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左乙拉西坦(开浦兰)治疗帕金森病左旋多巴诱导的异动症的开放标签试点研究。

Open-label pilot study of levetiracetam (Keppra) for the treatment of levodopa-induced dyskinesias in Parkinson's disease.

作者信息

Zesiewicz Theresa A, Sullivan Kelly L, Maldonado John L, Tatum William O, Hauser Robert A

机构信息

Parkinson's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida 336112, USA.

出版信息

Mov Disord. 2005 Sep;20(9):1205-9. doi: 10.1002/mds.20563.

Abstract

We evaluated the tolerability and preliminary efficacy of levetiracetam (LEV; Keppra) in reducing levodopa-induced dyskinesias in Parkinson's disease (PD) in an open-label pilot study. Nine PD patients who were experiencing peak-dose dyskinesias for at least 25% of the awake day and were at least moderately disabling were treated with LEV in doses up to 3,000 mg for up to 60 days. The primary outcome measure was the percent of the awake day that patients spent on without dyskinesia or with nontroublesome dyskinesia (good on time). The mean dose of LEV at endpoint was 625+/-277 mg/day. LEV significantly improved percent of the awake day on without dyskinesia or with nontroublesome dyskinesia at endpoint compared to baseline (43% +/- 12% vs. 61% +/- 17%; P=0.02). Percent on time with troublesome dyskinesia decreased from 23% +/- 10% at baseline to 11% +/- 6% at endpoint, although not significantly. There was no significant increase in off time from baseline to endpoint. There was a 56% dropout rate, mostly due to somnolence. In PD patients who experienced peak-dose dyskinesia for at least 25% of the awake day, LEV significantly improved on time without dyskinesia or with nontroublesome dyskinesia.

摘要

在一项开放标签的试点研究中,我们评估了左乙拉西坦(LEV;开浦兰)在减少帕金森病(PD)患者左旋多巴诱导的异动症方面的耐受性和初步疗效。9名帕金森病患者,其清醒日至少25%的时间处于峰值剂量异动症状态且至少为中度致残,接受了剂量高达3000毫克、持续长达60天的左乙拉西坦治疗。主要结局指标是患者在无异动症或有不麻烦的异动症(良好时间)状态下度过的清醒日百分比。终点时左乙拉西坦的平均剂量为625±277毫克/天。与基线相比,终点时左乙拉西坦显著改善了无异动症或有不麻烦的异动症状态下的清醒日百分比(43%±12%对61%±17%;P=0.02)。有麻烦的异动症的时间百分比从基线时的23%±10%降至终点时的11%±6%,尽管未达到显著差异。从基线到终点,关期时间没有显著增加。脱落率为56%,主要原因是嗜睡。在清醒日至少25%的时间处于峰值剂量异动症状态的帕金森病患者中,左乙拉西坦显著改善了无异动症或有不麻烦的异动症状态下的时间。

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