Objective To mining ADR signal of trastuzumab by using the drug adverse reactions database in OpenFDA,and to provide reference for the rational and safe use of trastuzumab in clinic.Methods The adverse reactions of trastuzumab reported by OpenFDA from January 1,2004 to March 31,2022 were counted and analyzed.The methods including reporting odd ratio(ROR),proportional reporting ratio(PRR)were used for mining of ADR signal related to trastuzumab.Results A total of 52 545 cases of trastuzumab adverse reactions were collected.The majority of patients were women(42 800 cases,81.45%).The age was mainly 45～74 years old(24 004 cases,43.78%).Serious adverse reactions were mainly hospitalization and death.After analysis,37 ADR signals were found.The four ADR signals not recorded in the instructions were hair growth disorder,hair texture abnormal,hair colour changes and dehydration.Conclusion The adverse reactions recorded in the instructions of trastuzumab are relatively comprehensive.However,clinical attention should also be paid to its adverse reactions to hair and the situation leading to dehydration,and necessary measures should be taken to prevent it.
TrastuzumabAdverse drug reactionsReporting odd ratioProportional reporting ratioSignal mining
万方数据
维普
