Boogaard Ruben, Hulsmann Anthon R, van Veen Leoniek, Vaessen-Verberne Anja A P H, Yap Yen Ni, Sprij Arwen J, Brinkhorst Govert, Sibbles Barbara, Hendriks Tom, Feith Sander W W, Lincke Carsten R, Brandsma Annelies E, Brand Paul L P, Hop Wim C J, de Hoog Matthijs, Merkus Peter J F M
Department of Pediatric Pulmonology, Erasmus MC-Sophia Children's Hospital, Rotterdam, Netherland.
Department of Pediatrics, Amphia Hospital, Breda, Netherland.
Chest. 2007 Mar;131(3):788-795. doi: 10.1378/chest.06-2282.
Treatment of hospitalized infants with respiratory syncytial virus (RSV) bronchiolitis is mainly supportive. Bronchodilators and systemic steroids are often used but do not reduce the length of hospital stay. Because hypoxia and airways obstruction develop secondary to viscous mucus in infants with RSV bronchiolitis, and because free DNA is present in RSV mucus, we tested the efficacy of the mucolytic drug recombinant human deoxyribonuclease (rhDNase).
In a multicenter, randomized, double-blind, controlled clinical trial, 225 oxygen-dependent infants admitted to the hospital for RSV bronchiolitis were randomly assigned to receive 2.5 mg bid of nebulized rhDNase or placebo until discharge. The primary end point was length of hospital stay. Secondary end points were duration of supplemental oxygen, improvement in symptom score, and number of intensive care admissions.
There were no significant differences between the groups with regard to the length of hospital stay (p = 0.19) or the duration of supplemental oxygen (p = 0.07). The ratio (rhDNase/placebo) of geometric means of length of stay was 1.12 (95% confidence interval, 0.96 to 1.33); for the duration of supplemental oxygen, the ratio was 1.28 (95% confidence interval, 0.97 to 1.68). There were no significant differences in the rate of improvement of the symptom score or in the number of intensive care admissions.
Administration of rhDNase did not reduce the length of hospital stay or the duration of supplemental oxygen in oxygen-dependent infants with RSV bronchiolitis.
住院的呼吸道合胞病毒(RSV)细支气管炎婴儿的治疗主要是支持性治疗。支气管扩张剂和全身用类固醇经常被使用,但并不能缩短住院时间。由于RSV细支气管炎婴儿因黏稠黏液继发缺氧和气道阻塞,且RSV黏液中存在游离DNA,我们测试了黏液溶解药物重组人脱氧核糖核酸酶(rhDNase)的疗效。
在一项多中心、随机、双盲、对照临床试验中,225名因RSV细支气管炎入院的依赖氧气的婴儿被随机分配接受每日两次雾化吸入2.5mg rhDNase或安慰剂,直至出院。主要终点是住院时间。次要终点是吸氧持续时间、症状评分改善情况和重症监护入院次数。
两组在住院时间(p = 0.19)或吸氧持续时间(p = 0.07)方面无显著差异。住院时间几何均数的比值(rhDNase/安慰剂)为1.12(95%置信区间,0.96至1.33);吸氧持续时间的比值为1.28(95%置信区间,0.97至1.68)。症状评分改善率或重症监护入院次数无显著差异。
对于依赖氧气的RSV细支气管炎婴儿,给予rhDNase并未缩短住院时间或吸氧持续时间。