Women's Health Research Program, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 222 Piedmont Avenue, Suite 8200, Cincinnati, OH 45219, USA.
Arthritis Res Ther. 2011 Jun 13;13(3):R86. doi: 10.1186/ar3359.
Fatigue is one of the most disabling symptoms associated with fibromyalgia that greatly impacts quality of life. Fatigue was assessed as a secondary objective in a 2-phase, 24-week study in outpatients with American College of Rheumatology-defined fibromyalgia.
Patients were randomized to duloxetine 60-120 mg/d (N = 263) or placebo (N = 267) for the 12-week acute phase. At Week 12, all placebo-treated patients were switched to double-blind treatment with duloxetine for the extension phase. Fatigue was assessed at baseline and every 4 weeks with the Multidimensional Fatigue Inventory (MFI) scales: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Activity, and Reduced Motivation. Other assessments that may be associated with fatigue included Brief Pain Inventory (BPI) average pain, numerical scales to rate anxiety, depressed mood, bothered by sleep difficulties, and musculoskeletal stiffness. Treatment-emergent fatigue-related events were also assessed. Changes from baseline to Week 12, and from Week 12 to Week 24, were analyzed by mixed-effects model repeated measures analysis.
At Week 12, duloxetine versus placebo significantly (all p < .05) reduced ratings on each MFI scale, BPI pain, anxiety, depressed mood, and stiffness. Improvement in ratings of being bothered by sleep difficulties was significant only at Weeks 4 and 8. At Week 24, mean changes in all measures indicated improvement was maintained for patients who received duloxetine for all 24 weeks (n = 176). Placebo-treated patients switched to duloxetine (n = 187) had significant within-group improvement in Physical Fatigue (Weeks 16, 20, and 24); General Fatigue (Weeks 20 and 24); Mental Fatigue (Week 20); and Reduced Activity (Weeks 20 and 24). These patients also experienced significant within-group improvement in BPI pain, anxiety, depressed mood, bothered by sleep difficulties, and stiffness. Overall, the most common (> 5% incidence) fatigue-related treatment-emergent adverse events were fatigue, somnolence, and insomnia.
Treatment with duloxetine significantly improved multiple dimensions of fatigue in patients with fibromyalgia, and improvement was maintained for up to 24 weeks.
ClinicalTrials.gov registry NCT00673452.
疲劳是纤维肌痛症相关的最具致残性症状之一，极大地影响了生活质量。在一项为期 24 周的、有 2 个阶段的门诊纤维肌痛症患者研究中，疲劳被评估为次要终点。
患者被随机分配接受度洛西汀 60-120mg/天（N=263）或安慰剂（N=267）治疗 12 周的急性阶段。在第 12 周时，所有接受安慰剂治疗的患者在扩展阶段均转换为度洛西汀的双盲治疗。在基线时和每 4 周时使用多维疲劳量表（MFI）评估疲劳：一般疲劳、身体疲劳、精神疲劳、活动减少和动机减少。还评估了可能与疲劳相关的其他评估，包括简明疼痛量表（BPI）平均疼痛、数字评分来评估焦虑、抑郁情绪、睡眠困难困扰、肌肉骨骼僵硬。还评估了治疗后出现的与疲劳相关的不良事件。通过混合效应模型重复测量分析来分析从基线到第 12 周和从第 12 周到第 24 周的变化。
在第 12 周时，度洛西汀与安慰剂相比，在 MFI 量表的每个评分（均 P<.05）、BPI 疼痛、焦虑、抑郁情绪和僵硬方面显著降低。睡眠困难困扰评分的改善仅在第 4 周和第 8 周时具有统计学意义。在第 24 周时，所有测量指标的平均变化表明，接受度洛西汀治疗 24 周的患者（n=176）的改善得以维持。转换为度洛西汀治疗的安慰剂治疗患者（n=187）在第 16、20 和 24 周时的身体疲劳（Physical Fatigue）、第 20 和 24 周时的一般疲劳（General Fatigue）、第 20 周时的精神疲劳（Mental Fatigue）和第 20 和 24 周时的活动减少（Reduced Activity）方面均有显著的组内改善。这些患者在 BPI 疼痛、焦虑、抑郁情绪、睡眠困难困扰和僵硬方面也经历了显著的组内改善。总体而言，最常见（发生率>5%）的与疲劳相关的治疗后出现的不良事件是疲劳、嗜睡和失眠。
度洛西汀治疗可显著改善纤维肌痛症患者的多种疲劳维度，并且这种改善可维持长达 24 周。
ClinicalTrials.gov 注册 NCT00673452。
Zotero 插件