Quetiapine with lithium or divalproex for the treatment of bipolar mania: a randomized, double-blind, placebo-controlled study
Quetiapine with lithium or divalproex for the treatment of bipolar mania: a randomized, double-blind, placebo-controlled study
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DOI：
10.1111/j.1399-5618.2004.00115.x
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发表时间：
2004-06-01
影响因子：
5.4
通讯作者：
Sweitzer, DE
中科院分区：
文献类型：
--
作者：
Sachs, G;Chengappa, KNR;Sweitzer, DE
目的：方法：采用随机双盲对照的方法，将患者随机分为两组，分别用奎替利（QTP）联合锂（Li）或双丙戊酸钠（DVP）治疗急性躁狂症21 d，安慰剂（PBO）联合锂（Li）或双丙戊酸钠（DVP）治疗21 d。QTP快速给药至最大800 mg至0.7-1.0 mEq/L;或DVP至50-100 mug/mL.Results：五十六人的91（61.5%）QTP +锂/DVP组与49/100（49%）服用PBO +锂/DVP完成了研究。与PBO + Li/DVP组相比，QTP + Li/DVP组在终点时观察到的杨氏躁狂量表（YMRS）总分平均降低幅度更大（-13.76 vs-9.93; p = 0.021）。QTP + Li/DVP组的缓解率（YMRS改善≥ 50%）显著高于PBO + Li/DVP组（54.3% vs 32.6%; p = 0.005），达到临床缓解（YMRS < 12）的患者比例也是如此（45.7% vs 25.8%; p = 0.007）。接受QTP + Li/DVP的患者在临床疗效总评量表-双极（CGI-BP）疾病严重程度评分方面的改善也显著更大（-1.38 vs-0.78; p = 0.001）。在符合缓解标准的患者中，QTP的平均最后一周剂量为584 mg/天。QTP + Li/DVP组常见的不良事件（至少10%和Li/DVP率的两倍）包括嗜睡、口干、乏力和体位性低血压。结论：奎替利联合Li或DVP治疗双相躁狂患者的疗效上级Li或DVP单药治疗。联合治疗耐受性良好，大多数不良事件轻微，仅5%因不良事件退出，而Li或DVP单药治疗为6%。
Objective: Evaluate the efficacy and tolerability of quetiapine (QTP) combined with lithium (Li) or divalproex (DVP) in the treatment of acute mania.Methods: Patients were randomized to 21 days of double-blind treatment with QTP plus Li/DVP, or placebo (PBO) plus Li/DVP. QTP was rapidly dosed up to a maximum of 800 mg to 0.7-1.0 mEq/L; or DVP to 50-100 mug/mL.Results: Fifty-six of 91 (61.5%) individuals in the QTP + Li/DVP group compared with 49 of 100 (49%) taking PBO + Li/DVP completed the study. A significantly greater mean reduction in total Young Mania Rating Scale (YMRS) score was observed at end-point in patients receiving QTP + Li/DVP compared with those in the PBO + Li/DVP group (-13.76 versus -9.93; p = 0.021). The response rate (greater than or equal to50% YMRS improvement) was significantly higher in the QTP + Li/DVP group than in PBO + Li/DVP-treated patients (54.3% versus 32.6%; p = 0.005), as was the proportion of patients achieving clinical remission (YMRS < 12) (45.7% versus 25.8%; p = 0.007). Patients receiving QTP + Li/DVP also had a significantly greater improvement in Clinical Global Impressions-Bipolar (CGI-BP) Severity of Illness scores (-1.38 versus -0.78; p = 0.001). The mean last-week dose of QTP was 584 mg/day in patients meeting response criteria. Common adverse events (at least 10% and twice the rate of Li/DVP) in the QTP + Li/DVP group included somnolence, dry mouth, asthenia, and postural hypotension.Conclusions: Quetiapine combined with either Li or DVP has superior efficacy compared with Li or DVP monotherapy for treating patients with bipolar mania. Combination therapy was well-tolerated and most adverse events were mild, withdrawal because of adverse events being only 5% compared with 6% on Li or DVP monotherapy.