Verberne A A, Frost C, Duiverman E J, Grol M H, Kerrebijn K F
Department of Pediatrics, Subdivision of Pediatric Respiratory Medicine, Erasmus University and University Hospital/Sophia Children's Hospital, Rotterdam, The Netherlands.
Am J Respir Crit Care Med. 1998 Jul;158(1):213-9. doi: 10.1164/ajrccm.158.1.9706048.
Studies in adults revealed that addition of salmeterol to a moderate dose of inhaled corticosteroid resulted in better symptom control and higher PEF compared with doubling the dose of inhaled corticosteroid. The aim of this three group study was to compare the effects of a moderate dose of beclomethasone, the same dose of beclomethasone with salmeterol, and a doubling dose of beclomethasone on lung function and symptoms in children with moderate asthma. A total of 177 children already treated with inhaled corticosteroids, were randomized in a double-blind parallel study either to salmeterol 50 microg twice daily (BDP400+salm), beclomethasone 200 microg twice daily (BDP800), or placebo (BDP400) in addition to beclomethasone 200 microg twice daily. No significant differences between groups were found in FEV1, PD20 methacholine, symptom scores, and exacerbation rates after 1 yr. Salmeterol resulted in slightly better PEF in the first months of treatment. FEV1, and PD20 methacholine significantly improved in all groups. After 1 yr mean changes in FEV1, percent predicted were 4.3% (95% CI 1.3; 7.2), 5.8% (95% CI 2.9; 8.7), and 4.3% (95% CI 2.1; 6.5) for BDP400+salm, BDP800, and BDP400, respectively. Changes in airway responsiveness were 0.60 (95% CI 0.05; 1.14), 1.30 (95% CI 0.73; 1. 87), and 0.80 (95% CI 0.33; 1.27) doubling doses. Growth was significantly slower in the BDP800 group. We conclude that no additional benefit was found of adding either salmeterol or more beclomethasone to a daily dose of 400 microg beclomethasone in this group of children with excellent compliance of medication.
针对成年人的研究表明，与将吸入性糖皮质激素剂量加倍相比，在中等剂量吸入性糖皮质激素基础上加用沙美特罗能更好地控制症状，且呼气峰流速（PEF）更高。这项三组研究的目的是比较中等剂量倍氯米松、相同剂量倍氯米松加沙美特罗以及倍氯米松剂量加倍对中度哮喘儿童肺功能和症状的影响。共有177名已接受吸入性糖皮质激素治疗的儿童，在一项双盲平行研究中被随机分为三组，分别接受每日两次50微克沙美特罗（BDP400 + 沙美特罗）、每日两次200微克倍氯米松（BDP800）或安慰剂（BDP400），同时每日两次服用200微克倍氯米松。1年后，各组在第1秒用力呼气容积（FEV1）、乙酰甲胆碱激发试验剂量反应曲线斜率（PD20）、症状评分和病情加重率方面均未发现显著差异。在治疗的最初几个月，沙美特罗使PEF略有改善。所有组的FEV1和PD20均有显著改善。1年后，BDP400 + 沙美特罗组、BDP800组和BDP400组的FEV1占预计值百分比的平均变化分别为4.3%（95%置信区间1.3；7.2）、5.8%（95%置信区间2.9；8.7）和4.3%（95%置信区间2.1；6.5）。气道反应性的变化分别为0.60（95%置信区间0.05；1.14）、1.30（95%置信区间；0.73；1.87）和0.80（95%置信区间0.33；1.27）倍剂量。BDP800组的生长明显较慢。我们得出结论，在这组药物依从性良好的儿童中，在每日400微克倍氯米松的基础上加用沙美特罗或增加倍氯米松剂量均未发现额外益处。
