Reconstructing Menopausal Hormone Therapy Guidelines: From Palliative Symptom Management to Age-Related Endocrine Insufficiency Disease Prevention

On November 10, 2025, the FDA formally reversed twenty-three years of restrictive guidance on menopausal hormone therapy (MHT), acknowledging that the Women's Health Initiative evidence does not appropriately apply to modern formulations. This regulatory reversal exposes a persistent institutional inertia: despite acknowledgment, no guideline review or reassessment has been announced by ACOG or NAMS. More broadly, legal doctrine is shifting to prioritize evidence-based over consensus-based practice; MHT evidence has matured across 15-20 years of registry data; and international guideline divergence reveals that current U.S. guideline restrictions do not reflect global evidence interpretation. Professional organizations maintaining current guidelines now do so with explicit knowledge of these contradictions. Comprehensive guideline reconstruction is therefore not optional refinement—it is institutional necessity. Such reconstruction must address three interconnected dimensions: menopause reclassification from genitourinary/reproductive to endocrine disease—specifically, age-related endocrine insufficiency; clinical practice evolution toward formulation-specific evidence and precision medicine; and standards aligned with contemporary legal-ethical requirements.2025年11月10日，美国食品药品监督管理局（Food and Drug Administration, FDA）正式推翻了延续二十三年的绝经激素治疗（menopausal hormone therapy, MHT）限制性指南，承认妇女健康倡议（Women's Health Initiative, WHI）的研究证据并不适用于现代临床制剂。这一监管政策反转暴露出长期存在的机构惰性：尽管已明确承认上述结论，但美国妇产科医师学会（American College of Obstetricians and Gynecologists, ACOG）与北美绝经学会（North American Menopause Society, NAMS）均未宣布启动任何指南审查或重新评估工作。从更宏观的视角来看，法律准则正转向优先采用循证实践而非共识导向的临床实践；绝经激素治疗的相关证据已通过15至20年的注册登记数据积累日趋成熟；同时国际指南间的分歧显示，当前美国指南中的限制性条款并未反映全球范围内的证据解读范式。目前仍维持现行指南的专业学术组织，在明确知悉这些矛盾的前提下仍沿用旧规。 因此，全面重构临床指南并非可选的优化调整，而是机构层面的必然需求。此类重构需涵盖三个相互关联的核心维度：将绝经从泌尿生殖/生殖系统疾病重新归类为内分泌疾病——具体而言，即年龄相关性内分泌功能不全；临床实践向基于特定制剂的循证证据与精准医学方向演进；建立符合当代法律与伦理要求的行业标准体系。