[A parallel comparative double blind study of cefixime with cefaclor in the treatment of acute suppurative otitis media in children]

Abstract

A double blind study was carried out to compare the efficacy and safety of cefixime (CFIX), a new oral cephem with cefaclor (CCL) in the treatment of 245 children weighing 10 approximately 30 kg, with acute suppurative otitis media. The daily dosages of CFIX and CCL were 3 approximately 6 mg/kg in 2 divided portions, and 20 approximately 40 mg/kg in 3 divided portions, respectively, and the drugs were administered for 7 days. The results obtained in this study are summarized as follows. Analyzed subjects were 211 patients (CFIX group: 108 patients, CCL group: 103 patients) for clinical efficacy. Efficacy rates judged by the doctor in charge were 88.9% and 83.5% in CFIX and CCL group, respectively, without significant difference between the 2 groups. Similar results were also obtained by the committee. When clinical effects were classified by clinical isolates, the efficacy rates against monomicrobial infections with Gram-negative bacteria were judged by the doctor in charge to be 100% in the CFIX group and 84.6% in the CCL group. Thus CFIX was judged to be significantly superior to CCL (P less than 0.05). The overall eradication rates of bacteria were 97.1% in the CFIX group and 90.3% in the CCL group. The eradication rate of CFIX was significantly superior to that of CCL (P less than 0.05). When improvements of individual symptoms were evaluated, regarding redness of the tympanic membrane and the tympanic cavity on the 3rd day of dosing, CFIX group (improvement in 84.1% of the cases) was significantly superior (P less than 0.05) to the CCL group (67.6%). Regarding purulent secretion on the 7th day of dosing, the CFIX group (improvement in 98.1% of the cases) was also significantly superior (P less than 0.05) to the CCL group (91.3%). Two hundred thirty eight patients were analyzed for side effects (CFIX group: 120 patients, CCL group: 118 patients). The incidence rates of side effects were 0.8% (1/120) in the CFIX group and 1.7% (2/118) in the CCL group, and there was no significant difference between the 2 drugs. From the above results, it is concluded that CFIX is a useful oral antibiotic in the treatment of acute suppurative otitis media in children. Furthermore, CFIX is expected to be equal or superior to CCL in clinical effects.