Germany was the ?rst country in which memantine was commercially available. The following two multicentre, post-marketing observational studies investigated the use of memantine in routine clinical practice in Germany and Austria.

This open-label study comprised 1,845 patients with moderate to severe AD who were treated with memantine 20 mg/day for a period of 6 months. Mean MMSE score at baseline ± SD (n=1,580) was 15.4 ± 5.7. The mean age of patients was 76.3 ± 8.7 years, and their mean duration of illness was 2.4 ± 1.9 years. The majority of patients (60.7%) had received prior treatment for AD, including Ginkgo extracts (24.9%), piracetam (20.1%), and AChEIs (17.3%). In addition, 21.6% received other treatments for AD during the study. A total of 74.4% of participants suffered ≥1 concomitant illness, the chief comorbidity being cardiovascular disease.

Ef?cacy was evaluated using the clinician’s global assessment, MMSE score, Nurse’s Observation Scale for Geriatric Patients (NOSGER) and Explorations Modul Demenz (EMD).

In patients receiving memantine:

         clinician’s global assessment rated 79% of patients stabilised or improved

         MMSE score (mean) was signi?cantly improved from baseline at 3- and 6-month assessments (p<0.0001)

         NOSGER (Figure 6.22) and EMD scores also improved from baseline

         marked improvements were seen in cognitive function, ability to perform daily activities, and global performance

         tolerability was cited as very good or good in 93% of patients, with <5% experiencing ≥1 AE during the study period.

 

This Austrian-based multicentre, open-label study comprised 377 patients with moderate to severe AD (MMSE <20), who received treatment with memantine 20 mg/day for a period of 4 months. In addition to analysis of the total population, ef?cacy was also recorded in two patient subgroups according to treatment prior to study initiation: no dementia treatment (n=211), or switched from AChEIs to memantine (n=106).

Ef?cacy analyses assessed cognition (MMSE scale), function (ADL total score; ADLs assessed were: ‘body hygiene’, ‘eating’, ‘interest in surroundings’, ‘hobbies’, and ‘taking care of housework’), and global status (CGI-C).

In the total study population, patients treated with memantine showed:

         improvement from baseline in mean MMSE score (p<0.001)

         improvement from baseline in ADL total score (p<0.001)

         global outcome rated as improved (70%) or unchanged (11.7%) in the majority of patients.

In the comparison of treatment-na?ve, and switch patient subgroups:

         both subgroups showed bene?t on cognition and function, although there was a signi?cantly higher improvement in the treatment-na?ve patients (p<0.05)

         global outcome was improved for 75% of treatment-na?ve patients, and 64% of switched patients.

Memantine safety and tolerability was generally good, with only 8.6% of patients withdrawing from the study, and 15.9% of patients reporting adverse reactions. In total, 88.6% of patients continued with memantine treatment after the study period.

         Overall, studies in routine clinical practice have supported the signi?cant ef?cacy shown by memantine in randomised, controlled trials of AD – including observations of memantine in combination with AChEIs.

 

Beijing Chinese Translation Service Company has translated many documents about In patients receiving memantine.

 

德国为美金刚第一个上市的国家。下面两个多中心、上市后研究在德国及奥地利研究了美金刚在日常临床实践中的应用。

 

该开放性研究入组了1,845名中、重度阿尔茨海默病患者，这些患者接受为期6个月的20mg/天的美金刚治疗。基线平均MMSE评分为15.4 ± 5.7（均数± SD，n=1,580），患者的平均年龄为76.3 ± 8.7岁，平均疾病持续时间为2.4 ± 1.9年。大部分患者（60.7%）先前已经接受过针对AD的治疗，包括银杏提取物（24.9%）、吡拉西坦（20.1%）及胆碱酯酶抑制剂（17.3%）。另外，21.6%的患者在研究期间接受了针对AD的其他治疗。74.4%的患者出现了一个及以上的合并疾病，主要的合并疾病为心血管病。

采用临床医生的整体评价、MMSE评分、老年患者护士观察量表（NOSGER）及EMD对有效性进行评价。

 

接受美金刚治疗的患者：

         79%的患者临床医生整体评价为稳定或者改善

         与基线比较，在3个月及6个月评估时，MMSE评分（平均）极大改善（P<0.0001）。

         与基线比较，NOSGER （图 6.22） 及 EMD评分也得到改善

         患者的认知能力、日常生活活动能力及整体状况得到显著改善

         93%的患者对药物的耐受性评价为非常好及良好，在研究期间，不到5%的患者发生了一个及以上的不良事件。

 

美金刚奥地利上市后研究（Rainer 等， 2005）⁶⁷

这项在奥地利开展的多中心、开放研究入组了377名中、重度阿尔茨海默病患者（MMSE<20），这些患者接受了为期4个月的美金刚治疗，20mg/天。除了分析总人群外，同时也记录了两个亚组患者的有效性[根据参加研究前患者的治疗进行分组：无痴呆治疗组（n=211），或者从胆碱酯酶抑制剂切换到美金刚治疗组（n=106）

有效性分析评价认知能力（MMSE量表）、功能（ADL总分；ADLs评估项包括：“身体卫生”、“饮食”、“对周围环境的兴趣”、“爱好”以及“做家务”）及整体状况（CGI-C）。

在总研究人群，接受美金刚治疗的患者表现出：

         平均MMSE评分较基线改善（p<0.001）

         ADL总分较基线改善（p<0.001）

         大部分患者整体状况评分为改善（70%）或者未改变（11.7%）。

从未接受过治疗的患者组与切换为美金刚治疗的治疗组比较：

         两组在认知能力及功能方面均受益，而在从未接受过治疗的患者组改善的程度更高（P<0.05）。

         75%的从未接受过治疗的患者整体状况得到改善，而切换为美金刚治疗的患者整体状况改善率为64%。

美金刚的安全性及耐受性总的来说良好，仅仅8.6%的患者的退出研究，15.9%的患者报告发生不良反应。在完成研究后，88.6%的患者继续接受美金刚治疗。

         总之，在日常临床实践中的研究支持美金刚治疗AD的随机、对照试验（包括美金刚联合胆碱酯酶抑制剂的研究）所得出的有效性结果。

 

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