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首页> 外文期刊>The journal of clinical psychiatry >A 28-week, randomized, double-blind study of olanzapine versus aripiprazole in the treatment of schizophrenia.
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A 28-week, randomized, double-blind study of olanzapine versus aripiprazole in the treatment of schizophrenia.

机译：奥氮平与阿立哌唑治疗精神分裂症的一项为期28周的随机，双盲研究。

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OBJECTIVE: To evaluate the effectiveness of olanzapine versus aripiprazole in patients with schizophrenia. METHOD: 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. RESULTS: 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 >/= 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 >/= 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. CONCLUSION: 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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00088049.
机译：目的：评价奥氮平与阿立哌唑在精神分裂症患者中的疗效。方法：将18至65岁的精神分裂症患者（根据DSM-IV-TR标准诊断）随机分配至奥氮平（n = 281）或阿立哌唑（n = 285）进行28周的双盲治疗。主要结果是全因停药的时间。疗效通过阳性和阴性综合征量表（PANSS）相对于基线的总变化来衡量。事件时间数据通过Kaplan-Meier方法进行了分析。该研究于2003年10月至2007年7月进行。结果：治疗组在全因停药（p = .067）或全因停药率（奥氮平为42.7％，阿立哌唑为50.2％）的时间上没有显着差异。 p = .053）。奥氮平治疗的患者与功效相关的停药时间显着延长（p <.001），与功效相关的停药率显着降低（奥氮平，8.9％vs阿立哌唑，16.8％; p = .006）。与阿立哌唑治疗的患者相比，奥氮平治疗的患者的PANSS总分（-30.2）平均降低（最近一次结转）显着更大（-25.9，p = .014）。奥氮平治疗的患者的平均体重变化为+3.4千克（阿立哌唑治疗的患者为+0.3千克; p <.001），并且在任何时候体重增加或大于7％的发生率均显着更高（40.3％对比16.4％; p <0.001）。奥氮平的空腹平均葡萄糖变化为+4.87 mg / dL，阿立哌唑的空腹平均葡萄糖变化为+0.90 mg / dL（p = .045）。在任何时候，奥氮平的基线葡萄糖<100 mg / dL和> / = 126 mg / dL的发生率分别为1.7％和阿立哌唑0.6％（p = .623）。奥氮平的空腹平均总胆固醇变化为+4.09 mg / dL，阿立哌唑为-9.85 mg / dL（p <.001）。基线总胆固醇<200 mg / dL和> / = 240 mg / dL的发生率在任何时候对于奥氮平为9.2％，对于阿立哌唑为1.5％（p = .008）。奥氮平的空腹平均甘油三酯变化为+25.66 mg / dL，阿立哌唑的空腹平均甘油三酯变化为-17.52 mg / dL（p <.001）。治疗组在锥体外系症状的测量上无显着差异。结论：治疗组在主要结局方面无显着差异。奥氮平治疗的患者在28周时的症状疗效显着改善，并且体重和葡萄糖的平均增加显着更大，脂质参数的恶化也明显更大。试验注册：clinicaltrials.gov标识符：NCT00088049。

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