门诊患者超说明书使用沙利度胺的调查与循证医学评价  

Investigation and evidence-based medicine evaluation of over-indications of thalidomide in outpatients

作　　者：薛静[1,2] XUE Jing(Department of Clinical Pharmacology,the Sixth Affiliated Hospital of Sun Yat-Sen University,Guangzhou 510655,Guangdong,China;Biomedical Innovation Center,the Sixth Affiliated Hospital,Sun Yat-sen University,Guangzhou 510005,Guangdong,China)

机构地区：[1]中山大学附属第六医院药学部,广东广州510655 [2]广州市黄埔区中六生物医学创新研究院,广东广州510005

出　　处：《暨南大学学报（自然科学与医学版）》2024年第1期95-101,共7页Journal of Jinan University(Natural Science & Medicine Edition)

基　　金：2023年广东省药学会肿瘤领域超说明书用药评价研究基金项目(2023ZLCS06);2023年广东省临床用药研究基金项目(2023JZ02)。

摘　　要：目的:采用循证医学评价方法,探讨沙利度胺(TLD)在门诊用药的合理性。方法:抽取2022年中山大学附属第六医院门诊开具的包含TLD的处方360张,对超说明书使用情况进行统计,采用循证医学评价路径进行评价,并对超说明书用药的原因进行分析。结果:门诊使用TLD均为超适应证用药,主要适应证为克罗恩病、系统性红斑狼疮和贝赫切特综合征。循证医学证据评价为可以使用或者可以在其他药物无效或效果不佳的情况下使用。超说明书用药的最主要原因是医生认为超说明书用药行为有指南等支持。结论:TLD在门诊的超说明书用药有循证医学证据支持,但仍应严格按照超说明用药备案流程进行备案。Objective:To explore the rationality of thalidomide(TLD)in outpatient use by evidence-based medicine evaluation method.Methods:A retrospective method was used to select 360 prescriptions containing TLD issued in outpatient clinics of the Sixth Affiliated Hospital of Sun Yat-Sen University in 2022.The off-label use was statistically analyzed,evaluated in evidence-based medicine evaluation path.The causes of off-label use were also analyzed.Results:The clinical use of TLD was off-label.The main indications were Crohn s disease,systemic lupus erythematosus and Beh et s syndrome.Evidence-based medical evidence evaluation is acceptable for use or could be used when other drugs were in valid or ineffective.The main reason for off-label drug use is that doctors believe that off-label drug use of TLD conforms to guidelines.Conclusion:The off-label use of TLD in outpatient clinics is supported by evidence-based medical evidence,but the off-label use of TLD should be strictly recorded in accordance with the record process.

关 键 词：沙利度胺 超说明书 循证医学 门诊患者 

分 类 号：R979.5[医药卫生—药品] R979.19[医药卫生—药学]