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美金刚(易倍申)在临床实践中的观察性研究结果

Memantine (Ebixa) in clinical practice - results of an observational study.

作者信息

Calabrese Pasquale, Essner Ute, Forstl Hans

机构信息

Neurologische Universitatsklinik Bochum, Bereich Neuropsychologie und Verhaltensneurologie, Bochum, Deutschland.

出版信息

Dement Geriatr Cogn Disord. 2007;24(2):111-7. doi: 10.1159/000104872. Epub 2007 Jun 29.

Abstract

BACKGROUND/AIMS: In a post-marketing observational study, the efficacy and tolerability of memantine were examined in patients with moderate to severe Alzheimer's disease.

METHODS

The patients were treated with 20 mg/day of memantine for a 6-month period. The efficacy of memantine was evaluated using the Mini-Mental State Examination, the Nurses' Observation Scale for Geriatric Patients (NOSGER) and the Explorationsmodul Demenz (EMD) scale. In addition, a global assessment was made by the physician.

RESULTS

After 6 months of open-label treatment with memantine, the patients' cognitive function, ability to perform daily activities and global performance all showed a marked improvement. In the overall evaluation by the physician, improvement or stabilisation had been achieved by 78.8% of patients after 6 months of therapy. Memantine also demonstrated an excellent tolerability profile.

CONCLUSION

The results of this naturalistic study support the significant efficacy and tolerability of memantine that has been previously demonstrated in randomised, controlled clinical Alzheimer's disease trials.

摘要

背景/目的:在一项上市后观察性研究中,对中重度阿尔茨海默病患者使用美金刚的疗效和耐受性进行了研究。

方法

患者接受每日20毫克美金刚治疗,为期6个月。使用简易精神状态检查表、老年患者护士观察量表(NOSGER)和痴呆症探索模块(EMD)量表评估美金刚的疗效。此外,由医生进行整体评估。

结果

在接受美金刚开放标签治疗6个月后,患者的认知功能、日常活动能力和整体表现均有显著改善。在医生的整体评估中,78.8%的患者在治疗6个月后病情得到改善或稳定。美金刚还表现出极佳的耐受性。

结论

这项自然主义研究的结果支持了美金刚在先前随机对照临床阿尔茨海默病试验中所显示的显著疗效和耐受性。

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