Department of Neurology, Harvard Vanguard Medical Associates, Boston, Massachusetts 02215, USA.
Mov Disord. 2010 May 15;25(7):927-31. doi: 10.1002/mds.23040.
We performed a retrospective analysis of the Efficacy And Safety Evaluation in Parkinson's Disease (EASE-PD) Adjunct Study, assessing the minimum time to symptom improvement after initiation of ropinirole prolonged release (2-24 mg/day) versus placebo in patients with moderate-to-advanced PD not optimally controlled with levodopa. Ropinirole prolonged release was superior to placebo at Week 2 for change from baseline in "off" time (adjusted mean treatment difference [AMTD] - 0.7 hours; 95% confidence interval [CI], -1.1, -0.2; P = 0.0029), and "on" time without troublesome dyskinesia (0.4 hours; 95%CI, 0.01, 0.88; P = 0.0444). At Week 4, improvements were seen in change from baseline in Unified Parkinson's Disease Rating Scale total motor score (AMTD, -3.1; 95%CI, -4.4, -1.8; P < 0.0001), activities of daily living score (AMTD, -1.1; 95%CI, -1.7, -0.5; P = 0.0004), and the cardinal symptoms of PD compared with placebo. These analyses indicate that once-daily, adjunctive ropinirole prolonged release can offer PD symptom control 2 weeks after treatment initiation.
我们对 EASE-PD 附加研究进行了回顾性分析,评估了罗匹尼罗缓释片(2-24mg/天)与安慰剂相比,在未接受左旋多巴优化治疗的中重度进展性帕金森病患者中,起始后症状改善的最短时间。罗匹尼罗缓释片在第 2 周时在“关期”(调整后的平均治疗差异 [AMTD] -0.7 小时;95%置信区间 [CI],-1.1,-0.2;P=0.0029)和“开期”无麻烦性运动障碍(0.4 小时;95%CI,0.01,0.88;P=0.0444)方面优于安慰剂。在第 4 周时,从基线变化来看,统一帕金森病评定量表(UPDRS)总运动评分(AMTD,-3.1;95%CI,-4.4,-1.8;P<0.0001)、日常生活活动评分(AMTD,-1.1;95%CI,-1.7,-0.5;P=0.0004)和 PD 的主要症状均有改善,与安慰剂相比。这些分析表明,每日一次的辅助罗匹尼罗缓释片可以在治疗开始后 2 周提供 PD 症状控制。