基于真实世界数据对比克恩丙诺片上市后不良事件信号的挖掘与分析  

Signal mining and analysis of adverse drug events for Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate based on real world database

作　　者：贠菊平 郝言[1] 刘炜 YUN Juping;HAO Yan;LIU Wei(Beijing YouAn Hospital,Capital Medical University,Beijing 100069,China)

机构地区：[1]首都医科大学附属北京佑安医院,北京100069

出　　处：《中国艾滋病性病》2023年第4期398-402,共5页Chinese Journal of Aids & STD

摘　　要：目的 基于美国食品药品监督管理局不良反应事件报告系统(FAERS)数据库,对比克恩丙诺片相关的不良事件进行信号挖掘分析,为临床用药提供参考。方法 利用报告比值法,对FAERS数据库中2018年第2季度至2022年第1季度关于比克恩丙诺片的药物不良事件(ADE)信号进行挖掘。结果 共获得以比克恩丙诺片为首要怀疑药物的不良事件报告844份,不良事件发生时间中位数为29(3,144)天,上报国家以美国、法国为主。挖掘出ADE信号141个,累及24个系统器官分类(SOCs),涉及10个说明书中未收录的SOCs,其中妊娠期、产褥期及围生期相关的ADE共29例次(2.44%)。对ADE与药物的相关性分析结果显示,报告例次排序前20位的ADE信号中说明书中未收录的信号14个,信号强度排序前20位的ADE信号中说明书中未收录的信号18个,且CFTR基因突变和胰管破裂与药物具有很强的相关性。结论 临床在使用比克恩丙诺片时,不仅要关注药品说明书中已有的不良反应,还需关注说明书中未提及的不良反应,此外,对于妊娠期妇女应做好用药评估,保证临床用药安全。Objective To mine and analyze the signals of adverse drug events(ADE) for Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate(B/F/TAF) based on the FDA adverse events reporting system(FAERS), and to provide a reference for the clinical application of the drug. Methods The data of B/F/TAF induced ADE were mined using the reporting odds ratio(ROR) method from the FAERS database during the second quarter of 2018 to the first quarter of 2022. Results A total of 844 ADE reports were obtained, in which B/F/TAF was the primary suspect drug. The median time from treatment initiation to events was 29(3, 144) days. The reporting countries were mainly the United States and France. A total of 141 ADE signals were extracted, involving 24 system organ classes(SOCs). 10 SOCs were not included in the drug inserts and 29 cases(2.44%) of ADE were related to pregnancy, puerperium, and perinatal period. The correlation analysis of ADE and the target drug showed that among the top 20 case reports in the ADE signals ranking, 14were not mentioned in the drug inserts. In the ADE signals strength ranking list, 18 out of the top 20 signals were not mentioned in the drug inserts. The CFTR gene mutation and pancreatic duct rupture have a strong correlation with the target drug. Conclusions In the clinical application of B/F/TAF, attention should be paid not only to the adverse drug reaction mentioned in the drug inserts but also to those that were not included. In addition, pre-medication evaluation should be done for pregnant women to ensure the safety of drug use.

关 键 词：比克恩丙诺片 整合酶抑制剂 药品不良事件 美国食品药品监督管理局不良反应事件报告系统数据库 真实世界数据 

分 类 号：R512.91[医药卫生—内科学] R373.9[医药卫生—临床医学]