Svendsen U G, Frølund L, Heinig J H, Madsen F, Nielsen N H, Weeke B
Department of Pulmonary Medicine, Gentofte County Hospital, Hellerup, Denmark.
Allergy. 1992 Apr;47(2 Pt 2):174-80. doi: 10.1111/j.1398-9995.1992.tb00960.x.
The efficacy of budesonide (800 micrograms b.d.) and beclomethasone dipropionate (750 micrograms b.d.) in controlling the symptoms of asthma, pulmonary function, bronchial responsiveness to histamine, and adrenal function, was assessed in a double-blind, double-dummy cross-over study of 36 adult chronic asthmatic patients. The patients, the majority of whom were assessed to be affected to a severe degree, were insufficiently controlled in their current regimen of inhaled steroids and/or inhaled and oral bronchodilators. A 2 weeks baseline period preceded 6 weeks of treatment with each of the study drugs. Both treatment groups showed improvements from baseline in clinical assessment of lung function carried out after the first 6 weeks of treatment. No significant differences were seen throughout the entire 12 weeks study, when comparing the effects of the treatments on FEV1, FVC, PEF or the histamine PC20. Asthma severity, symptom score and inhaled bronchodilator use showed the same results after both treatments. It is concluded that inhalations of budesonide and beclomethasone dipropionate in high doses are equally potent in the treatment of severe asthma. There is no significant influence on the adrenal function and no significant side effects during a period equal to that of the present study.
在一项针对36名成年慢性哮喘患者的双盲、双模拟交叉研究中,评估了布地奈德(每日两次,每次800微克)和丙酸倍氯米松(每日两次,每次750微克)在控制哮喘症状、肺功能、支气管对组胺的反应性以及肾上腺功能方面的疗效。这些患者大多被评估为重度哮喘,他们目前使用吸入性类固醇和/或吸入及口服支气管扩张剂的治疗方案控制不佳。在使用每种研究药物进行6周治疗之前,有2周的基线期。两个治疗组在治疗的前6周后进行的肺功能临床评估中均显示较基线有所改善。在整个12周的研究中,比较两种治疗对第一秒用力呼气容积(FEV1)、用力肺活量(FVC)、呼气峰值流量(PEF)或组胺激发浓度(PC20)的影响时,未发现显著差异。两种治疗后的哮喘严重程度、症状评分和吸入性支气管扩张剂的使用情况均显示相同结果。结论是,高剂量吸入布地奈德和丙酸倍氯米松在治疗重度哮喘方面同样有效。在与本研究相同的时间段内,对肾上腺功能无显著影响,也无显著副作用。