目的 采用美国FDA不良事件自发呈报系统（FAERS）数据库对阿哌沙班不良事件（AE）信号进行挖掘，为临床药物治疗监测提供参考。方法 从FAERS数据库中筛选2013年4月—2024年3月的阿哌沙班AE报告，完成数据清洗后采用报告比值比（ROR）、比例报告比（PRR）和贝叶斯可信传播神经网络法（BCPNN） 3种方法对AE信号进行挖掘和分析。结果 获得了124 098份与阿哌沙班相关的AE报告，挖掘出AE 331个，涉及9个系统器官分类（SOC），占比前3的SOC分别是各类神经系统疾病（12.22%），各类损伤、中毒及操作并发症（11.72%）和胃肠系统疾病（8.78%）。出血及相关AE是阿哌沙班主要的AE，与说明书描述一致。9个药品说明书未提到的AE：心瓣膜疾病、房颤、心脏疾病、二尖瓣疾病、跌倒、新型冠状病毒肺炎（COVID-19）、感染性肺炎、痴呆和恶性肿瘤。结论 阿哌沙班在真实世界中发生的常见AE与说明书一致，同时还存在部分新的AE信号，提示临床用药应该密切关注，保证患者用药安全。

Objective To conduct adverse event signal detection of apixaban using data from the US FDA Adverse Event Reporting System (FAERS) database, providing reference for clinical drug therapy monitoring. Methods Adverse event (AE) reports related to apixaban were extracted from the FAERS database covering the period from April 2013 to March 2024. After data cleaning, three methods—reporting odds ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN)—were employed to detect and analyze the adverse event signals. Results A total of 124 098 AE reports related to apixaban were obtained, uncovering 331 AEs, which were categorized into nine System Organ Classes (SOCs). The top three SOCs by proportion were Nervous System Disorders (12.22%), Injury, Poisoning and Procedural Complications (11.72%), and Gastrointestinal Disorders (8.78%). The results indicated that bleeding and related AEs were the primary adverse events for apixaban, consistent with the drug’s label information. In addition, this study identified nine AEs not mentioned in the drug’s label: valvular heart disease, atrial fibrillation, cardiac disorders, mitral valve disease, falls, COVID-19, infectious pneumonia, dementia, and malignant tumors. Conclusion The common AEs of apixaban observed in the real world were consistent with the drug’s label, but there were also several new AE signals. This suggests that close monitoring is essential in clinical practice to ensure patient safety.

R973

湖北省自然科学基金面上项目（2022CFB092）;吴阶平医学基金会临床科研专项（320.6750.2023-25-5）