目的 挖掘阿那白滞素（Anakinra）不良事件信号，为临床安全合理用药提供参考。方法 提取FAERS数据库建库至2023年第4季度的不良事件数据，利用报告比值比法（ROR）和贝叶斯可信区间递进神经网络法（BCPNN）对Anakinra可疑风险信号进行挖掘。结果 共获得相关不良事件报告7 428份，性别以女性（64.9%）为主，上报国家以美国（63.57%）为主。共检测到174个风险信号，涉及21个系统和器官分类，主要为全身性疾病及给药部位各种反应（4 362例，40.11%），各类损伤、中毒及操作并发症（3 722例，34.22%），发生频次较高的首选术语（PT）包括超说明书使用、注射部位各种反应等，新发现可疑不良反应包括肝胆系统相关不良反应、水痘等。剔除消费者和未知职业人员报告后分析结论同上。结论 Anakinra相关PT信号涉及系统器官较为广泛，应加强对Anakinra的临床规范化使用管理及超说明书用药管理，医务人员应帮助患者克服注射部位反应、加强用药依从性，在临床应用时应考虑药物对实验室相关指标的影响，在对待感染性疾病及免疫功能低下患者时应谨慎使用Anakinra，同时应警惕肝胆系统相关不良反应。

Objective The adverse event signal of Anakinra were mined to provide references for safe and rational clinical drug use. Methods Adverse event data from the establishment of FAERS database to the fourth quarter of 2023 were extracted, and the suspicious risk signals of Anakinra were mined by utilizing the reporting odds ratio (ROR) method and Bayesian confidence propagation neural network method (BCPNN). Results A total of 7 428 AE reports were obtained, of which gender predominantly male (64.9%) and country of reporting predominantly US (63.57%). A total of 174 risk signals were detected, involving 21 systems and organ classifications (SOC), mainly General disorders and administration site conditions (4 362 cases, 40.11%), Injury, poisoning and procedural complications (3 722 cases, 34.22%). The more frequent PT included off-label use, injection site reactions, etc. Newly found suspected adverse reactions include hepatobiliary system related adverse reactions, chickenpox, etc. After excluding the reports of consumers and unknown professionals, the analysis results are the same as above. Conclusions Anakinra related PT signals are widely involved in SOC, so standardized clinical use management and off-label use management of Anakinra should be strengthened, medical staff should help patients to overcome injection site reactions and enhance medication compliance, and the influence of drugs on relevant laboratory indicators should be considered in clinical application. Anakinra should be used with caution when treating patients with infectious diseases and immunocompromised patients. At the same time, we should be alert to hepatobiliary related adverse reactions.

R979.9