Perras C
Issues Emerg Health Technol. 2005 Mar(64):1-4.
Health Canada has issued a Notice of Compliance with conditions (NOC/c) for memantine in the treatment of moderate to severe Alzheimer's disease (AD). The evidence of relative benefit and harm from memantine in this population derives from two randomized controlled trials (RCT) of 24 to 28 weeks duration, in a total of 656 patients; and a post hoc subgroup analysis of 79 patients with severe AD from a third trial of 12 weeks. Memantine alone or in combination with donepezil demonstrates improvements in primary outcome scores of activities of daily living and cognition, but not of global performance. Memantine's rate of diffusion may be rapid, as it is the only drug available for severe AD and it has a potential for use in unapproved indications.
加拿大卫生部已发布美金刚用于治疗中度至重度阿尔茨海默病(AD)的附条件批准通知(NOC/c)。该人群中美金刚相对获益和危害的证据来自两项为期24至28周的随机对照试验(RCT),共656例患者;以及对来自第三项为期12周试验的79例重度AD患者的事后亚组分析。美金刚单独使用或与多奈哌齐联合使用可改善日常生活活动和认知的主要结局评分,但对整体表现无改善。美金刚的扩散速度可能很快,因为它是唯一可用于重度AD的药物,并且有可能用于未获批准的适应症。