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(hào)，為臨床安全用藥提供參考。方法 收集美國(guó)食品藥品監(jiān)督管理局不良事件報(bào)告系統(tǒng)（FAERS）數(shù)據(jù)庫(kù)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(shù)據(jù)，采用比例報(bào)告比（PRR）法和報(bào)告比值比（ROR）法進(jìn)行信號(hào)挖掘。結(jié)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(bào)告731份，去除無(wú)關(guān)信號(hào)后最終獲得不良事件信號(hào)34個(gè)。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(hào)較強(qiáng)的不良事件包括藥物敏感性試驗(yàn)?zāi)退?、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(shuō)明書(shū)未收錄。結(jié)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(yīng)和抗生素導(dǎo)致菌群失調(diào)相關(guān)的常見(jiàn)不良反應(yīng)之外，應(yīng)警惕其對(duì)肝腎功能的影響，以及說(shuō)明書(shū)中未提及的中樞神經(jīng)系統(tǒng)相關(guān)不良反應(yīng)。

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