Fluoxetine after weight restoration in anorexia nervosa - A randomized controlled trial

Fluoxetine after weight restoration in anorexia nervosa - A randomized controlled trial
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DOI:
10.1001/jama.295.22.2605
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发表时间:
2006-06-14
影响因子:
120.7
通讯作者:
Rockert, Wendi
Rockert, Wendi
中科院分区:
医学1区
文献类型:
--
作者:
Walsh, B. Timothy;Kaplan, Allan S.;Rockert, Wendi

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背景 神经性厌食症患者经常服用抗抑郁药物。目的 确定氟西汀是否可以促进体重恢复后神经性厌食症患者的康复并延长复发时间。设计、设置和参与者随机、双盲、安慰剂对照试验。从2000年1月到2005年5月,93名神经性厌食症患者在纽约州精神病研究所或多伦多总医院接受了强化住院或日间治疗。参与者的体重恢复到最低体重指数(按体重公斤数除以米身高的平方计算)为 19.0,然后有资格参加试验的随机阶段。 干预措施 参与者被随机分配接受氟西汀或安慰剂,并以双盲方式作为门诊患者接受长达 1 年的治疗。所有患者还接受了个体认知行为治疗。 主要结果指标 主要结果指标是复发时间和成功完成 1 年治疗的患者比例。结果 49 名患者被分配至氟西汀组,44 名患者被分配至安慰剂组。分配至氟西汀组和安慰剂组的患者中,体重指数保持在至少 18.5 并持续研究 52 周的患者比例相似(氟西汀组,26.5%;安慰剂组,31.5%;P=.57)。在 Cox 比例风险分析中,以随机化前的体重指数、部位和诊断亚型作为协变量,氟西汀和安慰剂在复发时间方面没有显着差异(风险比,1.12;95% CI,0.65-2.01;P=.64)。 结论 这项研究未能证明氟西汀治疗体重恢复后神经性厌食症患者有任何益处。未来的努力应集中于开发新模型来了解这种疾病的持续性,并探索新的心理和药物治疗方法。
Context Antidepressant medication is frequently prescribed for patients with anorexia nervosa.Objective To determine whether fluoxetine can promote recovery and prolong time-to-relapse among patients with anorexia nervosa following weight restoration.Design, Setting, and Participants Randomized, double-blind, placebo-controlled trial. From January 2000 until May 2005, 93 patients with anorexia nervosa received intensive inpatient or day-program treatment at the New York State Psychiatric Institute or Toronto General Hospital. Participants regained weight to a minimum body mass index ( calculated as weight in kilograms divided by the square of height in meters) of 19.0 and were then eligible to participate in the randomized phase of the trial.Interventions Participants were randomly assigned to receive fluoxetine or placebo and were treated for up to 1 year as outpatients in double-blind fashion. All patients also received individual cognitive behavioral therapy.Main Outcome Measures The primary outcome measures were time-to-relapse and the proportion of patients successfully completing 1 year of treatment.Results Forty-nine patients were assigned to fluoxetine and 44 to placebo. Similar percentages of patients assigned to fluoxetine and to placebo maintained a body mass index of at least 18.5 and remained in the study for 52 weeks ( fluoxetine, 26.5%; placebo, 31.5%; P=. 57). In a Cox proportional hazards analysis, with prerandomization body mass index, site, and diagnostic subtype as covariates, there was no significant difference between fluoxetine and placebo in time-to-relapse ( hazard ratio, 1.12; 95% CI, 0.65- 2.01; P=. 64).Conclusions This study failed to demonstrate any benefit from fluoxetine in the treatment of patients with anorexia nervosa following weight restoration. Future efforts should focus on developing new models to understand the persistence of this illness and on exploring new psychological and pharmacological treatment approaches.