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Biomedical subjects

J Mashiko

Publications and source records attributed to J Mashiko.

At least 19 recordsLinked to original sources

[Clinical evaluation of sulbactam/ampicillin in the pediatric infections].

Sulbactam/ampicillin (SBT/ABPC) was administered to 33 pediatric inpatients with 34 bacterial infections. Clinical efficacies were judged to be good in 33 cases (97.1%) out of 34 which included 13 cases of 14 with infections caused by beta-lactamase-producing strains of organisms, and successfully cured by this drug. There were no particular side effects to comment except some cases of diarrhea and loose stool. These results indicated that SBT/ABPC would be useful in the treatment of pediatric infections as a first choice of drug. Serum half-lives of ABPC and SBT were 0.79 hour and 1.02 hours, respectively, hence, q.i.d. dosage regimen would be appropriate.

Age Factors↗

[Clinical evaluation of sultamicillin fine granules in pediatric infections].

Sultamicillin fine granules (SBTPC), a mutual prodrug of sulbactam (SBT) and ampicillin (ABPC), were administered to 16 pediatric patients with bacterial infections. The efficacy rate was 93.3%. MICs (10(6) cells/ml) of SBTPC against beta-lactamase non-producing strains were not significantly different from those of ABPC, and ranged from less than or equal to 0.05 to 1.56 micrograms/ml. MICs of SBTPC, however, were 2-4 fold smaller than MICs of ABPC against beta-lactamase producing strains. Diarrhea and loose stool as side effects were observed in 4 (25%) of 16 patients, but none of them were severe. After oral administration of SBTPC (10 mg/kg), serum levels of ABPC and SBT peaked at 3.41 micrograms/ml and 2.43 micrograms/ml after 0.6 hour, and declined with half-lives of 1.79 and 1.00 hours, respectively.

Age Factors↗

[Clinical evaluation of flomoxef in children].

Flomoxef (FMOX, 6315-S), a new parenteral oxacephem antibiotic, was evaluated for its safety, efficacy and pharmacokinetics in children. Twenty-six patients with bacterial infections were treated with FMOX. Clinical efficacy rate was 92% and bacteriological cure rate was 85%. Three cases of infections due to methicillin-resistant Staphylococcus aureus were cured with FMOX therapy. No severe adverse reactions or abnormalities of laboratory test data were associated with FMOX therapy, although loose stools and diarrhea occurred frequently (23%). Serum half-lives of FMOX after a single bolus injection of 9 infants and children were 0.77 +/- 0.31 hour and excretion into urine was rapid. From these experiences, FMOX appeared to be a safe and effective antibiotic when used in children with susceptible bacterial infections.

Age Factors↗

[Clinical and pharmacokinetic evaluations of cefuzonam in children].

A new parenteral cephalosporin antibiotic, cefuzonam (L-105, CZON), was evaluated for its safety, efficacy and pharmacokinetics in children. Twenty-two cases of bacterial infections including pneumonia, lung abscess, sepsis, urinary tract infection and soft tissue infections were treated with CZON. Clinical effective rate was 95%. Serum half-lives of CZON were 1.04-1.33 hours in children with normal renal and hepatic functions. Significant depressions of the normal fecal flora were observed and diarrhea or loose stool was encountered in 7 of the 22 treated cases (32%).

Adolescent↗

[Pharmacokinetics and clinical effects of aspoxicillin in pediatric patients].

Since the efficacy and the safety of aspoxicillin (ASPC, TA-058) have been established on adult patients and the need of ASPC use on pediatric patients was anticipated, we performed a 16 center study on the clinical utility of ASPC in pediatric patients. 1. Pharmacokinetics ASPC was intravenously administered to 45 patients at a dose of 10, 20 or 40 mg/kg by one shot. Serum concentrations of ASPC were dependent of dose levels, and maximum levels of 58.4-230.8 micrograms/ml and half-lives (beta) of 1.08-1.16 hours were observed. Urinary recovery rates were 62.7-67.2% in 6 hours. Results obtained upon drip infusions (0.5-1 hour) were similar to one shot injections. 2. Clinical results (1) Clinical effectiveness Of 318 evaluable patients including 175 boys and 143 girls, 18.2% were nurslings and 61% were young children under 4 years of age. One hundred eighty six patients from whom causative organisms were isolated were classified as A group. Among them were 5 patients suffered with sepsis, but the ASPC treatment eradicated all the bacteria but Salmonella java in 1 case. All of 4 patients with meningitis were cured and all causative organisms (3 cases with Haemophilus influenzae and 1 case with Gram-positive coccus) were eradicated. Cure rates were 90% for 130 patients with respiratory tract infection, 88.6% for 35 with urinary tract infection, 85.7% for 7 with skin soft tissue infection and 89.8% for all the A group patients. Meanwhile, no causative organisms were isolated from 132 patients (B group patients) but cure rate of 91.7% was obtained for this group. No statistical difference was observed between A and B groups. For all the patients (318), the cure rate was 90.6%. (2) Bacteriological effects Of 63 Gram-positive bacteria isolated as pathogens, 58 strains were eradicated. Of 117 Gram-negative bacterial, 101 were eradicated. The eradication rate on all 180 strains was 88.3%. Overall, ASPC showed excellent effects against Streptococcus. Among strains of Staphylococcus aureus, 18 of 20 strains were eradicated. Of 59 strains of H. influenzae, 52 were eradicated and 3 decreased. Among strains of Escherichia coli, 25 of 28 strains were eradicated. Of Pseudomonas aeruginosa, 2 strains were decreased and one was unchanged. (3) ASPC was effective in 93.3% of 30 patients with serious infections and 79.2% of 72 patients with underlying diseases. Cure rates for patients with and without underlying disease were significantly different statistically (chi 2: P less than 0.005).(ABSTRACT TRUNCATED AT 400 WORDS)

Adolescent↗

[Pharmacokinetic and clinical studies on cefuzonam in the pediatric field].

A multi-center open study was conducted to investigate cefuzonam (L-105, CZON), a newly developed cephalosporin from pharmacokinetic, bacteriological and clinical aspects, in the pediatric field with the participation of 17 institutions and their related facilities. The results are summarized as follows. Serum concentrations and urinary excretion. The pharmacokinetics in pediatric patients was investigated with a dose of 20 mg/kg, via one shot intravenous injection or intravenous drip infusion over 1 hour. The results were nearly the same as those in adult patients. Mean serum concentrations 5 minutes after one shot intravenous injections were: 52.8 micrograms/ml with the dosage of 10 mg/kg, 135 micrograms/ml with 20 mg/kg, and 317 micrograms/ml with 40 mg/kg, and T1/2 beta's for the 3 dosages were 1.07 hours, 0.91 hour, and 1.01 hours, respectively. With 1-hour intravenous drip infusion, mean serum concentrations at the end of infusion were: 22.4 micrograms/ml with 10 mg/kg, 46.3 micrograms/ml with 20 mg/kg, 72.5 micrograms/ml with 40 mg/kg, and 69.2 micrograms/ml with 50 mg/kg, and T1/2 beta's for these dosages were 1.31 hours, 1.45 hours, 0.84 hour, and 0.66 hour, respectively. In 6 hours after administration of CZON, urinary excretion rates were 43.5-51.4% for one shot intravenous injections of 10-40 mg/kg, and 42.7-58.6% for 10-50 mg/kg drip infusions. Concentrations in cerebrospinal fluid Penetrations into cerebrospinal fluids in patients with purulent meningitis achieved levels of 2.80-6.40 micrograms/ml with the administration of CZON at 100 mg/kg in acute cases of within 6 days after onset. When the administration of the drug was done at the earlier stage, the greater penetration occurred. However, rates of penetration were 3.10% to 5.03% within 4 days after a drug administration, thus, the penetration was not thought to be as good as other beta-lactam agents which achieve higher penetration rates. Clinical results Of 407 cases treated with CZON, 18 cases were excluded from the statistical analysis. The remaining 389 cases plus 8 cases each of which had 2 complicated diseases, with a total of 397, were statistically analyzed for the clinical effectiveness of this drug against various infections. The efficacy was evaluated as "good" or "excellent" in 248 out of 266 cases from which pathogens were isolated, for an efficacy rate of 93.2%. The efficacy rate was 88.5% for 131 cases for which pathogens were unidentified, thus no statistically significant difference was noted between the 2 groups.(ABSTRACT TRUNCATED AT 400 WORDS)

Ceftizoxime↗

[Clinical and pharmacokinetic evaluations of ceftizoxime suppositories in children].

Ceftizoxime suppository (CZX-S) was evaluated for its safety, clinical efficacy and pharmacokinetics in pediatric patients. The Cmax, 4.8 to 9.5 micrograms/ml, was obtained 15 to 30 minutes after administration of CZX-S, and the serum half-life was 0.93 hour. Cross-over comparison with intramuscular CZX in a child showed approximately one-third bioavailability of the suppository against intramuscular injection. CZX-S was effective in all the 26 bacterial infections including acute pharyngitis, pneumonia, soft tissue infection, and urinary tract infections. The causative organisms were eradicated in 95%. Mild diarrhea (17%) was the only side effect observed in the study. The data suggest that CZX-S is an excellent alternative to oral and injectable antibiotics for the treatment of mild to moderate bacterial infections due to the susceptible organisms.

Bacteria↗

[Clinical evaluation of a new parenteral penicillin, aspoxicillin, in children].

Aspoxicillin (ASPC) was evaluated for its efficacy and safety in 30 infants and children with acute bacterial infections. The disease categories included acute respiratory tract (22), soft tissue (3), urinary tract (3) infections, sepsis with pyothorax (1) and purulent meningitis (1). ASPC was effective in all but 1 case of pneumonia due to beta-lactamase-positive H. influenzae (effective rate; 96.7%). Adverse reactions and abnormalities of the laboratory tests were not associated with the ASPC therapy in any of the cases. The serum half-life of ASPC after an intravenous bolus injection was 0.883 +/- 0.194 hour and excretion into urine was rapid. From the present results, ASPC is a safe and effective antibiotic when used in patients with susceptible bacterial infections.

Adolescent↗

[Clinical evaluation of sulbactam/cefoperazone in the pediatric infections].

Sulbactam/cefoperazone (SBT/CPZ), a fifty-fifty combination of a beta-lactamase inhibitor, SBT, and an already marketed broad spectrum cephalosporin, CPZ, was evaluated for its efficacy and safety in 25 children. The diagnoses included purulent lymphadenitis, pneumonia, acute UTI, bacteremia and purulent meningitis. SBT/CPZ was effective in all the 20 cases with bacterial infections, but strains highly resistant to CPZ were not isolated in this study. The serum and cerebrospinal-fluid levels of SBT were grossly parallel with those of CPZ, and the half-life of the serum SBT was 0.754 hour. Although severe adverse reactions were not encountered with SBT/CPZ therapy, loose stools in 20% and diarrhea in 16% of the cases were observed.

Adolescent↗

[Bacteriological, pharmacokinetic and clinical studies on sulbactam/cefoperazone in the pediatric field].

Bacteriological and clinical effect of a newly developed SBT/CPZ in the treatment for pediatric patients was assessed by a study group consisting of 15 institutions. The results were as follows. Antibacterial effect Susceptibility studies were performed with 93 clinical isolates. The MIC of SBT/CPZ was one-tube inferior or almost similar to that of CPZ in susceptible organisms. In CPZ-resistant organisms at the inoculum of 10(8) cells/ml, however, SBT/CPZ was much superior to CPZ on the basis of the MIC. When the MIC of SBT/CPZ was compared to that of CPZ in 27 strains which have high beta-lactamase-producing activity, it was found that many of CPZ-resistant organisms were susceptible to SBT/CPZ. Serum concentration and urinary excretion The serum concentrations of SBT and CPZ were 33.2 micrograms/ml, respectively at 15 minutes after 20 mg/kg SBT/CPZ was administered by intravenous bolus injection, and those of SBT and CPZ, 51.0 micrograms/ml and 108.3 micrograms/ml, respectively following 40 mg/kg SBT/CPZ therapy. The serum concentrations of CPZ were 2.1-2.4 times as high as those of SBT. The concentrations were dose-related. The half-lives of SBT and CPZ following 20 mg/kg SBT/CPZ administration were 0.94 hour and 1.50 hours, respectively, and those following 40 mg/kg SBT/CPZ were 0.95 hour and 1.53 hours, respectively. There was no significant difference between 20 mg/kg and 40 mg/kg administrations. When compared between SBT and CPZ, CPZ had slightly longer half-lives. At the termination of 1 hour drip infusion of 20 mg/kg SBT/CPZ, the serum concentrations of SBT and CPZ were 16.7 micrograms/ml and 40.1 micrograms/ml, respectively. In the case of 40 mg/kg, the levels of SBT and CPZ were 38.6 micrograms/ml and 94.9 micrograms/ml, respectively. The concentrations were found to be dose-related as were following intravenous bolus injections. The SBT half-lives obtained after 20 mg/kg and 40 mg/kg SBT/CPZ administrations were 1.39 hours and 0.89 hour, respectively; those of CPZ, 2.00 hours and 1.44 hours, respectively. The highest urinary concentration occurred 0-2 hours after intravenous bolus injections of 20 mg/kg or 40 mg/kg SBT/CPZ. Urinary excretion of SBT over 6 hours was 60.0% and 67.7%, and that of CPZ, 21.2% and 25.0%, indicating higher urinary excretion for SBT. When 20 mg/kg SBT/CPZ or 40 mg/kg was administered over 1 hour by drip infusion, urinary excretion became the highest at 1-3 hours after administration. Urinary excretion of SBT over 7 hours following 20 mg/kg and 40 mg/kg SBT/CPZ was 68.8% and 80.3%, respectively, and that of CPZ, 24.4% and 27.3%. The results were similar to those observed following intravenous bolus injections.

Adolescent↗

[Clinical evaluation of ceftazidime in the treatment of pediatric infections].

Ceftazidime (CAZ) was evaluated for its safety and efficacy in 31 children. Of the 25 confirmed bacterial infections, 23 were cured by the CAZ therapy (efficacy rate, 92%). CAZ was assessed as effective in acute pharyngitis with vomiting (4), acute laryngitis (1), pneumonia (8), urinary tract infections (5), acute gastroenteritis (1), infection accompanying acute leukemia (septicemia suspected) (1), acute purulent meningitis (2) and abscess of the lateral cervical cyst (1). The main pathogens which responded to CAZ were H. influenzae, S. pyogenes, E. coli and P. aeruginosa. As adverse events, mild melena with prolonged prothrombin time (1) was found to be associated with the CAZ therapy. Half-life of the CAZ serum level was 0.97 +/- 0.10 hours, and urinary excretion was high. Penetration into the CSF in 2 cases of acute purulent meningitis was satisfactory. The data suggest that CAZ is a safe and effective injectable antibiotic when used in children with infections of CAZ-susceptible bacteria including P. aeruginosa.

Adolescent↗

[Clinical evaluation of T-1982 (cefbuperazone) in the pediatric infections].

T-1982 (cefbuperazone) was evaluated in 25 children with a suspicion of bacterial infections, of the 21 confirmed bacterial infections, 18 were shown to be effective (efficacy rate, 85.7%). The diagnosis included pneumonia (4), bronchopneumonia (3), acute bronchitis (4), acute pharyngitis (1), acute laryngitis (1), acute epiglottitis (1), acute enterocolitis (3), cervical lymphadenitis (1), acute pyelonephritis (1) and suspected septicemia (2). The etiologic pathogens recovered were Haemophilus influenzae (4), Staphylococcus aureus (2), Salmonella typhimurium (1), Salmonella subgenus (1), and enteropathogenic Escherichia coli (2). Among these strains, 7 strains were eradicated after treatment. A case of suspected septicemia and 2 cases of acute enterocolitis with Salmonella infection were not effectively treated with T-1982. The serum half-life of T-1982 was 1.2 hours after an intravenous bolus injection. No severe adverse reaction was encountered with the T-1982 therapy. The data suggest that T-1982 is an effective and safe parenteral antibiotic in the treatment of susceptible pediatric bacterial infections.

Anti-Bacterial Agents↗

[Clinical evaluation of cefpiramide in pediatric].

Cefpiramide (CPM), a new broad-spectrum cephalosporin antibiotic with good antipseudomonas activities, was evaluated for its safety and efficacy in 20 children with bacterial infections. The diagnoses of the patients included pneumonia (10), acute bronchitis (1), streptococcal pharyngitis (1), purulent cervical lymphadenitis (1), urinary tract infections (2), acute enterocolitis (1), infections in agranulocytosis and acute leukemia (2), and acute purulent meningitis (2). Of the 20 patients, 17 were cured by the CPM therapy. The main etiologic pathogens were H. influenzae, P. aeruginosa, P. fluorescens, S. pneumoniae and E. coli. The serum half-life of CPM was 2.4 to 4.1 hours after an intravenous bolus injection. As an adverse reaction, diarrhea was encountered in 4 cases, and 1 of them experienced severe watery diarrhea with significant fecal colonization of K. oxytoca. The data suggest that CPM is an effective antibiotic when used in children with susceptible bacterial infections. Administrations divided in 2 to 3 dosages will be enough to maintain effective serum levels.

Age Factors↗

[Clinical evaluation of ceftizoxime in the pediatric infections (author's transl)].

Ceftizoxime (FK 749, CZX) was evaluated in 24 children with a suspicion of bacterial infection. Of the 17 confirmed bacterial infections, 16 were shown to be effective (effective rate, 94.1%). The diagnosis included acute pharyngitis (2), pneumonia (6), staphylococcal empyema (1), cervical purulent lymphadenitis (2), acute enterocolitis (2), acute pyelonephritis (1), SSSS (1) and suspected septicemia (2). The etiological pathogens recovered were Streptococcus anginosus (1), Streptococcus pneumoniae (1), Staphylococcus aureus (2), Haemophilus influenzae (3), enteropathogenic Escherichia coli (1) etc. A case of suspected Pseudomonas aeruginosa septicemia was not effectively treated with CZX. The serum half-life of CZX was 1.36 hours after intravenous bolus infection. A cerebrospinal fluid level of CZX was 6.2 mcg/ml 1 hour after intravenous bolus injection of 1 g (23.8 mg/kg) in a child with inflamed meninges. No severe adverse reaction was encountered with the CZX therapy. The data suggest that CZX is an excellent candidate for the first choice parenteral antibiotic in the pediatric infections.

Age Factors↗