消除了关于更年期荷尔蒙治疗的黑盒警告
Intira Sriprasert1, Howard N Hodis, Wendy J Mack
1Department of Obstetrics and Gynecology, the Atherosclerosis Research Unit, and the Department of Population and Public Health Sciences, Keck School of Medicine of USC, University of Southern California, Los Angeles, California; the Department of Obstetrics and Gynecology, the Vagelos College of Physicians and Surgeons, Columbia University, New York, New York; and the Department of Obstetrics and Gynecology, Tufts Medical Center, Boston, Massachusetts.
Obstetrics and gynecology
|February 13, 2026
概括
美国食品和药物管理局 (FDA) 删除了更年期激素治疗 (MHT) 的黑子警告. 此更新反映了新的证据,并支持个性化,基于证据的更年期管理,以改善患者的治疗结果.
科学领域:
- 生殖医学 生殖医学
- 内分泌学 在内分泌学.
- 公共卫生政策 公共卫生政策
背景情况:
- 2003年,FDA根据妇女健康倡议 (WHI) 研究的有限数据发布了关于更年期激素治疗 (MHT) 的黑子警告.
- 最初的警告被广泛应用,不考虑特定的MHT配方,剂量和施用途径,包括局部阴道疗法.
- 这导致了22年的临床争议,并可能阻碍了适当的MHT用于更年期症状管理.
研究的目的:
- 报告FDA决定删除MHT产品上的黑子警告.
- 突出监管转向以证据为基础的更年期管理和个性化的患者护理.
- 强调更新的MHT启动和使用指南的重要性.
主要方法:
- 美国食品和药物管理局对科学文献的全面审查.
- 2025年7月17日,专家小组的审议.
- 考虑60天的公众评论期限.
主要成果:
- 美国食品和药物管理局宣布将在2025年11月10日取消黑子警告.
- 该机构正在向MHT的产品特定标签过渡.
- "在最短的时间内使用最低有效剂量"的任务已被取消.
结论:
- 更新的FDA指南包括MHT启动的最佳时间 (绝经后10年内或60岁之前).
- 这一监管变化促进了个性化利益风险评估和共享决策.
- 这些更新旨在根据当前的证据优化MHT的使用,改善患者的长期健康结果.
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