盐酸美金刚治疗阿尔茨海默病多中心随机对照临床试验  

Clinical efficacy and safety of akatinol memantine in treatment of mild to moderate Alzheimer disease: a donepezil-controlled, randomized trial

作　　者：胡洪涛[1] 张振馨[1] 姚景莉[2] 余慧贞[3] 王荫华[4] 汤洪川[5] 冀成君[6] 徐涛[7] 

机构地区：[1]中国医学科学院中国协和医科大学北京协和医院神经科和临床流行病科,100730 [2]复旦大学华山医院神经科 [3]上海第二医科大学瑞金医院神经科 [4]北京大学第一医院神经科 [5]解放军总医院神经科 [6]北京回龙观医院神经科 [7]中国医学科学院中国协和医科大学基础医学院流行病统计学系

出　　处：《中华内科杂志》2006年第4期277-280,共4页Chinese Journal of Internal Medicine

摘　　要：目的盐酸多奈哌齐随机对照评估盐酸美金刚片(美金刚)治疗轻、中度阿尔茨海默病(AD)临床疗效和安全性。方法100例可能或很可能轻、中度AD患者随机接受美金刚或盐酸多奈哌齐治疗16周,每4周随访1次,8周评估采用Blessed Roth量表,16周评估采用简易智能状态检查量表(MMSE)、Blessed Roth量表和全面衰退量表(GDS)。结果两组分别自身前后比较差别均显示有统计学意义;GDS、Blessed Roth量表基本生活习惯改变部分评分的自身前后比较,各个量表评分变化均数在两组之间的比较差异均无统计学意义。试验组不良反应率为6%。结论美金刚和盐酸多奈哌齐均能显著改善轻、中度AD患者的认知功能、日常生活能力和人格情感障碍,两药疗效无明显差异且美金刚具有较好的安全性。Objective To evaluate the clinical efficacy and safety of akatinol memantine in the treatment of patients with mild to moderate Alzheimer disease （AD）, Methods One hundred patients with diagnosis of possible or probable AD and Mini Mental State Examination total scores between 10 and 26 from 6 centers in two cities of China were randomly divided into two groups ： akatinol memantine group （ n = 50, given akatinol memantine 5 mg/d in first week,10 mg/d in second week,15 mg/d in third week and 20 nag/ d from fourth to sixteenth week） ; donepezil group （n =50, donepezil 5 rag/d） . Different scales were used to evaluated cognitive function （ MMSE）, activity of daily life and behavior and mood （ Bleseed-Roth scale） as well as the severity of dementia （ GDS ）, Safety evaluation was conducted every 4 weeks. Results In comparison with the baseline data, there were significant improvements in cognition assessed with MMSE on 16th week in akatinol memantine group （P = 0. 000 ） and donepezil group （P = 0. 000） respectively; There also were significant improvements in activity of daily life, behavior and mood assessed by Bleseod- Roth scale in akatinol memantine group （P = 0. 000 ） and donepezil group （P = 0. 000 ） on 8th week and 16th week. However there was no improvements in the change of the basic habit of life assessed with the Part Ⅱ of Blessed-Roth scale （ P 〉 0. 05 ） , and nor an improvements in the serious level of dementia assessed with GDS （P 〉 0. 05 ）. In comparison with the data in donepezil group, there were no improvement in the change of MMSE score, Blessed-Roth scale score and GDS score in akatinol memantine group on 16th week （P 〉 0. 05 ）. Mild and transient adverse events were observed in 6% of akatinol memantine group. Condnsion As a safe and effective medicine, akatinol memantine, which has a similar effect as donepezil for AD, can remarkably improve the cognition, behavior, and mood of AD patients.

关 键 词：阿尔茨海默病 美金刚 盐酸多奈哌齐 

分 类 号：R749.161[医药卫生—神经病学与精神病学]