基于FAERS数据库的头孢菌素类药物胃肠系统不良事件信号挖掘与分析

目的 基于美国FDA不良事件报告系统（FAERS），全面评估头孢类药物在胃肠系统的不良反应特征，分析不同药物品种间的风险异质性及患者基线特征等因素的影响。方法 提取FAERS数据库中1994～2024年数据，结合比例失衡分析与贝叶斯方法，挖掘头孢类药物与胃肠系统不良事件的关联信号。结果 共纳入5 424.96万例不良事件报告，并筛选出793例与信号阳性头孢类药物相关的胃肠系统事件。其中头孢地尼的信号强度[ROR=2.69(2.52～2.88)]显著高于其他药物；贝叶斯方法验证了高风险事件的关联性，如头孢克肟的巨结肠信号[EBGM=75.21(23.54)]。阴性信号头孢类药物的风险均较低，极个别的具有一定强度的PT信号值。结论 本研究分析了使用不同类型的头孢类药物而发生的胃肠道系统不良反应的风险，其中头孢地尼胃肠系统相关不良反应（adverse event,AE）发生风险最高，非口服阴性信号头孢类药物AE发生风险较低，临床需依据已知风险优化用药，以平衡疗效与安全性。

OBJECTIVE Based on the US FDA Adverse Event Reporting System (FAERS), this study comprehensively evaluated the adverse reaction characteristics of cephalosporins on the gastrointestinal system, and analyzed the risk heterogeneity among different drug varieties and the influence of patients' baseline characteristics. METHODS The data from the FAERS database from 1994 to 2024 were extracted, and disproportionality analysis combined with Bayesian method was used to mine the correlation signals between cephalosporins and gastrointestinal adverse events. RESULTS A total of 54.249 6 million adverse event reports were included, and 793 gastrointestinal system adverse events related to signal-positive cephalosporins were screened out. The signal intensity of cefdinir [ROR=2.69(2.52-2.88)] was significantly higher than that of other drugs. The Bayesian method verified the association of high-risk events, such as the megacolon signal of cefixime [EBGM=75.21(95%CI:23.54)]. The risk of signal-negative cephalosporin was low, and very few had a certain intensity of PT signal values. CONCLUSION This study analyzed the risk of gastrointestinal adverse reactions associated with the use of different types of cephalosporins. Among them, cefdinir had the highest risk of gastrointestinal-related adverse events (AEs), while non-oral signal-negative ceped drugs.