目的 利用美国食品药品管理局不良事件报告系统（FAERS），分析阿基仑赛相关不良事件的发生情况，为临床安全用药提供参考。方法 挖掘FAERS数据库2018年1月—2023年9月阿基仑赛的不良事件数据，并使用报告比值法（ROR）、比例报告比值法（PRR）法对其相关不良事件进行分析和风险信号监测。结果 共收集到以阿基仑赛为首要怀疑药物的不良事件报告2 352例，共挖掘出331个首选术语（PT）。通过整理重复PT，阈值筛选最终生成182个PT，相关报告数共3 686份。对182个信号的PT进行分类，共涉及到19个SOC，按照PT报告数排名，前5名的依次是各类神经系统疾病、全身性疾病及给药部位各种反应、社会环境、各类检查及血管与淋巴管疾病，阿基仑赛发生最频繁的不良事件主要为神经毒性、热病及疾病进展等；按照信号强度排名，前5名的依次是各类神经系统疾病、血液及淋巴系统疾病、各类检查、肾脏及泌尿系统疾病、良性恶性及性质不明的肿瘤，与抗原受体T细胞（CAR-T）相关性脑病综合征与神经毒性关联性强，与说明书基本一致，验证了本研究的可靠性。结论 阿基仑赛常见不良事件信号与说明书记载的无较大差异，具有一致性，但用药过程中还需警惕说明书中未提及的不良事件，及时采取防治措施，保证临床用药安全。

Objective To analyze the occurrence of axicabtagene ciloleucel-related adverse events through FAERS database, and provide reference for clinical safety of drug use. Methods The adverse event data of axicabtagene ciloleucel from January 2018 to September 2023 were mined in FAERS database, and the relevant adverse events were analyzed and risk signals monitored by ROR and PRR. Results A total of 2 352 adverse events reports with axicabtagene ciloleucel as the primary suspect drug were collected, and 331 preferred terms (PT) were mined. After sorting out the duplicate PT, the threshold filter finally generated 182 PT, and the number of related reports was 3 686. The PT of 182 signals is classified, involving a total of 19 SOCs. According to the number of PT reports, the top 5 were neurological diseases, systemic diseases and reactions at the site of administration, social environment, various examinations, and vascular and lymphatic diseases. The most frequent adverse events of axicabtagene ciloleucel were neurotoxicity, fever, and disease progression. According to the signal intensity ranking, the top 5 are various neurological diseases, diseases of the blood and lymphatic system, various examinations, kidney and urinary system diseases, benign and malignant tumors of unknown nature. Antigen receptor T cell (CAR-T) -associated encephalopathy syndrome was strongly associated with neurotoxicity, which was basically consistent with the instructions, verifying the reliability of this study. Conclusion The common adverse event signals of axicabtagene ciloleucel are consistent with those recorded in the instructions, but it is necessary to be alert to adverse events not mentioned in the instructions and take preventive measures in time to ensure the safety of clinical use.

R979.1