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换用阿立哌唑后早期恶化的预测因素:一项随机、对照、开放标签研究。

Predictors of early worsening after switch to aripiprazole: a randomized, controlled, open-label study.

机构信息

Department of Psychiatry, The Catholic University of Korea College of Medicine, Seoul, South Korea.

出版信息

Clin Drug Investig. 2010;30(3):187-93. doi: 10.2165/11533060-000000000-00000.

DOI:10.2165/11533060-000000000-00000
PMID:20155991
Abstract

BACKGROUND

Despite the increasing evidence relating to strategies for switching between different antipsychotics, little evidence is available about predictors of improvement or worsening while switching. In a previous study, we compared different options for switching to aripiprazole and found that patients with schizophrenia switched to aripiprazole with immediate discontinuation of the previous antipsychotic showed an increase in symptom severity after 1 week.

OBJECTIVE

To identify predictors of worsening in the first 4 weeks after the switch to aripiprazole in partial non-responders to previous treatments.

METHODS

This was a 12-week randomized, controlled, open-label study that was carried out in the Department of Psychiatry of the Catholic University of Korea, Seoul, Korea. The study included 77 patients with schizophrenia whose symptoms were not optimally controlled and/or who did not tolerate their current antipsychotic medications well. Patients were randomly assigned to one of three different strategies for switching to aripiprazole 10 mg, i.e.: (i) simultaneous discontinuation of the current antipsychotic; (ii) tapering off the current antipsychotic over 4 weeks with half the dose after the first 2 weeks; or (iii) tapering off the current antipsychotic over 4 weeks after maintenance of the current dose for 2 weeks. The main outcome measure was the difference in Brief Psychiatric Rating Scale (BPRS) scores from baseline to weeks 1, 2 and 4.

RESULTS

Baseline severity of disease, as measured by the Clinical Global Impression-Severity Scale, BPRS and Schedule for the Assessment of Negative Symptoms, significantly predicted worsening at weeks 1, 2 and 4. Specifically, lesser disease severity at baseline significantly predicted worsening after switching to aripiprazole.

CONCLUSION

Patients with relatively mild illness severity might be more susceptible to early worsening of symptoms when switched to aripiprazole. However, the limitations of the present study, including a small sample size, absence of a control group designed to control for nonspecific factors such as regression to the mean, and implementation of a switching strategy that included only aripiprazole, mean the present findings should be considered with caution and further research is needed.

摘要

背景

尽管越来越多的证据表明切换不同抗精神病药物的策略,但关于切换过程中改善或恶化的预测因素却鲜有报道。在之前的一项研究中,我们比较了不同的切换到阿立哌唑的选择,发现先前抗精神病药物立即停药的精神分裂症患者在切换到阿立哌唑后 1 周内症状严重程度增加。

目的

确定部分对先前治疗反应不佳的患者在切换到阿立哌唑后的前 4 周内恶化的预测因素。

方法

这是一项为期 12 周的随机、对照、开放性研究,在韩国首尔天主教大学精神病学系进行。该研究纳入了 77 名精神分裂症患者,这些患者的症状没有得到最佳控制和/或不能很好地耐受目前的抗精神病药物。患者被随机分配到三种不同的切换到阿立哌唑 10mg 的策略之一:(i)立即停止当前的抗精神病药物;(ii)在前 2 周内将当前的抗精神病药物剂量减半,持续 4 周逐渐停药;或(iii)在当前剂量维持 2 周后,持续 4 周逐渐停药。主要结局指标是从基线到第 1、2 和 4 周时简明精神病评定量表(BPRS)评分的差异。

结果

基线疾病严重程度,用临床总体印象严重程度量表、BPRS 和负性症状评定量表来衡量,在第 1、2 和 4 周时显著预测恶化。具体来说,基线时疾病严重程度较轻显著预测切换到阿立哌唑后恶化。

结论

疾病严重程度相对较轻的患者在切换到阿立哌唑时可能更容易出现症状的早期恶化。然而,本研究存在一些局限性,包括样本量较小、缺乏设计来控制均值回归等非特异性因素的对照组,以及实施的切换策略仅包括阿立哌唑,这意味着目前的研究结果应谨慎考虑,需要进一步研究。

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Immediate versus gradual suspension of previous treatments during switch to aripiprazole: results of a randomized, open label study.换用阿立哌唑期间立即停用与逐渐停用先前治疗的比较:一项随机、开放标签研究的结果
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