Safety study of baloxavir marboxil in the treatment of influenza based upon real-world data

LI Bei; PAN Lulu

doi:10.3969/j.issn.1007-8134.2025.01.014

Abstract：Objective The aim is to examine the safety profile of baloxavir marboxil in treating influenza A(H1N1)and to provide valuable reference for its clinical application.Methods Using the electronic medical record system,we collected the medical records of adult patients from January 1 to December 31,2023 who were hospitalized in the Jiangsu Provincial Hospital of traditional Chinese medicine and treated with baloxavir marboxil tablets for influenza A(H1N1).The adverse drug reactions(ADR)of baloxavir marboxil were analyzed retrospectively,including the time,clinical manifestations,severity,treatment and prognosis,the clinical characteristics of patients with and without adverse reactions were compared.Results There were 176 patients,19 patients experienced 22 adverse drug reactions(ADRs),with an ADR incidence rate of 10.80％.The primary manifestations were digestive system abnormalities,followed by hepatic dysfunction,and no severe ADRs were reported.Most ADRs resolved or improved after symptomatic treatment or drug discontinuation,with good outcomes.Statistical analysis revealed no significant correlation between ADRs and patient gender,age,or most underlying diseases,but when comparing patients with underlying pulmonary diseases,the difference between the adverse reaction group and the non-adverse reaction group was statistically significant(P＜0.05).Conclusion The use of baloxavir marboxil in the treatment of influenza A(H1N1)has a good safety profile,and the main ADR is the digestive system reaction,which requires special attention to the drug reaction in patients with underlying lung diseases,and it is recommended to pay close attention to the patient's liver function during treatment.