3rd Department of Psychiatry, Aristotle University of Thessaloniki, Greece.
J Affect Disord. 2011 Oct;133(3):361-70. doi: 10.1016/j.jad.2010.10.018. Epub 2010 Oct 30.
Aripiprazole is approved for the acute and maintenance treatment of manic and mixed episodes associated with bipolar I disorder. The aim of the present work was to review and meta-analyze the findings of all the available randomized double-blind controlled trials (RCTs) on the efficacy of aripiprazole in the treatment of bipolar disorder.
Aripiprazole RCTs were identified with a systematic search of MEDLINE and repositories. Standard meta-analytic techniques were applied.
Two thousand three hundred and three patients took part in the aripiprazole acute mania RCTs. At week 3 the pooled aripiprazole vs. placebo effect size was 0.34 and the NNT was 6 for response and 14 for remission. On average, response started at day 3. Suicide rates were negligible for all groups in mania but they were not reported in the acute depression trials. The meta-analysis of acute bipolar depression RCTs revealed a significant difference at week 8 with a weak effect size equal to 0.17. The analysis of maintenance data suggest that the median survival time for the aripiprazole group was not evaluable (very long), while the median survival time for placebo was 118-203 days depending on the clinical subpopulation.
The current meta-analysis supports the usefulness of aripiprazole during all phases of bipolar illness. Its effect against acute bipolar depression is weak and the efficacy during the maintenance phase is proven only against new manic episodes in patients with an index manic episode who had previously responded to aripiprazole during the acute phase.
阿立哌唑获批用于治疗双相 I 障碍相关的躁狂和混合发作的急性期和维持期治疗。本研究旨在综述和荟萃分析所有关于阿立哌唑治疗双相障碍疗效的可用随机双盲对照试验(RCT)的结果。
通过对 MEDLINE 和存储库的系统搜索,确定了阿立哌唑 RCT。应用了标准的荟萃分析技术。
共有 2303 名患者参加了阿立哌唑急性躁狂症 RCT。在第 3 周时,阿立哌唑与安慰剂相比的 pooled aripiprazole vs. placebo 效应大小为 0.34,反应的 NNT 为 6,缓解的 NNT 为 14。平均而言,反应在第 3 天开始。在躁狂症中,所有组的自杀率都微不足道,但在急性抑郁症试验中没有报告。急性双相抑郁症 RCT 的荟萃分析显示,第 8 周时存在显著差异,效应大小较弱,为 0.17。维持数据的分析表明,阿立哌唑组的中位生存时间不可评估(非常长),而安慰剂组的中位生存时间为 118-203 天,具体取决于临床亚群。
目前的荟萃分析支持阿立哌唑在双相情感障碍的所有阶段都有用。它对急性双相抑郁症的疗效较弱,在维持期的疗效仅在指数躁狂发作的患者中得到证实,这些患者在急性期曾对阿立哌唑有反应,以防止新的躁狂发作。