银杏叶提取物安全性：来自 FDA 不良事件报告系统（FAERS）事件真实世界药物警戒研究的新视角。
Ginkgo biloba extract safety: Insights from a real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events.
机构信息
Faculty of Integrated Traditional Chinese and Western Medicine, Hebei University of Chinese Medicine, Shijiazhuang, 050200, China.
Department of Functional Center, Chengde Medical University, Chengde, 067000, China.
出版信息
J Ethnopharmacol. 2025 Jan 30;337(Pt 3):119010. doi: 10.1016/j.jep.2024.119010. Epub 2024 Oct 29.
ETHNOPHARMACOLOGICAL RELEVANCE
A traditional Chinese medicine extracted from the Ginkgophyta, Ginkgo biloba is commonly used to treat cardiac cerebral disease all over the world. Limited data exist regarding adverse drug reactions associated with Ginkgo biloba extract post-marketing.
AIM OF THE STUDY
Currently, the drug safety profile of Ginkgo biloba extract is assessed using a substantial volume of case safety reports within the FDA Adverse Event Reporting System (FAERS) database.
MATERIALS AND METHODS
The study collected adverse events (AEs) data associated with Ginkgo biloba extract as the primary suspected drug from 2004 to 2023 from the FAERS database. A standardized mapping analysis of System Organ Class (SOC) and preferred term (PT) was conducted. Utilizing reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC), and empirical Bayes geometric mean (EBGM), significant disproportionate measurement signals of adverse drug reactions (ADR) were identified and high-intensity signals were analyzed.
RESULTS
700 reports of adverse events related to Ginkgo biloba extract were found in the FAERS database, affecting 23 organ systems. 88 significant mismatches were identified using four algorithms, leading to unexpected major adverse events like amaurosis fugax, fractional exhaled nitric oxide created, and obstructive sleep apnoea syndrome. The study observed a median onset time of AE associated with Ginkgo biloba extract at 7 days (interquartile interval [IQR] 0-109 days), with the majority of AE manifesting within the initial 7 days of drug treatment initiation. This investigation identified a noteworthy AE signal for Ginkgo biloba extract, underscoring the importance of clinical surveillance and risk assessment in its use.
CONCLUSIONS
In clinical practice, this study provides a deeper and broader understanding of suspected adverse reactions associated with Ginkgo biloba extract.
民族药理学相关性
银杏，一种来源于银杏科的中药，被广泛应用于治疗心脑血管疾病。然而，关于银杏叶提取物上市后的不良反应数据有限。
研究目的
本研究旨在利用 FDA 不良事件报告系统（FAERS）数据库中大量的病例安全报告来评估银杏叶提取物的药物安全性概况。
材料与方法
本研究从 FAERS 数据库中收集了 2004 年至 2023 年与银杏叶提取物相关的不良事件（AE）数据，将其作为主要怀疑药物。采用标准化系统器官分类（SOC）和首选术语（PT）映射分析方法。利用报告比值比（ROR）、比例报告比值（PRR）、信息成分（IC）和经验贝叶斯几何均值（EBGM），识别出不良反应（ADR）的显著不成比例测量信号，并对高强度信号进行分析。
结果
在 FAERS 数据库中发现了 700 份与银杏叶提取物相关的不良事件报告，涉及 23 个器官系统。使用四种算法共识别出 88 个显著不匹配，导致了一些意外的严重不良事件，如一过性黑矇、呼出气一氧化氮分数增加和阻塞性睡眠呼吸暂停综合征。研究观察到银杏叶提取物相关 AE 的中位发病时间为 7 天（四分位间距 [IQR] 0-109 天），大多数 AE 在药物治疗开始后的最初 7 天内出现。该研究发现了银杏叶提取物的一个显著 AE 信号，强调了在其使用过程中进行临床监测和风险评估的重要性。
结论
在临床实践中，本研究为银杏叶提取物相关疑似不良反应提供了更深入和广泛的了解。
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