目的 基于美國食品藥品管理局(FDA)不良事件報(bào)告系統(tǒng)(FAERS)挖掘貝林妥歐單抗的藥品不良事件信號(hào),為臨床用藥提供依據(jù)。方法 收集FAERS中貝林妥歐單抗2014年9月-2023年12月的數(shù)據(jù),采用報(bào)告比值比(ROR)法和貝葉斯可信區(qū)間遞進(jìn)神經(jīng)網(wǎng)絡(luò)(BCPNN)法進(jìn)行信號(hào)挖掘,分析其不良事件發(fā)生情況。結(jié)果 共得到不良事件信號(hào)250個(gè),累及19個(gè)系統(tǒng)器官分類(SOC),合計(jì)報(bào)告5 013例。累及的SOC主要包括全身性疾病及給藥部位各種反應(yīng)、免疫系統(tǒng)疾病、各類神經(jīng)系統(tǒng)疾病、血液及淋巴系統(tǒng)疾病及各類檢查等;報(bào)告數(shù)較多的不良事件信號(hào)包括發(fā)熱、細(xì)胞因子釋放綜合征、神經(jīng)毒性、治療無反應(yīng)者、發(fā)熱性中性粒細(xì)胞減少和中性粒細(xì)胞減少等。挖掘到18個(gè)說明書未記錄的新發(fā)現(xiàn)可疑不良反應(yīng)。結(jié)論 貝林妥歐單抗在真實(shí)世界中發(fā)生的常見不良反應(yīng)與說明書有一致性,但存在部分新發(fā)現(xiàn)可疑的不良反應(yīng),臨床用藥應(yīng)重點(diǎn)關(guān)注此類不良反應(yīng)。

Objective To mine the adverse drug event signals of blinatumomab based on the FAERS, to provide a basis for clinical drug use. Methods Data of blinatumomab in FAERS from September 2014 to December 2023 were collected, and the signal mining was performed by using the ROR method and BCPNN method to analyze the occurrence of adverse drug event. Results A total of 250 adverse drug event signals were obtained, involving 19 system organ classifications (SOC), with a total of 5 013 cases reported. Accumulated SOC mainly included systemic diseases and various reactions at the site of administration, immune system diseases, various neurological diseases, blood and lymphatic system diseases, and various reactions. Adverse drug event signals with a high number of reports included fever, cytokine release syndrome, neurotoxicity, treatment non-responders, febrile neutropenia, and neutropenia. A total of 18 new findings of suspected adverse were found. Conclusion The common adverse reactions occurring in the real world with blinatumomab were consistent with the specification, but there were some newly found suspicious adverse reactions, which should be paid attention to in clinical diseases.

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