Razi Cem Hasan, Cörüt Nazlı, Andıran Nesibe
Division of Pediatric Allergy, Acıbadem, Ankara Private Hospital, Ankara, Turkey.
Division of Pediatric Allergy, Department of Pediatrics, Sami Ulus Pediatrics and Gynecology Education and Research Hospital, Ankara, Turkey.
Pediatr Pulmonol. 2017 Jun;52(6):720-728. doi: 10.1002/ppul.23667. Epub 2017 Jan 13.
The object of this study was to determine whether high doses of inhaled budesonide provide additional benefits to a standardized treatment regimen that includes systemic steroids and salbutamol in preschool patients presented to the emergency department (ED) with acute wheezing attacks. Methods This randomized, double-blind, placebo-controlled, parallel group trial was conducted in children, 6 months-6 years with moderate or severe acute wheezing epizode, as determined based on a pulmonary index score (PIS) of 7-13 points. We compared the addition of budesonide 3 mg versus placebo to standard acute asthma treatment, which included salbutamol and a single 1 mg/kg dose of methylprednisolone given at the beginning of therapy. The primary outcome was differences in hospitalization rates within 4 hr. Secondary outcome was difference in median PIS between treatment groups at 2 hr. Results One hundred patients were enrolled. Cumulative hospitalization rate at 120, 180, and 240 min were 0.72, 0.62, and 0.58 in placebo group; and 0.44, 0.30, and 0.24 in budesonide group. Discharged rate in budesonide group was significantly higher than the placebo group (log-rank = 12.407 ve P < 0.001). Expected mean discharged times were 200.4 (95%CI = 185.3-215.5) min in placebo group and 164.4 (95%CI = 149.4-179.4) min in budesonide group. Median (25-75%) PIS at the 120th min was significantly lower in budesonide group than the placebo group (5 [4-8] vs. 8 [5-9] respectively, P = 0.006). Conclusions The addition of budesonide nebulization may decrease the admission rate of preschool children who have moderate to severe acute wheezing epizodes. Pediatr Pulmonol. 2017;52:720-728. © 2017 Wiley Periodicals, Inc.
本研究的目的是确定对于因急性喘息发作就诊于急诊科(ED)的学龄前患者,高剂量吸入布地奈德相较于包含全身用类固醇和沙丁胺醇的标准化治疗方案是否能带来额外益处。方法 这项随机、双盲、安慰剂对照、平行组试验在6个月至6岁、根据肺指数评分(PIS)为7 - 13分判定为中度或重度急性喘息发作的儿童中进行。我们将3毫克布地奈德与安慰剂添加到标准急性哮喘治疗方案中进行比较,标准治疗方案包括沙丁胺醇以及在治疗开始时给予单次1毫克/千克剂量的甲泼尼龙。主要结局是4小时内的住院率差异。次要结局是治疗组在2小时时的PIS中位数差异。结果 共纳入100例患者。安慰剂组在120、180和240分钟时的累计住院率分别为0.72、0.62和0.58;布地奈德组分别为0.44、0.30和0.24。布地奈德组的出院率显著高于安慰剂组(对数秩检验 = 12.407,P < 0.001)。安慰剂组的预期平均出院时间为200.4(95%CI = 185.3 - 215.5)分钟,布地奈德组为164.4(95%CI = 149.4 - 179.4)分钟。在第120分钟时,布地奈德组的PIS中位数(25% - 75%)显著低于安慰剂组(分别为5 [4 - 8] 与8 [5 - 9],P = 0.006)。结论 添加布地奈德雾化可能会降低患有中度至重度急性喘息发作的学龄前儿童的住院率。《儿科肺脏病学》。2017;52:720 - 728。© 2017威利期刊公司。