《乳腺癌CDK4/6抑制剂药物相互作用管理中国专家共识(2024版)》计划书  

Protocol of Chinese Expert Consensus on the Management of Drug-Drug Interaction with CDK4/6 Inhibitors in Breast Cancer(2024 Edition)

作　　者：朱艳娜[1] 陈艳伟[1] 杨世磊[1] 栗云明[1] 翟晓涵[1] 吕林林 李璐[1] 陶旭锋 陈旭阳 何晓梦[1] 王丽岩[1] 李帅 柳杰[1] 董得时[1] ZHU Yanna;CHEN Yanwei;YANG Shilei;LI Yunming;ZHAI Xiaohan;LYU Linlin;LI Lu;TAOXufeng;CHEN Xuyang;HE Xiaomeng;WANG Liyan;LI Shuai;LIU Jie;DONG Deshi(Department of Pharmacy,the First Affiliated Hospital of Dalian Medical University,Liaoning Dalian 116011,China)

机构地区：[1]大连医科大学附属第一医院药学部,辽宁大连116011

出　　处：《中国医院药学杂志》2025年第1期1-5,共5页Chinese Journal of Hospital Pharmacy

摘　　要：细胞周期蛋白依赖性激酶4/6(Cyclin-dependent kinase 4/6,CDK4/6)抑制剂联合传统内分泌治疗可显著改善激素受体阳性、人表皮生长因子受体2阴性乳腺癌患者的无进展生存期和总生存期,该法应用广泛。CDK4/6抑制剂均经过细胞色素P450酶代谢及部分药物转运体的转运,易与其他药物之间存在药物代谢酶及药物转运体所介导的药物相互作用。为保障CDK4/6抑制剂在临床使用的有效性及安全性,该工作组遵循美国医学科学院(Institution of Medicine,IOM)临床实践指南的定义,参考《世界卫生组织指南制定手册》和《中国制订/修订临床诊疗指南的指导原则(2022版)》等要求,注册并撰写《乳腺癌CDK4/6抑制剂药物相互作用管理中国专家共识(2024版)》,并遵循共识制订流程,拟制订和发布共识文件。该计划书主要介绍该共识目标人群、共识制订工作小组的组成、临床问题的提出与收集、证据筛选和汇总以及推荐意见的产生等共识制订方法和流程,使之更加规范与透明。Cyclin-dependent kinase 4/6(CDK4/6)inhibitors combined with conventional endocrine therapy can significantly improve progression-free survival(PFS)and overall survival(OS)in hormone receptor(HR)-positive,human epidermal growth factor receptor 2(HER-2)-negative breast cancer patients.This combination therapy has a wide range of applications.Most CDK4/6 inhibitors are metabolized by cytochrome P450 enzymes and transported by some drug transporters,and may be susceptible to drug-drug interaction(DDI)mediated by drug-metabolizing enzymes and drug transporters with other drugs.To ensure the efficacy and safety of CDK4/6 inhibitors in clinical use,our writing group drafted the Chinese Expert Consensus on the Management of Drug-Drug Interaction with CDK4/6 inhibitors in Breast Cancer(2024 Edition)based on the definition of clinical practice guidelines of the Institute of Medicine(IOM)and the requirements of the World Health Organization(WHO)Handbook for Guideline Development and the Guidelines for the Formulation/Revision of Clinical Guidelines in China(2022 Edition).We will follow the consensus development process to develop and publish the consensus document.This plan focuses on the consensus development methodology and process,such as the target population of the consensus,the composition of the consensus development working group,the formulation and collection of clinical questions,the screening and summarization of evidence,and the generation of recommendations,so as to make it more standardized and transparent.

关 键 词：细胞周期蛋白依赖性激酶4/6抑制剂 药物相互作用 乳腺癌 专家共识 计划书 

分 类 号：R979.1[医药卫生—药品]