Lalloo Umesh G, Malolepszy Jóseph, Kozma Dezsó, Krofta Kamil, Ankerst Jaro, Johansen Bjørn, Thomson Neil C
Nelson R. Mandela School of Medicine, University of Natal, Durban, South Africa.
Chest. 2003 May;123(5):1480-7. doi: 10.1378/chest.123.5.1480.
We evaluated the efficacy and safety of low-dose budesonide/formoterol, 80 micro g/4.5 micro g, bid in a single inhaler (Symbicort Turbuhaler; AstraZeneca; Lund, Sweden) compared with an increased dose of budesonide, 200 micro g bid, in adult patients with mild-to-moderate asthma not fully controlled on low doses of inhaled corticosteroid alone.
All patients received budesonide, 100 micro g bid, during a 2-week run-in period. At the end of the run-in phase, 467 patients with a mean FEV(1) of 82% predicted received 12 weeks of treatment with budesonide/formoterol in a single inhaler or budesonide alone in a higher dose. Patients kept daily records of their morning and evening peak expiratory flow (PEF), nighttime and daytime symptom scores, and use of reliever medication.
The increase in mean morning PEF-the primary efficacy measure-was significantly higher for budesonide/formoterol compared with budesonide alone (16.5 L/min vs 7.3 L/min, p = 0.002). Similarly, evening PEF was significantly greater in the budesonide/formoterol group (p < 0.001). In addition, the percentage of symptom-free days and asthma-control days (p = 0.007 and p = 0.002, respectively) were significantly improved in the budesonide/formoterol group. Budesonide/formoterol decreased the relative risk of an asthma exacerbation by 26% (p = 0.02) compared with budesonide alone. Adverse events were comparable between the two treatment groups.
This study shows that in adult patients whose mild-to-moderate asthma is not fully controlled on low doses of inhaled corticosteroids, single-inhaler therapy with budesonide and formoterol provides greater improvements in asthma control than increasing the maintenance dose of inhaled corticosteroid.
我们评估了低剂量布地奈德/福莫特罗（80μg/4.5μg，每日两次，装于单一吸入器中，商品名信必可都保；阿斯利康公司；瑞典隆德）与增加剂量的布地奈德（每日两次，每次200μg）相比，在单独使用低剂量吸入性糖皮质激素未得到充分控制的轻至中度哮喘成年患者中的疗效和安全性。
所有患者在为期2周的导入期接受每日两次、每次100μg的布地奈德治疗。在导入期结束时，467例平均第一秒用力呼气容积（FEV₁）为预测值82%的患者接受了为期12周的治疗，一组使用单一吸入器中的布地奈德/福莫特罗，另一组使用更高剂量的布地奈德。患者每天记录早晚的呼气峰值流速（PEF）、夜间和白天的症状评分以及缓解药物的使用情况。
作为主要疗效指标的平均早晨PEF的增加，布地奈德/福莫特罗组显著高于单独使用布地奈德组（16.5L/分钟对7.3L/分钟，p = 0.002）。同样，布地奈德/福莫特罗组的晚上PEF也显著更高（p < 0.001）。此外，布地奈德/福莫特罗组无症状天数和哮喘控制天数的百分比分别显著改善（分别为p = 0.007和p = 0.002）。与单独使用布地奈德相比，布地奈德/福莫特罗使哮喘加重的相对风险降低了26%（p = 0.02）。两个治疗组的不良事件相当。
本研究表明，在单独使用低剂量吸入性糖皮质激素未得到充分控制的轻至中度哮喘成年患者中，布地奈德和福莫特罗的单一吸入器疗法在哮喘控制方面比增加吸入性糖皮质激素的维持剂量有更大改善。
