Queen's University of Belfast, Centre for Infection and Immunity, Belfast, Northern Ireland, UK.
Expert Opin Pharmacother. 2010 Jun;11(8):1373-85. doi: 10.1517/14656566.2010.482102.
Chronic endobronchial infection in cystic fibrosis (CF) leads to progressive lung function loss and respiratory failure. Most adult CF patients are infected with Pseudomonas aeruginosa, an important predictor of mortality. Suppressing chronic P. aeruginosa infection with inhaled antibiotics is standard of care for CF patients.
This review describes the development (2003 - 2010) of aztreonam lysine 75 mg powder and solvent for nebulizer solution (AZLI; Cayston), an aerosolized formulation of the monobactam antibiotic aztreonam.
AZLI was studied in patients with CF and chronic P. aeruginosa airway infection. In placebo-controlled trials, AZLI improved respiratory symptoms, increased forced expiratory volume in 1 sec (FEV(1)), decreased sputum P. aeruginosa density, and was well tolerated. An open-label follow-on trial of nine 'on/off' courses showed that AZLI was safe and the effect durable with repeated administration. AZLI was recently approved for use in CF patients in Australia and the USA, and conditionally approved in Canada and the European Union. AZLI is given three times daily for 28 days (2 - 3 min/dose), followed by 28 days off-drug. AZLI is used only with the Altera Nebulizer System, which provides appropriate particle size and small airway deposition, and has excellent portability.
AZLI is a new therapy that is safe and effectively improves respiratory symptoms and FEV(1) in patients with CF.
囊性纤维化(CF)中的慢性支气管内感染可导致肺功能进行性下降和呼吸衰竭。大多数成年 CF 患者都感染了铜绿假单胞菌,这是死亡的重要预测因素。用吸入抗生素抑制慢性铜绿假单胞菌感染是 CF 患者的标准治疗方法。
本篇综述描述了单环β-内酰胺抗生素氨曲南赖氨酸 75mg 干粉及雾化溶液(AZLI;Cayston)的开发历程(2003-2010 年),这是一种雾化制剂。
AZLI 已在 CF 伴慢性铜绿假单胞菌气道感染患者中进行了研究。在安慰剂对照试验中,AZLI 改善了呼吸症状,增加了 1 秒用力呼气量(FEV1),降低了痰铜绿假单胞菌密度,且具有良好的耐受性。一项九个“开/关”疗程的开放标签后续试验表明,AZLI 是安全的,且重复给药效果持久。AZLI 最近在澳大利亚和美国获得 CF 患者使用的批准,在加拿大和欧盟获得有条件批准。AZLI 每天使用三次,持续 28 天(每次 2-3 分钟),然后停药 28 天。AZLI 仅与 Altera 雾化器系统一起使用,该系统可提供适当的颗粒大小和小气道沉积,并具有出色的便携性。
AZLI 是一种新的治疗方法,在 CF 患者中安全且有效地改善了呼吸症状和 FEV1。