辅助系统性皮质类固醇治疗囊性纤维化肺部恶化
Oliver J McElvaney1,2, Sonya L Heltshe1,3, Katherine Odem-Davis1
1Cystic Fibrosis Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, Washington.
Annals of the American Thoracic Society
|December 14, 2023
概括
系统性皮质类固醇在添加抗生素治疗时,不会改善患有囊性纤维化 (PWCF) 患者肺恶化 (PEx) 的结果. 这项分析没有发现肺功能或症状改善的显著益处,并且不增加不良事件.
科学领域:
- 肺部病理学 肺部病理学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 肺部恶化 (PEx) 是患有囊性纤维化 (PWCF) 患者发病和死亡的主要原因.
- 系统性皮质类固醇是强大的抗炎药物,但它们在急性CF PEx中的疗效尚未通过随机对照试验得到充分确立.
- 有限的数据存在于皮质类固醇在管理CF PEx.的有效性.
研究的目的:
- 评估辅助系统性皮质类固醇治疗与急性PEx的成年PWCF临床结果之间的关联.
- 为了确定皮质类固醇的使用是否会影响肺功能恢复,症状缓解或随后PEx的时间.
主要方法:
- 标准化治疗肺部恶化2 (STOP2) 随机对照试验的二次分析.
- 倾向性得分匹配用于将皮质类固醇治疗的PWCF与仅接受抗生素的PWCF进行比较,控制关键共变量.
- 主要结局是1秒内预测的百分比强迫呼气量 (ppFEV1) 的变化;次要结局包括症状得分和下一个PEx的时间.
主要成果:
- 皮质类固醇在17%的PEx事件中被使用,并且与较低的基线ppFEV1,年龄较大和女性性别有关.
- 与倾向匹配的对照组相比,皮质类固醇治疗没有改善ppFEV1反应,更长的时间到下一次PEx,或更大的症状改善.
- 副作用没有增加,但在皮质类固醇组中,严重不良事件 (SAE) 的总数较高.
结论:
- 实证系统性皮质类固醇在PWCF和PEx中使用,尽管很常见,但在添加到标准抗生素治疗时没有显示出改善的临床结果.
- 这些发现表明,目前针对CF PEx的医生指导的皮质类固醇处方做法可能不有益.
- 可能需要进一步的研究来确定PWCF的特定亚组,这些亚组可能会在PEx期间受益于皮质类固醇治疗.
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