基于FAERS的B细胞成熟抗原靶向嵌合抗原受体T细细胞胞药物警戒研究  

A Pharmacovigilance Study of B-Cell Mature Antigen-Targeted Chimeric Antigen Receptor T Cells Based on FAERS

作　　者：程一美 郑明昱 谷文睿 CHENG Yimei;ZHENG Mingyu;GU Wenrui(The First Affiliated Hospital of Army Medical University,Chongqing,China 400038)

机构地区：[1]中国人民解放军陆军军医大学第一附属医院,重庆400038

出　　处：《中国药业》2024年第21期110-115,共6页China Pharmaceuticals

基　　金：重庆市临床药学重点专科建设项目[渝卫办发〔2021〕52号]。

摘　　要：目的为临床安全用药提供参考。方法检索美国食品和药物管理局不良事件报告系统(FAERS)中2003年9月至2024年3月有关B细胞成熟抗原(BCMA)靶向嵌合抗原受体T细胞(CAR-T)药物艾基维仑赛和西达基奥仑赛的药品不良事件(ADE)报告,采用报告比值比(ROR)法和英国药品和保健品管理局(MHRA)综合标准法挖掘ADE信号,采用《国际医学用语词典(23.0版)》(MedDRA 23.0)中的首选语(PT)和系统器官分类(SOC)进行分类与描述。结果共检索到56个ADE的PT,其中艾基维仑赛17个,西达基奥仑赛39个;累及15个SOC,主要集中在全身性疾病及给药部位各种反应、神经系统疾病、免疫系统疾病;西达基奥仑赛的药品不良反应(ADR)与良性、恶性及性质不明的肿瘤、感染及侵袭类疾病有较强的关联性。结论BCMA靶向CAR-T药物艾基维仑赛和西达基奥仑赛的ADE信号大致与其药品说明书中描述的ADR一致,但两药的ADR与涉及SOC的某些ADE信号关联强度存在差异。CAR-T疗法相比传统抗肿瘤疗法具有复杂性和技术特异性的特点,临床药师可积极参与到CAR-T疗法团队中,与医护团队密切合作,以药学监护、药物重整、ADR处理、用药教育与健康指导、药学随访等为切入点,为患者提供全程化药学服务,实现个体化精准治疗。Objective To provide a reference for safe medication in the clinic.Methods Adverse drug event(ADE)reports of B-cell mature antigen(BCMA)-targeted chimeric antigen receptor T cells(CAR-T)drugs idecabtagenevicleucel and ciltacabtageneautoleucel in the US Food and Drug Administration Adverse Event Reporting System(FAERS)from September 2003 to March 2024 were searched.The reporting odds ratio(ROR)method and the Medicines and Healthcare Products Regulatory Agency(MHRA)method were used to mine the signals.The preferred terms(PTs)and system organ classification(SOC)in the MedDRA 23.0 were used for classification and description.Results A total of 56 ADE PTs were searched,including 17 signals of idecabtagenevicleucel and 39 signals of ciltacabtageneautoleucel,which involved 15 SOC,mainly concentrated in general disorders and administration site conditions,nervous system disorders and immune system disorders.Ciltacabtageneautoleucel was strongly correlated with adverse drug reactions(ADRs)such as neoplasms benign,malignant and unspecified,infections and infestations.Conclusion The ADE signals of BCMA-targeted CAR-T drugs(idecabtagenevicleucel and ciltacabtageneautoleucel)are generally consistent with the ADRs listed in their drug instructions.However,there are differences in the strength of the association between the ADRs of the two drugs and some ADE signals related to SOC.Compared with traditional anti-tumor therapy,CAR-T therapy has the characteristics of complexity and technical specificity.Clinical pharmacists can actively participate in the CAR-T therapy team,work closely with physician and nurse teams,and provide patients with comprehensive pharmaceutical care through pharmaceutical monitoring,drug restructuring,ADR treatment,medication education and health guidance,and pharmaceutical follow-up,in order to achieve individualized and precise treatment.

关 键 词：嵌合抗原受体T细胞 艾基维仑赛 西达基奥仑赛 美国食品和药物管理局不良事件报告系统 药品不良事件 信号挖掘 药物警戒 

分 类 号：R969.3[医药卫生—药理学] R979.1[医药卫生—药学]