细胞周期蛋白依赖性激酶 4 和 6 (CDK4/6) 抑制剂是激素受体阳性/人表皮生长因子受体 2 阴性乳腺癌的一线治疗药物。随着临床应用的不断增加，与 CDK4/6 抑制剂相关的感染相关不良事件 (AE) 近年来被广泛报道。本研究旨在根据美国食品和药物管理局不良事件报告系统（FAERS）数据库的真实数据，分析与 CDK4/6 抑制剂（palbociclib、ribociclib 和 abemaciclib）相关的感染的发生情况。数据提取自2015 年第一季度至 2022 年第三季度的 FAERS 数据库。分析了原发疑似感染相关 AE 患者的临床特征。进行不成比例分析以研究 AE 与 CDK4/6 抑制剂之间的潜在关联。采用Pearson卡方检验评估影响因素。与ribociclib相关的感染相关AE报告占与ribociclib相关AE总报告的8.58%，其次是palbociclib（2.72%）和abemaciclib（1.24%）。 Ribociclib (67.65%) 比 palbociclib (30%) 或 abemaciclib (48.08%) 与更严重的结局事件相关。性别和年龄与结果严重程度无关。不成比例分析显示，palbociclib、ribociclib 和 abemaciclib 分别检测到 14 个、16 个和 2 个与感染相关的首选术语。基于现实世界，感染相关 AE 与 3 种 CDK4/6 抑制剂高度相关，尤其是 palbociclib 和 ribociclib数据来自 FAERS 数据库。然而，还需要进一步的因果关系评估。版权所有 © 2024 Chen、Tang、Song、Sun 和Zhang。

Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors are first-line treatments for hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer. With their increasing clinical use, infection-related adverse events (AEs) associated with CDK4/6 inhibitors have been widely reported in recent years. This study aimed to analyze the occurrence of infections associated with the CDK4/6 inhibitors (palbociclib, ribociclib and abemaciclib) based on the real-world data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.Data were extracted from the FAERS database between 2015Q1 and 2022Q3. The clinical characteristics of patients with primary suspected infection-related AEs were analyzed. A disproportionality analysis was performed to investigate the potential association between AEs and CDK4/6 inhibitors. The influencing factors were evaluated using Pearson's chi-square test.Reports of infection-related AEs associated with ribociclib accounted for 8.58% of the total reports of AEs associated with ribociclib, followed by palbociclib (2.72%) and abemaciclib (1.24%). Ribociclib (67.65%) was associated with more serious outcome events than palbociclib (30%) or abemaciclib (48.08%). The sex and age were not associated with outcome severity. Disproportionality analysis showed that fourteen, sixteen and two infection-related preferred terms were detected for palbociclib, ribociclib and abemaciclib, respectively.Infection-related AEs were highly associated with three CDK4/6 inhibitors, especially palbociclib and ribociclib, based on the real-world data from the FAERS database. However, further causality assessment is required.Copyright © 2024 Chen, Tang, Song, Sun and Zhang.