昂丹司琼（一种 5-HT3 受体拮抗剂）对慢性疲劳综合征的影响：一项随机对照试验。

The effect of ondansetron, a 5-HT3 receptor antagonist, in chronic fatigue syndrome: a randomized controlled trial.

机构信息

Radboud University Nijmegen Medical Centre, Department of Psychiatry, 966, Reinier Postlaan 10, 6525 GC Nijmegen, The Netherlands.

出版信息

J Clin Psychiatry. 2010 May;71(5):528-33. doi: 10.4088/JCP.08m04719whi. Epub 2010 Jan 26.

DOI:10.4088/JCP.08m04719whi

PMID:20122367

Abstract

BACKGROUND

Accumulating data support the involvement of the serotonin (5-hydroxytryptamine [5-HT]) system in the pathophysiology of chronic fatigue syndrome. Neuropharmacologic studies point to a hyperactive 5-HT system, and open-label treatment studies with 5-HT(3) receptor antagonists have shown promising results. In this randomized controlled clinical trial, the effect of ondansetron, a 5-HT(3) receptor antagonist, was assessed on fatigue severity and functional impairment in adult patients with chronic fatigue syndrome.

METHOD

A randomized, placebo-controlled, double-blind clinical trial was conducted at Radboud University Nijmegen Medical Centre, The Netherlands. Sixty-seven adult patients who fulfilled the US Centers for Disease Control and Prevention (CDC) criteria for chronic fatigue syndrome and who were free from current psychiatric comorbidity participated in the clinical trial. Participants received either ondansetron 16 mg per day or placebo for 10 weeks. The primary outcome variables were fatigue severity (Checklist Individual Strength fatigue severity subscale [CIS-fatigue]) and functional impairment (Sickness Impact Profile-8 [SIP-8]). The effect of ondansetron was assessed by analysis of covariance. Data were analyzed on an intention-to-treat basis. All patients were recruited between June 2003 and March 2006.

RESULTS

Thirty-three patients were allocated to the ondansetron condition, 34 to the placebo condition. The 2 groups were well matched in terms of age, sex, fatigue severity, functional impairment, and CDC symptoms. Analysis of covariance showed no significant differences between the ondansetron- and placebo-treated groups during the 10-week treatment period in fatigue severity and functional impairment.

CONCLUSIONS

This clinical trial demonstrates no benefit of ondansetron compared to placebo in the treatment of chronic fatigue syndrome.

TRIAL REGISTRATION

www.trialregister.nl: ISRCTN02536681.

摘要

背景

越来越多的数据支持 5-羟色胺（5-HT）系统参与慢性疲劳综合征的病理生理学。神经药理学研究表明该系统过度活跃，且 5-HT3 受体拮抗剂的开放性治疗研究结果也很有前景。在这项随机对照临床试验中，评估了 5-HT3 受体拮抗剂昂丹司琼对慢性疲劳综合征成年患者的疲劳严重程度和功能障碍的影响。

方法

该研究在荷兰奈梅亨拉德堡德大学医学中心进行，采用随机、安慰剂对照、双盲临床试验。67 名符合美国疾病控制与预防中心（CDC）慢性疲劳综合征标准且无当前合并精神疾病的成年患者参与了临床试验。参与者每天接受昂丹司琼 16 毫克或安慰剂治疗 10 周。主要结局变量为疲劳严重程度（Checklist Individual Strength 疲劳严重程度子量表[CIS-fatigue]）和功能障碍（Sickness Impact Profile-8[SIP-8]）。采用协方差分析评估昂丹司琼的疗效。采用意向治疗进行数据分析。所有患者均于 2003 年 6 月至 2006 年 3 月期间招募。