基于FAERS数据库的英夫利西单抗不良事件信号挖掘分析

doi:10.19803/j.1672-8629.20230523

摘要/Abstract

摘要： 目的挖掘英夫利西单抗不良事件（ADE）信号,为临床用药安全提供参考。方法收集美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）中建库至2023年第1季度英夫利西单抗相关ADE,利用报告比值比（ROR）法和贝叶斯可信区间递进神经网络（BCPNN）法进行数据挖掘。结果收集到满足阈值标准的ADE报告数175 930份,获得信号963个,共涉及26个系统-器官分类（SOC）。英夫利西单抗主要ADE表现为胃肠系统疾病,感染及侵染类疾病,全身性疾病及给药部位各种反应,良性、恶性及性质不明的肿瘤和各种肌肉骨骼及结缔组织疾病等,这与药品说明书记录一致。此外,还发现了英夫利西单抗可能导致的心血管疾病、肾损伤和皮肤及皮下组织类等疾病的风险。结论在应用英夫利西单抗时,除了关注药品说明书中记载的ADE之外,也应密切关注说明书未提及的ADE,以提高患者的用药安全。

关键词: 英夫利西单抗, 风险信号, 药品不良事件, FDA不良事件报告系统

Abstract: Objective To provide a reference for the safety in clinical use by exploring the risk signals of infliximab-related adverse drug events (ADE). Methods ADE data related to infliximab from FDA Adverse Event Reporting System (FAERS) were collected from the 1st quarter of 2004 to the 1st quarter of 2023. Data mining was performed using the reporting odds ratio (ROR) method and the Bayesian confidence propagation neural network (BCPNN) method. Results The number of ADE reports met the threshold criteria was 175 930 with 963 signals obtained, involving 26 system organ classes(SOC). The main ADE of infliximab were observed in gastrointestinal diseases, infectious and invasive diseases, systemic diseases and various reactions at the site of administration, benign, malignant and tumors of unknown nature, and various musculoskeletal and connective tissue diseases, which are consistent with the drug’s instructions. In addition, the risk of cardiovascular diseases, renal injury and skin and subcutaneous tissue-like disorders that may result from infliximab was identified in this study. Conclusion When applying infliximab, in addition to the ADE documented in the drug package insert, close attention should also be paid to ADE not mentioned in the instruction to improve the safety of patients medication.

Key words: infliximab, risk signal, adverse drug event, FDA adverse event reporting system (FAERS)

中图分类号:

R994.11

游晓炎, 郑盈盈, 王宪英. 基于FAERS数据库的英夫利西单抗不良事件信号挖掘分析[J]. 中国药物警戒, 2024, 21(3): 335-340.

YOU Xiaoyan, ZHENG Yingying, WANG Xianying. Data-mining and analysis of adverse events signals for infliximab based on FAERS database[J]. Chinese Journal of Pharmacovigilance, 2024, 21(3): 335-340.

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