Lerman Caryn, Kaufmann Vyga, Rukstalis Margaret, Patterson Freda, Perkins Kenneth, Audrain-McGovern Janet, Benowitz Neal
Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania 19104, USA.
Ann Intern Med. 2004 Mar 16;140(6):426-33. doi: 10.7326/0003-4819-140-6-200403160-00009.
Despite the well-documented efficacy and different pharmacokinetic and pharmacodynamic properties of different forms of nicotine replacement therapy, empirical data are insufficient to guide practitioners in selecting a particular form of treatment for individual patients with tobacco dependence.
To evaluate the comparative efficacy of transdermal nicotine and nicotine nasal spray and identify predictors of treatment outcome.
Randomized, open-label clinical trial with a 6-month follow-up period.
2 university-based smoking cessation research programs.
299 treatment-seeking smokers who were followed for 6 months after the target quit date.
Behavioral group counseling and 8 weeks of therapy with nicotine nasal spray or transdermal nicotine.
Demographic characteristics, smoking history, depression symptoms, and body mass index were measured at baseline. Smoking practices were biochemically verified at the end of treatment and at 6 months after the target quit date.
Abstinence rates for the transdermal nicotine and nicotine nasal spray groups were not significantly different at 6-month follow-up (15.0% vs. 12.2%, respectively; P > 0.2). Interactions in abstinence rates for subgroups of smokers were statistically significant (P < 0.05). Smokers who had low to moderate dependence levels, were not obese, and were white achieved higher abstinence rates with transdermal nicotine, whereas smokers who were highly dependent, obese, or members of minority groups achieved higher abstinence rates with nasal spray.
The subgroup findings need confirmation in additional large studies before they are routinely applied.
Ethnicity, weight, and level of nicotine dependence may help identify smokers who have greater or lesser abstinence rates with either transdermal or nasal spray nicotine.
尽管不同形式的尼古丁替代疗法的疗效、药代动力学和药效学特性都有充分记录，但实证数据不足以指导从业者为个体烟草依赖患者选择特定的治疗形式。
评估经皮尼古丁和尼古丁鼻喷雾剂的相对疗效，并确定治疗结果的预测因素。
为期6个月随访期的随机、开放标签临床试验。
2个大学戒烟研究项目。
299名寻求治疗的吸烟者，在目标戒烟日期后随访6个月。
行为小组咨询以及使用尼古丁鼻喷雾剂或经皮尼古丁进行8周治疗。
在基线时测量人口统计学特征、吸烟史、抑郁症状和体重指数。在治疗结束时以及目标戒烟日期后6个月对吸烟情况进行生化验证。
在6个月随访时，经皮尼古丁组和尼古丁鼻喷雾剂组的戒烟率无显著差异（分别为15.0%和12.2%；P>0.2）。吸烟者亚组的戒烟率交互作用具有统计学意义（P<0.05）。低至中度依赖水平、不肥胖且为白人的吸烟者使用经皮尼古丁戒烟率更高，而高度依赖、肥胖或属于少数群体的吸烟者使用鼻喷雾剂戒烟率更高。
在常规应用之前，亚组研究结果需要在更多大型研究中得到证实。
种族、体重和尼古丁依赖水平可能有助于确定使用经皮或鼻喷雾剂尼古丁时戒烟率较高或较低的吸烟者。
