简介：依托泊苷是一种广谱抗肿瘤药物，已在临床试验中得到广泛研究。然而，有关其现实世界不良反应的信息有限。因此，本研究旨在通过美国食品药品监督管理局不良事件报告系统（FAERS）数据库的数据挖掘方法，在现实环境中评估和评价依托泊苷相关的不良事件。方法：通过对FAERS数据库中16,134,686份报告的分析，共识别出9,892份依托泊苷相关的药物不良事件（ADE）报告。为了确定这些 ADE 的显着性，应用了各种不成比例分析算法，包括报告比值比 (ROR)、比例报告比 (PRR)、贝叶斯置信传播神经网络 (BCPNN) 和多项伽马泊松收缩器（MGPS）算法。结果：结果，所有四种算法识别出的 478 个显着不成比例的首选项 (PT) 均被保留。这些 PT 包括常见报告的不良事件，如血小板减少、白细胞减少、贫血、口腔炎和肺炎，与药物说明书和先前临床试验中记录的不良事件一致。然而，我们的分析还发现了意想不到的重要 ADE，包括血栓性微血管病、耳毒性、第二原发恶性肿瘤、肾病毒性和卵巢功能衰竭。此外，我们使用威布尔分布检验检查了这些 ADE 的起效时间 (TTO)，发现依托泊苷相关 ADE 的中位 TTO 为 10 天（四分位距 [IQR] 2-32 天）。大多数病例发生在依托泊苷给药后的第一个月内（73.8%）。此外，我们的分析揭示了男性的特定高风险信号，例如肺炎和心肌梗塞，而女性则显示出耐药性和耳毒性信号。讨论：这些发现为了解依托泊苷起始后 ADE 的发生提供了宝贵的见解，这可能支持临床监测和风险识别工作。版权所有 © 2023 Cui、Cheng、Wang、Zou、Pan、Tian、Zhang、She、Zhang 和 Yang。

Introduction: Etoposide is a broad-spectrum antitumor drug that has been extensively studied in clinical trials. However, limited information is available regarding its real-world adverse reactions. Therefore, this study aimed to assess and evaluate etoposide-related adverse events in a real-world setting by using data mining method on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database. Methods: Through the analysis of 16,134,686 reports in the FAERS database, a total of 9,892 reports of etoposide-related adverse drug events (ADEs) were identified. To determine the significance of these ADEs, various disproportionality analysis algorithms were applied, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) algorithms. Results: As a result, 478 significant disproportionality preferred terms (PTs) that were identified by all four algorithms were retained. These PTs included commonly reported adverse events such as thrombocytopenia, leukopenia, anemia, stomatitis, and pneumonitis, which align with those documented in the drug's instructions and previous clinical trials. However, our analysis also uncovered unexpected and significant ADEs, including thrombotic microangiopathy, ototoxicity, second primary malignancy, nephropathy toxic, and ovarian failure. Furthermore, we examined the time-to-onset (TTO) of these ADEs using the Weibull distribution test and found that the median TTO for etoposide-associated ADEs was 10 days (interquartile range [IQR] 2-32 days). The majority of cases occurred within the first month (73.8%) after etoposide administration. Additionally, our analysis revealed specific high-risk signals for males, such as pneumonia and cardiac infarction, while females showed signals for drug resistance and ototoxicity. Discussion: These findings provide valuable insight into the occurrence of ADEs following etoposide initiation, which can potentially support clinical monitoring and risk identification efforts.Copyright © 2023 Cui, Cheng, Wang, Zou, Pan, Tian, Zhang, She, Zhang and Yang.