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[Studies on sulbactam/ampicillin in the field of pediatrics]
H Nakamura1, M Miyazu, K Kasai
1Department of Pediatrics, Meitetsu Hospital.
Insights
This study evaluated sulbactam/ampicillin (SBT/ABPC) in pediatric patients. SBT/ABPC demonstrated high clinical efficacy and a favorable safety profile for treating pediatric infections.
Area of Science:
- Pediatric infectious diseases
- Pharmacokinetics and drug efficacy
- Antimicrobial resistance
Background:
- Sulbactam/ampicillin (SBT/ABPC) is a combination antibiotic used to treat bacterial infections.
- Pediatric infections require careful consideration of drug pharmacokinetics, efficacy, and safety.
Observation:
- Pharmacokinetic analysis in children aged 6-8 years showed predictable absorption and excretion of SBT/ABPC.
- Clinical evaluation in 36 pediatric patients (2 months to 11 years) demonstrated 100% efficacy for acute tonsillitis, pneumonia, and pyelonephritis.
- Bacteriological assessment showed a 95.5% eradication rate against various pathogens, including beta-lactamase producing strains.
Findings:
- SBT/ABPC achieved high serum concentrations and urinary recovery rates in pediatric subjects.
- The drug exhibited excellent clinical and bacteriological efficacy in treating diverse pediatric infections.
- Adverse effects were minimal, with only one case of diarrhea and transient elevations in liver enzymes.
Implications:
- SBT/ABPC is a valuable therapeutic option for pediatric infectious diseases, including those caused by beta-lactamase producing bacteria.
- The favorable safety profile supports its use in the pediatric population.
- Further research may explore optimal dosing and long-term outcomes.
Abstract:
Pharmacokinetic and clinical studies on sulbactam/ampicillin (SBT/ABPC) were carried out in the field of pediatrics. 1. Absorption and excretion Serum levels and urinary excretion of SBT/ABPC were studied in 4 children with ages 6 to 8 years. The mean serum concentration of SBT at 15 minutes following a single intravenous injection of 30 mg/kg of SBT/ABPC was 27.4 +/- 2.2 micrograms/ml and that of ABPC was 42.8 +/- 3.9 micrograms/ml, and their concentrations declined with mean half-lives of 1.06 +/- 0.15 hours and 0.84 +/- 0.05 hour, respectively, and at 6 hours were 0.3 +/- 0.2 microgram/ml and 0.2 +/- 0.1 microgram/ml on the average, respectively. The urinary recovery rates of SBT and ABPC at 6 hours after the injection were 59.0 +/- 22.4% and 58.4 +/- 25.3% on the average, respectively. 2. Clinical study SBT/ABPC was used for the treatment of a total of 36 pediatric patients with ages ranging 2 months to 11 years and it's clinical effectiveness, bacteriological efficacy and adverse effects were evaluated. Clinical efficacies in 5 patients with acute purulent tonsillitis, 26 with acute pneumonia and 1 with acute pyelonephritis were judged to be excellent in 27 cases and good in 5 cases with an overall efficacy ratio of 100.0%. Clinical efficacies in 6 patients whose infections were caused by beta-lactamase producing strains were judged to be excellent in all cases. Bacteriological efficacies of SBT/ABPC were assessed on 1 strain of Staphylococcus aureus (beta-lactamase producing strain), 2 strains of Streptococcus pneumoniae, 16 strains of Haemophilus influenzae (5 beta-lactamase producing strains and 11 non-beta-lactamase producing strains), 1 non-beta-lactamase strain of Haemophilus parainfluenzae and 2 strains of Escherichia coli (non-beta-lactamase producing strains). All strains except 1 strain of H. influenzae (beta-lactamase producing strain) which decreased in number were eradicated with a bacteriological eradication rate of 95.5%. Only 1 patient complained of diarrhea which was suspected to be related to the drug. No other side effect was reported. Elevations of GOT and GPT were observed in only 1 patient. The above results suggested that SBT/ABPC was a useful drug with preferable safety profile in the treatment for pediatric patients with infectious disease caused by beta-lactamase producing strains as well as those by non-beta-lactamase producing strains.