Azythromicin Versus Amoxicillin-clavulanate in the Treatment of Acute Sinusitis in Children

In this prospective study we compared the efficiency of azithromycin and amoxicillin-clavulanate in treatment of acute sinusitis in children. Seventy patients were included in the age between 5 and 15 years. Beside ENT and pediatricians examination, nasal and throat smear on culture and antibiogram is taken from all the patients, as well as, X-ray of paranasal sinuses and laboratory findings, followed by check-up of nasal and throat smear and X-ray of paranasal sinuses. Azithromycin in single daily dose of 10 mg/kg during three days showed same efficiency as amoxicillin-clavulanate given three times per day in dose of 45 mg/kg during ten days.


Introduction
Th e treatment of acute sinusitis in childhood is, in most cases, based on antibiotic treatment ().Even minimally invasive sinus surgery with aim to widen natural ostium doesn't have a lot of supporters in our country (,).Since the swelling of paranasal sinuses mucosa is very often in children and combined with the infection of upper respiratory tract, we conducted this study with goal to compare the effi ciency of azithromycin and amoxicillin-clavulanate in the treatment of acute sinusitis (,).

Patients and Methods
This research made in concordance of recommends from Good Clinical Practice guidelines (GCP) involving human subjects and material derived from human subjects complied with ethical principles outlined in World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects.Th e children treated in outpatient department were included in this prospective clinical study.Total number of children is ,  male and  female in the age between  and  years.Beside ENT and pediatricians examination, nasal and throat smear on culture and antibiogram is taken from all the patients, as well as, X-ray of paranasal sinuses and laboratory fi ndings.In the patients where positive bacteriological fi nding in the nose and X-ray obvious sinusitis (maxillary sinus was predominant site of infl ammation) were encountered, we applied azithromycin in single daily dose of  mg/ kg during three days or amoxicillin-clavulanate given three times per day in dose of  mg/kg during ten days with ephedrin hidrochloride nasal decongestive solution twice a day.- days following treatment we did checkup nasal and throat smear and X-ray of paranasal sinuses.

Results
Observed groups of examinees included  patients, treated with azithromycin and  with amoxicillin/ clavulanate, among them  patients received full dosage of azithromycin and  od amoxicillin clavulanate.Seven patients did not show up on follow up examination (Table ).Total number of observed children was ,  male and  female (Graph ).Age distribution was:  between - years,  between - years.In all observed groups we took nasal and throat smear, culture and antibiogram which showed normal fi nding in ,Moraxella catarrhalis was isolated in ,Haemophillus infl uenzae in , Staphylococcus aureus in , other bacteria were islolated in  of patients.We analyzed X ray fi ndings at the fi rst examination, as well as tenth day of treatment.According to sinus location, maxillary sinus prevailed (Table ).There was good response on azithromycin therapy in maxillary sinus infection as evident on X rays (th day of treatment).In some cases therapy eff ect was evident after  days.

Discussion
Both antibiotics were well tolerated.The incidence of adverse events was low in both treatment groups; there were no signifi cant diff erences between azithromycin and amoxicilin/ clavulanate.Th ere also were no severe adverse reactions attributable to either agent.Treatment with azithromycin in a single dose of  mg/kg during three days showed same efficiency as amoxicilin/ clavulanate which has been applied three times per day during ten days in a dose of  mg/ kg.Since all the patients had follow up check - days after treatment we couldn't make a conclusion regarding when, actually, the improvement occurred.Bacteriological eradication at the end of treatment was similar comparing both groups.X-ray verifi ed improvement or recovery was similar in both groups, too.

Conclusion
Azithromycin in a single day dose during three days has the same effi ciency as amoxicillin/ clavulanate applied three times per day during ten days in the treatment of acute sinusitis.