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在分层为指数躁狂或混合发作的双相 I 患者中,阿立哌唑与锂或丙戊酸盐联用预防躁狂或混合发作复发的疗效。

Efficacy of aripiprazole versus placebo as adjuncts to lithium or valproate in relapse prevention of manic or mixed episodes in bipolar I patients stratified by index manic or mixed episode.

机构信息

Department of Psychiatry, University of British Columbia, 2255 Westbrook Mall, Vancouver, British Columbia, Canada.

出版信息

J Affect Disord. 2013 May;147(1-3):365-72. doi: 10.1016/j.jad.2012.11.042. Epub 2013 Jan 3.

DOI:10.1016/j.jad.2012.11.042
PMID:23290791
Abstract

BACKGROUND

Differences in response to treatment have been observed for bipolar disorder (BPD) patients with manic or mixed episodes. This post-hoc analysis examined the maintenance effect of aripiprazole in combination with lithium or valproate in subpopulations of patients entering a relapse prevention study with either manic or mixed bipolar episodes.

METHODS

A long-term relapse prevention study of BPD patients with manic or mixed episodes included a single-blind stabilization phase, in which patients were stabilized with single-blind aripiprazole plus lithium or valproate (maintaining stability for 12 weeks), and a double-blind relapse assessment phase, where patients were randomized to aripiprazole or placebo plus lithium or valproate for up to 52 weeks. Lithium and valproate groups were pooled.

RESULTS

The time to relapse of any mood episode was longer in the adjunctive aripiprazole group versus the lithium/valproate monotherapy group for the manic (p<0.01) but not mixed population (p=0.59). The LOCF analysis indicated a significantly greater reduction in YMRS total score from baseline with continued aripiprazole versus placebo at 52 weeks in both manic (treatment difference=-3.32, p<0.01) and mixed episode populations (treatment difference=-2.56, p=0.02). Overall, adverse event profiles were similar between the populations.

LIMITATION

The lithium and valproate subgroups were combined.

CONCLUSIONS

The continuation of aripiprazole in stabilized BPD patients treated with lithium or valproate increased the time to relapse of any mood episode for manic but not mixed patients; both groups achieved greater stability in YMRS total score with adjunctive aripiprazole. Thus, adjunctive aripiprazole may be more appropriate for stabilized patients with manic episodes.

摘要

背景

对于有躁狂或混合发作的双相情感障碍(BPD)患者,治疗反应存在差异。本事后分析检查了在有躁狂或混合双相情感障碍发作的患者进入预防复发研究时,阿立哌唑联合锂或丙戊酸盐在亚组患者中的维持疗效。

方法

一项 BPD 患者有躁狂或混合发作的长期预防复发研究包括一个单盲稳定期,在此期间患者接受单盲阿立哌唑联合锂或丙戊酸盐治疗(稳定 12 周),以及一个双盲复发评估期,在此期间患者被随机分配接受阿立哌唑或安慰剂联合锂或丙戊酸盐治疗,最长 52 周。锂和丙戊酸盐组合并。

结果

与锂/丙戊酸盐单药治疗组相比,阿立哌唑联合治疗组躁狂(p<0.01)而非混合人群(p=0.59)的任何情绪发作复发时间更长。在 52 周时,继续阿立哌唑治疗与安慰剂相比,在躁狂(治疗差异=-3.32,p<0.01)和混合发作人群中(治疗差异=-2.56,p=0.02),YMRS 总分从基线显著降低。总体而言,不同人群的不良事件谱相似。

局限性

锂和丙戊酸盐亚组合并。

结论

在接受锂或丙戊酸盐治疗的稳定 BPD 患者中继续使用阿立哌唑可延长躁狂患者而非混合患者的任何情绪发作复发时间;两组患者在联合阿立哌唑治疗时 YMRS 总分的稳定性均提高。因此,阿立哌唑联合治疗可能更适合有躁狂发作的稳定患者。

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