Neurology Department, Shengjing Hospital of China Medical University, Shenyang, People's Republic of China.
Neuropsychiatr Dis Treat. 2013;9:1035-43. doi: 10.2147/NDT.S49454. Epub 2013 Jul 30.
Primary restless leg syndrome (RLS) is a common sensory-motor disorder that is characterized by an irresistible urge to move the limbs and unpleasant sensations in the legs, which affects 1.9%-4.6% adults. Pramipexole, a potent dopamine D2/3 agonist, is recommended as "effective" in the short-term and "possibly effective" in the long-term treatment of primary RLS in the European guidelines on management of RLS. In this meta-analysis, we summarized the efficacy and tolerability of pramipexole in treatment for primary RLS. Results of this meta-analysis showed a favorable effect of pramipexole versus placebo on RLS symptoms (mean change on International RLS Study Group Rating Scale [IRLS] score: mean difference [MD] = -5.96; 95% confidence interval [CI]: -7.79 to -4.41, P < 0.00001) and sleep quality (pooled standard mean difference [SMD] = -0.48, 95% CI: -0.61 to -0.35, P < 0.00001). Nausea (relative risk [RR] = 2.68, 95% CI: 1.82 to 3.95, P < 0.001) and fatigue (RR = 1.82, 95% CI: 1.14 to 2.93, P = 0.013) were the most common adverse events, but, by and large, pramipexole was well-tolerated in patients with primary RLS. Nevertheless, long-term studies and more evidence of head-to-head comparisons of pramipexole with other dopamine agonists, anticonvulsants, and levodopa are needed.
原发性不安腿综合征（RLS）是一种常见的感觉运动障碍，其特征是腿部不可抗拒的运动冲动和腿部不适感觉，影响 1.9%-4.6%的成年人。普拉克索是一种有效的多巴胺 D2/3 激动剂，在欧洲 RLS 管理指南中被推荐为短期“有效”和长期“可能有效”的原发性 RLS 治疗药物。在这项荟萃分析中，我们总结了普拉克索治疗原发性 RLS 的疗效和耐受性。荟萃分析结果表明，普拉克索与安慰剂相比，对 RLS 症状（国际 RLS 研究组评定量表[IRLS]评分的平均变化：平均差值[MD]=-5.96；95%置信区间[CI]：-7.79 至-4.41，P<0.00001）和睡眠质量（合并标准均数差[SMD]=-0.48；95%CI：-0.61 至-0.35，P<0.00001）有较好的疗效。恶心（相对风险[RR]=2.68；95%CI：1.82 至 3.95，P<0.001）和疲劳（RR=1.82；95%CI：1.14 至 2.93，P=0.013）是最常见的不良反应，但总的来说，普拉克索在原发性 RLS 患者中耐受性良好。然而，需要进行长期研究，并提供更多普拉克索与其他多巴胺激动剂、抗惊厥药和左旋多巴头对头比较的证据。
