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银杏叶特殊提取物EGb 761治疗阿尔茨海默型痴呆的临床疗效。

Clinical efficacy of Ginkgo biloba special extract EGb 761 in dementia of the Alzheimer type.

作者信息

Maurer K, Ihl R, Dierks T, Frölich L

机构信息

Klinik für Psychiatrie I, Johann-Wolfgang-Goethe-Universität, Frankfurt, Germany.

出版信息

J Psychiatr Res. 1997 Nov-Dec;31(6):645-55. doi: 10.1016/s0022-3956(97)00022-8.

Abstract

Among the psychiatric illnesses associated with old age primary degenerative dementia of the Alzheimer type (DAT) has gained increasing importance in recent years. Even though a curative treatment of the disease is currently impossible, various drugs can be used to slow down its progression. In the present study the influence of oral treatment with 240 mg/day of Ginkgo bilabo special extract EGb 761 (Tebonin forte, manufactured by Dr Willmar Schwabe, Karlsruhe) on the clinical course of DAT was investigated in a double-blind, randomized, placebo-controlled parallel-group design in 20 outpatients. The duration of treatment was 3 months. The primary outcome variable was the sum score in the SKT-test for the determination of attention and memory. Other psychometric tests (trailmaking test, ADAS, CGI) and electrophysiological investigations (EEG topography) were evaluated descriptively. Although the active-treatment group, with a mean sum score of 19.67 points in the, S.K.T., had a poorer baseline level than the placebo group (18.11 points), it experienced an improvement to 16.78 points under treatment with EGb 761 whereas the placebo group deteriorated to 18.89 points. The differences between the baseline and final values formed the basis for a statistical group comparison, which gave a result favourable to EGb 761, at a significance level of p < .013. In addition to this psychometric confirmation of efficacy, certain descriptive trends were found at the psychopathological (Clinical Global Impression) and dynamic functional (EEG findings) levels, which can be interpreted as evidence of effectiveness of Ginkgo biloba special extract EGb 761 in mild to moderate dementia and of local effects in the central nervous system. Inter-group differences in the ADAS cognitive and non-cognitive subscales did not reach statistical significance, probably because of the small sample size.

摘要

在与老年相关的精神疾病中,阿尔茨海默型原发性退行性痴呆(DAT)近年来愈发重要。尽管目前无法治愈该疾病,但可使用多种药物减缓其进展。在本研究中,采用双盲、随机、安慰剂对照平行组设计,对20名门诊患者进行了调查,研究每日口服240毫克银杏叶特殊提取物EGb 761(德国威玛舒培博士药厂生产的特宝林强力片)对DAT临床病程的影响。治疗持续时间为3个月。主要结局变量是用于测定注意力和记忆力的SKT测试总分。对其他心理测量测试(连线测验、阿尔茨海默病评估量表、临床总体印象量表)和电生理检查(脑电图地形图)进行了描述性评估。尽管活性治疗组在SKT测试中的平均总分基线水平(19.67分)比安慰剂组(18.11分)差,但在接受EGb 761治疗后改善至16.78分,而安慰剂组恶化至18.89分。基线值与最终值之间的差异构成了统计学组间比较的基础,结果显示EGb 761具有优势,显著性水平为p < 0.013。除了这种心理测量学上的疗效确认外,在精神病理学(临床总体印象)和动态功能(脑电图结果)水平上还发现了某些描述性趋势,这可解释为银杏叶特殊提取物EGb 761对轻度至中度痴呆有效及对中枢神经系统有局部作用的证据。阿尔茨海默病评估量表认知和非认知子量表的组间差异未达到统计学显著性,可能是由于样本量较小。

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