某院托法替布超说明书适应证用药循证医学评价  

Evidence-based medical evaluation of the off-label use of tofacitinib in a hospital

作　　者：孙超[1] Sun Chao(Department of Pharmacy,the Third People's Hospital of Bengbu,Bengbu 233099,China)

机构地区：[1]蚌埠市第三人民医院药学部,安徽蚌埠233099

出　　处：《实用药物与临床》2024年第9期682-688,共7页Practical Pharmacy and Clinical Remedies

摘　　要：目的了解某院门诊托法替布超说明书适应证用药情况,为该药的合理使用提供参考。方法调取某院2022年6月1日-2023年12月31日开具枸橼酸托法替布片的门诊患者的所有处方,对患者基本情况、诊断等进行统计分析,将诊断与最新版药品说明书进行比对,将所有超说明书适应证用药诊断与美国食品药品监督管理局(FDA)批准的适应证、Micromedex数据库、国内外指南与专家共识、《马丁代尔大药典》等进行比对,同时在PubMed、Cochrane数据库、中国知网(CNKI)等收集循证医学证据,参照Micromedex数据库的Thomson分级系统,对超说明书适应证用药进行循证医学等级评价并提出分级管理建议。结果共收集到使用托法替布的门诊处方1024张,其中符合说明书适应证用药的有946例(92.38%),超说明书适应证用药78例(7.62%)。超说明书适应证用药临床诊断有14种,系统性红斑狼疮、斑秃(普秃)和干燥综合征居前3位。超说明书适应证用药有1种已被FDA批准,1种循证医学证据存在冲突,9种存在不同级别的循证医学证据支持,其余3种(干燥综合征、结缔组织病、慢性肾炎)未能查询到循证医学证据。最终参考Thomson分级标准判定溃疡性结肠炎证据等级为Category A,有效性及推荐等级为Class IIb或以上,建议同意使用;斑秃(普秃)等4种适应证证据等级为Category B,有效性及推荐等级为Class IIb或以上,建议限制使用;皮肌炎等5种适应证证据等级为Category C,有效性及推荐等级为Class IIb或以上,建议特殊使用;系统性红斑狼疮等4种适应证循证医学证据冲突或不足,建议禁止使用。结论该院托法替布超说明书适应证用药现象普遍,虽多数有循证医学证据支持,但仍需进一步规范,从而促进临床合理用药。Objective To investigate the off-label use of tofacitinib in a hospital and to provide reference for rational drug use.Methods All prescriptions of tofacitinib issued to outpatients in a hospital from June 1,2022 to December 31,2023 were retrieved.The basic information and diagnosis of patients were statistically analyzed,and the diagnosis was compared with the latest version of drug instructions,and then all the off-label drug use based on the diagnosis were compared with the indications approved by the US Food and Drug Administration(FDA),the Micromedex database,domestic and foreign guidelines and expert consensus,and Martindale The Complete Drug Reference.At the same time,evidence-based medicine evidence was collected from PubMed,Cochrane database,and China National Knowledge Infrastructure(CNKI),and the off-label use of tofacitinib was classified referring to the Thomson grading system of the Micromedex database.The evidence-based medicine grade evaluation was conducted and the grading management recommendations were proposed.Results A total of 1024 prescriptions of tofacitinib were collected,of which there were 78 cases(7.62%)of off-label use.There were 14 types of clinical diagnosis with off-label drug use,and the top three were systemic lupus erythematosus,alopecia areata and Sjogren's syndrome.One of the off-label indications had been approved by the FDA,and there was conflicting evidence-based medicine for one.Among the remaining 12,9 had different levels of evidence-based medicine support,while the remaining 3(Sjogren's syndrome,connective tissue disease,chronic nephritis)had not been found to have evidence-based medicine evidence.Finally,according to Thomson grading system,the evidence level of ulcerative colitis was Category A,the effectiveness and recommendation level was Class IIb or higher,and the use was recommended.The evidence level of 4 indications,including alopecia areata,was Category B,the effectiveness and recommendation level was Class IIb or higher,and the use was recommended to be restri

关 键 词：托法替布 循证医学 超说明书 合理用药 

分 类 号：R95[医药卫生—药学]