Busse W W, Chervinsky P, Condemi J, Lumry W R, Petty T L, Rennard S, Townley R G
University Hospitals CSC, Madison, WI, USA.
J Allergy Clin Immunol. 1998 Apr;101(4 Pt 1):457-63. doi: 10.1016/S0091-6749(98)70353-7.
Airway inflammation is a hallmark of asthma, therefore current treatment recommendations include the use of inhaled glucocorticosteroids (GCS). However, there is little evidence that the effects of inhaled GCS are dose dependent.
The objective of this study was to assess the efficacy and safety of a second-generation GCS, budesonide, delivered by Turbuhaler, in adults with chronic asthma.
In a 12-week, randomized, double-blind, multicenter, parallel-group study, 473 subjects 18 to 70 years of age received either placebo or budesonide (200, 400, 800, or 1600 microg total daily dose) administered twice daily. Primary efficacy end points were mean change from baseline for FEV1 and morning peak expiratory flow. Safety was assessed by reported adverse events and by a cosyntropin-stimulation test.
The mean baseline FEV1 was 63% to 66% of predicted normal value between groups. All doses of budesonide were more effective than placebo (p < 0.001). The mean changes in morning peak expiratory flow were 12, 22, 27, and 30 L/min in the 200, 400, 800, and 1600 microg budesonide total daily dose groups, respectively, and -27 L/min for the placebo group. A statistically significant dose-response effect for the mean change from baseline over the 12-week study was seen for both morning peak expiratory flow and FEV1. Budesonide-treated subjects also demonstrated significant reduction in asthma symptoms and bronchodilator use compared with placebo. There were no clinically significant differences in treatment-related adverse experiences among groups.
Budesonide administered by Turbuhaler exhibited a dose response and was effective at low doses. It was well tolerated and significantly more effective than placebo.
气道炎症是哮喘的一个标志，因此目前的治疗建议包括使用吸入性糖皮质激素（GCS）。然而，几乎没有证据表明吸入性GCS的效果是剂量依赖性的。
本研究的目的是评估通过都保装置递送的第二代GCS布地奈德在成年慢性哮喘患者中的疗效和安全性。
在一项为期12周的随机、双盲、多中心、平行组研究中，473名年龄在18至70岁的受试者接受了安慰剂或布地奈德（每日总剂量200、400、800或1600微克），每日给药两次。主要疗效终点是第一秒用力呼气容积（FEV1）和早晨呼气峰值流速相对于基线的平均变化。通过报告的不良事件和促肾上腺皮质激素刺激试验评估安全性。
各组之间的平均基线FEV1为预测正常值的63%至66%。所有剂量的布地奈德均比安慰剂更有效（p<0.001）。在布地奈德每日总剂量200、400、800和1600微克组中，早晨呼气峰值流速的平均变化分别为12、22、27和30升/分钟，安慰剂组为-27升/分钟。在为期12周的研究中，早晨呼气峰值流速和FEV1相对于基线的平均变化均呈现出具有统计学意义的剂量反应效应。与安慰剂相比，布地奈德治疗的受试者在哮喘症状和支气管扩张剂使用方面也有显著减少。各组之间与治疗相关的不良经历在临床上无显著差异。
通过都保装置给药的布地奈德呈现出剂量反应，且低剂量时有效。它耐受性良好，且比安慰剂显著更有效。
