吸入性阿佐霉素赖氨酸与吸入性妥布霉素治疗囊性纤维化的比较疗效试验。
Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial.
机构信息
Cystic Fibrosis Center, Verona, Italy, Centro Fibrosi Cistica, Azienda Ospedalierouniversitaria di Verona, Piazza Stefani 1, 37100, Verona, Italy.
National University Hospital, Copenhagen, Denmark.
出版信息
J Cyst Fibros. 2013 Mar;12(2):130-40. doi: 10.1016/j.jcf.2012.07.006. Epub 2012 Sep 15.
BACKGROUND
Open-label, parallel-group, international trial comparing aztreonam for inhalation solution (AZLI) and tobramycin nebulizer solution (TNS) for cystic fibrosis patients with airway Pseudomonas aeruginosa.
METHODS
273 patients (≥ 6 years); randomized to three 28-day courses (AZLI 75 mg [three-times/day] or TNS 300 mg [twice/day]); 28 off-days separated each course.
RESULTS
268 patients were treated (AZLI/TNS: 136/132). Mean baseline FEV1 was 52% predicted. Mean relative changes after 1 course (AZLI: 8.35%; TNS: 0.55%; p<0.001) and mean actual changes across 3 courses (AZLI: 2.05%; TNS: -0.66%; p=0.002) indicated AZLI statistical superiority vs. TNS. AZLI-treated patients had fewer respiratory hospitalizations (p=0.044) and respiratory events requiring additional antipseudomonal antibiotics (p=0.004); both treatments were well tolerated. 133 patients received 1 to 3 courses of AZLI treatment in the open-label extension-period (28-day courses separated by 28 days off-treatment); lung function improvements were comparable regardless of whether patients had received TNS or AZLI in the preceding comparative period.
CONCLUSIONS
AZLI demonstrated statistical superiority in lung function and a reduction in acute pulmonary exacerbations compared to TNS over 3 treatment courses (ClinicalTrials.gov: NCT00757237).
背景
一项开放标签、平行分组的国际试验，比较了吸入用氨曲南溶液（AZLI）和妥布霉素雾化溶液（TNS）在气道铜绿假单胞菌感染的囊性纤维化患者中的疗效。
方法
共纳入 273 例（年龄≥6 岁）患者，随机分为三组，接受为期 28 天的三个疗程治疗（AZLI75mg，每日三次；或 TNS300mg，每日两次），每个疗程之间间隔 28 天的停药期。
结果
268 例患者接受了治疗（AZLI/TNS：136/132）。治疗前的平均基础 FEV1 为预计值的 52%。经过一个疗程的治疗后，AZLI 组的平均相对变化为 8.35%（p<0.001），3 个疗程后的平均实际变化为 2.05%（p=0.002），表明 AZLI 比 TNS 具有统计学优势。与 TNS 组相比，AZLI 组患者的呼吸道住院次数更少（p=0.044），需要额外使用抗假单胞菌抗生素的呼吸道事件更少（p=0.004），两种治疗方法均具有良好的耐受性。133 例患者在开放标签扩展期接受了 1 至 3 个疗程的 AZLI 治疗（每个疗程之间间隔 28 天停药期）；无论患者在前一个对照期是否接受过 TNS 或 AZLI 治疗，肺功能的改善情况均具有可比性。
结论
与 TNS 相比，AZLI 在三个疗程的治疗后，在肺功能方面具有统计学优势，并减少了急性肺部恶化的发生（ClinicalTrials.gov：NCT00757237）。
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