van der Giessen Lianne J, de Jongste Johan C, Gosselink Rik, Hop Wim C J, Tiddens Harm A W M
Department of Paediatric Physiotherapy, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.
Pediatr Pulmonol. 2007 Jul;42(7):624-30. doi: 10.1002/ppul.20636.
Little is known about the optimal timing of rhDNase nebulization in relation to airway clearance therapy (ACT).
To compare the effects of rhDNase before ACT versus rhDNase after ACT in children with CF.
randomized, double blind, double dummy, cross over study.
CF, stable clinical condition, rhDNase maintenance therapy. Children in Group I inhaled rhDNase 30 minutes before ACT, and placebo directly after ACT in week 1-3. The protocol was reversed during week 4-6. Group II performed the reversed sequence. Patients continued their daily routine ACT. Primary endpoint: MEF(25) %pred. Pulmonary functions tests were performed on days 0, 14, 21, 35 and 42. In weeks 3 and 6 children scored cough and sputum production on daily diary cards.
24 patients completed the study. Mean age = 12 years (range 7-19). Mean MEF(25) %pred was 5.8% higher after 3 weeks of rhDNase before ACT, compared to rhDNase after ACT (58.3% vs 52.5%, p=0.01). There were no significant differences for any of the other variables.
Inhalation of rhDNase before ACT improves peripheral airway patency in children with cystic fibrosis. Since all children were already on maintenance rhDNase therapy before the study, this effect is additional to any existing effect of regular rhDNase.
关于重组人脱氧核糖核酸酶(rhDNase)雾化吸入相对于气道清除治疗(ACT)的最佳时机,人们了解甚少。
比较在囊性纤维化(CF)患儿中,ACT前使用rhDNase与ACT后使用rhDNase的效果。
随机、双盲、双模拟、交叉研究。
CF,临床状况稳定,rhDNase维持治疗。第一组患儿在第1至3周的ACT前30分钟吸入rhDNase,ACT后立即吸入安慰剂。在第4至6周,方案颠倒。第二组执行相反的顺序。患者继续其日常ACT。主要终点:预计用力呼气流量(MEF)(25)%。在第0、14、21、35和42天进行肺功能测试。在第3周和第6周,患儿在每日日记卡上记录咳嗽和咳痰情况。
24例患者完成研究。平均年龄 = 12岁(范围7至19岁)。与ACT后使用rhDNase相比,ACT前使用rhDNase 3周后,平均MEF(25)%预计值高5.8%(58.3%对52.5%,p = 0.01)。其他任何变量均无显著差异。
ACT前吸入rhDNase可改善囊性纤维化患儿的外周气道通畅性。由于所有患儿在研究前已接受rhDNase维持治疗,这种效果是在常规rhDNase任何现有效果之外的额外效果。