长期吸入左氧氟沙星溶液（APT - 1026）治疗囊性纤维化和慢性铜绿假单胞菌气道感染的安全性和有效性。
Safety and efficacy of prolonged levofloxacin inhalation solution (APT-1026) treatment for cystic fibrosis and chronic Pseudomonas aeruginosa airway infection.
作者信息
Elborn J Stuart, Flume Patrick A, Cohen Fredric, Loutit Jeffery, VanDevanter Donald R
机构信息
Centre for Infection and Immunity, School of Medicine, Dentistry and Biomedical Sciences, University Belfast, 97 Lisburn Road, Belfast BT9 7AE, UK.
Department of Medicine, Medical University of South Carolina, Charleston, SC, USA; Department of Pediatrics, Medical University of South Carolina, Charleston, SC, USA.
出版信息
J Cyst Fibros. 2016 Sep;15(5):634-40. doi: 10.1016/j.jcf.2016.01.005. Epub 2016 Feb 28.
BACKGROUND
Levofloxacin inhalation solution (LIS) is the first aerosolized fluoroquinolone licensed for treatment of patients with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa lung infection. This study evaluated the safety and efficacy of extended LIS treatment.
METHODS
Patients completing a multinational, randomized study comparing LIS and tobramycin inhalation solution (TIS) were enrolled in an open-label extension in which all patients received three additional cycles of 28days of LIS 240mg twice daily followed by 28days off drug. Endpoints included mean relative change in percent predicted forced expiratory volume in 1s (FEV1), time to pulmonary exacerbation, and patient-reported quality of life.
RESULTS
Extended treatment with LIS in 88 patients was well tolerated with no new safety signals and evidence of positive effects on FEV1 and quality of life.
CONCLUSION
Patients receiving extended LIS treatment continued to show favorable efficacy with no additional safety concerns.
背景
左氧氟沙星吸入溶液（LIS）是首个被批准用于治疗囊性纤维化（CF）和慢性铜绿假单胞菌肺部感染患者的雾化氟喹诺酮类药物。本研究评估了延长LIS治疗的安全性和有效性。
方法
完成一项比较LIS和妥布霉素吸入溶液（TIS）的多国随机研究的患者参加了一项开放标签扩展研究，所有患者接受三个额外的疗程，每天两次吸入240mg LIS，持续28天，然后停药28天。终点指标包括1秒用力呼气容积（FEV1）预测值百分比的平均相对变化、肺部恶化时间以及患者报告的生活质量。
结果
88例患者接受LIS延长治疗耐受性良好，没有新的安全信号，且有证据表明对FEV1和生活质量有积极影响。
结论
接受LIS延长治疗的患者继续显示出良好的疗效，且没有额外的安全问题。
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