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首页> 外文期刊>BMC Family Practice >Effectiveness of topiramate for tobacco dependence in patients with depression; a randomised, controlled trial
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Effectiveness of topiramate for tobacco dependence in patients with depression; a randomised, controlled trial

机译：托吡酯对抑郁症患者烟草依赖的有效性;随机对照试验

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Background Tobacco dependence management is a multi-component intervention that includes pharmacological treatments such as Nicotine Substitution Therapy (NST) or bupropion, and psychological therapy. There are some preliminary reports on topiramate efficacy for tobacco dependence. The aim of this study is to determine whether topiramate is as effective as the standard NST treatment for tobacco cessation at 1-year follow-up in patients with depression. Method/design Design: A randomised, controlled trial involving two groups, one of which is the control group consisting of patients on the standard pharmacological treatment for tobacco cessation (NST) and the other is the intervention group consisting of patients on topiramate as pharmacological treatment. Setting: 29 primary care health centres in the city of Zaragoza, Spain. Sample: 180 patients, aged 18–65 years, diagnosed with major depression, smoke more than 20 cigarettes/day, who have voluntarily asked for tobacco cessation therapy. Intervention: A multi-component programme for tobacco cessation is offered to all of the patients in the study. This programme is made up of pharmacological therapy + group cognitive-behavioural therapy. Pharmacological therapy consists of NST for the control group and topiramate (200 mg/day) for the intervention group. Psychological therapy is made up of 16 sessions of manualised group therapy. Measurements: Cessation will be assessed by patient self-declared abstinence, expired air carbon monoxide levels, and cotinine levels in saliva. Questionnaires on tobacco dependence, anxiety, depression, impulsiveness and self-efficacy will be administered. The interviewers will not know which group the patient belongs to (blind). The assessments will be carried out at baseline, D (cessation day) -1, D+1, weeks 1, 2, 3, 4, 6, 8, 10 and 13, and months 4, 5, 6, 8, 10 and 12. Main variables: Tobacco cessation rates and tobacco dependence. Analysis: The analysis will be per intent to treat. We will use the general linear models of the SPSS version 15 statistical package, to analyse the effect of the treatment on the result variable (tobacco cessation rate). Discussion It is necessary to develop new and more effective pharmacological treatments for tobacco cessation. This randomised clinical trial will determine whether topiramate is effective for tobacco cessation in patients with depression. Trial registration Current Controlled Trials ISRCTN93532081
机译：背景技术烟草依赖管理是一个多成分干预措施，包括药物治疗，例如尼古丁替代疗法（NST）或安非他酮，以及心理治疗。关于托吡酯对烟草依赖的功效有一些初步的报道。这项研究的目的是确定在抑郁症患者接受1年随访时，托吡酯是否与标准NST治疗戒烟一样有效。方法/设计设计：一项包括两组的随机对照试验，一组为接受标准戒烟药物治疗的对照组，另一组为接受托吡酯药物治疗的干预组。 。地点：西班牙萨拉戈萨市的29个初级保健中心。样本：180名年龄在18-65岁之间的患者，被诊断出患有严重的抑郁症，每天吸烟超过20支香烟，他们自愿要求戒烟治疗。干预：向研究中的所有患者提供戒烟的多部分程序。该程序由药物治疗+团体认知行为治疗组成。药理治疗由对照组的NST和干预组的托吡酯（200 mg / day）组成。心理治疗由16节手动小组治疗组成。测量：戒断将通过患者自我宣布的禁欲，呼出的空气中一氧化碳水平和唾液中可替宁水平进行评估。将对烟草依赖，焦虑，抑郁，冲动和自我效能进行问卷调查。访调员不会知道患者属于哪个组（盲人）。评估将在基线，D（戒烟日）-1，D + 1，第1、2、3、4、6、8、10和13周以及第4、5、6、8、10个月进行。 12.主要变量：戒烟率和烟草依赖性。分析：将按意图进行分析。我们将使用SPSS 15版统计软件包的常规线性模型来分析治疗对结果变量（戒烟率）的影响。讨论有必要开发新的更有效的戒烟药物治疗方法。这项随机临床试验将确定托吡酯对抑郁症患者戒烟是否有效。试用注册电流对照试验ISRCTN93532081

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