目的：苯达莫司汀被批准用于治疗慢性淋巴细胞白血病和惰性B细胞非霍奇金淋巴瘤。尽管苯达莫司汀具有治疗功效，但其在大量人群中的长期安全性仍不清楚。本研究使用真实世界的药物警戒数据库来评估与苯达莫司汀相关的不良事件 (AE)，以支持其临床应用。方法：我们进行了上市后风险分析，以评估苯达莫司汀及其 AE 之间的关联。数据提取自美国FDA不良事件报告系统（FAERS），涵盖2017年1月至2023年9月期间。进一步分析苯达莫司汀相关AE的特征和发病时间。使用MYSQL 8.0、Navicat Premium 15、Microsoft EXCEL 2016和Minitab 21.0进行统计分析。结果：FAERS 数据库收集了 9,461,874 份报告，其中 9,131 份报告将苯达莫司汀确定为“主要可疑”药物。我们确定了 331 个显着不相称的首选条款 (PT)。常见的不良事件包括发热、中性粒细胞减少、输注部位反应、进行性多灶性白质脑病 (PML)、注射部位血管炎和肺炎——所有这些都记录在苯达莫司汀的标签上。值得注意的是，发现了 16 种意想不到的显着 AE，包括低丙种球蛋白血症，这种情况令人担忧，因为它可能会增加苯达莫司汀治疗后的感染易感性。其他重要发现包括过敏反应、PML 和皮肤恶性肿瘤，这表明可能有必要更新该药物的标签。医生应监测患者的神经系统和皮肤变化，如果怀疑患有 PML，则停止治疗。此外，苯达莫司汀相关 AE 的中位发病时间为 13 天，四分位数范围 [IQR] 为 0-59 天，主要发生在启动后的第一天。苯达莫司汀相关 AE 的 β 表明风险随着时间的推移而降低。结论：我们的研究发现了苯达莫司汀的一些潜在药物警戒信号，为其安全有效的临床使用提供了重要见解。版权所有 © 2024 Li、Zhang、Ni、Zhu、Lu、Chen、Cheng、Wang、Li、Wang、Lu、Chen and陈。

Objective: Bendamustine was approved for treating chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma. Despite its therapeutic benefits, the long-term safety of bendamustine in a large population remains inadequately understood. This study evaluates the adverse events (AEs) associated with bendamustine, using a real-world pharmacovigilance database to support its clinical application. Methods: We conducted a post-marketing risk analysis to assess the association between bendamustine and its AEs. Data were extracted from the US FDA's Adverse Event Reporting System (FAERS), covering the period from January 2017 to September 2023. The characteristics of bendamustine-associated AEs and the onset time were further analyzed. Statistical analysis was performed using MYSQL 8.0, Navicat Premium 15, Microsoft EXCEL 2016, and Minitab 21.0. Results: 9,461,874 reports were collected from the FAERS database, 9,131 identified bendamustine as the "primary suspected" drug. We identified 331 significant disproportionality preferred terms (PTs). Common AEs included pyrexia, neutropenia, infusion site reaction, progressive multifocal leukoencephalopathy (PML), injection site vasculitis, and pneumonia-all documented on bendamustine's label. Notably, 16 unexpected and significant AEs were discovered, including hypogammaglobulinemia, which is concerning due to its potential to increase infection susceptibility following bendamustine treatment. Other significant findings were anaphylactic reactions, PML, and cutaneous malignancies, suggesting updates to the drug's label may be necessary. Physicians should monitor for neurological and skin changes in patients and discontinue treatment if PML is suspected. Moreover, the median onset time for bendamustine-associated AEs was 13 days, with an interquartile range [IQR] of 0-59 days, predominantly occurring on the first day post-initiation. The β of bendamustine-related AEs suggested risk reduction over time. Conclusion: Our study uncovered some potential pharmacovigilance signals for bendamustine, providing important insights for its safe and effective clinical use.Copyright © 2024 Li, Zhang, Ni, Zhu, Lu, Chen, Cheng, Wang, Li, Wang, Lu, Chen and Chen.