Tratamiento de Pacientes Pediátricos con Faringitis Estreptocócica, Limitaciones

Debido al reducido tamaño de la muestra poblacional enrolada en el presente análisis, el poder del estudio constituye una limitante de importancia en el momento de extrapolar las conclusiones. Es por este motivo que estos hallazgos no deben ser considerados definitivos sino generadores de hipótesis.

Otra limitación de este subestudi o la constituye el caracter retrospectivo del mismo, no pudiendo eliminarse los posibles sesgos o confundidores derivados de este tipo de diseño. Pese a ello, la muestra poblacional “pura” de pacientes con faringitis estreptocócica confirmada que ha sido incorporada en el presente análisis es original en nuestro medio y resulta de valor al efectuar la toma de decisiones en la práctica médica cotidiana.

Conclusiones

Un tratamiento con azitromicina en dosis única diaria de 10 mg/kg durante tres días es tan efectivo como el régimen estándar de diez días con penicilina V, 25.000 a 50.000 U/kg tres veces por día para el tratamiento de niños con faringitis/tonsilitis estreptocócica aguda.

No existieron diferencias significativas en las respuestas clínicas y bacteriológicas entre los pacientes que recibieron tratamiento con azitromicina y los que recibieron penicilina V, así como tampoco en la incidencia de eventos adversos en ambos grupos.

Estos resultados confirman que un régimen de tratamiento de tres días con azitromicina es una alternativa válida al tratamiento estándar con penicilina V oral durante diez días, con la ventaja potencial de un mejor cumplimiento por parte del paciente debido a la duración más corta del mismo.

Agradecimientos

Agradecemos al Dr. Ernesto Ferreirós (Clinical Data Manager, Pfizer – Región Latinoamericana Sur [SOLA ]) por el análisis de la información, redacción y revisión del manuscrito.

Summary

Objectives: This open, prospective, multicenter, randomized, clinical trial compared the efficacy and safety of a 3-day azithromycin regimen versus a 10-day penicillin V course for the treatment of acute pharyngitis in pediatric patients with elevated ASLO titters.

Materials and methods: Two hundred and forty one patients aged between 3 and 14 years with a clinical diagnosis of streptococcal pharyngitis and isolates of Group A beta – haemolytic Streptococcus (GABHS) obtained from throat swabs were evaluated. The 125 patients, who modified ASLO titters in more than 2 dilutions at weeks 3-4 were eligible for comparison.

Serotyping of the strains was carried out. Patients were randomly assigned to study treatments [Group A (n =63): azithromycin (10 mg/kg once a day for 3 days) versus Group B (n =62): penicillin V (25-50 mg/kg tid for 10 days)]. Clinical and bacteriological outcomes were compared using the likelihood ratio chisquare test or Fischer’s exact test.

Results: satisf actory clinical responses (cure or improvement) were observed in 98.4% (62/63) of the patient sintheazithromycin group, and in 100% (62/62) of the patients in the penicillin V group (p = NS). A clinical failure was detected in only one patient in the azithromycin group. Bacteriological response was evaluated in 125 patients.

Eradication was obtained in 92.0% (58/63) of the patients who received azithromycin and 98.3% of the patients treated with penicillin V (p = NS). There were no clinical relapses in both groups. Two patients (one from each group) experienced mild nausea/diarrhoea, which disappeared after withdrawal of therapy.

Conclusions: azithromycin 10 mg/kg/day for three days is as safe and effective as penicillin V in the treatment of pediatric patients with GABHS pharingytis.

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Correspondencia: Lautaro de Vedia, Virrey
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