目的 挖掘和分析頭孢洛生他唑巴坦鈉的藥品不良事件信號，為臨床安全用藥提供參考。方法 收集美國食品藥品監(jiān)督管理局不良事件報告系統（FAERS）數據庫2015年第1季度—2025年第1季度的頭孢洛生他唑巴坦鈉不良事件數據，采用比例報告比（PRR）法和報告比值比（ROR）法進行信號挖掘。結果 最終篩選以頭孢洛生他唑巴坦鈉為主要懷疑藥物的不良事件報告731份，去除無關信號后最終獲得不良事件信號34個。發(fā)生頻次較高的不良事件包括耐藥、血小板減少癥、治療失敗、癇性發(fā)作等。信號較強的不良事件包括藥物敏感性試驗耐藥、耐藥、全身性念珠菌病等。其中血小板減少癥、癇性發(fā)作、全身性念珠菌病等說明書未收錄。結論 頭孢洛生他唑巴坦鈉總體安全性良好。除了胃腸道不良反應和抗生素導致菌群失調相關的常見不良反應之外，應警惕其對肝腎功能的影響，以及說明書中未提及的中樞神經系統相關不良反應。

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