标准与讨论一密肾内及风湿免疫类药物超药品说明书用药专家共识[山东省超药品说明书用药专家共识（2022版)系列]Expert Consensus on Off-Label Drug Use of Shandong Province(2022 Edition):for Intrarenal and Rheumatic Immune Drugs梁传鹏12，赵丽霞之，刘敏2，[摘要]风湿免疫疾病的诊疗手段日新月异，不断涌现的新型免疫抑制剂为免侯宁2,3疫性疾病的临床治疗开创了新格局。同时，该领域药品说明书更新滑后于临床实践发展的现象日益突出，超药品说明书用药(OLDU)发生率较高。OLDU在临床实践工作中普遍存在，在满足临床治疗需求、填补治疗空白的同时，也[作者简介]梁传鹏，男，博士，主管引发了一些用药相关问题。临床实践中如何规范、安全地OLDU是一个亟待药师，专业方向：临床药学。E-mail:解决的难题。《山东省超药品说明书用药专家共识》(2022版)中收录的肾内mmkjm369@163.com.及风湿免疫类药物均来自临床实践，提供了详实的循证证据和推荐意见，以期[通讯作者]侯宁，女，主任药师，硕士为临床用药提供参考依据。生导师，专业方间：药事管理与循证药学。E-mail:hou_ning@sina.com.[关键词]超药品说明书用药；肾内及风湿免疫类药物；循证药学；专家共识；用药目录1山东大学齐鲁医院药剂科，济南250012：[中图分类号]R95[文献标志码]A[文编号]2096-3327(2023)03-037-072山东省药学会循证药学专业委员会，济南D0I10.3969/j.issn.2096-3327.2023.03.005250021:3山东第一医科大学附属省立医院药学部，济南250021[A bstract]With the rapid development ofthe diagnosis and the treatment of rheumatic immune diseasesespecially the emergence of new immunosuppressive drugs has created a new pattem for the clinical treatmentof immune diseases.At the same time,the phenomenon that the udate of drug label in this fiek lags behindthe development of clinical practice is increasingly prominent,and the incidence of off-label drug use(OLDU)is relatively high.OLDU is prevalent in clinical practice.While meeting the needs of clinical treatment andfilling therapeutic gaps,it also causes some medication-related problems.The standardization and safetyof OLDU in clinical practice is an urgent problem to be solved.All the OLDU of intrarenal and rheumatiimmune drugs included in the Expert Consensus on Off Label Drug Use int Shandong Province (2022 Edinon)are derived from clinical practice,providing detailed evidence-based evidence and recommendations,with aview to providing important reference for clinical use of drugs[Key words)off-label drug use;intrarenal and rheumatic immune drugs;evidence-based pharmacy,expertconsensus medicine catalogueLIANG Chuan-peng2,ZHAO Li-xia2LIUMin2,HOU Ning23”1超药品说明书用药概况1 Department of Phammacy,Qilu Hospital of药品说明书是药品生产企业经药品监督管理部门批准，用以指导药品Shandong University,Jinan 250012,China:2安全、合理使用的法定文件。我国的药品说明书由国家药品监督管理局根Evidenoe-Based Pharmacy Specialites据申请人（药品生产企业）申报的资料及其他相关信息审核批准并执行，of Shandong Pharmaceutical Assocation,Jinan 250021,China:3 Department of具有法律效力，并且其法律效力高于一般的药物手册和教科书【”。在医Pharmacy,Shandong Provincial Hospital疗实践中，医生开具处方、药师调剂处方都应遵循药品说明书。然而，超Affiliated to Shandong First MedicalUniversity,Jinan 250021,Chine药品说明书用药(off-label drug use,OLDU)在国内外医疗实践中普2023年第03期1第20在1370
