基于FAERS数据库的古塞奇尤单抗ADE信号挖掘与分析

Data mining and analysis of adverse drug events signals for guselkumab based on FAERS database

目的为古塞奇尤单抗临床使用的安全性提供参考依据。方法采用报告比值比法和贝叶斯可信区间递进神经网络法对美国FAERS数据库中2017年第4季度至2022年第2季度古塞奇尤单抗相关不良事件(ADE)报告进行数据挖掘。结果与结论共筛选得到古塞奇尤单抗ADE报告29951份,获得197个(3871例)ADE信号,涉及21个系统器官。古塞奇尤单抗的主要ADE信号体现在感染及侵染类疾病、全身性疾病及给药部位各种反应、皮肤及皮下组织类疾病上,这与其说明书记载基本一致。其新的ADE信号包括眼眶肿瘤、胆囊腺癌、汗腺疾病、血尿酸降低、眼睑回缩、血管免疫母细胞性T细胞淋巴瘤、非酒精性脂肪肝、增生性胆囊病、气管软化、内耳疾病等。其严重的ADE信号包括全身各部位的严重感染、肝胆疾病、肿瘤疾病等。

OBJECTIVE To provide a reference for the safety of guselkumab in clinical use.METHODS The reporting odds ratio and the Bayesian confidence propagation neural network were used to mine the data of adverse drug events(ADE)related to guselkumab in FAERS database from the fourth quarter of 2017 to the second quarter of 2022.RESULTS&CONCLUSIONS A total of 29951 ADE reports related to guselkumab were screened,involving 197(3871 cases)ADE signals and 21 system organs.The major ADE signals of guselkumab manifested as infectious and invasive diseases,systemic disease and various reactions at the site of administration,and skin and subcutaneous tissue diseases,which were basically consistent with the instructions.The new ADE signals were found,such as neoplasm of orbit,gallbladder adenocarcinoma,sweat gland disorder,decreased blood uric acid,eyelid retraction,angioimmunoblastic T-cell lymphoma,nonalcoholic fatty liver disease,hyperplastic cholecystopathy,tracheomalacia,inner ear disorder,etc.And the severe ADE signals included severe infections in various parts of the body,liver and gallbladder diseases,tumor,etc.