University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Am J Manag Care. 2010 May;16(5 Suppl):S138-43.
To review the efficacy and safety of pregabalin, an alpha(2)-delta (alpha(2)-delta) ligand, for the management of fibromyalgia (FM).
Review of 2 pivotal phase 3 trials that evaluated the efficacy and safety of pregabalin for the management of FM.
FM is a chronic condition that is characterized by widespread musculoskeletal pain and has a greater prevalence in women than in men. In a 14-week, randomized, double-blind trial, pregabalin at all 3 doses (300, 450, and 600 mg daily) resulted in significantly greater improvements in pain and function relative to placebo. Parallel with these improvements, greater proportions of patients in the pregabalin groups reported improvement in global disease status compared with placebo. In a second study designed to evaluate the durability of response, patients were randomized to up to 6 months of treatment with pregabalin or placebo after a 6-week, open-label, dose-optimization treatment phase. Based on predefined criteria for loss of therapeutic response, patients treated with pregabalin were observed to maintain a therapeutic response for a significantly longer duration than patients treated with placebo. Pregabalin was tolerated by most patients in both trials; the incidence of the most commonly reported adverse events (dizziness, somnolence, weight gain, headache, dry mouth) appeared to be dose-related.
Pregabalin has been demonstrated to be efficacious and well-tolerated for the management of FM.
综述普瑞巴林（一种 α2-δ 配体）治疗纤维肌痛（FM）的疗效和安全性。
对评估普瑞巴林治疗 FM 的疗效和安全性的 2 项关键性 3 期临床试验进行综述。
FM 是一种慢性疾病，其特征为广泛的肌肉骨骼疼痛，且女性患病率高于男性。在为期 14 周的随机、双盲试验中，与安慰剂相比，所有 3 个剂量（每日 300、450 和 600 mg）的普瑞巴林均显著改善疼痛和功能。与这些改善平行的是，普瑞巴林组中更多比例的患者报告全球疾病状况改善，优于安慰剂组。在第二项旨在评估应答持久性的研究中，患者在 6 周的开放性、剂量优化治疗阶段后，被随机分配至接受长达 6 个月的普瑞巴林或安慰剂治疗。根据治疗应答丧失的预定标准，与接受安慰剂治疗的患者相比，接受普瑞巴林治疗的患者观察到应答维持时间显著更长。在这两项试验中，普瑞巴林通常被大多数患者耐受；最常报告的不良事件（头晕、嗜睡、体重增加、头痛、口干）的发生率似乎与剂量相关。
普瑞巴林已被证实对 FM 的治疗有效且耐受良好。
