摘要
目的基于美国食品药品管理局(FDA)不良事件报告系统(FAERS)数据挖掘抗新型冠状病毒试用药物磷酸氯喹的药品不良反应(ADR)信号,为临床安全合理用药提供参考。方法下载2004Q1至2019Q4共64个季度的FAERS数据,经过MedEx药品名称标准化、MedDRA不良事件系统分类等数据清洗后,提取以磷酸氯喹为首要怀疑药品不良事件(ADE)报告病例,利用报告比值比法(ROR)和比例报告比值法(PRR)进行ADR信号检测。结果共提取到以磷酸氯喹为首要怀疑ADE报告病例357例。男女比例为0.60。中位年龄39岁。报告者多为其他健康专家(49.86%)和医师(23.25%)。美国报告最多,占20.17%。主要给药途径为口服,占35.01%,大部分病例未报告给药途径。使用ROR法获得148个信号,PRR法获得147个信号,其中147个信号是一致的。其ADR信号检测结果显示心脏器官疾病ADE报告数最多,为372个反应数,占20.36%,共检出ADR信号28个,随后依次为各类异常检查、各类神经系统疾病及精神病类ADR信号。结论使用磷酸氯喹前应做好用药评估,尤其是患者存在心脏病、神经疾病、精神疾病等基础疾病时,需加强监测,以进一步降低和评估其相关ADR风险。
Objective To detect and analyze safety signals of chloroquine phosphate,which is one of the latest recommended drugs for the treatment of novel coronavirus pneumonia(NCP)due to COVID-19,through the data mining methods based on FAERS database,in order to provide references for clinical safe use of chloroquine phosphate.Methods FARES Data from 2004Q1 to 2019Q4(64 quarters)were downloaded.After drug names standardization by MedEx and adverse events classification by MedDRA,the adverse event reports were extracted using the chloroquine phosphate as the primary suspected drug,and the ADR signal detection was conducted using PRR and ROR methods.Results A total of 357 cases with chloroquine phosphate as the primary suspected drug were gathered.Among them,the male/female ratio was 0.60,and the median age was 39 years old.Reports from“other health-professional”accounted for 49.86%,and from“doctors”accounted for 23.35%.The United States reports the most,accounting for 20.17%.The main routes of administration were oral,accounting for 35.01%.A total of 148 ADR signals were detected by ROR method,while 147 ADR signals were detected by PRR,of which 147 signals are identical.The results of ADR signal detection showed that the number of ADE reports of“cardiac disorders”was the largest,of which was 372,accounting for 20.36%with 28 signals detected.Then,the number of the ADR signals of“all kinds of abnormalities”,“nervous system disorders”and“psychiatric disorders”were relatively larger in turns.Conclusion Before using chloroquine phosphate,med;cation evaluation should be performed well,especially when patients have basic diseases such as cardiac diseases,nervous diseases or mental illness etc.,and monitoring should be strengthened to further reduce and evaluate the risk of ADR.
作者
罗敏
胡巧织
肖桂荣
吴逢波
吴斌
徐珽
LUO Min;HU Qiaozhi;XIAO Guirong;WU Fengbo;WU Bin;XU Ting(Department of Pharmacy,West China Hospital,Sichuan University,Chengdu 610041,China)
出处
《医药导报》
CAS
北大核心
2020年第4期505-512,共8页
Herald of Medicine
基金
2018年四川省干部保健科研课题资助项目(川干研2018-104)。
