Abstract: Objective To find out about adverse drug reactions/events(ADR/ADE) caused by albumin-bound paclitaxel(ABP) in patients with gynecological tumors in our hospital and analyze the correlations between various influencing factors so as to provide reference for ensuring medication safety of patients. Methods The reports of ADR/ADE among patients who used ABP submitted by our hospital to the national adverse drug reactions monitoring system and the Chinese hospital pharmacovigilance system between January 1 and September 30, 2020 were retrieved and analyzed. Inpatients with gynecological cancer who had taken ABP and developed ADR in this period were selected as the subjects. The incidence of ADR/ADE was statistically analyzed. Results Eighty-five reports of ADR/ADE involving 43 patients were retrieved. The dominating disease was ovarian malignant tumor (73 cases, 85.88%). The results of correlation factor analysis showed that the incidence of ADR/ADE was not significantly correlated with the age of patients or with manufacturers. Body mass index (BMI) was of statistical significance for elevated transaminase (χ²=1.29, P=0.02), while dosage for the incidence of anemia (χ²=0.74, P=0.02). The combination of different chemotherapy drugs was correlated with the elevation of bone marrow inhibitors (χ²=1.09, P=0.03) and transaminase (χ²=0.00, P=0.01). There were 85 cases (100%) of off-label drug use, and 3 cases (3.53%) of improper doses. Conclusion Medical institutions should minimize off-label drug use, standardize medical records and review clinicians' instructions in earnest so as to prevent serious ADR/ADE and improve the life quality of patients.

Key words: albumin binds paclitaxel, adverse drug reaction/event, gynecologic malignant tumor, drug safety monitoring and management