抗肿瘤药物创新皮下制剂临床应用的药事服务专家共识  

Expert consensus on pharmaceutical services for clinical applications of innovative subcutaneous preparations of antineoplastic drugs

作　　者：中国药学会医院药学专业委员会 《抗肿瘤药物创新皮下制剂临床应用的药事服务专家共识》编写组 张玉[2] Working Group of Expert Consensus on Pharmaceutical Services for Clinical Applications of Innovative Subcutaneous Preparations of Antineoplastic Drugs;Hospital Pharmacy Specialty Committee of Chinese Pharmaceutical Association

机构地区：[1]不详 [2]华中科技大学同济医学院附属协和医院,湖北省重大疾病精准用药临床医学研究中心,武汉430022

出　　处：《中国医院药学杂志》2024年第14期1603-1612,1619,共11页Chinese Journal of Hospital Pharmacy

基　　金：国家重点研发计划项目(编号:2023YFF1205000)。

摘　　要：近年来,随着皮下给药制剂工艺的快速发展,已有静脉注射剂型抗肿瘤单克隆抗体相继获批皮下制剂且数量逐渐增长。抗肿瘤药物创新皮下制剂的工艺、药动学特点、临床有效性与安全性、临床合理使用、药事管理等问题也日益受到关注。然而,目前国内外尚缺乏针对抗肿瘤药物创新皮下制剂的规范指导意见。为此,中国药学会医院药学专业委员会牵头组织专家,基于现有循证医学证据并结合临床用药经验,提出抗肿瘤药物创新皮下制剂的定义,同时围绕全球已上市抗肿瘤药物创新皮下制剂的特点、临床合理应用、药事管理、药学监护等方面给予建议和指导,以期提高此类制剂的临床合理用药水平。In recent years,with a rapid development of subcutaneous drug delivery techniques,more and more antineoplastic monoclonal antibodies of existing intravenous agents have been approved for subcutaneous dosing.Pharmaceutical manufacturing,pharmacokinetic characteristics,clinical efficacy and safety,clinical rational use and pharmaceutical management of innovative subcutaneous antineoplastic drugs have attracted growing attention.However,there is still a global lack of normative guidance for innovative subcutaneous antineoplastic drugs.Therefore,Hospital Pharmacy Specialty Committee of Chinese Pharmaceutical Association organized domestic experts to propose the definition of innovative subcutaneous preparations of antineoplastic drugs based upon existing resources of evidence-based medicine and clinical drug dosing experiences.Recommendations were offered on unique characteristics,clinical rational use,pharmaceutical management and care of innovative subcutaneous antineoplastic drugs.

关 键 词：抗肿瘤药物 皮下制剂 药事服务 专家共识 

分 类 号：R979.1[医药卫生—药品]