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长效利培酮与喹硫平预防复发治疗精神分裂症和分裂情感性障碍的长期缓解效果比较(ConstaTRE)研究

Long-term remission in schizophrenia and schizoaffective disorder: results from the risperidone long-acting injectable versus quetiapine relapse prevention trial (ConstaTRE).

机构信息

Department of Clinical Neuroscience, San Raffaele University Scientific Institute, Vita-Salute University School of Medicine, Via Stamira D'Ancona 20, 20127 Milan, Italy.

出版信息

Ther Adv Psychopharmacol. 2013 Aug;3(4):191-9. doi: 10.1177/2045125313479127.

Abstract

OBJECTIVE

The objective of this study was to report the long-term remission results from the ConstaTRE relapse prevention trial, in which clinically stable adults with schizophrenia or schizoaffective disorder treated with oral risperidone, olanzapine, or oral conventional antipsychotics were randomized to risperidone long-acting injectable (RLAI) or oral quetiapine, dosed according to package-insert recommendations.

METHODS

In the ConstaTRE trial, efficacy and tolerability were recorded for up to 24 months. This post hoc analysis presents remission data, defined, according to the Schizophrenia Working Group criteria, as achieving and maintaining eight core symptoms of schizophrenia that are mild or less over 6 months. Additional secondary outcome measures are also presented.

RESULTS

A total of 710 patients were randomized to RLAI (n = 355) or quetiapine (n = 355). Mean mode ± standard deviation (SD) drug doses were RLAI 33 ± 10 mg every 2 weeks and quetiapine 413 ± 159 mg daily. Full remission was achieved by 51.1% of patients with RLAI and 39.3% with quetiapine (p = 0.003). Mean ± SD of full remission durations were not significantly different with RLAI (540 ± 181 days) and quetiapine (508 ± 188 days). Overall tolerability was similar between treatment groups.

CONCLUSIONS

Among stable patients with schizophrenia or schizoaffective disorder, remission was more likely after switching to RLAI than quetiapine.

摘要

目的

本研究旨在报告 ConstaTRE 复发预防试验的长期缓解结果,该试验纳入了接受口服利培酮、奥氮平或口服传统抗精神病药物治疗的临床稳定期精神分裂症或分裂情感障碍成人患者,将其随机分为利培酮长效注射剂(RLAI)或口服喹硫平组,根据说明书推荐剂量给药。

方法

在 ConstaTRE 试验中,记录了长达 24 个月的疗效和耐受性。本事后分析呈现了缓解数据,根据精神分裂症工作组标准,缓解定义为在 6 个月内实现并维持精神分裂症的 8 个核心症状,且症状较轻或较轻。还呈现了其他次要结局指标。

结果

共有 710 例患者被随机分配至 RLAI(n = 355)或喹硫平组(n = 355)。平均模式±标准偏差(SD)药物剂量分别为 RLAI 每 2 周 33 ± 10 mg 和喹硫平每日 413 ± 159 mg。RLAI 组 51.1%的患者达到完全缓解,喹硫平组为 39.3%(p = 0.003)。RLAI(540 ± 181 天)和喹硫平(508 ± 188 天)的完全缓解持续时间的平均值±SD 无显著差异。两组之间的总体耐受性相似。

结论

在稳定期精神分裂症或分裂情感障碍患者中,与换用喹硫平相比,换用 RLAI 更可能实现缓解。

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