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[Basic and clinical studies on new semisynthetic penicillin, PC-904, in pediatric field (author's transl)]
Insights
This study evaluated PC-904 in pediatric patients, finding it effective against various bacterial infections with a 100% clinical success rate. Pharmacokinetic analysis revealed specific serum levels and excretion rates, with minimal side effects observed.
Area of Science:
- Pediatric pharmacology
- Infectious diseases
- Pharmacokinetics
Background:
- PC-904 is an antimicrobial agent evaluated for pediatric use.
- Understanding its pharmacokinetic profile and clinical efficacy is crucial for therapeutic application.
Observation:
- PC-904 demonstrated favorable pharmacokinetics with peak serum levels and elimination half-lives varying by administration route (drip infusion vs. one-shot injection).
- Urinary excretion rates were approximately 20% for drip infusion and 11.9-19.9% for one-shot injection.
- The drug was administered for 3 to 48 days to pediatric patients with sepsis, bacterial endocarditis, pneumonia, staphylococcal scalded skin syndrome, and pyelonephritis.
Findings:
- PC-904 achieved a 100% clinical efficacy rate, with excellent outcomes in 11 cases and good outcomes in 5 cases.
- The agent eradicated or reduced key pathogens including Pseudomonas aeruginosa, Staphylococcus epidermidis, Streptococcus viridans, Acinetobacter anitratus, Hemophilus influenzae, Escherichia coli, and Klebsiella pneumoniae.
- Minor side effects included elevated liver enzymes (s-GOT, s-GPT) in two patients, and single cases of anemia, rash, and fever, with unknown causal relation.
Implications:
- PC-904 shows significant potential as a safe and effective antimicrobial treatment for various pediatric bacterial infections.
- Further research into its long-term safety and efficacy in diverse pediatric populations is warranted.
- The pharmacokinetic data supports optimized dosing strategies for PC-904 in pediatric patients.
Abstract:
PC-904 was administered to 16 pediatric patients and the following basic and clinical results were obtained. (1) PC-904 was administered 20 approximately 30 mg/kg. The serum peak level of PC-904 after drip intravenous infusion over 1 hour was 66.7 microgram/ml at 1 hour and T 1/2 of PC-904 was 67.8 minutes. PC-904 was administered 25 approximately 30 mg/kg intravenous one shot injection was 49.4 microgram/ml at 1 hour and T 1/2 of PC-904 was 52.2 minutes. (2) Urinary excretion rate was about 20% up to 6 hours after drip intravenous infusion of 20 mg/kg. In a case of intravenous one shot injection of 25 approximately 30 mg/kg, the excretion rate was 11.9 approximately 19.9%. (3) PC-904 was administered 60 approximately 120 mg/kg/day for 3 approximately 48 days to 5 cases of sepsis and bacterial endocarditis, 6 of pneumonia, 2 of sss syndrome (staphylococcal scald skin syndrome) and 3 of pyelonephritis. Clinical effects were excellent in 11 cases and good in 5 cases, effective ratio being 100%. (4) Pseudomonas aeruginosa, Staphylococcus epidermidis, Streptococcus viridans, Acinetobacter anitratus and Hemophilus influenzae isolated from clinical specimens disappeared by the treatment of PC-904, and Hemophilus influenzae isolated from clinical specimens disappeared by the treatment of PC-904. Escherichia coli and Klebsiella pneumoniae reduced. (5) As to the side effect by PC-904, s-GOT and s-GPT were elevated in 2 cases. Anemia, rash and fever were observed in each 1 case out of 16 patients though the causal relation with the agent was unknown.