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目的 遴选3种乳腺癌常用的抗人表皮生长因子受体2(HER2)靶向药物,为临床合理用药和医疗机构药品目录的遴选提供科学依据。方法 参照《中国医疗机构药品评价与遴选快速指南(第二版)》建立靶向药物综合评估细则,从药学特性、有效性、安全性、经济性和其他属性5个维度对临床常用的3种抗HER2靶向药物曲妥珠单抗(H,Herceptin)、恩美曲妥珠单抗(T-DM1)、德曲妥珠单抗(T-DXd,DS8201)进行量化评分,并根据评分结果划分推荐级别。结果 3种抗HER2靶向药物的得分排序为:H 80.1分,T-DM1 66.5分,T-DXd 68.2分。H是HER2阳性乳腺癌的基石药物,长期安全性数据成熟,疗效确切,在一线治疗和辅助治疗中不可或缺,医保覆盖全面,日均费用最低,综合获益最高,属强推荐。T-DM1疗效显著,可降低复发风险,晚期二线治疗安全性管理成熟,获益明显,但因经济负担大,属弱推荐。T-DXd疗效突出,显著延长晚期乳腺癌患者的无进展生存期(PFS)和总生存期(OS),逐渐替代T-DM1,成为二线首选,对HER2低表达人群具唯一性,医保纳入提升经济性,但真实世界数据有限,属弱推荐。结论 一线治疗和辅助治疗优选H,晚期耐药及复发转移的患者推荐T-DM1和T-DXd;HER2低表达患者推荐T-DXd。
Abstract：Objective To select three commonly used anti-human epidermal growth factor receptor 2(HER2) targeted drugs for breast cancer, providing a scientific basis for rational clinical medication and the selection of drug catalogs in medical institutions. Methods Referring to the rapid guidelines for drug evaluation and selection in chinese medical institutions(2 nd edition), comprehensive evaluation criteria for targeted drugs were established. three commonly used anti-HER2 targeted drugs—trastuzumab(H, herceptin), trastuzumab emtansine(T-DM1), and trastuzumab deruxtecan(T-DXd, DS8201)—were quantitatively scored across five dimensions: pharmaceutical characteristics, effectiveness, safety, economy, and other attributes. recommendation levels were assigned based on the scoring results. Results The scoring order of the three anti-HER2 targeted drugs was: H(80.1 points), T-DM1(66.5 points), and T-DXd(68.2 points). H is the cornerstone drug for HER2-positive breast cancer, featuring mature long-term safety data, definitive efficacy, and indispensable roles in first-line and adjuvant therapies. with comprehensive medical insurance coverage and the lowest daily cost, it offers the highest comprehensive benefit and is strongly recommended. T-DM1 demonstrates significant efficacy in reducing recurrence risk, with mature safety management in second-line treatment for advanced stages and obvious benefits. however, it is weakly recommended due to the heavy economic burden. T-DXd shows outstanding efficacy, significantly prolonging progression-free survival(PFS) and overall survival(OS) in patients with advanced breast cancer. it is gradually replacing T-DM1 to become the preferred second-line option and holds uniqueness for the HER2-low expression population. although its inclusion in medical insurance improves economic viability, real-world data remains limited, leading to a weak recommendation. Conclusion H is preferred for first-line and adjuvant therapies. T-DM1 and T-DXd are recommended for patients with advanced drug resistance, recurrence, and metastasis. T-DXd is recommended for patients with HER2-low expression.
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基本信息:
中图分类号:R979.1
引用信息:
[1]梁胜男,秦华珍,黄红颖,等.乳腺癌常用的抗HER2靶向药物的遴选与实践[J].贵州医药().
基金信息:
2024年百色市科学研究与技术开发计划课题(20241519)
2026-07-21
2026-07-21
2026-07-21