[Guidelines for pharmaceutical care of endocrine therapeutics for breast cancer(2023 edition)].

医学 乳腺癌 富维斯特朗 指南 肿瘤科 内分泌系统 癌症 内科学 三苯氧胺 药理学 激素 病理
出处
期刊:PubMed 卷期号:45 (10): 834-862
标识
DOI:10.3760/cma.j.cn112152-20230823-00097
摘要

Endocrine therapy is one of the primary treatment methods for hormone receptor-positive breast cancer patients. As of June 1 2023, the National Medical Product Administration has approved 56 drugs related to endocrine therapy in patients with HR+ /HER-2- breast cancer (including generic drugs that have passed the consistency evaluation), including 44 endocrine drugs which can be categorized according to their mechanisms of action into selective estrogen receptor modulators, selective estrogen receptor down-regulators, aromatase inhibitors, luteinizing hormone-releasing hormone analogs, and progestogens and 12 targeted drugs for combined with endocrine therapy, including CDK4/6 inhibitors, mTOR inhibitors, and HDAC inhibitors. The different pharmacological characteristics, mechanisms of action, and long-term medication factors of breast cancer endocrine therapy-related drugs can directly affect patients' medication adherence and medication safety. To standardize the pharmaceutical care of endocrine therapy drugs for breast cancer and promote rational use in clinical settings, the Oncology Specialty Pharmacist Subcommittee, in conjunction with multidisciplinary experts nationwide, has developed the "Guidelines for pharmaceutical care of endocrine therapy drugs for breast cancer (2023 edition)". The guidelines is based on clinical evidence-based evidence, relevant regulations of pharmaceutical management, and pharmaceutical care practices. The Delphi method and expert interviews were used to formulate the guidelines. The GRADE approach was used for assessing the certainty of evidence. This guideline mainly focuses on endocrine therapy for HR+ /HER-2- breast cancer patients. Due to space constraints, HER-2 positive targeted drugs were not included in the guideline. It covers 6 dimensions and 22 key problems of pharmaceutical care in the whole process of drug therapy, providing a scientific basis for pharmacists to carry out pharmaceutical care of such drugs.内分泌治疗是激素受体阳性(HR+)乳腺癌患者的主要治疗方法之一。截至2023年6月1日,国家药品监督管理局已批准56个用于HR+/人表皮生长因子受体2阴性(HER-2-)乳腺癌患者的内分泌治疗相关药物(含通过一致性评价的仿制药),按照其作用机制可分为选择性雌激素受体调节剂、选择性雌激素受体下调剂、芳香化酶抑制剂、促黄体生成素释放激素类似物、孕激素类44个内分泌药物以及CDK4/6抑制剂、mTOR抑制剂、HDAC抑制剂12个内分泌治疗联合使用的靶向药物。内分泌药物不同的作用机制和药学特性以及长期用药等因素能直接影响患者的用药依从性和用药安全,为规范乳腺癌内分泌治疗药物的药学服务,促进临床合理用药,中国药师协会肿瘤专科药师分会联合全国多学科专家,基于临床循证证据、药事管理相关法规和药学服务实践,采用推荐意见分级的评估、制定及评价证据分级法、德尔菲法和专家访谈,制定了乳腺癌内分泌治疗药物药学服务指南(2023版)。指南主要聚焦于HR+/HER-2-乳腺癌患者的内分泌治疗,由于篇幅所限指南中未纳入HER-2阳性靶向药物。指南涵盖内分泌治疗全程化药学服务的6个维度、22个关键问题,为药师进行药学服务提供科学依据。.
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