Fish J E, Karpel J P, Craig T J, Bensch G W, Noonan M, Webb D R, Silverman B, Schenkel E J, Rooklin A R, Ramsdell J W, Nathan R, Leflein J G, Grossman J, Graft D F, Gower R G, Garay S M, Frigas E, Degraff A C, Bronsky E A, Bernstein D I, Berger W, Shneyer L, Nolop K B, Harrison J E
Department of Pulmonary Medicine, Thomas Jefferson Hospital, Philadelphia, PA, USA.
J Allergy Clin Immunol. 2000 Nov;106(5):852-60. doi: 10.1067/mai.2000.110798.
Inhaled corticosteroid therapy in severe persistent asthma has been shown to reduce or eliminate oral corticosteroid (OCS) use while retaining effective asthma control.
We sought to evaluate the ability of mometasone furoate (MF) delivered by means of dry powder inhaler to reduce daily oral prednisone requirements in OCS-dependent patients with severe persistent asthma.
We performed a 12-week, double-blind, placebocontrolled trial (21 centers, 132 patients) comparing 2 doses of MF (400 and 800 microg administered twice daily) with placebo, followed by a 9-month open-label phase in which 128 patients received treatment with MF.
At the endpoint of the double-blind trial, MF 400 and 800 mg twice daily reduced daily OCS requirements by 46.0% and 23.9%, respectively, whereas placebo increased OCS requirements by 164.4% (P <.01). Oral steroids were eliminated in 40%, 37%, and 0% of patients in the MF 400 and 800 mg twice daily and placebo groups, respectively. Pulmonary function and quality of life significantly increased for MF-treated patients. Further reductions in OCS requirements were achieved with long-term MF treatment in the open-label phase.
MF inhaled orally as a dry powder is an effective alternative to systemic corticosteroids in patients with severe persistent asthma.
在重度持续性哮喘中,吸入性糖皮质激素治疗已被证明可减少或消除口服糖皮质激素(OCS)的使用,同时保持有效的哮喘控制。
我们旨在评估通过干粉吸入器递送的糠酸莫米松(MF)减少重度持续性哮喘依赖OCS患者每日口服泼尼松需求量的能力。
我们进行了一项为期12周的双盲、安慰剂对照试验(21个中心,132名患者),比较2种剂量的MF(每日2次,每次400和800微克)与安慰剂,随后是一个为期9个月的开放标签阶段,其中128名患者接受MF治疗。
在双盲试验的终点,每日2次,每次400和800毫克的MF分别将每日OCS需求量降低了46.0%和23.9%,而安慰剂使OCS需求量增加了164.4%(P<.01)。在每日2次,每次400和800毫克的MF组和安慰剂组中,分别有40%、37%和0%的患者停用了口服类固醇。接受MF治疗的患者肺功能和生活质量显著提高。在开放标签阶段,长期MF治疗使OCS需求量进一步降低。
对于重度持续性哮喘患者,口服干粉形式的MF是全身用糖皮质激素的有效替代药物。