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首页> 美国卫生研究院文献>The Journal of Neurology and Psychopathology >Ropinirole in the treatment of restless legs syndrome: results from the TREAT RLS 1 study a 12 week randomised placebo controlled study in 10 European countries
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Ropinirole in the treatment of restless legs syndrome: results from the TREAT RLS 1 study a 12 week randomised placebo controlled study in 10 European countries

机译：罗匹尼罗在治疗腿不安综合征中的应用：来自TREAT RLS 1研究的结果该研究为期12周在10个欧洲国家进行了随机安慰剂对照研究

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>Objective: To assess the efficacy, safety, and tolerability of ropinirole in the treatment of patients with restless legs syndrome. >Methods: A 12 week, prospective, double blind, randomised comparison involving 284 patients from 10 European countries. All participants had a score of ⩾15 on the international restless legs scale (IRLS). Patients were randomised (1:1) to receive either ropinirole 0.25–4.0 mg once daily or placebo. The primary efficacy end point was mean change from baseline to week 12 in total IRLS score. Global improvements (clinical global impression (CGI) scale) and improvements in sleep, health related quality of life (QoL; using generic and disease specific measures), work, and other activities were also assessed. >Results: 112/146 patients (76.7%) taking ropinirole and 109/138 (79.0%) taking placebo completed the study. Improvement in IRLS at week 12 with ropinirole (mean (SD) dose, 1.90 (1.13) mg/day) was greater than with placebo (mean (SE): -11.04 (0.719) v -8.03 (0.738) points; adjusted difference = -3.01 (95% confidence interval (CI), -5.03 to -0.99); p = 0.0036). More patients in the ropinirole group (53.4%) showed improvement on the CGI scale at week 12 than in the placebo group (40.9%; adjusted odds ratio = 1.7 (1.02 to 2.69); p = 0.0416). Significant differences on both IRLS and CGI scales favouring ropinirole were apparent by week 1. Ropinirole was also associated with significantly greater improvements in sleep and QoL end points. The most common adverse events were nausea and headache. >Conclusions: Ropinirole improves restless legs syndrome compared with placebo, with benefits apparent by week 1. It is generally well tolerated.
机译：>目的：评估罗匹尼罗在治疗腿部躁动综合征中的疗效，安全性和耐受性。 >方法：为期12周，前瞻性，双盲，随机比较，来自10个欧洲国家的284名患者参加了这项研究。所有参与者在国际不安定腿量表（IRLS）上的得分为⩾15。患者被随机（1：1）接受每日一次0.25–4.0 mg罗匹尼罗或安慰剂治疗。主要疗效终点是IRLS总评分从基线到第12周的平均变化。还评估了总体改善（临床总体印象（CGI）量表）和睡眠，与健康相关的生活质量（QoL；使用通用和针对疾病的措施），工作和其他活动的改善。 >结果：接受罗匹尼罗治疗的患者为112/146（76.7％），接受安慰剂的患者为10​​9/138（79.0％），完成了本研究。罗匹尼罗（平均（SD）剂量1.90（1.13）mg /天）在第12周时IRLS的改善大于安慰剂（平均（SE））：-11.04（0.719）对-8.03（0.738）点；调整后的差= -3.01（95％置信区间（CI），-5.03至-0.99）； p = 0.0036）。与安慰剂组相比，罗匹尼罗组第12周的CGI量表改善的患者更多（53.4％），安慰剂组为40.9％；校正后的优势比= 1.7（1.02至2.69）； p = 0.0416）。到第1周，IRLS和CGI量表对罗匹尼罗的支持率均出现明显差异。罗匹尼罗也与睡眠和QoL终点改善显着相关。最常见的不良事件是恶心和头痛。 >结论：与安慰剂相比，罗匹尼罗改善了躁动不安的腿综合征，在第1周时获益明显。通常耐受性良好。

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