Analysis of adverse events related to linezolid in tuberculosis treatment based on the US FAERS database
10.3969/j.issn.1671-332X.2024.10.021
- VernacularTitle:基于美国FAERS数据库的利奈唑胺抗结核治疗不良事件分析
- Author:
Yonghong ZOU
1
;
Honglan ZHONG
;
Duohua SU
;
Aiguang XU
;
Yi FANG
Author Information
1. 广州市胸科医院 广东 广州 510095
- Keywords:
FAERS;
Linezolid;
Adverse events;
Signal detection
- From:
Modern Hospital
2024;24(10):1554-1556,1559
- CountryChina
- Language:Chinese
-
Abstract:
Objective To analyze the adverse events(AEs)associated with linezolid in tuberculosis treatment reported in the FDA Adverse Event Reporting System(FAERS)database,assess its safety profile,and provide scientific evidence for ra-tional clinical use.Methods Reports of adverse events related to linezolid in tuberculosis treatment from Q1 2016 to Q1 2024 were extracted.The data were cleaned and pre-processed,and signal detection was performed using the Reporting Odds Ratio(ROR)and Information Component(IC)methods.Results A total of 1,135 linezolid-related AEs were identified,with the most common types being hospitalization(18.46%)and death(10.99%).The Results indicated that linezolid AEs primarily involved disorders of the blood and lymphatic system,as well as liver and biliary system diseases.Common adverse reactions in-cluded anemia,peripheral neuropathy,and optic neuropathy.Additionally,some adverse reaction signals not mentioned in the prescribing information were identified,such as polyneuropathy(ROR=75.25,IC025=5.8),toxic optic neuropathy(ROR=776.95,IC025=8.86),and hearing loss(ROR=14.66,IC025=3.26).Conclusion This study suggests that linezolid may be associated with some serious adverse reactions in tuberculosis treatment.It is recommended that patients on long-term linezolid therapy undergo regular neurological,ophthalmological,and auditory assessments to provide a more adequate basis for rational clinical use.