Adis, a Wolters Kluwer Business, Auckland, New Zealand.
CNS Drugs. 2010 May;24(5):443-52. doi: 10.2165/11204430-000000000-00000.
Olanzapine is an atypical antipsychotic that, in addition to its use in adults, is now indicated for the treatment of schizophrenia, and manic or mixed episodes associated with bipolar I disorder in adolescents aged 13-17 years. In a randomized, double-blind, multicentre, 6-week trial in adolescents aged 13-17 years with schizophrenia, the least squares mean reduction from baseline to 6 weeks in the Brief Psychiatric Rating Scale for Children (BPRS-C) total score (primary endpoint) was significantly greater with olanzapine than with placebo. In a randomized, double-blind, multicentre, 3-week trial in adolescents, aged 13-17 years, with manic or mixed episodes associated with bipolar I disorder, the mean reduction from baseline to 3 weeks in the Adolescent Structured Young Mania Rating Scale (YMRS) total score (primary endpoint) was significantly greater with olanzapine than with placebo. In extensions of each of the pivotal placebo-controlled trials in schizophrenia and bipolar mania, open-label treatment with olanzapine for up to 26 weeks produced significant reductions from baseline to endpoint in BPRS-C and YMRS total scores, respectively. Oral olanzapine was generally well tolerated in adolescents with schizophrenia or bipolar mania. Sedation and weight gain were the most common adverse events in placebo-controlled trials. Extrapyramidal symptoms were reported by 10% of olanzapine recipients compared with 6% of placebo recipients. Olanzapine-treated adolescents were likely to experience greater increases in bodyweight, sedation, blood lipids, serum prolactin and liver transaminase levels than olanzapine-treated adults. Therefore, careful consideration of risk-benefit is recommended before using olanzapine in adolescents.
奥氮平是一种非典型抗精神病药,除了在成人中的应用外,现在也被批准用于治疗 13-17 岁青少年的精神分裂症,以及双相 I 障碍相关的躁狂或混合发作。在一项针对 13-17 岁精神分裂症青少年的随机、双盲、多中心、6 周试验中,奥氮平治疗组从基线到 6 周的儿童Brief 精神病评定量表(BPRS-C)总分(主要终点)的最小二乘均值降低明显大于安慰剂组。在一项针对 13-17 岁青少年双相 I 障碍相关躁狂或混合发作的随机、双盲、多中心、3 周试验中,奥氮平治疗组从基线到 3 周的青少年躁狂评定量表(YMRS)总分(主要终点)的均值降低明显大于安慰剂组。在精神分裂症和双相躁狂的关键性安慰剂对照试验的扩展中,奥氮平开放标签治疗长达 26 周,分别使 BPRS-C 和 YMRS 总分从基线到终点显著降低。在精神分裂症或双相躁狂的青少年中,口服奥氮平通常具有良好的耐受性。在安慰剂对照试验中,镇静和体重增加是最常见的不良反应。与 6%的安慰剂组相比,10%的奥氮平组出现了锥体外系症状。与成人相比,接受奥氮平治疗的青少年更有可能出现体重增加、镇静、血脂异常、血清催乳素和肝转氨酶水平升高。因此,在青少年中使用奥氮平之前,建议仔细权衡利弊。