5种阿片受体激动剂不良反应信号的数据挖掘与分析  

Data mining and analysis of adverse reaction signals of five opioid receptor agonists

作　　者：孙璇 张科[1] 李正翔[1] SUN Xuan;ZHANG Ke;LI Zhengxiang(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：《安徽医药》2023年第2期420-424,共5页Anhui Medical and Pharmaceutical Journal

摘　　要：目的基于美国食品药品管理局不良事件报告系统(FAERS)对5种阿片受体激动剂(吗啡、可待因、哌替啶、芬太尼、美沙酮)相关不良反应进行挖掘分析,为阿片受体激动剂的临床安全用药提供参考依据。方法利用美国食品药品管理局公共数据开放项目(OpenFDA)平台,收集2004年第1季度至2021年第4季度FAERS数据库中5种阿片受体激动剂的不良反应报告数据,采用报告比值比(reporting odds ratio,ROR)法对5种阿片受体激动剂的药品不良反应(ADR)进行信号挖掘,分析ADR报告中的安全警告信号。结果最终得到吗啡165572份,可待因79574份,哌替啶9838份,芬太尼145819份,美沙酮43433份ADR报告。这些ADR报告中女性207657份多于男性156810份,主要集中于18~60岁年龄段病人,且美国地区的上报数最多为282820份,严重ADR报告中以住院或住院时间延长的上报数最多为129454份。在上报数前20位的ADR中,药物依赖、过量、新生儿戒断综合征、怀孕期间胎儿暴露相关ADR在5种药物的说明书中均有提及,各类神经系统疾病及精神病类相关ADR在说明书较为常见。经ROR法检测发现,常见有精神障碍相关ADR,吗啡和可待因信号强度最为显著,药物依赖性吗啡信号最强,除芬太尼外其余学习障碍和发育迟缓高危信号均较强,自杀身亡美沙酮信号最强。结论通过对吗啡、可待因、哌替啶、芬太尼和美沙酮等阿片受体激动剂的严重和其他重要ADR信号的挖掘与分析,可更深入了解此类药物的ADR特征和潜在风险,促进临床安全用药。Objective To mine and analyze the adverse reactions related to five opioid receptor agonists(morphine,codeine,pethidine,fentanyl and methadone)based on the FDA adverse event reporting system(FAERS),so as to provide reference basis for the clinical safety of opioid receptor agonists.Methods Using FDA open platform,the adverse reaction report data of five opioid receptor agonists in FAERS database from the first quarter of 2004 to the fourth quarter of 2021 were collected.The ADR signals of five opioid receptor agonists were mined by reporting odds ratio(ROR)method,and the safety warning signals in ADR reports were analyzed.Results A total of 165572 morphine,79574 codeine,9838 pethidine,145819 fentanyl and 43433 methadone ADR reports were obtained.Among these ADR reports,207657 were female more than 156810 were male,mainly concentrated in patients aged from 18 to 60 years old,and the maximum number of ADR reports in the United States was 282820,and the maximum number of serious ADR reports involving hospitalization or prolonged hospitalization was 129454.Among the top 20 ADRs reported,ADRs related to drug dependence,overdose,neonatal withdrawal syndrome and fetal exposure during pregnancy were mentioned in the instructions of five drugs,and ADRs related to various nervous system diseases and psychosis were common in the instructions.The ROR method showed that there were common ADRs related to mental disorders,the signal intensity of morphine and codeine was the most significant,the signal intensity of drug-dependent morphine was the strongest,except fentanyl,the high-risk signals of learning disabilities and growth retardation were strong,and the signal intensity of methadone for suicide was the strongest.Conclusion By mining and analyzing the severe and other important ADR signals of opioid receptor agonists such as morphine,codeine,pethidine,fentanyl and methadone,we can further understand the ADR characteristics and potential risks of these drugs and promote clinical safe drug use.

关 键 词：阿片受体激动剂 吗啡 可待因 哌替啶 芬太尼 美沙酮 数据挖掘 FAERS数据库 不良反应 报告比值比 

分 类 号：R971.2[医药卫生—药品]