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

作　　者：李杜廉 覃开羽 蓝鲜艳 万永艳 白发丽 陶晓静 LI Dulian;QIN Kaiyu;LAN Xianyan;WAN Yongyan;BAI Fali;TAO Xiaojing(Liuzhou Traditional Chinese Medicine Hospital·Liuzhou Zhuang Medical Hospital,Liuzhou,Guangxi,China 545001)

机构地区：[1]广西壮族自治区柳州市中医医院·广西壮族自治区柳州市壮医医院,广西柳州545001

出　　处：《中国药业》2025年第9期116-122,共7页China Pharmaceuticals

基　　金：广西壮族自治区卫生健康委员会自筹经费科研课题[Z-B20241378]。

摘　　要：目的评价环孢素超适应证用药的合理性,为其临床合理用药提供参考。方法收集医院2022年1月至2023年7月使用环孢素的门诊处方,根据最新版药品说明书筛选出超适应证用药的相关诊断。参考超药品说明书的循证医学评价流程,引用收载于Micro⁃medex数据库Thomson分级系统中的超适应证用药进行评价,并对诊断进行分类;该系统未收载的则检索临床指南和医学文献,采用临床实践指南质量评价量表Ⅱ(AGREEⅡ)对临床指南进行质量评价,采用系统评价方法学质量评价2(AMSTAR 2)对纳入系统评价/Meta分析进行方法学质量评价。评价超适应证用药是否具备循证医学证据支持,并给出分级管理建议。结果共收集门诊处方1058张,其中环孢素超适应证用药处方385张(占36.39%),涉及13种超适应证诊断。质量评价结果显示,其中环孢素的10种适应证有循证医学证据。分级管理建议:环孢素应限制用于再生障碍性贫血、干燥综合征、系统性红斑狼疮、荨麻疹、骨髓增生异常综合征、瘙痒症,建议B级管理;应限制特殊用于类天疱疮、混合性结缔组织病、荨麻疹性血管炎、复发性流产,建议C级管理;判定环孢素用于抗磷脂综合征、抗体效价增高及女性不孕症均无循证医学证据,应禁止使用,建议D级管理。结论临床实践中,环孢素存在超适应证使用情况,建议严格按适应证分级管理,以保证其安全、合理用药。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 AGREEⅡscale,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 1058 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

关 键 词：循证医学 环孢素 超适应证用药 合理用药 分组管理 

分 类 号：R95[医药卫生—药学] R979.5