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一项关于吗氯贝胺治疗慢性疲劳综合征患者的随机、双盲、安慰剂对照试验。

A randomized, double-blind placebo-controlled trial of moclobemide in patients with chronic fatigue syndrome.

作者信息

Hickie I B, Wilson A J, Wright J M, Bennett B K, Wakefield D, Lloyd A R

机构信息

School of Psychiatry, University of New South Wales, Sydney, Australia.

出版信息

J Clin Psychiatry. 2000 Sep;61(9):643-8. doi: 10.4088/jcp.v61n0909.

DOI:10.4088/jcp.v61n0909
PMID:11030484
Abstract

BACKGROUND

Chronic fatigue syndrome is characterized by prolonged and disabling fatigue and a range of neuropsychiatric symptoms including depressed and/or irritable mood. To date, no medical or psychotropic therapies have provided clear symptomatic benefit.

METHOD

Ninety patients with chronic fatigue syndrome, diagnosed with our system that approximates CDC criteria, participated in a randomized, placebo-controlled, double-blind trial of 450 to 600 mg/day of moclobemide, a novel reversible inhibitor of monoamine oxidase-A.

RESULTS

Fifty-one percent (24/47) of patients receiving moclobemide improved compared with 33% (14/43) of patients receiving placebo (odds ratio = 2.16, 95% confidence interval [CI] = 0.9 to 5.1). Drug response was best characterized symptomatically by an increase in the subjective sense of vigor and energy rather than a reduction in depressed mood. The effect of moclobemide on subjective energy was detectable within the first 2 weeks of treatment and increased across the course of the study. The greatest reduction in clinician-rated disability was in patients with concurrent immunologic dysfunction (mean difference in standardized units of improvement = 0.8, 95% CI = 0.03 to 1.6).

CONCLUSION

Moclobemide produces some improvement in key symptoms experienced by patients with chronic fatigue syndrome. This effect is not dependent on the presence of concurrent psychological distress and is likely to be shared with other monoamine oxidase inhibitors.

摘要

背景

慢性疲劳综合征的特征是长期且使人衰弱的疲劳以及一系列神经精神症状,包括情绪低落和/或易怒。迄今为止,尚无医学或精神药物疗法能带来明显的症状改善。

方法

90名经我们的系统诊断符合美国疾病控制与预防中心(CDC)标准的慢性疲劳综合征患者,参与了一项随机、安慰剂对照、双盲试验,服用剂量为每日450至600毫克的吗氯贝胺,这是一种新型的单胺氧化酶-A可逆抑制剂。

结果

接受吗氯贝胺治疗的患者中有51%(24/47)病情改善,而接受安慰剂治疗的患者中这一比例为33%(14/43)(优势比 = 2.16,95%置信区间[CI] = 0.9至5.1)。从症状上看,药物反应的最佳特征是主观活力和精力感增加,而非情绪低落减轻。吗氯贝胺对主观精力的影响在治疗的前2周内即可检测到,且在研究过程中不断增强。临床医生评定的残疾程度降低最明显的是伴有免疫功能障碍的患者(标准化改善单位的平均差异 = 0.8,95%CI = 0.03至1.6)。

结论

吗氯贝胺可使慢性疲劳综合征患者的关键症状得到一定改善。这种效果不依赖于同时存在的心理困扰,且可能与其他单胺氧化酶抑制剂相同。

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