盐酸美金刚治疗阿尔茨海默病多中心随机对照临床试验

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。

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

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 mg/d from fourth to sixteenth week); donepezil group (n = 50, donepezil 5 mg/d). Different scales were used to evaluated cognitive function (MMSE), activity of daily life and behavior and mood (Blessed-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 Blessed-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. CONCLUSION: 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.