目的 利用美國食品藥品管理局不良事件報告系統(tǒng)（FAERS），分析阿基侖賽相關(guān)不良事件的發(fā)生情況，為臨床安全用藥提供參考。方法 挖掘FAERS數(shù)據(jù)庫2018年1月—2023年9月阿基侖賽的不良事件數(shù)據(jù)，并使用報告比值法（ROR）、比例報告比值法（PRR）法對其相關(guān)不良事件進行分析和風(fēng)險信號監(jiān)測。結(jié)果 共收集到以阿基侖賽為首要懷疑藥物的不良事件報告2 352例，共挖掘出331個首選術(shù)語（PT）。通過整理重復(fù)PT，閾值篩選最終生成182個PT，相關(guān)報告數(shù)共3 686份。對182個信號的PT進行分類，共涉及到19個SOC，按照PT報告數(shù)排名，前5名的依次是各類神經(jīng)系統(tǒng)疾病、全身性疾病及給藥部位各種反應(yīng)、社會環(huán)境、各類檢查及血管與淋巴管疾病，阿基侖賽發(fā)生最頻繁的不良事件主要為神經(jīng)毒性、熱病及疾病進展等；按照信號強度排名，前5名的依次是各類神經(jīng)系統(tǒng)疾病、血液及淋巴系統(tǒng)疾病、各類檢查、腎臟及泌尿系統(tǒng)疾病、良性惡性及性質(zhì)不明的腫瘤，與抗原受體T細(xì)胞（CAR-T）相關(guān)性腦病綜合征與神經(jīng)毒性關(guān)聯(lián)性強，與說明書基本一致，驗證了本研究的可靠性。結(jié)論 阿基侖賽常見不良事件信號與說明書記載的無較大差異，具有一致性，但用藥過程中還需警惕說明書中未提及的不良事件，及時采取防治措施，保證臨床用藥安全。

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