Standardization of terms for linezolid-related adverse reactions and database establishment based on ICD-10 code
10.3760/cma.j.cn114015-20250126-00049
- VernacularTitle:基于ICD-10编码的利奈唑胺不良反应术语标准化及数据库的构建
- Author:
Shengnan QIU
1
;
Hailong LI
;
Wenwen MA
;
Shen′ao JING
;
Chenghao LI
;
Xin HUANG
Author Information
1. 山东中医药大学药学院，济南 250355
- Publication Type:Journal Article
- Keywords:
Linezolid;
Pharmacovigilance;
Drug-related side effects and adverse reactions;
International classification of diseases;
Database
- From:
Adverse Drug Reactions Journal
2025;27(10):605-612
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a standardized code database of adverse drug reactions (ADRs) terms related to linezolid and analyze the common ADRs of linezolid.Methods:Linezolid drug labels, websites (including Side Effect Resource, and the official websites of US Food and Drug Administration, European Medicines Agency and National Medical Products Administration) and scientific literature database (including CNKI, Wanfang, VIP, PubMed, Embase and Web of Science databases) were systematically searched, and ADR terms about linezolid were collected. ADR terms were mapped to the international classification of diseases-10 (ICD-10) code to establish a linezolid adverse reaction database.Results:A total of 117 ADR terms about linezolid were collected and 91 ICD-10 codes were obtained after being mapped to ICD-10. A standardized database was constructed and successfully embedded into the ADR spontaneous reporting system as a specific drug submodule. The gastrointestinal system, skin and subcutaneous tissue system, various nervous systems, blood and lymphatic systems were the most common system organs involved in linezolid-related ADRs under the 91 ICD-10 codes. Among them, ADRs under the gastrointestinal system codes K14.302 (black hairy tongue) and K52.104 (drug-induced gastroenteritis and colitis), the skin and subcutaneous tissue system code L27.005 (drug-induced dermatitis), various nervous system codes G90.800 (other disorders of autonomic nervous system), G62.001 (drug-induced polyneuropathy) and G44.400 (drug-induced headache, not elsewhere classified), the blood and lymphatic system codes D69.502 (drug- induced thrombocytopenia) and D70.x02 (drug-induced granulocytopenia), the metabolic and nutritional codes E87.204 (lactic acidosis), as well as the endocrine system code E16.000 (drug-induced hypoglycaemia without coma) had been reported frequently in the scientific literature. In addition, there were 14 ADR terms related to linezolid under 13 ICD-10 codes not recorded in the drug instructions.Conclusions:It is feasible to use ICD-10 code to standardize ADR terms related to linezolid and establish a database. Common ADRs of linezolid include thrombocytopenia, lactic acidosis, neutropenia, black hairy tongue, gastroenteritis/colitis, hypoglycemia, rash, serotonin syndrome, peripheral neuropathy and headache, which should be paid attention to and researched furtherly.
