Sands Dorota, Walicka-Serzysko Katarzyna, Milczewska Justyna, Postek Magdalena, Jeneralska Natalia, Cichocka Aleksandra, Siedlecka Ewa, Borawska-Kowalczyk Urszula, Morin Laurent
Cystic Fibrosis Department, Institute of Mother and Child, 01-211 Warsaw, Poland.
Cystic Fibrosis Centre, Pediatric Hospital, 05-092 Dziekanow Lesny, Poland.
Children (Basel). 2023 Jan 23;10(2):204. doi: 10.3390/children10020204.
Cystic fibrosis (CF) patients require regular airway clearance therapy (ACT). The aim of this study was to evaluate homecare therapeutic effects of a new ACT (Simeox) added to the optimal standard of care, including home chest physiotherapy, in the treatment of clinically stable children.
Forty pediatric CF patients (8-17 years old) with stable disease were randomized 1:1 in a single-center, prospective, open-label, cross-over trial into two groups: with or without Simeox. Lung function (impulse oscillometry, spirometry, body plethysmography, multi-breath nitrogen washout) results, health-related quality of life, and safety were assessed during the study after 1 month of therapy at home.
A significant decrease in proximal airway obstruction (as supported by improvement in airway resistance at 20 Hz (R20Hz) and maximum expiratory flow at 75% of FVC (MEF75)) compared to the control group was observed after 1 month of therapy with the device. Lung-clearance index was stable in the study group, while it worsened in the control group. In addition, the device group demonstrated a significant increase in the Cystic Fibrosis Questionnaire-Revised (CFQ-R) physical score. No side effects were identified during the study.
Simeox may improve drainage of the airways in children with clinically stable CF and could be an option in chronic treatment of the disease.
囊性纤维化（CF）患者需要定期进行气道清除治疗（ACT）。本研究的目的是评估在最佳标准治疗（包括家庭胸部物理治疗）基础上增加一种新的ACT（Simeox）对临床病情稳定的儿童的家庭护理治疗效果。
在一项单中心、前瞻性、开放标签、交叉试验中，40例病情稳定的儿科CF患者（8至17岁）按1:1随机分为两组：一组使用Simeox，另一组不使用。在居家治疗1个月后的研究期间，评估肺功能（脉冲振荡法、肺量计、体容积描记法、多次呼吸氮洗脱）结果、健康相关生活质量和安全性。
使用该设备治疗1个月后，与对照组相比，近端气道阻塞显著减轻（20 Hz时气道阻力（R20Hz）和用力肺活量（FVC）的75%时最大呼气流量（MEF75）改善支持这一结果）。研究组的肺清除指数保持稳定，而对照组则恶化。此外，设备组的囊性纤维化问卷修订版（CFQ-R）身体评分显著提高。研究期间未发现副作用。
Simeox可能改善临床病情稳定的CF儿童的气道引流，并且可能是该疾病长期治疗的一种选择。
