A 6-month controlled naltrexon'e study:: Combined effect with cognitive behavioral therapy in outpatient treatment of alcohol dependence
A 6-month controlled naltrexon'e study:: Combined effect with cognitive behavioral therapy in outpatient treatment of alcohol dependence
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DOI：
10.1097/01.alc.0000075548.83053.a9
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发表时间：
2003-07-01
影响因子：
3.2
通讯作者：
Willander, A
中科院分区：
文献类型：
--
作者：
Balldin, J;Berglund, M;Willander, A
背景：在几项研究中，接受阿片类拮抗剂纳曲酮治疗的酒精依赖患者与接受安慰剂的患者相比，酗酒复发的情况较少。已观察到纳曲酮效应与心理治疗类型之间的相互作用。方法：在 10 个不同的调查地点进行了一项为期 6 个月的双盲、安慰剂对照、平行组研究。经过 1 周的安慰剂磨合期后，118 名患者被随机分为 4 个治疗组——每日 50 毫克纳曲酮或安慰剂联合认知行为疗法 (CBT) 或支持疗法。根据 MATCH 项目（将酒精中毒治疗与客户异质性相匹配）手册，CBT 进行了九个疗程。支持疗法被定义为“照常治疗”。在所有访视中均评估了饮酒量、渴望、碳水化合物缺乏转铁蛋白、按片剂计数的药物依从性以及不良临床事件。还测定了其他肝酶和精神症状。结果：91 名 (77%) 患者完成了研究，92 名 (78%) 患者对药物治疗方案的依从性达到 80%。与安慰剂组相比，纳曲酮组的重度饮酒天数百分比较低 (p = 0.045)，渴求评分也较低 (p = 0.029)。在纳曲酮组中，这些结果得到了较低水平的肝酶活性的支持（天冬氨酸转氨酶、丙氨酸转氨酶和γ-谷氨酰转移酶的 p < 0.010），但不得到碳水化合物缺乏的转铁蛋白水平的支持。对于接受 CBT 治疗的组，在酗酒第一天之前的平均时间较长 (p = 0.010)，特别是与纳曲酮联合治疗 (p = 0.007)。纳曲酮的耐受性良好，没有患者因副作用而终止研究。结论：这项研究支持纳曲酮在门诊治疗酒精依赖中的作用，并表明可以预期与 CBT 会产生有益的相互作用。
Background: In several studies, patients with alcohol dependence treated with the opioid antagonist naltrexone have shown fewer relapses to heavy drinking than those receiving placebo. An interaction between the naltrexone effect and the type of psychological therapy has been observed.Methods: A 6-month, double-blind, placebo-controlled, parallel-group study was performed at 10 different investigation sites. After a placebo run-in period of 1 week, 118 patients were randomized into 4 treatment groups-50 mg of naltrexone daily or placebo in combination with either cognitive behavioral therapy (CBT) or supportive therapy. The CBT was performed over nine sessions according to the manual of Project MATCH (Matching Alcoholism Treatments to Client Heterogeneity). The supportive therapy was defined as "the treatment as usual." Alcohol consumption, craving, carbohydrate-deficient transferrin, medication compliance by tablet count, and adverse clinical events were assessed at all visits. Other liver enzymes and psychiatric symptoms were also determined.Results: Ninety-one (77%) patients completed the study, and 92 (78%) were 80% compliant with the medication regimen. A lower percentage of heavy-drinking days was shown in the naltrexone group (p = 0.045) compared with the placebo group, as was a lower craving score (p = 0.029). These results are supported by the lower levels of liver enzyme activities (p < 0.010 for aspartate aminotransferase, alanine aminotransferase, and gamma-glutamyltransferase), but not by the carbohydrate-deficient transferrin levels, in the naltrexone group. The mean time period before the first day of heavy drinking was longer for the group treated with CBT (p = 0.010), especially in combination with naltrexone (p = 0.007). Naltrexone was well tolerated, and no patients discontinued the study due to side effects.Conclusions: This study supports the effect of naltrexone in outpatient treatment of alcohol dependence and suggests that a beneficial, interaction effect with CBT can be expected.