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在日本进行的 3 期临床试验的系统评价和网络荟萃分析:鲁拉西酮、奥氮平、喹硫平缓释剂治疗双相抑郁。

Lurasidone, olanzapine, and quetiapine extended-release for bipolar depression: A systematic review and network meta-analysis of phase 3 trials in Japan.

机构信息

Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Japan.

Department of Psychiatry, University of Occupational and Environmental Health, Kitakyushu, Japan.

出版信息

Neuropsychopharmacol Rep. 2020 Dec;40(4):417-422. doi: 10.1002/npr2.12137. Epub 2020 Sep 9.

Abstract

AIM

This systematic review and random-effect model, network meta-analysis of the phase 3 trials in Japan assessed the efficacy and safety profile of lurasidone compared with olanzapine and quetiapine extended-release (QUE-XR) for the treatment of bipolar depression.

METHODS

The study included double-blind, randomized, placebo-controlled, phase 3 trials in Japan that included patients with bipolar depression. Outcomes included response rate (primary), remission rate (secondary), improvement of Montgomery-Åsberg Depression Rating Scale (MADRS) total score, discontinuation rates, and incidence of individual adverse events.

RESULTS

Three studies were included (n = 1223). Lurasidone and olanzapine but not QUE-XR were superior to placebo in response rate [risk ratio (95% credible interval): lurasidone = 0.78 (0.66, 0.92); olanzapine = 0.84 (0.71, 0.99); QUE-XR = 0.87 (0.73, 1.03)]. Lurasidone, olanzapine and QUE-XR were superior to placebo in remission rate [lurasidone = 0.90 (0.83, 0.98); olanzapine = 0.87 (0.77, 0.99); QUE-XR = 0.84 (0.73, 0.98)] and the improvement of MADRS total score. There were not differences in discontinuation rates between each antipsychotic and placebo. Compared with placebo, lurasidone was higher incidence of akathisia, and increased body weight and blood prolactin level; olanzapine was higher incidence of somnolence and ≥7% weight gain, and increased body weight, blood total cholesterol level, blood LDL cholesterol level, and blood triglyceride levels; QUE-XR was higher incidence of extrapyramidal symptoms, akathisia, somnolence, dry mouth, constipation and ≥7% weight gain, and increased body weight, blood total cholesterol level, blood LDL cholesterol level, and blood triglyceride levels.

CONCLUSIONS

Our results suggested although the efficacy of three SGAs was similar, there were the differences in the safety profile among the SGAs.

摘要

目的

本系统评价和随机效应模型,对日本的 3 期试验进行网络荟萃分析,评估了鲁拉西酮与奥氮平及喹硫平缓释片(QUE-XR)相比用于治疗双相抑郁的疗效和安全性概况。

方法

该研究纳入了日本的双盲、随机、安慰剂对照、3 期临床试验,纳入了双相抑郁患者。主要结局为应答率(首要结局),缓解率(次要结局),蒙哥马利-阿斯伯格抑郁评定量表(MADRS)总分的改善,停药率和个别不良反应的发生率。

结果

共纳入 3 项研究(n=1223)。与安慰剂相比,鲁拉西酮和奥氮平而非 QUE-XR 在应答率方面更优[风险比(95%可信区间):鲁拉西酮=0.78(0.66,0.92);奥氮平=0.84(0.71,0.99);QUE-XR=0.87(0.73,1.03)]。与安慰剂相比,鲁拉西酮、奥氮平和 QUE-XR 在缓解率方面更优[鲁拉西酮=0.90(0.83,0.98);奥氮平=0.87(0.77,0.99);QUE-XR=0.84(0.73,0.98)]和 MADRS 总分的改善方面更优。在停药率方面,每种抗精神病药与安慰剂之间无差异。与安慰剂相比,鲁拉西酮的静坐不能、体重增加和催乳素水平升高的发生率更高;奥氮平的嗜睡和体重增加≥7%及体重增加、总胆固醇水平、低密度脂蛋白胆固醇水平和甘油三酯水平升高的发生率更高;喹硫平的锥体外系症状、静坐不能、嗜睡、口干、便秘和体重增加≥7%及体重增加、总胆固醇水平、低密度脂蛋白胆固醇水平和甘油三酯水平升高的发生率更高。

结论

我们的结果表明,尽管三种 SGAs 的疗效相似,但在安全性特征方面存在差异。

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