Tullis D Elizabeth, Burns Jane L, Retsch-Bogart George Z, Bresnik Mark, Henig Noreen R, Lewis Sandra A, Lipuma John J
Department of Medicine, University of Toronto, Keenan Research Centre of Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.
University of Washington, Seattle Children's Research Institute, 1900 Ninth Avenue C9S8, Seattle, WA 98101, USA.
J Cyst Fibros. 2014 May;13(3):296-305. doi: 10.1016/j.jcf.2013.08.011. Epub 2013 Oct 28.
Individuals with Burkholderia spp. infection have historically been excluded from efficacy trials of inhaled antibiotics, including aztreonam for inhalation solution (AZLI).
A double-blind, placebo-controlled, 24-week trial of continuous AZLI/placebo treatment was undertaken in individuals with cystic fibrosis (CF) and chronic Burkholderia spp. infection. All subjects also received usual medical care (determined by their physicians). Additional antibiotic use was not restricted.
Baseline FEV1% predicted values ranged from 15.8% to 114.6%. No significant treatment differences (AZLI vs. placebo) were observed at week 24 for any endpoints, including FEV1% predicted, number of respiratory exacerbations requiring systemic/inhaled antibiotics, or hospitalizations. Continuous AZLI administration was well tolerated. Burkholderia spp. susceptibility to antibiotics commonly used in CF therapy showed little change.
24-weeks of continuous AZLI treatment did not significantly improve lung function in CF subjects with chronic Burkholderia spp. infection. Non-study antibiotic use may have confounded any potential AZLI effects.
历史上，伯克霍尔德菌属感染患者被排除在吸入性抗生素的疗效试验之外，包括吸入用氨曲南（AZLI）。
对患有囊性纤维化（CF）和慢性伯克霍尔德菌属感染的个体进行了一项为期24周的连续AZLI/安慰剂治疗的双盲、安慰剂对照试验。所有受试者也接受常规医疗护理（由其医生决定）。不限制额外使用抗生素。
预测的基线第一秒用力呼气容积（FEV1）百分比范围为15.8%至114.6%。在第24周时，对于任何终点指标，包括预测的FEV1百分比、需要全身/吸入性抗生素治疗的呼吸道加重次数或住院次数，均未观察到显著的治疗差异（AZLI与安慰剂相比）。连续使用AZLI耐受性良好。伯克霍尔德菌属对CF治疗中常用抗生素的敏感性变化不大。
连续24周使用AZLI治疗并未显著改善患有慢性伯克霍尔德菌属感染的CF患者的肺功能。非研究性抗生素的使用可能混淆了AZLI的任何潜在作用。
