Breier Alan, Berg Paul H, Thakore Jogin H, Naber Dieter, Gattaz Wagner F, Cavazzoni Patrizia, Walker Daniel J, Roychowdhury Suraja M, Kane John M
Lilly Research Laboratories, DC 2128, 1 Corporate Plaza, Indianapolis, IN 46285, USA.
Am J Psychiatry. 2005 Oct;162(10):1879-87. doi: 10.1176/appi.ajp.162.10.1879.
The efficacy and safety of olanzapine were compared with those of ziprasidone.
This was a multicenter randomized, double-blind, parallel-group, 28-week study of patients with schizophrenia. Patients were randomly assigned to treatment with 10-20 mg/day of olanzapine or 80-160 mg/day of ziprasidone. The primary efficacy measure was the Positive and Negative Syndrome Scale total score. Secondary efficacy and safety measures included Positive and Negative Syndrome Scale subscales as well as mood, quality of life, and extrapyramidal symptom scales. Safety was evaluated by recording treatment-emergent adverse events and measuring vital signs and weight.
The study was completed by significantly more olanzapine-treated patients (165 of 277, 59.6%) than ziprasidone-treated patients (115 of 271, 42.4%). At 28 weeks, the olanzapine-treated patients showed significantly more improvement than the ziprasidone-treated patients on the Positive and Negative Syndrome Scale overall scale and all subscales and on the Clinical Global Impression ratings of severity of illness and improvement. The responder rate was higher for olanzapine than for ziprasidone. Extrapyramidal symptoms were not significantly different between groups in change-to-endpoint analyses, but results favored olanzapine on baseline-to-maximum changes. Weight change was significantly greater with olanzapine (mean=3.06 kg, SD=6.87) than with ziprasidone (mean=-1.12 kg, SD=4.70). Fasting lipid profiles were significantly superior in the ziprasidone group; there was no significant difference in fasting glucose level.
Olanzapine treatment resulted in significantly greater psychopathology improvement and higher response and completion rates than ziprasidone treatment, while ziprasidone was superior for weight change and lipid profile.
比较奥氮平与齐拉西酮的疗效及安全性。
这是一项针对精神分裂症患者的多中心随机、双盲、平行组、为期28周的研究。患者被随机分配接受每日10 - 20毫克奥氮平或每日80 - 160毫克齐拉西酮治疗。主要疗效指标为阳性和阴性症状量表总分。次要疗效及安全性指标包括阳性和阴性症状量表各分量表以及情绪、生活质量和锥体外系症状量表。通过记录治疗中出现的不良事件并测量生命体征和体重来评估安全性。
完成研究的接受奥氮平治疗的患者（277例中的165例，59.6%）显著多于接受齐拉西酮治疗的患者（271例中的115例，42.4%）。在28周时，接受奥氮平治疗的患者在阳性和阴性症状量表总分及所有分量表、临床总体印象疾病严重程度和改善程度评分方面的改善均显著优于接受齐拉西酮治疗的患者。奥氮平的有效率高于齐拉西酮。在终点变化分析中，两组锥体外系症状无显著差异，但在基线至最大变化方面结果有利于奥氮平。奥氮平组的体重变化（均值 = 3.06千克，标准差 = 6.87）显著大于齐拉西酮组（均值 = -1.12千克，标准差 = 4.70）。齐拉西酮组的空腹血脂谱显著更好；空腹血糖水平无显著差异。
与齐拉西酮治疗相比，奥氮平治疗导致精神病理学改善更显著，有效率和完成率更高，但齐拉西酮在体重变化和血脂谱方面更具优势。
