Research and Signal Mining of Adverse Drug Events of Plerixafor Based on FAERS Database
OBJECTIVE To access the database of Food and Drug Administration Adverse Events Reporting System(FAERS)to mining risk signals of adverse drug events(ADE)of plerixafor,so as to provide references for drug safety in clinical practices.METHODS The ADE reports from January 1,2009 to March 31,2023 in FAERS database were retrieved and analyzed.With plerixafor as the target drug,the search keywords were"plerixafor"and"Mozobil".The WPS form was used to count the basic information of patients,including gender,ADE reporting per-sonnel and reporting country,ADE severity and type,etc.The preferred system organ classification(SOC)and pre-ferred term(PT)in the Medical Dictionary for Regulatory Activities(MedDRA)were used to describe,classify and count adverse events.The reported odds ratio(ROR)and the medicines and healthcare products regulatory agency(MHRA)in the ratio imbalance measurement method were used to mine the data of ADE of plerixafor.RESULTS 488 ADE reports of plerixafor were retrieved,which involved 26 kinds of SOC,including 595 reports belonged to seri-ous ADE.The reporting personnel are mainly healthcare professional(43.65％).The ADE mainly occurred in USA(58.40％),A total of 69 ADE risk signals were obtained by ROR and MHRA,including many new adverse reactions such as nictophobia,free haemoglobin present,urine bilirubin increased.CONCLUSION During clinical dosing of plerixafor,should be paid attention to the risks of nictophobia,infection,and urine bilirubin increased to insure the safety of drug in clinic.
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