在随机对照试验和日本超级老年社会之间,慢性心力衰竭患者的人口差距很大
Jun-Ichi Noiri1, Wataru Fujimoto1,2, Makoto Takemoto2
1Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine Kobe Japan.
Circulation reports
|May 12, 2025
概括
针对心力衰竭 (HF) 的指南导向医学治疗 (GDMT) 可能不适用于日本老龄化人口. 许多患者被排除在重大试验之外,不符合条件的患者面临更糟糕的结果,突出了需要真实世界的证据.
科学领域:
- 心脏病学 心脏病学
- 老年病的医生 老年病的医生
- 临床试验 临床试验
背景情况:
- 指南导向医学疗法 (GDMT) 改善了心力衰竭 (HF) 管理.
- 主要随机对照试验 (RCT) 发现对现实世界,超级老年人群 (如日本) 的适用性是不确定的.
研究的目的:
- 评估日本超年龄社会中慢性HF患者是否符合主要RCT的资格.
- 根据RCT排除标准,比较符合条件和不符合条件的HF患者之间的结果.
主要方法:
- 分析KUNIUMI注册表,这是一项针对日本阿瓦吉岛慢性HF患者的前性观察研究.
- 确定六个主要HFRCT (PARADIGM-HF, PARAGON-HF, DAPA-HF, DELIVER, EMPEROR-Reduced, EMPEROR-Preserved) 的患者资格和排除百分比.
- 符合条件和不符合条件的患者群体之间的三年内心血管死亡和HF住院病例发生率的比较.
主要成果:
- 显著的比例的患者被排除在主要的HFRCT之外:PARADIGM-HF (48.4%),DAPA-HF (36.4%),EMPEROR-Reduced (42.7%),PARAGON-HF (57.9%),DELIVER (32.3%) 和EMPEROR-Preserved (31.4%),这些患者被排除在主要的HFRCT之外.
- 与符合条件的患者相比,被排除在RCT之外的患者的预后明显较差 (心血管死亡和HF住院风险更高) (P<0.05).
结论:
- 在主要RCT中的HF患者和日本超级老年社会中的患者之间存在很大的差距.
- 需要进一步的研究来证明GDMT在现实世界,老年人群中的有效性.
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