Klassen T P, Feldman M E, Watters L K, Sutcliffe T, Rowe P C
Department of Pediatrics, University of Ottawa, Ont.
N Engl J Med. 1994 Aug 4;331(5):285-9. doi: 10.1056/NEJM199408043310501.
Although recent evidence has strongly supported the use of glucocorticoid therapy in children hospitalized with croup, the benefit of this therapy in children with less severe croup has not been documented. This randomized, double-blind trial compared a nebulized glucocorticoid, budesonide, with placebo in outpatients with mild-to-moderate croup.
Children three months to five years of age were eligible for the study if their croup scores fell in the mild-to-moderate range (scores of 2 to 7 out of a possible 17). The patients were randomly assigned to receive either 2 mg (4 ml) of nebulized budesonide (27 children) or 4 ml of nebulized normal saline (27 children); they were then assessed hourly for up to four hours by investigators who were unaware of the assigned treatments.
The median croup score at entry into the study was 4 in both groups. At the final study assessment, the median score was significantly lower in the budesonide group than in the placebo group (1 vs. 3, P = 0.005). The patients in the budesonide group were discharged from the emergency department significantly earlier than those in the placebo group (P = 0.002). One week after enrollment, 21 patients assigned to placebo had received dexamethasone, as compared with 15 patients assigned to budesonide (P = 0.10), and 7 patients assigned to placebo had been admitted to the hospital, as compared with 1 patient assigned to budesonide (P = 0.05).
We conclude that nebulized budesonide leads to a prompt and important clinical improvement in children with mild-to-moderate croup who come to the emergency department.
尽管近期有证据有力支持在因喉炎住院的儿童中使用糖皮质激素治疗，但该疗法对病情较轻的喉炎患儿的益处尚无文献记载。本随机双盲试验比较了雾化糖皮质激素布地奈德与安慰剂对轻至中度喉炎门诊患儿的疗效。
年龄在3个月至5岁之间、喉炎评分处于轻至中度范围（可能的17分中得2至7分）的儿童符合本研究条件。患者被随机分配接受2毫克（4毫升）雾化布地奈德（27名儿童）或4毫升雾化生理盐水（27名儿童）；然后由不知分配治疗情况的研究人员每小时评估一次，持续长达4小时。
两组进入研究时的喉炎评分中位数均为4分。在最终研究评估时，布地奈德组的中位数评分显著低于安慰剂组（1分对3分，P = 0.005）。布地奈德组患者从急诊科出院的时间明显早于安慰剂组（P = 0.002）。入组一周后，分配至安慰剂组的21名患者接受了地塞米松治疗，而分配至布地奈德组的为15名患者（P = 0.10）；分配至安慰剂组的7名患者入院治疗，而分配至布地奈德组的为1名患者（P = 0.05）。
我们得出结论，雾化布地奈德可使到急诊科就诊的轻至中度喉炎患儿迅速且显著地实现临床改善。
