Sustained efficacy of apomorphine in Japanese patients with advanced Parkinson's disease
Sustained efficacy of apomorphine in Japanese patients with advanced Parkinson's disease
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DOI：
10.1016/j.parkreldis.2014.04.008
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发表时间：
2014-08-01
影响因子：
4.1
通讯作者：
Nomoto, Masahiro
中科院分区：
文献类型：
--
作者：
Hattori, Nobutaka;Nomoto, Masahiro
背景资料：本报告提供了在日本进行的阿扑吗啡补救治疗晚期帕金森病（PD）的第一次试验的数据。这3个月的试验旨在评估间歇性阿扑吗啡救援treatment.Methods的疗效的可持续性：第三阶段，双盲，安慰剂对照试验进行了PD患者（n = 31）与运动波动，尽管个别滴定治疗与左旋多巴和其他抗PD。将间歇治疗滴定至维持剂量，随后进行为期12周的非盲门诊期。在第12周访视时，使用统一帕金森病评定量表（UNITED Parkinson's Disease Rating Scale，CAFRS）第III部分评估阿扑吗啡或安慰剂的反应作为主要疗效终点（运动检查）在双盲交叉条件下。在交叉期（n = 28），阿扑吗啡组的APORS第III部分评分较给药前的最小二乘平均变化为-24.5分，安慰剂组为-2.3分，显示与安慰剂相比，阿扑吗啡在APORS第III部分评分变化方面提供了显著更大的改善（治疗间差异：-22.1 [95%置信区间，-27.8，-16.4]; P < 0.001）。研究期间最常报告的不良事件是嗜酸性粒细胞计数增加（8例）、恶心（7例）、嗜睡（6例）、运动障碍（5例）、打哈欠（5例）和血压下降（3例）。结论：我们的研究结果表明，间歇性使用阿扑吗啡3个月是晚期PD患者“关闭”发作的有效补救治疗。(C)2014爱思唯尔有限公司版权所有。
Background: This report presents data from one of the first trials of apomorphine rescue treatment for advanced Parkinson's disease (PD) conducted in Japan. This 3 month trial aimed to evaluate the sustainability of efficacy of intermittent apomorphine rescue treatment.Methods: A phase III, double-blind, placebo-controlled trial was conducted in PD patients (n = 31) with motor fluctuations in spite of individually titrated treatment with levodopa and other anti PD. Intermittent treatment was titrated to the maintenance dose with a subsequent unblind 12-week outpatient phase. At the week-12 visit, response to apomorphine or placebo was assessed as primary efficacy endpoint using the Unified Parkinson's Disease Rating Scale (UPDRS) part III (Motor Examination) under double-blind crossover conditions.Results: In the crossover phase (n = 28), least squares mean changes in the UPDRS part III score from pre-dose were -24.5 points with apomorphine and -2.3 points with placebo, showing that apomorphine, compared with placebo, provided a significantly greater improvement in the UPDRS part III score change (difference between treatments: -22.1 [95% confidence interval, -27.8, -16.4]; P < 0.001). The most frequently reported adverse events during the study were increased eosinophil count (8 patients), nausea (7), somnolence (6), dyskinesia (5), yawning (5), and decreased blood pressure (3).Conclusions: Our results indicate that a 3-month use of intermittent apomorphine is an effective rescue therapy for "off" episodes in advanced PD patients. (C) 2014 Elsevier Ltd. All rights reserved.