萨特利珠单抗治疗视神经脊髓炎谱系疾病的不良事件风险信号挖掘:基于美国FDA不良事件报告系统数据库的研究  

Risk signal mining of adverse events of satralizumab treatment for neuromyelitis optica spectrum disorder:based on the US Food and Drug Administration Adverse Event Reporting System

作　　者：史华慧 季春梅 Shi Huahui;Ji Chunmei(Department of Pharmacy,the First Affiliated Hospital of Nanjing Medical University,Nanjing 210029,China)

机构地区：[1]南京医科大学第一附属医院药学部,南京210029

出　　处：《药物不良反应杂志》2025年第1期25-29,共5页Adverse Drug Reactions Journal

摘　　要：目的挖掘萨特利珠单抗治疗视神经脊髓炎谱系疾病(NMOSD)的不良事件(AE)风险信号,为临床安全使用该药提供参考。方法收集美国食品药品管理局(FDA)不良事件报告系统数据库2020年第1季度至2023年第4季度收到的萨特利珠单抗AE报告。采用《国际医学用语词典》26.1版首选术语(PT)和系统器官分类(SOC)对AE进行标准化和分类。采用报告比值比(ROR)法和贝叶斯置信传播神经网络(BCPNN)法进行风险信号挖掘。将报告数≥3、ROR值的95%置信区间(CI)下限>1且BCPNN法的信息成分-2倍标准差(IC-2SD)>0的PT定义为风险信号,进行描述性统计分析。结果共收集到AE报告526份,通过ROR法及BCPNN法检测到风险信号(PT)39个,涉及13个SOC。39个PT中11个为说明书已记载的不良反应,包括血清甘油三酯升高、肝功能异常、蜂窝织炎等;28个说明书中未记载,其中11个涉及感染及侵染类疾病。信号强度居前5位的PT为非典型分枝杆菌感染、肾盂肾炎、压缩性骨折、椎体压缩骨折、淋巴细胞计数降低。报告数居前5位的PT为尿路感染、感染性肺炎、新型冠状病毒感染、脓毒症、带状疱疹。结论萨特利珠单抗治疗NMOSD时除可引起说明书已记载的血清甘油三酯升高、肝功能异常、蜂窝织炎等不良反应外,还可能引起非典型分枝杆菌感染、肾盂肾炎、压缩性骨折等说明书未记载的AE,临床医师需予以警惕。Objective To mine the risk signals of adverse events(AE)of satralizumab for treatment of neuromyelitis optica spectrum disorder(NMOSD)and provide reference for safe use of the drug in clinic.Methods AE reports on satralizumab from the 1st quarter of 2020 to the 4th quarter of 2023 were collected by searching US Food and Drug Administration Adverse Event Reporting System(FAERS)database.AEs were classified and standardized according to the preferred term(PT)and system organ class(SOC)of Medical Dictionary for Regulatory Activities version 26.1.Reporting odds radio(ROR)method and Bayesian confidence progressive neural network(BCPNN)method were used to mine the AE risk signals.An AE with≥3 reports,lower limit of the 95%confidence interval(CI)of ROR>1,and the information component(IC)of BCPNN method minus 2 times of standard deviation(IC-2 SD)>0 were defined as a risk signal.Descriptive analysis on the signals was performed.Results A total of 526 AE reports were collected,39 risk signals(PT)were mined by ROR and BCPNN methods,involving 13 SOCs.Among the 39 PTs,11 were adverse reactions recorded in the label,including blood triglycerides increased,hepatic function abnormal,cellulitis,and etc.Twenty-eight PTs were not recorded in the label,11 of which involved infections and infestations.The top 5 PTs in signal intensity were atypical mycobacterium infection,pyelonephritis,compression fracture,spinal compression fractures,and lymphocyte count decreased.The top 5 PTs in number of reports were urinary tract infection,pneumonia,corona virus disease 2019,sepsis,and herpes zoster.Conclusion In addition to the blood triglycerides increased,hepatic function abnormal,cellulitis,and other AEs recorded in the label,NMOSD treatment with satralizumab may also cause atypical mycobacterial infection,pyelonephritis,compression fracture and other AEs not recorded in the label,which clinical physicians should be vigilant.

关 键 词：视神经脊髓炎 不良事件信号检测 数据挖掘 萨特利珠单抗 

分 类 号：R744.52[医药卫生—神经病学与精神病学] R969.3[医药卫生—临床医学]