Acute pulmonary exacerbations in cystic fibrosis. A double-blind trial of tobramycin and placebo therapy
R. Wientzen, C. B. Prestidge, R. I. Kramer, G. H. McCracken and J. D. Nelson
To determine the effect of antimicrobial therapy on acute pulmonary
exacerbations in cystic fibrosis, a randomized, double-blind trial of
tobramycin and placebo was carried out. Clinical responses were
satisfactory in all 11 children given tobramycin and in seven of 11 given
placebo. Two patients in the placebo group died. No patient given placebo
had improved results on pulmonary function studies, whereas improvement of
15% or more occurred in four of the six patients given tobramycin who could
cooperate with the testing. Quantitative cultures of sputum showed a
decrease of 1 logarithm or greater in Pseudomonas sp concentrations in six
of seven patients in the tobramycin group and in two of eight in the
placebo group. No difference in staphylococcal colonization was found.
Several features indicate that children with severer disease were randomly
assigned to the placebo group; nevertheless, the trend toward improved
response in patients given tobramycin suggests that empirical therapy with
antibiotics is beneficial for patients with acute pulmonary exacerbations
in cystic fibrosis.
