Sommer Oskar H, Aga Olav, Cvancarova Milada, Olsen Inge C, Selbaek Geir, Engedal Knut
Innlandet Hospital Trust, Department of Geriatric Psychiatry, Reinsvoll, Norway.
Dement Geriatr Cogn Disord. 2009;27(2):155-63. doi: 10.1159/000199236. Epub 2009 Feb 2.
BACKGROUND/AIMS: To evaluate the efficacy of oxcarbazepine (OXC) in the treatment of agitation and aggression in patients with Alzheimer's disease, vascular dementia or both.
This is an 8-week, multicenter, randomized, double-blind, placebo-controlled trial carried out independently of the pharmaceutical industry. Changes in the agitation and aggression subscore of the Neuropsychiatric Inventory (NPI) were the primary outcomes. The secondary out- comes were the changes in the caregivers' total burden scores (measured by the NPI) and changes in the Brief Agitation Rating Scale (BARS).
In total, 103 institutionalized patients at 35 sites were randomized to the trial. After 8 weeks, no statistically significant differences were found between the 2 groups for all outcomes. A trend was observed in favor of the OXC group in the reduction in the scores on the BARS (p = 0.07).
This study found no significant effect of OXC in treatment of agitation and aggression in patients with dementia.
背景/目的:评估奥卡西平(OXC)治疗阿尔茨海默病、血管性痴呆或两者兼有的患者的激越和攻击行为的疗效。
这是一项为期8周的多中心、随机、双盲、安慰剂对照试验,独立于制药行业进行。神经精神科问卷(NPI)中激越和攻击行为子评分的变化是主要结局。次要结局是照料者总负担评分的变化(通过NPI测量)和简易激越评定量表(BARS)的变化。
共有来自35个地点的103名住院患者被随机分配至该试验。8周后,两组在所有结局方面均未发现统计学上的显著差异。在BARS评分降低方面观察到有利于奥卡西平组的趋势(p = 0.07)。
本研究发现奥卡西平在治疗痴呆患者的激越和攻击行为方面无显著效果。