摘要
目的 利用美国食品药品管理局不良事件报告系统(FAERS)数据库对白消安的药品不良事件(ADE)进行研究,挖掘潜在的ADE信号,为临床安全用药提供参考。方法 检索FAERS数据库中2004年第1季度至2023年第1季度的数据,通过数据清洗、目标药物名称标准化,获得以白消安为首要怀疑药物的ADE记录。采用报告比值比法、比例报告比值法和综合标准法挖掘白消安ADE信号,并利用信息成分法进行信号强弱判断。以《国际医学用语词典》对ADE进行系统器官分类(SOC),并按照ADE发生频次和信号强度分别排序。结果 共获得20 326份以白消安为首要怀疑药物的ADE报告,涉及患者5 615例,男性患者比例高于女性(40.71%vs.30.74%);年龄小于18岁占31.56%;上报人群主要为医师(33.71%)、其他健康专业人员(24.35%)以及药师(23.86%);上报国家主要为美国(29.69%)、日本(15.78%)、法国(11.79%)。共挖掘出白消安相关ADE信号556个,其中117个ADE信号未被药品说明书收载。556个ADE信号中,发生频次前五位ADE分别为产品用于未经批准的适应证、肝小静脉闭塞症、黏膜炎症、巨细胞病毒感染和移植物抗宿主病;信号强度排名前五位ADE分别为肝小静脉闭塞症、急性移植物抗宿主病、静脉闭塞性疾病、移植物抗宿主病以及慢性移植物抗宿主病。挖掘的ADE信号共累及23个SOC,数量排名前三的SOC分别为感染及侵染类疾病,各类检查,良性、恶性及性质不明的肿瘤(包括囊状和息肉状)。结论 白消安临床应用中,应警惕肝小静脉闭塞症、感染、移植物抗宿主病、神经相关毒性和血栓性微血管病等易造成严重后果的ADE,临床药师协助医师做好ADE的预防方案,提高白消安的使用安全性。
Objective To study adverse drug events(ADEs) of busulfan the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS),and to mine the potential ADE signals,so as to provide reference for the safe drug use in clinical practice.Methods Data from the first quarter of 2004 to the first quarter of 2023 were retrieved from the FAERS database,and ADE records for busulfan as a primary suspect drug were obtained through data cleaning and standardization of target drug names.Risk signals for busulfan ADEs were mined based on the reporting odds ratio method,the proportional reporting ratio method,and Medicines and Healthcare Products Regulatory Agency method.The information component method was used to assess the intense of the risk signals.The ADEs were systematically classified according to Medical Dictionary for Regulatory Activities(MedDRA),and two ranking sequence of busulfan ADEs were generated by signal occurrence frequency and signal intense,respectively.Results A total of 20 326 ADE records were collected,involving 5 615 patients with 556 related ADE signals,of which 117 were newly reported as compared to those in the drug instruction of busulfan.Male patients accounted for a higher proportion than female patients(40.71% vs.30.74%).The main population of patients were younger than 18 years old(31.56%).The reports were most reported by physicians(33.71%) and other health professionals(24.35%) as well as pharmacists(23.86%),mainly from the United States(29.69%),Japan(15.78%),and France(11.79%).The top five ADEs in terms of occurrence frequency were busulfan use in unapproved indications,hepatic veno-occlusive disease(HVOD),mucosal inflammation,cytomegalovirus infection,and graft versus host disease.The top five ADEs in terms of signal intense were HVOD,acute graft versus host disease,veno-occlusive disease,graft versus host disease,and chronic graft versus host disease.The ADE signals involves 23 system organ classes.The top three SOCs in terms of the number of ADE signals were infections/infestations,investigations and neoplasms benign/malignant/unspecified(include cysts and polyps).Conclusion When busulfan is used in clinic,attention should be paid to its adverse events in hepatic veno-occlusive disease,infections,graft versus host disease,neurotoxicity,and venous thromboembolism,which are likely to cause serious consequences.The clinical pharmacists can assist clinicians to make prevention plans in case of busulfan ADEs,so as to improve the safety of busulfan use in clinic.
作者
王广飞
张俊琦
黄怡蝶
王月玥
翟晓文
李智平
WANG Guangfei;ZHANG Junqi;HUANG Yidie;WANG Yueyue;ZHAI Xiaowen;LI Zhiping(Department of Clinical Pharmacy,National Children's Medical Center/Children's Hospital of Fudan University,Shanghai 201102,China;Department of Pharmacy,Qidong Branch,Children's Hospital of Fudan University/Qidong Women's and Children's Health Hospital,Qidong 226299,Jiangsu Province,China;Department of Hematology,National Children's Medical Center/Children's Hospital of Fudan University,Shanghai 201102,China)
出处
《药物流行病学杂志》
CAS
2024年第3期259-268,共10页
Chinese Journal of Pharmacoepidemiology
基金
上海青年药学人才能力提升项目(沪药会字[2023]04号)
上海市医药卫生发展基金会项目(20221128)。
