The Qure study: Q fever fatigue syndrome--response to treatment; a randomized placebo-controlled trial.
The Qure study: Q fever fatigue syndrome--response to treatment; a randomized placebo-controlled trial.
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DOI：
10.1186/1471-2334-13-157
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发表时间：
2013-03-27
影响因子：
3.7
通讯作者：
Bleeker-Rovers CP
中科院分区：
文献类型：
--
作者：
Keijmel SP;Delsing CE;Sprong T;Bleijenberg G;van der Meer JW;Knoop H;Bleeker-Rovers CP
Q热是一种人畜共患病，在许多国家都存在。Q热疲劳综合征（QFS）是急性Q热感染后最常见的后遗症之一。QFS的特征是急性Q热感染后持续疲劳，导致大量发病率和高社会经济负担。QFS的发生是有据可查的，并且在过去几十年中在许多国家都有描述。然而，目前尚无有效的治疗方法。只有少数非对照研究测试了抗生素治疗QFS的疗效。这些研究表明，四环素长期治疗对体能状态有积极影响;然而，尚未进行随机对照试验。认知行为疗法（CBT）已被证明是其他疾病慢性疲劳的有效治疗方式，但尚未在QFS中进行测试。因此，我们设计了一项试验，以评估长期治疗的疗效与四环素强力霉素和CBT的患者与QFS。将进行一项随机安慰剂对照试验。将招募180名诊断为QFS的成年患者，并随机分为三组：CBT，长期多西环素或安慰剂。首先，参与者将在CBT和药物之间随机分配（比例1：2）。将在药物条件下进行多西环素和安慰剂（比例1：1）之间的第二次双盲随机化。每组治疗6个月。将在基线和干预后评估结局指标。主要结局指标是疲劳严重程度。次要结果指标是功能障碍、心理困扰程度、贝氏柯克斯体PCR和血清学。Qure研究是第一个随机安慰剂对照试验，评估了长期多西环素和认知行为治疗对QFS患者的疗效。本研究的结果将为成人QFS患者提供循证治疗方案。ClinicalTrials.gov：http：//NCT 01318356，荷兰试验注册中心：NTR 2797
Q fever is a zoonosis that is present in many countries. Q fever fatigue syndrome (QFS) is one of the most frequent sequelae after an acute Q fever infection. QFS is characterized by persistent fatigue following an acute Q fever infection, leading to substantial morbidity and a high socio-economic burden. The occurrence of QFS is well-documented, and has been described in many countries over the past decades. However, a treatment with proven efficacy is not available. Only a few uncontrolled studies have tested the efficacy of treatment with antibiotics on QFS. These studies suggest a positive effect of long-term treatment with a tetracycline on performance state; however, no randomized controlled trials have been performed. Cognitive behavioral therapy (CBT) has been proven to be an effective treatment modality for chronic fatigue in other diseases, but has not yet been tested in QFS. Therefore, we designed a trial to assess the efficacy of long-term treatment with the tetracycline doxycycline and CBT in patients with QFS. A randomized placebo-controlled trial will be conducted. One-hundred-eighty adult patients diagnosed with QFS will be recruited and randomized between one of three groups: CBT, long-term doxycycline or placebo. First, participants will be randomized between CBT and medication (ratio 1:2). A second double-blinded randomization between doxycycline and placebo (ratio 1:1) will be performed in the medication condition. Each group will be treated for six months. Outcome measures will be assessed at baseline and post intervention. The primary outcome measure is fatigue severity. Secondary outcome measures are functional impairment, level of psychological distress, and Coxiella burnetii PCR and serology. The Qure study is the first randomized placebo-controlled trial, which evaluates the efficacy of long-term doxycycline and of cognitive behavioral therapy in patients with QFS. The results of this study will provide knowledge about evidence-based treatment options for adult patients with QFS. ClinicalTrials.gov: http://NCT01318356, and Netherlands Trial Register: NTR2797