Russell G, Williams D A, Weller P, Price J F
Department of Medical Paediatrics, Royal Aberdeen Children's Hospital, United Kingdom.
Ann Allergy Asthma Immunol. 1995 Nov;75(5):423-8.
Current UK and international guidelines on asthma management recommend that, in pediatric patients still symptomatic on treatment with high-dose inhaled corticosteroids, consideration should be given to the introduction of regular twice daily long-acting beta 2-agonists.
The purpose of this study was to assess the efficacy and safety of inhaled salmeterol xinafoate 50 micrograms bid via the Diskhaler when added to the existing treatment of children with moderate to severe asthma.
A 12-week multicenter, double-blind, placebo-controlled, parallel group study was conducted at 78 hospital centers throughout the United Kingdom, involving 210 asthmatic children aged between 4 and 16 years of age. Morning peak expiratory flow (PEF), evening PEF, night-time and daytime symptoms and relief medication usage were recorded daily by the patient or parent over a 12-week treatment period.
Compared with placebo, the addition of salmeterol xinafoate to existing high dose inhaled corticosteroid treatment significantly improved mean morning PEF expressed as percent predicted (PEF-PP) during the first 4 weeks of treatment (median increase 6.5 percentage points P < .001). This effect persisted throughout the 12-week treatment period (P < .05). Both groups demonstrated an overall improvement in mean morning PEF-PP, 7.5 percentage points for salmeterol xinafoate and 4 percentage points for placebo. The mean evening PEF-PP followed a similar although less pronounced trend which was significant only during the first 4 weeks of treatment (P = .014). Daytime relief medication and recorded symptoms were reduced significantly in both groups. There was a greater improvement in the number of symptom-free days during the first 4 weeks (P < .01) and the last 4 weeks (P < .05) of treatment for salmeterol xinafoate. The overall incidence and nature of minor adverse events was similar in both groups.
This study demonstrates that the addition of salmeterol xinafoate to inhaled corticosteroid therapy in symptomatic asthmatic children significantly improves morning PEF-PP, and reduces their symptoms and use of relief medication.
英国及国际现行的哮喘管理指南建议，对于接受高剂量吸入性糖皮质激素治疗后仍有症状的儿科患者，应考虑引入每日两次规律使用的长效β2受体激动剂。
本研究旨在评估当吸入性昔萘酸沙美特罗50微克，每日两次，通过都保装置添加到中重度哮喘儿童的现有治疗方案中时的疗效和安全性。
在英国各地的78家医院中心进行了一项为期12周的多中心、双盲、安慰剂对照、平行组研究，涉及210名年龄在4至16岁之间的哮喘儿童。在为期12周的治疗期间，患者或家长每天记录早晨呼气峰值流速（PEF）、晚上PEF、夜间和白天症状以及缓解药物的使用情况。
与安慰剂相比，在现有的高剂量吸入性糖皮质激素治疗中添加昔萘酸沙美特罗，在治疗的前4周显著改善了以预测值百分比表示的平均早晨PEF（PEF-PP）（中位数增加6.5个百分点，P <.001）。这种效果在整个12周的治疗期间持续存在（P <.05）。两组的平均早晨PEF-PP均有总体改善，昔萘酸沙美特罗组为7.5个百分点，安慰剂组为4个百分点。平均晚上PEF-PP遵循类似但不太明显的趋势，仅在治疗的前4周有显著差异（P =.014）。两组的白天缓解药物使用和记录的症状均显著减少。在治疗的前4周（P <.01）和最后4周（P <.05），昔萘酸沙美特罗组无症状天数的改善更大。两组轻微不良事件 的总体发生率和性质相似。
本研究表明，在有症状的哮喘儿童中，在吸入性糖皮质激素治疗中添加昔萘酸沙美特罗可显著改善早晨PEF-PP，并减轻其症状和缓解药物的使用。
