| アブストラクト | 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. |
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| 投稿者 | Yao, Yinhui; Zhao, Jingyi; Li, Chen; Chen, Yan; Zhang, Tianci; Dong, Xianhui; Gao, Weijuan; Shang, Yazhen |
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| 組織名 | 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.;Institute of Traditional Chinese Medicine, Chengde Medical University / Hebei;Province Key Research Office of Traditional Chinese Medicine Against Dementia /;Hebei Province Key Laboratory of Traditional Chinese Medicine Research and;Development / Hebei Key Laboratory of Nerve Injury and Repair, Chengde, 067000,;of Chinese Medicine, Shijiazhuang, 050200, China; Hebei Key Laboratory of Chinese;Medicine Research on Cardio-Cerebrovascular Disease, Hebei University of Chinese;Medicine, Shijiazhuang, 050200, China.;Hebei Key Laboratory of Chinese Medicine Research on Cardio-Cerebrovascular;Disease, Hebei University of Chinese Medicine, Shijiazhuang, 050200, China.;Electronic address: gwj6088@163.com.;of Chinese Medicine, Shijiazhuang, 050200, China; Institute of Traditional;Chinese Medicine, Chengde Medical University / Hebei Province Key Research Office;of Traditional Chinese Medicine Against Dementia / Hebei Province Key Laboratory;of Traditional Chinese Medicine Research and Development / Hebei Key Laboratory;of Nerve Injury and Repair, Chengde, 067000, China. Electronic address:;973358769@qq.com. |
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