摘要
目的利用美国FDA不良事件系统(FAERS)数据库对呋喹替尼潜在药品不良事件(ADE)进行挖掘分析,为优化临床用药决策提供依据。方法收集FAERS中呋喹替尼上市后ADE报告,采用不成比例分析法进行数据挖掘,采用《国际医学用语词典》对ADE进行分类统计。结果共收集到1188份ADE报告,挖掘到101个ADE信号,严重ADE占63.81%,93.06%ADE发生在前4个治疗周期。胃肠系统疾病相关ADE最为常见。挖掘出肾局限性血栓性微血管病等68种未被药品说明书记录的ADE。结论临床使用呋喹替尼前应评估患者用药风险,前4个治疗周期需密切监测患者,并关注新可疑风险ADE,以确保癌症患者用药安全。
OBJECTIVE The U.S.FDA Advers e Event System(FAERS)database was use d to mine and analyze the potential adverse drug event s(ADE)of fruquintinib to provide a ba sis for optimizing clinical drug deci sionmaking.METHODS The post-marketing AD E reports of fruquintinib in FAERS wer e collected,and the data were mined by disproportionate analysis,a nd the Medical Dictionary for Regulat ory Activities was used to classify an d count the ADE.RESULTS A total of 1188 ADE reports were collected,and 101 AD E signals were mined,of which 63.81%were severe ADE,and 93.06%ADE o ccurred in the first four treatment cy cles.ADE associated with gastrointestinal disorders were the most co mmon.68 types of ADE that were not reco rded in the drug label,such as renal l ocalized thrombotic microangiopathy,w ere excavated.CONCLUSION Patients sh ould be evaluated for drug risk before clinical use of fruquintinib,and patients should be closely monitored for the first four cycles of treatment,and attention should be paid to new suspecte d risk ADE to ensure drug safety for ca ncer patients.
作者
饶媚
吴丽华
陈洋溢
王慧颖
RAO Mei;WU Li-hua;CHEN Yang-yi;WANG Hui-ying(Department of Pharmac y,Longyan First Affiliated Hospital of Fujian MedicalUniversity,Longyan 364000,China;The School of Pharmacy,Fujian Medical University,Fuzhou 350122,China)
出处
《海峡药学》
2025年第11期80-85,共6页
Strait Pharmaceutical Journal
基金
龙岩市科技计划项目资助(基金编号2024 LYF17067)。
