Vol.56 No.4 July 2008
The efficacy and safety of cefteram pivoxil(CFTM-PI) fine granules at the maximum approved dosager in pediatric with respiratory tract infections
1)Sotobo Children's Clinic, 1880-4 Misakimachi-Izumi, Isumi, Chiba, Japan
2)Department of Pediatrics, Asahikawa Kosei Hospital
3)Department of Pediatrics, General Ota Hospital, Society of Health Insurance of Fuji Heavy Industries Ltd.
4)Takashima Children's Clinic
5)Department of Pediatrics, Meitetsu Hospital
6)Kawasaki Medical School Hospital
7)Division of Infectious Disease, Kitasato Institute for Life Sciences, Kitasato University
Abstract
We compared the efficacy and safety of cefteram pivoxil(CFTM-PI) fine granules at the maximum approved dosager and the frequency of adverse events comparied to a group of other oral cephems (CE group). Among children under 15 years of age who visited designated medical facilities from September 2005 to March 2006 and were diagnosed with laryngeal pharyngitis, tonsillitis, acute bronchitis, or pneumonia, 259 in the CFTM-PI fine granules group (median age: 4.2 years) and 108 in the CE group (45 administered cefcapene pivoxil, 49 cefditoren pivoxil, and 14 other agents) (median age: 3.5 years). CFTM-PI fine granules were administered at 18 mg/kg/day in 3 divided doses for, in principle, 5 days (or 7 days for pneumonia), and efficacy was evaluated by day 5 or day 7 for pneumonia. For the CE group, although the duration of administration was not predetermined, dosage was determined based on the approved dosage and dosage regimen. Adverse events were assessed at the end of administration.
Duration of administration of CFTM-PI fine granules was 5.96±1.76 days and CE groups 6.27±1.94 days. In the CFTM-PI granules group, 223 cases were subjected to efficacy analysis; clinical efficacy was evaluated after 4.21±1.18 days, resulting in efficacy of 96.2% (128/133) for pharyngitis, 97.4% (38/39) for acute bronchitis, 97.4% (37/38) for tonsillitis, 97.4% (37/38) for tonsillstis, 100% (13/13) for pneumonia, and 96.9% (216/223) overall. Clinical efficacy for each major detected bacterium was 100% (28/28) for Streptococcus pneumoniae, 98.8% (85/86) for Streptococcus pyogenes, 95.0% (57/60) for Haemophilus influenzae, and 100% (24/24) for Moraxella (Branhamella) catarrhalis. Out of 28 strains of S. pneumoniae, 6 of PISP and 7 of PRSP were found, whereas 9 of BLNAR were found among 60 strains of H. influenzae. Organoleptic evaluation showed that 70.7% (183/259) of patients felt the drug was "easy to take". Adverse events observed in all cases gastrointestinal symptoms and the incidence in CFTM-PI fine granules group was 5.4% (14/259) and in CE group 13.0% (14/108). For children under 3 years of age, the incidence of adverse reactions was 26.2% in the CE group and 9.4% in the CFTM-PI fine granules group, the latter being significantly lower than that in the CE group (p=0.0129).
These findings suggest that a high dosage of CFTM-PI fine granules produces a sufficient therapeutic effect in children with respiratory tract infections and can be expected to be effective for treating infectious diseases caused by resistant bacteria.
Key word
cefteram pivoxil, pediatric respiratory infection, high dosing, post-marketing surveillance
Received
December 19, 2007
Accepted
March 5, 2008
Jpn. J. Chemother. 56 (4): 453-461, 2008
