Stedman Clinical Trials, 3212 Cove Bend Dr., Tampa, FL 33613, USA.
Alcohol Clin Exp Res. 2010 Oct;34(10):1822-31. doi: 10.1111/j.1530-0277.2010.01270.x. Epub 2010 Jul 19.
This study evaluated the efficacy of quetiapine versus placebo as an adjunct to lithium or divalproex in reducing alcohol consumption in patients with bipolar I disorder and coexisting alcohol dependence.
Male and female outpatients (21 to 60 years) with a history of bipolar I disorder and alcohol dependence were included in this 12-week, placebo-controlled study. Patients treated with lithium or divalproex (ongoing or assigned at screening) were randomized to receive quetiapine (dosed up to 400 mg/d over 7 days, followed by 300 to 800 mg/d flexible dosing until study end) or placebo. The primary outcome measure was the change in the proportion of heavy drinking days from baseline to Week 12 (as derived from the Timeline Followback method). Secondary outcome measures included time to the first consecutive 2 weeks of abstinence, changes from baseline to Week 12 in the proportion of nondrinking days, mean number of standardized drinks per day, and Clinical Global Impressions-Severity of Illness score.
Of 362 enrolled patients (mean 38.6 years), 176 were randomized to receive quetiapine and 186 to placebo. The mean proportion of heavy drinking days at baseline was 0.66 in the quetiapine group and 0.67 in the placebo group. At Week 12, the mean change in the proportion of heavy drinking days was -0.36 with quetiapine and -0.36 with placebo (p = 0.93). No statistically significant differences in any of the secondary outcome measures were noted between the quetiapine and placebo groups. The incidence of adverse events was consistent with the previously known tolerability profile of quetiapine.
The efficacy of quetiapine in the treatment of bipolar disorder is already well established. In this study, however, quetiapine added to lithium or divalproex did not result in significantly greater improvement compared with placebo in measures of alcohol use and dependence in patients with bipolar I disorder and alcohol dependence.
本研究评估喹硫平作为锂或丙戊酸钠辅助治疗双相 I 障碍合并酒精依赖患者减少饮酒量的疗效。
本 12 周、安慰剂对照研究纳入了有双相 I 障碍和酒精依赖病史的男性和女性门诊患者（21 至 60 岁）。正在接受锂或丙戊酸钠治疗（入组时正在接受或入组时开始）的患者被随机分为接受喹硫平（在第 7 天内增至 400mg/d，随后根据情况灵活调整剂量至 300 至 800mg/d，直至研究结束）或安慰剂治疗。主要结局指标是从基线到第 12 周时重度饮酒天数的变化（根据时间线回溯法得出）。次要结局指标包括首次连续 2 周戒酒的时间、从基线到第 12 周时不饮酒天数的比例、每天标准饮料的平均数量和临床总体印象-疾病严重程度评分的变化。
362 例入组患者（平均年龄 38.6 岁）中，176 例被随机分至喹硫平组，186 例分至安慰剂组。喹硫平组和安慰剂组基线时重度饮酒天数的平均比例分别为 0.66 和 0.67。第 12 周时，喹硫平组和安慰剂组重度饮酒天数的平均变化分别为-0.36 和-0.36（p=0.93）。喹硫平组和安慰剂组的任何次要结局指标均无统计学显著差异。不良事件的发生率与喹硫平已知的耐受性特征一致。
喹硫平治疗双相障碍的疗效已得到充分证实。然而，在本研究中，与安慰剂相比，喹硫平添加到锂或丙戊酸钠并未显著改善双相 I 障碍合并酒精依赖患者的饮酒和依赖相关测量结果。
