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奥氮平治疗精神分裂症的开放性标签对照临床试验:来自印度北部的研究。

Olanzapine in the treatment of schizophrenia : an open label comparative clinical trial from north India.

机构信息

AJIT AVASTHI, MD., Additional Professor, Department of Psychiatry, Postgraduate Institute of Medical Education and Research, Chandigarh-160012.

出版信息

Indian J Psychiatry. 2001 Jul;43(3):257-63.

Abstract

The aim of the present study was to assess the efficacy and safety of olanzapine in the treatment of schizophrenic patients. 27 patients were randomly assigned to treatment with olanzapine or haloperidol over 12 weeks. The primary efficacy measure was the mean change from baseline to endpoint in total scores on the Brief Psychiatric Rating Scale (BPRS) and assessing treatment emergent adverse events. Secondary measures were positive symptoms, negative symptoms, general psychopathology depression, anxiety and quality of life. Compared to haloperidol, olanzapine had equal effect in improving overall psychopathology, positive symptoms, and severity of schizophrenic illness. Olanzapine showed supehor improvement on negative symptoms and secondary depressive features. Commonest side effects were weight gain, sleepiness and increased duration of sleep. Olanzapine is effective in improving overall psychopathology including positive symptoms, negative and secondary depressive features in Indian patients with schizophrenia and it is safe and well tolerated at dosage between 5 to 20 mg/day.

摘要

本研究旨在评估奥氮平治疗精神分裂症患者的疗效和安全性。27 名患者被随机分配接受奥氮平或氟哌啶醇治疗 12 周。主要疗效指标为简明精神病评定量表(BPRS)总分从基线到终点的平均变化,并评估治疗中出现的不良事件。次要指标为阳性症状、阴性症状、一般精神病学、抑郁、焦虑和生活质量。与氟哌啶醇相比,奥氮平在改善整体精神病学、阳性症状和精神分裂症严重程度方面效果相当。奥氮平在改善阴性症状和继发性抑郁特征方面表现出更好的效果。最常见的副作用是体重增加、嗜睡和睡眠时间延长。奥氮平在改善印度精神分裂症患者的整体精神病学方面(包括阳性症状、阴性症状和继发性抑郁特征)有效,在 5 至 20 毫克/天的剂量范围内安全且耐受性良好。

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