目的 基于美国食品药品管理局(FDA)不良事件报告系统(FAERS)数据库挖掘奥加伊妥珠单抗的药品不良事件信号,为临床安全用药提供参考。方法 收集FAERS数据库自奥加伊妥珠单抗上市至2023年12月31日的奥加伊妥珠单抗不良事件数据,利用比例失衡法中的报告比值比法(ROR)和综合标准法(MHRA)进行数据挖掘。结果 共获得目标药物奥加伊妥珠单抗不良事件报告2 485例,患者年龄集中于18~64岁(39.32%),性别以男性为主(49.74%),上报国家以美国为主(42.98%)。共检测到不良事件信号72个,涉及22个系统和器官分类(SOC),主要为全身性疾病及给药部位各种反应,免疫系统疾病和血液及淋巴系统疾病等。不良事件发生频次较高的首选术语(PT)与药品说明书基本一致,如静脉闭塞性肝病、静脉闭塞性疾病、血小板计数下降、发热、血液胆红素升高及败血症等;不良事件信号较强的PT包括静脉闭塞性疾病、静脉闭塞性肝病、肿瘤复发、脾梗塞、移植物抗宿主病、肿瘤进展及细胞因子释放综合征等。结论 使用奥加伊妥珠单抗前应做好患者的用药评估,尤其是伴有肝静脉闭塞性疾病以及患有严重的持续性肝病低下的患者;治疗期间应密切关注患者的肝毒性,发现异常应及时干预。

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

安徽医科大学校基金资助项目（2021xkj095）；亳州市人民医院院级科研项目（by2023006）