基于OpenFDA数据挖掘和分析瑞莎珠单抗的不良事件信号  

Adverse event signals of risankizumab based on OpenFDA data mining and analysis

作　　者：林晓娜 LIN Xiao-na(Department of Pharmacy,Guangdong Provincial People’s Hospital(Guangdong Academy of Medical Sciences),Southern Medical University,Guangzhou 510080,China)

机构地区：[1]南方医科大学附属广东省人民医院(广东省医学科学院)药学部,广州510080

出　　处：《中国处方药》2024年第6期6-8,共3页Journal of China Prescription Drug

摘　　要：目的 通过OpenFDA数据库挖掘并分析瑞莎珠单抗的不良反应事件报告,为临床合理用药提供参考。方法 提取美国食品药品管理局(FDA)收录自2019年1月~2023年8月期间相关瑞莎珠单抗的不良反应事件进行分析。通过上报者性别、年龄段、职业等信息分析,并采用报告比值比法(reporting odds ration,ROR)和比例报告比值法(proportional reporting ration,PRR),对报告例数居前80位的不良事件信号进行筛选和分析。结果 数据库显示与瑞莎珠单抗相关的不良反应事件报告31 985例,其中2022年上报数16 511例,为历年最高。报告者性别分别为女性17 120例(53.53%)、男性13 322例(41.65%)。报告来源主要来自消费者或非医疗系统专业人士。经报告比值比法获取具临床意义的不良反应信号75个,其中比值靠前的有银屑病(ROR=30.42)、缩短治疗反应(ROR=27.69)、癣性关节炎(ROR=7.51)、新型冠状病毒感染(ROR=7.26)、皮肤去角质化(ROR=3.81)。结论 通过OpenFDA数据库对瑞莎珠单抗的不良事件信号的挖掘和分析,发现和指出其在治疗过程中潜在的不良反应风险,为临床安全、合理用药提供参考,有效保障患者用药安全。Objective To mine and analyze adverse reaction event reports of risankizumab through the OpenFDA database,providing reference for clinical rational drug use.Methods Extract and analyze adverse reaction events related to risankizumab recorded by the US Food and Drug Administration(FDA)from January 2019 to August 2023.By analyzing the gender,age group,occupation and other information of the reporter,and using the reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods,the adverse event signals with the top 80 reported cases were screened and analyzed.Results The database showed 31985 reported adverse reactions related to risankizumab,with 16511 reported in 2022,the highest number in history.The reported gender was 17120 females(53.53%)and 13322 males(41.65%),respectively.The report mainly comes from consumers or non healthcare professionals(85%).Seventy five clinically significant adverse reaction signals were obtained by the reported ratio method,including psoriasis(ROR=30.42),shortened treatment response(ROR=27.69),tinea arthritis(ROR=7.51),neocoronavirus disease(ROR=7.26),and skin exfoliation(ROR=3.81).Conclusion By mining and analyzing the adverse event signals of risankizumab through the OpenFDA database,potential adverse reaction risks during the treatment process are identified and pointed out,providing reference for clinical safety and rational medication,and effectively ensuring patient medication safety.

关 键 词：瑞莎珠单抗 不良反应事件 报告比值法 

分 类 号：R986[医药卫生—药品]