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氟西汀用于轻度抑郁症急性治疗的随机安慰剂对照试验。

Randomized, placebo-controlled trial of fluoxetine for acute treatment of minor depressive disorder.

作者信息

Judd Lewis L, Rapaport Mark Hyman, Yonkers Kimberly A, Rush A John, Frank Ellen, Thase Michael E, Kupfer David J, Plewes John M, Schettler Pamela J, Tollefson Gary

机构信息

Department of Psychiatry, University of California, San Diego, 9500 Gilman Dr., La Jolla, CA 92093-0603, USA.

出版信息

Am J Psychiatry. 2004 Oct;161(10):1864-71. doi: 10.1176/ajp.161.10.1864.

DOI:10.1176/ajp.161.10.1864
PMID:15465984
Abstract

OBJECTIVE

Minor depressive disorder is both common and associated with significant psychosocial impairment. This study examined antidepressant treatment efficacy in a large group of patients with minor depressive disorder.

METHOD

One hundred sixty-two patients with minor depressive disorder were randomly assigned to receive fluoxetine or placebo in a 12-week, double-blind study; 73% (59 of 81) of the patients in each treatment group completed the study. Patients were evaluated weekly with standard depression rating instruments and measures of psychosocial impairment. Hypotheses were tested by last-observation-carried-forward analysis of variance (ANOVA) and confirmed by mixed (random-effects) regression analysis.

RESULTS

At baseline, minor depressive disorder patients were mildly to moderately depressed, with a corresponding degree of functional impairment. Over 12 weeks of treatment, both ANOVA and mixed regression showed fluoxetine to be superior to placebo as indicated by significantly greater improvement of fluoxetine-treated patients in scores on the 30-item clinician-rated Inventory of Depressive Symptomatology, the 17-item and 21-item Hamilton Depression Rating Scale, the Beck Depression Inventory, and the Clinical Global Impression severity scale. Improvement in Global Assessment of Functioning Scale score was significantly greater for the fluoxetine group in mixed regression analysis only. Patients in both treatment groups reported a similar number and severity of adverse events during the 12-week treatment period.

CONCLUSIONS

Clinicians frequently encounter minor depressive disorder either as a prodromal or residual phase of illness in major depressive disorder or as de novo minor depressive disorder episodes. Fluoxetine is significantly superior to placebo in reducing minor depressive disorder symptoms within a 12-week period. Improvement in psychosocial function with fluoxetine may take longer than 12 weeks.

摘要

目的

轻度抑郁症既常见又与显著的心理社会功能损害相关。本研究在一大群轻度抑郁症患者中检验了抗抑郁药的治疗效果。

方法

在一项为期12周的双盲研究中,162例轻度抑郁症患者被随机分配接受氟西汀或安慰剂治疗;每个治疗组中73%(81例中的59例)的患者完成了研究。每周使用标准抑郁评定工具和心理社会功能损害测量方法对患者进行评估。通过末次观察结转方差分析(ANOVA)检验假设,并通过混合(随机效应)回归分析进行确认。

结果

在基线时,轻度抑郁症患者为轻度至中度抑郁,伴有相应程度的功能损害。在12周的治疗期间,ANOVA和混合回归均显示氟西汀优于安慰剂,这表现为接受氟西汀治疗的患者在30项临床医生评定的抑郁症状量表、17项和21项汉密尔顿抑郁评定量表、贝克抑郁量表以及临床总体印象严重程度量表上的得分有显著更大的改善。仅在混合回归分析中,氟西汀组在总体功能评估量表得分上的改善显著更大。在12周的治疗期间,两个治疗组的患者报告的不良事件数量和严重程度相似。

结论

临床医生经常遇到轻度抑郁症,它要么是重度抑郁症的前驱期或残留期,要么是新发的轻度抑郁症发作。在12周内,氟西汀在减轻轻度抑郁症症状方面显著优于安慰剂。使用氟西汀改善心理社会功能可能需要超过12周的时间。

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