Eficacia clínica de la asociación amoxicilina/sulbactam (4:1) en otitis media aguda en niños* JOSÉ COFRÉ G., ANDRÉS ROSENBLÜT R., CECILIA BOREL M., PATRICIA GONZÁLEZ A., ALICIA VÁSQUEZ M., M. TERESA SIRI A. e IRMELI ROINE A.Clinical efficacy of amoxicillin/sulbactam (4:1) association in acute otitis media in children Use of increased amoxicillin dose associated with beta-lactamase inhibitor is a reasonable strategy to counterbalance increasing S. pneumoniae and H. influenzae resistance in AOM. Aim: To evaluate clinical efficacy and tolerance of amoxicillin/sulbactam in a 4:1 proportion in children with AOM. Methods:In an open, 18 month, treatment study, children with 3-86 months, diagnosed at 2 emergency rooms of Santiago, Chile with AOM by ENT specialist without previous antimicrobial treatment were enrolled. After informed consent a diagnostic tympanocentesis was performed and children were prescribed 50/12,5 mg/kg of amoxicillin/sulbactam, bid for 10 days. Children were followed with clinical exam on days 3, 10, and 40 and impedance testing on day 10 and 40 if previously abnormal. The Dagan score (DS) was used for evaluation and criteria for improvement/cure were predefined. Results: 172 children (mean age: 30,9 months, range 4-86) completed the study. Most common microorganisms isolated were S. pneumoniae 40% (30% penicillin resistance), Haemophilus 28% (10.9% β-lactamase producers), and Moraxella 4%. Median DS decreased from 10 at enrollment to 3 on day 3 and 1 on day 10 (p < 0.001). At day 10 and 40, 48.1/74.1% were cured, 45.1/18.5% improved, and 6.8/3.1% had failed treatment. Diarrhea increased from 6.4% at enrollment to 32.5% on day 3 and 8.1% on day 10, requiring dietary management only. Two children discontinued treatment due to vomiting one and exanthema another. Conclusions: Amoxicillin/sulbactam at 100/25 mg/kg/ day for 10 days had a clinical efficacy (healing or improvement) of 93.2% in the treatment of AOM. Transitory diarrhea was common although not severe requiring dietary restriction only.
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