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基于美国食品药品监督管理局不良事件报告系统数据库的西妥昔单抗不良反应报告分析

Analysis of ADR reports of cetuximab based on the FDA adverse event reporting system database.

作者信息

Zhao Shuai, Wang Yan, Deng Xiaoli, Chen Xi, Lu Zhaoyi

机构信息

Department of Galactophore, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, 350005, China.

Medical Reproductive Center, Jiuquan Hospital, Shanghai General Hospital, Jiuquan, 735000, Gansu, China.

出版信息

Sci Rep. 2025 Feb 3;15(1):4104. doi: 10.1038/s41598-025-88838-z.

Abstract

This study aims to monitor and identify adverse events (AEs) associated with cetuximab, a drug used to treat various late-stage (metastatic) tumors, to improve patient safety and guide drug use. This study retrospectively analyzed the cases reported in the FDA adverse event reporting system (FAERS) related to the application of cetuximab from 2013 Q1 to 2022 Q4. Disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the empirical Bayesian geometric mean (EBGM) algorithms, were employed to quantify the signals of cetuximab-associated AEs. A total of 8364225 reports were contained in the FAERS database, of which 5186 reports of cetuximab were identified as 'primary suspected (PS)' AEs. The application of cetuximab resulted in AEs in 22 system organ classes (SOCs), which preserved 176 significant disproportionality preferred terms (PTs) through the computation of four algorithms. The main SOCs (Skin and subcutaneous tissue disorders, investigations, metabolism and nutrition disorders, and blood and lymphatic system disorders) accounted for 58.63%. Some AEs were not on the drug label: speech disorder, intervertebral discitis, glomerulonephritis rapidly progressive and disseminated intravascular coagulation. This study identified new signals of adverse drug reactions (ADRs) other than those mentioned in the specification associated with cetuximab, providing valuable insights into the relationship between ADRs and cetuximab use. The findings highlight the importance of continuous surveillance to detect and manage AEs effectively, ultimately improving patient safety during treatment with cetuximab.

摘要

本研究旨在监测和识别与西妥昔单抗相关的不良事件(AE),西妥昔单抗是一种用于治疗各种晚期(转移性)肿瘤的药物,以提高患者安全性并指导药物使用。本研究回顾性分析了2013年第一季度至2022年第四季度美国食品药品监督管理局不良事件报告系统(FAERS)中与西妥昔单抗应用相关的病例报告。采用不成比例分析,包括报告比值比(ROR)、比例报告比值(PRR)、贝叶斯置信传播神经网络(BCPNN)和经验贝叶斯几何均值(EBGM)算法,来量化与西妥昔单抗相关不良事件的信号。FAERS数据库中共包含8364225份报告,其中5186份西妥昔单抗报告被确定为“主要怀疑(PS)”不良事件。西妥昔单抗的应用导致22个系统器官类别(SOC)出现不良事件,通过四种算法的计算保留了176个显著不成比例的首选术语(PT)。主要的系统器官类别(皮肤和皮下组织疾病、检查、代谢和营养紊乱以及血液和淋巴系统疾病)占58.63%。一些不良事件未在药品标签上列出:言语障碍、椎间盘炎、快速进展性肾小球肾炎和弥散性血管内凝血。本研究识别出了与西妥昔单抗相关的、规格中未提及的药物不良反应(ADR)新信号,为药物不良反应与西妥昔单抗使用之间的关系提供了有价值的见解。研究结果强调了持续监测以有效检测和管理不良事件的重要性,最终在西妥昔单抗治疗期间提高患者安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/525e/11790939/a3c2f0b0e452/41598_2025_88838_Fig1_HTML.jpg

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