药物相关炎症性肠病：基于FAERS和JADER数据库的真实世界药物警戒研究
Drug-associated inflammatory bowel disease: a real-world pharmacovigilance study using the FAERS and JADER databases.
摘要(中文译文)
尽管已有多种药物被报道与炎症性肠病（IBD）相关，但大多数药物与IBD之间的关联仍不明确。本研究旨在通过分析美国食品药品监督管理局不良事件报告系统（FAERS）和日本不良药物事件报告（JADER）数据库的大规模数据，识别与IBD关联报告最频繁的药物。我们从FAERS中提取了药物相关IBD不良事件的报告，并使用JADER进行外部验证。采用四种方法对可疑药物进行不相称性分析：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器（MGPS）。其他分析包括发病时间（TTO）评估、Weibull分布建模，以及按年龄、性别和IBD亚型进行的亚组分析，以评估信号稳定性和临床特征。FAERS数据库共获得52,395份药物相关IBD报告，对应50,426名患者。女性报告比例高于男性，大多数病例发生于18-64岁人群。年度报告数量呈整体上升趋势。在报告至少50次的药物中，17种满足全部四项算法阈值标准，被归类为阳性信号。抗肿瘤坏死因子-α（抗TNF-α）抑制剂的报告频率最高，而异维A酸的信号强度最强。使用JADER进行的外部验证证实了某些抗TNF-α抑制剂、抗白细胞介素生物制剂、传统免疫抑制剂和抗生素的信号一致性。发病时间分析显示，大多数药物相关病例的IBD中位发病时间在一年以内。Weibull模型表明大多数阳性信号呈“早期失败型”发病模式。从药物警戒的角度来看，本研究提供了与IBD相关药物的全面概述，提供了具有临床相关性的见解。我们的研究结果为药物相关IBD的识别和监测提供了真实世界证据；然而，仍需在大规模前瞻性队列研究中加以证实。
Abstract
Although several medications have been linked to inflammatory bowel disease (IBD), the association between most drugs and IBD remains unclear. This study aimed to identify medications most frequently reported in connection with IBD by analyzing large-scale data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japan Adverse Drug Event Report (JADER) database. We extracted reports of drug-associated IBD adverse events from FAERS and performed external validation using JADER. Disproportionality analyses of suspected drugs were conducted using four methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS). Additional analyses included time-to-onset (TTO) assessment, Weibull distribution modeling, and subgroup analyses by age, sex, and IBD subtype to evaluate signal stability and clinical characteristics. The FAERS database yielded 52,395 reports of drug-associated IBD, corresponding to 50,426 patients.Females accounted for a higher proportion of reports than males, with the majority of cases occurring in individuals aged 18-64 years. The annual number of reports showed an overall upward trend. Among drugs reported at least 50 times, 17 met all four algorithmic threshold criteria and were classified as positive signals. Anti-tumor necrosis factor-alpha (anti-TNF-α) inhibitors ranked highest by reporting frequency, whereas isotretinoin demonstrated the strongest signal intensity. External validation using JADER confirmed consistent signals for certain anti-TNF-α inhibitors, anti-interleukin biologic agents, conventional immunosuppressants, and antibiotics. Time-to-onset analysis revealed that the median onset of IBD occurred within one year for most drug-associated cases. The Weibull model indicated an "early failure-type" onset pattern for the majority of positive signals. From a pharmacovigilance perspective, this study provides a comprehensive overview of medications associated with IBD, offering clinically relevant insights. Our findings deliver real-world evidence to support the identification and monitoring of drug-associated IBD; however, confirmation in large prospective cohort studies remains necessary.
如何引用
AMA
Yuou Ying, Mengyuan Shen, Jinhan Chen, Tongfei Feng, Zejiong Li, Zhekai Ying, et al. Drug-associated inflammatory bowel disease: a real-world pharmacovigilance study using the FAERS and JADER databases.. Frontiers in immunology. 2026; doi:10.3389/fimmu.2026.1873829.
APA
Yuou Ying, Mengyuan Shen, Jinhan Chen, Tongfei Feng, Zejiong Li, Zhekai Ying, et al (2026). Drug-associated inflammatory bowel disease: a real-world pharmacovigilance study using the FAERS and JADER databases.. Frontiers in immunology. https://doi.org/10.3389/fimmu.2026.1873829
GB/T 7714
Yuou Ying, Mengyuan Shen, Jinhan Chen, Tongfei Feng, Zejiong Li, Zhekai Ying, et al. Drug-associated inflammatory bowel disease: a real-world pharmacovigilance study using the FAERS and JADER databases.[J]. Frontiers in immunology, 2026 doi:10.3389/fimmu.2026.1873829.
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