Bergmann Karl-Christian, Lindemann L, Braun R, Steinkamp G
Allergie-und Asthmaklinik, Bad Lippspringe, Germany.
Swiss Med Wkly. 2004 Jan 24;134(3-4):50-8. doi: 10.4414/smw.2004.10403.
if patients with asthma remain symptomatic in spite of chronic treatment with inhaled corticosteroids (ICS), increasing the ICS dosage or adding another drug to the treatment regimen are possible therapeutic alternatives. We compared the efficacy and safety of combined salmeterol fluticasone therapy (SFC, 50/250 microg twice daily) with twice the dose of fluticasone propionate (FP, 500 microg b.i.d.) in symptomatic asthmatics.
this prospective, double-blind study was conducted in 76 study centres. 365 symptomatic patients with moderate asthma aged >18 years and receiving ICS in a dose equivalent to 1000 microg beclomethasone propionate per day were randomly assigned to receive either salmeterol xinafoate (50 microg) and fluticasone propionate (250 microg) in a single dry powder inhaler (Diskus) or 500 microg FP twice daily. The primary efficacy endpoint was morning peak expiratory flow rate (PEFR). Secondary measurements included forced expiratory volume in 1 second (FEV1), asthma symptom scores, and use of rescue medication.
combined salmeterol fluticasone therapy resulted in significantly greater improvements in PEFR and symptom control than doubling the dose of FP. At week 12, morning PEFR had increased by 52 L/min from baseline in patients on SFC and by 36 L/min in subjects receiving FP. The adjusted difference between groups was 16.6 L/min (95% confidence interval, 1.1 to 32.0 L/min). In the SFC group, the percentage of symptom-free days increased from baseline by 49% of days as compared with 38% of days after FP (adjusted difference: 12.6% of days, 95% CI 4.0 to 20.7). Quality of life improved to a greater degree after SFC therapy, and patients regarded study drugs as superior to their previous asthma medication. Adverse event profiles were similar between groups.
the combination of salmeterol 50 microg and fluticasone 250 microg in a single dry powder inhaler was superior to twice the dose of FP (500 microg). It seems justified to add salmeterol rather than increasing the ICS dose if symptomatic asthmatics require supplementary therapy.
尽管对哮喘患者采用吸入性糖皮质激素（ICS）进行长期治疗，但仍有症状的患者，增加ICS剂量或在治疗方案中添加另一种药物可能是可供选择的治疗方法。我们比较了沙美特罗氟替卡松联合疗法（SFC，50/250微克，每日两次）与双倍剂量丙酸氟替卡松（FP，500微克，每日两次）对有症状哮喘患者的疗效和安全性。
这项前瞻性、双盲研究在76个研究中心进行。365例年龄大于18岁、接受相当于每日1000微克丙酸倍氯米松剂量ICS治疗的中度症状性哮喘患者被随机分配，分别接受单剂量干粉吸入器（Diskus）中的昔萘酸沙美特罗（50微克）和丙酸氟替卡松（250微克），或每日两次500微克FP治疗。主要疗效终点是早晨呼气峰值流速（PEFR）。次要测量指标包括1秒用力呼气量（FEV1）、哮喘症状评分和急救药物的使用情况。
沙美特罗氟替卡松联合疗法在改善PEFR和症状控制方面比双倍剂量的FP有显著更大的效果。在第12周时，接受SFC治疗的患者早晨PEFR较基线增加了52升/分钟，接受FP治疗的患者增加了36升/分钟。组间调整差异为16.6升/分钟（95%置信区间，1.1至32.0升/分钟）。在SFC组，无症状天数占总天数的百分比较基线增加了49%，而接受FP治疗后为38%（调整差异：占总天数的12.6%，95%置信区间4.0至20.7）。SFC治疗后生活质量改善程度更大，患者认为研究药物优于他们之前使用的哮喘药物。两组间不良事件情况相似。
单剂量干粉吸入器中50微克沙美特罗和250微克氟替卡松的联合用药优于双倍剂量的FP（500微克）。如果有症状的哮喘患者需要辅助治疗，添加沙美特罗似乎比增加ICS剂量更合理。
