Mortimer Ann, Martin Stephen, Lôo Henri, Peuskens Joseph
University of Hull, Hull, UK.
Int Clin Psychopharmacol. 2004 Mar;19(2):63-9. doi: 10.1097/00004850-200403000-00002.
Atypical antipsychotics offer advantages over earlier drugs for the treatment of schizophrenia, although few data exist on the relative merits of different atypical antipsychotics. A multicentre, double-blind, randomized trial was performed to compare amisulpride and olanzapine in the treatment of acute schizophrenia. Adult schizophrenic patients with dominant positive symptomatology received amisulpride (200-800 mg/day) or olanzapine (5-20 mg/day) for 6 months. The primary efficacy variable was change from baseline of the Brief Psychiatric Rating Scale (BPRS) score, assessed with a non-inferiority analysis. The evolution of positive and negative symptomatology, depression, social functioning and quality of life were assessed. Safety evaluation included adverse event reporting, neurological status and body weight. The improvement of BPRS score was 32.7% in the amisulpride group and 33.0% in the olanzapine group; thus, the efficacy of amisulpride was not inferior to that of olanzapine. All other secondary efficacy outcome variables evolved to a similar extent in both groups. Adverse event frequency was similar in both groups. Amenorrhoea was encountered only in the amisulpride group (6.2% of patients), whereas elevations of liver transaminases were more frequent in the olanzapine group (17% versus 3.7% of patients). The incidence and mean extent of clinically relevant weight gain were higher in the olanzapine group (35.1% and 3.9 kg) than in the amisulpride group (20.6% and 1.6 kg). The efficacy of amisulpride is not inferior to that of olanzapine in the treatment of acute schizophrenia. The side-effect profile of the two drugs differed.
非典型抗精神病药物在治疗精神分裂症方面比早期药物具有优势，尽管关于不同非典型抗精神病药物的相对优点的数据很少。进行了一项多中心、双盲、随机试验，以比较氨磺必利和奥氮平治疗急性精神分裂症的效果。以阳性症状为主的成年精神分裂症患者接受氨磺必利（200 - 800毫克/天）或奥氮平（5 - 20毫克/天）治疗6个月。主要疗效变量是简明精神病评定量表（BPRS）评分相对于基线的变化，采用非劣效性分析进行评估。对阳性和阴性症状、抑郁、社会功能和生活质量的演变进行了评估。安全性评估包括不良事件报告、神经状态和体重。氨磺必利组BPRS评分的改善率为32.7%，奥氮平组为33.0%；因此，氨磺必利的疗效不劣于奥氮平。两组中所有其他次要疗效结局变量的演变程度相似。两组不良事件发生率相似。闭经仅在氨磺必利组出现（6.2%的患者），而奥氮平组肝转氨酶升高更为常见（患者比例分别为17%和3.7%）。奥氮平组临床相关体重增加的发生率和平均增加幅度高于氨磺必利组（分别为35.1%和3.9千克，以及20.6%和1.6千克）。在治疗急性精神分裂症方面，氨磺必利的疗效不劣于奥氮平。两种药物的副作用情况有所不同。
