• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Pulmonary pharmacology & therapeutics >Randomized comparison of ciclesonide 160 and 640mug/day in severe asthma.
【24h】

Randomized comparison of ciclesonide 160 and 640mug/day in severe asthma.

机译：严重哮喘患者中ciclesonide 160和640 ug /天的随机比较。

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

OBJECTIVE: Demonstrating clinical benefit of higher doses of inhaled corticosteroids in asthma is frequently problematic owing to their relatively flat dose-response curve in this condition. In this study we compared the efficacy and safety of a fourfold difference in the dose of ciclesonide-ciclesonide 320mug twice daily (CIC640) versus ciclesonide 160mug once daily (CIC160)-in patients with severe persistent asthma. METHODS: Patients with bronchial asthma (6 months) were included in this randomized, double-blind study. After receiving fluticasone propionate 250mug twice daily during run-in, patients were randomized to CIC160 (n=339) or CIC640 (n=341) for 12 weeks. Primary endpoints were time to first asthma exacerbation and forced expiratory volume in 1s (FEV(1)). Secondary endpoints included other lung function variables, asthma symptom scores and rescue medication use (RMU). RESULTS: Asthma exacerbations occurred in 12.7% of patients receiving CIC160 and 6.7% receiving CIC640. CIC640 was superior for time to first exacerbation (p=0.0050, one-sided). FEV(1) increased significantly with CIC160 and CIC640 (least squares mean+/-SE of mean: 269+/-31 and 332+/-31mL, respectively; p<0.0001), with no significant difference between groups. Change in % predicted FEV(1) and morning peak expiratory flow (PEF) were significantly higher with CIC640 (p<0.05). Asthma symptom score sums and RMU decreased in both groups; CIC640 was statistically superior (p=0.0108 and 0.0005, respectively). No unexpected adverse events were reported in either group and the majority of the events reported were mild or moderate in intensity. No significant changes in serum cortisol were observed from the baseline to the study end. Small decreases in creatinine-adjusted 24h urine cortisol levels from baseline were seen in both the treatment groups, which, due to the large patient numbers, were statistically significant (p<0.05); however, no dose-response effect was seen and the difference between groups was not significant (p=0.7892). CONCLUSION: CIC640 was superior to CIC160 for time to first exacerbation, % predicted FEV(1), morning PEF, asthma symptom score sum and RMU in patients with severe asthma; both doses had similar tolerability profiles and no significant changes in serum cortisol were seen in either treatment group.
机译：目的：在哮喘中证明较高剂量吸入皮质类固醇的临床获益常常是有问题的，因为在这种情况下它们的剂量反应曲线相对平坦。在这项研究中，我们比较了重度持续性哮喘患者每日两次ciclesonide-ciclesonide（CIC640）与每日一次ciclesonide 160mug（CIC160）剂量四倍差异的疗效和安全性。方法：这项随机，双盲研究纳入了支气管哮喘患者（6个月）。在磨合期间每天两次接受丙酸氟替卡松250杯后，将患者随机分为CIC160（n = 339）或CIC640（n = 341），持续12周。主要终点为首次哮喘发作时间和强制呼气量（1秒）（FEV（1））。次要终点包括其他肺功能变量，哮喘症状评分和急救药物使用（RMU）。结果：接受CIC160的患者中有12.7％发生哮喘恶化，接受CIC640的患者中有6.7％发生哮喘。 CIC640在首次加重时间方面优势明显（p = 0.0050，单侧）。 CIC160和CIC640的FEV（1）显着增加（均方差的最小二乘均值分别为269 +/- 31和332 +/- 31 mL; p <0.0001），两组之间无显着差异。 CIC640预测的FEV％（1）和呼气高峰峰值流量（PEF）的变化显着更高（p <0.05）。两组的哮喘症状评分总和和RMU均降低; CIC640具有统计学上的优势（分别为p = 0.0108和0.0005）。两组均未报告意外不良事件，并且报告的大多数事件为轻度或中度强度。从基线到研究结束，未观察到血清皮质醇的显着变化。在两个治疗组中，肌酐调整后的24h尿皮质醇水平均较基线水平有小幅下降，这是由于患者人数众多而具有统计学意义（p <0.05）;但是，未观察到剂量反应作用，各组之间的差异也不显着（p = 0.7892）。结论：重度哮喘患者的首次发作时间，预测FEV（1）％，早晨PEF，哮喘症状评分和RMU均优于CIC160;两种剂量的耐受性特征相似，并且在任一治疗组中血清皮质醇均无明显变化。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号