[Clinical studies of cefteram pivoxil in pediatrics].

The clinical efficacy and the safety of cefteram pivoxil granule (CFTM-PI, T-2588), a newly prepared drug for pediatric use, were performed. A total of 60 patients with ages between 6 months and 14 years 3 months with pediatric infections were medicated with CFTM-PI at dose levels of 3.2-9.9 mg/kg 3 times daily for 3-11 days. Clinical responses to the drug were excellent in 3 of 3 patients with acute pharyngitis, excellent in 14, good in 5 and poor in 2 of 21 patients with acute purulent tonsillitis, excellent in 1 and good in 2 of 3 patients with acute bronchitis, excellent in 16 and good in 8 of 24 patients with acute pneumonia, excellent in 3 and good in 1 of 4 patients with acute urinary tract infection and excellent in 2 of 2 patients with acute purulent lymphadenitis, hence the overall clinical efficacy rate was 96.5% in a total of 57 patients. Bacteriological responses to the drug were as follows: Eradicated, 8 strains of Streptococcus pyogenes, 3 strains of Streptococcus pneumoniae, 19 strains of Haemophilus influenzae (beta-lactamase positive; 7, beta-lactamase negative; 12), 1 strain of Haemophilus parainfluenzae (beta-lactamase positive) and 4 strains of Escherichia coli (beta-lactamase positive; 1, beta-lactamase negative; 3), decreased, 1 strain of S. pyogenes, hence the eradication rate was 97.2%. No side effects were encountered in any of the patients but for 3 who had diarrhoea and 1 who had loose stool, though these changes were slight. As abnormal laboratory test data, elevation of GOT was noted in 1 case, thrombocytosis and elevation of GPT in another. Also, none of the patients refused or complained of difficulty in intaking of the drug via oral route. In conclusion, CFTM-PI appeared to be a safe and highly effective antibiotic against pediatric infections.