一项关于喹硫平治疗双相情感障碍（混合或抑郁相）合并酒精依赖患者的随机、双盲、安慰剂对照试验。
A randomized, double-blind, placebo-controlled trial of quetiapine in patients with bipolar disorder, mixed or depressed phase, and alcohol dependence.
作者信息
Brown E Sherwood, Davila Domingo, Nakamura Alyson, Carmody Thomas J, Rush A John, Lo Alexander, Holmes Traci, Adinoff Bryon, Caetano Raul, Swann Alan C, Sunderajan Prabha, Bret Mary E
机构信息
Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, Texas.
出版信息
Alcohol Clin Exp Res. 2014 Jul;38(7):2113-8. doi: 10.1111/acer.12445. Epub 2014 Jun 27.
BACKGROUND
Alcohol dependence is common in bipolar disorder (BPD) and associated with treatment nonadherence, violence, and hospitalization. Quetiapine is a standard treatment for BPD. We previously reported improvement in depressive symptoms, but not alcohol use, with quetiapine in BPD and alcohol dependence. However, mean alcohol use was low and a larger effect size on alcohol-related measures was observed in those with higher levels of alcohol consumption. In this study, efficacy of quetiapine in patients with BPD and alcohol dependence was examined in patients with higher mean baseline alcohol use than in the prior study.
METHODS
Ninety outpatients with bipolar I or II disorders, depressed or mixed mood state, and current alcohol dependence were randomized to 12 weeks of sustained release quetiapine (to 600 mg/d) add-on therapy or placebo. Drinking was quantified using the Timeline Follow Back method. Additional assessment tools included the Hamilton Rating Scale for Depression, Inventory of Depressive Symptomatology-Self-Report, Young Mania Rating Scale, Penn Alcohol Craving Scale, liver enzymes, and side effects. Alcohol use and mood were analyzed using a declining-effects random-regression model.
RESULTS
Baseline and demographic characteristics in the 2 groups were similar. No significant between-group differences were observed on the primary outcome measure of drinks per day or other alcohol-related or mood measures (p > 0.05). Overall side effect burden, glucose, and cholesterol were similar in the 2 groups. However, a significant weight increase was observed with quetiapine at week 6 (+2.9 lbs [SE 1.4] quetiapine vs. -2.0 lbs [SE 1.4], p = 0.03), but not at week 12. Scores on the Barnes Akathisia Scale increased significantly more (p = 0.04) with quetiapine (+0.40 [SE 0.3]) than placebo (-0.52 [SE 0.3]) at week 6 but not week 12. Retention (survival) in the study was similar in the groups.
CONCLUSIONS
Findings suggest that quetiapine does not reduce alcohol consumption in patients with BPD and alcohol dependence.
背景
酒精依赖在双相情感障碍（BPD）中很常见，且与治疗不依从、暴力行为和住院治疗相关。喹硫平是治疗BPD的标准药物。我们之前报道过，喹硫平可改善BPD和酒精依赖患者的抑郁症状，但对酒精使用情况无效。然而，平均酒精使用量较低，且在酒精摄入量较高的患者中，观察到对与酒精相关指标有更大的效应量。在本研究中，我们对平均基线酒精使用量高于先前研究的BPD和酒精依赖患者，考察了喹硫平的疗效。
方法
90例患有双相I型或II型障碍、处于抑郁或混合情绪状态且目前存在酒精依赖的门诊患者，被随机分为两组，分别接受为期12周的缓释喹硫平（剂量增至600毫克/天）附加治疗或安慰剂治疗。使用时间线追溯法对饮酒情况进行量化。其他评估工具包括汉密尔顿抑郁评定量表、抑郁症状自评量表、杨氏躁狂评定量表、宾夕法尼亚酒精渴望量表、肝酶以及副作用。使用递减效应随机回归模型分析酒精使用情况和情绪。
结果
两组的基线和人口统计学特征相似。在每日饮酒量这一主要结局指标或其他与酒精相关或情绪的指标上，未观察到显著的组间差异（p>0.05）。两组的总体副作用负担、血糖和胆固醇水平相似。然而，在第6周时，喹硫平组出现了显著的体重增加（喹硫平组增加2.9磅[标准误1.4]，而安慰剂组减少2.0磅[标准误1.4]，p=0.03），但在第12周时未出现。在第6周时，喹硫平组的巴恩斯静坐不能量表得分显著高于安慰剂组（p=0.04）（喹硫平组增加0.40[标准误0.3]，安慰剂组减少0.52[标准误0.3]），但在第12周时未出现。两组在研究中的保留率（生存率）相似。
结论
研究结果表明，喹硫平不能减少BPD和酒精依赖患者的酒精摄入量。
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