Hort Jakub, Duning Thomas, Hoerr Robert
Memory Clinic, Department of Neurology, Charles University, 2nd Faculty of Medicine and Motol University Hospital, Prague, Czech Republic.
Department of Neurology, Klinikum Bremen-Ost, Bremen, Germany.
Neuropsychiatr Dis Treat. 2023 Mar 23;19:647-660. doi: 10.2147/NDT.S401231. eCollection 2023.
Many clinical trials testing extract EGb 761 in patients with mild forms of cognitive impairment were conducted before widely accepted terms and diagnostic criteria for such conditions were available. This makes it difficult to compare any results from earlier and more recent trials. The objective of this systematic review was to provide a descriptive overview of clinical trials of EGb 761 in patients who met the diagnostic criteria for mild neurocognitive disorder (mild NCD) according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5).
MEDLINE, PubMed and EMBASE were searched for randomized, placebo-controlled double-blind trials of EGb 761 in mild impairment of cognitive functioning. All trials involving patients who met retrospectively applied diagnostic criteria for mild NCD were included. Trials of primary prevention of dementia and trials of combinations of medical treatments were excluded.
Among 298 records found in databases and 76 further records related to EGb 761 in references of systematic reviews, 9 reports on clinical trials involving 946 patients met the pre-specified criteria for inclusion. Beneficial effects of EGb 761 were seen in neuropsychological tests (8 of 9 studies), scales for neuropsychiatric symptoms (3 of 3 studies), geriatric rating scales (1 of 2 studies) and global ratings of change (1 of 1 study). Significant effects were found in several domains of cognition (memory, speed of processing, attention and executive functioning). Among the neuropsychiatric symptoms, depression (2 of 3 studies) and anxiety (1 of 1 study) were significantly improved. No differences between EGb 761 treatment and placebo were seen with regard to the rates of adverse events.
The included studies demonstrate treatment benefits of extract EGb 761, mainly on cognitive deficits and neuropsychiatric symptoms, in patients with mild NCD. The drug was safe and well tolerated.
许多在轻度认知障碍患者中测试银杏叶提取物EGb 761的临床试验是在针对此类病症的广泛认可的术语和诊断标准出台之前进行的。这使得比较早期和近期试验的任何结果都很困难。本系统评价的目的是对根据《精神疾病诊断与统计手册》第五版（DSM-5）符合轻度神经认知障碍（轻度NCD）诊断标准的患者中EGb 761的临床试验进行描述性概述。
检索MEDLINE、PubMed和EMBASE，查找EGb 761在认知功能轻度损害方面的随机、安慰剂对照双盲试验。纳入所有涉及回顾性应用轻度NCD诊断标准患者的试验。排除痴呆症一级预防试验和联合药物治疗试验。
在数据库中找到的298条记录以及系统评价参考文献中与EGb 761相关的另外76条记录中，9项涉及946名患者的临床试验报告符合预先设定的纳入标准。在神经心理学测试（9项研究中的8项）、神经精神症状量表（3项研究中的3项）、老年评定量表（2项研究中的1项）和整体变化评定（1项研究中的1项）中均观察到EGb 761的有益效果。在几个认知领域（记忆、处理速度、注意力和执行功能）发现了显著效果。在神经精神症状中，抑郁（3项研究中的2项）和焦虑（1项研究中的1项）得到显著改善。EGb 761治疗组和安慰剂组在不良事件发生率方面未见差异。
纳入的研究表明，EGb 761提取物对轻度NCD患者具有治疗益处，主要体现在认知缺陷和神经精神症状方面。该药物安全且耐受性良好。
