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加巴喷丁与普萘洛尔治疗特发性震颤的随机安慰剂对照比较试验。

A randomized placebo-controlled comparative trial of gabapentin and propranolol in essential tremor.

作者信息

Gironell A, Kulisevsky J, Barbanoj M, López-Villegas D, Hernández G, Pascual-Sedano B

机构信息

Department of Neurology, Sant Pau Hospital, Autonomous University of Barcelona, Spain.

出版信息

Arch Neurol. 1999 Apr;56(4):475-80. doi: 10.1001/archneur.56.4.475.

DOI:10.1001/archneur.56.4.475
PMID:10199338
Abstract

BACKGROUND

New medication is needed to treat essential tremor. Preliminary evidence suggests that gabapentin may be effective in the treatment of this disorder.

OBJECTIVE

To study the effects of gabapentin in a comparative, double-blind, crossover, placebo-controlled trial of patients who have essential tremor.

PATIENTS AND METHODS

16 patients with essential tremor (6 with a new onset and 10 with a 2-week washout period of previous treatment with propranolol hydrochloride) received gabapentin (Neurontin), 400 mg 3 times daily; propranolol hydrochloride, 40 mg 3 times daily; and placebo for 15 days with a 1-week washout period between treatments.

MAJOR OUTCOME MEASURES

Major outcome evaluations consisted of a Tremor Clinical Rating Scale, accelerometric recordings, and a self-reported disability scale obtained before drug intake on study days 1 and 15 of each treatment period. In addition, the initial (day 1) and superimposed (day 15) drug effects were studied before and 2, 4, 6, and 8 hours after drug intake.

RESULTS

At day 15, both gabapentin and propranolol demonstrated significant and comparable efficacy in reducing tremor from baseline in all tremor measures. The initial drug effects evaluated through accelerometry revealed no significant changes with the use of a placebo, but gabapentin and propranolol use significantly reduced tremor power.

CONCLUSION

Gabapentin may be useful for the treatment of essential tremor.

摘要

背景

治疗特发性震颤需要新的药物。初步证据表明加巴喷丁可能对治疗这种疾病有效。

目的

在一项针对特发性震颤患者的比较、双盲、交叉、安慰剂对照试验中研究加巴喷丁的效果。

患者和方法

16例特发性震颤患者(6例为新发,10例在之前使用盐酸普萘洛尔治疗后有2周的洗脱期)接受加巴喷丁(Neurontin),每日3次,每次400mg;盐酸普萘洛尔,每日3次,每次40mg;以及安慰剂,疗程15天,各治疗期之间有1周的洗脱期。

主要结局指标

主要结局评估包括震颤临床评定量表、加速度计记录以及在每个治疗期第1天和第15天服药前获得的自我报告残疾量表。此外,在服药前以及服药后2、4、6和8小时研究初始(第1天)和叠加(第15天)的药物效果。

结果

在第15天,加巴喷丁和普萘洛尔在所有震颤测量指标中均显示出与基线相比显著且相当的震颤减轻效果。通过加速度计评估的初始药物效果显示,使用安慰剂时无显著变化,但使用加巴喷丁和普萘洛尔可显著降低震颤功率。

结论

加巴喷丁可能对治疗特发性震颤有用。

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Arch Neurol. 1999 Apr;56(4):475-80. doi: 10.1001/archneur.56.4.475.
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