在心血管和病的临床试验中整合肝脏终点
Faiez Zannad1, Arun J Sanyal2, Javed Butler3,4
1Université de Lorraine, Inserm Clinical Investigation Center at Institut Lorrain du Coeur et des Vaisseaux, University Hospital of Nancy, Nancy, France. f.zannad@chru-nancy.fr.
Nature medicine
|September 3, 2024
概括
在心脏-脏-代谢试验中包括与代谢功能障碍相关的脂肪性肝病 (MASLD) 患者至关重要. 这种方法可以在相互关联的疾病中揭示新的治疗益处,同时确保患者的安全.
科学领域:
- 心脏病学 心脏病学
- 腎臟病學 (nephrology) 是一種醫學.
- 肝病学 肝病学是一种肝病学.
- 代谢障碍 代谢障碍 代谢障碍
背景情况:
- 心血管疾病,代谢障碍和慢性病带来了复杂的临床挑战.
- 与代谢功能障碍相关的脂肪性肝病 (MASLD) 经常与这些疾病同时发生,具有共同的风险因素和机制.
- 从临床试验中排除患有MASLD的患者限制了对潜在的跨疾病治疗益处的理解.
研究的目的:
- 倡导将MASLD患者纳入心脏-脏-代谢临床试验.
- 强调在这些试验中测量肝脏结果的重要性.
- 探索对临床试验设计和监管途径的影响.
主要方法:
- 这篇视角论文回顾了现有证据,关于MASLD和心脏-脏-代谢疾病之间的共享机制.
- 它讨论了将MASLD患者纳入相关临床试验的理由.
- 它概述了试验设计,安全监测和监管批准的考虑因素.
主要成果:
- 新疗法可能会在心血管,脏,代谢和肝脏疾病中带来好处.
- 排除MASLD患者阻碍了这些广泛的治疗效果的发现.
- 包括MASLD患者需要仔细考虑试验设计和安全性.
结论:
- 将MASLD患者纳入心脏-脏-代谢试验对于全面的治疗开发至关重要.
- 这种方法需要强有力的安全监测和适应的监管策略.
- 未来的临床试验行为应采用这种包容性范式,以推进患者护理.
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