Naltrexone in the treatment of alcohol dependence.
Naltrexone in the treatment of alcohol dependence.
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DOI：
10.1056/nejmoa011127
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发表时间：
2001-12-13
影响因子：
158.5
通讯作者：
Rosenheck, RA
中科院分区：
文献类型：
--
作者：
Krystal, JH;Cramer, JA;Rosenheck, RA
背景资料：虽然纳洛酮，阿片受体拮抗剂，已被美国食品和药物管理局批准用于治疗酒精dependence.Methods的，其疗效是不确定的：我们进行了一个多中心，双盲，安慰剂对照的评价纳洛酮作为一种辅助规范的心理治疗。我们将627名患有慢性严重酒精依赖的退伍军人（几乎都是男性）随机分配到12个月的纳洛酮（50 mg，每日一次），3个月的纳洛酮，随后9个月的安慰剂，或12个月的安慰剂。所有患者提供个人咨询和方案，以提高他们的研究药物的依从性，并鼓励参加酗酒者匿名meetings.Results：有209例患者在每组中，所有已清醒至少5天前随机化。在13周时，我们发现两个纳洛酮组（平均72.3天）和安慰剂组（平均62.4天;组间差异的95%置信区间为-3.0至22.8）患者之间的复发天数无显著差异。在52周，有三个组之间的饮酒发生的天数和饮酒次数的百分比没有显着差异daily.Conclusions：我们的研究结果不支持使用纳洛酮治疗男性慢性，严重的酒精依赖。（N Engl J Med 2001;345：1734-9.）版权所有（C）2001马萨诸塞州医学会。
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. (N Engl J Med 2001;345:1734-9.) Copyright (C) 2001 Massachusetts Medical Society.