Hu Hong-tao, Zhang Zhen-xin, Yao Jing-li, Yu Hui-zhen, Wang Yin-hua, Tang Hong-chuan, Ji Cheng-jun, Xu Tao
Department of Neurology and Clinical Epidemiology Unit, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
Zhonghua Nei Ke Za Zhi. 2006 Apr;45(4):277-80.
To evaluate the clinical efficacy and safety of akatinol memantine in the treatment of patients with mild to moderate Alzheimer disease (AD).
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.
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.
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.
评估阿卡丁醇美金刚治疗轻至中度阿尔茨海默病（AD）患者的临床疗效及安全性。
来自中国两个城市6个中心的100例诊断为可能或很可能患有AD且简易精神状态检查表总分在10至26分之间的患者被随机分为两组：阿卡丁醇美金刚组（n = 50，第1周给予阿卡丁醇美金刚5mg/d，第2周10mg/d，第3周15mg/d，第4至16周20mg/d）；多奈哌齐组（n = 50，多奈哌齐5mg/d）。使用不同量表评估认知功能（MMSE）、日常生活活动及行为和情绪（Blessed-Roth量表）以及痴呆严重程度（GDS）。每4周进行一次安全性评估。
与基线数据相比，阿卡丁醇美金刚组（P = 0.000）和多奈哌齐组（P = 0.000）在第16周时用MMSE评估的认知功能均有显著改善；阿卡丁醇美金刚组（P = 0.000）和多奈哌齐组（P = 0.000）在第8周和第16周时用Blessed-Roth量表评估的日常生活活动、行为和情绪也有显著改善。然而，用Blessed-Roth量表第二部分评估的基本生活习惯变化无改善（P > 0.05），用GDS评估的痴呆严重程度也无改善（P > 0.05）。与多奈哌齐组数据相比，阿卡丁醇美金刚组在第16周时MMSE评分、Blessed-Roth量表评分和GDS评分的变化无改善（P > 0.05）。阿卡丁醇美金刚组6%的患者出现轻度短暂不良事件。
作为一种安全有效的药物，阿卡丁醇美金刚对AD的治疗效果与多奈哌齐相似，可显著改善AD患者的认知、行为和情绪。
