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银杏叶标准提取物(EGb761®)治疗遗忘型轻度认知障碍患者的有效性和安全性。

Effectiveness and Safety Profile of Ginkgo biloba Standardized Extract (EGb761®) in Patients with Amnestic Mild Cognitive Impairment.

机构信息

Department of Neurology, Faculty of Medicine, University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania.

Department of Geriatrics and Gerontology, Faculty of Medicine, University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania.

出版信息

CNS Neurol Disord Drug Targets. 2021;20(4):378-384. doi: 10.2174/1871527320666210208125524.

DOI:10.2174/1871527320666210208125524
PMID:33557741
Abstract

BACKGROUND

Ginkgo biloba is a common symptomatic treatment for cognitive impairment, although data on its efficacy are controversial.

OBJECTIVE

The aim of the current study was to evaluate the effectiveness of standardized Ginkgo biloba extract EGb761® (Tanakan®) for the improvements of cognitive functions over 24 months in a local cohort of patients diagnosed with amnestic mild cognitive impairment (aMCI).

METHODS

This multicentre non-interventional study included 500 eligible patients with a MCI treated with 120 mg/day standardized Ginkgo biloba extract EGb761® (Tanakan®). Patients were evaluated using several scales for assessment of cognition, memory, activities of daily living, and depression (MMSE, FAQ, CGI, HAM-D) at baseline and every 6 months after that for a 24-month period. The median change in MMSE at the 24-month follow-up was the primary outcome of the study.

RESULTS

A statistically significant increase of 2 points in the median MMSE score was obtained. In patients with other concomitant cognitive disorders, the improvement in MMSE was less significant. Tanakan® improved memory impairment (using the delayed recall test) and the ability to accomplish activities of daily living (mean FAQ score, 1.7); it also decreased the severity of depression (mean HAM-D score, 2.4) at the end of the study. More than 80% of the patients showed minimal improvement of their condition as assessed by the CGI-Improvement Scale.

CONCLUSION

The administration of EGb761® (Tanakan®) led to a significant improvement of cognitive decline, memory, activities of daily living, and depression in subjects with aMCI over 24 months.

摘要

背景

银杏叶是一种常用于治疗认知障碍的对症治疗药物,但其疗效数据存在争议。

目的

本研究旨在评估标准化银杏叶提取物 EGb761®(Tanakan®)在本地队列中对诊断为遗忘型轻度认知障碍(aMCI)的患者认知功能改善的有效性,疗程为 24 个月。

方法

这项多中心非干预性研究纳入了 500 名符合条件的 MCI 患者,他们接受了 120mg/天的标准化银杏叶提取物 EGb761®(Tanakan®)治疗。患者在基线时和之后每 6 个月使用认知、记忆、日常生活活动和抑郁评估量表(MMSE、FAQ、CGI、HAM-D)进行评估,为期 24 个月。24 个月随访时 MMSE 的中位数变化是研究的主要终点。

结果

中位 MMSE 评分得到了统计学上显著的 2 分提高。在伴有其他认知障碍的患者中,MMSE 的改善程度较小。Tanakan®改善了记忆障碍(使用延迟回忆测试)和日常生活活动能力(FAQ 评分平均提高 1.7 分),还降低了抑郁严重程度(HAM-D 评分平均降低 2.4 分)。研究结束时,超过 80%的患者根据 CGI-改善量表评估显示病情有轻微改善。

结论

在 24 个月的疗程中,EGb761®(Tanakan®)的给药导致 aMCI 患者的认知下降、记忆、日常生活活动和抑郁显著改善。

相似文献

1
Effectiveness and Safety Profile of Ginkgo biloba Standardized Extract (EGb761®) in Patients with Amnestic Mild Cognitive Impairment.银杏叶标准提取物(EGb761®)治疗遗忘型轻度认知障碍患者的有效性和安全性。
CNS Neurol Disord Drug Targets. 2021;20(4):378-384. doi: 10.2174/1871527320666210208125524.
2
Ginkgo biloba for cognitive impairment and dementia.银杏叶用于认知障碍和痴呆症。
Cochrane Database Syst Rev. 2002(4):CD003120. doi: 10.1002/14651858.CD003120.
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Efficacy and adverse effects of ginkgo biloba for cognitive impairment and dementia: a systematic review and meta-analysis.银杏叶对认知障碍和痴呆的疗效及不良反应:一项系统评价和荟萃分析。
J Alzheimers Dis. 2015;43(2):589-603. doi: 10.3233/JAD-140837.
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Ginkgo biloba for cognitive impairment and dementia.银杏叶治疗认知障碍和痴呆症。
Cochrane Database Syst Rev. 2009 Jan 21(1):CD003120. doi: 10.1002/14651858.CD003120.pub3.
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Ginkgo biloba extract and long-term cognitive decline: a 20-year follow-up population-based study.银杏叶提取物与长期认知衰退:一项基于人群的 20 年随访研究。
PLoS One. 2013;8(1):e52755. doi: 10.1371/journal.pone.0052755. Epub 2013 Jan 11.
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Ginkgo biloba for cognitive impairment and dementia.银杏叶用于认知障碍和痴呆症。
Cochrane Database Syst Rev. 2007 Apr 18(2):CD003120. doi: 10.1002/14651858.CD003120.pub2.
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[Experience in clinical use of tanakan in the treatment of the syndrome of mild cognitive impairment].[达纳康治疗轻度认知功能障碍综合征的临床应用经验]
Zh Nevrol Psikhiatr Im S S Korsakova. 2006;106(10):42-6.
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[Effects of Ginkgo biloba extract in improving episodic memory of patients with mild cognitive impairment: a randomized controlled trial].银杏叶提取物改善轻度认知障碍患者情景记忆的效果:一项随机对照试验
Zhong Xi Yi Jie He Xue Bao. 2012 Jun;10(6):628-34. doi: 10.3736/jcim20120605.
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An examination of the efficacy of Ginkgo biloba extract EGb761 on the neuropsychologic functioning of cognitively intact older adults.一项关于银杏叶提取物EGb761对认知功能正常的老年人神经心理功能疗效的研究。
J Altern Complement Med. 2000 Jun;6(3):219-29. doi: 10.1089/acm.2000.6.219.
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[Possibilities of medical correction of moderate cognitive impairment].[中度认知障碍的医学矫正可能性]
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