Radboud Expertise Center for Q Fever, Nijmegen, The Netherlands.
Department of Internal Medicine, Division of Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.
Clin Infect Dis. 2017 Apr 15;64(8):998-1005. doi: 10.1093/cid/cix013.
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.
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.
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).
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.
NCT01318356.
约 20%的急性 Q 热患者会发展为慢性疲劳，称为 Q 热疲劳综合征（QFS）。本随机对照临床试验的目的是评估长期使用多西环素或认知行为疗法（CBT）治疗是否能降低 QFS 患者的疲劳严重程度。
符合荷兰指南 QFS 标准的成年患者纳入研究：新出现的严重疲劳持续≥6 个月，伴有明显残疾，与急性 Q 热感染有关，无其他躯体或精神合并症解释疲劳。采用区组随机化，将患者按 2:1 的比例随机分为口服研究药物和 CBT 组（24 周）。在药物组中，随后进行了多西环素（200mg/天，每日 1 次）与安慰剂之间的双盲随机分组。主要结局是治疗结束时（EOT；第 26 周）的疲劳严重程度，采用个体力量检查表疲劳严重程度子量表评估。
155 例随机患者中，154 例纳入意向治疗分析（多西环素组 52 例，安慰剂组 52 例，CBT 组 50 例）。EOT 时，多西环素组（40.8 [95%置信区间 {CI}，37.3-44.3]）与安慰剂组（37.8 [95% CI，34.3-41.2]）的疲劳严重程度相似（差异，多西环素 vs 安慰剂，-3.0 [97.5% CI，-8.7 至 2.6]；P =.45）。与安慰剂组相比，CBT 后疲劳严重程度显著降低（31.6 [95% CI，28.0-35.1]）（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，长期使用多西环素并不能降低 QFS 患者的疲劳严重程度。
NCT01318356。
