Study on Adverse Reaction Monitoring and Influencing Factors of Off-label Use of Albumin-bound Paclitaxel
LONG Shuke
CHEN Qinbang
LI Lu
ZHENG Antai
WANG Jinping
Abstract：Objective To evaluate the safety of off-label use of albumin-bound paclitaxel by using the China Hospital Pharmacovigilance System(CHPS),analyze the influencing factors of adverse drug reactions(ADRs),and provide references for rational drug use.Methods A retrospective analysis was conducted on 251 tumor patients who received off-label use of albumin-bound paclitaxel at Shenzhen Second People's Hospital from September 1,2022 to December 31,2023.An automatic monitoring plan for albumin-bound paclitaxel was established using CHPS to study the incidence of ADRs and analyze the related factors.Results A total of 196 cases were monitored.The proportions of adverse reactions such as leukopenia,neutropenia,thrombocytopenia,anemia,gastrointestinal reactions,and abnormal liver and kidney functions were 16.46%,12.80%,8.54%,23.78%,15.24%,and 6.70%,respectively.The analysis of related factors indicated that the body mass index(BMI)of patients and the treatment cycle had a significant impact on hematological ADRs caused by albumin-bound paclitaxel.Conclusion The most common ADRs of off-label use of albumin-bound paclitaxel are hematological reactions,which are related to the BMI and treatment cycle of patients.For patients with low BMI and a longer treatment period,enhanced monitoring should be implemented.
Keywords：Off-label useAlbumin-bound paclitaxelChina Hospital Pharmacovigilance SystemAdverse drug reactions
Publication Date：2025-05-30
Online Publishing Date：2025-09-15(First online date of this platform, not the publication date of the document)
Pages：6( 10-14,后插6 )