基于FAERS数据库的阿替普酶上市后的不良事件的分析研究  

Analysis of Adverse Events after Listing of Alteplase Based on FAERS Database

作　　者：孙璇 张科[1] SUN Xuan;ZHANG Ke(Department of Pharmacy,Tianjin Medical University General Hospital,Tianjin 300052,China)

机构地区：[1]天津医科大学总医院药剂科,天津300052

出　　处：《海峡药学》2023年第2期103-108,共6页Strait Pharmaceutical Journal

摘　　要：目的基于FDA不良事件报告系统(FDA adverse event reporting system,FAERS)数据库,对血栓溶解药阿替普酶上市后主要不良事件的情况进行研究,为临床合理使用提供借鉴。方法通过分析2004年以来FAERS数据库中阿替普酶所有的不良事件(Adverse drug events,ADEs)报告数据,采用报告比值比(Reporting odds ratio,ROR)法对不良事件报告进行挖掘分析,将得到的阳性信号按照《国际医学用语词典》(Medical dictionary for regulatory activities,MedDRA)进行分类。结果最终得到阿替普酶ADE报告共12090份。这些报告中男性多于女性,主要集中于65岁以上年龄段患者,且美国地区的上报数最多,报告主要呈报人员职业为医师,不良事件年度分布2017年提交了2693份ADE达到峰值。在上报数前10位的ADR中死亡排名第一,ROR的95%Cl下限值前20位的风险信号,主要集中在各类神经系统疾病大多与出血相关。结论基于FAERS大数据库对阿替普酶的ADE相关信息进行全面、多角度的分析,同时使用ROR法挖掘得到的阳性信号有助于广大医务人员及患者充分了解其相关不良反应,尽可能地降低这些不良反应所造成的危害。在使用该类药物期间,如果出现出血不良事件,应考虑将阿替普酶视为可能的原因,同时终止此类药物的治疗。OBJECTIVE To study the main adverse events after the listing of thrombolytic drug alteplase based on the FDA adverse event reporting system(FAERS),so as to provide reference for clinical rational use.METHODS By analyzing the adverse drug event(ADE)report data in the FAERS database since 2004,the adverse event reports were mined and analyzed by using the reporting odds ratio(ROR)method,and the positive signals were classified by using the medical dictionary for regulatory activities(MedDRA).RESULTS Finally,12090 ADE reports of alteplase were obtained.More men than women in these reports,mainly concentrated in patients over the age of 65,and the number of reports was the largest in the United States.The main reporting personnel were doctors.The annual distribution of adverse events was 2693,and ADE reached the peak in 2017.Among the top 10 ADRs,death ranked first,and the top 20 risk signals of 95%Cl lower limit of ROR were mainly concentrated in various nervous system diseases,most of which were related to bleeding.CONCLUSION Based on the FAERS database,the ADE related information of alteplase is analyzed comprehensively and from multiple angles.At the same time,the positive signals mined by ROR method will help the majority of medical staff and patients fully understand its related adverse reactions,reduce the harm caused by these adverse reactions as much as possible.During the use of these drugs,if there is an adverse event of bleeding,alteplase should be considered as a possible cause and the treatment of these drugs should be terminated.

关 键 词：阿替普酶 FAERS数据库 不良事件 报告比值比 

分 类 号：R969.4[医药卫生—药理学]