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| 盐酸美金刚治疗阿尔茨海默病的多中心随机对照研究 | |
| 引用本文： | 程焱,张楠,杜红坚,陈海波,彭丹涛,蔡晓杰,肖世富,李霞,马崔,冯亚青,莫雪安,高宗良,赵钢,张高魁.盐酸美金刚治疗阿尔茨海默病的多中心随机对照研究[J].中华神经科杂志,2009,42(4). |
| 作者姓名： | 程焱 张楠 杜红坚 陈海波 彭丹涛 蔡晓杰 肖世富 李霞 马崔 冯亚青 莫雪安 高宗良 赵钢 张高魁 |
| 作者单位： | 1. 天津医科大学总医院神经内科,300052 2. 卫生部北京医院神经内科 3. 上海市精神卫生中心老年科 4. 广州市脑科医院神经内科 5. 河北省人民医院老年三科 6. 广西医科大学第一附属医院神经内科 7. 安徽医科大学第一附属医院神经内科 8. 第四军医大学两京医院神经内科 9. 北京迪美斯科技发展有限公司 |
| 摘 要： | 目的 与盐酸多奈哌齐对照评价盐酸荚金刚片治疗阿尔茨海默病(AD)的有效性和安全性.方法 241例AD患者(MMSE评分3-24分)随机分为2组,采用双盲双模拟的方法,埘照组给予盐酸多奈哌齐10 mg/d,试验组给予盐酸美金刚20 mg/d,疗程24周,分别在基线、第4、12和24周进行随访.主要疗效指标为印象变化(CIBIC-Plus)、AD评估量表-认知部分(ADAS-cog)和日常生活能力(ADL)量表,次要疗效指标为神经精神症状问卷(NPI)和MMSE.结果 207例患者完成试验,盐酸美金刚组和盐酸多奈哌齐组治疗24周后各量表评分均较基线有显著改善.盐酸美金刚组与盐酸多奈哌齐组相比较,各量表的评分变化分别为:CIBIC-Plus评分:3.4±0.8、3.5±0.8;ADAS-cog评分:-4.7±5.8、-4.6±6.5;ADL评分:-2.4±6.7、-2.2±5.3;NPI评分:-5.8±9.0、-3.1±8.5;MMSE评分:1.7±3.1、1.8±2.8;差异均无统计学意义.不良事件发生率盐酸多奈哌齐组41.88%,盐酸美金刚组30.58%.结论 盐酸美金刚作为治疗AD的新药,町以改善AD患者的总体功能、认知障碍、日常生活能力和精神行为症状,疗效与盐酸多奈哌齐相当,且具有良好的安全性和耐受性. |
| 关 键 词： | 阿尔茨海默病 美金刚 茚满类 哌啶类 随机对照试验 |
Multicenter controlled randomized clinical trial of akatinol memantine for treatment of Aizheimer's disease |
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| CHENG Yan,ZHANG Nan,DU Hong-jian,CHEN Hai-bo,PENG Dan-tao,Cai Xiao-jie,XIAO Shi-fu,LI Xia,MA Cui,FENG Ya-qing,MO Xue-an,GAO Zong-liang,ZHAO Gang,ZHANG Gao-kui.Multicenter controlled randomized clinical trial of akatinol memantine for treatment of Aizheimer's disease[J].Chinese Journal of Neurology,2009,42(4). | |
| Authors: | CHENG Yan ZHANG Nan DU Hong-jian CHEN Hai-bo PENG Dan-tao Cai Xiao-jie XIAO Shi-fu LI Xia MA Cui FENG Ya-qing MO Xue-an GAO Zong-liang ZHAO Gang ZHANG Gao-kui |
| Abstract: | Objective To evaluate the clinical efficacy and safety of akatinol memantine in the treatment of Alzheimer's disease (AD).Methods Two hundred and forty-one patients with AD were randomly assigned to receive 10 mg of donepezil daily or 20 mg of memantine daily for 24 weeks.The primary efficacy variables were the Clinician' s Interview-Based Impression of Change Plus (CIBIC-Plus),the Alzheimer Disease Assessment Scale-cognition (ADAS-cog) and the Activities of Daily Living (ADL).The secondary efficacy variables were the Neuropsychiatric Inventory (NPI) and the Mini-Mental Status Examination (MMSE).Results Two hundred and seven patients completed the study and were evaluated at week 24.Both memantine and donepezil had significant efficacies at the end point, according to the ADAS-cog, the ADL, the NPI and the MMSE.Patients receiving memantine had a similar outcome as those receiving donepezil, according to the results of all the variables changes (CIBIC-Plus: memantine 3.4±0.8vs donepezil 3.5±0.8; ADAS-cog: memantine-4.7±5.8 vs donepezil-4.6±6.5; ADL: memantine -2.4±6.7 vs donepezil-2.2±5.3 ; NP1: memantine-5.8±9.0 vs donepezil-3.1±8.5 ; MMSE:memantine 1.7±3.1 vs donepezil 1.8±2.8, all P >0.05).The adverse events were as following: donepezil group 41.88% and memanintine group 30.58%.Conclusion The memantine as a new drug for AD, has the similar efficacy as donepezil, and it is safe. |
| Keywords: | Alzheimer disease Memantine Indans Piperidines Randomized controlled trial |
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