Miyamoto T, Takahashi T, Nakajima S, Makino S, Yamakido M, Mano K, Nakashima M, Tollemar U, Selroos O
National Sagamihara Hospital, Japan.
Respirology. 2000 Sep;5(3):247-56. doi: 10.1046/j.1440-1843.2000.00256.x.
The aim of this study was to investigate the dose-response for inhaled budesonide via Turbuhaler in Japanese patients with mild to moderate asthma.
Inhaled budesonide 100 microg, 200 microg, 400 microg or placebo was administered twice daily via Turbuhaler for 6 weeks, to 267 adult Japanese patients (mean age 51 years) with mild-to-moderate, non-steroid-dependent bronchial asthma, in a double-blind, placebo-controlled, randomized, parallel group study. The patients had to be symptomatic for more than 3 days/week and have an average morning peak expiratory flow (PEF) 50-80% of predicted normal value.
The response to budesonide was rapid, all treatments showing a significant improvement in morning PEF after 1 week (P<0.05). During week 6, mean improvements of 15, 45, 53 and 71 L/min were observed for the placebo, 200 microg, 400 microg and 800 microg budesonide groups, respectively. Compared with placebo all improvements in the budesonide groups were statistically significant and a significant dose-response was demonstrated (P<0.001). The difference between the 200 microg and 800 microg doses was significant. Also, for several secondary efficacy variables (e.g. evening PEF, symptom score, treatment score, daily activity score and sleep score) significant dose-responses were shown. Other variables included the investigators' assessments of improvement and usefulness. They also showed statistically significant dose-response relationships and confirmed the rapid onset of action. Budesonide was well tolerated at all tested doses, with a low incidence of adverse events, all of which were minor in severity.
Budesonide Turbuhaler in the doses 100 microg to 400 microg twice daily was effective, well tolerated and showed a rapid onset of action in patients with mild-to-moderate asthma. Dose-response was demonstrated for several variables of clinical efficacy.
本研究旨在调查日本轻至中度哮喘患者使用都保吸入布地奈德的剂量反应情况。
在一项双盲、安慰剂对照、随机、平行组研究中，267名成年日本轻至中度非类固醇依赖型支气管哮喘患者（平均年龄51岁），通过都保每日两次吸入100微克、200微克、400微克布地奈德或安慰剂，为期6周。患者每周出现症状超过3天，且平均晨起呼气峰值流速（PEF）为预计正常值的50 - 80%。
对布地奈德的反应迅速，所有治疗组在1周后晨起PEF均有显著改善（P<0.05）。在第6周时，安慰剂组、200微克、400微克和800微克布地奈德组的平均改善值分别为15、45、53和71升/分钟。与安慰剂相比，布地奈德各治疗组的所有改善均具有统计学意义，且呈现显著的剂量反应关系（P<0.001）。200微克和800微克剂量组之间的差异显著。此外，对于几个次要疗效变量（如夜间PEF、症状评分、治疗评分、日常活动评分和睡眠评分）也呈现出显著的剂量反应关系。其他变量包括研究者对改善情况和有效性的评估。它们也显示出具有统计学意义的剂量反应关系，并证实了起效迅速。所有测试剂量的布地奈德耐受性良好，不良事件发生率低，且严重程度均较轻。
每日两次吸入100微克至400微克剂量的布地奈德都保，对轻至中度哮喘患者有效、耐受性良好且起效迅速。临床疗效的几个变量呈现出剂量反应关系。
