目的 利用EudraVigilance数据库挖掘并分析阿替卡因肾上腺素注射液的药物不良事件信号，为临床安全用药提供参考。方法 通过EudraVigilance数据库下载2002年1月1日—2025年12月31日以阿替卡因肾上腺素注射液为怀疑药物上报的不良事件数据，依据《国际医学用语词典》（MedDRA）的系统器官分类（SOC）和首选术语（PT）对数据进行描述与分类，采用比例失衡法中的报告比值比（ROR）法、英国药品和保健产品管理局综合标准（MHRA）法、贝叶斯可信区间递进神经网络（BCPNN）法及多项式伽马泊松分布缩减（MGPS）法开展数据挖掘。结果 共获得阿替卡因肾上腺素注射液相关不良事件11 043例次，阳性信号190个，映射至27个SOC；在分析查询（SMQ）层级下筛选出超敏性不良事件1 049例次，包含22个PT信号，其中面部肿胀、循环性虚脱为强信号。此外，挖掘出苍白、寒战、高血压、多汗、吞咽困难、嗜睡等新的可疑不良反应。结论 临床使用阿替卡因肾上腺素注射液中需重点关注新的可疑不良反应，高度警惕超敏反应，尤其对于4岁以下患儿，需重点关注用药安全性，以保障患者用药安全。

Objective To mine and analyze the adverse drug events signals of Articaine Hydrochloride and Epinephrine Tartrate Injection by using the EudraVigilance database, providing reference for clinical medication safety. Methods Adverse drug events data reported with Articaine Hydrochloride and Epinephrine Tartrate Injection as the suspected drug from January 1, 2002, to December 31, 2025, were downloaded from the EudraVigilance database. The data were described and classified according to the SOC and PT of the MedDRA. Data mining was conducted using disproportionality analysis techniques including the ROR method, MHRA method, BCPNN method, and MGPS method. Results A total of 11 043 Articaine Hydrochloride and Epinephrine Tartrate Injection-related adverse drug events cases were obtained, with 190 positive signals mapped to 27 SOCs, 1 049 hypersensitivity adverse drug events were screened at the analysis query (SMQ) level, including 22 PT signals, among which facial swelling and circulatory collapse were strong signals. In addition, new suspected adverse reactions such as pallor, chills, hypertension, sweating, dysphagia, and sleepiness were identified. Conclusion Attention should be paid to new suspected adverse reactions in the clinical use of Articaine Hydrochloride and Epinephrine Tartrate Injection, with heightened vigilance for symptoms related to hypersensitivity reactions, especially for patients under 4 years old, to ensure medication safety for patients.

R971

安徽省卫生健康科研项目（AHWJ2023A20391）