Date mining and analysis of adverse events of levofloxacin in children:a real world study based on FAERS database
10.12173/j.issn.1008-049X.202310020
- VernacularTitle:儿童应用左氧氟沙星不良反应信号挖掘与分析:基于FAERS数据库的真实世界研究
- Author:
Xiaochan GUAN
1
;
Zhijun LIU
;
Zhenwei FANG
;
Zhuo XIANG
;
Nannan LIU
Author Information
1. 北京燕化医院药剂科(北京 102500)
- Keywords:
Child safety;
Mycoplasma pneumoniae;
Adverse events;
FAERS database
- From:
China Pharmacist
2024;27(1):85-92
- CountryChina
- Language:Chinese
-
Abstract:
Objective To search for the reports of adverse events of levofloxacin use in children using the FAERS database,and to mine and analyze the data to provide reference for safe clinical use.Methods The data reported of adverse events of levofloxacin use in children from January 1,2004 to June 30,2023 were retrieved through the OpenVigil 2.1 platform,and the relevant data were analyzed based on the reporting odds ratio(ROR)method.Results A total of 484 cases of adverse events of levofloxacin in children were retrieved,and 94 positive risk signals were found.The main systemic organs involved were various musculoskeletal and connective tissues,gastrointestinal system,systemic and administration sites,and the top five positive signals were Dimycodes infection(ROR=822.87),tendon pain(ROR=563.71),Mycobacterium ulcers infection(ROR=352.65),tendon rupture(ROR=341.91),and immune reconstitution inflammatory syndrome-related tuberculosis(ROR=310.84).The top five positive signals not mentioned in the label were Mycobacterium ulcerans infection(ROR=352.65),immune reconstitution inflammatory syndrome-associated tuberculosis(ROR=310.84),central nervous system tuberculoma(ROR=102.85),linear IgA disease(ROR=82.68),and increased intracranial pressure(ROR=32.46).Conclusion In addition to the known adverse events,levofloxacin is used in children,and the risk signal intensity of adverse reactions such as increased intracranial pressure and tuberculosis-related diseases is high,so it is recommended to carefully select and strengthen relevant safety monitoring.
