Study design (if review, criteria of inclusion for studies)
double blind cross over design with random order
Participants
21 children with cystic fibrosis aged 6 to 15 years, chronically infected with Ps. Aeruginosa. 18 patients completed the study.
Interventions
4 month treatment periods separated by 2 month treatment-free periods.
Outcome measures
number of respiratory infections, number of hospital admissions, weight gain. Lung function, chest X-ray scores and ventilation/perfusion lung scan scores, adverse reactions, resistance of Ps. aeruginosa to azlocillin
Main results
The number of respiratory infections during combination therapy was significantly less compared with azlocillin (p< 0. 01) and mistabron (p, 0.01). The number of hospital admissions was also less during combination therapy, compared with mistabron (p < 0.02). Percentage weight gain was significantly more during combination therapy compared with mistabron (p< 0.05). Lung function, chest X-ray scores and ventilation/perfusion lung scan scores were not significantly different during any treatment period. No apparent allergic, bronchospastic or other adverse reactions to treatment were noted. Although resistance of Ps. aeruginosa to azlocillin did develop during all 3 treatment periods, in no case did it persist. Combination therapy with inhaled azlocillin and mistabron is superior to either treatment used alone.
Authors' conclusions
These results support previous invitro findings that inhibition of Ps.aeruginosa by azlocillin is enhanced by mistabron.