Oertel W H, Benes H, Bodenschatz R, Peglau I, Warmuth R, Happe S, Geisler P, Cassel W, Leroux M, Kohnen R, Stiasny-Kolster K
Department of Neurology, Center of Nervous Diseases, Philipps-University Marburg, Rudolf-Bultmann-Str. 8, D-35033 Marburg, Germany.
Neurology. 2006 Sep 26;67(6):1040-6. doi: 10.1212/01.wnl.0000237742.08297.22. Epub 2006 Aug 23.
To assess the efficacy and safety of the dopamine agonist cabergoline in the treatment of patients with idiopathic restless legs syndrome (CATOR study).
Patients with moderate to severe restless legs syndrome (RLS) were randomly assigned to cabergoline (single evening dose: 2 mg) or placebo and treated for 5 weeks in a double-blind, multicenter polysomnography (PSG) trial. The primary efficacy measures were the periodic leg movements during sleep arousal index (PLMS-AI) and sleep efficiency. These and further PSG variables were monitored by centrally evaluated PSG. Severity of RLS was assessed using the International RLS Study Group Severity Scale (IRLS), the RLS-6 scales, the Sleep Questionnaire Form A (SF-A; quality of sleep), and the Quality of Life for RLS questionnaire.
Forty-three patients were treated and 40 patients were evaluated with PSG (age 56 +/- 10 years, 73% women). Cabergoline was superior to placebo in terms of the PLMS-AI (-17.7 +/- 16.4 vs -4.5 +/- 20.0 placebo; p = 0.0024), sleep efficiency (+6.2 +/- 13.9% vs +3.3 +/- 11.7%; p = 0.0443), PLMS index (p = 0.0014), PLM index (p = 0.0012), and total sleep time (p = 0.0443). Improvements in IRLS total score (-23.7 +/- 11.2 vs -7.9 +/- 11.0 placebo; p = 0.0002), RLS-6 severity scales during the night (p = 0.0010) and during the day (p = 0.0018), Clinical Global Impressions severity item (p = 0.0003), sleep quality (p = 0.0180), SF-A sleep quality (p = 0.0371), and QoL-RLS (p = 0.0247) were larger in patients treated with cabergoline compared with the placebo group. Adverse events were only mild and well-known side effects of dopamine agonists.
Single-evening cabergoline is an efficacious and well-tolerated short-term therapy for sensorimotor symptoms of restless legs syndrome and associated sleep disturbances.
评估多巴胺激动剂卡麦角林治疗特发性不安腿综合征患者的疗效和安全性（CATOR研究）。
中重度不安腿综合征（RLS）患者被随机分配至卡麦角林组（单次夜间剂量：2mg）或安慰剂组，在一项双盲、多中心多导睡眠图（PSG）试验中接受5周治疗。主要疗效指标为睡眠觉醒期周期性腿部运动指数（PLMS-AI）和睡眠效率。这些指标以及其他PSG变量通过集中评估的PSG进行监测。使用国际不安腿综合征研究组严重程度量表（IRLS）、RLS-6量表、睡眠问卷A表（SF-A；睡眠质量）和不安腿综合征生活质量问卷评估RLS的严重程度。
43例患者接受治疗，40例患者接受PSG评估（年龄56±10岁，73%为女性）。在PLMS-AI方面，卡麦角林优于安慰剂（-17.7±16.4 vs安慰剂组-4.5±20.0；p=0.0024）、睡眠效率（+6.2±13.9% vs +3.3±11.7%；p=0.0443）、PLMS指数（p=0.0014）、PLM指数（p=0.0012）和总睡眠时间（p=0.0443）。与安慰剂组相比，接受卡麦角林治疗的患者在IRLS总分（-23.7±11.2 vs -7.9±11.0安慰剂；p=0.0002）、夜间（p=0.0010）和白天（p=0.0018）的RLS-6严重程度量表、临床总体印象严重程度项目（p=0.0003）、睡眠质量（p=0.0180）、SF-A睡眠质量（p=0.0371）和QoL-RLS（p=0.0247）方面的改善更大。不良事件仅为多巴胺激动剂的轻度且常见的副作用。
单次夜间服用卡麦角林是治疗不安腿综合征感觉运动症状及相关睡眠障碍的一种有效且耐受性良好的短期疗法。
