盐酸美金刚片治疗中、重度阿尔茨海默病的临床研究

目的评估盐酸关金刚片治疗中、重度阿尔茨海默病（Alzheimer disease，AD）的有效性和安全性。方法将100例中、重度AD患者随机分为2组，对照组给予盐酸多奈哌齐10mg·d，试验组给予盐酸美金刚片20mg·d，疗程16周，每4周随访1次，评估简易精神状态量表（MMSE）、阿尔茨海默病评价量表-认知分量表（ADAS-cog）、日常生活能力量表（ADL）、临床疗效总评量表（CGI）。结果盐酸多奈哌齐组MMSE、ADAS-cog、ADL评分治疗前后比较有统计学意义（P〈0．05），盐酸美金刚片组ADL、ADAS-cog和MMSE评分治疗前后比较有统计学意义（P〈0．05）。治疗前2组各量表评分比较（P〉0．05）与治疗16周后2组评分比较（P〉0．05），无统计学差异。试验组不良反应率为6．25％。结论盐酸美金刚片可以改善中、重度AD患者的症状，且具有良好的安全性和耐受性。

Memantine in the treatment of patients with moderate to severe Alzheimer disease

Objective To evaluate the clinical efficacy and safety of memantine in the treatment of patients with moderate to severe Alzheimer disease （AD）. Methods A total of 100 patients with moderate to severe AD were randomly divided into 2 groups, who respectively received 10 mg of donepezil daily or 20 mg of memantine daily for 16 weeks. Clinical evaluation was conducted every 4 weeks. The primary efficacy was evaluated by using the Mini-Mental Status Examination （MMSE）, the Alzheimer Disease Assessment Scale-cognition （ADAS-cog） , the Activities of Daily Living （ADL） and the Clinical Global Impression （CGI）. Results Memantine had similar efficacies to donepezil in improving symptoms of Alzheimer disease as evidenced by the increase in scores of MMSE, and the decrease in scores of ADAS-cog and ADL （P〈0. 05）. Compared with the data in the donepezil group, there was no significance in the change of these measuring scales in the memantine group before the therapy and at 16th week （P~0.05）. Mild and transient ad- verse events were observed in 5% of the memantine group. Conclusion Memantine is safe and effective, which has a similar effect as donepezil for patients with moderate to severe Alzheimer disease （AD）, and can remarkably improve the symptoms.