摘要
Abstract
AIM To mine the adverse drug event(ADE)report of aripiprazole in FDA Adverse Event Reporting System(FAERS)database,and to provide reference frame for the clinical safety of drugs.METHODS Using methods of reporting odds ratio(ROR)and medicines and healthcare products regulatory agency(MHRA)to mine ADEs of aripiprazole from January 1,2004 to June 30,2022 in the FAERS database,and the risk signals which were mined would be classified and described by the International Dictionary of Medical terms.RESULTS A total of 48 183 ADEs related to aripiprazole were retrieved,161 ADEs unrelated to drug use such as social environment,various injuries,poisoning and product problems were removed,and 542 signals were excavated,of which 79 were not included in the specification and severe ADEs were mainly in psychiatric and neurological diseases,as well as pregnancy,puerperium and perinatal periods.Through further analysis of the relevant ADEs of gender and age differences,it was found that there were 23 high-risk signals with gender differences.Male patients should be vigilant against decreased blood prolactin,malignant syndrome,and increased libido.Female patients should be alert to abnormal blood prolactin,agnosia syndrome,orthostatic hypertension,and gaze paralysis.There were 17 high-risk signals with age differences,which were high-risk signals for juvenile patients with decreased blood prolactin,oculomotor nerve crisis,and salivation.For adult patients,agnosia syndrome,schizophrenia,mania,etc.were high-risk signals.CONCLUSION By mining the ADE report of aripiprazole in the FAERS database,post-marketing safety should be analyzed in depth to ensure the safety of patients.New adverse drug reaction signals unearthed in this study that did not appear in the specification and were not reported in other literature should be alerted.关键词
阿立哌唑/药品不良事件/美国食品药品管理局不良事件报告系统/信号挖掘Key words
aripiprazole/adverse drug event/FDA adverse event reporting system/signal mining
