在成人哮喘研究中，大量证据支持采用联合吸入糖皮质激素（ICS）和长效β2受体激动剂治疗，不建议增加吸入性糖皮质激素剂量，但儿童中类似的研究资料较少。本试验为双盲、平行分组、非劣效性研究，基于全球哮喘防治倡议指南，在哮喘儿童中比较肺功能和哮喘控制情况。这些患儿连续12周接受沙美特罗/丙酸氟替卡松(SFC) 50/100 μg bd (n =160)或接受丙酸氟替卡松(FP) 200 μg bd(n =161)治疗。与基线状态值相比，治疗后SFC组的平均晨间呼气峰值流量的变化值大于FP组[校正后平均变化值(s.e.) (l/min): SFC: 26.9 (2.13), FP: 19.3 (2.12); 治疗差异: 7.6 (3.01); 95% CI: 1.7, 13.5; P= 0.012)]。哮喘控制随时间逐渐改善。与FP组相比，SFC 组在50%肺活量下的平均支气管扩张剂使用前最大呼气流量及无救护天数显著增加。其他疗效指标两组间类似。对于前期低剂量ICS治疗下哮喘未得到有效控制的患儿，SFC 50/100μg bd在改善个体的临床预后和总体哮喘控制方面与双倍剂量的FP（200 μg bd）同样有效。
（ 陈欣 审校）
Pediatr Allergy Immunol. 2009 Dec;20(8):763-71. Epub 2009 Feb 20.
Salmeterol/fluticasone propionate vs. double dose fluticasone propionate on lung function and asthma control in children.
de Blic J, Ogorodova L, Klink R, Sidorenko I, Valiulis A, Hofman J, Bennedbaek O, Anderton S, Attali V, Desfougeres JL, Poterre M.
Université Paris Descartes; Necker-Enfant Malades Hospital, 75015 Paris, France.
There is a large body of data to support the use of an inhaled corticosteroid (ICS) plus a long-acting beta(2)-agonist vs. increasing the dose of ICS in adults, but less data in children. This double-blind, parallel group, non-inferiority study compared lung function and asthma control, based on Global Initiative for Asthma guidelines, in children receiving either salmeterol/fluticasone propionate (SFC) 50/100 microg bd (n = 160) or fluticasone propionate (FP) 200 microg bd (n = 161) for 12 wks. Change from baseline in mean morning peak expiratory flow increased following both treatments, but was significantly greater in the SFC group compared with FP [Adjusted mean change (s.e.) (l/min): SFC: 26.9 (2.13), FP: 19.3 (2.12); treatment difference: 7.6 (3.01); 95% CI: 1.7, 13.5; p = 0.012)]. Asthma control improved over time in both groups. Mean pre-bronchodilator maximal-expiratory flow at 50% vital capacity and percentage rescue-free days showed significantly greater improvements in the SFC group compared with FP. All other efficacy indices showed comparable improvements in each group. Treatment with SFC 50/100 microg bd compared with twice the steroid dose of FP (200 microg bd), was at least as effective in improving individual clinical outcomes and overall asthma control, in asthmatic children previously uncontrolled on low doses of ICS.
de Blic J, et al. Pediatr Allergy Immunol. 2009 Dec;20(8):763-71. Epub 2009 Feb 20.
（ 陈欣 审校）
Pediatr Allergy Immunol. 2009 Dec;20(8):763-71. Epub 2009 Feb 20.
Salmeterol/fluticasone propionate vs. double dose fluticasone propionate on lung function and asthma control in children.
de Blic J, Ogorodova L, Klink R, Sidorenko I, Valiulis A, Hofman J, Bennedbaek O, Anderton S, Attali V, Desfougeres JL, Poterre M.
Université Paris Descartes; Necker-Enfant Malades Hospital, 75015 Paris, France.
There is a large body of data to support the use of an inhaled corticosteroid (ICS) plus a long-acting beta(2)-agonist vs. increasing the dose of ICS in adults, but less data in children. This double-blind, parallel group, non-inferiority study compared lung function and asthma control, based on Global Initiative for Asthma guidelines, in children receiving either salmeterol/fluticasone propionate (SFC) 50/100 microg bd (n = 160) or fluticasone propionate (FP) 200 microg bd (n = 161) for 12 wks. Change from baseline in mean morning peak expiratory flow increased following both treatments, but was significantly greater in the SFC group compared with FP [Adjusted mean change (s.e.) (l/min): SFC: 26.9 (2.13), FP: 19.3 (2.12); treatment difference: 7.6 (3.01); 95% CI: 1.7, 13.5; p = 0.012)]. Asthma control improved over time in both groups. Mean pre-bronchodilator maximal-expiratory flow at 50% vital capacity and percentage rescue-free days showed significantly greater improvements in the SFC group compared with FP. All other efficacy indices showed comparable improvements in each group. Treatment with SFC 50/100 microg bd compared with twice the steroid dose of FP (200 microg bd), was at least as effective in improving individual clinical outcomes and overall asthma control, in asthmatic children previously uncontrolled on low doses of ICS.
de Blic J, et al. Pediatr Allergy Immunol. 2009 Dec;20(8):763-71. Epub 2009 Feb 20.
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