基于FDA不良事件报告系统(FAERS)数据库的磺胺氮嗪药物警戒研究和药理学分析。

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Dandan Guo, Bufu Tang, Peng Luo, Jian Zhang, Lvdan Deng, Sentao Fu, Zhijun Shen, Qing Li, Zhao Xie, Na Hang, Hongjie Fan, Ling Wang
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引用次数: 0

摘要

目的:本研究旨在利用FDA不良事件报告系统(FAERS)检测和识别与柳硫氮嗪相关的不良事件(ae),为临床使用提供参考。方法:采用4种算法(ROR、PRR、BCPNN和EBGM)检测真实数据中的柳氮磺嘧啶相关AE信号,计算出柳氮磺嘧啶相关AE信号。结果:在研究期间,FAERS共提取了91,509例磺胺嘧啶相关(sasp相关)不良事件报告。共发现6830例磺胺嘧啶不良反应信号,涉及23个器官系统。分析显示了几种常见的不良反应;最常见的不良反应是头晕、不适、乏力、食欲减退、皮疹和贫血,这些不良反应列在磺胺氮嗪的警告标签上。值得注意的是,在我们的研究中,在首选术语(PT)中,我们还发现了一些警告标签上没有提及的反应,如视力模糊和心力衰竭。结论:本研究揭示了磺胺吡啶可能导致的新的不良反应,需要进一步的研究来证实这些新的不良反应。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A real-world pharmacovigilance study and pharmacological analysis of sulfasalazine based on the FDA adverse event reporting system (FAERS) database.

Objective: The purpose of this study was to use the FDA Adverse Event Reporting System (FAERS) to detect and identify adverse events (AEs) related to sulfasalazine to provide a reference for clinical use.

Methods: Four algorithms (ROR, PRR, BCPNN and EBGM) were used to detect sulfasalazine-correlated AE signals in real data to calculate the signals associated with sulfasalazine-related AEs.

Results: During the study period, FAERS was used to extract a total of 91,509 sulfasalazine-related (SASP-related) adverse event reports. In total, 6830 sulfasalazine adverse event signals were found, involving 23 organ systems. The analysis revealed several common adverse reactions; the most common were dizziness, malaise, asthenia, decreased appetite, rash, and anemia, and these adverse reactions are listed on the warning label for sulfasalazine. It is worth noting that in our study, in the preferred term (PT), we also found some reactions that were not mentioned on the warning label, such as blurred vision and cardiac failure.

Conclusion: This study revealed potential new AEs resulting from sulfasalazine, and further studies are needed to confirm these new AEs.

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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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