Impacto clínico y evolución microbiológica tras tratamiento con tobramicina inhalada en bronquiectasias colonizadas por Pseudomonas aeruginosa

OBJECTIVES: To evaluate the effectiveness of nebulized tobramycin TOBI® in the modification of the natural history of the disease, identify the adverse effects and to weigh the microbiological impact on the bronchial bacterial flora. PATIENTS AND METHOD: Between May 2004 and March 2006 those patients with bronchiectases, except those secondary to cystic fibrosis, that presented bronchial colonization by Pseudomonas aeruginosa were started on treatment with 300 mg TOBI® twice a day, in an alternating on/off every 28 days regime, once its use as a drug of compassionate use was approved. Prior to treatment, the number of exacerbations, the pulmonary function, the microbiological isolations and the minimum inhibitory concentration (MIC) for aminoglucosides were noted. At the ninth month of treatment, the patients returned for re-evaluation with the same parameters together with the identification of possible adverse effects. RESULTS: Nineteen patients began the treatment and 15 completed it. The average of the FEV1 prior to the beginning of treatment was 51.6 ± 15.1%, and on completion was 54.1 ± 17.1 (without significant differences, p 0.068). The number of exacerbations that required antibiotic treatment, in the nine months prior to treatment with TOBI®, was 5.53 ± 2.7, significantly greater than that noted at the end of the therapeutic intervention (0.8 ± 1; p=0.001). The average MIC for tobramycin was 2.8 ± 2.1 mcg/ml before the treatment and 5.8 ± 2.7 at the completion of the study (p=0.02). Seven patients displayed secondary effects although the medication had to be suspended in only two. CONCLUSIONS: The use of TOBI® does not improve pulmonary function in these patients but the number of exacerbations that deteriorate the quality of life diminishes, at the expense of an increase of secondary effects and microbiological resistance without notable clinical impact. FUNDAMENTO: Evaluar la eficacia de tobramicina nebulizada TOBI® en la modificación de la historia natural de la enfermedad, identificar los efectos adversos y sopesar el impacto microbiológico sobre la flora bacteriana bronquial. PACIENTES Y MÉTODO: Entre mayo de 2004 y marzo de 2006 aquellos pacientes con bronquiectasias, excepto las secundarias a fibrosis quística, que presentaban colonización bronquial por Pseudomonas aeruginosa iniciaron tratamiento con TOBI® 300 mg dos veces al día en pauta alternante on/off cada 28 días, una vez aprobado su empleo como fármaco de uso compasivo. Se recogier