使用喘控制问卷对FeNO最小临床重要差异的外部验证
Jonathan Noble1,2, Orlagh Bean1, Ross Sayers1
1Medical Research Institute of New Zealand, Wellington, New Zealand.
在喘中,分数呼出的氧化 (FeNO) 的最小临床重要差异 (MCID) 是不确定的. 在FeNO中20%的变化很少支持ATS的建议,因为它与控制喘的改善有很差的相关性.
科学领域:
- 肺部病理学 肺部病理学
- 临床试验 临床试验
- 生物标志物 生物标志物
背景情况:
- 对于喘中部分排气的氧化 (FeNO) 的最小临床重要差异 (MCID) 仍然不确定.
- 美国胸腔学会 (ATS) 建议FeNO的相对变化≥20%,但这缺乏针对临床结果的验证.
- 对RCT的二次分析可以通过检查其与喘控制的关联来帮助估计FeNO MCID.
研究的目的:
- 估计喘中分数呼出的氧化 (FeNO) 的最小临床重要差异 (MCID).
- 评估FeNO变化与喘控制问卷-5 (ACQ-5) 之间的关联.
- 评估ATS对FeNO MCID的建议与临床结果措施相比.
主要方法:
- 两项随机对照试验 (PRACTICAL和Novel START) 的二次分析,涉及1553名患有轻度至中度喘的参与者.
- 后勤回归评估了FeNO和ACQ-5相对于ACQ-5MCID (0.5分) 的变化之间的关联.
- 一个t测试对参与者实现ACQ-5MCID的日志FeNO差异进行了比较.
主要成果:
- 在FeNO和ACQ-5的变化之间发现了一个微弱的关联 (相关系数=0.08,p=0.002).
- 在ACQ-5中具有临床意义的改善的参与者在FeNO的几何平均值中显示出22%的变化 (比率=0.78).
- 对于20%的FeNO变化,灵敏度和特异性分别为47%和57%.
结论:
- 根据ACQ-5测量,FeNO的变化对喘控制的变化是一个糟糕的替代品.
- 在改善ACQ-5的患者中观察到的FeNO变化仅为ATS建议为FeNO20%的MCID提供了微弱的支持.
- 需要进行进一步的研究,以建立在喘管理中用于FeNO的验证的MCID.
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