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)數(shù)據(jù)庫挖掘奧加伊妥珠單抗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FAERS數(shù)據(jù)庫自奧加伊妥珠單抗上市至2023年12月31日的奧加伊妥珠單抗不良事件數(shù)據(jù),利用比例失衡法中的報(bào)告比值比法(ROR)和綜合標(biāo)準(zhǔn)法(MHRA)進(jìn)行數(shù)據(jù)挖掘。結(jié)果 共獲得目標(biāo)藥物奧加伊妥珠單抗不良事件報(bào)告2 485例,患者年齡集中于18~64歲(39.32%),性別以男性為主(49.74%),上報(bào)國家以美國為主(42.98%)。共檢測(cè)到不良事件信號(hào)72個(gè),涉及22個(gè)系統(tǒng)和器官分類(SOC),主要為全身性疾病及給藥部位各種反應(yīng),免疫系統(tǒng)疾病和血液及淋巴系統(tǒng)疾病等。不良事件發(fā)生頻次較高的首選術(shù)語(PT)與藥品說明書基本一致,如靜脈閉塞性肝病、靜脈閉塞性疾病、血小板計(jì)數(shù)下降、發(fā)熱、血液膽紅素升高及敗血癥等;不良事件信號(hào)較強(qiáng)的PT包括靜脈閉塞性疾病、靜脈閉塞性肝病、腫瘤復(fù)發(fā)、脾梗塞、移植物抗宿主病、腫瘤進(jìn)展及細(xì)胞因子釋放綜合征等。結(jié)論 使用奧加伊妥珠單抗前應(yīng)做好患者的用藥評(píng)估,尤其是伴有肝靜脈閉塞性疾病以及患有嚴(yán)重的持續(xù)性肝病低下的患者;治療期間應(yīng)密切關(guān)注患者的肝毒性,發(fā)現(xiàn)異常應(yīng)及時(shí)干預(yù)。

Objective To mine the adverse drug event signals of inotuzumab ozogamicin based on FAERS database, and provide reference for rational use of inotuzumab ozogamicin. Methods Adverse event data of inotuzumab ozogamicin in FAERS database from its listing to 31 December 2023 were collected, and data mining was carried out using the reported ratio ratio method (ROR) and the medicines and healthcare products regulatory agency (MHRA) in the disproportional method. Results A total of 2 485 adverse event reports of inotuzumab ozogamicin were obtained. The age of the patients was 18-64 years old (39.32%), the gender was mainly male (49.74%), and the reporting country was mainly the United States (42.98%). A total of 72 adverse event signals were detected, involving 22 system organ class (SOC), mainly including general disorders and administration site conditions, immune system disorders, blood and lymphatic system disorders. The PT with higher frequency of adverse event occurrence is basically consistent with the drug instructions, such as venoocclusive liver disease, venoocclusive disease, platelet count decreased, pyrexia, blood bilirubin increased, sepsis. PT with strong ADE signals include venoocclusive disease, venoocclusive liver disease, neoplasm recurrence, splenic infarction, graft versus host disease, neoplasm progression, cytokine release syndrome. Conclusion Before using inotuzumab ozogamicin, medication evaluation should be done for patients, especially those with hepatic vein occlusion disease and severe persistent liver disease. During treatment, close attention should be paid to the patient's liver toxicity, and timely intervention should be taken in case of abnormality.

R979.1

安徽醫(yī)科大學(xué)校基金資助項(xiàng)目（2021xkj095）；亳州市人民醫(yī)院院級(jí)科研項(xiàng)目（by2023006）