Vol.57 No.6 November 2009

Clinical research on pediatric acute otitis media

Rinya Sugita¹⁾, Yutaka Fujimaki²⁾, Shinako Harada³⁾, Yuki Sata³⁾, Yasutomo Yoshida⁴⁾, Shigeru Kimura⁵⁾, Yasuko Kimura⁵⁾, Nobuyuki Komatsu⁶⁾, Fuyuki Enomoto⁷⁾, Ken Arai⁸⁾, Mikio Tanaka⁹⁾, Akira Kusumi¹⁰⁾, Hisao Fujiwara¹¹⁾ and Toru Ogiwara¹²⁾

¹⁾Sugita ENT Clinic, 3-14-1 Takasu, Mihama-ku, Chiba, Japan
²⁾Fujimaki ENT Clinic
³⁾Harada Dental ENT Clinic
⁴⁾Yoshida ENT Clinic
⁵⁾Kimura Pediatric ENT Clinic
⁶⁾Komatsu ENT Clinic
⁷⁾Enomoto ENT Clinic
⁸⁾Arai ENT Clinic
⁹⁾Tanaka ENT Clinic
¹⁰⁾Kusumi ENT Clinic
¹¹⁾Fujiwara ENT Clinic
¹²⁾Ogiwara ENT Clinic

Abstract

Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis are well-known causes agents of pediatric acute otitis media. The increasing prevalence of Penicillin-intermediate S. pneumoniae(PISP), penicillin-resistant S. pneumoniae(PRSP), and β-lactamase-negative ABPC-resistant H. influenzae(BLNAR) is a serious clinical problem. Cefcapene pivoxil(CFPN-PI) acts antibacterially against these pathogens. Using a CFPN-PI preparation we evaluated its safety and clinical and bacteriological efficacy in 214 of 223 children with moderate or severe acute otitis media at an usual 9 mg/kg/day or a 18 mg/kg/day high dose for an average of 7 days. Adverse drug reactions occurred in 15.5% of usual-dose and 15.3% of high-dose subjects with no significant difference between groups (p=0.48) and both dosing regimens confirmed equivalent in safety. Clinical efficacy, for usual-dose subjects was 75.0% and for high-dose 77.6% with no significant difference between groups (p=0.33). In the usual-dose group, efficacy for severe cases, however was 71.7% compared to 87.5% for moderate cases, meaning that clinical efficacy tended to differ with otitis media severity (p=0.056). In the 18-mg/kg/day group efficacy for moderate cases was 78.9% and for severe cases 77.2%,with no significant difference between groups (p=0.44). CFPN-PI was thus bacteriologically efficacious against S. pneumoniae, H. influenzae including BLNAR, and M. catarrhalis, the major causes of pediatric acute otitis media (Figures 5, 6).
These findings suggest that, within the scope of our research, high-dose CFPN-PI is useful for treating of pediatric acute otitis media.

Key word

cefcapene pivoxil, child, acute otitis media, clinical study

Received

March 3, 2009

Accepted

September 17, 2009

Jpn. J. Chemother. 57 (6): 491-501, 2009