Clemens C J, Taylor J A, Almquist J R, Quinn H C, Mehta A, Naylor G S
Department of Pediatrics, University of Washington, Seattle, USA.
J Pediatr. 1997 Mar;130(3):463-6. doi: 10.1016/s0022-3476(97)70211-7.
To determine whether an antihistamine-decongestant combination (ADC) is superior to placebo in temporarily relieving symptoms of upper respiratory tract infection (URI) in preschool children.
Randomized, double-blind, placebo-controlled trial.
Four pediatric offices in the Seattle, Wash, area.
Children 6 months through 5 years of age with a URI of less than 7 days' duration.
Children were randomly assigned to receive an ADC (brompheniramine maleate-phenylpropanolamine hydrochloride) or placebo as needed for URI symptoms. Two hours after each dose of study medication, changes in the child's runny nose, nasal congestion, cough, and sleep status were assessed by means of a standardized questionnaire.
A total of 175 responses were recorded for 59 patients. There were no statistically significant differences in symptom improvement between the ADC and the placebo group (runny nose, p = 0.48; nasal congestion, p = 0.94; cough, p = 0.66). However, the proportion of children asleep 2 hours after receiving the ADC was significantly higher than the proportion receiving placebo (46.6% vs 26.5%; p = 0.01). Results were unchanged after control for the correlated nature of repeated responses, age, symptom duration, use of acetaminophen, time that the medication was given, and parental desire for medication.
The ADC was equivalent to placebo in providing temporary relief of URI symptoms in preschool children. However, the ADC did have significantly greater sedative effects than did placebo.
确定抗组胺药-减充血剂组合（ADC）在临时缓解学龄前儿童上呼吸道感染（URI）症状方面是否优于安慰剂。
随机、双盲、安慰剂对照试验。
华盛顿州西雅图地区的四家儿科诊所。
6个月至5岁、URI病程小于7天的儿童。
根据URI症状需要，将儿童随机分配接受ADC（马来酸溴苯那敏-盐酸苯丙醇胺）或安慰剂。每次服用研究药物两小时后，通过标准化问卷评估儿童流鼻涕、鼻塞、咳嗽和睡眠状态的变化。
共记录了59名患者的175份回复。ADC组和安慰剂组在症状改善方面无统计学显著差异（流鼻涕，p = 0.48；鼻塞，p = 0.94；咳嗽，p = 0.66）。然而，接受ADC两小时后入睡的儿童比例显著高于接受安慰剂的儿童比例（46.6%对26.5%；p = 0.01）。在对重复回复的相关性、年龄、症状持续时间、对乙酰氨基酚的使用、给药时间以及家长对药物的需求进行控制后，结果不变。
在为学龄前儿童临时缓解URI症状方面，ADC与安慰剂相当。然而，ADC的镇静作用确实比安慰剂显著更强。
