Japan Somnology Center, Neuropsychiatric Research Institute, Tokyo, Japan.
Neuropsychobiology. 2011;63(1):35-42. doi: 10.1159/000322289. Epub 2010 Nov 9.
To assess the safety and efficacy of pramipexole in Japanese patients with restless legs syndrome (RLS) and to investigate factors predictive of early treatment response.
Patients with primary RLS and the International Restless Legs Syndrome Study Group rating scale (IRLS) total score of >15 were randomized to receive pramipexole 0.25, 0.5 or 0.75 mg/day for 6 weeks.
A total of 154 patients were recruited. Following treatment, the mean adjusted change in IRLS score in the 0.25, 0.5 and 0.75 mg/day groups was -12.3, -12.5 and -11.8, respectively. The proportion of IRLS responders at week 2, when all patients were receiving pramipexole at a dose of 0.25 mg/day, was 34.0-37.7%. At 6 weeks, when the patients were on 0.25, 0.5 or 0.75 mg/day, IRLS responders defined as those having a ≥50% reduction in IRLS score accounted for 60.4, 58.5 and 49.1%, respectively. Older age above the median value (≥55 years) and low IRLS score at baseline (<21.5 points) were significantly associated with early response to low-dose pramipexole therapy. The type and frequency of adverse events were consistent with the known safety profile for dopamine agonists in RLS.
Pramipexole at 0.25-0.75 mg/day is efficacious, safe and well tolerated in Japanese patients with primary RLS.
评估普拉克索治疗日本不安腿综合征（RLS）患者的安全性和疗效，并探讨预测早期治疗反应的因素。
原发性 RLS 患者和国际不安腿综合征研究组评分量表（IRLS）总分>15 分的患者被随机分为接受普拉克索 0.25、0.5 或 0.75 mg/天治疗 6 周。
共招募了 154 名患者。治疗后，0.25、0.5 和 0.75 mg/天组的 IRLS 评分平均调整变化分别为-12.3、-12.5 和-11.8。在所有患者接受普拉克索 0.25 mg/天剂量治疗的第 2 周时，IRLS 应答者的比例为 34.0-37.7%。在第 6 周时，当患者接受 0.25、0.5 或 0.75 mg/天时，IRLS 应答者（定义为 IRLS 评分降低≥50%）的比例分别为 60.4%、58.5%和 49.1%。年龄大于中位数（≥55 岁）和基线时 IRLS 评分较低（<21.5 分）与低剂量普拉克索治疗的早期反应显著相关。不良反应的类型和频率与 RLS 中多巴胺激动剂的已知安全性特征一致。
普拉克索 0.25-0.75 mg/天治疗日本原发性 RLS 患者是有效、安全且耐受良好的。
