中国合理用药探索2026，Vol.23Issue(4)：8-14,7.DOI:10.3969/j.issn.2096-3327.2026.04.002
硫代硫酸钠超说明书用药的安全性分析
Safety Analysis of Off-Label Use of Sodium Thiosulfate
李洪盟 1陈晓旭 1郑芳 1刘克锋1
作者信息
- 1. 郑州大学第一附属医院药学部调剂科,郑州 450000
- 折叠
摘要
Abstract
Objective:To evaluate the safety of off-label use of sodium thiosulfate in clinical practice,and to provide a reference for its rational application.Methods:A retrospective analysis was performed on 243 hospitalized patients who received sodium thiosulfate for injection in our hospital from April 2023 to April 2024.Using a group design,patients were divided into control group(label-based use,100 cases)and study group(off-label use,143 cases).The total incidence,onset time,drug discontinuation rate and outcome of adverse drug reactions(ADR)were compared between the two groups.Results:All off-label use types were off-indication use.No significant differences were observed on the total incidence of ADR,onset time,drug discontinuation rate or outcome between the two groups(P>0.05).The incidence of pruritus,rash and erythema in the study group was higher than that in the control group(P<0.05).Conclusion:Off-label use of sodium thiosulfate is common in clinical practice.Although the overall safety risk is not significantly increased,skin-related ADR should be closely monitored.Strict regulations should be followed in clinical use to ensure medication safety for patients.关键词
硫代硫酸钠/超说明书用药/药品不良反应/药物警戒/临床应用评价Key words
sodium thiosulfate/off-label use/adverse drug reaction/pharmacovigilance/clinical application evaluation分类
医药卫生引用本文复制引用
李洪盟,陈晓旭,郑芳,刘克锋..硫代硫酸钠超说明书用药的安全性分析[J].中国合理用药探索,2026,23(4):8-14,7.
