氟尼缩松气雾剂治疗儿童支气管哮喘有效性与安全性的双盲评估

Double-blind evaluation of effectiveness and safety of flunisolide aerosol for treatment of bronchial asthma in children.

作者信息

Piacentini G L, Sette L, Peroni D G, Bonizzato C, Bonetti S, Boner A L

机构信息

Pediatric Department, University of Verona, Italy.

出版信息

Allergy. 1990 Nov;45(8):612-6. doi: 10.1111/j.1398-9995.1990.tb00947.x.

DOI:10.1111/j.1398-9995.1990.tb00947.x

PMID:2288396

Abstract

A double-blind study was carried out in 20 asthmatic children in order to evaluate the therapeutic efficacy and safety of inhaled corticosteroid flunisolide. 0.5 mg of the drug was administered by a jet nebulizer twice daily for 2 months. Respiratory symptoms, pulmonary function values and methacholine PC20-FEV1 were evaluated, as also morning cortisol levels, plasma cortisol increase after ACTH test, and 24-h urinary cortisol excretion. The data obtained show the efficacy of the drug in reducing symptoms. No significant difference was observed in pulmonary function values and in bronchial reactivity results between the two groups. No effect of flunisolide was observed on hypothalamic-pituitary-adrenal function. This study confirms the efficacy and safety of flunisolide (0.5 mg b.i.d.) in the treatment of asthmatic children.

摘要

为评估吸入性皮质类固醇氟尼缩松的治疗效果和安全性，对20名哮喘儿童进行了一项双盲研究。通过喷射雾化器每天两次给予0.5毫克该药物，持续2个月。评估了呼吸道症状、肺功能值和乙酰甲胆碱PC20-FEV1，还评估了早晨皮质醇水平、促肾上腺皮质激素试验后血浆皮质醇增加情况以及24小时尿皮质醇排泄量。获得的数据显示了该药物在减轻症状方面的疗效。两组之间在肺功能值和支气管反应性结果方面未观察到显著差异。未观察到氟尼缩松对下丘脑-垂体-肾上腺功能有影响。本研究证实了氟尼缩松（0.5毫克，每日两次）治疗哮喘儿童的疗效和安全性。