γ-羟基丁酸（GHB）治疗酒精戒断综合征：与苯二氮䓬类药物的随机对照研究

Gamma-hydroxybutyric acid (GHB) in the treatment of alcohol withdrawal syndrome: a randomized comparative study versus benzodiazepine.

作者信息

Addolorato G, Balducci G, Capristo E, Attilia M L, Taggi F, Gasbarrini G, Ceccanti M

机构信息

Institute of Internal Medicine, Universita' Cattolica del Sacro Cuore, Rome, Italy.

出版信息

Alcohol Clin Exp Res. 1999 Oct;23(10):1596-604.

DOI:

PMID:10549990

Abstract

BACKGROUND

Benzodiazepine has been shown to be one of the most effective class of drugs in the management of alcohol withdrawal syndrome (AWS). Gamma-hydroxybutyric acid (GHB) has recently been introduced in the treatment of alcohol problems, including AWS. At present there are no comparative studies between benzodiazepines and GHB in AWS treatment. The aim of the present randomized, controlled, single-blind study was to evaluate the efficacy and safety of GHB compared with diazepam in the treatment of AWS.

METHODS

Sixty alcoholics affected by AWS were enrolled in the study. Diazepam (0.5-0.75 mg/kg body weight for 6 days, tapering the dose 25% daily until day 10) was administered orally to 30 patients (25 males, 5 females; mean age 44.3 +/- 10.9 years); GHB (50 mg/kg body weight for 10 days) was administered orally to 30 patients (26 males,4 females; mean age 41.7 +/- 10.4 years). The Clinical Institute Withdrawal Assessment for Alcohol-revised scale (CIWA-Ar) was used to evaluate the AWS physical symptoms. The State Anxiety Inventory test for current anxiety assessment and the Zung self-rating Depression Scale for current depression assessment were performed.

RESULTS

Eight patients (26.6%) in the diazepam group and 4 patients (13.3%) in the GHB group dropped out. Both treatments were effective in reducing AWS. No significant difference was found between the groups in CIWA-Ar total score at baseline and at the different times of observation. Considering the CIWA-Ar subscore and Zung scale, a significant reduction of anxiety on day 4 (p < 0.02), agitation on day 5 (p < 0.02) and time of recovery of depression on day 5 (p < 0.02) was observed in the GHB group with respect to the diazepam group. Drowsiness and vertigo developed after initial drug administration in the GHB (19.2%) and diazepam (36.4%) groups and quickly resolved in both groups.

CONCLUSIONS

GHB is as effective in the management of AWS as benzodiazepine and it seems to be quicker in reducing anxiety, agitation, and depression. Both drugs are safe and well-tolerated in AWS management.

摘要

背景

苯二氮䓬类药物已被证明是治疗酒精戒断综合征（AWS）最有效的药物类别之一。γ-羟基丁酸（GHB）最近已被用于治疗包括AWS在内的酒精问题。目前尚无关于苯二氮䓬类药物与GHB在AWS治疗方面的比较研究。本随机、对照、单盲研究的目的是评估GHB与地西泮在治疗AWS方面的疗效和安全性。

方法

60名患有AWS的酗酒者被纳入研究。30名患者（25名男性，5名女性；平均年龄44.3±10.9岁）口服地西泮（0.5 - 0.75mg/kg体重，持续6天，每日剂量递减25%直至第10天）；30名患者（26名男性，4名女性；平均年龄41.7±10.4岁）口服GHB（50mg/kg体重，持续10天）。采用酒精戒断临床研究所修订量表（CIWA-Ar）评估AWS的身体症状。进行状态焦虑量表测试以评估当前焦虑状况，并采用zung自评抑郁量表评估当前抑郁状况。

结果

地西泮组有8名患者（26.6%）退出，GHB组有4名患者（13.3%）退出。两种治疗方法在减轻AWS方面均有效。在基线及不同观察时间点，两组的CIWA-Ar总分无显著差异。就CIWA-Ar子评分和zung量表而言，与地西泮组相比，GHB组在第4天焦虑显著减轻（p<0.02），第5天激越显著减轻（p<0.02），第5天抑郁恢复时间显著缩短（p<0.02）。GHB组（19.2%）和地西泮组（36.4%）在首次用药后均出现嗜睡和眩晕，且两组均迅速缓解。