基于真实世界数据的氯吡格雷信号挖掘研究  

Data-mining of ADR signals for clopidogrel based on real world data

作　　者：张臣宇 钟雯 李灏 陈晨[1,2,3] 陈力[1,2] ZHANG Chen-yu;ZHONG Wen;LI Hao;CHEN Chen;CHEN Li(Department of Pharmacy/Evidence Based Pharmacy Center,West China Second University Hospital,Sichuan University,Chengdu 610041;Key Laboratory of Birth Defects and Related Diseases of Women and Children,Sichuan University,Ministry of Education,Chengdu 610041;West China School of Pharmacy,Sichuan University,Chengdu 610041)

机构地区：[1]四川大学华西第二医院药学部/循证药学中心,成都610041 [2]出生缺陷与相关妇儿疾病教育部重点实验室,成都610041 [3]四川大学华西药学院,成都610041

出　　处：《中南药学》2020年第8期1318-1322,共5页Central South Pharmacy

基　　金：四川省科技厅项目(No.2019JDR0163)。

摘　　要：目的通过对美国FDA不良事件报告系统(FAERS)进行检索,对氯吡格雷相关不良事件进行数据挖掘,为临床安全用药提供参考。方法利用报告比值比(ROR)法和比例报告比值(PRR)法对FAERS 2010年第1季度~2019年第4季度的不良事件报告进行数据挖掘。结果采用ROR法和PRR法计算共得到氯吡格雷信号836个,筛选出的信号强度前20位的首选术语(PT)中未在氯吡格雷说明书中出现的信号共计6个。除心血管相关不良反应外,不良反应信号主要集中在胃肠系统疾病、各类神经系统疾病、各类损伤、中毒及手术并发症等。结论氯吡格雷不良反应信号累及器官系统达26个,应注意加强对胃肠系统和神经系统不良反应的监测。Objective To conduct data-mining of clopidogrel-related adverse events based on the FDA Adverse Event Reporting System (FAERS) to provide a reference for safe clinical medication.Methods Measures of disproportionality were used to conduct data-mining based on the data from FAERS in the first quarter of 2010 to the fourth quarter of 2019.Results Totally 836 signals were detected with ROR and PRR,and 6 signals were not reported in the proved label of the most relevant 20 preferred terms.In addition to cardiovascular adverse events majority of adverse events included gastrointestinal disorders,nervous system disorders,injury,poisoning and procedural complications.Conclusion Adverse reaction signals of clopidogrel involve 26 systems and organs.We should strengthen the monitoring of gastrointestinal and nervous system adverse reactions.

关 键 词：氯吡格雷 药品不良事件 比例失衡法 

分 类 号：R969.3[医药卫生—药理学]