Este estudio demuestra que la azitromicina, administrada en dosis de 10 mg/kg durante tres días, da como resultado una respuesta clínica y bacteriológica comparable a la de la penicilina G benzatínica en el tratamiento de niños con faringoamigdalitis causada por el EBHGA. La tasa de reinfección también es similar entre los grupos después de 26-38 días de tratamiento. La seguridad y tolerabilidad fueron excelentes en ambos grupos de tratamiento. Los datos de eficacia y seguridad de este estudio se encuentran dentro de los rangos encontrados en otras publicaciones.
Summary
Objectives: to compare effi cacy, safety of 3-day course of azithromycin (AZM) oral suspension vs single intramuscular dose of penicillin-G-benzathine (PGB) for the treatment of acute pharyngitis/tonsillitis caused by Group A â -hemolytic streptococci (GABHS).
Design: randomized, open label, multicenter, comparative study. Ethics committee approval and written informed consent of legal guardians were obtained. After a positive immunoassay test, a clinical evaluation, leukocytes count, erythrosedimentation rate (ESR), Anti – Streptolysin – O (ASO) titers, culture and in-vitro sensitivity were performed at days 0,10-16 and 26 – 38.
Drug: AZM: 10 mg/kg/day. PGB: 600,000 units in patients
Subjects: a total of 192 Colombian children were included, 68%males, aged 2 to 15 years (mean=7.8). Forty subjects were discontinued from the study (21 of AZM and 19 of PGB).
Efficacy: the GABHS eradication at 10-16 day was 84% for AZM and 84% for PGB (p=0.883). Good Clinical response was 99% for AZM and 100% for PGB (p=1). At 26-38 day, the GABHS re-infection rate was 11 % for AZM (95%CI:1.6-20.2 ) and 6% for PGB (95% CI: 4.3 – 25.3) (p=0.306). The laboratory parameters had similar progression between groups. The ITT analysis showed similar trends.
Safety: two children suffered diarrhea and one abdominal pain in the AZM group. In the PGB group, all children had pain at injection site and one suffered hemoglobin decrease. No one was discontinued due to adverse events and there were not significant laboratory test abnormalities related to both treatments.
Conclusions: 1) There were not safety, clinical and bacteriological statistical differences between AZM and PGB.2) The re-infection rates at day 26-38 were not different.
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Correspondencia: Hugo Trujillo. Calle 2 Sur N° 46–55.
Clínica Las Vegas Fase I. Consultorio 434
E-mail:hugot@colomsat.net.co Medellín,Colombia
