基于OpenFDA数据挖掘和分析维得利珠单抗的不良事件报告

Mining and analysis of adverse event reports of Vedolizumab by OpenFDA

目的通过数据平台OpenFDA对维得利珠单抗(Vedolizumab)的安全警戒信号进行挖掘和分析,为临床安全用药提供参考依据。方法借助OpenFDA平台检索提取美国FDA不良事件报告系统(FDA adverse event reporting system,FAERS)建立至2022年4月25日维得利珠单抗相关的药品不良事件(adverse drug event,ADE)报告,并对相关数据进行分析。结果提取获得的14468348份ADE报告中,以维得利珠单抗为主要怀疑药物的有36180份。根据数据分析提示,维得利珠单抗的ADE报告数量逐年递增,报告者主要为消费者及医务人员,报告国家排名前5位的分别是美国、加拿大、英国、澳大利亚和德国。利用报告比值比法(reporting odds ratio,ROR)进行药品不良反应(adverse drug reaction,ADR)检测共得到34个信号,累及11个系统器官分类(system organ class,SOC),其中信号强度排前3位的ADR是结肠切除术(ROR=44.2683)、频繁排便(ROR=34.0482)、排便紧急(ROR=25.7788),共有18个ADR信号和4个SOC尚未被说明书记载。结论使用维得利珠单抗治疗炎症性肠病前应做好用药评估,重点关注患者的胃肠疾病、感染相关及输注反应,为减少临床不良反应提供参考依据。

Objective To provide reference for safe use in clinical practice by OpenFDA to mine and analyze security alert signals of Vedolizumab.Methods FAERS of FDA was searched with OpenFDA to extract adverse drug event(ADE)reports of Vedolizumab established up to Apr.25th,2022.Results A total of 14468348 ADE reports were extracted,of which 36180 ADE reports were mainly induced by Vedolizumab.The number of ADE reports grew significantly.The top 5 reporting countries were the USA,Canada,UK,Australia and Germany.After the detection of top 100 ADE reports by reporting odds ratio(ROR),34 adverse drug reaction(ADR)signals related to 11 system organ class(SOC)were identified in total,and the top 3 ADR in signal intensity were colectomy(ROR=44.2683),frequent bowel movements(ROR=34.0482),defaecation urgency(ROR=25.7788).A total of 18 ADR signals and 4 SOC were not recorded in the manual.Conclusion Focus on patients'gastrointestinal disease,infection-related and infusion reactions prior to Vedolizumab for inflammatory bowel disease to reduce the adverse reactions.