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首页> 外文期刊>Journal of affective disorders >Long-term efficacy of quetiapine in combination with lithium or divalproex on mixed symptoms in bipolar i disorder
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Long-term efficacy of quetiapine in combination with lithium or divalproex on mixed symptoms in bipolar i disorder

机译：喹硫平与锂或双丙戊酸钠合用治疗双相性精神障碍综合症状的长期疗效

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Background: To evaluate quetiapine in patients with bipolar I disorder with mixed symptoms. Methods: Data from 2 studies (D1447C00126, D1447C00127) were pooled and mixed events analyzed separately. Patients received quetiapine (400-800 mg/day) plus lithium/divalproex to achieve ≥12 weeks of clinical stability, followed by double-blind quetiapine (400-800 mg/day) or placebo, plus lithium/divalproex, for up to 104 weeks. Primary endpoint was time to first mood event post-randomization. Results: The ITT population included 1326 patients, of whom 445 had a mixed episode at study entry, 219 received quetiapine plus lithium/divalproex, and 226 received placebo plus lithium/divalproex. Mood events were reported by fewer quetiapine-plus-lithium/ divalproex than placebo-plus-lithium/divalproex-treated patients (21.0% vs 54.0%), and included mixed (6.4% vs 22.1%), pure manic (5.0% vs 13.3%), and pure depressed events (9.6% vs 18.6%). Hazard ratios (HR) for time to recurrence were longer for quetiapine plus lithium/divalproex than placebo plus lithium/divalproex for mixed (HR=0.23; 95% CI: 0.13-0.42; p<0.0001), pure manic (HR=0.30; 95% CI: 0.15-0.60; p=0.0007), and pure depressed events (HR=0.38; 95% CI: 0.22-0.64; p=0.0003). No new safety concerns were noted. Limitations: The post hoc nature of the analyses as patients were not randomized according to index symptom status. Conclusions: In stable patients with bipolar I disorder, quetiapine plus lithium/divalproex significantly increased time to recurrence of mood events versus placebo in patients with mixed symptoms at study entry and time to occurrence of mixed-mood events in patients with any mood episode at study entry.
机译：背景：评价喹硫平在患有混合症状的双相I型障碍患者中的​​作用。方法：汇总来自2个研究（D1447C00126，D1447C00127）的数据，并分别分析混合事件。患者接受喹硫平（400-800 mg /天）加锂/双丙戊酸达到≥12周的临床稳定性，然后接受双盲喹硫平（400-800 mg /天）或安慰剂加锂/双丙戊酸，直至104周。主要终点是随机化后发生首次情绪事件的时间。结果：ITT人群包括1326例患者，其中445例在研究开始时混合发作，219例接受喹硫平加锂/双丙戊酸钠，226例接受安慰剂加锂/双丙戊酸钠。据报道，喹硫平+锂/双丙戊酸患者的情绪事件少于安慰剂+锂/双丙戊酸钠治疗的患者（21.0％vs 54.0％），包括混合（6.4％vs 22.1％），纯躁狂（5.0％vs 13.3） ％）和纯粹的抑郁事件（9.6％比18.6％）。对于混合型（HR = 0.23; 95％CI：0.13-0.42; p <0.0001），纯狂躁症，喹硫平+锂/双丙戊酸的复发时间危险比（HR）长于安慰剂+锂/双丙戊酸。 95％CI：0.15-0.60; p = 0.0007）和单纯的抑郁事件（HR = 0.38; 95％CI：0.22-0.64; p = 0.0003）。没有发现新的安全隐患。局限性：由于患者没有根据指标症状状态随机分组，因此分析的事后性质。结论：在患有双相性I型障碍的稳定患者中，喹硫平加锂/双丙戊酸钠在进入研究时有混合症状的患者与安慰剂相比显着增加了情绪事件复发的时间，并且在研究中出现任何情绪发作的患者出现混合情绪事件的时间均显着增加条目。

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