目的 挖掘瑞美吉泮的風險信號，為臨床安全合理用藥提供參考。方法 收集FAERS數據庫2020年1月1日—2024年3月31日的瑞美吉泮相關不良事件報告數據。采用比例失衡法中的ROR法和BCPNN法進行數據挖掘，利用藥物不良反應術語集的首選系統(tǒng)器官分類和首選術語對挖掘到的風險信號進行分類和描述。結果 共提取以瑞美吉泮為首要懷疑藥物的不良事件報告10 550份，排除缺失數據，共有男性患者965份（占比9.15%），女性患者6 710份（占比63.60%）。經篩選共獲得陽性信號38個，發(fā)生報告數較多的系統(tǒng)器官為胃腸系統(tǒng)疾病、各類神經系統(tǒng)疾病和全身性疾病及給藥部位各種反應；信號強度較強的新的不良事件主要有治療產品效果不穩(wěn)、賦形劑反應、舌不適、晨吐、醉酒感和鼻水腫等。結論 瑞美吉泮在真實世界中發(fā)生的常見不良反應與說明書有一致性，但存在較多新的、可疑的、未載入說明書的不良反應，臨床用藥時應予以重點關注，以保障患者用藥安全。

Objective To explore the risk signals of rimegepant, and provide reference for clinical rational and safe drug use. Methods Adverse drug event report data related to rimegepant from January 1, 2020 to March 31, 2024 were collected from the FAERS database. The ROR and BCPNN methods of the proportional imbalance method were used for data mining, and the preferred system organ classification and preferred terminology of the Adverse Drug Reaction Terminology Set were utilized to classify and describe the mined risk signals. Results A total of 10 550 adverse event reports were extracted with rimegepant as the first suspected drug, excluding missing data, there were a total of 965 (9.15%) male patients and 6 710 (63.60%) female patients. A total of 38 positive signals were obtained after screening, and the systemic organs where more reports occurred were gastrointestinal disorders, various neurological disorders and systemic disorders, and various reactions at the site of administration, the main new adverse events with a strong signal strength were instability of therapeutic product effect, excipient reaction, tongue discomfort, morning sickness, intoxication sensation, and nasal edema. Conclusion The common adverse reactions occurring in the real world with rimegepant are consistent with the specification, but there are more new, suspicious, and not contained in the specification of the adverse reactions, the clinical use of the drug should be focused on to protect the safety of patients using the drug.

R971

云南省教育廳科學研究基金項目(2024J0371);云南省教育廳科學研究基金項目-青年人才基礎研究專項(2024J0277);昆明市衛(wèi)生科技人才培養(yǎng)項目[2023-SW (后備)-84];昆明市衛(wèi)生健康委員會衛(wèi)生科研課題項目(2023-13-01-017);昆明市衛(wèi)生科技人才培養(yǎng)項目[2021-SW (后備)-08];云南省醫(yī)療機構藥師協(xié)會科研專項基金項目(2024YSXH06)