美金刚口服液治疗阿尔采末病的多中心、随机、双盲、平行对照试验  

Memantine oral solution in treatment of moderate to severe Alzheimer's disease:a multicenter,randomized,double-blind,parallel-group controlled study

作　　者：李冠军[1,2] 肖世富[1,2] 李霞[1,2] 杨期明[3] 冯连元[4] 许秀峰[5] 唐牟尼[6] 胡连平 

机构地区：[1]上海交通大学医学院附属精神卫生中心 [2]上海交通大学阿尔茨海默病诊治中心,上海200030 [3]郴州市第一人民医院,湖南郴州423000 [4]白求恩国际和平医院,河北石家庄050000 [5]昆明医学院第一附属医院,云南昆明650200 [6]广州市精神病院,广东广州510370 [7]北京万全阳光医药科技有限公司数据管理与统计中心,北京100089

出　　处：《中国新药与临床杂志》2011年第3期184-188,共5页Chinese Journal of New Drugs and Clinical Remedies

基　　金：国家"重大新药创制"科技重大专项(2008ZX09312;2008ZX09312-003)

摘　　要：目的评价美金刚口服液治疗中、重度阿尔采末病(AD)的有效性及安全性。方法将237例中、重度AD患者随机分为2组,试验组服用美金刚口服溶液20mL·d^(-1),对照组服用美金刚片20mg·d^(-1),治疗16wk,在wk4、8、12和16末进行AD认知评定量表(ADAS-Cog)、日常生活能力量表(ADL)和临床疗效总评量表(CGI)的评定。在试验的wk 8、16进行辅助检查、生命体征检查并记录不良事件,以评定药物的安全性。结果纳入安全性数据集(SS)、全分析数据集(FAS)和符合方案数据集(PPS)的病例数试验组分别为119、114和103例,对照组分别为118、115和102例。2组ADAS-Cog、ADL总分在治疗wk4、8、12、16末与基线相比均显著下降(P<0.01),2组在基线和各观察时点的ADAS-Cog和ADL量表总分组间比较无显著差异(P>0.05),2组CGI总体改善程度无显著差异(P>0.05)。试验组和对照组不良事件的发生率分别为20.2%和23.7%,无显著差异(P>0.05)。结论美金刚口服液用于中、重度AD患者的治疗安全、有效。AIM To evaluate the efficacy and safety of memantine oral solution in the treatment of moderate to severe Alzheimer＇s disease（AD）.METHODS A total of 237 patients with moderate to severe AD were randomly assigned to 2 groups received memantine oral solution 20 mL·d^-1or memantine tablet 20 mg·d^-1 for 16 weeks respectively.The Alzheimer＇s Disease Assessment Scale-cognition（ADAS-Cog）,the Activities of Daily Living（ADL）and Clinical Global Impression（CGI）were evaluated at baseline and 4,8,12 and 16 weeks after the treatment respectively to assess the efficacy.Laboratory testing and physical examination were performed at 8 and 16 weeks and the vital signs and adverse events were recorded to assess the safety.RESULTS SS,FAS and PPS was 119,114 and 103 patients in the memantine oral solution group,and 118,115 and 102 in the memantine tablet group,respectively.The ADAS-Cog and ADL total scores at the end of week 4,8, 12,16 decreased significantly compared with baseline for each group（P0.01）,and there were no significant differences in ADAS-Cog total scores,ADL total scores and improving level of CGI between the two groups at every time-point（P0.05）.The adverse event rate was 20.2%in the memantine oral solution group and 23.7% in the memantine tablet group with no significant difference（P0.05）.CONCLUSION Memantine oral solution has good efficacy and safety in treatment of patients with moderate to severe Alzheimer＇s disease.

关 键 词：美金刚 阿尔茨海默病 随机对照试验 双盲法 

分 类 号：R971[医药卫生—药品]