Xu Qinyun, Zhang Jing, Tang Weihong, Zhou Minhong, Zhang Xiaoling, Yuan Pu
Nanjing University of Chinese Medicine Wuxi Affiliated Hospital: Wuxi Hospital of Traditional Chinese Medicine, Wuxi, 214071, China.
Sci Rep. 2025 Jan 2;15(1):278. doi: 10.1038/s41598-024-75421-1.
This study aims to mine and analyze adverse events (AEs) of Vedolizumab based on the FAERS database to better understand its safety and potential risks in the real world. Data from the second quarter of 2014 to the third quarter of 2023 were collected, employing various signal mining methods such as Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM). The study gathered 14,753,012 reports of AEs, of which 46,726 were related to Vedolizumab. Signal mining identified 401 Preferred Terms (PTs) involving 27 System Organ Classes (SOCs). There was an increasing trend in the number of reports, with a slightly higher proportion of reports from women compared to men, and the primary reporting group was adults, especially those aged between 18 and 65 years. New potential AE signals were identified, such as a higher incidence of Pregnancy, Haematochezia, and Clostridium difficile infection. Although less frequent, strong signals were noted for Incisional hernia, Intestinal fistula infection, Anastomotic complication, Drug metabolising enzyme increased, Gingival graft, Intestinal anastomosis complication, Anorectal infection, Perineal rash, and Abdominal hernia obstructive. Despite the positive prospects of Vedolizumab in the treatment of inflammatory bowel diseases, the AEs related to its use identified in this study, particularly the newly identified potential risks, suggest that even targeted therapies can have systemic effects beyond expectations.
本研究旨在基于美国食品药品监督管理局不良事件报告系统（FAERS）数据库挖掘和分析维得利珠单抗的不良事件（AE），以更好地了解其在现实世界中的安全性和潜在风险。收集了2014年第二季度至2023年第三季度的数据，采用了多种信号挖掘方法，如报告比值比（ROR）、比例报告比（PRR）、贝叶斯置信传播神经网络（BCPNN）和经验贝叶斯几何均值（EBGM）。该研究收集了14753012份不良事件报告，其中46726份与维得利珠单抗有关。信号挖掘确定了涉及27个系统器官分类（SOC）的401个首选术语（PT）。报告数量呈上升趋势，女性报告比例略高于男性，主要报告群体为成年人，尤其是18至65岁的成年人。确定了新的潜在不良事件信号，如妊娠、便血和艰难梭菌感染的发生率较高。虽然不太常见，但切口疝、肠瘘感染、吻合口并发症、药物代谢酶增加、牙龈移植、肠吻合并发症、肛肠感染、会阴皮疹和腹疝梗阻等方面出现了强烈信号。尽管维得利珠单抗在治疗炎症性肠病方面前景乐观，但本研究中确定的与其使用相关的不良事件，特别是新发现的潜在风险，表明即使是靶向治疗也可能产生超出预期的全身影响。
