目的 基于美国食品药品管理局不良事件报告系统（FAERS）分析头孢洛林酯在真实世界中的不良事件，为临床安全使用提供参考。方法 通过收集FAERS数据库中2011年第1季度—2025年第2季度的头孢洛林酯不良事件报告，采用报告比值比法（ROR）与比例报告比值比法（PRR）进行信号挖掘。结果 获得头孢洛林酯不良事件报告1 430份，涉及608例患者，不良事件诱发中位时间是2 d，47.94%不良事件发生在用药的前3 d内，联合用药以抗菌药物为主（86.01%）。去除无效信号后获得62个不良事件风险信号，涉及12个系统器官，其中累及血液及淋巴系统疾病的不良事件包括全血细胞减少症、溶血性贫血、溶血症、骨髓抑制等。发生频次较高的不良事件包括中性粒细胞减少、白细胞减少、皮疹等，风险信号较强的不良事件是急性嗜酸性粒细胞性肺炎、嗜酸性粒细胞性肺炎、剥脱性皮疹等，检测到剥脱性皮疹、溶血性贫血、菌血症等不良事件未在药品说明书中提及。结论 头孢洛林酯在临床应用过程中，不仅需要关注血液、皮肤等方面不良事件，还需要警惕说明书未提及的潜在不良事件，从而保障患者用药安全。

Objective To analyze the adverse events associated with ceftaroline fosamil in the real world based on FAERS, and provide evidence for its safe clinical use. Methods Adverse event reports for ceftaroline fosamil from the first quarter of 2011 to the second quarter of 2025 were extracted from the FAERS database. Signal detection was performed using the reporting odds ratio (ROR) and proportion reporting ratio (PRR) methods. Results A total of 1 430 adverse event reports involving 608 patients were identified. The median time to adverse event onset was 2 days, with 47.94% of adverse events occurring within the first 3 days of medication. Concomitant medications primarily consisted of antibacterial agents (86.01%). A total of 62 related adverse event risk signals were excavated after removing invalid signals, involving 12 organ systems. Adverse events involving blood and lymphatic system disorders included pancytopenia, haemolytic anaemia, haemolysis, and myelosuppression. Frequently reported adverse events included neutropenia, leukopenia and rash. Stronger risk signals were identified for acute eosinophilic pneumonia, eosinophilic pneumonia, and exfoliative rash, among others. Adverse events, such as exfoliative rash, haemolytic anaemia, and bacteraemia were not listed in the drug's prescribing information. Conclusion During the clinical use of ceftaroline fosamil, attention should be paid not only to known adverse events related to the blood and skin but also to potential adverse events not currently mentioned in the prescribing information, in order to ensure patient medication safety.

R978.1

承德市科技计划项目（202204A062）；承德市科学技术研究与发展计划项目（201706A043）；河北省药学会医院药学科研项目（2020-Hbsyxhqn0029）