Pettinati Helen M, Gastfriend David R, Dong Qunming, Kranzler Henry R, O'Malley Stephanie S
Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.
Alcohol Clin Exp Res. 2009 Feb;33(2):350-6. doi: 10.1111/j.1530-0277.2008.00843.x. Epub 2008 Nov 25.
Extended-release naltrexone (XR-NTX) is a once-a-month injectable formulation for the treatment of alcohol dependence previously shown to reduce drinking and heavy drinking relative to placebo (Garbutt et al., 2005). A 24-week, randomized, double-blind, placebo-controlled study established the efficacy and safety of XR-NTX in this patient population. In this report, the effect of XR-NTX on quality of life (QOL) was examined.
Alcohol-dependent patients were randomly assigned to receive XR-NTX 380 mg (N = 205), XR-NTX 190 mg (N = 210), or placebo (N = 209), combined with a standardized psychosocial intervention. QOL was assessed using the Medical Outcomes Study 36-item short-form health survey, administered at baseline and at 4-week intervals during 24 weeks of treatment.
Compared with U.S. population norms, patients showed initial impairment in the health-related QOL domains of mental health, social functioning, and problems with work or other daily activities due to emotional problems. Adherence to all 6 injections was 65% for XR-NTX 190 mg, 63% for XR-NTX 380 mg, and 64% for placebo. Generalized estimating equations analyses using an intention-to-treat sample revealed that XR-NTX 380 mg was associated with significantly greater improvements from baseline in mental health (p = 0.0496), social functioning (p = 0.010), general health (p = 0.048), and physical functioning (p = 0.028), compared with placebo. Linear regression analyses revealed that reductions from baseline in drinking (percentage of drinking days and percentage of heavy drinking days in the last 30 days) were significantly (p < 0.05) correlated with improvements in quality of life.
Extended-release naltrexone 380 mg in combination with psychosocial intervention was associated with improvements in QOL, specifically in the domains of mental health, social functioning, general health, and physical functioning.
长效纳曲酮（XR-NTX）是一种每月注射一次的制剂，用于治疗酒精依赖，先前的研究表明，与安慰剂相比，它能减少饮酒量和重度饮酒量（Garbutt等人，2005年）。一项为期24周的随机、双盲、安慰剂对照研究确定了XR-NTX在该患者群体中的疗效和安全性。在本报告中，研究了XR-NTX对生活质量（QOL）的影响。
将酒精依赖患者随机分配接受380毫克XR-NTX（N = 205）、190毫克XR-NTX（N = 210）或安慰剂（N = 209），并结合标准化的社会心理干预。使用医学结果研究36项简短健康调查评估生活质量，在基线时以及治疗24周期间每4周进行一次评估。
与美国人群标准相比，患者在心理健康、社会功能以及因情绪问题导致的工作或其他日常活动问题等与健康相关的生活质量领域最初存在损害。190毫克XR-NTX的6次注射依从率为65%，380毫克XR-NTX为63%，安慰剂为64%。使用意向性治疗样本的广义估计方程分析显示，与安慰剂相比，380毫克XR-NTX与心理健康（p = 0.0496）、社会功能（p = 0.010）、总体健康（p = 0.048）和身体功能（p = 0.028）从基线的显著更大改善相关。线性回归分析显示，饮酒量从基线的减少（过去30天内饮酒天数的百分比和重度饮酒天数的百分比）与生活质量的改善显著（p < 0.05）相关。
380毫克长效纳曲酮与社会心理干预相结合可改善生活质量，特别是在心理健康、社会功能、总体健康和身体功能领域。
