首页> 外文期刊>The journal of clinical psychiatry >Combination therapy of zonisamide and bupropion for weight reduction in obese women: a preliminary, randomized, open-label study.
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Combination therapy of zonisamide and bupropion for weight reduction in obese women: a preliminary, randomized, open-label study.

机译:唑尼沙胺和安非他酮的联合疗法可减轻肥胖女性的体重:一项初步的,随机,开放标签的研究。

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OBJECTIVE: Zonisamide and bupropion have been investigated for weight reduction in obese adults. We conducted a preliminary study comparing the effect on body weight of the combination of these 2 drugs versus zonisamide monotherapy. METHOD: This was a 12-week, randomized, open-label, parallel-group comparison of 2 active interventions conducted from October 2003 to June 2004. Eighteen obese women (mean [SE] body mass index of 36.8 [1.2] kg/m(2)) were randomly assigned to receive the combination of zonisamide and bupropion (N = 9) or zonisamide alone (N = 9). All subjects were prescribed a balanced hypocaloric diet (500 kcal/day deficit) and compliance was monitored with self-rated food diaries. Zonisamide therapy was started at 100 mg/day, with a gradual increase to 400 mg/day over 4 weeks for both groups. In addition, the group assigned to combination therapy received bupropion, which was started at 100 mg/day, with an increase to 200 mg/day after 2 weeks. Zonisamide was administered at night and bupropion in the morning. Body weight in kilograms was the primary outcome measure. RESULTS: In an intent-to-treat analysis, carrying the last observation forward for all randomly assigned participants with at least 1 postbaseline assessment, the combination group lost more body weight than the zonisamide group (mean [SE] = 7.2 [1.2] kg [7.5%] vs. 2.9 [0.7] kg [3.1%]; F = 4.7, df = 4,56; p = .003) during the 12-week period. For the subset of 12 patients (combination, N = 7; zonisamide, N = 5) that completed the full 12-week treatment, the mean (SE) weight loss was 8.1 (1.4) kg (8.5%) for the combination group versus 3.0 (0.9) kg (3.3%) for the zonisamide group (F = 4.6, df = 4,40; p = .004). Six subjects in the combination group and 2 in the zonisamide group lost at least 5% of body weight. CONCLUSION: In this short-term, open-label, preliminary trial, combination treatment of zonisamide and bupropion resulted in more weight loss than treatment with zonisamide alone.
机译:目的:唑尼沙胺和安非他酮已被研究用于减轻肥胖成年人的体重。我们进行了一项初步研究,比较了这两种药物与zonisamide单药治疗对体重的影响。方法:这是对2003年10月至2004年6月进行的2项积极干预措施进行的为期12周,随机,开放标签,平行分组的比较。18名肥胖妇女(平均[SE]体重指数为36.8 [1.2] kg / m (2))随机分配接受唑尼沙胺和安非他酮的组合(N = 9)或单独使用唑尼沙胺(N = 9)。所有受试者均接受均衡的低热量饮食(每天500大卡/天的热量不足),并通过自我评估的食物日记来监测依从性。唑尼沙胺治疗的起始剂量为100毫克/天,两组在4周内逐渐增加至400毫克/天。此外,分配给联合治疗的组接受了安非他酮,安非他酮的剂量为100 mg /天,两周后增加到200 mg /天。唑尼沙胺在晚上和安非他酮在早上给药。体重以公斤为主要指标。结果:在意向性治疗分析中,对所有至少经过1个基线评估的随机分配的参与者进行了最后观察,合并组的体重减轻比唑尼沙胺组重(平均[SE] = 7.2 [1.2] kg [7.5%] vs. 2.9 [0.7] kg [3.1%]; F = 4.7,df = 4,56; p = 0.003)。对于完成了整整12周治疗的12例患者(组合,N = 7; zonisamide,N = 5),组合组的平均(SE)体重减轻为8.1(1.4)kg(8.5%)唑尼沙胺组为3.0(0.9)千克(3.3%)(F = 4.6,df = 4,40; p = .004)。组合组中的六名受试者和唑尼沙胺组中的两名受试者的体重减轻了至少5%。结论:在这个短期的,开放的,初步的试验中,唑尼沙胺和安非他酮的联合治疗比单独使用唑尼沙胺治疗可导致更多的体重减轻。

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