Donepezil and Memantine for Moderate-to-Severe Alzheimer's Disease
Donepezil and Memantine for Moderate-to-Severe Alzheimer's Disease
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DOI：
10.1056/nejmoa1106668
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发表时间：
2012-03-08
影响因子：
158.5
通讯作者：
Phillips, Patrick
中科院分区：
文献类型：
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作者：
Howard, Robert;McShane, Rupert;Phillips, Patrick
背景临床试验已经显示胆碱酯酶抑制剂对于治疗轻至中度阿尔茨海默病的益处。目前尚不清楚进展为中度至重度疾病后治疗益处是否会持续。 方法我们将 295 名接受多奈哌齐治疗至少 3 个月且患有中度或重度阿尔茨海默氏病（标准化简易精神状态检查得分为 5 至 13 [SMMSE，得分范围为 0 至 30，得分越高表明认知功能更好]）的社区居民患者指定为继续使用多奈哌齐，停止使用多奈哌齐多奈哌齐，停用多奈哌齐并开始美金刚，或继续使用多奈哌齐并开始美金刚。患者接受了为期 52 周的研究治疗。共同主要结果是 SMMSE 和布里斯托尔日常生活活动量表（BADLS，分数范围从 0 到 60，分数越高表明损伤越大）的分数。临床上最小的重要差异为 SMMSE 上的 1.4 分和 BADLS 上的 3.5 分。结果 与分配停止多奈哌齐的患者相比，分配继续使用多奈哌齐的患者的 SMMSE 得分平均高出 1.9 分（95% 置信区间 [CI]，1.3 至 2.5），而 BADLS 得分则较低（表明损伤较小） 3.0 分（95% CI，1.8 至 4.3）（P
BACKGROUNDClinical trials have shown the benefits of cholinesterase inhibitors for the treatment of mild-to-moderate Alzheimer's disease. It is not known whether treatment benefits continue after the progression to moderate-to-severe disease.METHODSWe assigned 295 community-dwelling patients who had been treated with donepezil for at least 3 months and who had moderate or severe Alzheimer's disease (a score of 5 to 13 on the Standardized Mini-Mental State Examination [SMMSE, on which scores range from 0 to 30, with higher scores indicating better cognitive function]) to continue donepezil, discontinue donepezil, discontinue donepezil and start memantine, or continue donepezil and start memantine. Patients received the study treatment for 52 weeks. The coprimary outcomes were scores on the SMMSE and on the Bristol Activities of Daily Living Scale (BADLS, on which scores range from 0 to 60, with higher scores indicating greater impairment). The minimum clinically important differences were 1.4 points on the SMMSE and 3.5 points on the BADLS.RESULTSPatients assigned to continue donepezil, as compared with those assigned to discontinue donepezil, had a score on the SMMSE that was higher by an average of 1.9 points (95% confidence interval [CI], 1.3 to 2.5) and a score on the BADLS that was lower (indicating less impairment) by 3.0 points (95% CI, 1.8 to 4.3) (P