Comparative Effectiveness of High Dose Versus Standard Dose of Tebipenem-Pivoxil (TBPI-PI) in Intractable Acute Otitis Media in Children

Abstract

Recently, drug resistant strains, penicillin resistant Streptococcus peumoniae (PRSP) and β-latamase- nonproducing ampicillin-resitant Haemophilus influenzae (BLNAR) and β-lactamase-producing ampicillin- resistant H. influenzae (BLPAR) cause the increase in intractable cases of acute otitis media (AOM) in children. We treated 88 intractable AOM in children (0–3 years old) who were treated with the prior antibiotics and consequently ineffective. Forty five cases were treated with standard dose (4 mg/kg/dose, twice a day) of Tebipenem pivoxil (TBPM-PI) and 43 cases were treated with high dose (6 mg/kg/dose, twice a day) of TBPM- PI.

S. pnemoniae was isolated in 29 cases and H. influenzae was isolated in 53 cases. 27 cases (93.1%) were PISP/PRSP and 45 cases (84.9%) were BLNAR/BLPAR. The clinical response rate in regular dose group was 84.4% and the rate in high dose group was 93.0% (n.s. independent t-test). Whereas, the medication period in high dose group was 5.1 days and it was shorter than 6.0 days in standard dose group (p < 0.01, independent t-test). In this study, we employed this severity classification by the scoring system to evaluate the efficacy of TBPM-PI. In the evaluation of scoring system, the score in the high dose group was significantly better than that in regular dose group in 3 days and 7 days later from starting of administration (p < 0.05, independent t-test). Each one patient in both groups experienced mild diarrhea in adverse drug reaction. This result suggested the high dose administration of TBPM-PI (6 mg/kg/dose) was useful in intractable cases of infant AOM.