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首页> 外文期刊>The journal of clinical psychiatry >Zonisamide in the treatment of binge-eating disorder: an open-label, prospective trial.
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Zonisamide in the treatment of binge-eating disorder: an open-label, prospective trial.

机译：唑尼沙胺治疗暴食症：一项开放性，前瞻性试验。

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BACKGROUND: Binge-eating disorder is characterized by recurrent episodes of uncontrollable overeating without compensatory weight-loss behaviors. It commonly co-occurs with obesity. Zonisamide is a novel antiepileptic drug associated with weight loss. The purpose of this study was to preliminarily assess zonisamide in the treatment of binge-eating disorder. METHOD: Fifteen outpatients with DSM-IV-TR binge-eating disorder were enrolled from Jan. 25, 2002, through Sept. 10, 2002, in an open-label, prospective, 12-week, flexible dose (100-600 mg/day) study of zonisamide. The primary outcome measure was binge-eating episode frequency. Secondary measures included binge day frequency, body mass index (BMI), weight, Clinical Global Impressions-Severity of Illness scale (CGI-S) scores, Yale-Brown Obsessive-Compulsive Scale Modified for Binge Eating (YBOCS-BE) scores, Three Factor Eating Questionnaire (TFEQ) scores, and Hamilton Rating Scale for Depression scores. Safety measures included adverse events, routine blood chemical and hematology laboratory values, urinalyses, plasma zonisamide levels, physical examination findings, and electrocardiograms. Outcome measures were analyzed by a repeated-measures random regression analysis using all data and an endpoint analysis using last observation carried forward. RESULTS: Eight subjects completed the 12 weeks of treatment. The mean (SD) zonisamide daily dose at endpoint evaluation was 513 (103) mg/day. Both the random regression and endpoint analyses found a highly significant decrease in binge-eating episode frequency, binge day frequency, BMI, weight, CGI-S scores, YBOCS-BE total scores, and TFEQ hunger and disinhibition scores (p <.0001 for all measures in both analyses except p =.001 for endpoint analysis of binge eating frequency, p =.0001 for endpoint analysis of TFEQ disinhibition, and p =.0008 for endpoint analysis of TFEQ hunger). The 7 subjects who discontinued zonisamide prematurely did so due to lack of response (N = 1), protocol non-adherence (N = 2), and adverse events (N = 4). CONCLUSION: Zonisamide was effective in reducing binge-eating frequency, severity of illness, and weight and was generally well tolerated in an open trial of binge-eating disorder. Controlled trials appear warranted.
机译：背景：暴饮暴食症的特征是反复发作的无法控制的暴饮暴食，没有补偿性的减肥行为。它通常与肥胖同时发生。唑尼沙胺是与体重减轻有关的新型抗癫痫药。这项研究的目的是初步评估zonisamide治疗暴食症。方法：从2002年1月25日至2002年9月10日，对15名患有DSM-IV-TR暴饮暴食症的门诊患者采用开放标签，前瞻性，为期12周的灵活剂量（100-600 mg /天）研究唑尼沙胺。主要结局指标为暴饮暴食发作频率。次要测量指标包括暴饮暴食日频率，体重指数（BMI），体重，临床总体印象-疾病严重程度量表（CGI-S）得分，耶鲁-布朗强迫症饮食强迫症量表（YBOCS-BE）得分，三个因子饮食调查表（TFEQ）评分和汉密尔顿抑郁量表评分量表。安全措施包括不良事件，常规血液化学和血液学实验室值，尿液分析，血浆唑尼沙胺水平，体格检查结果和心电图。通过对所有数据进行重复测量的随机回归分析，并对结转的分析进行终点分析。结果：8名受试者完成了12周的治疗。终点评估时的平均（SD）唑尼沙胺每日剂量为513（103）mg /天。随机回归和终点分析均发现暴饮暴食发作频率，暴饮暴食日频率，BMI，体重，CGI-S得分，YBOCS-BE总得分以及TFEQ饥饿和禁忌得分显着降低（对于p <.0001两种分析中的所有指标，除了暴饮暴食频率的终点分析为p = .001，TFEQ抑制作用的终点分析为p = .0001以及TFEQ饥饿的终点分析为p = .0008）。由于缺乏反应（N = 1），方案未坚持（N = 2）和不良事件（N = 4），提前中止唑尼沙胺的7名受试者这样做。结论：唑尼沙胺可有效减少暴饮暴食的频率，疾病的严重程度和体重，并且在暴食暴食症的公开试验中通常具有良好的耐受性。对照试验似乎是必要的。

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