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Bacteriological pharmacokinetic and clinical studies on aztreonam in the pediatric field



Bacteriological pharmacokinetic and clinical studies on aztreonam in the pediatric field



Japanese Journal of Antibiotics 38(11): 3195-3216



This report summarizes the results of joint studies in pediatrics on aztreonam, the first monobactam antibiotic for practical use. 1. Pharmacokinetics was studied in 52 cases administered with 10, 20, 40 and 50 mg/kg of aztreonam (AZT) by intravenous injection and 20 cases with 10, 20, 30, and 40 mg/kg by drip infusion. All the cases had normal hepatic and renal functions at the administration. T 1/2 was in a relatively fixed range of 1.35 .apprx. 1.56 hours in intravenous injection cases and 1.30 .apprx. 1.55 hours in drip infusion. One hour after commencing administration of standard 20 mg/kg, the serum concentrations were 50.18 .+-. 4.24 .mu.g/ml in intravenous injection and 116.33 .+-. 10.18 .mu.g/ml in drip infusion and even 6 hours after the end of the administration, they were 5.80 .+-. 1.16 .mu.g/ml and 3.38 .+-. 0.58 .mu.g/ml, respectively. The cerebrospinal fluid penetration was studied on suppurative meningitis (5 cases) and nonbacterial meningitis (3 cases). The penetration was generally good with sufficient concentration for meningitis caused by Escherichia coli and Haemophilus influenzae. Amount of the penetration decreased as the cases were improved. 2. Twenty-nine (29) cases were excluded and 262 cases of total 291 were clinically assessed, and the pathogen-isolated 167 cases of 262 were principally analyzed. Efficacy of AZT was "excellent" for all 3 cases of E. coli sepsis and 1 case of Neisseria meningitidis meningitis and "good" for 1 case fo H. influenzae meningitis. The effective rate was 94.6% for 37 pneumonia cases, 94.7% for 76 UTI cases and 88.5% on the whole including as many as 98 "excellent" cases. However, the effective rate for 21 enteritis cases was only 52.4%. Similar trend was observed in the pathogen-unknown group and overall effective rate of total 267 cases was 86.8%. 3. The clinical effect by pathogen was 97.7% for 44 E. coli cases and 97.1% for 34 H. influenzae cases, showing excellent results for the GNB group. AZT was also effective for 8 out of 11 Pseudomonas aeruginosa cases. 4. With regard to microbiological effect by pathogen, AZT showed a high rate of bacterial elimination for GNB, primarily 98.1% for E. coli and 100% for H. influenzae followed by 76.9% for P. aeruginosa. However, it was only 30.0% for Salmonella. Excluding the Salmonella cases, GNB elimination rate was 93.5%. 5. Clinical and microbiological dose response was not clear partly because, same as the previous studies, the effective rate of AZT was high. It was considered, however, standard dose of 20 mg/kg .times. 3 .apprx. 4 times a day was recommendable. 6. AZT was administered to the 53 cases which had not been responsive to more than 3 days administration of other antibiotics and 27 cases showed "excellent" result, 13 cases "good" with total effective rate of 75.5%. Causative microorganisms eliminated by AZT were E. coli (5/6), H. influenzae (5/5), P. aeruginosa (4/6) and K. pneumoniae (3/3). On the whole bacteria were eliminated in 26 of total 32 GNB strains, decreased in 2 and unchanged only in 4. There was 1 Staphylococcus aureus strain, which was unchanged. The bacterial elimination rate of AZT administered to the cases previously treated by penicillins was 88.9% and to the cases previously treated by cephalospolins was 66.7%. Clinically successful cases were sepsis (2/3), suppurative meningitis (2/2), pneumonia (12/16), respiratory tract infection (9/10) and UTI (13/16). 7. Side effects were only rash (3 cases) and diarrhea (2 cases) with little digestive disturbance. Coagulopathy was not encountered. There were no significant abnormal laboratory findings same as available cephalosporins. 8. It was recognized that AZT is an effective and safe antibiotic for the GNB infections in pediatrics. Position of AZT is considered to be very high as a substitutional drug when first-selected antibiotics are ineffective. In consideration of the ineffectiveness of AZT to the Gram-positive bacteria and anaerobes, early identification of pathogens is required for AZT to be a first-choice product to the disea.

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