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中国生物类似药临床应用循证管理指南(2024)

宋再伟胡杨余玲玲朱军张伶俐张玉缪丽燕翟所迪赵荣生

中国药房2024，Vol.35Issue(16)：1933-1945,13.

中国药房2024，Vol.35Issue(16)：1933-1945,13.DOI:10.6039/j.issn.1001-0408.2024.16.01

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)

宋再伟 ¹胡杨 ¹余玲玲 ¹朱军 ²张伶俐 ³张玉 ⁴缪丽燕 ⁵翟所迪 ¹赵荣生⁶

作者信息

1. 北京大学第三医院药学部,北京 100191||北京大学医学部药物评价中心,北京 100191||北京大学治疗药物监测和临床毒理学中心,北京 100191
2. 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||中国临床肿瘤学会淋巴瘤专家委员会
3. 四川大学华西第二医院药学部/循证药学中心,成都 610044||中国药学会循证药学专业委员会||海峡两岸医药卫生交流协会医院药学专业委员会
4. 华中科技大学同济医学院附属协和医院药学部,武汉 430022||中国药学会医院药学专业委员会
5. 苏州大学附属第一医院药学部,江苏苏州 215006||中国药理学会治疗药物监测研究专业委员会
6. 北京大学第三医院药学部,北京 100191||北京大学医学部药物评价中心,北京 100191||北京大学治疗药物监测和临床毒理学中心,北京 100191||中国医院协会医院药学联合体
折叠

摘要

Abstract

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

Key words

biosimilars/clinical application/guideline/evidence-based medicine/patient willingness

分类

医药卫生

引用本文复制引用

宋再伟,胡杨,余玲玲,朱军,张伶俐,张玉,缪丽燕,翟所迪,赵荣生..中国生物类似药临床应用循证管理指南(2024)[J].中国药房,2024,35(16):1933-1945,13.

基金项目

国家自然科学基金项目(No.72304007,No.720740-05) （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) （No.BHTPP-2022079）

中国药房

OA北大核心CSTPCD

ISSN：1001-0408

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