美金刚与多奈哌齐比较治疗阿尔茨海默病疗效和安全性的Meta分析  

Efficacy and Safety of Memantine versus Donepezil for Alzheimer's Disease:A Meta-Analysis

作　　者：陈艳春[1] 周晓辉[1] 苏冉[2] 刘玉[3] 

机构地区：[1]新疆医科大学第一附属医院干部病房内一科,乌鲁木齐830054 [2]新疆医科大学第一附属医院风湿免疫科,乌鲁木齐830054 [3]新疆医科大学第一附属医院循证医学教研室,乌鲁木齐830054

出　　处：《中国循证医学杂志》2012年第2期209-215,共7页Chinese Journal of Evidence-based Medicine

基　　金：国家自然科学基金资助项目(编号:30460140)

摘　　要：目的系统评价美金刚与多奈哌齐比较治疗阿尔茨海默病(Alzheimer's disease,AD)的临床疗效和安全性,为临床应用提供循证依据。方法计算机检索CBM、CNKI、WanFang Data、MEDLINE、OVID、EMbase和Cochrane Library,检索时间截至2011年7月,纳入有关美金刚与多奈哌齐比较治疗AD的随机对照试验(RCT),由两位研究者独立进行文献筛选、资料提取和方法学质量评价后,采用RevMan 5.0软件进行Meta分析。结果共纳入12个RCT,共计2?761例患者,其中美金刚组1?459例,多奈哌齐组1302例。Meta分析结果显示:美金刚组在简易智能精神状态检查量表(MMSE)、总体功能量表(CIBIC-Plus)、精神行为量表(NPI)和认知功能量表(SIB)评分方面的疗效均优于多奈哌齐组,其差异均有统计学意义[MD=0.53,95%CI(0.21,0.85),P=0.001;MD=–0.19,95%CI(–0.31,–0.07),P=0.002;MD=–2.9,95%CI(–4.57,–1.22),P=0.000 7;MD=3.12,95%CI(0.57,5.67),P=0.02)],而在日常生活能力量表(ADCS-ADL19)评分方面,两组疗效相当(MD=0.29,95%CI(–0.03,0.60),P=0.07)。美金刚组与多奈哌齐组副反应发生率差异无统计学意义[RR=1.14,95%CI(0.94,1.38),P=0.17],但美金刚组耐受性更好[RR=0.78,95%CI(0.63,0.97),P=0.03]。结论美金刚治疗阿尔茨海默病疗效优于多奈哌齐,其副反应与多奈哌齐相当,且耐受性优于后者,是一种较为安全有效的药物。受纳入研究质量的限制和可能存在的发表性偏倚的影响,上述结论尚需更多高质量随机双盲对照试验加以验证。Objective To evaluate the efficacy and safety of memantine in the treatment of Alzheimer＇s disease（AD）.Methods The randomized controlled trials（RCTs） about memantine vs.donepezil for patients with AD from January 1989 to July 2011 were searched in CBM,CNKI,WanFang Data,MEDLINE,OVID,EMbase and The Cochrane Library.Two reviewers independently screened the literatures,extracted the data,and evaluated the methodological quality.Then meta-analyses were conducted by using RevMan 5.0 software.Results The total 12 RCTs were included.Among the 2716 patients involved,1459 were in the memantine group,while the other 1302 were in the donepezil group.The results of meta-analyses showed that the efficacy of the memantine group was superior to that of the donepezil group in MMSE（MD=0.53,95%CI 0.21 to 0.85,P=0.001）,CIBIC-Plus（MD= –0.19,95%CI –0.31 to –0.07,P=0.002）,NPI（MD=–2.9,95%CI–4.57 to–1.22,P=0.0007） and SIB（MD=3.12,95%CI 0.57 to 5.67,P=0.02）,with significant differences;but the efficacy of the two groups was similar in ADCS-ADL19（MD=0.29,95%CI –0.03 to 0.60,P=0.07）.There was no significant difference between the two groups in incidence of side effects（RR=1.14,95%CI 0.94 to 1.38,P=0.17）,but the tolerability of the memantine group was much better（RR=0.78,95%CI 0.63 to 0.97,P=0.03）.Conclusion Based on the current studies,memantine is superior to donepezil in treating Alzheimer＇s disease（AD） at present.Although the side effects are similar to donepezil,memantine has much better intolerability and is considered to be safe and effective.For the quality restrictions and possible publication bias of the included studies,more double blind RCTs with high quality are required to further assess the effects.

关 键 词：美金刚 多奈哌齐 阿尔茨海默病 META分析 系统评价 

分 类 号：R749.16[医药卫生—神经病学与精神病学]