Long-term benefits of inhaled tobramycin in children with cystic fibrosis: first clinical observations from Poland.

BACKGROUND

Respiratory disease is the major cause of mortality in cystic fibrosis (CF) patients and inhaled antibiotic therapy may contribute to the stabilization of lung function.

OBJECTIVES

This is a small, open, uncontrolled, observational study of clinical experience obtained with 2 years of maintenance treatment with inhaled tobramycin in 12 children and adolescents with CF.

METHODS

Twelve subjects aged 6-18 years infected by Pseudomonas aeruginosa were qualified for treatment with inhaled tobramycin. Pulmonary function, weight and height, clinical status, and chest X-ray were continually monitored. After an active 2-year treatment period, results of all measured parameters in our patients were compared with their previous results (2-year period before treatment with tobramycin).

RESULTS

During 2 years before treatment with tobramycin solution for inhalation (TOBI), pulmonary function decline was observed, the median value of FEV(1) change was -7.6% (lower quartile -13.1, upper quartile -5.9). After 2 years of treatment, FEV(1) percent predicted value declined by 1.5% (lower quartile -11.1, upper quartile 3.7) from baseline; 2 years of TOBI therapy significantly reduced lung function decline (p = 0.049). There were no significant changes in thoracic gas volume and specific airway resistance before and after treatment. Two years of TOBI therapy significantly improved body mass index (p = 0.02). TOBI treatment significantly delayed progression of pulmonary X-ray changes assessed by Brasfield score (p = 0.02).

CONCLUSIONS

We found that patients with CF can gain substantial benefits from long-term TOBI treatment, including reduced pulmonary function decline, delayed progression of pulmonary X-ray changes and improved weight gain in growing children and adolescents.