Department of Neurology, Sleep Disorders Center, Scientific Institute and University Ospedale San Raffaele, Vita-Salute University, Milan, Italy.
Mov Disord. 2011 Apr;26(5):892-5. doi: 10.1002/mds.23543. Epub 2011 Mar 2.
Pramipexole and ropinirole have become the first-line treatment for restless legs syndrome. The aim of this study was to perform the first direct comparison between these two molecules in restless legs syndrome.
A double-blind, placebo-controlled, double-night and prospective investigation was carried out in 45 consecutive naïve patients with idiopathic restless legs syndrome. Each patient underwent two consecutive full-night polysomnographies: the first baseline recording was performed without premedication and, before the second recording, first group received a single oral dose of 0.25 mg pramipexole, second group a single oral dose of 0.5 mg ropinirole, and the remaining patients received placebo.
Both dopamine agonists improved restless legs syndrome symptoms and markedly suppressed periodic leg movements during sleep compared to placebo, without significant differences between pramipexole and ropinirole. No significant side effects, except for mild morning nausea (2 patients treated with ropinirole, 3 with pramipexole, and 1 with placebo), were reported.
普拉克索和罗匹尼罗已成为治疗不安腿综合征的一线药物。本研究旨在对这两种药物在不安腿综合征中的首次直接比较。
对 45 例连续的特发性不安腿综合征初治患者进行了一项双盲、安慰剂对照、双夜前瞻性研究。每位患者进行了两次连续的全夜多导睡眠描记术：第一次基线记录在未用药前进行，第二次记录前，第一组患者口服 0.25mg 普拉克索，第二组患者口服 0.5mg 罗匹尼罗，其余患者服用安慰剂。
与安慰剂相比，两种多巴胺激动剂均改善了不安腿综合征的症状，并显著抑制了睡眠中的周期性肢体运动，而普拉克索和罗匹尼罗之间无显著差异。除轻度晨吐（2 例罗匹尼罗治疗患者，3 例普拉克索治疗患者，1 例安慰剂治疗患者）外，未报告其他明显副作用。
