Ferini-Strambi Luigi, Aarskog Dagfinn, Partinen Markku, Chaudhuri K Ray, Sohr Mandy, Verri Daniela, Albrecht Stefan
Institute San Raffaele Turro, Milan, Italy.
Sleep Med. 2008 Dec;9(8):874-81. doi: 10.1016/j.sleep.2008.09.001. Epub 2008 Oct 25.
Patients with Restless Legs Syndrome (RLS) often seek treatment because of sleep problems related to nocturnal symptoms. Our goal was to test the ability of pramipexole to improve sleep in RLS patients and to reconfirm its efficacy for primary RLS symptoms.
Adults with moderate or severe RLS were randomized to receive placebo or pramipexole (flexibly titrated from 0.25 to 0.75mg), 2-3h before bedtime for 12 weeks. The co-primary outcome measures were change in Medical Outcomes Study (MOS) sleep disturbance score and International RLS Study Group Rating Scale (IRLS) score at 12 weeks.
The intent-to-treat population included 357 patients: 178 received pramipexole and 179 received placebo. At 12 weeks, the adjusted mean change from baseline was greater for pramipexole (vs. placebo) for IRLS score (-13.4+/-0.7 vs. -9.6+/-0.7) and MOS sleep disturbance score (-25.3+/-1.5 vs. -16.8+/-1.5) (p<or=0.0001; ANCOVA). Responder rates (clinical and patient global impression and IRLS) were also significantly higher in the pramipexole group. RLS-QOL score was improved over placebo at Week 12 (p<0.01) as were MOS sleep adequacy (p=0.0008) and quantity (p=0.08) scores. Nine percent of patients in each group withdrew because of adverse events.
Pramipexole is effective and well-tolerated for RLS and related sleep disturbance.
不安腿综合征（RLS）患者常因与夜间症状相关的睡眠问题而寻求治疗。我们的目标是测试普拉克索改善RLS患者睡眠的能力，并再次确认其对原发性RLS症状的疗效。
患有中度或重度RLS的成年人被随机分配，在睡前2 - 3小时接受安慰剂或普拉克索（从0.25毫克灵活滴定至0.75毫克），持续12周。共同主要结局指标为12周时医学结局研究（MOS）睡眠障碍评分和国际RLS研究组评分量表（IRLS）评分的变化。
意向性治疗人群包括357名患者：178名接受普拉克索治疗，179名接受安慰剂治疗。在12周时，普拉克索组（与安慰剂组相比）的IRLS评分（-13.4±0.7对-9.6±0.7）和MOS睡眠障碍评分（-25.3±1.5对-16.8±1.5）从基线的调整后平均变化更大（p≤0.0001；协方差分析）。普拉克索组的反应率（临床和患者整体印象以及IRLS）也显著更高。在第12周时，RLS - QOL评分比安慰剂组有所改善（p<0.01），MOS睡眠充足度（p = 0.0008）和睡眠时间（p = 0.08）评分也是如此。每组有9%的患者因不良事件退出。
普拉克索对RLS及相关睡眠障碍有效且耐受性良好。
