抽象的
如果吸入的抗生素可以改善支气管扩张患者的呼吸系统症状是未知的。在最近的第3期轨道试验中,使用ARD-3150(吸入脂质体CIPROXACIN)48周的治疗(吸入脂质体CIPROXACIN)没有显着改善使用预先分析的分析方法的症状,将基线症状与48周后的基线症状进行比较,当时患者已脱离治疗28 days. This method of analysis does not take account of possible improvements in symptoms while on active treatment.
A后HOCARD-3150(orbit-3和-4)的两种相同随机试验分析28天和28天的支气管扩张和慢性患者28天。Pseudomonas aeruginosainfection. The quality-of-life bronchiectasis respiratory symptom scale (QOL-B-RSS), which has a one-week recall period, was administered every 28 days. We examined whether respiratory symptoms improved during on-treatment periods and the relationship of changes in QOL-B-RSS to changes in bacterial load using a mixed-model repeated measures approach.
ARD-3150 treatment resulted in a significant improvement in respiratory symptoms during the on-treatment periods with concordant results between ORBIT-3 (estimate 1.4 points,se0.49; p=0.004) and ORBIT-4 (estimate 1.1 point,se0.41;p = 0.006)。在治疗循环期间与安慰剂相比,在最低临床上重要差异的患者比例较低的临床重要差异更高(P = 0.024)。呼吸系统症状的变化与治疗组中的细菌载荷的变化相关(R = -0.89,P <0.0001)。在加剧期间QoL-B RSS减少的个人估计为-9.4分(se0.91)在轨道-3和-10.8点(0.74)中,在轨道-4(p <0.0001)。
Inhaled ARD-3150 resulted in significant improvements in respiratory symptoms during the on-treatment periods which were lost during off-treatment periods. These results supports the concept that reducing bacterial load can improve respiratory symptoms in patients with bronchiectasis.
抽象的
吸入的环丙沙星改善了支气管扩张患者的症状https://bit.ly/2ZzvQdv
脚注
本文提供了补充材料www.qdcxjkg.com
This study is registered as a clinical trial, identifierNCT01515007和NCT02104245。Data are available from Aradigm Corporation.
兴趣冲突:J.D. Chalmers从Astrazeneca,Glaxosmithkline,Grifols,Insmed和Boehringer Ingelheim报告赠款和个人费用,从Chiesi的个人费用,来自Gilead的赠款,在提交的工作之外。
兴趣冲突:D. CIPolla专利US 10,420,765,US 9,987,227,US 9,968,555,US 9,545,401,US 9,545,401,US 9,259,424,US 9,078,897,US 9,028,864,US 8,414,915,US 8,268,347,US 8,119,156和US 8,071,127发布。
Conflict of interest: B. Thompson reports personal fees for consultancy from Aradigm, during the conduct of the study.
利益冲突:上午戴维斯是Grifols的雇员。
利益冲突:A. O'Donnell在研究期间向Aradigm报告个人费用。
利益冲突:G. TINO没有任何披露。
Conflict of interest: I. Gonda reports personal fees from Aradigm Corporation, during the conduct of the study; hold shares in Aradigm Corporation, outside the submitted work; and has two patents licensed with Aradigm Corporation.
兴趣冲突:C. Haworth在研究期间报告了从Aradigm的研究,咨询和讲座的顾问和讲座的个人费用;来自Zambon /简介的咨询和讲座的个人费用,顾问的咨询,Gilead和GSK的个人费用,咨询和个人费用从Insmed,Novartis的讲授,赠送和个人费用从TEVA的讲义,在提交的工作之外。
利益冲突:J. Froehllich是一名Aradigm的雇员。
Support statement: The study was funded by Aradigm Corporation. J.D. Chalmers is supported by the British Lung Foundation Chair of Respiratory Research and a Scottish Senior Fellowship from the Chief Scientist Office. Funding information for this article has been deposited with theCrossref Funder Registry。
- 已收到January 18, 2020.
- AcceptedMay 21, 2020.
- 复制right ©ERS 2020