Rheumatologische Schwerpunktpraxis, Gräfelfing, Germany.
Ann Rheum Dis. 2012 Jun;71(6):935-42. doi: 10.1136/annrheumdis-2011-200418. Epub 2012 Jan 31.
Fibromyalgia is characterised by chronic musculoskeletal pain and multiple symptoms including fatigue, multidimensional function impairment, sleep disturbance and tenderness. Along with pain and fatigue, non-restorative sleep is a core symptom of fibromyalgia. Sodium oxybate (SXB) is thought to reduce non-restorative sleep abnormalities. This study evaluated effects of SXB on fibromyalgia-related pain and other symptoms.
573 patients with fibromyalgia according to 1990 American College of Rheumatology criteria were enrolled at 108 centres in eight countries. Subjects were randomly assigned to placebo, SXB 4.5 g/night or SXB 6 g/night. The primary efficacy endpoint was the proportion of subjects with ≥30% reduction in pain visual analogue scale from baseline to treatment end. Other efficacy assessments included function, sleep quality, effect of sleep on function, fatigue, tenderness, health-related quality of life and subject's impression of change in overall wellbeing.
Significant improvements in pain, sleep and other symptoms associated with fibromyalgia were seen in SXB treated subjects compared with placebo. The proportion of subjects with ≥30% pain reduction was 42.0% for SXB4.5 g/night (p=0.002) and 51.4% for SXB6 g/night (p<0.001) versus 26.8% for placebo. Quality of sleep (Jenkins sleep scale) improved by 20% for SXB4.5 g/night (p≤0.001) and 25% for SXB6 g/night (p≤0.001) versus 0.5% for placebo. Adverse events with an incidence ≥5% and twice placebo were nausea, dizziness, vomiting, insomnia, anxiety, somnolence, fatigue, muscle spasms and peripheral oedema.
These results, combined with findings from previous phase 2 and 3 studies, provide supportive evidence that SXB therapy affords important benefits across multiple symptoms in subjects with fibromyalgia.
纤维肌痛的特征是慢性肌肉骨骼疼痛和多种症状，包括疲劳、多维功能障碍、睡眠障碍和压痛。除了疼痛和疲劳外，非恢复性睡眠也是纤维肌痛的核心症状。羟丁酸钠（SXB）被认为可减少非恢复性睡眠异常。本研究评估了 SXB 对纤维肌痛相关疼痛和其他症状的影响。
根据 1990 年美国风湿病学院标准，来自 8 个国家的 108 个中心共纳入了 573 名纤维肌痛患者。受试者被随机分配至安慰剂、SXB 4.5 g/晚或 SXB 6 g/晚组。主要疗效终点是自基线至治疗结束时疼痛视觉模拟量表（VAS）改善≥30%的受试者比例。其他疗效评估包括功能、睡眠质量、睡眠对功能的影响、疲劳、压痛、健康相关生活质量和受试者对整体健康状况改善的印象。
与安慰剂相比，SXB 治疗的受试者疼痛、睡眠和其他与纤维肌痛相关的症状均有显著改善。SXB 4.5 g/晚组（p=0.002）和 SXB 6 g/晚组（p<0.001）中≥30%疼痛缓解的受试者比例分别为 42.0%和 51.4%，而安慰剂组为 26.8%。SXB 4.5 g/晚组（p≤0.001）和 SXB 6 g/晚组（p≤0.001）的睡眠质量（詹金斯睡眠量表）改善了 20%，而安慰剂组仅改善了 0.5%。发生率≥5%且是安慰剂的两倍的不良反应有恶心、头晕、呕吐、失眠、焦虑、嗜睡、疲劳、肌肉痉挛和外周水肿。
这些结果与之前的 2 期和 3 期研究结果相结合，为羟丁酸钠治疗可在纤维肌痛患者的多种症状中带来重要获益提供了支持性证据。
