国产尼古丁舌下含片终止吸烟效果的随机双盲研究

目的 评价国产尼古丁舌下含片戒烟治疗的疗效及安全性。方法 采用随机双盲安慰剂对照研究方法，将230例符合入组条件并签署知情同意书的吸烟者分为尼古丁舌下含片组（治疗组；2mg／片）和安慰剂组，每组各115例，疗程12周；观察治疗期间不同时点戒烟成功率（吸烟量≤1支／d）、吸烟减少有效率（治疗期间吸烟量较治疗前减少≥50％的比例），并评定可视性渴求强度测评表；以尿可替宁和呼气一氧化碳浓度验证吸烟情况。结果 治疗后，治疗组和安慰剂组戒烟成功率分别为52．2％和19．1％，吸烟减少有效率分别为42．6％和14．8％，两组差异具有统计学意义（P〈0．01）；治疗第2～12周末治疗组渴求强度的得分、CO呼出量均小于安慰剂组（P〈0．01）；治疗组尿可替宁含量在第8周和第12周低于安慰剂组（P〈0．01）。治疗期间两组均无严重不良事件发生。结论 尼古丁舌下含片在12周内的戒烟疗效优于安慰剂，不良反应轻，耐受性好，适用于戒烟治疗。

The smoking cessation efficacy of nicotine sublingual tablet :a double-blind, placebo-controlled trial

Objective To evaluate the efficacy and safety of nicotine sublingual tablet on smoking cessation.Methods In the double-blind,placebo-controlled study,230 eligible smokers were randomly given nicotine sublingual tablet(2 mg/pill) treatment(n=115) or placebo(n=115).The smokers in treatment group were prescribed holding the maximum of 15 to 20 pills daily in the mouth from the 1~(st) to 4~(th) week,then decreased progressively from the 5~(th) week,and discontinued at the end of the 8~(th) week.At the end of 12~(th) week,the smoking abstinence rate,expired breath carbon monoxide(CO) level,urinary cotinine concentration and side effects were compared.Results The rates of complete abstinence were 52.2% in nicotine-treatment group and 19.1% in placebo group,and the rates of smoking reduction,i.e.,reduction 50% of smoking were 42.6% and 14.8%,respectively.The severity of smoking craving,concentration of expired CO and urinary cotinine was decreasing along with the treatment progress.The side effects were mild and tolerable.Conclusion The results indicate that nicotine sublingual tablets is acutely effective in smoking cessation for Chinese smokers,with mild and tolerable side effects.