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换用伊潘立酮:一项针对500名精神分裂症患者的为期12周的开放标签随机临床试验的临床相关观察汇总

Switching to iloperidone: An omnibus of clinically relevant observations from a 12-week, open-label, randomized clinical trial in 500 persons with schizophrenia.

作者信息

Citrome Leslie, Weiden Peter J, Alva Gus, Glick Ira D, Jackson Richard, Mattingly Greg, Kianifard Farid, Meng Xiangyi, Winseck Adam

机构信息

New York Medical College, Valhalla, NY.

University of Illinois at Chicago, Chicago, IL.

出版信息

Clin Schizophr Relat Psychoses. 2015 Jan;8(4):183-95. doi: 10.3371/CSRP.CIWE.103114.

DOI:10.3371/CSRP.CIWE.103114
PMID:25367165
Abstract

OBJECTIVE

To describe secondary analyses from a 12-week, randomized, open-label trial where adult schizophrenia outpatients receiving risperidone, olanzapine, or aripiprazole were switched to iloperidone.

METHODS

Patients were randomized into two groups: one where the antecedent antipsychotic dose was titrated downwards to zero over 2 weeks (n=240), and the other group where the antecedent antipsychotic was abruptly stopped (n=260). Adaptations of the Clinical Global Impression scale were used to evaluate clinical changes. Other assessments included the reporting of adverse events (AEs), study discontinuation, body weight, and metabolic variables.

RESULTS

Improvement was steady throughout the study for both gradual- and immediate-switch groups starting at Week 1 and continuing through Week 12. Discontinuations due to AEs in the first 2 weeks of treatment were higher for the immediate-switch group compared with the gradual-switch group (10.8% vs. 5.4%, NNT 19, 95% CI 10-151). Fewer patients in the gradual-switch group experienced dizziness as an AE, whereas a higher percentage of patients in the immediate-switch group exhibited earlier onset of a therapeutic response within the first 2 weeks; both groups were comparable thereafter with low rates of dizziness and similar efficacy outcomes.

CONCLUSIONS

Switching to iloperidone can be accomplished either with a gradual crossover or immediate discontinuation of the prior antipsychotic; however, the immediate-switch method is associated with greater proportion of initial dizziness. The observed outcomes are consistent with what has been previously reported regarding iloperidone's favorable akathisia/EPS profile and modest impact on somnolence/sedation, body weight, and metabolic variables.

摘要

目的

描述一项为期12周的随机开放标签试验的二次分析结果,该试验中接受利培酮、奥氮平或阿立哌唑治疗的成年精神分裂症门诊患者换用了齐拉西酮。

方法

患者被随机分为两组:一组在前驱抗精神病药物剂量在2周内逐渐减至零(n = 240),另一组则突然停用前驱抗精神病药物(n = 260)。采用临床总体印象量表的改编版评估临床变化。其他评估包括不良事件(AE)报告、研究停药情况、体重和代谢变量。

结果

从第1周开始至第12周,逐渐换药组和立即换药组在整个研究过程中改善情况均保持稳定。与逐渐换药组相比,立即换药组在治疗的前2周因AE停药的比例更高(10.8%对5.4%,NNT 19,95%CI 10 - 151)。逐渐换药组较少患者将头晕作为AE,而立即换药组有更高比例的患者在最初2周内更早出现治疗反应;此后两组头晕发生率较低且疗效相当。

结论

换用齐拉西酮可以通过逐渐交叉或立即停用先前的抗精神病药物来实现;然而,立即换药方法与初始头晕的比例更高相关。观察到的结果与先前关于齐拉西酮有利的静坐不能/锥体外系反应特征以及对嗜睡/镇静、体重和代谢变量影响较小的报道一致。

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