Simpson George M, Glick Ira D, Weiden Peter J, Romano Steven J, Siu Cynthia O
Department of Psychiatry and the Behavioral Sciences, LAC + USC Medical Center, IRD RM 204, Psychiatric Outpatient Clinic, 2020 Zonal Ave., Los Angeles, CA 90033, USA.
Am J Psychiatry. 2004 Oct;161(10):1837-47. doi: 10.1176/ajp.161.10.1837.
Limited randomized, controlled trial data exist on possible differences between atypical antipsychotics in efficacy, overall tolerability, and important indices of health status. The authors compared the efficacy and tolerability of ziprasidone and olanzapine in the treatment of acutely ill inpatients with schizophrenia or schizoaffective disorder.
In this 6-week, multicenter, double-blind, parallel-design, flexible-dose trial, patients were randomly assigned to receive ziprasidone (N=136) or olanzapine (N=133). Primary efficacy measures were improvement in Brief Psychiatric Rating Scale and Clinical Global Impression (CGI) severity scale scores; secondary measures were scores on the CGI improvement scale, Positive and Negative Syndrome Scale, and Calgary Depression Scale for Schizophrenia. Tolerability assessments included fasting lipid profiles, fasting glucose and insulin measurements, electrocardiography, and monitoring of vital signs and body weight.
The overall mean daily doses were 129.9 mg (SD=27.3) for ziprasidone and 11.3 mg (SD=2.8) for olanzapine. Both antipsychotics were efficacious in improving symptoms and global illness severity. The two treatment groups did not differ significantly in primary or secondary efficacy measures at endpoint or in by-visit analysis. Both agents were well tolerated. Body weight, total cholesterol, triglycerides, and low-density lipoprotein cholesterol significantly increased with olanzapine but not with ziprasidone; all between-group comparisons of these variables were significant and favored ziprasidone. Olanzapine, but not ziprasidone, was associated with significant increases in fasting insulin level. No patient in either group exhibited a corrected QT interval >/=500 msec.
During 6 weeks' treatment, ziprasidone and olanzapine demonstrated comparable antipsychotic efficacy. Differences favoring ziprasidone were observed in metabolic parameters.
关于非典型抗精神病药物在疗效、总体耐受性和健康状况重要指标方面可能存在的差异，现有的随机对照试验数据有限。作者比较了齐拉西酮和奥氮平治疗急性发病的精神分裂症或分裂情感性障碍住院患者的疗效和耐受性。
在这项为期6周的多中心、双盲、平行设计、灵活剂量试验中，患者被随机分配接受齐拉西酮（N = 136）或奥氮平（N = 133）治疗。主要疗效指标为简明精神病评定量表和临床总体印象（CGI）严重程度量表评分的改善情况；次要指标为CGI改善量表、阳性和阴性症状量表以及精神分裂症卡尔加里抑郁量表的评分。耐受性评估包括空腹血脂谱、空腹血糖和胰岛素测量、心电图以及生命体征和体重监测。
齐拉西酮的总体日均剂量为129.9 mg（标准差 = 27.3），奥氮平为11.3 mg（标准差 = 2.8）。两种抗精神病药物在改善症状和总体疾病严重程度方面均有效。在终点或逐次访视分析中，两个治疗组在主要或次要疗效指标上均无显著差异。两种药物耐受性均良好。奥氮平使体重、总胆固醇、甘油三酯和低密度脂蛋白胆固醇显著升高，而齐拉西酮则无此现象；这些变量的所有组间比较均有显著差异，且有利于齐拉西酮。奥氮平而非齐拉西酮与空腹胰岛素水平显著升高有关。两组均无患者校正QT间期≥500毫秒。
在6周的治疗期间，齐拉西酮和奥氮平显示出相当的抗精神病疗效。在代谢参数方面观察到有利于齐拉西酮的差异。
