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一项针对额颞叶痴呆患者的美金刚6个月开放标签研究。

A 6-month, open-label study of memantine in patients with frontotemporal dementia.

作者信息

Diehl-Schmid Janine, Förstl Hans, Perneczky Robert, Pohl Corina, Kurz Alexander

机构信息

Department of Psychiatry and Psychotherapy, Technische Universität München, Munich, Germany.

出版信息

Int J Geriatr Psychiatry. 2008 Jul;23(7):754-9. doi: 10.1002/gps.1973.

DOI:10.1002/gps.1973
PMID:18213609
Abstract

OBJECTIVE

To evaluate safety and effects on cognition and behavior of memantine 20 mg/day in the treatment of patients with frontotemporal dementia (FTD).

METHODS

This was a single-center, 6-month, open, uncontrolled study. Sixteen outpatients with a diagnosis of FTD were enrolled.

RESULTS

On the CIBIC plus 26 weeks after baseline four of the 16 patients were minimally improved, four were unchanged, seven were minimally worse and one patient was moderately worse. Neither the Neuropsychiatric Inventory nor the Frontal Behavioral Inventory demonstrated statistically significant differences in behavior between baseline and final visit. There was an increase in the total Alzheimer's Disease Assessment Scale score, reflecting a decline in cognitive performance. Executive functions as well as activities of daily living and extrapyramidal motor symptoms (EPMS) remained unchanged during the trial.

CONCLUSION

The number of patients was small, so that the evidence given by statistical tests is limited. Thus, the present study can only show trends regarding drug effects. As memantine is well-tolerated, further randomized and controlled studies should be conducted to evaluate drug efficacy.

摘要

目的

评估每日20毫克美金刚治疗额颞叶痴呆(FTD)患者时对认知及行为的安全性和影响。

方法

这是一项单中心、为期6个月的开放性非对照研究。纳入了16例诊断为FTD的门诊患者。

结果

在基线后26周的临床综合印象量表加(CIBIC plus)评估中,16例患者里有4例稍有改善,4例无变化,7例稍有恶化,1例中度恶化。神经精神科问卷(Neuropsychiatric Inventory)和额叶行为问卷(Frontal Behavioral Inventory)均未显示基线与末次访视之间行为上有统计学显著差异。阿尔茨海默病评估量表总分增加,反映出认知功能下降。在试验期间,执行功能以及日常生活活动和锥体外系运动症状(EPMS)保持不变。

结论

患者数量较少,因此统计检验提供的证据有限。所以,本研究只能显示有关药物作用的趋势。由于美金刚耐受性良好,应开展进一步的随机对照研究以评估药物疗效。

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