Jartti Tuomas, Lehtinen Pasi, Vanto Timo, Vuorinen Tytti, Hiekkanen Heikki, Hartiala Jaakko, Mäkelä Mika J, Ruuskanen Olli
Department of Pediatrics, Turku University Hospital, Turku, Finland.
Pediatr Pulmonol. 2007 Dec;42(12):1125-33. doi: 10.1002/ppul.20706.
We wanted to test the hypothesis that the efficacy of systemic corticosteroid is associated with atopic characteristics in wheezing children. A randomized controlled trial comparing oral prednisolone (2 mg/kg/day in 3 divided doses for 3 days) with placebo in hospitalized wheezing children (n = 266, median 1.6 years, range 3 months to 15.2 years) was conducted. In this post-hoc analysis, we assessed the link between the efficacy of prednisolone and several atopic characteristics, such as atopy, aeroallergen sensitization, total IgE level, number of sensitizations, eczema, atopic eczema, blood or nasal eosinophils, exhaled nitric oxide, positive modified asthma predictive index/asthma, inhaled corticosteroid medication and parental asthma/allergy. Virology was studied comprehensively. Our primary endpoint was the time until ready for discharge, and the most important secondary endpoint was the occurrence of relapses during the following 2 months. For statistics, we used interaction analyses in uni- and multivariate regression models. Overall, prednisolone did not decrease any of our predefined clinical endpoints. Neither was the efficacy of prednisolone associated with atopy. However, prednisolone significantly decreased the time until ready for discharge in children with positive modified asthma predictive index/asthma, inhaled corticosteroids, or rhinovirus infection and/or in children without azithromycin treatment. Prednisolone significantly decreased relapses in children with eczema, nasal eosinophilia and rhinovirus infection. The multiple clinical, inflammatory and viral markers associating with the efficacy of prednisolone should be confirmed in prospective trials. It is important that corticosteroid intervention trials have strict design for these potentially confounding factors.
我们想要检验系统性糖皮质激素的疗效与喘息儿童的特应性特征相关这一假设。我们开展了一项随机对照试验,将住院喘息儿童(n = 266,中位数1.6岁,范围3个月至15.2岁)口服泼尼松龙(2 mg/kg/天,分3次给药,共3天)与安慰剂进行比较。在这项事后分析中,我们评估了泼尼松龙疗效与几种特应性特征之间的联系,如特应性、吸入性过敏原致敏、总IgE水平、致敏数量、湿疹、特应性皮炎、血液或鼻腔嗜酸性粒细胞、呼出一氧化氮、改良哮喘预测指数/哮喘阳性、吸入性糖皮质激素用药以及父母哮喘/过敏情况。我们全面研究了病毒学。我们的主要终点是准备出院的时间,最重要的次要终点是接下来2个月内复发的情况。在单变量和多变量回归模型中,我们使用交互分析进行统计。总体而言,泼尼松龙并未降低我们预先设定的任何临床终点。泼尼松龙的疗效也与特应性无关。然而,泼尼松龙显著缩短了改良哮喘预测指数/哮喘阳性、使用吸入性糖皮质激素、感染鼻病毒和/或未接受阿奇霉素治疗的儿童准备出院的时间。泼尼松龙显著降低了患有湿疹、鼻腔嗜酸性粒细胞增多和鼻病毒感染儿童的复发率。与泼尼松龙疗效相关的多种临床、炎症和病毒标志物应在前瞻性试验中得到证实。糖皮质激素干预试验对这些潜在混杂因素进行严格设计很重要。