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普瑞巴林、硫必利与劳拉西泮治疗酒精戒断综合征的多中心、随机、单盲对照试验

Pregabalin, tiapride and lorazepam in alcohol withdrawal syndrome: a multi-centre, randomized, single-blind comparison trial.

机构信息

Clinica Villa Maria Pia, Via del Forte Trionfale 36, Rome 00135 Italy.

出版信息

Addiction. 2010 Feb;105(2):288-99. doi: 10.1111/j.1360-0443.2009.02792.x.

DOI:10.1111/j.1360-0443.2009.02792.x
PMID:20078487
Abstract

INTRODUCTION

The aim of this trial was to compare lorazepam with non-benzodiazepine medications such as pregabalin and tiapride in the treatment of alcohol withdrawal syndrome (AWS). These drugs were chosen for their inhibitorial effects on the hypersecretion of neurotransmitters usually observed in AWS. Craving reduction and improvement of psychiatric symptoms were the secondary end-points.

METHODS

One hundred and ninety subjects affected by current alcohol dependence were considered consecutively: 111 were enrolled and divided into three groups of 37 subjects each. Within a treatment duration of 14 days, medication was given up to the following maximum doses (pregabalin 450 mg/day; tiapride 800 mg/day; lorazepam 10 mg/day). Withdrawal (CIWA-Ar), craving [visual analogue scale (VAS); Obsessive and Compulsive Drinking Scale (OCDS)], psychiatric symptoms [Symptom Check List 90 Revised (SCL-90-R)] and quality of life (QL-index) rating scales were applied.

RESULTS

On the CIWA-Ar score, all the groups showed a significant reduction between times (P < 0.001) with a higher reduction for the pregabalin group (P < 0.01) on items regarding headache and orientation. Retention in treatment was lower in the tiapride group (P < 0.05), while the number of subjects remaining alcohol free was higher in the pregabalin group (P < 0.05). Significant reduction between baseline and the end of the treatment was found in all the groups at the OCDS and the VAS for craving, at the SCL-90-R and QL-index (P < 0.001).

DISCUSSION

All the medications in the trial showed evidence of safety and efficacy in the treatment of uncomplicated forms of AWS, with some particular differences. The efficacy of pregabalin was superior to that of tiapride, used largely in research trials and, for some measures, to that of the 'gold standard', lorazepam. Accordingly, pregabalin may be considered as a potentially useful new drug for treatment of AWS, deserving further investigation.

摘要

简介

本试验旨在比较劳拉西泮与非苯二氮䓬类药物(如普瑞巴林和硫必利)在治疗酒精戒断综合征(AWS)中的疗效。选择这些药物是因为它们对 AWS 中通常观察到的神经递质过度分泌有抑制作用。减少渴求及改善精神症状是次要终点。

方法

连续纳入 190 例当前患有酒精依赖的受试者:共纳入 111 例,并分为三组,每组 37 例。在 14 天的治疗期间,给予以下最大剂量的药物:普瑞巴林 450 mg/天;硫必利 800 mg/天;劳拉西泮 10 mg/天。采用戒断评估量表(CIWA-Ar)、渴求(视觉模拟量表(VAS);强迫性和饮酒量表(OCDS))、精神症状(症状清单 90 修订版(SCL-90-R))和生活质量(QL 指数)评分量表进行评估。

结果

在 CIWA-Ar 评分上,所有组在时间上均显示出显著降低(P < 0.001),其中普瑞巴林组在头痛和定向项目上的降低更为显著(P < 0.01)。硫必利组的治疗保留率较低(P < 0.05),而普瑞巴林组的戒酒人数较高(P < 0.05)。在所有组中,OCDS 和渴求的 VAS、SCL-90-R 和 QL 指数在治疗结束时均较基线显著降低(P < 0.001)。

讨论

试验中的所有药物在治疗单纯性 AWS 中均显示出安全性和疗效,且具有一些特殊差异。普瑞巴林的疗效优于硫必利,后者主要用于研究试验,在某些指标上优于“金标准”劳拉西泮。因此,普瑞巴林可被视为治疗 AWS 的一种潜在有用的新药,值得进一步研究。

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