硫代硫酸钠超说明书用药的安全性分析OA
Safety Analysis of Off-Label Use of Sodium Thiosulfate
目的:评价硫代硫酸钠在临床中超说明书用药的安全性,为其合理应用提供参考依据.方法:回顾性分析 2023 年4月~2024年4月期间在某院使用注射用硫代硫酸钠的 243 例住院患者作为研究对象.采用成组设计法,按用药是否符合说明书分为对照组(规范用药,100 例)和研究组(超说明书用药,143 例).比较两组患者的药品不良反应(ADR)发生率、发生时间、停药率及转归情况.结果:超说明书用药类型均为超适应症用药.两组患者 ADR 发生率、发生时间、停药率、转归等比较均无统计学差异(P>0.05).研究组患者瘙痒、皮疹和红斑的 ADR 发生率高于对照组(P<0.05).结论:硫代硫酸钠超说明书用药在临床实践中较常见,虽其用药时安全性风险未见显著增加,但仍需关注皮肤相关ADR.临床使用时应严格遵循规定,保障患者用药安全.
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.
李洪盟;陈晓旭;郑芳;刘克锋
郑州大学第一附属医院药学部调剂科,郑州 450000郑州大学第一附属医院药学部调剂科,郑州 450000郑州大学第一附属医院药学部调剂科,郑州 450000郑州大学第一附属医院药学部调剂科,郑州 450000
医药卫生
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
sodium thiosulfateoff-label useadverse drug reactionpharmacovigilanceclinical application evaluation
《中国合理用药探索》 2026 (4)
8-14,7
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