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.
关键词
曲妥珠单抗/药品不良反应/报告比值比法/比例报告比值比法/信号挖掘
Key words
Trastuzumab/Adverse drug reactions/Reporting odd ratio/Proportional reporting ratio/Signal mining
维普
万方数据