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.
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.
复制标题
罗匹尼罗治疗不宁腿综合征：TREAT RLS 1 研究的结果，该研究是在 10 个欧洲国家进行的一项为期 12 周的随机安慰剂对照研究。
DOI：
10.4137/cmt.s2053
复制
发表时间：
2009
期刊：
影响因子：
--
通讯作者：
P. Montagna
中科院分区：
文献类型：
--
作者：
R. Vetrugno;P. Montagna
目的
评估罗匹尼罗治疗不宁腿综合征患者的疗效、安全性和耐受性。
方法
一项为期12周的前瞻性、双盲、随机比较，涉及来自10个欧洲国家的284例患者。所有参与者在国际不宁腿量表（IRLS）上的得分>或=15。患者随机（1：1）接受罗匹尼罗0.25-4.0 mg每日一次或安慰剂。主要疗效终点是总IRLS评分从基线至第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、健康相关生活质量（QoL;使用通用和疾病特异性指标）、工作和其他活动的改善。
结果
112/146例接受罗匹尼罗的患者（76.7%）和109/138例接受安慰剂的患者（79.0%）完成了研究。第12周时，罗匹尼罗（平均（SD）剂量，1.90（1.13）mg/天）的IRLS改善大于安慰剂（平均（SE）：-11.04（0.719）v-8.03（0.738）分;校正差异=-3.01（95%置信区间（CI），-5.03至-0.99）; p = 0.0036）。第12周时，罗匹尼罗组（53.4%）的CGI量表改善的患者多于安慰剂组（40.9%;校正比值比= 1.7（1.02至2.69）; p = 0.0416）。第1周时，IRLS和CGI量表的显著差异均有利于罗匹尼罗。罗匹尼罗还与睡眠和QoL终点的显著改善相关。最常见的不良反应是恶心和头痛。
结论
与安慰剂相比，罗匹尼罗改善不宁腿综合征，第1周获益明显。它通常是很好的耐受性。
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 > or =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.
老年人睡眠时周期性腿部运动和睡眠障碍。
DOI：
10.1093/gerona/53a.5.m391
发表时间：
1998
期刊：
The journals of gerontology. Series A, Biological sciences and medical sciences
影响因子：
--
作者：
Youngstedt,SD;Kripke,DF;Klauber,MR;Sepulveda,RS;Mason,WJ
通讯作者：
Mason,WJ
影响因子：
3.2
作者：
Abetz, L;Allen, R;Knight, H
通讯作者：
Knight, H