Jia Peng, Zhou Yusen, Gao Yuan, Wang Shangyu, Yin Jiangliu, Lian Yixiang, Lai Quanyou
Department of Hepato-Biliary and Pancreato-Splenic Surgery, Xijing Hospital, Air Force Military Medical University, Xi'an, China.
Department of Neurosurgery, The Affiliated Changsha Central Hospital, University of South China, Changsha, China.
Front Pharmacol. 2025 Feb 13;16:1524159. doi: 10.3389/fphar.2025.1524159. eCollection 2025.
Although imipenem/cilastatin (IMI/CIL) has demonstrated favorable therapeutic efficacy against various infections, the incidence of potential adverse events (AEs) has escalated in parallel with its increased utilization and has been documented in clinical trials. However, a comprehensive understanding of real-world implications remains lacking.
By conducting a comprehensive search in the FDA Adverse Event Reporting System (FAERS) database, AE reports associated with IMI/CIL as the primary suspect (PS) were selected for analysis, spanning from the first quarter of 2004 to the fourth quarter of 2023. Utilizing disproportionality analysis techniques, potential signals of AE s were identified through reported odds ratio (ROR), proportional report ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayesian geometric mean (EBGM). The obtained results were systematically classified using Medical Dictionary for Regulatory Activities (MedDRA).
From the first quarter of 2004 to the fourth quarter of 2023, a total of 2,574 reports documenting AEs associated with IMI/CIL were obtained, with more than half (n = 1,517, 58.94%) involving individuals aged over 60 years old. Descriptive analysis was conducted based on age groups and time to onset, revealing that the majority of AEs occurred within 3 days. Adverse drug reactions caused by IMI/CIL were classified into 24 system organ classes (SOCs) at the preferred term (PT) level. Furthermore, previously unreported and clinically significant AEs such as cerebral atrophy, and delirium were also identified at the PT level.
This study offers a more comprehensive insight into the monitoring, supervision, and management of adverse drug reactions associated with IMI/CIL. Clinicians should pay further attention to the implications of numerous AEs and their corresponding signal intensities, as well as unrecorded signals of severe AEs. This holds significant value in enhancing the clinical safety profile of IMI/CIL.
尽管亚胺培南/西司他丁（IMI/CIL）已显示出对各种感染具有良好的治疗效果，但随着其使用频率的增加，潜在不良事件（AE）的发生率也相应上升，临床试验中已有相关记录。然而，对于其在现实世界中的影响仍缺乏全面了解。
通过在美国食品药品监督管理局不良事件报告系统（FAERS）数据库中进行全面检索，选取以IMI/CIL为主要怀疑对象（PS）的AE报告进行分析，时间跨度为2004年第一季度至2023年第四季度。利用不成比例分析技术，通过报告比值比（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）识别AE的潜在信号。使用监管活动医学词典（MedDRA）对所得结果进行系统分类。
2004年第一季度至2023年第四季度，共获得2574份记录与IMI/CIL相关AE的报告，其中一半以上（n = 1517，58.94%）涉及60岁以上个体。基于年龄组和发病时间进行描述性分析，结果显示大多数AE发生在3天内。IMI/CIL引起的药物不良反应在首选术语（PT）级别被分为24个系统器官类别（SOC）。此外，在PT级别还识别出了如脑萎缩和谵妄等先前未报告且具有临床意义的AE。
本研究为与IMI/CIL相关的药物不良反应的监测、监督和管理提供了更全面的见解。临床医生应进一步关注众多AE的影响及其相应的信号强度，以及严重AE的未记录信号。这对于提高IMI/CIL的临床安全性具有重要价值。
