We analyzed 96 strains of Streptococcus pneumoniae isolated from 96 children. Penicillin-nonsusceptible strains comprised 73%. The most effective oral antimicrobial agent was faropenem (MIC₉₀: 0.25μg/mL). The most effective parenteral antimicrobial agent was panipenem (MIC₉₀: 0.125μg/mL). PBP gene alterations were seen even in PSSP. According to serotypes in penicillin-nonsusceptible strains, 6 B, 23 F, and 19 F comprised 73% of all isolates, while heptavalent pneumococcal vaccine comprised 83%. This situation should accelerate the use of vaccine in Japanese children.

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Acute uncomplicated cystitis is caused mainly by Escherichia coli and seems to be treatable with oral cephem antibiotics. Cefdinir (CFDN) has excellent activity against E. coli and displayed good clinical efficacy against acute uncomplicated cystitis in clinical development. However, there is little postmarketing data on the effectiveness of CFDN against cystitis, thus we conducted an investigation based on the criteria for the evaluation of the clinical efficacy of antimicrobial agents on urinary tract infection (draft fourth edition) defined by the UTI Subcommittee of the Clinical Evaluation Guidelines Committee, Japanese Society of Chemotherapy. From Sept. 2001 to Sept. 2002, 79 women aged 16 to 70 diagnosed as suffering from acute uncomplicated cystitis were treated with CFDN: 100mg×3/day for 3 days. Subjective symptoms, pyuria and bacteriuria were investigated before and after (3 to 5 days after the start of treatment) administration of CFDN. Investigation one week after treatment was also done where possible. Examination of bacteriuria before treatment showed 66.7% E. coli followed by Enterococcus faecalis (13.3%) and coagulase-negative staphylococci (13.3%). The effectiveness of CFDN against 60 evaluable patients was 100%(excellent: 71.7%), and bacteriuria was eradicated in 95.0% of patients. The effectiveness at 5-9 days post-treatment (13 patients evaluable) was 92.3%. Side effects observed in 3 cases were mild. Oral administration of CFDN, 100mg×3/day for 3 days was determined to be useful against acute uncomplicated cystitis and could be considered as a first choice antibacterial agent in empiric therapy in this indication.

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A 58-year-old man admitted for gaitdisturbance and dysarthria was fbund in postcontrast MRI of the brain to have a hyperintense mass in the splenium of the corpus callosum and around bilateral deep white matter. Ile was referred to the department of neurosurgery in July 2002. Brain tumor biopsy showed diff'use large B cell lymphoma, and he was diagnosed with primary central nervous system lymphoma. After a ndergoing two courses of high-dose methotrexate chemtotherapy, he developed drug-induced pneumonitis with high lever, shortness of breath, and fine crackles, confirmed by drug lymphocyte stimulation tests. Alter steroid pulse therapy, his pneumonitis markedly improved. Therefore, it is important that patients receiving rnethotrexate be carefully watched for adverse pulmonary effects.

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The purpose of this study was to evaluate the efficacy, safety and PK profile of meropenem (MEPM) in the treatment of hospitalized infants and children with various infections. A total 52 patients, average 3.48 years old, were enrolled in the study. MEPM was administered intravenously every 8 hours at a daily dose of 10, 20 or 40 mg/kg. The overall favorable clinical response rate was 95.9%(47 out of 49 eligible patients). The breakdown of the clinical response rate was 96.2%(25/26) for RTI, 100%(6/6) for sepsis, 100%(5/5) for meningitis, 100%(3/3) for UTI and 88.9%(8/9) for the other infections. There were no sequelae or mortality in five cases of meningitis treated with 40 mg/kg MEPM. The microbiological response was satisfactory in 97.0%(30 cases of “Eradicated” plus 2 cases of “Presumed eradicated” out of 33 evaluable patients). The two most frequently isolated bacteria were Streptococcus pneumoniae (16 strains) and Haemophilus influenzae (21 strains). These strains were favorably susceptible to MEPM. Plasma MEPM concentrations at 20-30 min after infusion were 65.52-38.22μg/mL on 40 mg/kg, 30.81-13.73μg/mL on 20 mg/kg and 16.37-5.86 iug/mL on 10 mg/kg, respectively. Urinary recovery was 56.4-70.7% after administration up to 8 hours. Cerebrospinal fluid (CSF) MEPM level was sustained at 0.29-2.75μg/mL up to 6 hours in the meningitis patients at a dose of 40 mg/kg. There were adverse drug reactions in 23 out of 52 patients, but no severe incidence was observed. In conclusion, MEPM appeared to be a useful agent for treatment of common infentions in infant and child patients at a dose of 10 or 20 mg/kg three times daily, and for severe infections such as meningitis at a dose of 40 mg/kg.

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We conducted a Use-Results Surveillance study of Farom^® Dry Syrup for Pediatric (faropenem, FRPM) in the first four years after its launch in 1999, covering 3, 823 cases at 630 institutions nationmide. Of these, the safety was analyzed in 3, 613 and the efficacy in 3, 424 excluding inappropriate cases. Results were as follows.
1. The incidence of adverse drug reactions (ADRs) associated with the use of FRPM (including abnormal laboratory findings) was 10.16%(367 cases), higher than the 8.18%(48 of 587 cases) recorded in pre-marketing studies.
2. The main ADRs were 9.80%(354 cases) in gastrointestinal disorders, including 349 cases of diarrhea, loose bowels, caddy stools and watery stools. Any symptoms were mild, and resolved with early termination of use. Other ADRs were skin and appendages disorders including rash.
3. FRPM efficacy exceeded 93.3%(3, 193 cases) for all indicatios, similar to those observed in the pre-marketing studies. For the penicillin-resistant Streptococcus pneumoniae (PRSP) or penicillin intermediated S. pneumoniae (PISP), efficacy in otorhinolaryngeal cases was 90.0%(18 of 20 cases).

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