Olanzapine versus haloperidol: Acute phase results of the international double-blind olanzapine trial
Olanzapine versus haloperidol: Acute phase results of the international double-blind olanzapine trial
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DOI：
10.1016/s0924-977x(96)00392-6
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发表时间：
1997-05-01
影响因子：
5.6
通讯作者：
Beuzen, JN
中科院分区：
文献类型：
--
作者：
Beasley, CM;Hamilton, SH;Beuzen, JN
一项为期一年的国际双盲研究进行了为期6周的急性期研究，比较了奥氮平的3个剂量范围(5+/-2.5 mg/天、10+/-2.5 mg/天和15+/-2.5 mg/天)与固定剂量的奥氮平(1.0 mg/天)和氟哌啶醇(15+/-5 mg/天)治疗431名精神分裂症患者的疗效，目的是确定奥氮平是否表现出剂量相关的能力，在精神分裂症患者中减少总体精神病理学和最小的相关锥体外系症状。与1.0 mg/天的奥氮平组相比，大剂量奥氮平组基于CGI严重程度评分的平均变化在总体精神病理学方面的改善具有统计学意义上的显著意义，以及基于BPRS阳性评分和PANSS阳性评分的平均变化的阳性精神病症状的改善在统计学上显著高于奥氮平组。分析表明，在所有奥氮平剂量组中，观察到了剂量-反应曲线的增加。与氟哌啶醇组相比，所有奥氮平组中急性锥体外系综合征的报告频率较低。Simpson-Angus量表和Barnes静坐不能量表的终点平均值变化反映了所有奥氮平治疗组的改善，而氟哌啶醇组的恶化。奥氮平与体重增加有关，但似乎对生命体征没有任何临床意义的影响。虽然奥氮平与催乳素浓度的升高有关，但升高是短暂的，发生的频率较低，且幅度小于氟哌啶醇组。(C)1997年爱思唯尔科学公司。
A 6-week acute phase of an international 1-year double-blind study was conducted comparing three dose ranges of olanzapine (5+/-2.5 mg/day, 10+/-2.5 mg/day, and 15+/-2.5 mg/day) with a fixed dose of olanzapine (1.0 mg/day) and with a dose range of haloperidol (15+/-5 mg/day) in the treatment of 431 patients with schizophrenia, The purpose was to determine whether olanzapine demonstrated a dose-related ability to decrease overall psychopathology with minimal associated extrapyramidal symptoms in patients with schizophrenia. The high-dose olanzapine group showed statistically significantly greater improvement in overall psychopathology based on mean change in the CGI Severity score and statistically significantly greater improvement in positive psychotic symptoms based on mean change in both the BPRS positive score and the PANSS positive score compared with the 1.0-mg/day olanzapine group. Analyses indicated that an increasing dose-response curve was observed across the range of all olanzapine dose groups. Acute extrapyramidal syndromes were reported less frequently among all olanzapine groups compared with the haloperidol group. Endpoint mean change on both the Simpson-Angus Scale and the Barnes Akathisia Scale reflected improvement for all olanzapine treatment groups compared with worsening for the haloperidol group. Olanzapine was associated with weight gain but did not appear to have any clinically meaningful effect on vital signs. Although olanzapine was associated with some increase in prolactin concentrations, increases were transient, occurred less often, and were of lesser magnitude than those observed with haloperidol. (C) 1997 Elsevier Science B.V.