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银杏叶提取物 EGb 761 ® 对伴有神经精神症状的痴呆的影响:近期完成的随机对照试验综述。

Effects of Ginkgo biloba extract EGb 761 ® in dementia with neuropsychiatric features: review of recently completed randomised, controlled trials.

机构信息

Clinic of Geriatric Psychiatry and Psychotherapy, Alexian Hospital Maria Hilf, Krefeld, Germany, and Department of Psychiatry and Psychotherapy, University of Düsseldorf , Germany.

出版信息

Int J Psychiatry Clin Pract. 2013 Nov;17 Suppl 1:8-14. doi: 10.3109/13651501.2013.814796. Epub 2013 Aug 27.

Abstract

OBJECTIVE

We review four randomised, controlled trials investigating the efficacy of Ginkgo biloba extract EGb 761(®) in elderly patients with Alzheimer or vascular dementia with neuropsychiatric features.

METHODS

Patients with a total score of 9-23 in the Syndrom-Kurz test (SKT) cognitive test battery (cognitive domain) and with a composite score 6 and greater in the Neuropsychiatric Inventory (NPI; behavioural domain) were included. Three trials compared 2 × 120 mg/day or 1 × 240 mg/day EGb 761(®) to placebo while one used donepezil as an active control. The duration of randomised treatment was 22 or 24 weeks.

RESULTS

One thousand, two hundred and ninety-four patients were analysed for efficacy. Patients treated with EGb 761(®) showed improvements of cognitive performance and behavioural symptoms that were associated with advances in activities of daily living and a reduced burden to caregivers. Placebo-treated patients, on the other hand, showed only minimal improvements or signs of progression. In each placebo-controlled trial, EGb 761(®) was significantly superior in all mentioned domains (p < 0.01). In the actively controlled trial, EGb 761(®) and donezepil as well as a combination of both drugs had similar effects.

CONCLUSIONS

The review supports the efficacy of EGb 761(®) in age-related dementia with neuropsychiatric features. The drug was safe and well-tolerated.

摘要

目的

我们回顾了四项随机对照试验,研究了银杏叶提取物 EGb 761(®)在伴有神经精神症状的老年阿尔茨海默病或血管性痴呆患者中的疗效。

方法

纳入 Syndrom-Kurz 测试(SKT)认知测试组合(认知域)总分 9-23 分,神经精神疾病问卷(NPI;行为域)总分 6 分及以上的患者。三项试验比较了 2×120mg/天或 1×240mg/天 EGb 761(®)与安慰剂,一项试验则使用多奈哌齐作为活性对照。随机治疗的持续时间为 22 或 24 周。

结果

1294 名患者进行了疗效分析。接受 EGb 761(®)治疗的患者在认知表现和行为症状方面有所改善,这与日常生活活动的进步和照顾者负担的减轻有关。另一方面,接受安慰剂治疗的患者仅表现出最小的改善或进展迹象。在每个安慰剂对照试验中,EGb 761(®)在所有提到的领域都显著优于安慰剂(p<0.01)。在活性对照试验中,EGb 761(®)和多奈哌齐以及两者的联合药物具有相似的效果。

结论

综述支持 EGb 761(®)在伴有神经精神症状的年龄相关性痴呆中的疗效。该药物安全且耐受性良好。

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