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小儿腺样体肥大与鼻气道阻塞:鼻用布地奈德水剂治疗可减轻症状

Pediatric adenoidal hypertrophy and nasal airway obstruction: reduction with aqueous nasal beclomethasone.

作者信息

Demain J G, Goetz D W

机构信息

Allergy-Immunology Department, Wilford Hall Medical Center, Lackland Air Force Base, TX 78236-5300.

出版信息

Pediatrics. 1995 Mar;95(3):355-64.

PMID:7862473
Abstract

OBJECTIVE

Pediatric adenoidal obstruction of the nasal airway is associated with significant morbidity and is a frequent indication for surgery. Because efficacious medical alternatives to adenoidectomy are lacking, we assessed the potency of standard-dose topical nasal beclomethasone in reduction of adenoidal obstruction of the nasal airway.

METHODS

Seventeen children, 5 to 11 years of age, exhibiting chronic obstructive nasal symptoms and a group mean (+/- SE) adenoid/choana ratio of 91 +/- 1% on rhinoscopic examination, completed an 8-week, double-blind, placebo-controlled crossover study of standard-dose aqueous nasal beclomethasone (total 336 micrograms/day) in the treatment of adenoidal hypertrophy. In a 16-week, open-label, follow-on study, subjects received beclomethasone 1 spray in each nostril twice daily (168 micrograms/day).

RESULTS

Over the initial 4 weeks, improvements in the mean adenoidal obstruction of the choanae were significantly greater in the group receiving beclomethasone than in the group receiving placebo (right, -14.0% vs. +0.4%, P = .0002) (left, -15.0% vs. -2.0%, P = .0006). In the subsequent crossover 4 weeks, a significant beclomethasone carryover effect resulted in further adenoid size reduction in both treatment groups. All patients demonstrated a decrease in adenoid size with beclomethasone treatment, compared with a mixed response to placebo. Over the full 8-week crossover study, the mean (+/- SE) obstructive symptom score after beclomethasone treatment (20.5 +/- 3.0) was significantly improved compared to patients' initial (43.1 +/- 2.9) and placebo scores (31.1 +/- 4.2, P < or = .05), despite the active drug carryover effect into the placebo treatment period. Significant improvements in adenoidal obstruction and symptom scores over the 8-week crossover study were enhanced in the subsequent 16-week open-label period (P = .0001). By 24 weeks, an 82% reduction in group mean nasal obstruction symptom score accompanied a 29% mean reduction in adenoid/choana ratio. No clinical or demographic characteristic predicted a patient's degree of response to treatment.

CONCLUSIONS

Properly administered aqueous nasal beclomethasone in standard doses can significantly reduce adenoidal hypertrophy and nasal airway obstructive symptoms in children.

摘要

目的

小儿腺样体阻塞气道会导致严重发病,是常见的手术指征。由于缺乏有效的腺样体切除替代药物治疗方法,我们评估了标准剂量的鼻用倍氯米松减少腺样体气道阻塞的效果。

方法

17名5至11岁的儿童,表现出慢性阻塞性鼻症状,鼻镜检查时腺样体/后鼻孔比例平均(±标准误)为91±1%,完成了一项为期8周的标准剂量鼻用倍氯米松水制剂(共336微克/天)治疗腺样体肥大的双盲、安慰剂对照交叉研究。在一项为期16周的开放标签随访研究中,受试者每天在每个鼻孔喷入1次倍氯米松(168微克/天)。

结果

在最初4周内,接受倍氯米松治疗组的后鼻孔平均腺样体阻塞改善程度显著大于接受安慰剂治疗组(右侧,-14.0%对+0.4%,P = 0.0002)(左侧,-15.0%对-2.0%,P = 0.0006)。在随后的交叉4周内,显著的倍氯米松残留效应导致两个治疗组的腺样体大小进一步减小。与安慰剂的混合反应相比,所有患者接受倍氯米松治疗后腺样体大小均减小。在整个8周的交叉研究中,倍氯米松治疗后的平均(±标准误)阻塞症状评分(20.5±3.0)与患者初始评分(43.1±2.9)和安慰剂评分(31.1±4.2)相比有显著改善(P≤0.05),尽管活性药物残留效应进入了安慰剂治疗期。在随后的16周开放标签期,8周交叉研究中腺样体阻塞和症状评分的显著改善得到增强(P = 0.0001)。到24周时,组平均鼻阻塞症状评分降低82%,同时腺样体/后鼻孔比例平均降低29%。没有临床或人口统计学特征可预测患者的治疗反应程度。

结论

标准剂量的鼻用倍氯米松水制剂合理给药可显著减轻儿童腺样体肥大和鼻气道阻塞症状。

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