中国生物类似药临床应用循证管理指南(2024)  

Evidence-based guideline for the management of clinical application of biosimilars in China(2024 edition)

作　　者：宋再伟 胡杨 余玲玲[1,2,3] 朱军 张伶俐[6,7,8] 张玉 缪丽燕[11,12] 翟所迪 赵荣生[1,2,3,13] Zaiwei;HU Yang;YU Lingling;ZHU Jun;ZHANG Lingli;ZHANG Yu;MIAO Liyan;ZHAI Suodi;ZHAO Rongsheng(Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Institute for Drug Evaluation,Peking University Health Science Center,Beijing 100191,China;Therapeutic Drug Monitoring and Clinical Toxicology Center,Peking University,Beijing 100191,China;Department of Lymphoma,Peking University Cancer Hospital&Beijing Institute for Cancer Research,Beijing 100142,China;Expert Committee on Lymphoma,Chinese Society of Clinical Oncology;Department of Pharmacy/Evidence-based Pharmacy Center,West China Second University Hospital,Sichuan University,Chengdu 610044,China;Evidence-based Pharmacy Professional Committee,Chinese Pharmaceutical Association;Hospital Pharmacy Professional Committee,Cross-Straits Medicine Exchange Association;Department of Pharmacy,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430022,China;Hospital Pharmacy Professional Committee,Chinese Pharmaceutical Association;Department of Pharmacy,the First Affiliated Hospital of Soochow University,Jiangsu Suzhou 215006,China;Division of Therapeutic Drug Monitoring,Chinese Pharmacological Society;Hospital Pharmacy Consortium of Medical Consortium Work Committee,Chinese Hospital Association)

机构地区：[1]北京大学第三医院药学部,北京100191 [2]北京大学医学部药物评价中心,北京100191 [3]北京大学治疗药物监测和临床毒理学中心,北京100191 [4]北京大学肿瘤医院暨北京市肿瘤防治研究所淋巴肿瘤内科,北京100142 [5]中国临床肿瘤学会淋巴瘤专家委员会 [6]四川大学华西第二医院药学部/循证药学中心,成都610044 [7]中国药学会循证药学专业委员会 [8]海峡两岸医药卫生交流协会医院药学专业委员会 [9]华中科技大学同济医学院附属协和医院药学部,武汉430022 [10]中国药学会医院药学专业委员会 [11]苏州大学附属第一医院药学部,江苏苏州215006 [12]中国药理学会治疗药物监测研究专业委员会 [13]中国医院协会医院药学联合体

出　　处：《中国药房》2024年第16期1933-1945,共13页China Pharmacy

基　　金：国家自然科学基金项目(No.72304007,No.720740-05);北京市卫生健康科技成果和适宜技术推广项目(No.BHTPP-2022079)。

摘　　要：目的为生物类似药临床应用与管理提供规范化指导,促进其广泛、合理地用于临床治疗。方法遵循《WHO指南制订手册(第2版)》等指南研究方法学规范进行《中国生物类似药临床应用循证管理指南(2024)》的设计、规划、制订流程和全文报告,并充分考虑当前最佳循证医学证据、多学科专家经验和患者意愿及价值观,采用推荐意见分级的评估、制订与评价(GRADE)方法评价证据质量并确定推荐意见强度。结果与结论《中国生物类似药临床应用循证管理指南(2024)》共形成10条推荐意见,其中强推荐7条、弱推荐3条。推荐意见涵盖生物类似药临床应用管理全流程,医疗机构及相关卫生监管部门可参考本指南科学管理生物类似药未获批适应证的外推应用,医务人员可参考本指南进行用药前评估、患者教育、用药前预处理、用药方案调整,多学科治疗团队可参考本指南提供涵盖治疗前、中、后全流程的药物警戒与患者管理。OBJECTIVE To provide standardized guidance for the clinical application and management of biosimilars,and promote their widespread and rational use in clinical treatment.METHODS The design,planning,and drafting process as well as the full report of Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China(2024 Edition)followed the WHO Handbook for Guideline Development(2nd edition),which fully considered the best current evidence from evidence-based medicine,multidisciplinary expert experience,and patient preferences and values.Grading of Recommendations Assessment,Development,and Evaluation(GRADE)approach was adopted to evaluate the quality of evidence and determine the strength of recommendations.RESULTS&CONCLUSIONS Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China(2024 Edition)presented 10 recommendations including 7 strong recommendations and 3 weak recommendations.The recommendations covered the entire process of clinical application and management of biosimilars.Medical institutions and relevant health regulatory departments can refer to this guideline for the scientific management of the extrapolation of unapproved indications of biosimilars.Healthcare providers can refer to this guideline for pre-treatment assessments,patient education,pre-treatment regimen before administration,and dosage regimen adjustments.Multidisciplinary medical teams can refer to this guideline to provide pharmacovigilance and patient management throughout the treatment process.

关 键 词：生物类似药 临床应用 指南 循证医学 患者意愿 

分 类 号：R95[医药卫生—药学]