Analysis of cyclophosphamide adverse events in clinical applications
10.13699/j.cnki.1001-6821.2024.07.027
- VernacularTitle:临床应用中环磷酰胺不良事件的分析
- Author:
Wan-Chun ZHANG
1
;
Mei-Jiao WANG
;
Zhi-Jun XIE
Author Information
1. 浙江中医药大学 基础医学院,浙江 杭州 310000
- Keywords:
cyclophosphamide;
adverse drug reaction;
pharmacovigilance;
Food and Drug Administration adverse event reporting system;
signal mining and analysis
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(7):1063-1067
- CountryChina
- Language:Chinese
-
Abstract:
Objective To provide clinical practitioners with references for rational and safe usage of cyclophosphamide(CTX)by conducting an in-depth analysis of its adverse drug events(ADE)reported in clinical settings.Methods Based on the Food and Drug Administration(FDA)adverse event reporting system,the online pharmacovigilance tool OpenVigil collected ADE data of CTX from January 1,2013 to March 11,2023.The ADE data mining analysis was performed using the reporting odds ratio(ROR)and Bayesian confidence propagation neural network(BCPNN)methods.Results A total of 8 223 ADE reports met the inclusion criteria,and 422 ADE signals were obtained,involving 21 system organ classification(SOC),of which women(44.12％)accounted for a higher proportion than men(31.02％),the age distribution was mainly in the population 46-65 years old.The involved SOC mainly included infections and invasive diseases,hematologic and lymphatic system diseases,systemic diseases and various reactions at the site of administration,etc.;the ADE signals with a higher number of reports were myelosuppression,disease progression,pyrexia,febrile neutropenia,etc.A total of 18 suspected adverse drug reaction(ADR)not documented in the CTX drug insert were unearthed.Conclusion Clinical practitioners should be alert to ADE signals outside the drug insert,such as neonatal diseases and maternal exposure before pregnancy,methemoglobinemia,etc.,when using cyclophosphamide to improve the safety and effectiveness of clinical treatment.
