PDF(Pubmed)
Abstract：
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.
摘要：
目的：苯达莫司汀已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。尽管有治疗上的好处,苯达莫司汀在大量人群中的长期安全性仍未得到充分理解.本研究评估了与苯达莫司汀相关的不良事件（AE），使用真实世界的药物警戒数据库来支持其临床应用。方法：我们进行了上市后风险分析，以评估苯达莫司汀与其AE之间的关联。数据来自美国FDA的不良事件报告系统(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的特点及发病时间。使用MYSQL8.0、NavicatPremium15、MicrosoftEXCEL2016和Minitab21.0进行统计分析。结果：从FAERS数据库收集了9,461,874份报告，9131人确定苯达莫司汀为“主要可疑”药物。我们确定了331个显著的不成比例偏好术语(PT)。常见的不良事件包括发热，中性粒细胞减少症,输液部位反应,进行性多灶性白质脑病（PML），注射部位血管炎，和肺炎-都记录在苯达莫司汀的标签上。值得注意的是,发现了16个意外和显著的不良事件，包括低球蛋白血症,这是令人担忧的，因为它有可能增加苯达莫司汀治疗后的感染易感性。其他重要的发现是过敏反应，PML,和皮肤恶性肿瘤，建议更新药物标签可能是必要的。医师应监测患者的神经和皮肤变化，如果怀疑PML，则应停止治疗。此外，苯达莫司汀相关AE的中位发病时间为13天，四分位数间距[IQR]为0-59天，主要发生在启动后的第一天。苯达莫司汀相关不良事件的β值提示随着时间的推移风险降低。结论：我们的研究发现了苯达莫司汀的一些潜在的药物警戒信号，为其安全有效的临床使用提供重要见解。
