目的 挖掘和分析头孢洛生他唑巴坦钠的药品不良事件信号，为临床安全用药提供参考。方法 收集美国食品药品监督管理局不良事件报告系统（FAERS）数据库2015年第1季度—2025年第1季度的头孢洛生他唑巴坦钠不良事件数据，采用比例报告比（PRR）法和报告比值比（ROR）法进行信号挖掘。结果 最终筛选以头孢洛生他唑巴坦钠为主要怀疑药物的不良事件报告731份，去除无关信号后最终获得不良事件信号34个。发生频次较高的不良事件包括耐药、血小板减少症、治疗失败、痫性发作等。信号较强的不良事件包括药物敏感性试验耐药、耐药、全身性念珠菌病等。其中血小板减少症、痫性发作、全身性念珠菌病等说明书未收录。结论 头孢洛生他唑巴坦钠总体安全性良好。除了胃肠道不良反应和抗生素导致菌群失调相关的常见不良反应之外，应警惕其对肝肾功能的影响，以及说明书中未提及的中枢神经系统相关不良反应。

Objective To explore and analyze the drug adverse event signals of ceftolozane tazobactam sodium, and provide reference for safe clinical use.Methods Drug adverse event data for ceftolozane tazobactam sodium was collected from the first quarter of 2015 to the first quarter of 2025 in the FAERS database. Signal mining was conducted using proportional reporting ratio (PRR) and ratio reporting ratio (ROR) methods.Results A total of 731 cases with ceftolozane tazobactam sodium as the main suspected drug were ultimately screened, and 34 drug adverse event signals were obtained after removing irrelevant signals. Frequent occurrences of drug adverse event include drug resistance, thrombocytopenia, treatment failure, and epileptic seizures. Drug adverse event with strong signals include microbial drug sensitivity test resistance, resistance, systemic candidiasis, etc. Thrombocytopenia, epileptic seizures, systemic candidiasis, etc. were not included in the drug label.Conclusion Ceftolozane tazobactam sodium has good safety. In addition to common adverse reactions related to gastrointestinal and antibiotic induced dysbiosis, attention should be paid to their impact on liver and kidney function, as well as central nervous system related adverse reactions not mentioned in the instructions.

R978.1