Deberdt Walter G, Dysken Maurice W, Rappaport Stephen A, Feldman Peter D, Young Carrie A, Hay Donald P, Lehman Deborah L, Dossenbach Martin, Degenhardt Elisabeth K, Breier Alan
Lilly Research Laboratories, Indianapolis, IN, USA.
Am J Geriatr Psychiatry. 2005 Aug;13(8):722-30. doi: 10.1176/appi.ajgp.13.8.722.
The authors compared efficacy of olanzapine versus placebo and risperidone as measured by the Neuropsychiatric Inventory and Clinical Global Impression-Severity of Psychosis scale in patients with dementia-related psychosis.
Patients with moderate-to-severe psychotic symptoms associated with dementia were recruited from outpatient or residential settings and randomly assigned to 10-week, double-blind, flexible-dose treatment with olanzapine (N=204; 2.5 mg-10 mg/day; mean: 5.2 mg/day), risperidone (N=196; 0.5 mg-2 mg/day; mean: 1.0 mg/day) or placebo (N=94).
Most measures of neuropsychiatric functioning improved in all treatment groups, including the placebo group, and no significant treatment differences occurred. Overall discontinuation was lowest in the placebo group, and the olanzapine group had a significantly higher incidence of discontinuation due to adverse events (16.2%) relative to placebo (3.2%) and risperidone (8.7%) groups. Treatment-emergent extrapyramidal symptoms were more numerous for risperidone- than placebo- or olanzapine-treated patients. Abnormally high prolactin levels occurred in 78.0% of risperidone patients, compared with 16.7% for olanzapine and 5.0% for placebo. The incidence of weight gain greater than 7% from baseline was higher in the olanzapine group relative to risperidone, but neither active-treatment group showed a statistical difference from placebo (1.1%). No other statistically significant and clinically relevant differences were seen for any other vital sign, electrocardiographic measure, or laboratory hematology and chemistry, including glucose, except for cholesterol, which decreased from baseline to endpoint in both active-treatment groups.
Patients' neuropsychiatric functioning improved with olanzapine, risperidone, and placebo treatment. There was a substantial response in the placebo group, and no significant differences emerged among treatments.
作者通过神经精神科问卷和精神病临床总体印象严重程度量表，比较奥氮平与安慰剂及利培酮对痴呆相关精神病患者的疗效。
从中度至重度痴呆相关精神病性症状患者中招募门诊或住院患者，随机分配至接受为期10周的双盲、灵活剂量治疗，分别给予奥氮平（N = 204；2.5毫克至10毫克/天；平均：5.2毫克/天）、利培酮（N = 196；0.5毫克至2毫克/天；平均：1.0毫克/天）或安慰剂（N = 94）。
所有治疗组（包括安慰剂组）的大多数神经精神功能指标均有改善，且未出现显著的治疗差异。总体停药率在安慰剂组最低，奥氮平组因不良事件导致的停药发生率（16.2%）显著高于安慰剂组（3.2%）和利培酮组（8.7%）。利培酮治疗的患者出现的治疗中出现的锥体外系症状比安慰剂或奥氮平治疗的患者更多。78.0%的利培酮患者出现催乳素水平异常升高，相比之下，奥氮平患者为16.7%，安慰剂患者为5.0%。奥氮平组相对于利培酮组，体重较基线增加超过7%的发生率更高，但两个活性治疗组与安慰剂组（1.1%）均未显示出统计学差异。除胆固醇在两个活性治疗组中从基线至终点均下降外，在任何其他生命体征、心电图指标或实验室血液学及化学指标（包括血糖）方面，均未观察到其他具有统计学意义且临床相关的差异。
奥氮平、利培酮和安慰剂治疗均使患者的神经精神功能得到改善。安慰剂组有显著反应，各治疗组之间未出现显著差异。
