Department of Pharmacy Practice, Massachusetts College of Pharmacy and Health Sciences-Worcester/Manchester, USA.
Ann Pharmacother. 2012 Jul-Aug;46(7-8):1076-85. doi: 10.1345/aph.1Q653. Epub 2012 Jul 3.
To evaluate the pharmacology, clinical efficacy, and safety of aztreonam lysine for inhalation (AZLI) for cystic fibrosis (CF)-related signs and symptoms of pulmonary disease.
Literature was searched in MEDLINE through PubMed and cross-referenced with EMBASE (1980-June 2012). The key search terms used were aztreonam lysine, nebulized, inhaled, and cystic fibrosis. Bibliographies of selected articles were used to identify additional references. Ongoing trials were identified through a review of Web site trial registries.
Articles were limited to those written in English about studies conducted in humans. Studies included in this review examined both adult and pediatric patients with CF.
Aztreonam lysine is an inhaled monocyclic β-lactam antibiotic approved for use in the CF population. Four completed clinical trials with peer-reviewed published data were reviewed to assess the efficacy and safety of single-course AZLI; a fifth trial assessed the safety and efficacy of repeat courses of AZLI. None of these trials compared AZLI in a head-to-head manner with tobramycin for inhalation. In patients with moderate to severe pulmonary disease, AZLI administration improved forced expiratory volume in 1 second measurements, decreased sputum bacterial Pseudomonas aeruginosa density, and improved symptoms. Adverse effects in clinical trials were generally mild and similar to those with placebo.
AZLI is safe and effective for management of pulmonary-related symptoms in patients with CF who are colonized with P. aeruginosa and have moderate to severe pulmonary disease. Additional trial data comparing AZLI with tobramycin are warranted to further establish the place of AZLI in therapy.
评估赖氨酸单环β-内酰胺抗生素阿佐克隆（AZLI）治疗囊性纤维化（CF）相关肺部疾病的药理学、临床疗效和安全性。
通过 PubMed 检索 MEDLINE 中的文献，并与 EMBASE（1980 年-2012 年 6 月）交叉引用。使用的主要检索词是阿佐克隆赖氨酸、雾化、吸入和囊性纤维化。通过对选定文章的参考文献进行查阅，以确定其他参考文献。通过审查网站试验登记处，确定正在进行的试验。
文章仅限于英语撰写的、在人类中进行的研究。本综述中纳入的研究检查了 CF 成人和儿科患者。
阿佐克隆赖氨酸是一种已获批准用于 CF 人群的吸入性单环β-内酰胺抗生素。综述评估了单疗程 AZLI 的疗效和安全性，共纳入了四项完成的、有同行评审发表数据的临床试验；第五项试验评估了重复疗程 AZLI 的安全性和疗效。这些试验均未将 AZLI 与吸入用妥布霉素进行头对头比较。在中重度肺部疾病患者中，AZLI 给药可改善 1 秒用力呼气量测量值，降低痰液铜绿假单胞菌密度，并改善症状。临床试验中的不良反应通常较轻，与安慰剂相似。
对于肺部受 P. aeruginosa 定植且患有中重度肺部疾病的 CF 患者，AZLI 是一种安全有效的治疗方法，可改善与肺部相关的症状。需要进一步比较 AZLI 与妥布霉素的临床试验数据，以确定 AZLI 在治疗中的地位。
