Ishigooka J, Inada T, Miura S
Department of Psychiatry, Kitasato University School of Medicine, 2-1-1 Asamizodai, Sagami-hara 228-8520, Japan.
Psychiatry Clin Neurosci. 2001 Aug;55(4):403-14. doi: 10.1046/j.1440-1819.2001.00882.x.
This randomized double-blind trial was conducted to test the efficacy and safety of olanzapine in Japanese patients with schizophrenia. Importantly, this study also represents the first large clinical trial of olanzapine conducted in an Asian population. Patients (n = 182) were randomly assigned to treatment with olanzapine or haloperidol over a period of 8 weeks. The primary analyses included: (i) a test of non-inferiority of olanzapine compared with haloperidol in efficacy using the Final Global Improvement Rating (FGIR); and (ii) comparison between the treatment groups in extrapyramidal symptom severity using the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS). Olanzapine was comparable to haloperidol in efficacy in treating positive symptoms and significantly superior in treating negative symptoms. Extrapyramidal symptom severity was significantly improved for olanzapine-treated patients versus haloperidol-treated patients. Olanzapine was shown to be more effective and better tolerated than haloperidol in the treatment of Japanese patients suffering from chronic schizophrenia.
这项随机双盲试验旨在测试奥氮平对日本精神分裂症患者的疗效和安全性。重要的是，本研究也是在亚洲人群中进行的第一项关于奥氮平的大型临床试验。182名患者被随机分配接受奥氮平或氟哌啶醇治疗，为期8周。主要分析包括：（i）使用最终总体改善评分（FGIR）测试奥氮平与氟哌啶醇在疗效上的非劣效性；（ii）使用药物性锥体外系症状量表（DIEPSS）比较治疗组之间锥体外系症状的严重程度。在治疗阳性症状方面，奥氮平与氟哌啶醇疗效相当，在治疗阴性症状方面明显更优。与氟哌啶醇治疗的患者相比，奥氮平治疗的患者锥体外系症状严重程度得到显著改善。结果表明，在治疗患有慢性精神分裂症的日本患者方面，奥氮平比氟哌啶醇更有效且耐受性更好。
