Boe J, Rosenhall L, Alton M, Carlsson L G, Carlsson U, Hermansson B A, Hetta L, Kiviloog J, Karlson B W, Lundbäck B
Division of Lung Medicine, Karlskrona, Sweden.
Allergy. 1989 Jul;44(5):349-55. doi: 10.1111/j.1398-9995.1989.tb00457.x.
The dose-response effects of inhaled beclomethasone dipropionate (BDP) and budesonide (BUD) administered b.i.d. with the aid of metered dose aerosols were studied in 128 patients (67 men and 61 women, mean age 53 years) suffering from asthma bronchiale. The study was designed as a multi-centre, double-blind, four-period cross-over study, followed by a single-blind double placebo period. BDP was administered in doses of 400 and 1000 micrograms, and BUD in doses of 400 and 800 micrograms. The results in terms of peak expiratory flow (PEF) in the morning and evening, daily symptoms score and use of inhaled beta 2-agonists did not reveal any clinically significant differences between the drugs or between high (800 micrograms BUD, 1000 micrograms BDP) and low (400 micrograms BUD/BDP) doses. However, statistically significant differences were recorded for the corresponding parameters when comparing the placebo with preceding steroid periods. Adverse effects consisting mainly of oropharyngeal candidiasis, hoarseness and cough occurred in 54 of 468 treatment months (12%). The carry-over effects of inhaled steroids are longer lasting than was previously assumed.
在128例支气管哮喘患者(67例男性,61例女性,平均年龄53岁)中,研究了借助定量气雾剂每日两次吸入丙酸倍氯米松(BDP)和布地奈德(BUD)的剂量 - 反应效应。该研究设计为多中心、双盲、四期交叉研究,随后是单盲双安慰剂期。BDP的给药剂量为400微克和1000微克,BUD的给药剂量为400微克和800微克。就早晚的呼气峰值流速(PEF)、每日症状评分和吸入β2 - 激动剂的使用情况而言,这些药物之间或高剂量(800微克BUD,1000微克BDP)与低剂量(400微克BUD/BDP)之间均未显示出任何临床上的显著差异。然而,在将安慰剂与先前的类固醇治疗期进行比较时,相应参数记录到了统计学上的显著差异。在468个治疗月中有54个(12%)出现了主要由口咽念珠菌病、声音嘶哑和咳嗽组成的不良反应。吸入类固醇的残留效应比以前认为的持续时间更长。