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普瑞巴林(乐瑞卡)治疗特发性震颤的一项先导性、双盲、安慰剂对照试验。

A pilot, double-blind, placebo-controlled trial of pregabalin (Lyrica) in the treatment of essential tremor.

作者信息

Zesiewicz Theresa A, Ward Christopher L, Hauser Robert A, Salemi Jason L, Siraj Shaila, Wilson Maria-Carmen, Sullivan Kelly L

机构信息

Parkinson's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida 33612, USA.

出版信息

Mov Disord. 2007 Aug 15;22(11):1660-3. doi: 10.1002/mds.21629.

Abstract

We performed a pilot, double-blind, placebo-controlled, randomized trial to evaluate the efficacy and tolerability of pregabalin (PGB, Lyrica), an antiepileptic agent, in treating essential tremor (ET). Twenty two patients with ET were randomly assigned to receive PGB or placebo. PGB was initiated at 50 mg/day and was escalated by 75 mg/day every 4 days to a maximum dose of 600 mg/day. Patients were evaluated by accelerometry and the Fahn-Tolosa-Marin (FTM) rating scale. There was a significant reduction in tremor amplitude in the PGB group compared with the placebo group, as measured by accelerometry, at a mean dose of 286.76+/-100.05 mg/day. Action tremor limb scores on the FTM also improved in the PGB group compared with the placebo group (P-value for multilevel modeling=0.04). PGB was fairly well tolerated, with about one-third of patients dropping out of the study because of adverse events. PGB provided significant improvements in accelerometry and in action tremor limb scores on the FTM. However, larger studies are needed to further evaluate the potential effect of PGB on ET.

摘要

我们进行了一项初步的、双盲、安慰剂对照、随机试验,以评估抗癫痫药物普瑞巴林(PGB,乐瑞卡)治疗特发性震颤(ET)的疗效和耐受性。22例ET患者被随机分配接受PGB或安慰剂治疗。PGB起始剂量为50mg/天,每4天增加75mg/天,最大剂量为600mg/天。通过加速度测量法和法恩-托洛萨-马林(FTM)评分量表对患者进行评估。通过加速度测量法测得,PGB组平均剂量为286.76±100.05mg/天时,与安慰剂组相比,震颤幅度显著降低。与安慰剂组相比,PGB组FTM上的动作性震颤肢体评分也有所改善(多水平模型的P值=0.04)。PGB耐受性相当良好,约三分之一的患者因不良事件退出研究。PGB在加速度测量法和FTM上的动作性震颤肢体评分方面有显著改善。然而,需要更大规模的研究来进一步评估PGB对ET的潜在影响。

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