CAJ | 학술논문

目的评价酒石酸伐尼克兰片1 mg(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周的持续戒烟率、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(1 mg,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.
목적 평개주석산벌니극란편1 mg(2차/d)계연료효화안전성.방법 채용전첨성、수궤、쌍맹、안위제대조설계,비교주석산벌니극란편화안위제종제9주도제12주적4주지속계연솔、종제9주도제24주적지속계연솔、제12주화제24주적7d시점계연솔、제24주적4주시점계연솔.결과 ①9도12주적지속계연솔、9도24주적장기계연솔급제12주적7d시점계연솔치료조고우안위제대조조(P＜0.05),제24주적7d시점계연솔화제24주적4주시점계연솔량자무현저차이(P＞0.05).②주석산벌니극란편적주요불량사건시집중재위장도방면,병미관찰도여주석산벌니극란편직접상관엄중불량사건.결론 주석산벌니극란편제근거추천제량(1 mg,2차/d,12주)사용시,계연료효우우안위제,병미발현유명현적안전성문제.
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.