CAJ | 학술논문

目的评估伐尼克兰联合心理咨询行为干预对烟草依赖的疗效和安全性,并对中国烟草依赖者短期、长期戒烟率和安全性进行随访.方法采用前瞻性、开放临床试验.对入选烟草依赖者给予口服12周伐尼克兰,联合戒烟建议随访,共随访到24周,观察戒烟者呼出气一氧化碳证实的戒烟率、不良反应及戒断症状.结果入选病例27例,12周和24周持续戒烟率分别为78%和74%.不良反应主要为恶心(37%)、失眠(19%)、头痛(11%)、疲乏(7%)、异常梦境(7%)等,程度轻微,多为一过性.治疗阶段12周体质量平均增加(1.0±1.3)kg.戒断症状轻微,12周评分为1.9±2.3.结论伐尼克兰联合心理咨询行为干预短期和长期戒烟率高,伐尼克兰安全、耐受性好,对中国烟草依赖者具有适用性.
목적 평고벌니극란연합심리자순행위간예대연초의뢰적료효화안전성,병대중국연초의뢰자단기、장기계연솔화안전성진행수방.방법 채용전첨성、개방림상시험.대입선연초의뢰자급여구복12주벌니극란,연합계연건의수방,공수방도24주,관찰계연자호출기일양화탄증실적계연솔、불량반응급계단증상.결과 입선병례27례,12주화24주지속계연솔분별위78%화74%.불량반응주요위악심(37%)、실면(19%)、두통(11%)、피핍(7%)、이상몽경(7%)등,정도경미,다위일과성.치료계단12주체질량평균증가(1.0±1.3)kg.계단증상경미,12주평분위1.9±2.3.결론 벌니극란연합심리자순행위간예단기화장기계연솔고,벌니극란안전、내수성호,대중국연초의뢰자구유괄용성.
Objective To evaluate the efficiency and safety of varenicline in combination with psychological and behavioral support for tobacco dependence in China. Methods In this post-marketing, prospective, open-label study, participants of tobacco dependence without a serious or unstable disease were included for treatment with 12-week varenicline in combination with up to 10 minutes of smoking cessation counseling. Thereafter, participants continued into a nontreatment follow-up phase for an additional 12 weeks. Adverse reactions and clinical efficacy of carbon monoxide-confirmed continuous abstinence rates(CAR) from both week 9-12 and week 20-24 were recorded. Results The CAR of treatment phase from week 9-12 was 78% , and this advantage was maintained through the nontreatment follow-up to week 24, with CAR from week 20-24 being 74%. The common adverse drug reactions were nausea (37%), insomnia (19%), headache ( 11%) , fatigue (7%) and abnormal dreams (7%), which were generally mild to moderate intensity and often diminished over time. Mean increased in body weight during the 12-week treatment period were (1.0±1.3)kg. Mean withdrawal scale score from week 12 for all subjects was 1.9±2.3, showing that varenicline reduced the urge to smoke during treatment phase. Conclusions Varenicline, in combination with psychological and behavioral support, was efficacious, safe, and well-tolerated agent for smoking cessation in Chinese smokers over a 12-week treatment period,and its effects persisted for a further 12-week follow-up period.