Centre for Research and Treatment on Cognitive Dysfunctions, Chair of Neurology, University of Milan, Luigi Sacco Hospital, Via G.B. Grassi, 74, 20157 Milan, Italy.
Neurol Sci. 2012 Feb;33(1):23-31. doi: 10.1007/s10072-011-0618-0. Epub 2011 May 17.
The aim of this study is to evaluate memantine effectiveness on behavioural and psychological symptoms of dementia (BPSD) in clinical practice and to identify variables that may predict the therapy effects. The effects of memantine on behaviour were analysed in the database of a post-marketing surveillance study promoted by the Lombardy Region Health Office and involving 43 Alzheimer's disease (AD) Units. From July to December 2005, 399 moderately severe-to-severe AD patients free of cholinergic medications were enrolled, treated with memantine and followed-up for 6 months. BPSD were assessed in a subgroup of 297 patients [mean age 77 ± 8 years; 73% females; mean neuropsychiatric inventory (NPI) score 28 ± 24] for whom the 12-item NPI subscores at baseline, and at 3 and 6 months were available. The 12 BPSD were clustered as follows: affect, physical behaviour, psychosis and hypomania. The main outcome measure was the proportion of individual cluster responders at 6 months of therapy. The proportion of individual cluster responders was 30% affect, 24% physical behaviour, 29% psychosis, 27% hypomania. Patients taking 20 mg memantine daily during the study period had a statistically significant higher probability to experience behavioural improvement than those who discontinued treatment or did not complete memantine titration (affect OR 9.0; 95% CI 3.8-21.6; physical behaviour OR 17.8; 95% CI 5.9-53.6; psychosis OR 23.6; 95% CI 5.1-110.8). The logistic regression analysis was not applicable to the hypomania subsyndrome because of the low cluster prevalence. The standard 20 mg daily memantine treatment regimen was found to be associated with a modest 6-month behavioural improvement in the affect, physical behaviour and psychosis domains in 24-30% of patients.
本研究旨在评估美金刚在临床实践中对痴呆患者行为和心理症状（BPSD）的疗效，并确定可能预测治疗效果的变量。在伦巴第大区卫生局推动的一项上市后监测研究数据库中分析了美金刚对行为的影响，该研究涉及 43 个阿尔茨海默病（AD）单位。2005 年 7 月至 12 月，纳入 399 名无胆碱能药物治疗的中重度 AD 患者，给予美金刚治疗并随访 6 个月。在 297 名患者亚组中评估了 BPSD，该亚组患者[平均年龄 77 ± 8 岁；73%为女性；平均神经精神问卷（NPI）评分为 28 ± 24]在基线时以及在 3 个月和 6 个月时可用 12 项 NPI 亚评分。12 项 BPSD 分为以下几类：情感、躯体行为、精神病和轻躁狂。主要观察指标为治疗 6 个月时各亚组的个体反应比例。个体亚组的反应比例为：情感 30%、躯体行为 24%、精神病 29%、轻躁狂 27%。在研究期间每天服用 20 mg 美金刚的患者比停止治疗或未完成美金刚滴定的患者经历行为改善的可能性具有统计学意义（情感 OR 9.0；95%CI 3.8-21.6；躯体行为 OR 17.8；95%CI 5.9-53.6；精神病 OR 23.6；95%CI 5.1-110.8）。由于亚组的患病率较低，逻辑回归分析不适用于轻躁狂亚综合征。在 24%-30%的患者中，发现标准的 20mg 每日美金刚治疗方案与 6 个月时情感、躯体行为和精神病领域的适度行为改善相关。
