Abstract
A fixed combination of erythromycin ethylsuccinate and sulfisoxazole acetyle, PediazoleR (P) was compared to amoxicillin (A) for the Rx of AOM in children. Middle ear fluid was obtained by tympanocentesis. Of 145 patients (pts) studied, 76 boys and 69 girls were compliant and were evaluated for drug efficacy (72A, 73P). Based on otoscopic and tympanometric results, cure rates at 10-14 days for Hemophilus species (Hem), including mixed infections, were 84% (26/31) for A and 83% (20/14) for P. P was successful Rx in 7/8 pts with ampicillin-resistant (AmpR) Hem species; one had persistent AOM at Day 10. A was successful Rx in one pt with AmpR Hem. Cure rates for AOM due to all organisms were 83% for A and 89% for P. The cure rate for S. pneumoniae AOM was 82% (29/35) in the A group and 98% (39/40) in the P group (p>.05). A pts with S. pneumoniae as the initial infecting organism had significantly more clinical recurrences than their P counterparts, 8/12 vs 3/9 (p=.045). There was no difference between Rx in recurrence rates for pts with Hem as the initial infecting organism (3A vs 4P). By Day 10-14, 27/72 A pts and 35/73 P pts had middle ear effusion; by Day 28, 7/71 A and 11/70 P pts. There were no significant differences in adverse reactions. P is safe and effective Rx for AOM, including AmpR Hem.
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Rodriguez, W., Schwartz, R., Sait, T. et al. ERYTHROMYCIN-SULFISOXAZOLE (PEDIAZOLER) vs AMOXICILLIN IN THE TREATMENT (Rx) OF ACUTE OTITIS MEDIA (AOM) IN CHILDREN: A DOUBLE-BLIND MULTIPLE-DOSE COMPARATIVE STUDY. Pediatr Res 18 (Suppl 4), 232 (1984). https://doi.org/10.1203/00006450-198404001-00835
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DOI: https://doi.org/10.1203/00006450-198404001-00835