基于美国FAERS数据库的芦可替尼相关感染性不良事件的挖掘与分析
Mining and Analysis of Ruxolitinib-Associated Infectious Adverse Events Based on the US FAERS
曹燕妮 1谭皓文2
作者信息
- 1. 重庆医科大学第一附属医院药学部,重庆 400042
- 2. 梧州市红十字会医院药物临床试验机构办公室,广西 梧州 543002
- 折叠
摘要
目的:基于美国食品药品监督管理局不良事件报告系统(FAERS),挖掘芦可替尼相关感染性不良事件,以评估临床用药的安全性.方法:使用《国际医学用语词典》(26.1 版)医学标准术语集中的系统器官分类(SOC)和首选术语(PT),收集 2011 年第 4 季度至 2023 年第 3 季度FAERS数据库中芦可替尼相关感染性不良事件的报告,并使用比例失衡算法中的报告比值比法(ROR)进行风险信号的检测与分析.结果:共收集到芦可替尼相关感染性不良事件报告6406 例,检测到芦可替尼在SOC水平的感染及侵染类疾病具有风险信号,ROR=1.52(95%CI=1.48～1.56);在SOC为感染及侵染类疾病下的PT水平共检测到103 个具有风险信号的PT,其中最常见的PT为感染性肺炎、感染、脓毒症、尿路感染、带状疱疹、鼻咽炎、流行性感冒、支气管炎、结核病、蜂窝织炎等,多个感染性疾病相关的PT没有在芦克替尼的药品说明书中记载.结论:临床上使用芦可替尼时,需要注意监护患者感染性疾病的出现,保证患者用药安全.
Abstract
OBJECTIVE:To explore the ruxolitinib-associated infectious adverse events based on the US Food and Drug Administration Adverse Event Reporting System(FAERS)database,so as to evaluate the safety of clinical use.METHODS:Reports of rucotinib-associated infectious adverse events were collected from the FAERS database from the fourth quarter of 2011 to the third quarter of 2023 by using the preferred system organ classification(SOC)and preferred terminology(PT)in the Medical Dictionary for Regulatory Activities(version 26.1).The risk signal was detected and analyzed by reporting odds ratio(ROR)in ratio imbalance method.RESULTS:A total of 6406 reports of ruxolitinib-associated infectious adverse events were collected.Ruxolitinib was detected as a risk signal for infection and infectious diseases at SOC level,ROR=1.52(95%CI=1.48-1.56).A total of 103 PT with risk signals were detected in the SOC for infection and infectious diseases,among which the most common PT were infectious pneumonia,infection,sepsis,urinary tract infection,herpes zoster,nasopharyngitis,influenza,bronchitis,tuberculosis,and phlegmonitis.Multiple infectious disease-associated PT were not documented in the drug instructions of ruxolitinib.CONCLUSIONS:When rucotinib is used clinically,attention needs to be paid to monitoring the emergence of infectious diseases to ensure the safety of medication for patients.
关键词
芦可替尼/美国食品药品监督管理局不良事件报告系统/数据挖掘/感染性不良事件Key words
Ruxolitinib/FAERS/Data mining/Infectious adverse events引用本文复制引用
基金项目
广西卫生健康委西医类科研课题(Z-D20231663)
出版年
2024
国家科技期刊平台
NSTL
万方数据