Kane John M, Osuntokun Olawale, Kryzhanovskaya Ludmila A, Xu Wen, Stauffer Virginia L, Watson Susan B, Breier Alan
Department of Psychiatry, The Zucker Hillside Hospital, Glen Oaks, NY 11004-1150, USA.
J Clin Psychiatry. 2009 Apr;70(4):572-81. doi: 10.4088/jcp.08m04421. Epub 2009 Mar 24.
To evaluate the effectiveness of olanzapine versus aripiprazole in patients with schizophrenia.
Patients aged 18 to 65 years with schizophrenia (diagnosed according to DSM-IV-TR criteria) were randomly assigned to either olanzapine (n = 281) or aripiprazole (n = 285) for 28 weeks of double-blind treatment. The primary outcome was time to all-cause discontinuation. Efficacy was measured by Positive and Negative Syndrome Scale (PANSS) total change from baseline. Time-to-event data were analyzed via the Kaplan-Meier method. The study was conducted from October 2003 to July 2007.
Treatment groups did not differ significantly in time to all-cause discontinuation (p = .067) or all-cause discontinuation rate (olanzapine, 42.7% vs. aripiprazole, 50.2%; p = .053). Olanzapine-treated patients had significantly longer time to efficacy-related discontinuation (p < .001) and a significantly lower efficacy-related discontinuation rate (olanzapine, 8.9% vs. aripiprazole, 16.8%; p = .006). Olanzapine-treated patients had a significantly greater mean decrease (last observation carried forward) in PANSS total score (-30.2) than did aripiprazole-treated patients (-25.9, p = .014). Olanzapine-treated patients had a mean weight change of +3.4 kg (vs. +0.3 kg for aripiprazole-treated patients; p < .001) and a significantly greater incidence of >or= 7% body weight gain at any time (40.3% vs. 16.4%; p < .001). Fasting mean glucose change was +4.87 mg/dL for olanzapine and +0.90 mg/dL for aripiprazole (p = .045). Incidence of baseline glucose < 100 mg/dL and >or= 126 mg/dL at any time was 1.7% for olanzapine and 0.6% for aripiprazole (p = .623). Fasting mean total cholesterol change was +4.09 mg/dL for olanzapine and -9.85 mg/dL for aripiprazole (p < .001). Incidence of baseline total cholesterol < 200 mg/dL and >or= 240 mg/dL at any time was 9.2% for olanzapine and 1.5% for aripiprazole (p = .008). Fasting mean triglycerides change was +25.66 mg/dL for olanzapine and -17.52 mg/dL for aripiprazole (p < .001). Treatment groups did not significantly differ on measures of extrapyramidal symptoms.
Treatment groups did not differ significantly on the primary outcome. Olanzapine-treated patients had significantly greater improvement in symptom efficacy at 28 weeks as well as significantly greater mean increases in weight and glucose and significantly greater worsening on lipids parameters.
clinicaltrials.gov Identifier: NCT00088049.
评估奥氮平与阿立哌唑治疗精神分裂症患者的有效性。
年龄在18至65岁之间的精神分裂症患者（根据DSM-IV-TR标准诊断）被随机分配至奥氮平组（n = 281）或阿立哌唑组（n = 285），进行为期28周的双盲治疗。主要结局指标为全因停药时间。疗效通过阳性和阴性症状量表（PANSS）自基线的总分变化来衡量。生存时间数据采用Kaplan-Meier方法进行分析。该研究于2003年10月至2007年7月进行。
治疗组在全因停药时间（p = 0.067）或全因停药率（奥氮平组为42.7%，阿立哌唑组为50.2%；p = 0.053）方面无显著差异。接受奥氮平治疗的患者与疗效相关的停药时间显著更长（p < 0.001），且与疗效相关的停药率显著更低（奥氮平组为8.9%，阿立哌唑组为16.8%；p = 0.006）。接受奥氮平治疗的患者PANSS总分（末次观察向前结转）的平均降幅（-30.2）显著大于接受阿立哌唑治疗的患者（-25.9，p = 0.014）。接受奥氮平治疗患者的平均体重增加3.4 kg（接受阿立哌唑治疗患者为0.3 kg；p < 0.001），且在任何时间体重增加≥7%的发生率显著更高（40.3%对16.4%；p < 0.001）。奥氮平组空腹平均血糖变化为+4.87 mg/dL，阿立哌唑组为+0.90 mg/dL（p = 0.045）。在任何时间，基线血糖<100 mg/dL和≥126 mg/dL的发生率，奥氮平组为1.7%，阿立哌唑组为0.6%（p = 0.623）。奥氮平组空腹平均总胆固醇变化为+4.09 mg/dL，阿立哌唑组为-9.85 mg/dL（p < 0.001）。在任何时间，基线总胆固醇<200 mg/dL和≥240 mg/dL的发生率，奥氮平组为9.2%，阿立哌唑组为1.5%（p = 0.008）。奥氮平组空腹平均甘油三酯变化为+25.66 mg/dL，阿立哌唑组为-17.52 mg/dL（p < 0.001）。治疗组在锥体外系症状指标方面无显著差异。
治疗组在主要结局指标上无显著差异。接受奥氮平治疗的患者在28周时症状疗效改善显著更大，体重、血糖平均增加显著更多，血脂参数恶化也更显著。
clinicaltrials.gov标识符：NCT00088049。
