A real-world pharmacovigilance study using disproportionality analysis of united states food and drug administration adverse event reporting system events for vinca alkaloids: comparing vinorelbine and Vincristine

Vinca alkaloids are widely used in cancer treatment for their ability to target microtubule dynamics. While their efficacy in treating certain cancers is well-established, the full spectrum of their adverse event profiles remains an area of ongoing research. We analyzed AEs related to vinorelbine and vincristine using a retrospective case/non-case approach with data from the FDA Adverse Event Reporting System (FAERS). We applied various algorithms to detect AE signals: the reporting odds ratio (ROR) and proportional reporting ratio (PRR) measured disproportionality and association strength; the Bayesian confidence propagation neural network (BCPNN) calculated the Information Component (IC) for associations against background rates; and the multi-item gamma Poisson shrinker (MGPS) yielded empirical Bayes geometric mean (EBGM) values, accounting for reporting variability. Both medications significantly involve the blood and lymphatic systems, with vinorelbine reporting 401 cases in this System Organ Class (SOC), exhibiting a ROR of 17.4, PRR of 12.4, IC of 3.63, and EBGM of 12.38. An intersection analysis of Preferred Terms (PTs) has uncovered previously unreported AEs shared by both drugs, including posterior reversible encephalopathy syndrome and inappropriate antidiuretic hormone secretion. This analysis highlights the need for ongoing research of the risks associated with vinorelbine and vincristine.

长春花生物碱（Vinca alkaloids）因具备靶向微管动力学的特性，被广泛应用于癌症治疗。尽管其在特定癌症治疗中的疗效已得到广泛证实，但其完整的不良事件（adverse events, AEs）谱仍是当前持续研究的领域。本研究采用回顾性病例/非病例研究方法，借助美国食品药品监督管理局不良事件报告系统（FDA Adverse Event Reporting System, FAERS）的数据，对长春瑞滨（vinorelbine）与长春新碱（vincristine）相关的不良事件进行了分析。我们应用多种算法检测不良事件信号：报告比值比（reporting odds ratio, ROR）与比例报告比值比（proportional reporting ratio, PRR）用于衡量不成比例性与关联强度；贝叶斯置信传播神经网络（Bayesian confidence propagation neural network, BCPNN）计算信息组分（Information Component, IC）以评估与背景发生率相比的关联情况；多项目伽马泊松收缩器（multi-item gamma Poisson shrinker, MGPS）则得出经验贝叶斯几何均值（empirical Bayes geometric mean, EBGM）值，以考量报告变异性。两种药物均显著累及血液和淋巴系统，其中长春瑞滨在该系统器官分类（System Organ Class, SOC）中上报了401例病例，其ROR值为17.4、PRR值为12.4、IC值为3.63，EBGM值为12.38。对首选术语（Preferred Terms, PTs）的交叉分析揭示了两种药物此前未被报道的共有不良事件，包括后部可逆性脑病综合征与抗利尿激素分泌异常综合征。本研究凸显了持续开展长春瑞滨与长春新碱相关风险研究的必要性。