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雾化妥布霉素用于早期治疗囊性纤维化患者铜绿假单胞菌定植的安慰剂对照、双盲、随机研究

Placebo-controlled, double-blind, randomized study of aerosolized tobramycin for early treatment of Pseudomonas aeruginosa colonization in cystic fibrosis.

作者信息

Wiesemann H G, Steinkamp G, Ratjen F, Bauernfeind A, Przyklenk B, Döring G, von der Hardt H

机构信息

Department of Pediatrics, University Hospital, Essen, Germany.

出版信息

Pediatr Pulmonol. 1998 Feb;25(2):88-92. doi: 10.1002/(sici)1099-0496(199802)25:2<88::aid-ppul3>3.0.co;2-j.

DOI:10.1002/(sici)1099-0496(199802)25:2<88::aid-ppul3>3.0.co;2-j
PMID:9516091
Abstract

In chronic Pseudomonas aeruginosa pulmonary infection of patients with cystic fibrosis (CF), antibiotic therapy generally fails to eradicate the bacterial pathogen. The mucoid bacterial phenotype, high sputum production by the host, and low airway levels of antibiotics seem to be responsible for the observed decrease in antibiotic efficacy. We hypothesized that early antibiotic treatment by inhalation in CF patients may be able to prevent or at least delay airway infection. In a prospective placebo-controlled, double-blind, randomized multicenter study, 22 CF patients received either 80 mg b.i.d. of aerosolized tobramycin or placebo for a period of 12 months shortly after the onset of P. aeruginosa pulmonary colonization. Two patients in the tobramycin and six patients in the placebo group stopped inhalation before the 12 month treatment period. Using life table analysis, the time to conversion from a P. aeruginosa-positive to a P. aeruginosa-negative respiratory culture was significantly shorter in the tobramycin-treated group than in the placebo group (P < 0.05, log rank test). Lung function parameters and markers of inflammation did not change in either group during treatment. The results of this study suggest that early tobramycin inhalation may prevent and/or delay P. aeruginosa pulmonary infection in CF patients.

摘要

在囊性纤维化(CF)患者的慢性铜绿假单胞菌肺部感染中,抗生素治疗通常无法根除该细菌病原体。黏液样细菌表型、宿主痰液分泌过多以及气道内抗生素水平较低似乎是观察到的抗生素疗效下降的原因。我们推测,CF患者早期吸入抗生素治疗或许能够预防或至少延缓气道感染。在一项前瞻性、安慰剂对照、双盲、随机多中心研究中,22例CF患者在铜绿假单胞菌肺部定植后不久,接受了为期12个月的每日两次、每次80mg雾化妥布霉素治疗或安慰剂治疗。妥布霉素组有2例患者,安慰剂组有6例患者在12个月治疗期前停止吸入治疗。使用生存分析,妥布霉素治疗组从铜绿假单胞菌阳性呼吸道培养物转为阴性的时间显著短于安慰剂组(P<0.05,对数秩检验)。治疗期间两组的肺功能参数和炎症标志物均未改变。本研究结果表明,早期吸入妥布霉素可能预防和/或延缓CF患者的铜绿假单胞菌肺部感染。

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