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primary studies published RCT

Oral ciprofloxacin vs. intravenous ceftazidime plus tobramycin in pediatric cystic fibrosis patients: comparison of antipseudomonas efficacy and assessment of safety with ultrasonography and magnetic resonance imaging. Cystic Fibrosis Study Group.

  • Year: 1997
  • Date: 2001
  • Author: Richard DA
Source

Pediatr Infect Dis J. 1997 Jun;16(6):572-8.

Study design (if review, criteria of inclusion for studies)

randomized, double-blind, placebo-controlled pilot study

Participants

12 patients with CF younger than 5 years of age. University of Michigan Cystic Fibrosis Center (Ann Arbor, MI)

Interventions

inhaled recombinant human DNase (rhDNase)

Outcome measures

The changes in the HRCT and CXR score from baseline to day 100 of therapy were assessed using a previously validated scoring system.

Main results

The mean changes of HRCT scores between the rhDNase and placebo groups were found to be significant at the 95% level, with mean change +/- SE mean of - 1.00 +/- 0.53 and 0.58 +/- 0.24 for rhDNase and placebo groups, respectively (P = 0.02). The difference in CXR score was not significant between the two groups. An analysis was performed to relate HRCT subscores to CXR score; only thickening of the intra-interlobular septae was significantly correlated with the total CXR score (r = - 0.7, P < 0.01). There was improvement in the parents' assessments of the patients' well-being, with improvement in physical activity, decreased cough, sleep quality, and appetite in those subjects receiving rhDNase.

Authors' conclusions

the administration of rhDNase was associated with improvement in the HRCT scan in CF patients younger than 5 years of age. Findings indicate that HRCT of the chest is useful and sensitive in studying responses to therapy in patients with CF lung disease. To our knowledge, this is the first report of the use of HRCT to assess the effectiveness of a therapeutic modality in so young a CF patient population.

Keywords: Child; computed tomography; Deoxyribonuclease; Airway clearance drugs -expectorants- mucolytic- mucociliary-; Infant; Inhalation OR nebulised; non pharmacological intervention - diagn; pharmacological_intervention; Recombinant Proteins; diagnostic procedures; Respiratory System Agents; Dornase alpha; Pulmozyme;