title: [PK/PD breakpoints and clinical/bacteriological effects of cefcapene pivoxil fine granules for children at free drug concentrations in pediatric patients with respiratory infection].
abstract: A post-marketing clinical study was previously conducted in pediatric patients with respiratory infection to evaluate the pharmacokinetics, efficacy and safety of cefcapene pivoxil (CFPN-PI) fine granules for children. Based on the results from this study, we evaluated PK/PD breakpoints and clinical/bacteriological effects of CFPN-PI at free drug concentrations in pediatric patients with respiratory infection to determine an effective and safe dosage regimen of CFPN-PI. The following results were obtained from 61 pediatric patients evaluated in our research. 1) The response rate of pediatric respiratory infection to CFPN-PI was 100% for laryngopharyngitis, 84.6% for acute bronchitis, 100% for tonsillitis, 100% for pneumonia and 95.8% for all. 2) The bacteriological response (eradication rate of Haemophilus influenzae, Streptococcus pyogenes, Moraxella catarrhalis, Streptococcus pneumoniae, etc.) of pediatric respiratory infection to CFPN-PI was 87.5% for laryngopharyngitis, 66.7% for acute bronchitis, 75.0% for tonsillitis, 63.6% for pneumonia and 73.8% for all. 3) The blood concentration simulation demonstrated that the PK/PD breakpoint exceeding the time above MIC (TAM) of 40% after administration of CFPN-PI 3 mg/kg three times daily was 0.27 microg/mL. 4) The pediatric patients with respiratory infection were stratified by the TAM (%) of CFPN-PI into 40% to 100% (TAM > or = 40% group) and 0% to 40% (TAM < 40% group) to compare the clinical and bacteriological effects of CFPN-PI. The clinical and bacteriological response rates, respectively, were 97.4% and 77.8% in the TAM > or = 40% group, and 88.9% and 62.5% in the TAM < 40% group. There was no difference in the clinical effect between the two TAM-stratified groups. On the other hand, the bacteriological effect, i.e., eradication rate, tended to be higher in the TAM > or = 40% group than in the TAM < 40% group, although the between-group difference was not statistically significant.
authors.affiliation: Sekishinkai Sayama Hospital.
authors.forename: Yoshikiyo
authors.initials: Y
authors.lastname: Toyonaga
authors.forename: Naoichi
authors.initials: N
authors.lastname: Iwai
authors.forename: Takashi
authors.initials: T
authors.lastname: Motohiro
authors.forename: Keisuke
authors.initials: K
authors.lastname: Sunakawa
authors.forename: Ryochi
authors.initials: R
authors.lastname: Fujii
mesh_terms: D001419:Bacteria / Q000187:drug effects; D002511:Cephalosporins / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics* / Q000494:pharmacology*; D002648:Child; D006801:Humans; D011358:Product Surveillance, Postmarketing; D012141:Respiratory Tract Infections / Q000188:drug therapy*
chemical_list: D002511:Cephalosporins; C425944:cefcapene pivoxil hydrochloride