Verberne A A, Frost C, Roorda R J, van der Laag H, Kerrebijn K F
Department of Pediatrics, Erasmus University, Rotterdam, The Netherlands.
Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):688-95. doi: 10.1164/ajrccm.156.3.9611067.
The aim of this study was to compare the effects of salmeterol and beclomethasone on lung function and symptoms in children with mild to moderate asthma. Sixty-seven children not treated with inhaled corticosteroids were randomized in a double-blind parallel study either to salmeterol 50 micrograms b.i.d. or beclomethasone 200 micrograms b.i.d. After one year, FEV1 significantly increased in the beclomethasone group, whereas in the salmeterol group there was a small reduction. Differences between groups were 14.2% predicted (p < 0.0001) and 7.0% predicted (p = 0.007) for pre- and postbronchodilator FEV1 values, respectively. PD20 methacholine decreased by 0.73 DD (p = 0.05) in the salmeterol group and increased by 2.02 DD (p < 0.0001) in the beclomethasone group. Morning and evening PEF and symptom scores improved in both groups, although more in the beclomethasone group. Asthma exacerbations, for which prednisolone was needed, were more frequent in the salmeterol group (17 versus two), as were the number of withdrawals due to exacerbations (six versus one). However, growth was significantly slower in the beclomethasone group (-0.28 SDS) compared with that in the salmeterol group (-0.03 SDS) (p = 0.001). We conclude that treatment with a moderate dose of beclomethasone is superior to salmeterol in children with mild to moderate asthma and recommend that salmeterol should not be used as monotherapy.
本研究的目的是比较沙美特罗和倍氯米松对轻至中度哮喘儿童肺功能和症状的影响。67名未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两组，一组接受沙美特罗50微克，每日两次，另一组接受倍氯米松200微克，每日两次。一年后，倍氯米松组的第一秒用力呼气容积（FEV1）显著增加，而沙美特罗组则略有下降。两组之间支气管扩张剂使用前和使用后FEV1值的差异分别为预测值的14.2%（p < 0.0001）和7.0%（p = 0.007）。沙美特罗组的乙酰甲胆碱激发试验剂量反应（PD20）降低了0.73个剂量加倍（DD）（p = 0.05），而倍氯米松组增加了2.02个DD（p < 0.0001）。两组的早晚呼气峰值流速（PEF）和症状评分均有所改善，不过倍氯米松组改善更明显。需要使用泼尼松龙治疗的哮喘急性加重在沙美特罗组更频繁（17次 vs 2次），因急性加重而退出研究的人数也是沙美特罗组更多（6人 vs 1人）。然而，与沙美特罗组（-0.03标准差评分）相比，倍氯米松组儿童的生长显著更缓慢（-0.28标准差评分）（p = 0.001）。我们得出结论，对于轻至中度哮喘儿童，中等剂量倍氯米松治疗优于沙美特罗，并建议沙美特罗不应作为单一疗法使用。
