Data Mining and Analysis on Adverse Drug Events of Novel Agents for Anti-multidrug-resistant Tuberculosis Based on FAERS
10.3870/j.issn.1004-0781.2025.09.013
- VernacularTitle:基于FAERS数据库的新型抗耐多药结核药物的不良事件信号挖掘与分析
- Author:
Liling ZHAO
1
;
Junxia LI
;
Shuang CHEN
;
Weiwei ZHAO
;
Haipeng YANG
;
Ruohan XIE
;
Li ZENG
Author Information
1. 河南省胸科医院(郑州大学附属胸科医院)药学部,郑州 450008
- Publication Type:Journal Article
- Keywords:
Bedaquiline;
Delamanid;
Pretomanid;
Multi-drug resistant tuberculosis;
FAERS database;
Signal mining
- From:
Herald of Medicine
2025;44(9):1456-1464
- CountryChina
- Language:Chinese
-
Abstract:
Objective To mine and analyze adverse drug events(ADEs)of novel agents for multi-drug-resistant tuberculosis(MDR-TB)based on the FDA Adverse Event Reporting System(FAERS)database,to explore the signals of ADEs,and to provide reference for clinical use.Methods The FAERS database was searched and extracted from Q1 of 2015 to Q4 of 2023,and the ADE reports about bedaquiline,delamanid,and pretomanid were collected.Data mining and analysis were carried out on relevant reports of the drug using the reporting odds ratio(ROR),proportional reporting ratio(PRR),medicines and healthcare products regulatory agency(MHRA),and the Bayesian confidence progressive neural network(BCPNN).Results The number of ADE reports for the target drugs bedaquiline,delamanid,and pretomanid were 2 477,1 630,and 173,respectively.ADE of the target drugs involved multiple organ systems.Positive signals detected by the ROR,PRR,MHRA,and BCPNN methods were 246,246,215,204 for bedaquiline;251,251,224,200 for delamanid;and 25,25,24,22 for pretomanid.Clinically significant high-risk signals include prolonged QT interval on ECG,anemia,liver toxicity,peripheral neuropathy,etc.Conclusions The signal mining of ADEs based on the FAERS database indicates that close attention should be paid to risks such as prolonged QT interval on ECG,anemia,liver toxicity,and peripheral neuropathy during the clinical use of bedaquiline,delamanid,and pretomanid.In addition,monitoring of new potential ADE signals(such as acute heart failure,respiratory failure,acute kidney injury,etc.)should be strengthened,and timely intervention measures should be taken to ensure medication safety.
