Yang Chengkai, Guo Qian, Cheng Yang, Liu Fengjing, Zhang Hui, Wang Huaxiang
Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, China.
Department of Rhinology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
PLoS One. 2025 Aug 6;20(8):e0329636. doi: 10.1371/journal.pone.0329636. eCollection 2025.
Flurbiprofen, as a widely used nonsteroidal anti-inflammatory drug (NSAID), is commonly employed to relieve mild to moderate pain and inflammation. Understanding its adverse reactions in real-world usage is of significant importance.
Reports of all adverse drug events (ADEs) related to flurbiprofen were extracted from the FAERS database, covering the period from Q1 2004 to Q3 2024. These reports were standardized and analyzed using various signal quantification techniques, including Reporting Odds Ratios (ROR), Proportional Reporting Ratios (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinkage (MGPS). Finally, the association between flurbiprofen and ADEs as well as clinical medical events was assessed.
A total of 275 cases from the target population were identified in the FAERS database, with 788 instances of adverse events (AEs) occurring across 46 organ systems. We identified not only some common adverse reactions listed in the drug's package insert, such as acute kidney injury, nausea and vomiting, and facial edema, but also significant signals that were not mentioned in the package insert, including Dysphonia, Drug abuse, and Pancreatitis acute. The median time to onset of flurbiprofen-related AEs was 1 day (interquartile range [IQR] 0-5 days), with most AEs occurring within the first month of flurbiprofen use.
This study confirmed some common adverse reactions listed in the flurbiprofen drug package insert and identified significant unexpected adverse reactions. These findings can assist clinicians in conducting more comprehensive clinical monitoring when using the drug, thereby ensuring patient safety during treatment.
氟比洛芬作为一种广泛使用的非甾体抗炎药（NSAID），常用于缓解轻至中度疼痛和炎症。了解其在实际使用中的不良反应具有重要意义。
从FAERS数据库中提取了2004年第一季度至2024年第三季度期间所有与氟比洛芬相关的药物不良事件（ADEs）报告。使用多种信号量化技术对这些报告进行标准化和分析，包括报告比值比（ROR）、比例报告比值比（PRR）、贝叶斯置信传播神经网络（BCPNN）和多项目伽马泊松收缩法（MGPS）。最后，评估氟比洛芬与ADEs以及临床医疗事件之间的关联。
在FAERS数据库中识别出目标人群中的275例病例，46个器官系统共发生788例不良事件（AEs）。我们不仅识别出了药品说明书中列出的一些常见不良反应，如急性肾损伤、恶心呕吐和面部水肿，还发现了药品说明书中未提及的重要信号，包括声音嘶哑、药物滥用和急性胰腺炎。氟比洛芬相关AEs的中位发病时间为1天（四分位间距[IQR]为0 - 5天），大多数AEs发生在使用氟比洛芬的第一个月内。
本研究证实了氟比洛芬药品说明书中列出的一些常见不良反应，并识别出了显著的意外不良反应。这些发现有助于临床医生在使用该药物时进行更全面的临床监测，从而确保治疗期间患者的安全。
