Oral Ciprofloxacin in the Treatment of Pseudomonas Exacerbations of Paediatric Cystic Fibrosis: Clinical Efficacy and Safety Evaluation Using Magnetic Resonance Image Scanning

摘要

Ciprofloxacin is effective for treating pulmonary infection in adult cystic fibrosis patients, and demonstrates excellent efficacy against Pseudomonas aeruginosa, but its use in paediatric cystic fibrosis patients has been limited because quinolone-induced cartilage toxicity has been observed in juvenile animals and has been considered a potential risk for children. Children with cystic fibrosis (n = 26; aged 6 – 16 years), with proven P. aeruginosa colonization of their sputum, were enrolled into a 14-day, open, non-comparative study. Patients were assigned to twice-daily treatment with oral ciprofloxacin 250 mg, 500 mg or 750 mg, depending on their body weight. None of the patients exhibited any signs or symptoms of arthropathy, as assessed by magnetic resonance imaging of the right knee, during or immediately after treatment, or at the 3-month post-therapy assessment. Cough, sputum production and sputum purulence were improved in more than 70% of patients. Patients showed a mean weight increase of 0.4 kg (95% confidence interval 0.1 to 0.7 kg) over the study period. Only one patient required a repeat chest radiograph, which showed no resolution of the abnormal radiographic appearances. Three patients reported adverse events during the trial, none of which were considered to be related to the study treatment.