van Noord J A, Schreurs A J, Mol S J, Mulder P G
Department of Respiratory Diseases, Atrium Medisch Centrum, Heerlen, The Netherlands.
Thorax. 1999 Mar;54(3):207-12. doi: 10.1136/thx.54.3.207.
The objective of this multicentre, randomised, double blind, parallel group study was to compare the efficacy and safety of the addition of salmeterol with that of doubling the dose of fluticasone propionate in asthmatic patients not controlled by a low or intermediate dose of inhaled corticosteroids.
After a four week run in period of treatment with fluticasone propionate (100 micrograms twice daily if pre-trial dose was 400-600 micrograms inhaled corticosteroids or 250 micrograms twice daily if pre-trial dose was 800-1200 micrograms inhaled corticosteroids), 274 patients were randomised to treatment for 12 weeks with either salmeterol 50 micrograms twice daily plus the run in dose of fluticasone propionate or twice the run in dose of fluticasone propionate (200 or 500 micrograms twice daily). Outcome measures were daily records of peak expiratory flow (PEF), symptom scores, and clinic lung function.
The improvements in both the morning and evening PEF were better in the salmeterol than in the fluticasone propionate group, the mean increase in morning PEF being 19 l/min higher (95% CI 11.0 to 26.1) and in evening PEF being 16 l/min (95% CI 18.4 to 24.0) higher in the salmeterol group. The increase in forced expiratory volume in one second (FEV1) was 0.09 1 greater in the salmeterol group than in the fluticasone propionate group after four weeks of treatment (95% CI 0.01 to 0.18), but not after 12 weeks. Both regimens showed an increase in symptom free days and a reduction in the need for rescue salbutamol both during the day and the night, but these improvements were greater in the salmeterol group. There were no significant differences between the groups in adverse effects or in the number of rescue course of oral corticosteroids.
In this group of patients still symptomatic despite 100 or 250 micrograms fluticasone propionate twice daily, the addition of salmetterol caused a greater improvement in lung function and symptom control than doubling the dose of fluticasone propionate.
这项多中心、随机、双盲、平行组研究的目的是比较在未被低剂量或中等剂量吸入性糖皮质激素控制的哮喘患者中，添加沙美特罗与将丙酸氟替卡松剂量加倍的疗效和安全性。
在用丙酸氟替卡松进行为期四周的导入期治疗后（如果试验前剂量为400 - 600微克吸入性糖皮质激素，则每日两次，每次100微克；如果试验前剂量为800 - 1200微克吸入性糖皮质激素，则每日两次，每次250微克），274例患者被随机分配接受为期12周的治疗，一组为每日两次，每次50微克沙美特罗加导入期剂量的丙酸氟替卡松，另一组为两倍导入期剂量的丙酸氟替卡松（每日两次，每次200或500微克）。观察指标为每日的呼气峰值流速（PEF）记录、症状评分和临床肺功能。
沙美特罗组早晨和晚上的PEF改善均优于丙酸氟替卡松组，沙美特罗组早晨PEF的平均增加量高19升/分钟（95%可信区间11.0至26.1），晚上PEF高16升/分钟（95%可信区间18.4至24.0）。治疗四周后，沙美特罗组一秒用力呼气容积（FEV1）的增加量比丙酸氟替卡松组多0.09升（95%可信区间0.01至0.18），但12周后无此差异。两种治疗方案均显示无症状天数增加，白天和夜间使用急救沙丁胺醇的需求减少，但沙美特罗组的这些改善更为明显。两组在不良反应或口服糖皮质激素急救疗程数量方面无显著差异。
在这组尽管每日两次使用100或250微克丙酸氟替卡松仍有症状的患者中，添加沙美特罗比将丙酸氟替卡松剂量加倍能更显著地改善肺功能和控制症状。
