针对吉西他滨的 FDA 不良事件报告系统 (FAERS) 真实世界药物警戒研究。

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Expert Opinion on Drug Safety Pub Date : 2024-10-24 DOI:10.1080/14740338.2024.2419999
Cheng Zhang, Ke Li, Shu-Ning Xu, Lei Qiao, Yu-Lin Ren, Qun Li, Ying Liu
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引用次数: 0

摘要

背景:吉西他滨被广泛用于治疗各种癌症。本研究旨在利用美国食品和药物管理局不良事件报告系统(FAERS)数据库评估吉西他滨相关不良事件(AEs):我们分析了2004年1月至2023年6月的数据。采用报告几率比(ROR)和贝叶斯置信传播神经网络(BCPNN)算法,我们确定了吉西他滨用药患者中出现阳性信号的 AEs:在16,623,939份报告中,有23,645份涉及吉西他滨作为 "主要疑似药物(PS)",导致74,306例AE。与规范和临床试验中的报告一致,血小板减少、发热、中性粒细胞减少和贫血是最常见的不良反应。值得注意的是,我们的研究发现了一些意外的 AE,如腹痛、胸腔积液、腹水和消化道出血等。最重要的SOC是 "血液和淋巴系统疾病"。吉西他滨相关AEs的中位发病时间为24天(四分位数间距[IQR] 6-82天),大多数病例发生在服用吉西他滨后的最初30天内:结论:吉西他滨与影响多个器官系统的广泛AEs有关,住院治疗的发生率很高。本研究强调了预期和意外的AEs,这可能会提高吉西他滨未来的临床应用和安全性。
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A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) for gemcitabine.

Background: Gemcitabine is widely used in the treatment of various cancers. This study aims to evaluate gemcitabine-associated adverse events (AEs) using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Research design and methods: We analyzed data spanning from January 2004 to June 2023. Employing reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN) algorithms, we identified AEs with positive signals in patients administered gemcitabine.

Results: Out of 16,623,939 reports, 23,645 involved gemcitabine as the 'primary suspected (PS)' resulting in 74,306 AEs. Consistent with the reports in the specification and clinical trials, thrombocytopenia, pyrexia, neutropenia, and anemia were the most common AEs. Notably, our study identified some unexpected AEs such as abdominal pain, pleural effusion, ascites, and gastrointestinal hemorrhage, among others. The most significant SOC was 'Blood and lymphatic system disorders'. The median onset time for gemcitabine-related AEs was 24 days (interquartile range [IQR] 6-82 days), with most cases occurring within the initial 30 days following gemcitabine administration.

Conclusion: Gemcitabine is associated with a broad spectrum of AEs affecting multiple organ systems, with a notable incidence of hospitalization. The study highlights both expected and unexpected AEs, which could enhance future clinical applications and safety of gemcitabine.

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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.
期刊最新文献
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