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一项开放性多中心研究,评估179名酒精依赖患者中期使用4-羟基丁酸钠盐的疗效。γ-羟基丁酸研究组。

An open multicentric study evaluating 4-hydroxybutyric acid sodium salt in the medium-term treatment of 179 alcohol dependent subjects. GHB Study Group.

作者信息

Addolorato G, Castelli E, Stefanini G F, Casella G, Caputo F, Marsigli L, Bernardi M, Gasbarrini G

机构信息

Internal Medicine II Chair, Catholic University Sacro Cuore, Rome, Italy.

出版信息

Alcohol Alcohol. 1996 Jul;31(4):341-5. doi: 10.1093/oxfordjournals.alcalc.a008160.

DOI:10.1093/oxfordjournals.alcalc.a008160
PMID:8879280
Abstract

We report the results of an "open' multicentre study evaluating the use, tolerability and therapeutic efficacy of the sodium salt of 4-hydroxybutyric acid (GHB) for the medium-term treatment of withdrawal symptoms in 179 patients with alcohol dependence followed up as outpatients. The follow-up of patients was 6 and 12 months after drug discontinuation. Following a daily oral administration of 50 mg/kg for approximately 6 months, no serious systemic or single-organ consequences leading to drug discontinuation were reported, and tolerability was fair in all patients. Eleven subjects (10.1%) showed craving for the drug and voluntarily increased their doses (6-7 times the recommended levels). GHB led to complete abstinence during drug administration in 78.0% of the patients. A significant reduction of compulsive desire ("craving') was observed in parallel, as deduced from evaluation of a specific questionnaire, the Alcohol Craving Scale. At follow-up examination, 43 of the treated subjects remained abstinent at 6 months, and 30 subjects were abstinent for 1 year after drug discontinuation.

摘要

我们报告了一项“开放性”多中心研究的结果,该研究评估了4-羟基丁酸(GHB)钠盐对179例酒精依赖门诊患者戒断症状的中期治疗效果、耐受性及用药情况。患者在停药后6个月和12个月进行随访。每日口服50mg/kg,持续约6个月,未报告导致停药的严重全身或单一器官不良反应,所有患者耐受性良好。11名受试者(10.1%)出现对该药物的渴望并自行增加剂量(达到推荐剂量的6至7倍)。在用药期间,78.0%的患者实现了完全戒酒。通过特定问卷“酒精渴望量表”评估得出,同时观察到强迫性欲望(“渴望”)显著降低。在随访检查中,43名接受治疗的受试者在6个月时仍保持戒酒状态,30名受试者在停药后1年保持戒酒。

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