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奥氮平与安慰剂治疗成人神经性厌食症患者的随机临床试验。

Olanzapine Versus Placebo in Adult Outpatients With Anorexia Nervosa: A Randomized Clinical Trial.

机构信息

From the Department of Psychiatry, Columbia University Irving Medical Center, New York (Attia, Steinglass, Walsh, Wang); the Department of Biostatistics, Mailman School of Public Health, Columbia University, New York (Wang, Wu); the Eating Disorders Research Program, New York State Psychiatric Institute, New York (Attia, Steinglass, Walsh); the Center for Eating Disorders, Weill Cornell Medical College, New York (Attia); the Department of Psychiatry and Behavioral Sciences, Johns Hopkins Medicine (Schreyer, Guarda); the Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh (Wildes, Marcus); the Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago (Wildes); the Center of Excellence for Eating Disorders, University of North Carolina (Yilmaz); and the Department of Psychiatry and the Toronto Center for Addiction and Mental Health, University of Toronto (Kaplan).

出版信息

Am J Psychiatry. 2019 Jun 1;176(6):449-456. doi: 10.1176/appi.ajp.2018.18101125. Epub 2019 Jan 18.

Abstract

OBJECTIVE

This study evaluated the benefits of olanzapine compared with placebo for adult outpatients with anorexia nervosa.

METHODS

This randomized double-blind placebo-controlled trial of adult outpatients with anorexia nervosa (N=152, 96% of whom were women; the sample's mean body mass index [BMI] was 16.7) was conducted at five sites in North America. Participants were randomly assigned in a 1:1 ratio to receive olanzapine or placebo and were seen weekly for 16 weeks. The primary outcome measures were rate of change in body weight and rate of change in obsessionality, assessed with the Yale-Brown Obsessive Compulsive Scale (YBOCS).

RESULTS

Seventy-five participants were assigned to receive olanzapine and 77 to receive placebo. A statistically significant treatment-by-time interaction was observed, indicating that the increase in BMI over time was greater in the olanzapine group (0.259 [SD=0.051] compared with 0.095 [SD=0.053] per month). There was no significant difference between treatment groups in change in the YBOCS obsessions subscale score over time (-0.325 compared with -0.017 points per month) and there were no significant differences between groups in the frequency of abnormalities on blood tests assessing potential metabolic disturbances.

CONCLUSIONS

This study documented a modest therapeutic effect of olanzapine compared with placebo on weight in adult outpatients with anorexia nervosa, but no significant benefit for psychological symptoms. Nevertheless, the finding on weight is notable, as achieving change in weight is notoriously challenging in this disorder.

摘要

目的

本研究评估了奥氮平对成年厌食症门诊患者的疗效优于安慰剂。

方法

这是一项在北美五家机构开展的、针对成年厌食症门诊患者(N=152,其中 96%为女性;样本的平均体重指数[BMI]为 16.7)的随机、双盲、安慰剂对照试验。参与者以 1:1 的比例随机分配接受奥氮平或安慰剂治疗,并在 16 周内每周接受一次治疗。主要结局指标是体重变化率和强迫观念变化率,使用耶鲁-布朗强迫量表(Yale-Brown Obsessive Compulsive Scale,YBOCS)进行评估。

结果

75 名参与者被分配接受奥氮平治疗,77 名参与者接受安慰剂治疗。观察到治疗与时间之间存在统计学显著的交互作用,表明奥氮平组的 BMI 随时间增加的幅度更大(0.259[SD=0.051]与每月 0.095[SD=0.053])。两组之间在 YBOCS 强迫观念子量表评分随时间的变化方面没有显著差异(每月分别减少 0.325 分和减少 0.017 分),在评估潜在代谢紊乱的血液检查异常频率方面也没有显著差异。

结论

本研究记录了奥氮平治疗成年厌食症门诊患者的体重与安慰剂相比具有适度的疗效,但对心理症状没有显著益处。然而,体重方面的发现值得注意,因为在这种疾病中,体重的变化是极具挑战性的。

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