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关于肺移植临床试验终点的考虑:一个ISHLT共识声明

John R Greenland¹, Michael Perch², Kieran Halloran³

¹Department of Medicine, University of California San Francisco, San Francisco, CA.

The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation

|December 16, 2025

概括

标准化肺移植临床试验终点,包括初级移植功能障碍 (PGD) 和慢性肺全移植功能障碍 (CLAD),旨在加速新疗法开发. 这些共识建议改善了试验设计和患者的结果.

科学领域:

* 肺部医学和移植手术
* 临床试验设计和方法学

背景情况:

* 肺移植临床试验面临挑战,因为终点定义和意义不明确.
* 缺乏标准化的终点阻碍了治疗疗效评估和药物开发.

研究的目的:

*为肺移植试验中超出死亡率的关键终点制定共识建议.
* 为在临床研究中运行和优化终点使用提供实际指导.

主要方法:

* 由国际心脏和肺移植学会召开的多学科工作组.
*子组审查了测量最佳实践,临床益处联系以及对PGD,CLAD,ACR,AMR和PROs等终点的证据.
* 通过三轮的德尔菲进程达成共识.

主要成果:

* 针对关键终点制定了建议:原发性移植功能障碍 (PGD),慢性肺异位移植功能障碍 (CLAD),急性细胞排斥 (ACR),抗体中介排斥 (AMR),免疫抑制并发症,患者报告结果 (PROs) 和儿科考虑.
*关于这些终点的测量,临床效用和试验应用的指导.

结论:

*标准化终点将提高肺移植临床试验的设计和可比性.
*这些建议旨在加快新疗法的开发,以改善长期的肺全移植存活率和患者的生活质量.

关键词:

急性细胞排斥细胞排斥抗体介导的排斥抗体介导的排斥慢性肺异位移植功能障碍慢性肺异位移植功能障碍临床试验中的临床试验.终点终点终点肺移植肺移植肺移植主要移植功能障碍主要移植功能障碍

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