Division of Infectious Diseases, Department of Pediatrics, Hospital for Sick Children, University of Toronto 555 University Avenue, Toronto, Ontario, Canada M5G 1X8.
Expert Rev Respir Med. 2014 Aug;8(4):401-9. doi: 10.1586/17476348.2014.918507. Epub 2014 May 31.
Arikace™ is a novel formulation of inhaled liposomal amikacin that can penetrate deep within airway secretions and within Pseudomonas aeruginosa biofilms, making it an attractive therapeutic option for the treatment of cystic fibrosis (CF) pulmonary infections. Initial Phase I and Phase II studies in CF patients with chronic P. aeruginosa infection demonstrated that Arikace™ was a safe drug that resulted in significant improvements in lung function after 14-28 days of treatment. Phase III studies of inhaled liposomal amikacin compared to tobramycin inhalation solution in CF patients with P. aeruginosa infection revealed a comparable increase in forced expiratory volume in 1 second at the end of three cycles. In addition, inhaled liposomal amikacin has other potential applications in the management of difficult-to-treat pulmonary infections. A Phase II trial is currently underway to study the use of Arikace™ for the treatment of recalcitrant nontuberculous mycobacterial lung disease.
阿瑞卡塞(Arikace)™是一种新型的吸入用脂质体硫酸阿米卡星制剂,能够深入气道分泌物和铜绿假单胞菌生物膜内,这使其成为治疗囊性纤维化(CF)肺部感染的一种有吸引力的治疗选择。在患有慢性铜绿假单胞菌感染的 CF 患者中进行的初步 I 期和 II 期研究表明,阿瑞卡塞(Arikace)™是一种安全的药物,在治疗 14-28 天后可显著改善肺功能。在 CF 患者的铜绿假单胞菌感染中,与妥布霉素吸入溶液相比,吸入用脂质体硫酸阿米卡星的 III 期研究显示,在三个周期结束时,第 1 秒用力呼气量的增加相当。此外,吸入用脂质体硫酸阿米卡星在治疗难治性肺部感染方面还有其他潜在的应用。目前正在进行一项 II 期临床试验,以研究使用阿瑞卡塞(Arikace)™治疗难治性非结核分枝杆菌肺病。