精神分裂症患者采用伐尼克兰林戒烟：为期12周的
2012/12/13
摘要
目的：2006年，美国FDA批准伐尼克兰用于戒烟。2009年，基于病例报道，FDA增加了对伐尼克兰和安非他酮戒烟副作用警示：可能出现神经精神副作用，包括抑郁及自杀想法和行为。有关伐尼克兰的前瞻性临床试验也未报道除睡眠障碍外其他精神副作用事件发生率增加，但有主要精神疾病的吸烟者都排除在伐尼克兰临床试验之外。本研究进行一项标准的开放标记的、为期12周的伐尼克兰临床试验，在尼古丁依赖的稳定期精神分裂症患者中，评价伐尼克兰戒烟的安全性和戒烟转归。
方法：112名稳定期门诊患者参与为期12周的、开放标记的伐尼克兰联合每周认知行为治疗的戒烟临床试验，参与者吸烟>10支/天。试图戒烟前使用伐尼克兰治疗4周。经过培训的研究者每周收集有关安全性和吸烟转归的数据。
结果：治疗12周后或早期终止治疗后，参与者显示精神症状、抑郁症状和尼古丁撤退症状得到改善。在研究终点，14天和28天的持续戒断率分别为47.3%和34%。在未获得戒断的吸烟者，呼出气CO在治疗期间也显著下降。
结论：此项前瞻性研究显示，伐尼克兰具有较好的耐受性，对于精神分裂症稳定期门诊患者（这些患者具有较高的吸烟率和吸烟相关疾病患病率和死亡率），与认知行为治疗联合，能有效促进戒烟。
（林江涛 审校）
J Dual Diagn. 2012;8(2):117-125. Epub 2012 May 11.
Varenicline for Smoking Cessation in Schizophrenia: Safety and Effectiveness in a 12-Week, Open-Label Trial.
Pachas GN, Cather C, Pratt SA, Hoeppner B, Nino J, Carlini SV, Achtyes ED, Lando H, Mueser KT, Rigotti NA, Goff DC, Evins AE.
Source
Massachusetts General Hospital.
Abstract
OBJECTIVES: Varenicline was approved by the FDA in 2006. In 2009, based largely on case reports, the FDA issued a warning of possible adverse neuropsychiatric effects including depression and suicidal thoughts and behavior for varenicline and bupropion. Prospective trials of varenicline have not reported increased incidence of psychiatric adverse events other than sleep disturbance, but smokers with major mental illness have been excluded from large prospective trials of varenicline to date. We sought to evaluate the effect of a standard open-label 12-week varenicline trial on prospectively assessed safety and smoking outcomes in stable, treated adults with schizophrenia spectrum disorder and nicotine dependence.
METHODS: One-hundred-and-twelve stable outpatients who smoked >10 cigarettes/day participated in a 12-week, open-label, smoking cessation trial of varenicline and weekly group cognitive behavioral therapy. Participants took varenicline for 4 weeks before attempting cessation. Trained raters collected safety and smoking outcome data weekly.
RESULTS: Participants demonstrated improved psychotic symptoms, depressive symptoms and nicotine withdrawal symptoms from baseline to week 12 or early termination. At the end of 12 weeks open label treatment, the 14- and 28-day continuous abstinence rates were 47.3 and 34%, respectively. Expired CO declined significantly during treatment in those who did not achieve abstinence.
CONCLUSIONS: This prospective study suggests that varenicline may be well-tolerated and effective for smoking cessation in combination with group CBT in stable outpatients with schizophrenia, a group with high rates of smoking and smoking-attributable morbidity and mortality.
目的：2006年，美国FDA批准伐尼克兰用于戒烟。2009年，基于病例报道，FDA增加了对伐尼克兰和安非他酮戒烟副作用警示：可能出现神经精神副作用，包括抑郁及自杀想法和行为。有关伐尼克兰的前瞻性临床试验也未报道除睡眠障碍外其他精神副作用事件发生率增加，但有主要精神疾病的吸烟者都排除在伐尼克兰临床试验之外。本研究进行一项标准的开放标记的、为期12周的伐尼克兰临床试验，在尼古丁依赖的稳定期精神分裂症患者中，评价伐尼克兰戒烟的安全性和戒烟转归。
方法：112名稳定期门诊患者参与为期12周的、开放标记的伐尼克兰联合每周认知行为治疗的戒烟临床试验，参与者吸烟>10支/天。试图戒烟前使用伐尼克兰治疗4周。经过培训的研究者每周收集有关安全性和吸烟转归的数据。
结果：治疗12周后或早期终止治疗后，参与者显示精神症状、抑郁症状和尼古丁撤退症状得到改善。在研究终点，14天和28天的持续戒断率分别为47.3%和34%。在未获得戒断的吸烟者，呼出气CO在治疗期间也显著下降。
结论：此项前瞻性研究显示，伐尼克兰具有较好的耐受性，对于精神分裂症稳定期门诊患者（这些患者具有较高的吸烟率和吸烟相关疾病患病率和死亡率），与认知行为治疗联合，能有效促进戒烟。
（林江涛 审校）
J Dual Diagn. 2012;8(2):117-125. Epub 2012 May 11.
Varenicline for Smoking Cessation in Schizophrenia: Safety and Effectiveness in a 12-Week, Open-Label Trial.
Pachas GN, Cather C, Pratt SA, Hoeppner B, Nino J, Carlini SV, Achtyes ED, Lando H, Mueser KT, Rigotti NA, Goff DC, Evins AE.
Source
Massachusetts General Hospital.
Abstract
OBJECTIVES: Varenicline was approved by the FDA in 2006. In 2009, based largely on case reports, the FDA issued a warning of possible adverse neuropsychiatric effects including depression and suicidal thoughts and behavior for varenicline and bupropion. Prospective trials of varenicline have not reported increased incidence of psychiatric adverse events other than sleep disturbance, but smokers with major mental illness have been excluded from large prospective trials of varenicline to date. We sought to evaluate the effect of a standard open-label 12-week varenicline trial on prospectively assessed safety and smoking outcomes in stable, treated adults with schizophrenia spectrum disorder and nicotine dependence.
METHODS: One-hundred-and-twelve stable outpatients who smoked >10 cigarettes/day participated in a 12-week, open-label, smoking cessation trial of varenicline and weekly group cognitive behavioral therapy. Participants took varenicline for 4 weeks before attempting cessation. Trained raters collected safety and smoking outcome data weekly.
RESULTS: Participants demonstrated improved psychotic symptoms, depressive symptoms and nicotine withdrawal symptoms from baseline to week 12 or early termination. At the end of 12 weeks open label treatment, the 14- and 28-day continuous abstinence rates were 47.3 and 34%, respectively. Expired CO declined significantly during treatment in those who did not achieve abstinence.
CONCLUSIONS: This prospective study suggests that varenicline may be well-tolerated and effective for smoking cessation in combination with group CBT in stable outpatients with schizophrenia, a group with high rates of smoking and smoking-attributable morbidity and mortality.
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高剂量和联合尼古丁替代治疗、伐尼克兰和安非
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戒烟治疗的疗效：来自国际烟草控制组织（ITC）
