Effectiveness of Long-term Doxycycline Treatment and Cognitive-Behavioral Therapy on Fatigue Severity in Patients with Q Fever Fatigue Syndrome (Qure Study): A Randomized Controlled Trial
Effectiveness of Long-term Doxycycline Treatment and Cognitive-Behavioral Therapy on Fatigue Severity in Patients with Q Fever Fatigue Syndrome (Qure Study): A Randomized Controlled Trial
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DOI：
10.1093/cid/cix013
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发表时间：
2017-04-15
影响因子：
11.8
通讯作者：
Bleeker-Rovers, Chantal P.
中科院分区：
文献类型：
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作者：
Keijmel, Stephan P.;Delsing, Corine E.;Bleeker-Rovers, Chantal P.
背景大约20%的急性Q热患者会出现慢性疲劳，称为Q热疲劳综合征（QFS）。这项随机对照临床试验的目的是评估长期使用强力霉素或认知行为疗法（CBT）治疗QFS患者在降低疲劳严重程度方面的疗效。根据荷兰指南，纳入符合QFS标准的成人患者：新发持续≥ 6个月的严重疲劳伴严重残疾，与急性Q热感染相关，无其他躯体或精神共病可解释疲劳。采用区组随机化，患者随机分为口服研究药物和CBT（2：1），持续24周。其次，在药物组中进行多西环素（200 mg/天，每日一次）和安慰剂之间的双盲随机化。主要结局是治疗结束时（EOT;第26周）的疲劳严重程度，采用个体强度子量表疲劳严重程度检查表进行评估。在155例随机化患者中，154例被纳入意向治疗分析（多西环素，52例;安慰剂，52例; CBT，50例）。EOT时，多西环素组（40.8 [95%置信区间{CI}，37.3-44.3]）和安慰剂组（37.8 [95% CI，34.3-41.2];差异，多西环素vs安慰剂，-3.0 [97.5% CI，-8.7至2.6]; P = 0.45）的疲乏严重程度相似。CBT治疗后疲劳严重程度（31.6 [95%CI，28.0-35.1]）显著低于安慰剂治疗后（差异，CBT vs安慰剂，6.2 [97.5%CI，.5 -11.9]; P =.03）。CBT可有效降低QFS患者的疲劳严重程度。与安慰剂相比，长期使用强力霉素治疗并不能降低QFS患者的疲劳严重程度。
Background. Approximately 20% of patients with acute Q fever will develop chronic fatigue, referred to as Q fever fatigue syndrome (QFS). The objective of this randomized controlled clinical trial was to assess the efficacy of either long-term treatment with doxycycline or cognitive-behavioral therapy (CBT) in reducing fatigue severity in patients with QFS.Methods. Adult patients were included who met the QFS criteria according to the Dutch guideline: a new onset of severe fatigue lasting >= 6 months with significant disabilities, related to an acute Q fever infection, without other somatic or psychiatric comorbidity explaining the fatigue. Using block randomization, patients were randomized between oral study medication and CBT (2: 1) for 24 weeks. Second, a double-blind randomization between doxycycline (200 mg/day, once daily) and placebo was performed in the medication group. Primary outcome was fatigue severity at end of treatment (EOT; week 26), assessed with the Checklist Individual Strength subscale Fatigue Severity.Results. Of 155 patients randomized, 154 were included in the intention-to-treat analysis (doxycycline, 52; placebo, 52; CBT, 50). At EOT, fatigue severity was similar between doxycycline (40.8 [95% confidence interval {CI}, 37.3-44.3]) and placebo (37.8 [95% CI, 34.3-41.2]; difference, doxycycline vs placebo, -3.0 [97.5% CI, -8.7 to 2.6]; P =.45). Fatigue severity was significantly lower after CBT (31.6 [95% CI, 28.0-35.1]) than after placebo (difference, CBT vs placebo, 6.2 [97.5% CI,.5-11.9]; P =.03).Conclusions. CBT is effective in reducing fatigue severity in QFS patients. Long-term treatment with doxycycline does not reduce fatigue severity in QFS patients compared to placebo.