多奈哌齐治疗重度阿尔茨海默病患者:双盲、平行分组、安慰剂对照研究  

Donepezil in patients with severe Alzheimer’s disease: double-blind, parallel-group, place-bo-controlled study

作　　者：Winblad B. Kilander L. Eriksson S. 周永(译) 

机构地区：[1]Karolinska Institutet, Alzheimer's Disease Research Center, Department of Neurotec, Huddinge, 14186 Stockholm, Sweden [2]不详

出　　处：《世界核心医学期刊文摘（神经病学分册）》2006年第9期4-5,共2页Digest of the World Core Medical Journals:Clinical Neurology

摘　　要：Background: The cholinesterase inhibitor donepezil is used to treat mild-to-moderate Alzheimer’s disease. Its efficacy in severe dementia has not been assessed and is controversial. Our aim was to ascertain the effectiveness of donepezil in patients with severe Alzheimer’s disease, by focusing primarily on cognition and activities of daily living. Methods: We did a 6-month, double-blind, parallel-group, placebo-controlled study in 248 patients with severe Alzheimer‘s disease (mini mental state examination score 1-10) who were living in assisted care nursing homes ran by trained staff in Sweden. We assigned patients oral donepezil (5 mg per day for 30 days then up to 10 mg per day thereafter, n=128) or matched placebo (n=120). Our primary endpoints were change from baseline to month 6 in the severe impairment battery (SIB) and modified Alzheimer’s Disease Cooperative Study activities of daily living inventory for severe Alzheimer’s disease (ADCS-ADL-severe). We analysed outcomes for patients with data at baseline and at one or more other timepoints (modified intent-to-treat population) with last observation carried forward used to replace missing data. Findings: 95 patients assigned donepezil and 99 patients assigned placebo completed the study. Patients treated with donepezil improved more in SIB scores and declined less in ADCS-ADL-severe scores at 6 months after initiation of treatment compared with baseline than did controls (least squares [LS] mean difference, 5.7, 95%CI 1.5-9.8; p=0.008, and 1.7, 0.2-3.2; p=0.03, respectively). The incidence of adverse events was comparable between groups (donepezil 82%[n=105] vs placebo 76%[n=91]), with most being transient and mild or moderate in severity. More patients discontinued treatment because of adverse events in the donepezil group (n=20) than in the placebo group (n=8). Interpretation: Donepezil improves cognition and preserves function in individuals with severe Alzheimer’s disease who live in nursing homes.Background： The cholinesterase inhibitor donepezil is used to treat mild-to-moderate Alzheimer＇s disease. Its efficacy in severe dementia has not been assessed and is controversial. Our aim was to ascertain the effectiveness of donepezil in patients with severe Alzheimer＇s disease, by focusing primarily on cognition and activities of daily living. Methods： We did a 6-month, double-blind, parallel-group, placebo-controlled study in 248 patients with severe Alzheimer＇s disease （mini mental state examination score 1- 10） who were living in assisted care nursing homes ran by trained staff in Sweden. We assigned patients oral donepezil （5 mg per day for 30 days then up to 10 mg per day thereafter, n = 128） or matched placebo （n = 120）. Our primary endpoints were change from baseline to month 6 in the severe impairment battery （SIB） and modified Alzheimer＇s Disease Cooperative Study activities of daily living inventory for severe Alzheimer＇s disease （ADCS-ADL-severe） . We analysed outcomes for patients with data at baseline and at one or more other timepoints （modified intent-to-treat population） with last observation carried forward used to replace missing data. Findings： 95 patients assigned donepezil and 99 patients assigned placebo completed the study. Patients treated with donepezil improved more in SIB scores and declined less in ADCS-ADL-severe scores at 6 months after initiation of treatment compared with baseline than did controls （least squares [LS] mean difference, 5.7, 95% CI 1.5 -9.8; p =0. 008, and 1.7, 0. 2 -3.2; p =0. 03, respectively）. The incidence of adverse events was comparable between groups （donepezil 82% [n = 105] vs placebo 76% [n = 91 ] ）,

关 键 词：阿尔茨海默病患者 意向性治疗 安慰剂对照 多奈哌齐 重度 对照研究 双盲 平行 

分 类 号：R749.16[医药卫生—神经病学与精神病学]