Signal mining and analysis of the adverse effects of alpelisib in skin and subcutaneous tissue based on the database FAERS
Objective:To provide a reference for the safe and rational drug use in the clinical treatment of breast cancer,a data mining and analysis work of post-marketing adverse events(AEs)and signals of alpelisib is developed in this paper based on the database US FDA adverse event reporting system(FAERS).Methods:The reporting odds ratio(ROR)was used to mine and analyze the adverse reaction signals from the data of alpelisib between April of 2019 and Sep-tember of 2021 in FAERS.Results:A total of 11 427 AE reports of alpelisib were collected,including 166 related adverse signals,among which a total of 1 287 AE reports of skin and subcutaneous tissue,including 20 skin-related AE signals,were sorted out.The majority of the reports are from women,most of whom are over 40 years old.Univariate analysis showed that daily dose was not an independent risk factor to the occurrence of skin and subcutaneous tissue AEs(P＞0.05),while the course of treatment is probably a risk factor to the occurrence of skin and subcutaneous tissue AEs(P＜0.05).Conclusion:Alpelisib causes a variety of skin reactions such as rash,dermatitis exfoliative,alopecia,etc.During the treatment for breast cancer patients,it is necessary to closely monitor AEs and identify them as soon as possible.The incidence of AEs caused by alpelisib should be reduced.
NETL
NSTL
万方数据
