摘要
目的基于FAERS数据库对低分子肝素(依诺肝素、达肝素)和磺达肝癸进行不良事件信号挖掘,探索不同药物间不良反应发生的差异及其与药物的关联强度,为临床安全用药提供参考。方法提取FAERS数据库2016年第一季度至2021年第二季度共22个季度的不良事件报告数据,利用报告比值比法(ROR)和综合标准法(MHRA)对依诺肝素、达肝素和磺达肝癸的不良事件报告进行信号挖掘。结果三种药物共得到406个信号,累及21个不同的系统器官。依诺肝素主要集中于全身性疾病及给药部位各种反应和血管与淋巴管类疾病;达肝素主要集中于血管与淋巴管类疾病和胃肠系统疾病;磺达肝癸主要集中于血管与淋巴管类疾病和血液及淋巴系统疾病。依诺肝素、磺达肝癸与腹膜后出血事件的关联性最强,达肝素、磺达肝癸与颅内出血事件的关联性最强;未见达肝素引起过敏反应相关事件;未见磺达肝癸引起肝损伤相关事件。结论本研究中依诺肝素、达肝素和磺达肝癸发生的不良事件所累及的系统疾病具有一定的差异,在患者存在相关风险疾病的情况下,可为临床选择合适的品种提供参考。
Objective To analyze and explore the adverse drug event differences of enoxaparin,dalteparin and fondaparinux based on FAERS database and offer a reference to clinical administration of heparin drugs.Methods We mined the adverse events signals of three heparin drugs using ROR and MHRA methods from the adverse events report data extracted from the FAERS database of 22 quarters from the first quarter of 2016 to the second quarter of 2021.Results Totally 406 signals was found from three heparin drugs which involved 21 different system organ classes.Enoxaparin mainly focused on general disorders and administration site conditions,and vascular disorders.Dalteparin mainly focused on vascular disorders and gastrointestinal disorders.Fondaparinux mainly focused on vascular disorders and blood and lymphatic system disorders.Among three heparin drugs,the correlation strength between dalteparin and retroperitoneal hemorrhage was the weakest,and the correlation strength between enoxaparin and intracranial hemorrhage was the weakest.There was no event related to allergic reaction caused by dalteparin and no event related to liver injury caused by fondaparinux.Conclusion The differences involved in adverse drug event of three heparin drugs are analyzed,which can offer a reference for clinical choice and promote rationality of drug use.
作者
孔苗
何绪成
舒亚民
陈力
KONG Miao;HE Xu-cheng;SHU Ya-min;CHEN Li(Department of Pharmacy/Center for Evidence-Based Pharmacy,West China Second Hospital,Sichuan University,Chengdu 610041;Key Laboratory of Birth Defects and Related Gynecological Diseases,Ministry of Education,Chengdu 610041;Department of Pharmacy,Sanmenxia Central Hospital,Sanmenxia Henan 472000;Department of Pharmacy,Pengzhou Second People’s Hospital,Chengdu 611934;Department of Pharmacy,Tongji Hosiptal,Tongji Medical College of Huazhong University of Science and Technology,Wuhan 430030)
出处
《中南药学》
CAS
2022年第9期2164-2170,共7页
Central South Pharmacy
基金
四川省科技计划项目(No.2019JDR0163)。
