biochemically verified continuous smoking abstinence was assessed at 6 weeks (28-day abstinence) and 6 months.
OTC success rates were consistently higher than Rx rates: differences were significant at 6 weeks for both patch [OR = 1.45 (1.05-1.98)] and gum [OR 2.92 (1.58-5.40)], and remained significant at 6 months for patch [OR = 3.63: (1.74-7.61)] but not gum [OR = 1.37: (0.73-2.58)]. Among OTC gum users. 16.1% were abstinent at 6 weeks and 8.4% at 6 months. For Rx gum users, abstinence rates were 7.7% at 6 weeks and 7.7% at 6 months. With OTC patch, 19.0% were abstinent at 6 weeks and 9.2% at 6 months. With Rx patch. abstinence rates were 16.0% at 6 weeks and 3.0% at 6 months.
Smoking cessation rates achieved with nicotine gum and patch under OTC conditions were as good as those under real-world prescribing conditions.
评估在模拟非处方（OTC）和实际处方（Rx）环境下使用尼古丁口香糖和贴片实现的戒烟率。
在OTC和Rx环境中分别进行的关于口香糖和贴片的开放标签研究。
有多个样本：OTC口香糖：2981名吸烟者；OTC贴片：2367名；Rx口香糖：324名；Rx贴片：669名。
所有吸烟者均接受活性尼古丁替代治疗。在OTC环境中，吸烟者自行选择尼古丁口香糖（2或4毫克尼古丁口香糖）或贴片（21、14或7毫克尼古丁透皮贴剂）的剂量。未提供干预措施。在Rx环境中，吸烟者由医生开处方使用口香糖或贴片。
在6周（28天戒烟）和6个月时评估经生化验证的持续戒烟情况。
OTC成功率始终高于Rx成功率：贴片在6周时差异显著[比值比（OR）=1.45（1.05 - 1.98）]，口香糖在6周时差异也显著[OR = 2.92（1.58 - 5.40）]；贴片在6个月时差异仍显著[OR = 3.63：（1.74 - 7.61）]，但口香糖在6个月时差异不显著[OR = 1.37：（0.73 - 2.58）]。在OTC口香糖使用者中，6周时16.1%的人戒烟，6个月时为8.4%。Rx口香糖使用者6周时的戒烟率为7.7%，6个月时为7.7%。使用OTC贴片时，6周时19.0%的人戒烟，6个月时为9.2%。使用Rx贴片时，6周时的戒烟率为16.0%，6个月时为3.0%。
在OTC条件下使用尼古丁口香糖和贴片实现的戒烟率与实际处方条件下的戒烟率相当。
