摘要
目的利用美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)数据库挖掘维得利珠单抗的药品不良事件(ADE)信号,为该药的临床安全使用提供参考。方法采用报告比值比(ROR)法和综合标准(MHRA)法,对FAERS中2017年至2021年共19个季度的报告进行数据挖掘,采用世界卫生组织药品不良反应术语集累及的系统器官对报告中的ADE描述用语进行标准化,筛选出ROR法和MHRA法共有信号进行分析。结果筛选得到维得利珠单抗ADE报告8563例,涉及19905个ADE,共挖掘出维得利珠单抗ADE信号228个,主要累及19个器官系统,包括胃肠系统疾病、全身性疾病及给药部位各种反应、感染及侵染类疾病等。按信号强度排序,前30中有8个信号未在药品说明书中出现,有待进一步确认。结论使用维得利珠单抗前应加强感染相关风险的评估,用药过程中加强监护,警惕药物诱发胰腺炎,并加强儿童等特殊人群超说明书用药评价,确保患者用药安全。
Objective To mine and analyze the signals of adverse drug event(ADE)of vedolizumab by using the US FDA Adverse Event Reporting System(FAERS)database,and to provide reference for the safe clinical use of this drug.Methods Reporting odds ratio(ROR),medicines and healthcare products regulatory agency(MHRA)method were used for the data mining on the 19 quarterly reports of the FAERS database(the first quarter of 2017 to the third quarter of 2021).The ADE descriptive terminologies in the report were standardized with the World Health Organization Adverse Reaction Terminology(System-Organ Class).Common signals by ROR and MHRA methods were screened.Results After screening,we obtained 8563 ADE reports of vedolizumab,involving 19905 ADEs.A total of 228 ADE signals of vedolizumab were collected,mainly covering 19 organ systems,including diseases of the gastrointestinal system,general disorders and administration site conditions,infections and infestations diseases,etc.Ranked by signal strength,8 of the top 30 signals did not appear in the drug instructions and need further confirmation.Conclusion Before using vedolizumab,we should assess infection-related risks,monitor the medication process,watch out for drug-induced pancreatitis,and evaluate off-label medication use in children and other populations to ensure the safe use.
作者
普燕芳
陈力
曹玮
PU Yan-fang;CHEN Li;CAO Wei(Department of Pharmacy,the First People’s Hospital of Yunnan Province,the Affiliated Hospital of Kunming University of Science and Technology,Kunming 650032;Department of Pharmacy,West China Second Hospital,Sichuan University,Chengdu 610041;Center for Evidence-Based Pharmacy,West China Second Hospital,Sichuan University,Chengdu 610041)
出处
《中南药学》
2023年第11期3062-3067,共6页
Central South Pharmacy
基金
四川省科技计划项目(No.2019JDR0163)
白求恩医学科学研究基金(No.B19112DS)。
