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  Česky / Czech version Otorinolaryngol. /Prague/, 49, 2000, No. 2, p. 105-109
 
Azithromycin and Clarithromycin: Clinical and Economic Comparative Study in the Treatment of Acute Otitis Media in Children 
Šlapák I., Horník P., Dezort J. 

Dětská ORL klinika FDN, Brno, přednosta doc. MUDr. I. Šlapák, CSc. ORL ambulance, Pekařská, Brno
 


Summary:

       Acute otitis media in children is the most frequent indication in childhood for antibiotics which must be effective against all most frequently occurring bacterial agents and be economically acceptable. At the ENT Clinic of the Paediatric Hospital in Brno an open randomized comparative study was implemented to compare the use of azithromycin and clarithromycin in the treatment of this disease. Clinical signs and symptoms were followed up at given time intervals and scored according to a defined pattern. Allocation of patients into groups treated with AZI or CLARI was done according to a random procedure. AZI was administered in syrup, 10 mg/kg/day, CLARI as a suspension, 15 mg/kg. The study included a total of 100 patients aged 6 months to 12 years, 50 were treated with AZI, 50 with CLARI. The clinical outcome at the time of termination of treatment (10th-12th day) was evaluated in 50/50 patients (100%) in the AZI group and in 48/49 (98%) patients in the CLARI group (p = 0.600). In the AZI group 49 patients (98%) were classified as cured, in the CLARI group 47 (96%) patients. During the subsequent check-up examination (28th-30st day) the clinical outcome was assessed in 49/50 (98%) AZI patients and in 48/49 (98%) CLARI patients. Some pharmacoeconomic data were also assembled. Evaluation of the parents absence from work revealed a significant difference (mean 5.74 in AZI and 9.02 in CLARI, p = 0.0154). The authors evaluated the mean cost of antibiotic treatment. In AZI the cost was lower as administration of CLARI suspension to the older children required two packages. A statistically significant shorter period of the parents’ absence from work was recorded in the group on AZI.

        Key words: acute otitis media, children, azithromycin, clarithromycin, comparative study of treatment of otitis media.
       

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