用口内微型系统连续输送levodopa:一个开放标签的药理动力学和临床研究
C Warren Olanow1,2, Deborah McIntyre3, Michele Matarazzo4
1Department of Neurology, Mount Sinai School of Medicine, New York, New York, USA.
概括
与标准口服药物相比,DopaFuse系统提供连续的Levodopa/Carbidopa输送,显著减少帕金森病患者的运动波动和OFF时间.
科学领域:
- 神经学 神经学
- 药理动力学 药理动力学
- 医疗器械 医疗器械
背景情况:
- 帕金森病 (PD) 的运动并发症可以通过持续的利沃多巴输送来减轻.
- DopaFuse系统是一个口内微型,可以连续输送利沃多巴/卡比多巴 (LD/CD).
研究的目的:
- 评估通过DopaFuse提供的LD/CD的安全性,药理动力学和疗效.
- 与间歇性口服LD/CD在PD患者的运动波动的比较.
主要方法:
- 一项为期2周的开放性研究 (NCT04778176),涉及16名PD患者.
- 患者接受了标准的LD/CD,然后DopaFuse治疗以及可选的早晨口服剂量.
- 临床评估在第1天和第15天,在家中使用第4-14天.
主要成果:
- DopaFuse 降低了血中乐伏多巴的可变性 (波动指数从 2.15 降至 1.03,P < 0.0001).
- 显著减少了OFF时间 (-1.72小时,P=0.0004) 和增加了ON时间,没有动 (+1.72小时,P=0.0004).
- 在DopaFuse治疗中没有报告临床显著的不良事件.
结论:
- 通过DopaFuse的连续LD/CD输送显著降低了勒沃多巴度的变化.
- DopaFuse疗法有效地减少了OFF时间,并且在PD患者中耐受良好.
- 在帕金森病中,DopaFuse系统为管理运动波动提供了一个有希望的替代方案.
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