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托吡酯治疗与肥胖相关的暴饮暴食症:一项随机、安慰剂对照试验。

Topiramate in the treatment of binge eating disorder associated with obesity: a randomized, placebo-controlled trial.

作者信息

McElroy Susan L, Arnold Lesley M, Shapira Nathan A, Keck Paul E, Rosenthal Norman R, Karim M Rezaul, Kamin Marc, Hudson James I

机构信息

Division of Psychopharmacology Research, Department of Psychiatry, University of Cincinnati College of Medicine, OH 45267-0559, USA.

出版信息

Am J Psychiatry. 2003 Feb;160(2):255-61. doi: 10.1176/appi.ajp.160.2.255.

DOI:10.1176/appi.ajp.160.2.255
PMID:12562571
Abstract

OBJECTIVE

Binge eating disorder is associated with obesity. Topiramate is an antiepileptic agent associated with weight loss. The objective of this study was to evaluate topiramate in the treatment of binge eating disorder associated with obesity.

METHOD

For this 14-week, double-blind, flexible-dose (25-600 mg/day) topiramate trial, 61 outpatients (53 women, eight men) with binge eating disorder who were obese (body mass index >/=30 kg/m(2)) were randomly assigned to receive topiramate (N=30) or placebo (N=31). The primary efficacy measure was binge frequency. The primary analysis of efficacy was a repeated-measures random regression with treatment-by-time as the effect measure.

RESULTS

Compared with placebo, topiramate was associated with a significantly greater rate of reduction in binge frequency, binge day frequency, body mass index, weight, and scores on the Clinical Global Impression severity scale and the Yale-Brown Obsessive Compulsive Scale (modified for binge eating). Topiramate was also associated with significantly greater reductions in binge frequency (topiramate: 94%, placebo: 46%) and binge day frequency (topiramate: 93%, placebo: 46%) and with a significantly higher level of response than placebo. The mean weight loss for topiramate-treated subjects who completed the study was 5.9 kg. Median topiramate dose was 212 mg/day (range=50-600). Nine patients (three receiving placebo, six given topiramate) discontinued because of adverse events. The most common reasons for discontinuing topiramate were headache (N=3) and paresthesias (N=2).

CONCLUSIONS

Topiramate was efficacious and relatively well tolerated in the short-term treatment of binge eating disorder associated with obesity.

摘要

目的

暴饮暴食症与肥胖相关。托吡酯是一种与体重减轻相关的抗癫痫药物。本研究的目的是评估托吡酯治疗与肥胖相关的暴饮暴食症的效果。

方法

在这项为期14周的双盲、灵活剂量(25 - 600毫克/天)托吡酯试验中,61名患有暴饮暴食症且肥胖(体重指数≥30千克/米²)的门诊患者(53名女性,8名男性)被随机分配接受托吡酯(N = 30)或安慰剂(N = 31)。主要疗效指标是暴饮暴食频率。疗效的主要分析是采用以治疗时间为效应指标的重复测量随机回归分析。

结果

与安慰剂相比,托吡酯与暴饮暴食频率、暴饮暴食日频率、体重指数、体重以及临床总体印象严重程度量表和耶鲁 - 布朗强迫量表(针对暴饮暴食进行修改)得分的显著更大降幅相关。托吡酯还与暴饮暴食频率(托吡酯组:94%,安慰剂组:46%)和暴饮暴食日频率(托吡酯组:93%,安慰剂组:46%)的显著更大降幅以及比安慰剂显著更高的缓解水平相关。完成研究的接受托吡酯治疗的受试者平均体重减轻5.9千克。托吡酯的中位剂量为212毫克/天(范围 = 50 - 600)。9名患者(3名接受安慰剂,6名给予托吡酯)因不良事件停药。停用托吡酯的最常见原因是头痛(N = 3)和感觉异常(N = 2)。

结论

托吡酯在短期治疗与肥胖相关的暴饮暴食症方面有效且耐受性相对良好。

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