酒石酸伐尼克兰片戒烟的疗效和安全性评价  

Evaluation and safety of varenicline tartrate tablets for smoking cessation

作　　者：张静[1] 陈宝元[1] 李津娜[1] 曹洁[1] 周宁[1] 郭美南[1] 王彦[1] 

机构地区：[1]天津医科大学总医院呼吸科,300052

出　　处：《国际呼吸杂志》2012年第8期592-595,共4页International Journal of Respiration

摘　　要：目的评价酒石酸伐尼克兰片1mg（2次／d）戒烟疗效和安全性。方法采用前瞻性、随机、双盲、安慰剂对照设计，比较酒石酸伐尼克兰片和安慰剂从第9周到第12周的4周持续戒烟率、从第9周到第24周的持续戒烟率、第12周和第24周的7d时点戒烟率、第24周的4周时点戒烟率。结果①9到12周韵持续戒烟率、9到24周的长期戒烟率及第12周的7d时点戒烟率治疗组高于安慰剂对照组（P〈0．05），第24周的7d时点戒烟率和第24周的4周时点戒烟率两者无显著差异（P〉0．05），②酒石酸伐尼克兰片的主要不良事件是集中在胃肠道方面，并未观察到与酒石酸伐尼克兰片直接相关严重不良事件。结论酒石酸伐尼克兰片剂根据推荐剂量（1mg，2次／d，12周）使用时，戒烟疗效优于安慰剂，并未发现有明显的安全性问题。Objective To evaluate efficacy and safety of varenicline tartrate tablets （1 mg BID） for smoking cessation. Methods A prospective, randomized, double-blind, placebo-controlled trial to compare the 4-week continuous quit rate （CQR） for weeks 9-12, the continuous abstinence rate （CAR） for weeks 9-24,7-day point prevalence of nonsmoking at week 12 and 24 and 4-week point prevalence of nonsmoking at week 24 of varenicline and placebo for smoking cessation. Results ①The 4-week CQR for weeks 9 12, the CAR for weeks 9-24 and 7-day point prevalence of nonsmoking at week 12 in the treatment group were higher than the placebo control group （ P 〈0.05）. 7-day point prevalence and 4-week point prevalence of nonsmoking at week 24 in all groups showed no significant difference （ P 〉0.05）.②Main adverse events of varenicline focused on gastrointestinal tract. Serious adverse events directly related to varenicline were not observed. Conclusions The efficacy of varenicline of recommended dose （1 mg BID for 12 weeks） for smoking cessation is better than placebo. Serious safety issues are not observed.

关 键 词：伐尼克兰 戒烟 疗效 安全性 

分 类 号：R96[医药卫生—药理学]