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普瑞巴林治疗特发性震颤的疗效和耐受性:一项随机、双盲、安慰剂对照、交叉试验。

Efficacy and tolerability of pregabalin in essential tremor: a randomized, double-blind, placebo-controlled, crossover trial.

机构信息

Parkinson's Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine, 6550 Fannin, Suite 1801, Houston, Texas 77030, USA.

出版信息

J Neurol Sci. 2009 Oct 15;285(1-2):195-7. doi: 10.1016/j.jns.2009.06.044. Epub 2009 Jul 25.

DOI:10.1016/j.jns.2009.06.044
PMID:19631949
Abstract

We performed a double-blind, crossover-design study to assess the tolerability and efficacy of pregabalin (PGB) in patients with essential tremor (ET). Twenty patients (11 women; mean age of 62.2+/-12.7 years, mean ET duration of 25.5+/-14.9 years) with ET were randomized for treatment with PGB (150-600 mg/day) or placebo, titrated over 6 weeks. Identical assessments of the Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (primary endpoint), Clinical Global Impression of Change (CGI-C), Quality of Life in Essential Tremor Questionnaire (QUEST), Hamilton Anxiety Scale (HAM-A), and a sleep hygiene questionnaire (HD-16) were made at the baseline, at the end of treatment periods for both drug and placebo, and following the 2-week washout period preceding crossover. We found no improvement in any of the TRS measures and a statistically significant worsening of QUEST scores while patients were taking PGB. Adverse events were similar in frequency to previously published studies of PGB, the most common being drowsiness and dizziness.

摘要

我们进行了一项双盲、交叉设计研究,以评估普瑞巴林(PGB)在特发性震颤(ET)患者中的耐受性和疗效。20 名 ET 患者(11 名女性;平均年龄 62.2+/-12.7 岁,平均 ET 病程 25.5+/-14.9 年)随机接受 PGB(150-600mg/天)或安慰剂治疗,在 6 周内滴定。在基线时、药物和安慰剂治疗结束时以及交叉前 2 周洗脱期后,使用 Fahn-Tolosa-Marin 震颤评定量表(TRS)(主要终点)、临床总体印象变化量表(CGI-C)、特发性震颤生活质量问卷(QUEST)、汉密尔顿焦虑量表(HAM-A)和睡眠卫生问卷(HD-16)进行相同的评估。我们发现,在服用 PGB 期间,任何 TRS 测量都没有改善,QUEST 评分反而出现了统计学上的显著恶化。不良反应的频率与之前发表的 PGB 研究相似,最常见的是嗜睡和头晕。

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