中国临床药理学杂志2024，Vol.40Issue(7)：1063-1067,5.DOI:10.13699/j.cnki.1001-6821.2024.07.027
临床应用中环磷酰胺不良事件的分析
Analysis of cyclophosphamide adverse events in clinical applications
摘要
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.关键词
环磷酰胺/药品不良反应/药物警戒/美国食品药品监督管理局不良事件报告系统/数据挖掘与分析Key words
cyclophosphamide/adverse drug reaction/pharmacovigilance/Food and Drug Administration adverse event reporting system/signal mining and analysis分类
医药卫生引用本文复制引用
章婉春,汪梅姣,谢志军..临床应用中环磷酰胺不良事件的分析[J].中国临床药理学杂志,2024,40(7):1063-1067,5.基金项目
国家自然科学基金资助项目(81973829) （81973829）
浙江省中医药科技计划基金资助项目(2020ZZ006) （2020ZZ006）
