中国药业2025，Vol.34Issue(9)：116-122,7.DOI:10.3969/j.issn.1006-4931.2025.09.026
环孢素超适应证用药情况的循证医学评价
Assessment of Off-Label Use of Cyclosporine by Evidence-Based Medical Approach
摘要
Abstract
Objective To evaluate the rationality of off-label use of cyclosporine,and to provide a reference for its clinical rational use.Methods The outpatient prescriptions for cyclosporine used in the hospital from January 2022 to July 2023 were collected to screen for relevant diagnoses of off-label use according to the latest instructions.Referring to the evidence-based medicine evaluation process of the off-label drug use,the off-label indications included in the study were directly cited using the Thomson classification system of Micromedex database,and the diagnosis was classified,while those not included were searched in relevant guidelines and literature databases.The quality of clinical guidelines was evaluated by the AGREE Ⅱ scale,and the quality of systematic reviews/Meta-analyses was evaluated by the AMSTAR 2 scale.Whether the off-label drug use was supported by evidence-based medicine was evaluated and recommendations for graded management were provided.Results A total of 1 058 outpatient prescriptions were collected,including 385 prescriptions(36.39%)for cyclosporine with off-label drug use,involving one type of off-label drug use-related diagnosis.The quality evaluation results showed that there was evidence-based medicine for cyclosporine in 10 indications.Grade management suggested that the use of cyclosporine to aplastic anemia,Sjogren's syndrome,systemic lupus erythematosus,urticaria,myelodysplastic syndrome should be restricted,pruritus,and these indications were recommended for grade B management;the use of cyclosporine in pemphigoid,mixed connective tissue disease,urticarial vasculitis and recurrent abortion should be strictly limited with a recommendation for grade C management.However,there was no evidence-based medical support for using cyclosporine in antiphospholipid syndrome,female infertility or increased antibody titer,therefore its usage should be prohibited with a recommended D-level management.Conclusion In clinical practice,the off-label use of cyclosporine exists,so it is recommended to strictly follow the hierarchical management to ensure the safe and rational use of cyclosporine.关键词
循证医学/环孢素/超适应证用药/合理用药/分组管理Key words
evidence-based medicine/cyclosporine/off-label drug use/rational drug use/hierarchical management分类
医药卫生引用本文复制引用
李杜廉,覃开羽,蓝鲜艳,万永艳,白发丽,陶晓静..环孢素超适应证用药情况的循证医学评价[J].中国药业,2025,34(9):116-122,7.基金项目
广西壮族自治区卫生健康委员会自筹经费科研课题[Z-B20241378]. （）
