目的 分析與銀杏葉提取物有關(guān)的過敏反應(yīng)不良事件信號(hào)特征，以期為臨床安全應(yīng)用提供參考。方法 基于美國(guó)食品藥品監(jiān)督管理局不良事件報(bào)告系統(tǒng)（FAERS）數(shù)據(jù)庫(kù)進(jìn)行數(shù)據(jù)挖掘，采用比例失衡法與貝葉斯置信傳播神經(jīng)網(wǎng)絡(luò)結(jié)合進(jìn)行信號(hào)監(jiān)測(cè)，提取滿足信號(hào)閾值的不良事件進(jìn)行進(jìn)一步的分析。結(jié)果 篩選出使用銀杏葉提取物且上報(bào)過敏反應(yīng)的病例133例，不良事件報(bào)告376例。滿足信號(hào)閾值的不良事件有咳嗽、胸部不適、異物感、哮鳴、瘙癢，嚴(yán)重的不良事件信號(hào)有心臟呼吸驟停。結(jié)論 FAERS數(shù)據(jù)庫(kù)中所收錄的與銀杏葉提取物使用相關(guān)的過敏反應(yīng)主要是呼吸系統(tǒng)反應(yīng)，同時(shí)患者的基礎(chǔ)疾病與合并用藥也可能會(huì)增加不良事件的發(fā)生風(fēng)險(xiǎn)，所以在應(yīng)用該類藥物時(shí)應(yīng)針對(duì)患者的個(gè)體特點(diǎn)進(jìn)行用藥監(jiān)護(hù)，保證患者用藥安全。

Objective To analyze the characteristics of adverse event signals related to Ginkgo biloba extract allergies to provide references for its safety of clinical use. Methods Based on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database for data mining, the proportional imbalance method was used in conjunction with Bayesian confidence propagation neural network for signal monitoring, and the adverse events that met the signal threshold were extracted for further analysis. Results A total of 133 cases were screened who had used G. biloba extract and reported allergic reactions, and 376 adverse events were reported. Adverse events that met the signal threshold included cough, chest discomfort, sensation of foreign body, wheezing, and pruritus with important signals being cardio-respiratory arrest. Conclusion Respiratory disorders are predominant in allergic reactions to G. biloba extract reported in the FAERS database. The risk of adverse events may be increased by patients' underlying conditions and concurrent medications, necessitating tailored medication monitoring based on individual patient characteristics to prevent adverse reactions.

R285.6

國(guó)家自然科學(xué)基金資助項(xiàng)目（81703738）