Department of Medicine, University of Texas Health Science Center at San Antonio, TX, USA Pacific Rheumatology Associates, Inc, Renton, WA, USA Houston Sleep Center, University of Texas-Houston School of Medicine, Houston, TX, USA Jazz Pharmaceuticals, Inc, Palo Alto, CA, USA.
Pain. 2011 May;152(5):1007-1017. doi: 10.1016/j.pain.2010.12.022. Epub 2011 Mar 11.
This 14-week, phase 3, double-blind, randomized, controlled trial evaluated sodium oxybate (SXB) 4.5 and 6g per night versus placebo in patients with fibromyalgia (FM). SXB is the sodium salt of γ-hydroxybutyrate (GHB). GHB is an endogenous compound, synthesized from γ-aminobutyric acid (GABA) and found broadly in the central nervous system and body. Among 548 randomized patients, a ≥30% reduction in pain was experienced by 54.2% and 58.5% of patients treated with SXB 4.5 and 6g, respectively, versus 35.2% for placebo with a 100-mm Visual Analog Scale (VAS) (P<0.001 for both comparisons). Relative to placebo, both SXB doses significantly reduced fatigue (with a 100-mm VAS; P<0.001) and sleep disturbance (with the Jenkins Sleep Scale; P<0.001), and resulted in significant improvements in function as measured by the FM Impact Questionnaire (P=0.003 and P=0.001 for 4.5 and 6 g per night, respectively). On the Short-Form 36 Health Survey, SXB-related improvement was significant on the Physical, but not the Mental, Component Scale. The proportion of patients who reported a global improvement of "much" or "very much" better on the Patient Global Impression of Change was significantly greater in both SXB groups versus placebo (P<0.001). Headache, nausea, dizziness, vomiting, diarrhea, anxiety, and sinusitis were the most commonly reported adverse events, with an incidence at least twice that of placebo. These results expand the evidence from previous clinical trials suggesting that SXB is effective and safe in FM.
这项为期 14 周、3 期、双盲、随机、对照试验评估了钠氧基丁酸（SXB）每晚 4.5 和 6 克与安慰剂在纤维肌痛（FM）患者中的疗效。SXB 是 γ-羟基丁酸（GHB）的钠盐。GHB 是一种内源性化合物，由 γ-氨基丁酸（GABA）合成，广泛存在于中枢神经系统和体内。在 548 名随机患者中，分别接受 SXB 4.5 和 6 克治疗的患者中有 54.2%和 58.5%经历了疼痛减轻≥30%，而安慰剂组为 35.2%，用 100 毫米视觉模拟量表（VAS）（两者比较均 P<0.001）。与安慰剂相比，两种 SXB 剂量均显著降低了疲劳（用 100 毫米 VAS；P<0.001）和睡眠障碍（用詹金斯睡眠量表；P<0.001），并显著改善了 FM 影响问卷测量的功能（分别为 4.5 和 6 克/晚，P=0.003 和 P=0.001）。在健康调查简表 36 项中，SXB 相关的改善在身体方面显著，但在精神方面不显著。在 SXB 组中，报告患者整体改善“明显”或“非常明显”的患者比例明显高于安慰剂组（均 P<0.001）。头痛、恶心、头晕、呕吐、腹泻、焦虑和鼻窦炎是最常见的不良反应，其发生率至少是安慰剂的两倍。这些结果扩展了先前临床试验的证据，表明 SXB 在 FM 中有效且安全。
