A multicenter study of alternate-day prednisone therapy in patients with cystic fibrosis☆,☆☆,★
Section snippets
METHODS
We conducted a 4-year double-blind, placebo-controlled, parallel-group multicenter trial of two different doses of prednisone therapy in patients with mild-to-moderate CF. A total of 285 patients were enrolled at 15 participating CF centers in the United States and Canada. Cystic fibrosis was diagnosed on the basis of clinical signs and symptoms and two elevated sweat chloride (or sweat sodium) values according to published standards.11 Inclusion criteria were as follows: age 6 to 14 years;
RESULTS
There were no significant differences among the treatment groups at the beginning of the study with the exception that the Pseudomonas aeruginosa colonization rate was higher in the 2 mg/kg group than in the other two groups (Table I). The patients were characterized clinically as having mild-to-moderate disease on the basis of their modified Shwachman clinical score, Brasfield radiologic score, and lung function measurements. Pulmonary function values were similar in all three groups (Table I
DISCUSSION
Our findings suggest a role for alternate-day prednisone therapy, 1 mg/kg, in the treatment of patients with CF who were aged 6 to 14 years and had mild-to-moderate clinical status and P. aeruginosa colonization. In this group of patients, there was significant improvement in FVC, first evident at 6 months and persisting throughout the 4 years of the study. The administration of prednisone yielded no significant clinical benefit in patients who were not colonized with P. aeruginosa. The higher
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From the Section of Pediatric Pulmonology and Critical Care, Indiana University School of Medicine, Indianapolis; the Eudowood Division of Pediatric Respiratory Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland; the Section of Pediatric Pulmonology, Department of Pediatrics, Temple University School of Medicine, St. Christopher's Hospital for Children, Philadelphia, Pennsylvania; and the Cystic Fibrosis Foundation, Bethesda, Maryland
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Reprint requests: Howard Eigen, MD, 702 Barnhill Drive, Room 2750, Indianapolis, IN 46202-5225
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0022-3476/95/$3.00 + 0 9/20/61098