目的 利用美國食品藥品監(jiān)督管理局不良事件報告系統(tǒng)（FAERS）數(shù)據(jù)庫分析兩性霉素B脫氧膽酸鹽（AmB-D）與兩性霉素B脂質體（L-AmB）的風險信號，為臨床合理用藥提供參考。方法 基于FAERS數(shù)據(jù)庫提取AmB-D和L-AmB 2004年第1季度—2023年第4季度的不良事件報告，并導入SAS 9.4軟件中進行數(shù)據(jù)清理與分析，采用報告比值比法（ROR）、比例報告比值法（PRR）、英國藥品和健康產品管理局綜合標準（MHRA）及貝葉斯可信區(qū)間遞進神經網絡法（BCPNN）進行不良事件信號挖掘。結果 分別檢索到AmB-D與L-AmB的藥品不良事件報告1 308、4 304份。AmB-D與L-AmB發(fā)生頻次最多的不良反應均為低鉀血癥和急性腎損傷。AmB-D與L-AmB腎臟及泌尿系統(tǒng)疾病不良事件報告比例接近，提示臨床可能低估了脂質體的腎毒性。并挖掘到AmB-D較強的可疑不良事件信號為免疫重建炎性綜合征、白質病變；L-AmB的可疑信號為中毒性表皮壞死松解癥、免疫重建炎性綜合征、β2微球蛋白升高、脾損害和血管內溶血，說明書中未注明，應予以重視。結論 AmB-D與L-AmB可疑不良事件信號的挖掘，大多數(shù)與說明書記錄的一致，但仍發(fā)現(xiàn)新的信號，需積極監(jiān)測。

Objective To explore the risk signals of amphotericin B deoxycholate (AmB-D) and amphotericin B liposome (L-AmB) by using FAERS database, to provide reference for clinical rational drug use. Methods Adverse event reports of AmB-D and L-AmB from the first quarter of 2004 to the fourth quarter of 2023 were extracted based on FAERS database and imported into SAS 9.4 software for data cleaning and analysis. The adverse event signal mining was performed by ROR, PRR, MHRA, and BCPNN. Results Adverse drug event reports of AmB-D and L-AmB were 1 308 and 4 304, respectively. The most frequent adverse drug event of the two drugs were hypokalemia and acute kidney injury. It was found that the proportion of adverse event reports for renal and urinary diseases was similar between AmB-D and L-AmB, suggesting that the nephrotoxicity of liposomes may be underestimated in clinical practice. The suspected adverse event signal of AmB-D was found to be immune reconstructive inflammatory syndrome and white matter disease. The suspicious signals of L-AmB are toxic epidermal necrolysis, immune reconstitution inflammatory syndrome, elevated β2 microglobulin, spleen damage and intravascular hemolysis, which are not indicated in the instructions and should be paid attention to. Conclusion The mining of AmB-D and L-AmB suspected adverse event signals was mostly consistent with those recorded in the manual, but new signals were still found, which required active monitoring.

R978.5

巴音郭楞蒙古自治州2022年科學技術研究計劃項目（202209）