Adverse drug events associated with fluorouracil use in patients with metastatic colorectal cancer: a real-world pharmacovigilance study based on the FDA adverse event reporting system.

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Expert Opinion on Drug Safety Pub Date : 2024-10-01 Epub Date: 2024-07-23 DOI:10.1080/14740338.2024.2380513
Ruiqi Zhao, Mengyao Han, Sen Lin, Zhimei Lin, Mengjiao Yu, Bei Zhang, Lanyue Ma, Danfei Li, Lisheng Peng
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引用次数: 0

Abstract

Background: Fluorouracil (5-FU) is widely used to treat metastatic colorectal cancer (mCRC), but real-world safety data is limited. Our study aimed to evaluate 5-FU's safety profile in a large mCRC population using the FAERS database.

Research design and methods: We conducted disproportionality analyses to identify adverse drug events associated with 5-FU use in mCRC patients from 2004 to 2023. Subgroup analyses, gender difference analyses, and logistic regression were also performed.

Results: We identified 1,458 reports with 5-FU as the primary suspected drug, with males accounting for 48.8% of reports. Gastrointestinal disorders were the most common adverse event (864 cases), while pregnancy-related conditions showed the strongest signal intensity (ROR = 2.97). We found 19 preferred terms with positive signals, including ischemic hepatitis (ROR = 59.32), blood iron increased (ROR = 59.32), and stress cardiomyopathy (ROR = 51.94). Males were more susceptible to weight loss and skin toxicity. Most adverse events occurred within the first month of 5-FU administration.

Conclusion: Our study provides a comprehensive analysis of 5-FU's safety profile in mCRC patients, helping healthcare professionals mitigate risks in clinical practice.

与转移性结直肠癌患者使用氟尿嘧啶相关的药物不良事件:基于美国食品药物管理局不良事件报告系统的真实世界药物警戒研究。
背景:氟尿嘧啶(5-FU)被广泛用于治疗转移性结直肠癌(mCRC),但真实世界的安全性数据有限。我们的研究旨在利用 FAERS 数据库评估 5-FU 在大量 mCRC 患者中的安全性:我们进行了比例失调分析,以确定 2004 年至 2023 年间在 mCRC 患者中使用 5-FU 的相关药物不良事件。我们还进行了亚组分析、性别差异分析和逻辑回归:结果:我们发现了 1458 份以 5-FU 为主要可疑药物的报告,其中男性占 48.8%。胃肠功能紊乱是最常见的不良事件(864 例),而与妊娠相关的情况显示出最强的信号强度(ROR = 2.97)。我们发现 19 个首选术语具有阳性信号,包括缺血性肝炎(ROR = 59.32)、血铁增加(ROR = 59.32)和应激性心肌病(ROR = 51.94)。男性更容易出现体重减轻和皮肤中毒。大多数不良反应发生在服用 5-FU 的第一个月内:我们的研究全面分析了5-FU在mCRC患者中的安全性,有助于医护人员在临床实践中降低风险。
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来源期刊
CiteScore
5.90
自引率
3.20%
发文量
97
审稿时长
6-12 weeks
期刊介绍: Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
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