@article {Aksamit1702053, author = {Aksamit, Timothy和De Soyza, Anthony和Bandel, Tiemo-Joerg和Criollo, Margarita和Elborn, J. Stuart和Operschall, Elisabeth和Polverino, Eva和Roth, Katrin和Winthrop, Kevin L.和Wilson, Robert}, title = {RESPIRE 2:一项吸入环丙沙星干粉治疗非囊性纤维化支气管扩张症的III期安慰剂对照随机试验},体积={51},数量={1},位置= id ={1702053},年份= {2018},doi ={10.1183/13993003.02053-2017},出版商={欧洲呼吸学会},188bet官网地址我们评估了吸入性环丙沙星干粉(DPI)对非囊性纤维化支气管扩张、前一年两次或两次以上病情加重以及预先确定的痰菌患者的疗效和安全性。患者被随机分为2:1至每日两次的环丙沙星DPI 32.5 mg或安慰剂,在48周的14或28天的开/关治疗周期内。主要终点为首次恶化的时间和恶化的频率。招募国家和α水平分裂(分别为0.049和0.001,14和28天周期)与RESPIRE 1不同。患者随机分为环丙沙星DPI组(14天开/关(n=176)或28天开/关(n=171))或安慰剂组(14天开/关(n=88)或28天开/关(n=86))。各治疗组的病情加重率较低(平均{textpm}sd 0.6{textpm}0.9)。积极治疗可延长首次发作的时间(环丙沙星DPI开/停14天:危险比0.87,95.1% CI 0.62;p = 0.3965;环丙沙星DPI开/关28天:危害比0.71,99.9\% CI 0.39{\textendash}1.27; p=0.0511) and reduced frequency of exacerbations (ciprofloxacin DPI 14 days on/off: incidence rate ratio 0.83, 95.1\% CI 0.59{\textendash}1.17; p=0.2862; ciprofloxacin DPI 28 days on/off: incidence rate ratio 0.55, 99.9\% CI 0.30{\textendash}1.02; p=0.0014), although neither achieved statistical significance. Ciprofloxacin DPI was well tolerated.Trends towards clinical benefit were seen with ciprofloxacin DPI, but primary end-points were not met.RESPIRE 2 supports ciprofloxacin DPI clinical benefits in bronchiectasis, but did not reach statistical significance http://ow.ly/es9E30gNhos}, issn = {0903-1936}, URL = {//www.qdcxjkg.com/content/51/1/1702053}, eprint = {//www.qdcxjkg.com/content/51/1/1702053.full.pdf}, journal = {European Respiratory Journal} }