Data mining and analysis of adverse drug events signals for guselkumab based on FAERS database
- VernacularTitle:基于FAERS数据库的古塞奇尤单抗ADE信号挖掘与分析
- Author:
Li YANG
1
;
Hao WANG
1
;
Xiaoying LIU
1
;
Yue ZHOU
1
;
Xiaoyan FU
1
Author Information
1. Xindu District People’s Hospital of Chengdu，Chengdu 610500，China
- Publication Type:Journal Article
- Keywords:
guselkumab;
adverse drug events;
adverse drug reaction;
data mining
- From:
China Pharmacy
2022;33(22):2766-2769
- CountryChina
- Language:Chinese
-
Abstract:
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 29 951 ADE reports related to guselkumab were screened， involving 197 （3 871 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.
