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加兰他敏治疗路易体痴呆患者的疗效与安全性:一项为期24周的开放标签研究。

Efficacy and safety of galantamine in patients with dementia with Lewy bodies: a 24-week open-label study.

作者信息

Edwards Keith, Royall Donald, Hershey Linda, Lichter David, Hake Ann, Farlow Martin, Pasquier Florence, Johnson Stewart

机构信息

Alzheimer's Diagnostic and Treatment Center, Bennington, VT 05201, USA.

出版信息

Dement Geriatr Cogn Disord. 2007;23(6):401-5. doi: 10.1159/000101512. Epub 2007 Apr 3.

DOI:10.1159/000101512
PMID:17409748
Abstract

BACKGROUND

Dementia with Lewy bodies (DLB) is a common dementia of the elderly. A significant cholinergic deficit has been demonstrated that may be responsive to treatment by cholinesterase inhibitors (ChEIs).

METHODS

A 24-week, open-label study was designed to assess the efficacy and safety of a ChEI, galantamine, in 50 patients with DLB.

RESULTS

This study showed beneficial effects with galantamine in 2 of the 3 primary efficacy parameters. The scores on the Neuropsychiatric Inventory (NPI-12) improved by 8.24 points from baseline (p = 0.01) especially in visual hallucinations and nighttime behaviors (p = 0.004). The scores on the Clinician's Global Impression of Change improved by 0.5 points from baseline (p = 0.01). The third primary efficacy parameter, the Cognitive Drug Research Computerized Cognitive Assessment System, was unchanged from baseline. Adverse events were generally mild and transient.

CONCLUSION

Galantamine appears to be an effective and safe therapy for patients with DLB.

摘要

背景

路易体痴呆(DLB)是一种常见的老年痴呆症。已证实存在显著的胆碱能缺陷,胆碱酯酶抑制剂(ChEIs)治疗可能对此有反应。

方法

设计了一项为期24周的开放标签研究,以评估ChEI加兰他敏对50例DLB患者的疗效和安全性。

结果

本研究显示加兰他敏在3个主要疗效参数中的2个方面有有益效果。神经精神科量表(NPI - 12)得分较基线提高了8.24分(p = 0.01),尤其是在视幻觉和夜间行为方面(p = 0.004)。临床医生总体变化印象量表得分较基线提高了0.5分(p = 0.01)。第三个主要疗效参数,认知药物研究计算机化认知评估系统,与基线相比无变化。不良事件一般较轻且为一过性。

结论

加兰他敏似乎是DLB患者的一种有效且安全的治疗方法。

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