盐酸美金刚治疗阿尔茨海默病的多中心随机对照研究
염산미금강치료아이자해묵병적다중심수궤대조연구
Multicenter controlled randomized clinical trial of akatinol memantine for treatment of Aizheimer's disease
  • 万方数据
    中华神经科杂志 중화신경과잡지
    Chinese Journal of Neurology
    2009年 4期 268-272 ,共5页

    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

    정염%장남%두홍견%진해파%팽단도%채효걸%초세부%리하%마최%풍아청%막설안%고종량%조강%장고괴

    阿尔茨海默病%美金刚%茚满类%哌啶类%随机对照试验 阿爾茨海默病%美金剛%茚滿類%哌啶類%隨機對照試驗
    아이자해묵병%미금강%인만류%고정류%수궤대조시험
    Alzheimer disease%Memantine%Indans%Piperidines%Randomized controlled trial
    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.
    목적 여염산다내고제대조평개염산협금강편치료아이자해묵병(AD)적유효성화안전성.방법 241례AD환자(MMSE평분3-24분)수궤분위2조,채용쌍맹쌍모의적방법,시조조급여염산다내고제10 mg/d,시험조급여염산미금강20 mg/d,료정24주,분별재기선、제4、12화24주진행수방.주요료효지표위인상변화(CIBIC-Plus)、AD평고량표-인지부분(ADAS-cog)화일상생활능력(ADL)량표,차요료효지표위신경정신증상문권(NPI)화MMSE.결과 207례환자완성시험,염산미금강조화염산다내고제조치료24주후각량표평분균교기선유현저개선.염산미금강조여염산다내고제조상비교,각량표적평분변화분별위:CIBIC-Plus평분:3.4±0.8、3.5±0.8;ADAS-cog평분:-4.7±5.8、-4.6±6.5;ADL평분:-2.4±6.7、-2.2±5.3;NPI평분:-5.8±9.0、-3.1±8.5;MMSE평분:1.7±3.1、1.8±2.8;차이균무통계학의의.불량사건발생솔염산다내고제조41.88%,염산미금강조30.58%.결론 염산미금강작위치료AD적신약,정이개선AD환자적총체공능、인지장애、일상생활능력화정신행위증상,료효여염산다내고제상당,차구유량호적안전성화내수성.
    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.
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