肺清除指数在囊性纤维化和其他肺部疾病婴幼儿中的三中心可行性。
Three-center feasibility of lung clearance index in infants and preschool children with cystic fibrosis and other lung diseases.
机构信息
Division of Pediatric Pulmonology and Allergy and Cystic Fibrosis Center, Department of Pediatrics, University of Heidelberg, Im Neuenheimer Feld 430, 69120 Heidelberg, Germany; Department of Translational Pulmonology, Translational Lung Research Center Heidelberg (TLRC), German Centre for Lung Research (DZL), University of Heidelberg, Im Neuenheimer Feld 156, 69120 Heidelberg, Germany.
Division of Pediatric Pulmonology and Allergy and Cystic Fibrosis Center, Department of Pediatrics, University of Heidelberg, Im Neuenheimer Feld 430, 69120 Heidelberg, Germany; Department of Translational Pulmonology, Translational Lung Research Center Heidelberg (TLRC), German Centre for Lung Research (DZL), University of Heidelberg, Im Neuenheimer Feld 156, 69120 Heidelberg, Germany.
出版信息
J Cyst Fibros. 2018 Mar;17(2):249-255. doi: 10.1016/j.jcf.2017.08.001. Epub 2017 Aug 12.
BACKGROUND
Lung clearance index (LCI) detects early ventilation inhomogeneity and has been suggested as sensitive endpoint in multicenter intervention trials in infants and preschoolers with cystic fibrosis (CF). However, the feasibility of multicenter LCI in this age group has not been determined. We, therefore, investigated the feasibility of LCI in infants and preschoolers with and without CF in a three-center setting.
METHODS
Following central training, standardized SF-MBW measurements were performed in 73 sedated children (10 controls, 49 with CF and 14 with other lung diseases), mean age 2.3±1.2years across three centers, and data were analyzed centrally.
RESULTS
Overall success rate of LCI measurements was 91.8% ranging from 78.9% to 100% across study sites. LCI was increased in patients with CF (P<0.05) and with other lung diseases (P<0.05) compared to controls.
CONCLUSION
Our results support feasibility of LCI as multicenter endpoint in clinical trials in infants and preschoolers with CF.
背景
肺清除指数（LCI）可早期检测到通气不均，并已被提议作为患有囊性纤维化（CF）的婴儿和学龄前儿童的多中心干预试验的敏感终点。然而，尚未确定该年龄段多中心 LCI 的可行性。因此，我们在三个中心研究了 CF 和非 CF 婴儿和学龄前儿童的 LCI 可行性。
方法
在中央培训后，对 73 名镇静儿童（10 名对照，49 名 CF 和 14 名其他肺部疾病）进行了标准化的 SF-MBW 测量，三个中心的平均年龄为 2.3±1.2 岁，数据在中央进行分析。
结果
LCI 测量的总体成功率为 91.8%，在研究地点的范围为 78.9%至 100%。与对照组相比，CF 患者（P<0.05）和其他肺部疾病患者（P<0.05）的 LCI 增加。
结论
我们的结果支持将 LCI 作为 CF 婴儿和学龄前儿童临床试验的多中心终点的可行性。
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