Mizuno Yoshikuni, Abe Takashi, Hasegawa Kazuko, Kuno Sadako, Kondo Tomoyoshi, Yamamoto Mitsutoshi, Nakashima Mitsuyoshi, Kanazawa Ichiro
Department of Neurology, Juntendo University School of Medicine, Bunkyo, Tokyo, Japan.
Mov Disord. 2007 Oct 15;22(13):1860-5. doi: 10.1002/mds.21313.
We report the results of a randomized, double-blind, placebo-controlled, 16-week study to evaluate the efficacy and safety of ropinirole, 0.75 to 15.0 mg/day, as an adjunct to levodopa. A total of 243 patients were randomly assigned into placebo or ropinirole groups. The mean (standard deviation) dose of ropinirole at endpoint was 7.12 (2.88) mg/day. The primary endpoint-the mean reduction in the Unified Parkinson's Disease Rating Scale (UPDRS) total motor score-was significantly greater for the ropinirole group than the placebo group (-9.5 vs. -4.5, P = 0.00001). The mean reduction in the UPDRS total activities of daily living (ADL) score was also significantly greater for ropinirole than for placebo (-2.7 vs. -1.0, P = 0.0002). The percentage of patients showing at least a 20% reduction in the percentage of time spent "off" was significantly greater for the ropinirole group than for the placebo group (58.7% vs. 38.6%, P = 0.030). A total of 84.3 and 65.6% of the patients experienced adverse events while receiving ropinirole or placebo, respectively. The results showed that ropinirole was more effective than placebo in improving motor function and ADL when used as an adjunct to levodopa in patients with advanced Parkinson's disease.
我们报告了一项随机、双盲、安慰剂对照、为期16周的研究结果，该研究旨在评估0.75至15.0毫克/天的罗匹尼罗作为左旋多巴辅助药物的疗效和安全性。共有243名患者被随机分为安慰剂组或罗匹尼罗组。终点时罗匹尼罗的平均（标准差）剂量为7.12（2.88）毫克/天。主要终点——统一帕金森病评定量表（UPDRS）总运动评分的平均降低值——罗匹尼罗组显著高于安慰剂组（-9.5对-4.5，P = 0.00001）。罗匹尼罗组UPDRS日常生活活动（ADL）总评分的平均降低值也显著高于安慰剂组（-2.7对-1.0，P = 0.0002）。“关”期时间百分比至少降低20%的患者比例，罗匹尼罗组显著高于安慰剂组（58.7%对38.6%，P = 0.030）。接受罗匹尼罗或安慰剂治疗的患者分别有84.3%和65.6%经历了不良事件。结果表明，在晚期帕金森病患者中，罗匹尼罗作为左旋多巴的辅助药物在改善运动功能和ADL方面比安慰剂更有效。
