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随机临床试验表明,托吡酯可治疗帕金森病患者左旋多巴诱导的运动障碍。

Randomized clinical trial of topiramate for levodopa-induced dyskinesia in Parkinson's disease.

机构信息

Centre for Clinical and Cognitive Neurosciences, Institute of Brain, Behaviour and Mental Health, University of Manchester, Manchester, UK; Department of Neurology, Greater Manchester Neurosciences Centre, Salford Royal NHS Foundation Trust, Salford, UK.

Institute for Ageing and Health, Newcastle University, Newcastle, UK.

出版信息

Parkinsonism Relat Disord. 2014 Apr;20(4):452-5. doi: 10.1016/j.parkreldis.2014.01.016. Epub 2014 Jan 28.

Abstract

BACKGROUND

The antiepileptic drug topiramate reduces levodopa-induced dyskinesia without exacerbating parkinsonism in animal models. We report a randomized, double-blind, placebo-controlled crossover trial in patients with Parkinson's disease and levodopa-induced dyskinesia.

METHODS

Fifteen patients with Parkinson's disease and stable levodopa-induced dyskinesia were enrolled into the study, of whom 13 were randomized to topiramate or placebo. The study medication was titrated to 100 mg/day over four weeks, and assessments were carried out after a further two weeks. Dyskinesia severity assessed by a blinded rater from video recordings was the primary outcome measure.

RESULTS

Seven patients (mean age 58.9 ± 12.8 years) completed the study. Patients taking topiramate vs. placebo showed a significant increase in dyskinesia severity compared to baseline (Wilcoxon signed rank test, P = 0.043). Five patients withdrew from the study whilst taking topiramate due to adverse effects.

CONCLUSIONS

Topiramate tended to worsen dyskinesia in patients with Parkinson's disease, and was poorly tolerated.

摘要

背景

抗癫痫药物托吡酯可减少动物模型中左旋多巴诱导的运动障碍,而不会加重帕金森病。我们报告了一项在帕金森病伴左旋多巴诱导运动障碍患者中进行的随机、双盲、安慰剂对照交叉试验。

方法

15 名患有帕金森病且左旋多巴诱导运动障碍稳定的患者被纳入研究,其中 13 名患者被随机分配至托吡酯或安慰剂组。研究药物在四周内滴定至 100mg/天,然后在两周后进行评估。通过盲法评估员从视频记录中评估运动障碍严重程度是主要的观察指标。

结果

7 名患者(平均年龄 58.9±12.8 岁)完成了研究。与基线相比,服用托吡酯的患者运动障碍严重程度显著增加(Wilcoxon 符号秩检验,P=0.043)。5 名患者在服用托吡酯时因不良反应而退出研究。

结论

托吡酯可能使帕金森病患者的运动障碍恶化,且耐受性差。

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