标准与讨论二山东省超药品说明书用药专家共识(2022版)系列抗肿瘤药物超药品说明书用药专家共识Expert Consensus on Off-Label Drug Use of Shandong Province(2022Edition):Part of Antineoplastic Drug王珺，侯宁，张文八，张莉2[摘要]随着现今肿瘤发病率和死亡率的持续上升，抗肿瘤药物的研发已成为全球创新药研发的热点问题，药物研发投入高速增长，新药上市速度明显提高[作者简介】王珺，女，博士，主管药师，使肿瘤的规范诊疗、合理用药，尤其是新型的免疫治疗、靶向治疗受到社会的专业方向：临床药学。E-ma止广泛关注。抗肿瘤药物超药品说明书用药在临床实践中普遍存在。2022年3slyywj85@163.com.月起施行的《中华人民共和国医师法》为我国超药品说明书用药提供了法律依据。国家卫生健康委发布《抗肿瘤药物临床应用管理办法（试行）》促进了抗[通讯作者】侯宁，女，主任药师，硕士肿瘤药物超说明书用药的规范管理和临床应用。《山东省超药品说明书用药专研究生导师。专业方询：药事管理与循证家共识》(2022版)按临床专业领域分类，其中抗肿瘤药物部分基于山东省内药学。E-mail:hou_ning@sina.com。多家大型医院在抗肿瘤治疗领域的临床需求，根据专家组制定的循证评价方法，通过查阅文献、证据质量评价分级、专家论证等过程凝练完成，以期为临床用1山东第一医科大学附属省立医院药学部，济药提供参考。南250021：2山东第一医科大学附属肿瘤医院/山东省肿油防治研究院/山东省肿油医院，[关键词]超说明书用药；抗肿瘤药物；循证药学；专家共识；推荐意见济南250117[中图分类号]R95[文献标志码]A[文编号]2096-3327(2023)01-025-11D0I10.3969/1.issn.2096-3327.2023.01.003[Abstract]With the increasing incidence and mortality of cancer,the research and development ofantineoplastic drugs has become a hotspot of innovative drugs globally.Both the research investmentand speed of new drugs launching have been continuously improved,which has made the standardizeddiagnosis and treatmert of cancer,rational drug use,especially for new immunotherapy and targeted therapy,increasingly attracted clinical and social attention extensively.The offlabel drug use of antineoplastic drugsis ubiquitous in clinical practice.The implementation of the Law on Doctors of the People's Republic ofChinaeffective on March 2022 provides a legal basis for off-label drug use in China.The AdministrativeMeasures for the Clinical Application of Antineoplastic Drugs (Trial)issued by the National HealthCommission has promoted the standardized management and clinical application of offlabel drug use.TheExpert Consensus on Off-label Drug Use of Shandong Province (2022 Edition)is classified according to theclinical professional field.The part for antineoplastic drugs is based on the clinical needs of many leadinghospitals in Shandong Province in the field of antineoplastic treatment,taking the evidence-based evaluationmethod developed by the expert group as the basis and condensed through literature review,evidence qualityevaluation grading,expert argumentation,to provide reference for clinical drug use.[Key wordsl off-label drug use;antineoplastic drugs;evidence-based pharmacy;expert consensus;WANG Jun',HOU Ning",ZHANG Wen'.ZHANG LI1 Department of Pharmacy,Shandong1背景介绍Provincial Hospital Affiliated to ShandongFirst Medical Univer sity,Jinan 250021,药品说明书是经国家药品监督管理部门核准的法定文书，应当包含药China;2 Shandong Cancer Hospital品安全性、有效性的重要科学数据、结论和信息，用以指导安全、合理使Institute,Shandong Cancer Hospital Affiliated用药品，是医护人员、药师及患者购置、储存、使用药品的重要参考资料，to Shandong First Medical University,Jinan250117,China具有法律的约束性及临床适用性。但经调研，临床应用的药品有的尚存(C)1994-2023 China Academic Journal Electronic Publishing House.All rights reserved.httpiln2 I 25
