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氟西汀治疗慢性疲劳综合征的随机、双盲、安慰剂对照研究。

Randomised, double-blind, placebo-controlled study of fluoxetine in chronic fatigue syndrome.

作者信息

Vercoulen J H, Swanink C M, Zitman F G, Vreden S G, Hoofs M P, Fennis J F, Galama J M, van der Meer J W, Bleijenberg G

机构信息

Department of Medical Psychology, University Hospital, Nijmegen, The Netherlands.

出版信息

Lancet. 1996 Mar 30;347(9005):858-61. doi: 10.1016/s0140-6736(96)91345-8.

DOI:10.1016/s0140-6736(96)91345-8
PMID:8622391
Abstract

BACKGROUND

No somatic treatment has been found to be effective for chronic fatigue syndrome (CFS). Antidepressant therapy is commonly used. Fluoxetine is recommended in preference to tricyclic agents because it has fewer sedative and autonomic nervous system effects. However, there have been no randomised, placebo-controlled, double-blind studies showing the effectiveness of antidepressant therapy in CFS. We have carried out such a study to assess the effect of fluoxetine in depressed and non-depressed CFS patients.

METHODS

In this randomised, double-blind study, we recruited 44 patients to the depressed CFS group, and 52 to the non-depressed CFS group. In each group participants were randomly assigned to receive either fluoxetine (20 mg once daily) or placebo for 8 weeks. The effect of fluoxetine was assessed by questionnaires, self-observation lists, standard neuropsychological tests, and a motion-sensing device (Actometer), which were applied on the day treatment started and on the last day.

FINDINGS

The two groups were well matched in terms of age, sex distribution, employment and marital status, and duration of CFS. There were no significant differences between the placebo and fluoxetine-treated groups in the change during the 8-week treatment period for any dimension of CFS. There was no change in subjective assessments of fatigue, severity of depression, functional impairment, sleep disturbances, neuropsychological function, cognitions, or physical activity in the depressed or the non-depressed subgroup.

INTERPRETATION

Fluoxetine in a 20 mg daily dose does not have a beneficial effect on any characteristic of CFS. The lack of effect of fluoxetine on depressive symptoms in CFS suggests that processes underlying the presentation of depressive symptoms in CFS may differ from those in patients with major depressive disorder.

摘要

背景

尚未发现有任何躯体治疗方法对慢性疲劳综合征(CFS)有效。抗抑郁治疗是常用的方法。推荐使用氟西汀而非三环类药物,因为它的镇静和自主神经系统作用较少。然而,尚无随机、安慰剂对照、双盲研究表明抗抑郁治疗对CFS有效。我们开展了这样一项研究,以评估氟西汀对抑郁和非抑郁CFS患者的疗效。

方法

在这项随机、双盲研究中,我们招募了44例患者进入抑郁CFS组,52例进入非抑郁CFS组。在每组中,参与者被随机分配接受氟西汀(每日20毫克)或安慰剂治疗8周。通过问卷、自我观察清单、标准神经心理学测试和一种运动传感装置(活动计)来评估氟西汀的疗效,这些评估在治疗开始日和最后一日进行。

研究结果

两组在年龄、性别分布、就业和婚姻状况以及CFS病程方面匹配良好。在8周治疗期间,安慰剂组和氟西汀治疗组在CFS的任何维度变化上均无显著差异。抑郁或非抑郁亚组在疲劳、抑郁严重程度、功能损害、睡眠障碍、神经心理功能、认知或身体活动的主观评估方面均无变化。

解读

每日20毫克剂量的氟西汀对CFS的任何特征均无有益作用。氟西汀对CFS抑郁症状缺乏疗效表明,CFS中抑郁症状表现的潜在机制可能与重度抑郁症患者不同。

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