与连接组织疾病相关的间歇性肺病中使用宁泰达尼布的现实世界经验:一项回顾性队列研究
Marko Barešić1, Srđan Novak2, Dijana Perković3
1Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, University of Zagreb, School of Medicine, University Hospital Center Zagreb, Zagreb, Croatia. markobaresic@gmail.com.
现实世界的数据显示,nintedanib在治疗带有间歇性肺病 (CTD-ILD) 的结合组织疾病方面是有效的和耐受性的. 该药物在稳定肺功能方面表现出有效性,并且具有与临床试验相似的安全性.
科学领域:
- 肺部病理学 肺部病理学
- 类风湿病学 类风湿病学
- 药理学 药理学是指药理学的学科.
背景情况:
- 间歇性肺病 (ILD) 是连接组织疾病 (CTD) 的严重并发症,往往导致预后不佳.
- 根据积极的注册研究,Nintedanib已被批准用于治疗异常性肺纤维化和CTD-ILD.
- 在日常临床实践中,收集真实世界的数据对于验证受控试验的结果至关重要.
研究的目的:
- 评估在CTD-ILD患者中忍者达尼布的实际有效性和安全性.
- 为了确定临床试验结果是否适用于日常患者护理.
- 在专业的临床环境中分析患者的结果和副作用.
主要方法:
- 进行了一项追溯观察案例系列研究.
- 从克罗地亚三大专门从事CTD-ILD的中心收集了用nintedanib治疗的患者的数据.
- 分析了患者的肺功能 (FVC,DLco) 和不良事件.
主要成果:
- 根据FVC,nintedanib在68%的患者中稳定或改善了肺功能,根据DLco.co.在72%的患者中改善了肺功能.
- 几乎所有患者 (98%) 接受了宁泰达尼布与免疫抑制剂联合使用.
- 最常见的副作用是胃肠道问题,在较小程度上是肝功能测试异常.
结论:
- 现实世界的数据证实了nintedanib在CTD-ILD患者的耐受性和有效性.
- 观察到的疗效和安全性概况与关键临床试验的发现一致.
- 丁丁达尼布代表了管理CTD-ILD的有价值的治疗选择,支持其在临床实践中的使用.
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