一项针对临床实践中接受美金刚治疗的阿尔茨海默病患者的开放标签、多中心观察性研究。

An open-label, multicenter observational study for patients with Alzheimer's disease treated with memantine in the clinical practice.

作者信息

Stamouli S S, Tzanakaki M, Giatas S, Georgiadis G, Papalexi E, Parashos I A

机构信息

1st Psychiatric Department, University of Athens, Eginition Hospital, Athens.

出版信息

Dement Geriatr Cogn Dis Extra. 2011 Jan;1(1):10-9. doi: 10.1159/000322882. Epub 2011 Jan 5.

DOI:10.1159/000322882

PMID:22163229

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3199890/

Abstract

BACKGROUND/AIMS: In this post-marketing observational study, the safety and effectiveness of memantine were evaluated in patients with Alzheimer's disease (AD).

METHODS

In a 6-month, observational, open-label study at 202 specialist sites in Greece, the effectiveness of memantine was evaluated using the Mini-Mental State Examination (MMSE) and the Instrumental Activities of Daily Living (IADL) scale at baseline, and after 3 and 6 months. Discontinuation rates and adverse drug reactions (ADRs) were also recorded to evaluate the safety profile of memantine.

RESULTS

2,570 patients participated in the study. Three and 6 months after baseline, MMSE and IADL scores were significantly improved compared to baseline. At the end of the study, 67% of the patients had improved their MMSE score; 7.1% of the patients reported ≥1 ADRs, and treatment was discontinued due to ADR in 0.7%.

CONCLUSION

Memantine was well tolerated and had a positive effect on the patient's cognitive and functional ability in real-life clinical practice, in agreement with randomized, controlled trials.

摘要

背景/目的：在这项上市后观察性研究中，对美金刚在阿尔茨海默病（AD）患者中的安全性和有效性进行了评估。