Piquet J, Zuck P, Dennewald G, Dugue P, Grivaux M, Brun P, Severac J C, Ostinelli J, Cheeseman K H
Service de Pneumologie, Centre Hospitalier Intercommunal Montfermeil, France.
Adv Ther. 1996 Jan-Feb;13(1):38-50.
To avoid the side effects associated with long-term administration of high doses of inhaled glucocorticosteroids, they should be used at the lowest effective dose. This study compared the clinical efficacy of budesonide given via a dry-powder, inspiratory flow-driven device (Turbuhaler), at a daily dose of 800 micrograms, with beclomethasone dipropionate (BDP) 1500 to 2000 micrograms given via pressurized metered-dose inhaler (pMDI) with spacer to adults requiring the latter dose of BDP to control their asthma. The study was performed as a 2-week run-in, 8-week open, randomized, multicenter, parallel-group design. Adult asthmatics with a forced expiratory volume in 1 second 55% or more of predicted normal and receiving BDP 1500 to 2000 micrograms daily entered the study. After a 2-week run-in, one group continued with BDP and the other was switched to budesonide through the Turbuhaler. After 8 weeks, morning peak expiratory flow (PEF) had increased by 5.9 L/min from a mean of 390 L/min in the budesonide group and by 1.9 L/min from a mean of 402 L/min in the BDP group. No clinically or statistically significant differences between groups were evident with regard to the change in this primary variable. Similarly, only small changes in evening PEF and secondary variables of lung function were seen, with no statistically significant difference between groups. The authors concluded that both treatments were equivalent in managing asthma in adult patients with stable asthma.
为避免长期大剂量吸入糖皮质激素带来的副作用,应使用最低有效剂量。本研究比较了通过干粉、吸气流量驱动装置(都保)每日800微克布地奈德与通过带储雾罐的压力定量吸入器(pMDI)给予1500至2000微克丙酸倍氯米松(BDP)对需要后者剂量BDP来控制哮喘的成年人的临床疗效。该研究采用2周导入期、8周开放、随机、多中心、平行组设计。1秒用力呼气容积为预测正常值55%或更高且每日接受1500至2000微克BDP的成年哮喘患者进入研究。经过2周导入期后,一组继续使用BDP,另一组通过都保改用布地奈德。8周后,布地奈德组的晨峰呼气流量(PEF)从平均390升/分钟增加了5.9升/分钟,BDP组从平均402升/分钟增加了1.9升/分钟。在这一主要变量的变化方面,两组之间没有明显的临床或统计学显著差异。同样,夜间PEF和肺功能次要变量仅有微小变化,两组之间无统计学显著差异。作者得出结论,两种治疗方法在治疗病情稳定的成年哮喘患者方面效果相当。