背景：贝伐单抗（BV）广泛应用于常规癌症治疗和与许多其他药物联合的临床治疗。本研究旨在通过挖掘美国食品和药物管理局不良事件报告系统（FAERS）数据库中的数据来描述和分析不同 BV 治疗方案报告的上市后肺出血和咯血病例。方法：从 FAERS 数据库收集 2004 年第一季度至 2023 年第一季度的数据。采用包括报告比值比 (ROR) 在内的不成比例分析来量化与 BV 相关治疗方案相关的肺出血和咯血不良事件 (AE) 的不成比例报告信号。人口特征、发病时间和结果得到进一步明确。结果：从 FAERS 数据库中总共提取了 55,184 份 BV 相关报告，其中 497 份报告与肺出血和咯血相关。总体而言，肺出血和咯血 AE 的中位发病时间为 43 天（四分位距 (IQR) 15-117 天）。亚组分析中，BV加靶向治疗的中位起效时间最长，为90.5天（IQR 34-178.5天），BV加化疗的中位起效时间最短，为40.5天（IQR 14-90.25）。 BV 加化疗报告的死亡百分比最高（292 例中有 148 例死亡，50.68%）。此外，我们研究中包括四个亚组的 BV 相关治疗显示出与肺出血和咯血不成比例报告相关的积极信号。值得注意的是，与 BV 单药治疗相比，BV 加化疗显示出肺出血和咯血信号不成比例报告的风险显着较高（ROR 5.35 [95% CI, 4.78-6.02] vs. ROR 4.19 [95% CI, 3.56-4.91]） ，p = 0.0147）。结论：本研究描述了肺出血和咯血的报告情况，以及不同 BV 相关治疗方案的发病时间和人口特征。可为BV的进一步研究和临床实践提供有价值的证据。版权所有©2024胡、付、刘、张、李、张、游。

Background: Bevacizumab (BV) is widely used in routine cancer treatment and clinical therapy in combination with many other agents. This study aims to describe and analyse post-market cases of pulmonary haemorrhage and haemoptysis reported with different BV treatment regimens by mining data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. Methods: Data were collected from the FAERS database between 2004 Q1 and 2023 Q1. Disproportionality analysis including the reporting odds ratio (ROR) was employed to quantify the signals of disproportionate reporting of pulmonary haemorrhage and haemoptysis adverse events (AEs) associated with BV-related treatment regimens. The demographic characteristics, time to onset and outcomes were further clarified. Results: A total of 55,184 BV-associated reports were extracted from the FAERS database, of which 497 reports related to pulmonary haemorrhage and haemoptysis. Overall, the median onset time of pulmonary haemorrhage and haemoptysis AEs was 43 days (interquartile range (IQR) 15-117 days). In the subgroup analysis, BV plus targeted therapy had the longest median onset time of 90.5 days (IQR 34-178.5 days), while BV plus chemotherapy had the shortest of 40.5 days (IQR 14-90.25). BV plus chemotherapy disproportionately reported the highest percentage of death (148 deaths out of 292 cases, 50.68%). Moreover, the BV-related treatments including four subgroups in our study demonstrated the positive signals with the association of disproportionate reporting of pulmonary haemorrhage and haemoptysis. Notably, BV plus chemotherapy showed a significant higher reporting risk in pulmonary haemorrhage and haemoptysis signals of disproportionate reporting in comparison to BV monotherapy (ROR 5.35 [95% CI, 4.78-6.02] vs. ROR 4.19 [95% CI, 3.56-4.91], p = 0.0147). Conclusion: This study characterized the reporting of pulmonary haemorrhage and haemoptysis, along with the time to onset and demographic characteristics among different BV-related treatment options. It could provide valuable evidence for further studies and clinical practice of BV.Copyright © 2024 Hu, Fu, Liu, Zhang, Li, Zhang and You.