定义和确定器官系统参与系统性硬化症发病时间的标准
Marie Hudson1, John D Pauling2,3, Tatiana S Rodriguez-Reyna4
1Division of Rheumatology, Department of Medicine, Jewish General Hospital, Lady Davis Institute and McGill University, Montreal, QC, Canada.
Journal of scleroderma and related disorders
|September 29, 2025
概括
为改善临床试验的一致性,制定了系统性硬化器官参与和发病的标准化标准. 这些指导方针提高了未来系统性硬化症研究的可比性.
科学领域:
- 类风湿病学 类风湿病学
- 临床试验 临床试验
- 系统性硬化症研究研究
背景情况:
- 系统性硬化症 (SSc) 诊断和监测受到各种器官参与定义的挑战.
- 缺乏标准化的标准,阻碍了SSc临床试验和观察性研究的可比性.
研究的目的:
- 为系统性硬化症中个体器官系统的参与建立标准化定义.
- 确定SSc.中器官系统参与的发病日期.
- 提高未来的SSc研究的内部有效性和可比性.
主要方法:
- 一个国际工作组为关键的SSc器官系统组建了九个子组.
- 进行了一次为期三轮的德尔菲演习,该演习涉及多发性硬皮肤病临床试验联盟 (SCTC) 和欧洲多发性硬皮肤病试验和研究 (EUSTAR) 成员.
- 通过分组提案和国际工作组批准复合标准,达成共识.
主要成果:
- 开发了九个常见的SSc器官系统的标准化标准:皮肤,外周血管,关节/肌,骨肌肉,胃肠道,副细胞肺,肺动脉高血压,心脏和脏.
- 为每个器官系统的参与提供了关于发病日期的建议.
- 包括解释性注释,以澄清标准的应用.
结论:
- 开发的SSc器官系统参与和发病日期的标准化标准提供了有价值的指导方针.
- 这些标准有望提高未来临床试验和系统性硬化症观察性研究的可比性.
- 这项以共识驱动的项目涉及160多名全球专家和患者合作伙伴.
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