Donders Centre forNeuroscience, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.
Schizophr Bull. 2011 Mar;37(2):352-61. doi: 10.1093/schbul/sbp037. Epub 2009 Jun 19.
Head-to-head comparisons of antipsychotics have predominantly included patients with chronic conditions. The aim of the present study was to compare the efficacy and tolerability of ziprasidone and olanzapine in patients with recent-onset schizophrenia.
The study was an 8-week, double-blind, parallel-group, randomized, controlled multicenter trial (NCT00145444). Seventy-six patients with schizophreniform disorder, schizophrenia or schizoaffective disorder (diagnosis < 5 y), and a maximum lifetime antipsychotic treatment < 16 weeks participated in the study. Efficacy of ziprasidone (80-160 mg/d) and olanzapine 10-20 mg was measured using the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression (CGI) Scale, the Calgary Depression Scale for Schizophrenia (CDSS), and the Heinrich Quality of Life Scale (HQLS); tolerability assessments included laboratory assessments, body weight, and electroencephalogram.
Olanzapine (n = 34) and ziprasidone (n = 39) showed equal efficacy as measured by the PANSS, CDSS, CGI, and HQLS. However, mean weight gain was significantly higher in the olanzapine group (6.8 vs 0.1 kg, P < .001). Ziprasidone was associated with decreasing levels of triglycerides, cholesterol, and transaminases, while these parameters increased in the olanzapine group (all P values < .05). There were no significant differences in fasting glucose and prolactin levels or in cardiac or sexual side effects. Patients on ziprasidone used biperiden for extrapyramidal side effects more frequently (P < .05).
The results of this study indicate that ziprasidone and olanzapine have comparable therapeutic efficacy but differ in their side effect profile. However, there is a risk of a type II error with this sample size. Clinically significant weight gain and laboratory abnormalities appear early after initiating treatment and are more prominent with olanzapine, while more patients on ziprasidone received anticholinergic drugs to treat extrapyramidal symptoms.
抗精神病药的头对头比较主要包括慢性疾病患者。本研究的目的是比较齐拉西酮和奥氮平在近期发病的精神分裂症患者中的疗效和耐受性。
该研究为 8 周、双盲、平行组、随机、对照多中心试验（NCT00145444）。76 例精神分裂症样障碍、精神分裂症或分裂情感障碍患者（诊断<5 年）和最大终生抗精神病药物治疗<16 周参与了该研究。使用阳性和阴性综合征量表（PANSS）、临床总体印象量表（CGI）、卡尔加里精神分裂症抑郁量表（CDSS）和 Heinrich 生活质量量表（HQLS）测量齐拉西酮（80-160mg/d）和奥氮平 10-20mg 的疗效；耐受性评估包括实验室评估、体重和脑电图。
奥氮平（n=34）和齐拉西酮（n=39）在 PANSS、CDSS、CGI 和 HQLS 测量的疗效上相同。然而，奥氮平组的平均体重增加明显更高（6.8 比 0.1kg，P<.001）。齐拉西酮与甘油三酯、胆固醇和转氨酶水平降低有关，而奥氮平组这些参数升高（所有 P 值<.05）。空腹血糖和催乳素水平或心脏和性副作用无显著差异。使用齐拉西酮的患者更频繁地使用比哌立登治疗锥体外系副作用（P<.05）。
这项研究的结果表明，齐拉西酮和奥氮平具有相当的治疗效果，但在副作用谱上有所不同。然而，在这个样本量下，存在 II 型错误的风险。临床显著的体重增加和实验室异常在开始治疗后早期出现，且奥氮平更为明显，而更多的齐拉西酮患者使用抗胆碱能药物治疗锥体外系症状。
