Nelson H S, Bernstein I L, Fink J, Edwards T B, Spector S L, Storms W W, Tashkin D P
Department of Medicine, National Jewish Medical and Research Center, Denver, CO 80206, USA.
Chest. 1998 May;113(5):1264-71. doi: 10.1378/chest.113.5.1264.
To determine the ability of budesonide via an inhaler (Pulmicort Turbuhaler; Astra Draco AB) to replace oral glucocorticosteroids (GCSs) in adult subjects with moderate-to-severe asthma.
Double-blind, randomized, and placebo-controlled study, with parallel groups.
Multicenter study in outpatient setting.
Eighty men and 79 women, aged 20 to 69 years, with moderate-to-severe asthma and a mean FEV1 of 58.3% predicted normal. All subjects were receiving oral GCS treatment and 79% of subjects were also receiving inhaled beclomethasone dipropionate (BDP). The mean daily doses of prednisone at baseline, including converted dose of BDP, for the placebo, budesonide 400 microg, and budesonide 800 microg, respectively, were 19.7 mg, 19.5 mg, and 18.7 mg.
After a 2-week baseline period, subjects entered a 20-week treatment period, during which the oral dose of prednisone was reduced by forced down-titration at 2-weekly intervals.
Subjects receiving 400 microg or 800 microg bid of budesonide achieved a significantly greater reduction (82.9% and 79.0% respectively) in oral GCS dose compared with placebo-treated subjects (27%; p<0.001). Two thirds of the subjects receiving budesonide were able to achieve sustained oral corticosteroid cessation, compared with 8% in the placebo group. Additionally, both doses of budesonide resulted in significant improvement in results of pulmonary function tests and asthma symptoms scores, and a significant decrease in the use of bronchodilator therapy. The mean plasma cortisol levels before and after adrenocorticotropic hormone stimulation increased most toward the normal range in the budesonide-treated groups compared with placebo-treated subjects.
Budesonide administered via Turbuhaler has a significant oral GCS-sparing capacity with maintained or improved asthma control in adult subjects with moderate-to-severe asthma.
确定通过吸入器（普米克都保；阿斯特拉·德拉科公司）使用布地奈德替代中度至重度哮喘成年患者口服糖皮质激素（GCS）的能力。
双盲、随机、安慰剂对照研究，采用平行组设计。
门诊多中心研究。
80名男性和79名女性，年龄20至69岁，患有中度至重度哮喘，预计平均第一秒用力呼气容积（FEV1）为正常的58.3%。所有受试者均接受口服GCS治疗，79%的受试者还接受吸入丙酸倍氯米松（BDP）治疗。安慰剂组、布地奈德400微克组和布地奈德800微克组在基线时泼尼松的平均每日剂量（包括BDP的换算剂量）分别为19.7毫克、19.5毫克和18.7毫克。
经过2周的基线期后，受试者进入为期20周的治疗期，在此期间，泼尼松的口服剂量每2周通过强制递减滴定法降低。
与接受安慰剂治疗的受试者（27%）相比，接受布地奈德每日两次400微克或800微克治疗的受试者口服GCS剂量显著降低（分别为82.9%和79.0%；p<0.001）。接受布地奈德治疗的受试者中有三分之二能够实现持续停用口服糖皮质激素，而安慰剂组为8%。此外，两种剂量的布地奈德均使肺功能测试结果和哮喘症状评分显著改善，支气管扩张剂治疗的使用显著减少。与接受安慰剂治疗的受试者相比，布地奈德治疗组促肾上腺皮质激素刺激前后的平均血浆皮质醇水平向正常范围升高最多。
通过都保吸入布地奈德在中度至重度哮喘成年患者中具有显著的节省口服GCS能力，同时维持或改善了哮喘控制。
