奥氮平或氯丙嗪联合锂盐治疗首发精神病性躁狂：一项为期8周的随机对照试验。

Olanzapine or chlorpromazine plus lithium in first episode psychotic mania: An 8-week randomised controlled trial.

作者信息

Conus P, Berk M, Cotton S M, Kader L, Macneil C, Hasty M K, Hallam K, Lambert M, Murphy B P, McGorry P D

机构信息

Treatment and Early Intervention in Psychosis Program (TIPP), département de psychiatrie CHUV, université de Lausanne, clinique de Cery, 1008 Prilly, Switzerland; Orygen Youth Health Research Centre, Centre for Youth Mental Health, University of Melbourne, 35 Poplar Road, Parkville Victoria 3052, Melbourne, Australia.

Orygen Youth Health Research Centre, Centre for Youth Mental Health, University of Melbourne, 35 Poplar Road, Parkville Victoria 3052, Melbourne, Australia; Department of Clinical and Biomedical Sciences, Barwon Health, University of Melbourne, Geelong, Australia; Mental Health Research Institute, Parkville, Australia.

出版信息

Eur Psychiatry. 2015 Nov;30(8):975-82. doi: 10.1016/j.eurpsy.2015.09.009. Epub 2015 Oct 21.

DOI:10.1016/j.eurpsy.2015.09.009

PMID:26485297

Abstract

BACKGROUND

Treatment strategies for mental disorders may vary according to illness stage. However no data currently exist to guide treatment in first episode psychotic mania. The aim of this study was to compare the safety and efficacy profile of chlorpromazine and olanzapine, as add-on to lithium, in patients with a first episode of psychotic mania, expecting better safety profile and adherence to olanzapine but similar efficacy for both treatments.

METHODS

Data from 83 patients were collected in an 8-week randomised controlled trial on clinical variables, side effects, vital signs, and weight. Analyses of treatment differences over time were based on intent-to-treat principles. Kaplan-Meier estimated survival curves were used to analyse time-to-event data and mixed effects models repeated measures analysis of variance were used to determine treatment group differences over time on safety and efficacy measures.

RESULTS

Ethics committee approval to delay informed consent procedure until recovery from the acute episode allowed the inclusion of 83 patients highly representative of those treated in the public sector. Contrary to our hypotheses, safety profile of both medications was similar. A signal for higher rate (P=.032) and earlier occurrence (P=.043) of mania remission was observed in the olanzapine group which did not survive correction for multiple comparisons.

CONCLUSIONS

Olanzapine and chlorpromazine have a similar safety profile in a uniquely representative cohort of patients with first episode psychotic mania. The possibility for a greater impact of olanzapine on manic symptoms leading to earlier remission of the episode needs exploration in a large sample.

摘要

背景

精神障碍的治疗策略可能因疾病阶段而异。然而，目前尚无数据可指导首次发作的精神病性躁狂症的治疗。本研究的目的是比较氯丙嗪和奥氮平作为锂盐附加治疗药物，在首次发作的精神病性躁狂症患者中的安全性和有效性，预期奥氮平具有更好的安全性和依从性，但两种治疗方法的疗效相似。

方法

在一项为期8周的随机对照试验中，收集了83例患者的临床变量、副作用、生命体征和体重数据。基于意向性治疗原则分析治疗随时间的差异。采用Kaplan-Meier估计生存曲线分析事件发生时间数据，并使用混合效应模型重复测量方差分析来确定治疗组在安全性和有效性测量上随时间的差异。

结果

伦理委员会批准将知情同意程序推迟到急性发作恢复后，使得83例患者得以纳入，这些患者具有高度的代表性，代表了公共部门接受治疗的患者群体。与我们的假设相反，两种药物的安全性相似。在奥氮平组中观察到躁狂症缓解率较高（P = 0.032）和发作较早（P = 0.043）的信号，但在多重比较校正后该信号不成立。