纳曲酮治疗酒依赖患者的安慰剂双盲对照研究

NALTREXONE FOR ALCOHOL DEPENDENCE:A DOUBLE BLIND PLACEBO-CONTROLLED TRIAL

目的:探讨纳曲酮治疗酒依赖患者的疗效与安全性。方法:采用纳曲酮和安慰剂双盲对照研究方法,将68例门诊酒依赖患者随机入组,治疗12周,在不同治疗时段采用密执根酒精依赖调查表(MAST)、饮酒渴求度、饮酒量调查表、SCL-90、不良事件、血生化、心电图等各项工具进行测试。结果:观察期内纳曲酮组可视渴求量表在治疗的第10周及第12周分别为1.77±s1.71、1.52±s1.61,与安慰剂组比较差异有显著性(P值均<0.05)。饮酒量纪录表显示纳曲酮组的患者酒精消耗量(g)在治疗的第6、8、10周分别为116.55±s302.19、127.36±s316.13、170.43±s388.14,与安慰剂组差异具有显著性(P值均<0.05);复饮患者纳曲酮组和安慰剂组分别有4/32例、13/33例,卡方检验(Fisher)χ2=6.08,差异有显著性;SCL-90测试显示纳曲酮组在治疗的第8周,其焦虑、恐怖、偏执三个子量表的数值分别为1.16±s0.27、1.06±s0.21、1.13±s0.22,显著低于安慰剂组,差异有显著性(P值均<0.05)。在治疗的第12周,纳曲酮组的躯体化、焦虑两个子量表分数为1.14±s0.28、1.10±s0.20,较安慰剂组显著下降,差异非常显著(P值均<0.01);纳曲酮组与安慰剂组在血生化、心电图、血压、体重等方面的比较差异无显著性(P>0.05);不良事件纪录显示纳曲酮比较常见的不良反应主要为消化道反应(9/34)和乏力、头疼等神经系统副作用(3/34)。结论:纳曲酮能有效降低酒依赖患者的心理渴求、酒精消耗和复饮风险。同时也能缓解酗酒导致的焦虑、恐怖、偏执及躯体化症状。纳曲酮的不良反应程度较轻,持续时间较短,患者多可耐受,是一种安全有效的酒依赖治疗药物。

Objective：To explore the therapeutic effects and safety of naltrexone for treating patients with alcohol dependence. Methods：A total of 68 outpatients with alcohol dependence were randomly assigned to naltrexone group treated with naltrexone or control group treated with placebo for 12 weeks. The Michigan Alcohol Screening （MAST）,Alcohol Craving Scale,Drinking Recorder Scale,Symptom Checklist 90（SCL-90）,adverse events,blood biochemistry and electrocardiograph（ECG）were tested to evaluate the effects and safety of nahrexone. Results ：The scores of Alcohol Craving Scale in nahrexone group at the 10th and 12th week were 1.77 ±s 1.71 and 1.52±s 1.61, respectively, showing significant difference when compared with those of the control group （ P 〈 0. 05 ） ; alcohol consumption in nahrexone group at the 6th,8th and 10th week （ 116. 55± s 302. 19,127.36± s 316. 13,170.43±s 388.14） were significantly lower than those in control group （ P 〈 0. 05 ） ; relapse to drink also showed significant difference between the two groups （4：13,χ^2 = 6. 08 ）. The factor -scores of anxiety, phobia and paranoid in nahrexone group after 8 -week treatment were 1.16 ±s 0. 27, 1.06 ±s 0.21 and 1.13±s 0. 22, which were significantly lower than those in control group （ P 〈 0. 05 ）. The factor - scores of somatization and anxiety in nahrexone group after 12 - week treatment were 1.14 ±s 0. 28 and 1.10± s 0. 20, which were significantly lower than those in control group（P 〈0. 01 ）. No significant differences were observed in the blood biochemistry, ECG, blood pressure and body weight between the two groups（P〉0.05）. The main adverse effects of naltrexone were digestive tract reaction （9/34）, hypodynamia, headache and other nervous system side effects （3/34）. Conclusion： Nahrexone can effectively inhibit alcohol craving, decrease alcohol consumption and incidence of relapse in alcohol dependent patients. It can also relieve alcohol abuse - induced anxiety, fear, crankiness and somatization symptoms and the adverse effects are slight and transitory. Naltrexone is effective and safe for the treatment of alcohol dependant patients.