【摘要】 目的:对西达基奥仑赛的药品不良事件(adverse drug event, ADE)信号进行挖掘与分析，为其临床合理安全用药提供建议与参考。方法:收集FAERS数据库中2022年第1季度至2024年第2季度以西达基奥仑赛为首要怀疑药品的ADE数据，采用报告比值比法(reporting odds ratio, ROR)、比例报告比法(proportional reporting ratio, PRR)、多重伽马-泊松收缩估计法(muti-item Gamma Poisson shrinker, MGPS)和贝叶斯置信区间神经网络传播法(Bayesian confidence propagation neural network, BCPNN)筛选药品ADE的有效信号。结果:共检索到以西达基奥仑赛为首要怀疑药物的ADE报告1 364份，具有严重结局的ADE(导致住院或住院延长、死亡、危及生命、残疾)报告占比为41.3%。ADE报告共挖掘出556个首选术语(preferred terms, PT),涉及24个系统-器官分类(system organ class, SOC),剔除与药品不良反应无关的信号后，共挖掘到符合4种检测方法的PT阳性信号68个，其中14个信号未在说明书中收录，包括血清铁蛋白升高、巨细胞病毒性肺炎、免疫介导的小肠结肠炎、大肠穿孔、皮肤鳞状细胞癌等。不良事件的发病时间主要集中在西达基奥仑赛治疗开始后的第1个月；在治疗1年后，6.91%的患者也出现了不良事件。结论:在使用西达基奥仑赛治疗复发难治性多发性骨髓瘤患者时，除了密切关注说明书中已知不良反应之外，也要警惕未知不良反应的发生，同时建议对使用西达基奥仑赛的患者进行长期随访。更多还原

【Abstract】 Objective: To conduct mining and analyzing of the adverse drug event(ADE) signals of ciltacabtagene autoleucel for its rational and safe clinical use. Methods: ADE data from the FAERS database were collected from Q1 2022 to Q2 2024 with ciltacabtagene autoleucel as primary suspect drug, and valid signals for ADEs were screened using the reporting odds ratio(ROR), proportional reporting ratio(PRR), muti-item Gamma Poisson shrinker(MGPS), and Bayesian confidence propagation neural network(BCPNN) methods. Results: A total of 1 364 ADE reports were retrieved with ciltacabtagene autoleucel as primary suspect drug, and the percentage of ADEs with serious outcomes(resulting in hospitalization or prolonged hospitalization, death, life-threatening, and disability) was 41.3%. A total of 556 preferred terms(PTs) were mined from the ADE reports involving 24 system organ class(SOCs), and after excluding signals that were not related to the adverse drug reactions, the PTs that met the four assays were collected. There were 68 positive signals, of which 14 ADEs were not included in the specification, including cytomegalovirus pneumonia, immune-mediated small bowel colitfis, large bowel perforation, squamous cell carcinoma of the skin, and basal cell carcinoma. The onset of adverse events was concentrated in the 1st month after the initiation of ciltacabtagene autoleucel treatment and occurred in 6.91% of patients after 1 year of treatment. Conclusion: In addition to paying close attention to adverse reactions documented in the insert, it is also important to be alert to the occurrence of potential adverse events when treating patients with relapsed refractory multiple myeloma with ciltacabtagene autoleucel, and long-term follow-up is recommended for patients using ciltacabtagene autoleucel.更多还原