Bogan Richard K, Fry June M, Schmidt Markus H, Carson Stanley W, Ritchie Sally Y
SleepMed of South Carolina, 1333 Taylor St, Columbia, SC 29201, USA.
Mayo Clin Proc. 2006 Jan;81(1):17-27. doi: 10.4065/81.1.17.
To assess the efficacy, safety, and tolerability of the dopamine agonist ropinirole in the treatment of patients with moderate to severe primary restless legs syndrome (RLS).
This multicenter, 12-week, double-blind, placebo-controlled, flexible-dose study enrolled US patients and was conducted between September 2003 and May 2004. Patients were randomized to ropinirole or placebo, 0.25-4.0 mg as needed and tolerated, once daily, 1 to 3 hours before bedtime. The primary end point was mean change from baseline to week 12 in International Restless Legs Scale (IRLS) total score. Key secondary efficacy measures included the Clinical Global Impression-Improvement scale.
A total of 381 patients were enrolled; 164 (87.7%) of 187 patients randomized to ropinirole and 167 (86.1%) of 194 randomized to placebo completed the study. Significant treatment differences favoring ropinirole, compared with placebo, were observed for change in IRLS total score at week 12 (adjusted mean treatment difference, -3.7; 95% confidence interval, -5.4 to -2.0; P < .001) and for all 3 key secondary end points: mean change from baseline in IRLS total score at week 1 and proportion of patients who were much/very much improved on the Clinical Global Impression Improvement scale at weeks 1 and 12. Ropinirole was associated with significantly greater Improvements in subjective measures of sleep disturbance, quantity, and adequacy; quality of life; and anxiety. Although treatment differences favoring ropinirole in daytime somnolence were observed, they were not statistically significant (P = .10). Ropinirole was generally well tolerated, with an adverse-event profile consistent with other dopamine agonists.
This study confirms that ropinirole improves RLS symptoms and subjective measures of sleep, quality of life, and anxiety and that it is generally well tolerated.
评估多巴胺激动剂罗匹尼罗治疗中度至重度原发性不宁腿综合征（RLS）患者的疗效、安全性和耐受性。
这项多中心、为期12周的双盲、安慰剂对照、灵活剂量研究纳入了美国患者，于2003年9月至2004年5月进行。患者被随机分为罗匹尼罗组或安慰剂组，根据需要和耐受情况，睡前1至3小时每日一次服用0.25 - 4.0毫克。主要终点是从基线到第12周国际不宁腿量表（IRLS）总分的平均变化。关键的次要疗效指标包括临床总体印象改善量表。
共纳入381例患者；随机分组至罗匹尼罗组的187例患者中有164例（87.7%）、随机分组至安慰剂组的194例患者中有167例（86.1%）完成了研究。与安慰剂相比，在第12周时观察到罗匹尼罗在IRLS总分变化方面有显著的治疗差异（调整后的平均治疗差异为 - 3.7；95%置信区间为 - 5.4至 - 2.0；P <.001），并且在所有3个关键的次要终点方面均有差异：第1周时IRLS总分相对于基线的平均变化，以及第1周和第12周时在临床总体印象改善量表上有显著/非常显著改善的患者比例。罗匹尼罗与睡眠障碍、睡眠量和充足度、生活质量以及焦虑的主观测量指标的显著更大改善相关。尽管观察到罗匹尼罗在白天嗜睡方面有有利于它的治疗差异，但差异无统计学意义（P = 0.10）。罗匹尼罗总体耐受性良好，不良事件谱与其他多巴胺激动剂一致。
本研究证实罗匹尼罗可改善RLS症状以及睡眠、生活质量和焦虑的主观测量指标，并且总体耐受性良好。
