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Naltrexone in the treatment of alcohol dependence.

机译:纳曲酮可治疗酒精依赖症。

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BACKGROUND: Although naltrexone, an opiate-receptor antagonist, has been approved by the Food and Drug Administration for the treatment of alcohol dependence, its efficacy is uncertain. METHODS: We conducted a multicenter, double-blind, placebo-controlled evaluation of naltrexone as an adjunct to standardized psychosocial treatment. We randomly assigned 627 veterans (almost all men) with chronic, severe alcohol dependence to 12 months of naltrexone (50 mg once daily), 3 months of naltrexone followed by 9 months of placebo, or 12 months of placebo. All patients were offered individual counseling and programs to improve their compliance with study medication and were encouraged to attend Alcoholics Anonymous meetings. RESULTS: There were 209 patients in each group; all had been sober for at least five days before randomization. At 13 weeks, we found no significant difference in the number of days to relapse between patients in the two naltrexone groups (mean, 72.3 days) and the placebo group (mean, 62.4 days; 95 percent confidence interval for the difference between groups, -3.0 to 22.8). At 52 weeks, there were no significant differences among the three groups in the percentage of days on which drinking occurred and the number of drinks per drinking day. CONCLUSIONS: Our findings do not support the use of naltrexone for the treatment of men with chronic, severe alcohol dependence.
机译:背景:尽管纳曲酮是一种鸦片受体拮抗剂,已被美国食品药物管理局批准用于治疗酒精依赖症,但其疗效尚不确定。方法:我们对纳曲酮进行了多中心,双盲,安慰剂对照的评估,作为标准化社会心理治疗的辅助手段。我们将627名具有慢性,严重酒精依赖的退伍军人(几乎所有男性)随机分配给12个月的纳曲酮(每天一次50 mg),3个月的纳曲酮,9个月的安慰剂或12个月的安慰剂。为所有患者提供了个人咨询和计划,以提高他们对研究药物的依从性,并鼓励他们参加戒酒匿名会议。结果:每组209例。在随机分组之前,所有人都清醒了至少五天。在13周时,我们发现两个纳曲酮组(平均72.3天)和安慰剂组(平均62.4天;两组之间差异的95%置信区间)之间的复发天数无显着差异- 3.0至22.8)。在第52周时,三组之间的饮酒天数百分比和每饮酒天的饮酒次数没有显着差异。结论:我们的发现不支持使用纳曲酮治疗患有慢性,严重酒精依赖的男性。

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