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阿立哌唑增效氯氮平治疗精神分裂症的双盲、安慰剂对照研究。

Effect of aripiprazole augmentation of clozapine in schizophrenia: a double-blind, placebo-controlled study.

机构信息

Section of Psychiatry, Department of Neurosciences, Psychiatric and Anaesthesiological Sciences, University of Messina, Messina, Italy.

出版信息

Schizophr Res. 2011 Apr;127(1-3):93-9. doi: 10.1016/j.schres.2010.12.011. Epub 2011 Jan 23.

DOI:10.1016/j.schres.2010.12.011
PMID:21262565
Abstract

The simultaneous prescription of two or more antipsychotic drugs in combination is a common treatment strategy for those patients who have demonstrated a suboptimal response to clozapine; nevertheless, evidence suggesting potential advantages of combination treatment with clozapine plus one antipsychotic in terms of efficacy and tolerability are still sparse. The present 24-week double-blind, randomized, placebo-controlled trial of adjunctive aripiprazole to clozapine therapy in schizophrenia was aimed to explore the efficacy of aripiprazole add-on pharmacotherapy on clinical symptomatology and cognitive functioning in a sample of patients with treatment-resistant schizophrenia receiving clozapine. After clinical and neurocognitive assessments patients were randomly allocated to receive, in a double-blind design, either up to 15 mg/day of aripiprazole or a placebo. A final sample of thirty-one patients completed the study. The results obtained indicate that aripiprazole added to stable clozapine treatment showed a beneficial effect on the positive and general psychopathological symptomatology in a sample of treatment-resistant schizophrenia patients. Regarding executive cognitive functions, aripiprazole augmentation of clozapine had no significant effects. The findings provide evidence that aripiprazole augmentation of clozapine treatment is well-tolerated and may be of benefit for patients who are partially responsive to clozapine monotherapy; further double-blind, placebo-controlled trials in a larger number of patients are required to evaluate the therapeutic potential of aripiprazole augmentation of clozapine.

摘要

同时开具两种或两种以上抗精神病药物联合处方是一种常见的治疗策略,适用于那些对氯氮平反应不佳的患者;然而,关于氯氮平联合一种抗精神病药物治疗在疗效和耐受性方面可能具有潜在优势的证据仍然很少。本研究旨在探讨在氯氮平治疗的精神分裂症患者中,阿立哌唑辅助治疗的疗效和对认知功能的影响。经过临床和神经认知评估后,患者被随机分配接受阿立哌唑(最高 15mg/天)或安慰剂治疗,采用双盲设计。最终有 31 名患者完成了研究。结果表明,阿立哌唑联合稳定剂量的氯氮平治疗对治疗抵抗性精神分裂症患者的阳性和一般精神病症状有有益的影响。关于执行认知功能,阿立哌唑联合氯氮平治疗没有显著影响。这些发现表明,阿立哌唑联合氯氮平治疗具有良好的耐受性,可能对氯氮平单药治疗部分反应的患者有益;需要进一步进行更大规模的双盲、安慰剂对照试验,以评估阿立哌唑联合氯氮平的治疗潜力。

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