Treatment of early Pseudomonas aeruginosa infection in patients with cystic fibrosis: the ELITE trial
Treatment of early Pseudomonas aeruginosa infection in patients with cystic fibrosis: the ELITE trial
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DOI：
10.1136/thx.2009.121657
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发表时间：
2010-04-01
期刊：
影响因子：
10
通讯作者：
Angyalosi, Gerhild
中科院分区：
文献类型：
--
作者：
Ratjen, Felix;Munck, Anne;Angyalosi, Gerhild
抗生素治疗囊性纤维化（CF）患者早期铜绿假单胞菌感染是有效的，但早期治疗的最佳治疗方案和持续时间仍不清楚。EarLy吸入妥布霉素根除（ELITE）研究旨在评估两种方案的有效性和安全性妥布霉素吸入溶液（TIS）300 mg/5 ml每日2次（28和56天）治疗CF患者的早发性铜绿假单胞菌感染。患有早期绿脓杆菌感染的CF（年龄≥ 6个月）的患者用TIS治疗28天，每天两次，通过PARILCPLUS（PARIGmbH，斯塔恩贝格，德国）喷射雾化器给药。28天后，患者以1：1的比例随机分配至停止TIS（n=45）或继续接受28天的TIS（n=43）。主要终点是铜绿假单胞菌（任何菌株）复发的中位时间。次要终点包括患者的比例铜绿假单胞菌感染1个月后停止治疗和安全性assessments.Results复发铜绿假单胞菌（任何菌株）的中位时间是两组之间的相似。总体而言，在28天和56天组中，治疗结束后1个月分别有93%和92%的患者未发生铜绿假单胞菌感染，最终访视时分别有66%和69%的患者未发生铜绿假单胞菌感染。结论TIS治疗CF患者早期铜绿假单胞菌感染28天是一种有效且耐受性好的治疗方法。
Rationale Antibiotic therapy for early Pseudomonas aeruginosa infection in patients with cystic fibrosis (CF) is effective, but the optimal therapeutic regimen and duration for early treatment remains unclear. The EarLy Inhaled Tobramycin for Eradication (ELITE) study was designed to assess the efficacy and safety of two regimens (28 and 56 days) of tobramycin inhalation solution (TIS) 300 mg/5 ml twice daily for the treatment of early onset P aeruginosa infection in patients with CF.Methods In this open-label randomised multicentre study, patients with CF (aged >= 6 months) with early P aeruginosa infection were treated for 28 days with TIS twice daily administered by the PARI LC PLUS (PARI GmbH, Starnberg, Germany) jet nebuliser. After 28 days, patients were randomised 1: 1 to either stop TIS (n=45) or to receive a further 28 days of TIS (n=43). The primary endpoint was the median time to recurrence of P aeruginosa (any strain). Secondary endpoints included the proportion of patients free of P aeruginosa infection 1 month after cessation of therapy and safety assessments.Results The median time to recurrence of P aeruginosa (any strain) was similar between the two groups. In total, 93% and 92% of the patients were free of P aeruginosa infection 1 month after the end of treatment and 66% and 69% remained free at the final visit in the 28-day and 56-day groups, respectively. TIS was well tolerated.Conclusions Treatment with TIS for 28 days is an effective and well tolerated therapy for early P aeruginosa infection in patients with CF.