Kushida Clete A, Geyer James, Tolson Jerry M, Asgharian Afsaneh
Stanford Center of Excellence for Sleep Disorders, 401 Quarry Road, Suite 3301-A, Stanford, CA 94305-5730, USA.
Clin Neuropharmacol. 2008 Sep-Oct;31(5):281-6. doi: 10.1097/WNF.0b013e31815a3eec.
To investigate the effect of twice-daily ropinirole in patients with early evening restless legs syndrome (RLS) symptoms, particularly focusing on the relationship of patient- and physician-rated assessment of treatment outcomes.
In this multicenter, double-blind, randomized, 12-week, flexible-dose study, patients with primary RLS, with symptom onset no earlier than 5 PM and a baseline International Restless Legs Syndrome Study Group Rating Scale (IRLS) total score > or = 20 received ropinirole 0.5 to 6.0 mg/d twice daily in equally divided doses, or placebo. First dose was 1 hour before the usual onset of symptoms; second dose was 3 to 8 hours after the first. Primary end point: change from baseline in IRLS total score at week 12 last observation carried forward (LOCF). Key secondary end points: proportion of responders (rated "very much improved" or "much improved") on the Clinical Global Impression-Improvement and the Patient Global Improvement scales.
Improvements in IRLS total score were statistically significantly greater for ropinirole (n = 175), compared with placebo (n = 184) at all assessment points beginning at day 3 through to week 12 LOCF (P < 0.001). A statistically significantly greater proportion of patients were classified as responders on the Clinical Global Impression-Improvement scale at all assessment points from day 3 through week 12 LOCF (P < 0.001) and on the Patient Global Improvement scale at all assessment points from day 1 (P = 0.013) through day 7 LOCF (P < or = 0.05 for days 2-7 LOCF) and at week 12 LOCF (P < 0.001).
Ropinirole is associated with consistent early and sustained improvements in the symptoms of RLS, as rated by patients and physicians.
研究每日两次服用罗匹尼罗对傍晚早期出现不安腿综合征（RLS）症状患者的影响，尤其关注患者和医生对治疗结果评估的关系。
在这项多中心、双盲、随机、为期12周的灵活剂量研究中，原发性RLS患者症状发作不早于下午5点且基线国际不安腿综合征研究组评分量表（IRLS）总分≥20，接受每日两次罗匹尼罗0.5至6.0毫克/天，分等量剂量服用，或安慰剂。首剂在通常症状发作前1小时服用；第二剂在首剂后3至8小时服用。主要终点：第12周末次观察结转（LOCF）时IRLS总分相对于基线的变化。关键次要终点：临床总体印象改善量表和患者总体改善量表上的反应者（评为“非常改善”或“明显改善”）比例。
从第3天开始至第12周LOCF的所有评估点，罗匹尼罗组（n = 175）的IRLS总分改善在统计学上显著大于安慰剂组（n = 184）（P < 0.001）。从第3天至第12周LOCF的所有评估点，在临床总体印象改善量表上，分类为反应者的患者比例在统计学上显著更高（P < 0.001）；从第1天（P = 0.013）至第7天LOCF（第2 - 7天LOCF时P≤0.05）以及第12周LOCF时，在患者总体改善量表上分类为反应者的患者比例在统计学上显著更高（P < 0.001）。结论：患者和医生评定，罗匹尼罗与RLS症状的持续早期和持续改善相关。
