作　　者： ; ; ; ; ; ; ; ; (杨斯明）; (胡连平）;

机构地区： 上海交通大学

出　　处： 《上海精神医学》 2013年第4期244-253,共10页

摘　　要： 背景:盐酸美金刚是目前用于治疗阿尔茨海默病(Alzheimer's disease,AD)唯一的N-甲基-D-天门冬氨酸(N-methyl-D-aspartic acid receptor,NMDA)受体拮抗剂。目的 :以进口盐酸美金刚(Ebixa)为对照,评价国产美金刚片治疗中度至重度AD的有效性及安全性。方法 :采用随机、双盲双模拟、平行对照、多中心研究方法,将229例中、重度AD患者分为研究组(国产美金刚片)和对照组(进口美金刚片),治疗16周。所有的患者在基线时以及入组后第4、8、12、16周接受评估。主要疗效指标为阿尔茨海默病评定量表认知分量表(Alzheimer's Disease Assessment Scale-Cognition,ADAS-Cog)评分,次要疗效指标为简易智能状态检查量表(Mini-Mental Statue Examination,MMSE)、日常生活能力量表(Activities of Daily Living,ADL)和临床疗效总评量表(Clinical Global Impression,CGI)的评分。结果 :研究组纳入安全性数据集(Safety Set,SS)、全分析数据集(Full Analysis Set,FAS)和完成方案数据集(Per Protocol Set,PPS)分析的病例数分别为112、109和103例,对照组分别为111、107和101例。两组ADAS-Cog总分和ADL总分在治疗4周、8周、12周、16周末与基线相比均有所下降(p<0.001),两组MMSE总分在治疗4周、8周、12周、16周末与基线相比均有所增加(p<0.001)。各观察时点的ADAS-Cog评分、ADL评分和病情改善程度(CGI评分)两组之间的比较无统计学差异。研究组和对照组不良事件发生率分别为20.5%和27.0%,差异无统计学意义(χ2=1.30,p=0.255)。结论 :在治疗中、重度AD患者的前16周中,国产美金刚片的疗效和安全性与进口美金刚片相当。 Background： Memantine hydrochloride is a N-methyI-D-aspartate （NMDA） antagonist that may be useful in the treatment of Alzheimer＇s disease. Aim： Compare the efficacy and safety of generic memantine hydrochloride produced in China to that of the imported proprietary version of the medication （Ebixa） in the treatment of moderate to severe Alzheimer＇s disease （AD）. Methods： In this multicenter, double-blind randomized controlled trial 229 patients with moderate to severe AD were randomly assigned to a 16-week trial of either the generic preparation or the proprietary preparation of memantine hydrochloride. All participants were assessed at baseline and at 4, 8, 12 and 16 weeks after enrolment. The primary outcome variable was the Alzheimer Disease Assessment Scale-cognition （ADAS-Cog） score. Secondary outcomes were scores in the Mini-Mental State Examination （MMSE）, the Activities of Daily Living （ADL） scale and the Clinical Global Impression （CGI） scale. Results： Sample sizes for the safety set （SS） analysis, full analysis set （FAS） and per protocol set （PPS） analysis were 112, 109 and 103 in the generic medication group, and 111, 107 and 101 in the proprietary medication group, respectively. The ADAS-Cog and ADL total scores at the end of weeks 4, 8, 12, and 16 decreased significantly compared with baseline for both groups （p〈0.001） and the MMSE total scores at the end of weeks 4, 8, 12, and 16 increased significantly compared with baseline for both groups （p〈0.001）. There were no significant differences in ADAS-Cog total scores, ADL total scores and level of improvement based on the CGI scores between the two groups at any of the follow-up assessments. The occurrence of adverse events was 20.5% in the generic medication group and 27.0% in the proprietary medication group; this difference was not statistically significant （x2=1.30, p=0.255）. Conclusion： There are no significant differences in the effectiveness or safety between memantine that is

关 键 词： 阿尔茨海默病 随机对照试验 中国生产 金刚胺 安全性 多中心 通用 治疗

领　　域： [化学工程] [生物学] [生物学]