Lilly USA, LLC, Indianapolis, IN 46285, USA.
Curr Med Res Opin. 2012 Mar;28(3):315-23. doi: 10.1185/03007995.2012.657300. Epub 2012 Jan 31.
To assess the effects of olanzapine long-acting injection (olanzapine-LAI) on levels of functioning in acutely ill patients with schizophrenia.
During this 8-week randomized, double-blind, placebo-controlled trial, 404 inpatients were randomized to four treatment arms (olanzapine-LAI 210 mg/2 weeks = 106; olanzapine-LAI 300 mg/2 weeks = 100; olanzapine-LAI 405 mg/4 weeks = 100; placebo = 98). Also, data from the three active dosing arms were combined and compared to placebo data.
NCT00088478.
The treatment group comparison of mean change from baseline to endpoint in the total score and four subdomains of the Heinrichs-Carpenter Quality of Life Scale (QLS) and in the 2 summary scores and 8 subscale scores of the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) were assessed using an ANOVA model.
All three olanzapine-LAI treatment groups and the combined olanzapine-LAI group were superior to placebo on the QLS total score (all p-values < 0.01) and the Intrapsychic Foundations subdomain (all p-values < 0.02). Olanzapine-LAI 210 mg/2 weeks (p < 0.001), 300 mg/2 weeks (p = 0.006), and the combined olanzapine-LAI group (p = 0.003) were superior to placebo on the Interpersonal Relations subdomain. The 300 mg/2 weeks group (p = 0.027) and the combined olanzapine-LAI group (p = 0.014) were also superior to placebo on the Instrumental Role subdomain. For the SF-36, the 300 mg/2 weeks and 405 mg/4 weeks olanzapine-LAI groups and the combined olanzapine-LAI group were superior to placebo on the Mental component score (all p-values < 0.05). Each olanzapine-LAI group and the combined group were superior on the Mental Health scale (all p-values < 0.05). Significant negative correlations between PANSS scores and measures of functioning indicate that as symptoms decreased, functioning increased.
These results suggest that olanzapine-LAI may improve level of functioning in acutely ill patients with schizophrenia within 8 weeks of initiating treatment.
评估奥氮平长效注射剂（奥氮平-LAI）对急性精神病患者功能水平的影响。
在这项为期 8 周的随机、双盲、安慰剂对照试验中，404 名住院患者被随机分配到四个治疗组（奥氮平-LAI 210mg/2 周=106；奥氮平-LAI 300mg/2 周=100；奥氮平-LAI 405mg/4 周=100；安慰剂=98）。此外，还将三个活性给药组的数据合并并与安慰剂数据进行比较。
NCT00088478。
采用方差分析模型评估从基线到终点时 Heinrichs-Carpenter 生活质量量表（QLS）总分和四个亚域、医疗结果研究 36 项简明健康调查（SF-36）两个综合评分和 8 个亚量表评分的治疗组间平均变化。
所有三种奥氮平-LAI 治疗组和合并的奥氮平-LAI 组在 QLS 总分（均 p 值<0.01）和心理基础亚域（均 p 值<0.02）上均优于安慰剂。奥氮平-LAI 210mg/2 周（p<0.001）、300mg/2 周（p=0.006）和合并的奥氮平-LAI 组（p=0.003）在人际关系亚域优于安慰剂。300mg/2 周组（p=0.027）和合并的奥氮平-LAI 组（p=0.014）在工具角色亚域也优于安慰剂。对于 SF-36，奥氮平-LAI 210mg/2 周、300mg/2 周和 405mg/4 周组和合并的奥氮平-LAI 组在心理成分评分上均优于安慰剂（均 p 值<0.05）。每个奥氮平-LAI 组和合并组在心理健康量表上均优于安慰剂（均 p 值<0.05）。PANSS 评分与功能测量之间的显著负相关表明，随着症状的减轻，功能得到改善。
这些结果表明，奥氮平-LAI 可能在开始治疗后 8 周内改善急性精神病患者的功能水平。
