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帕利哌酮长效注射剂与利培酮治疗精神分裂症患者神经认知功能的随机、开放标签、对照试验。

Paliperidone ER versus risperidone for neurocognitive function in patients with schizophrenia: a randomized, open-label, controlled trial.

机构信息

Department of Psychiatry, Chonnam National University Medical School, Jeonju, Republic of Korea.

出版信息

Int Clin Psychopharmacol. 2012 Sep;27(5):267-74. doi: 10.1097/YIC.0b013e328356acad.

DOI:10.1097/YIC.0b013e328356acad
PMID:22809972
Abstract

This study aims to determine the effectiveness of paliperidone extended release (ER) on cognitive function in patients with schizophrenia in comparison with risperidone. This was a 12-week, randomized, open-label study on schizophrenia patients who were receiving risperidone. The patients were randomized to a risperidone-continuation group or a paliperidone-switch group. The primary outcome measure was neurocognitive function, which was measured using a computerized battery. Secondary efficacy measures included the Positive and Negative Syndrome Scale, Social and Occupational Functioning Scale, and Calgary Depression Scale for Schizophrenia. In total, 58 patients participated in this trial. Improvements in recall after an interference phase in the verbal learning test were significantly greater in the paliperidone-switch than in the risperidone-continuation group. No significant differences in changes were observed in the other six neurocognitive domains measured. Improvements in the Social and Occupational Functioning Scale were significantly greater in the paliperidone ER-switch group than in the risperidone-continuation group. In other efficacy outcome measures, no significant differences were observed between the two drugs. Paliperidone ER had a side-effect profile similar to that of risperidone, including metabolic problems and prolactin-related adverse events. In conclusion, switching from risperidone to paliperidone ER may lead to additional cognitive and social functional improvements.

摘要

本研究旨在比较帕利哌酮长效制剂(ER)与利培酮对精神分裂症患者认知功能的疗效。这是一项为期 12 周的、随机、开放性的精神分裂症患者接受利培酮治疗的研究。患者随机分为利培酮维持组或帕利哌酮转换组。主要疗效指标是使用计算机化电池测量的神经认知功能。次要疗效指标包括阳性和阴性症状量表、社会和职业功能量表以及精神分裂症的卡尔加里抑郁量表。共有 58 名患者参加了这项试验。在言语学习测试的干扰阶段后,帕利哌酮转换组的回忆能力改善明显大于利培酮维持组。在其他六个测量的神经认知领域,未观察到变化的显著差异。社会和职业功能量表的改善在帕利哌酮 ER 转换组明显大于利培酮维持组。在其他疗效指标方面,两种药物之间未观察到显著差异。帕利哌酮 ER 的副作用谱与利培酮相似,包括代谢问题和与催乳素相关的不良事件。总之,从利培酮转换为帕利哌酮 ER 可能会导致认知和社会功能的进一步改善。

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