Croop R S, Faulkner E B, Labriola D F
DuPont Merck Pharmaceutical Company, Wilmington, Del, USA.
Arch Gen Psychiatry. 1997 Dec;54(12):1130-5. doi: 10.1001/archpsyc.1997.01830240090013.
Naltrexone hydrochloride is the first medication approved in the United States for the treatment of alcohol dependence in almost 50 years. This study was designed to collect safety data in a setting that reflected the expected clinical use of naltrexone.
This was a 12-week, nonrandomized, open-label usage study conducted in 40 alcoholism treatment centers throughout the United States, including free-standing alcoholism treatment programs, university clinics, Veterans Administration hospitals, and office-based primary care practices. Eligible patients were assigned, at the investigators' discretion, to a naltrexone treatment group or to a reference group that did not receive study medication. At study entry, patients must have been abstinent from alcohol for 1 to 6 weeks and enrolled in a psychosocial treatment program for alcoholism. Patients often underrepresented in controlled clinical trials, including women and patients with comorbid medical and psychiatric illness, were eligible. Patients with polysubstance abuse or infection with the human immunodeficiency virus were not excluded.
Of 865 patients enrolled, 570 received naltrexone and 295 were in a reference group. The most common new-onset adverse clinical events in the naltrexone group were nausea (9.8%) and headache (6.6%). Naltrexone was discontinued in 15.0% of patients because of adverse events, most frequently nausea. The results of liver function tests in the naltrexone group were similar to those in the reference group. No death occurred during the study.
This is the largest study to date describing the safety of naltrexone in a heterogeneous population of persons with alcoholism. No new safety concerns were identified.
盐酸纳曲酮是近50年来美国批准用于治疗酒精依赖的首款药物。本研究旨在收集反映纳曲酮预期临床应用情况的安全性数据。
这是一项为期12周的非随机、开放标签使用研究，在美国40个酒精中毒治疗中心开展，包括独立的酒精中毒治疗项目、大学诊所、退伍军人管理局医院及门诊初级保健机构。符合条件的患者由研究者酌情分配至纳曲酮治疗组或未接受研究药物的参照组。研究开始时，患者必须已戒酒1至6周，并参加针对酒精中毒的社会心理治疗项目。在对照临床试验中代表性不足的患者，包括女性以及患有合并内科和精神疾病的患者，均符合条件。多药滥用患者或感染人类免疫缺陷病毒的患者未被排除。
865名入组患者中，570名接受了纳曲酮治疗，295名在参照组。纳曲酮组最常见的新发不良临床事件为恶心（9.8%）和头痛（6.6%）。15.0%的患者因不良事件停用纳曲酮，最常见的原因是恶心。纳曲酮组的肝功能测试结果与参照组相似。研究期间无死亡病例。
这是迄今为止描述纳曲酮在异质性酒精中毒患者群体中安全性的最大规模研究。未发现新的安全问题。
