Effect of oral acamprosate on abstinence in patients with alcohol dependence in a double-blind, placebo-controlled trial: The role of patient motivation
Effect of oral acamprosate on abstinence in patients with alcohol dependence in a double-blind, placebo-controlled trial: The role of patient motivation
复制标题
DOI：
10.1016/j.jpsychires.2006.02.002
复制
发表时间：
2006-08-01
影响因子：
4.8
通讯作者：
Lehert, Philippe
中科院分区：
文献类型：
--
作者：
Mason, Barbara J.;Goodman, Anita M.;Lehert, Philippe
这是美国第一项评估阿坎酸（坎普拉尔）临床疗效的研究，阿坎酸是一种新近被美国食品药品监督管理局批准用于酒精戒断后维持酒精依赖患者戒酒的药物。我们比较了标准的2克剂量（n = 258）和探索性的3克剂量的阿坎酸（n = 83）与安慰剂（n = 260）的效果，并在一项横跨美国21家门诊诊所进行的为期6个月的双盲、安慰剂对照试验中评估了药物安全性。参与者是601名主要通过广告招募的当前患有酒精依赖的志愿者。所有患者同时接受了8次简短的手册指导咨询（www.alcoholfree.info）。主要的结果衡量指标是6个月研究期间无酒精天数的百分比。自我报告通过呼气酒精浓度、γ - 谷氨酰转移酶（GGT）以及旁证访谈进行了验证。在先验分析中，各组之间的戒酒天数百分比没有显著差异（安慰剂组为54.3%，2克剂量组为56.1%，3克剂量组为60.7%）。对基线变量和治疗暴露进行控制的事后分析发现，与安慰剂相比，阿坎酸与显著更高的戒酒天数百分比相关（安慰剂组为52.3%，2克剂量组为58.2%，3克剂量组为62.7%；P = 0.01），在241名以戒酒为基线目标的患者亚组中效果更显著（安慰剂组为58.1%，2克剂量组为70.0%，3克剂量组为72.5%；P = 0.02）。没有死亡或严重的药物相关不良事件发生。美国的研究结果表明，阿坎酸在广泛涵盖的酗酒者样本中是安全的且耐受性良好，并且在有戒酒治疗目标的患者群体中似乎是有效的。（c）2006爱思唯尔有限公司。保留所有权利。
This is the first US study to evaluate the clinical efficacy of acamprosate (Campral), a newly FDA-approved medication for maintaining abstinence in patients with alcohol dependence following alcohol withdrawal. We compared effects of the standard 2 g dose (n = 258) and an exploratory 3 g dose of acamprosate (n = 83) versus placebo (n = 260), and evaluated drug safety in a double-blind, placebo-controlled 6-month trial conducted in 21 outpatient clinics across the US. Participants were 601 volunteers with current alcohol dependence recruited primarily by advertisement. All patients concomitantly received eight sessions of brief manual-guided counseling (www.alcoholfree.info). The main outcome measure was the percentage of alcohol-free days over the 6-month study. Self-report was validated by breath alcohol concentration, gamma-glutamyltransferase (GGT) and collateral informant interviews. The percentage of abstinent days did not differ significantly across groups in a priori analysis (54.3% for placebo, 56.1% for 2 g, 60.7% for 3 g). Post-hoc analysis controlling for baseline variables and treatment exposure found acamprosate was associated with a significantly higher percentage of abstinent days than placebo (52.3% for placebo, 58.2% for 2 g, 62.7% for 3 g; P = 0.01), with an even greater effect in the subgroup of 241 patients having a baseline goal of abstinence (58.1% for placebo, 70.0% for 2 g, 72.5% for 3 g; P = 0.02). There were no deaths or serious drug-related adverse events. The US study findings suggest that acamprosate is safe and well tolerated in a broadly inclusive sample of alcoholics and appears effective in populations of patients motivated to have a treatment goal of abstinence. (c) 2006 Elsevier Ltd. All rights reserved.