单位：[1]Department of Pharmacy, Dongguan Binhaiwan Center Hospital.[2]Department of Thoracic Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.外科学系胸外科华中科技大学同济医学院附属同济医院[3]Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.华中科技大学同济医学院附属协和医院
To analyze and identify the signals of gender differences in adverse events (ADEs) related to Osimertinib and to provide reference for clinical implementation of individualized drug use.ADE reports of Osimertinib received from FAERS database from the first quarter of 2016 to the fourth quarter of 2022 were extracted. Reporting odd ratio (ROR) data analysis strategy was used for mining of signal strength that represents gender differences in ADEs related to Osimertinib.The number of Osimertinib ADE reports included in the analysis was 7968 in females and 7570 in males, respectively. According to ROR, men were more likely to develop pneumonia aspiration, lung infection, interstitial lung disease, pulmonary toxicity, dyspnea, ventricular extrasystoles, and pulmonary thrombosis, while women were more likely to develop cardiac failure congestive, stomatitis, diarrhea, muscle spasms, nail disorder, onycholysis, skin disorder, dry skin, and rash.Gender differences existed in ADE signals related to Osimertinib. The higher risk of ADEs in male patients were lung diseases that seem more serious than those nail toxicities or skin problems occurred in the female patients. In order to ensure the safety of medication, we should be alert to the differences between different genders and take corresponding preventive measures to reduce the occurrence of serious ADEs.
基金：
This work was funded by the National Natural Science Foundation of China, China (Grant No.:
82204758).
第一作者单位：[1]Department of Pharmacy, Dongguan Binhaiwan Center Hospital.
共同第一作者：
通讯作者：
通讯机构：[1]Department of Pharmacy, Dongguan Binhaiwan Center Hospital.[3]Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.[*1]111 Humen Blvd, Dongguan, Guangdong Province, China, 523918.[*2]1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei Province, China, 430000.
推荐引用方式(GB/T 7714)：
Li Zhiping,Zou Wenbin,Yuan Jiao,et al.Gender differences in adverse events related to Osimertinib: a real-world pharmacovigilance analysis of FDA adverse event reporting system[J].EXPERT OPINION ON DRUG SAFETY.2023,doi:10.1080/14740338.2023.2243220.
APA：
Li Zhiping,Zou Wenbin,Yuan Jiao,Zhong Yunxiang&Fu Zhiwen.(2023).Gender differences in adverse events related to Osimertinib: a real-world pharmacovigilance analysis of FDA adverse event reporting system.EXPERT OPINION ON DRUG SAFETY,,
MLA：
Li Zhiping,et al."Gender differences in adverse events related to Osimertinib: a real-world pharmacovigilance analysis of FDA adverse event reporting system".EXPERT OPINION ON DRUG SAFETY .(2023)
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