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Biomedical subjects

M Miyazu

Publications and source records attributed to M Miyazu.

At least 37 records · Page 2Linked to original sources
PubMed1991

[A study of the absorption and excretion of fosfomycin sodium in children].

Fosfomycin sodium (FOM-Na, Forocyle-S) was administered at 25 mg/kg or 50 mg/kg to 15 children between the ages of 3 and 15 through intravenous injection or through 1 hour intravenous drip infusion, and concentrations in blood serum and excretion through urine were examined and a pharmacokinetic analysis was carried out using the one-compartment model. 1. Average concentrations in the blood serum after injections with 25 mg/kg and 50 mg/kg were 55.3 +/- 6.3 micrograms/ml and 118.8 +/- 31.1 micrograms/kg 30 minutes after injection, respectively, and their half-lives were 1.04 +/- 0.15 hours and 0.98 +/- 0.17 hours, respectively. Six hours after injection, the levels were 2.7 +/- 1.6 micrograms/kg and 6.2 +/- 5.5 micrograms/kg, respectively. With 1 hour intravenous drip infusion of 25 mg/kg and 50 mg/kg, average concentrations the blood serum were 34.2 +/- 14.9 micrograms/ml and 89.7 +/- 6.7 micrograms/ml, respectively, and their half-lives were 0.87 +/- 0.24 hour and 0.69 +/- 0.10 hour, respectively. Six hours after the administration, the levels were 2.7 +/- 1.8 micrograms/ml and 6.7 +/- 0.8 micrograms/ml. There was a clear dose response in the concentration levels in the blood in those given the drug at 25 mg/kg and 50 mg/kg in either method of administration. 2. Average levels in urine after injection of 25 mg/kg and 50 mg/kg were 5,778 +/- 2,257 micrograms/ml and 6,268 +/- 3,329 micrograms/ml 0-2 hours after administration, respectively, and average levels at 4-6 hours were 701 +/- 765 micrograms/ml and 1,588 +/- 1,324 micrograms/ml, respectively. Average excretion, rates into the urine were 72.8 +/- 11.0 and 73.9 +/- 11.1%, respectively. In case of 1 hour drips infusion of 25 mg/kg and 50 mg/kg, average concentrations in the urine 0-2 hours after administration were 3,570 +/- 1,540 micrograms/ml and 11,800 micrograms/ml, respectively, and averages for 4-6 hours were 211 +/- 124 micrograms/ml and 1,300 micrograms/ml. Average rates of excretion into the urine for the first group was 57.9 +/- 16.3% and the second group was 78.4%. Clear dose response was observed in changes of drug concentration levels in the urine with 25 mg/kg and 50 mg/kg doses through either administration method, and in terms of excretion into the urine, no noticeable differences were observed between the different amounts administered or different administration methods.(ABSTRACT TRUNCATED AT 400 WORDS)

Child↗
PubMed1991

[Laboratory and clinical studies on cefpirome in pediatrics].

Cefpirome (HR 810, CPR), a new cephem antibiotic, was investigated for its experimental and clinical studies in pediatrics. The results obtained are summarized as follows. 1. Plasma and urinary levels of CPR were determined in 2 children (age 5 and 7 years) after the one shot intravenous injection of the drug at 20 mg/kg. Average plasma levels of the drug were 44.7 micrograms/ml, 28.5 micrograms/ml, 10.5 micrograms/ml, 4.6 micrograms/ml and 1.5 micrograms/ml at 1/2 hour, 1 hour, 2 hours, 4 hours and 6 hours, respectively, and the average half life was 1.57 hours. Average urinary levels of the drug were 1,785 micrograms/ml, 545 micrograms/ml and 198 micrograms/ml at 0-2 hours, 2-4 hours, 4-6 hours, respectively and the average urinary elimination rate was 52.0%. The results were nearly equivalent to those in adults except for urinary elimination rate which tended to be slightly lower than that in adults. 2. Cerebrospinal fluid levels in 3 cases of purulent meningitis treated with CPR were investigated. Cerebrospinal fluid levels in a case of Neisseria meningitidis were 11.5-23.1 micrograms/ml at 1 hour and 0.94 microgram/ml at 5 hours after intravenous injection of 44.4 mg/kg, 4 times a day. Cerebrospinal fluid levels in a case of Streptococcus pneumoniae were 1.01-4.23 micrograms/ml at 1 hour after intravenous injection of 49.0 mg/kg, 6 times a day, and in the other case with Streptococcus pneumoniae, the levels were 16.8-37.1 micrograms/ml at 1 hour, 11.3 and 3.60 micrograms/ml at 3 and 4 hours after intravenous injection 52.2 mg/kg, 6 times a day. These results are not inferior to those with cefotaxime or ceftriaxone. These levels appear to be higher than MIC90 values against Escherichia coli, Streptococcus agalactiae, S. pneumoniae or Haemophilus influenzae which are the major pathogens of these diseases. 3. CPR was given to 62 patients and clinical efficacy, bacteriological response and adverse reactions were evaluated. Evaluated cases for clinical efficacy included 3 cases of purulent meningitis, 1 case of acute purulent otitis media, 2 cases of acute purulent tonsillitis, 1 case of acute bronchitis, 49 cases of acute pneumoniae, 1 case of scarlet fever, 1 case of acute osteomyelitis, 1 case of acute enterocolitis, and 2 cases of acute UTI, totalling 61 cases. Clinical efficacies were excellent in 38 cases, good in 22 cases and fair in 1 case with an efficacy rete of 98.4% (excellent + good).(ABSTRACT TRUNCATED AT 400 WORDS)

Acute Disease↗
PubMed1990

[Basic and clinical studies on norfloxacin in the pediatric field].

Pharmacokinetic , bacteriological and clinical studies on norfloxacin (NFLX), a quinolone-carboxylic acid antibacterial agent, were conducted in the pediatric field. 1. Serum concentrations and urinary excretion of NFLX after single dose of 2.2 approximately 5.6 mg/kg (mean 4.4 +/- 1.2 mg/kg) were determined in 13 children with ages between 6 and 11 years. The mean peak serum concentration of the drug was 0.37 +/- 0.20 micrograms/ml at 2 hours after administration. The mean half-life of the drug in serum was 2.8 +/- 0.4 hours and the serum concentration at 8 hours was 0.11 +/- 0.06 micrograms/ml. The mean urinary concentration reached a maximum of 125.2 +2- 166.2 micrograms/ml in pooled urine from 0 to 2 hours and the mean urinary recovery rate in the first 8 hours after administration was 22.1 +/- 6.0%. A dose-response relationship was observed between doses/body weight and peak serum concentrations. 2. The clinical efficacy, bacteriological efficacy and the safety of NFLX were evaluated in 65 pediatric patients with ages between 2 years 10 months and 15 years 7 months with infections. In 62 assessable cases (acute purulent tonsillitis 9 cases, acute pneumonia 3 cases, chronic rhinitis 1 case, urinary tract infections 15 cases, and acute colitis 34 cases), clinical efficacies were excellent in 48 cases, good in 13 cases, and fair in 1 case with an overall efficacy rate of 98.4%. Staphylococcus aureus 1 strain, Staphylococcus epidermidis 1 strain, Escherichia coli 10 strains, Salmonella sp. 5 strains, Morganella morganii 1 strain, Pseudomonas aeruginosa 3 strains, Haemophilus parainfluenzae 1 strain and Campylobacter jejuni 12 strains were isolated from the patients as pathogens. Bacteriologically, all of these strains were eradicated except that 3 strains of C. jejuni only decreased. With regard to side effects, dizziness and nausea were observed in 1 case each but they were slight and the continuation of the treatment was possible. No abnormal laboratory test data were observed. From the above results, NFLX was considered to be a useful drug for the treatment of pediatric infections.

Adolescent↗
PubMed1989

[Basic and clinical studies on clarithromycin in pediatrics].

Clarithromycin (TE-031, A-56268) is a new macrolide antibiotic developed by Taisho Pharmaceutical Co., Ltd. Basic and clinical studies in the field of pediatrics were carried out on a granular preparation and 50 mg tablets of TE-031 designed for use in children. The following results were obtained. 1. Concentrations of TE-031 in the serum and its excretion in the urine were investigated in children. Six children were orally administered with a TE-031 granular preparation at 10 mg/kg in a cross-over study 30 minutes before meal and 30 minutes after meal. When the drug was ingested before meal, the mean peak serum concentration occurred 1 hour later and was 5.32 +/- 1.20 micrograms/ml. The mean half-life of TE-031 in the serum was 3.6 +/- 1.0 hours, and drug levels decreased to 1.94 +/- 0.55 micrograms/ml at 6 hours after dosing. In cases of the postprandial administration, the mean peak serum level was 4.21 +/- 1.25 micrograms/ml, occurring 2 hours after ingestion. The mean serum half-life in these cases was 3.5 +/- 1.3 hours, and serum levels decreased to 1.66 +/- 0.47 micrograms/ml at 6 hours after dosing. Mean urinary recovery rates during the initial 6 hours after ingestion were 30.5 +/- 6.4% in the cases of preprandial administration and 34.7 +/- 7.3% with postprandial administration. In addition, 30 minutes before meal, 50 mg tablets of TE-031 were orally administered to 3 children in a dose level equivalent to approximately 10 mg/kg, followed by monitoring of serum and urinary levels. It was found that the mean serum concentration showed a peak value of 4.10 +/- 0.44 micrograms/ml at 2 hours after dosing, the mean serum half-life was 3.5 +/- 0.7 hours, and the mean level fell to 1.90 +/- 0.55 micrograms/ml by 6 hours after dosing. The mean 6-hour urinary recovery rate was 32.7 +/- 12.1%. On the basis of the above results, it has been surmised that, in comparison to conventional macrolide antibiotics. TE-031 is better maintained in the blood at a high concentration and is more efficiently excreted into the urine. In addition, the data show that the bioavailability of TE-031 is slightly superior when the drug is administered on an empty stomach compared with after a meal. And finally, it was found that the granular and 50 mg tablet preparations of TE-031 are almost equivalent in terms of the absorption and the excretion of the drug.(ABSTRACT TRUNCATED AT 400 WORDS)

Age Factors↗
PubMed1989

[Studies on sulbactam/ampicillin in the field of pediatrics].

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.

Age Factors↗
PubMed1989

[Pharmacokinetic, bacteriological and clinical studies on imipenem/cilastatin sodium in neonates].

Pharmacokinetic, bacteriological and clinical studies on imipenem/cilastatin sodium (IPM/CS) were performed in neonates. The results obtained are summarized as follows. 1. Plasma levels and urinary excretion of IPM and CS sodium were determined in 7 neonates with ages between 7 and 26 days (gestation periods were 37 to 41 weeks and birth weights were 2,410 to 3,890 g) upon 1 hour drip intravenous infusion of IPM/CS at 10 mg/10 mg/kg, or 20 mg/20 mg/kg. Mean plasma concentrations of IPM reached their peaks at the end of infusion with levels of 12.7 +/- 3.0 micrograms/ml for the group given 10 mg/10 mg/kg, and 19.1 +/- 4.1 micrograms/ml for 20 mg/20 mg/kg. The concentration of IPM in plasma showed a dose-response to the 10 mg/10 mg/kg and 20 mg/20 mg/kg dosages. Concentrations decreased with half-lives of 1.87 +/- 0.71 hours and 1.97 +/- 0.21 hours for the low and the high dosages, and plasma levels at 8 hours after administration were 0.3 +/- 0.1 microgram/ml and 0.8 +/- 0.3 microgram/ml, respectively. Mean urinary recovery rates in 8 hours after administration were 37.6 +/- 11.8% and 26.8 +/- 17.2% for the low and the high dosages. While, mean plasma concentrations and mean urinary recovery rates of CS were higher than those of IPM, mean plasma half-lives of CS were similar to IPM. 2. IPM/CS was administered to 11 neonatal patients (with ages between 1 and 26 days) of various bacterial infections, and clinical effectiveness, bacteriological efficacy and adverse reactions were evaluated. Clinical efficacies in cases including 7 with acute pneumonia and 1 each with suspected septicemia, intrauterine infection, acute urinary tract infection and periproctal abscess were judged excellent in 10 and good in 1 case, and the efficacy rate was 100%. Causative organisms isolated from these patients included 3 strains of Escherichia coli and 1 strain each of Streptococcus pyogenes, Streptococcus agalactiae Enterococcus faecalis and Haemophilus influenzae. All the organisms were eradicated by IPM/CS, thus the bacteriological eradication rate was 100%. No adverse reactions were observed, but decreased platelet in 1 patient and increased GOT in 2 patients were found as abnormal laboratory test values. These changes, however were transient, and returned to normal after discontinuation of IPM/CS. It was concluded that the clinical results of IPM/CS are indicative of excellent efficacy, safety and usefulness of the drug in the treatment of infections in neonates.

Anti-Bacterial Agents↗
PubMed1989

[Experimental and clinical studies on cefodizime in pediatrics].

1. Absorption and elimination Serum and urinary levels of cefodizime (CDZM, THR-221) were determined in 7 children with ages ranging from 3 to 12 years after a intravenous bolus injection of the drug at 20 mg/kg. The average serum level of the drug was 119.27 +/- 13.83 micrograms/ml at 30 minutes, then decreased gradually with a half-life of 2.01 +/- 0.25 hours to 10.56 +/- 2.93 micrograms/ml at 6 hours. The average urinary elimination rate was 77.34 +/- 12.60%. 2. Clinical study CDZM was given to the following 39 patients with ages ranging from 2 months to 15 years and clinical efficacy, bacteriological response and adverse reactions were evaluated. The treated cases were 2 cases of acute purulent tonsillitis, 30 cases of acute pneumonia, 1 case of acute purulent otitis media and 2 cases of acute urinary tract infections. Clinical efficacies were excellent in 29 cases, good in 5 cases and poor in 1 with an efficacy rate of 97.1%. Organisms presumed to be pathogens included 3 strains of Streptococcus pneumoniae, 1 beta-Streptococcus, 1 Staphylococcus epidermidis, 9 Haemophilus influenzae (1 beta-lactamase producing strain and 8 non-producing strains) and 1 Enterococcus faecalis. The last one was decreased and the others were eradicated with an eradication rate of 93.3% for all strains. Adverse reactions occurred in no patients. Abnormal changes in laboratory test values involved only 1 case each of elevated GOT, elevated GOT and GPT, eosinophilia and thrombocytosis. Based on the above-mentioned result and features of this drug, it was confirmed that this drug showed an excellent usefulness in the treatment of infections in childhood. It may be also effective in the management of infections under immunosuppression.

Adolescent↗
PubMed1989

[Pharmacokinetic, bacteriological and clinical evaluation of cefpodoxime proxetil in pediatrics].

Pharmacokinetic, bacteriological, and clinical studies in pediatrics on cefpodoxime proxetil (CPDX-PR, CS-807) (pediatric dry syrup) were performed. 1. Serum concentrations and urinary excretions of CPDX after administration of CPDX-PR to children (ages between 6 and 14) were investigated. Four cases were administered with CPDX-PR at a dose level of 3 mg/kg 30 minutes before or after meal. Effects of timings of administration were investigated using a crossover study. Average serum concentrations in the group administered with the drug before meal reached their peaks at 1 hour after administration with an average level of 2.34 +/- 0.16 micrograms/ml and diminished with a half-life of 1.94 +/- 0.08 hours to 0.29 +/- 0.04 microgram/ml at 8 hours after administration. In the group administered with the drug after meal, average serum concentrations attained their peaks at 4 hours after administration at an average level of 1.93 +/- 0.09 micrograms/ml, and decreased with a half-life of 2.08 +/- 0.19 hours to 0.58 +/- 0.16 microgram/ml at 8 hours. Urinary recovery rates of CPDX in the first 8 hours after administration of CPDX-PR in the before-meal and the after-meal groups averaged 34.4 +/- 6.3% and 38.5 +/- 7.0%, respectively. In a separate experiment, 7 cases were administered with CPDX-PR, 30 minutes after meal, at a dose level of either 3 or 6 mg/kg. Effects of the 2 different dose levels were investigated also using a crossover study. Average serum concentrations at their peaks attained at a 4 hours after administration for the 2 dosage groups (3 and 6 mg/kg) were 1.76 +/- 0.11 and 3.08 +/- 0.41 micrograms/ml, respectively. Average half-life values for the 2 groups were 2.40 +/- 0.14 and 2.25 +/- 0.07 hours, respectively, with average 8 hour values of 0.64 +/- 0.10 and 1.30 +/- 0.21 micrograms/ml, respectively. Urinary recovery rates in the first 8 hours after administration averaged 40.4 +/- 3.2% and 46.3 +/- 6.5%, respectively. From these results, it appeared that the absorption of the drug was affected by the timing of administration (before or after meal), and the presence of ingested foods in the digestive system delayed the absorption. The overall quantity absorbed, however, did not seem to be affected by the timing of administration. These data also showed that serum and urinary concentrations of the drug depended on dose levels.(ABSTRACT TRUNCATED AT 400 WORDS)

Absorption↗
PubMed1989

[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.

Adolescent↗
PubMed1988

[Pharmacokinetic, bacteriological and clinical studies of ceftizoxime in neonates].

Pharmacokinetic, bacteriological and clinical studies of ceftizoxime (CZX) were performed in neonates. 1. Serum concentrations and urinary excretion of CZX were investigated in 12 neonates ranging ages from 1 to 27 days (gestational age, 35-41 weeks; birth weight, 2,150-4,030 g) and 2 infants ranging ages from 55 to 57 days (gestational age, 39-40 weeks; birth weight, 2,320-2,650 g). Each of the subjects was given a single intravenous dose of 20 mg/kg by one shot. Serum concentrations of CZX in the neonates were 24.9-53.7 micrograms/ml at 1/4 hour after intravenous injection, with an average of 40.6 +/- 7.6 micrograms/ml. Serum half-lives of CZX were 1.32-4.75 hours and averaged 2.60 +/- 1.06 hours. Serum concentrations ranged from 2.01 to 14.6 micrograms/ml at 6 hours after injection with an average of 7.70 +/- 3.89 micrograms/ml. In the 2 infants, serum concentrations were 42.0 and 46.2 micrograms/ml at 1/4 hour (average: 44.1 +/- 3.0 micrograms/ml), and 2.91 and 5.04 micrograms/ml at 6 hours after injection (average: 3.98 +/- 1.51 micrograms/ml). Half-lives were 1.54 hours in 1 infant and 1.93 hours in the other (average: 1.74 +/- 0.28 hours). Furthermore, 6-hour urinary recovery rates were 28.5-71.7% (average: 49.3 +/- 12.8%) in the neonates and 42.1-55.5% (average: 48.8 +/- 9.5%) in the infants. The above results suggest that the following 3 points are accepted; 1) peak serum concentrations (at 1/4 hour) in neonates were similar to those in infants and older children irrespective of age (days after birth). 2) Serum half-lives of CZX in neonates shortly after birth were 4 or 5 times longer than those in older children, but decreased rapidly with the advance of day-ages. The half-life in neonates of 2 weeks of age or so became shorter to about twice the normal value in infants. Furthermore, half-lives of the drug in those at an age of the first half of infancy were similar to those in older children. 3) The urinary excretion rates tended to be somewhat low with neonates soon after birth, but became very similar to those in infants and older children at a relatively early stage.(ABSTRACT TRUNCATED AT 400 WORDS)

Bacterial Infections↗
PubMed1988

[Studies of rokitamycin in pediatrics].

Pharmacokinetic, bacteriological and clinical studies on a new macrolide antibiotic, rokitamycin (RKM) dry syrup for pediatric use, were done, and results as summarized below were observed: 1. Five children with ages between 6 and 10 years were administered orally with RKM at a dose level of 10 mg/kg either at 30 minutes before or 30 minutes after meal on a crossover design, and plasma concentrations and urinary excretion rates of the drug were measured. Plasma concentrations of RKM following the administration before meal were 0.50 microgram/ml at 1/2 hour, 0.43 microgram/ml at 1 hour, 0.15 microgram/ml at 2 hours, 0.03 microgram/ml at 4 hours, and not detectable at 6 hours. Plasma concentrations following the administration after meal were 0.11 microgram/ml at 1/2 hour, 0.15 microgram/ml at 1 hour, 0.09 microgram/ml at 2 hours, 0.03 microgram/ml at 4 hours, and not detectable at 6 hours. The 0-6 hour urinary recovery rates were 1.41% following the administration before meal, and 0.93% following the administration after meal. These results suggested that the drug might be absorbed more rapidly, giving a higher plasma concentration, when administered before meal than when administered after meal. Changes in plasma concentrations of RKM following the administration of 10 mg/kg before meal were similar to those of two 100 mg RKM tablets (TMS-19-Q.GC tablets) to adult patients. Therefore, it seemed optimal to administer 10 mg/kg 3 times daily at fasting to children as a rule.(ABSTRACT TRUNCATED AT 250 WORDS)

Acute Disease↗
PubMed1988

[Studies on sultamicillin in the field of pediatrics].

Pharmacokinetic and clinical studies on sultamicillin (SBTPC) were carried out in the field of pediatrics. 1. Absorption and excretion. A crossover study with a single oral administration of 10 mg/kg of SBTPC in fasting and after meal, and that with 10 mg/kg and 20 mg/kg of SBTPC after meal were carried out in 11 children (5-15 years) and in 6 children (8-15 years), respectively. Serum levels and urinary excretion of sulbactam (SBT) and ampicillin (ABPC) were determined. Mean serum concentrations of ABPC after oral administration of 10 mg/kg of SBTPC with in fasting or after meal, in the former study, peaked at 4.75 +/- 1.97 micrograms/ml in 1 hour and declined with a mean half-life of 0.81 +/- 0.18 hour and the mean serum concentration of ABPC at 6 hours after administration was 0.06 +/- 0.07 micrograms/ml. Mean serum concentration of ABPC study in the latter peaked at 2.95 +/- 0.79 micrograms/ml in 1 hour, and declined with a mean half-life of 1.35 +/- 0.43 hours, and the mean serum concentration of ABPC at 6 hours was 0.22 +/- 0.13 microgram/ml. Mean urinary recovery rates of ABPC in 6 hours after administration were 54.5 +/- 17.6% in the former study, and 63.2 +/- 14.3% in the latter. These results suggested a delay of absorption with meal. Mean serum concentrations of ABPC after oral administration of 10 mg/kg or 20 mg/kg of SBTPC after meal, in the former study, were 3.10 +/- 0.72 micrograms/ml at 1 hour and declined with a half-life of 1.22 +/- 0.32 hours, and those of ABPC were 0.22 +/- 0.12 microgram/ml at 6 hours, and they were 6.46 +/- 1.57 micrograms/ml, 1.48 +/- 0.51 hours and 0.55 +/- 0.40 microgram/ml, respectively in the latter study. Mean urinary recovery rates of ABPC in 6 hours, were 50.4 +/- 10.2% in the former study and 57.7 +/- 11.4%, in the latter. A dose response was observed with time course of mean serum concentrations. Mean serum concentrations of SBT were lower than those of ABPC, and they declined in a similar manner. The mean urinary recovery rate of SBT was similar or lower than that of ABPC. 2. Clinical study SBTPC was used for the treatment of a total of 38 pediatric patients with ages 6 months to 11 years and it's clinical effectiveness, bacteriological efficacy and adverse effects were evaluated.(ABSTRACT TRUNCATED AT 400 WORDS)

Administration, Oral↗
PubMed1988

[Pharmacokinetic and clinical evaluations on ceftriaxone in neonates].

1. Ten neonates 0 to 28 days old (gestation: 37-42 weeks; birth weight: 2,160-3,640 g) received 20 mg/kg CTRX (8 cases) or 10 mg/kg (2 cases) by intravenous bolus injection, while 9 infants 35 days to 9 months old (gestation: 37-43 weeks; birth weight: 2,800-3,560 g) received 20 mg/kg by intravenous bolus injection, and their blood drug concentrations and urinary drug excretions were examined. Average blood levels of CTRX in the 20 mg/kg dosage group were 114 +/- 14.6 micrograms/ml at 30 minutes, 109 +/- 12.8 micrograms/ml at 1 hour, 100 +/- 12.6 micrograms/ml at 2 hours, 87.9 +/- 15.8 micrograms/ml at 4 hours, 72.8 +/- 15.3 micrograms/ml at 6 hours, and 50.1 +/- 12.3 micrograms/ml at 12 hours in the neonates; and 113 +/- 20.0 micrograms/ml at 30 minutes, 101 +/- 14.7 micrograms/ml at 1 hour, 83.6 +/- 9.3 micrograms/ml at 2 hours, 70.3 +/- 10.7 micrograms/ml at 4 hours, 56.9 +/- 8.6 micrograms/ml at 6 hours, and 35.7 +/- 9.2 micrograms/ml at 12 hours in the infants. Average half-lives of CTRX in blood were 10.3 +/- 4.5 hours in the neonates, and 6.6 +/- 1.9 hours in the infants. Average blood concentrations of CTRX in the 10 mg/kg dosage neonate group were 63.8 +/- 6.0 micrograms/ml at 30 minutes, 57.8 +/- 2.5 micrograms/ml at 1 hour, 53.5 +/- 0.7 micrograms/ml at 2 hours, 41.8 +/- 7.4 micrograms/ml at 4 hours, 32.4 +/- 5.9 micrograms/ml at 6 hours, and 20.8 +/- 1.1 micrograms/ml at 12 hours, and the half-life was 7.2 +/- 0.4 hours. These results suggest that blood concentrations are apparently dose-related in the neonate period; that the peak levels of the neonate and infant groups were similar (the levels at 30 minutes) not showing a relationship to age, gestation period or to birth weight; and that the higher the age was the shorter the half-life became with the half-life in the one week old group was 1.5 times as long as that in the older infant group. The half-life in the younger infant group, however, was similar to that in the older infant group. Urinary excretion was examined in 4 neonates and 2 infants. Average urinary recovery rates in 12 hours after intravenous injection were 40.8 +/- 8.3% in the neonate group and 44.8 +/- 12.8% in the infant group, showing that CTRX is excreted well even in the neonate period.(ABSTRACT TRUNCATED AT 400 WORDS)

Bacterial Infections↗
PubMed1987

[Pharmacokinetical, bacteriological and clinical studies of flomoxef in the pediatric field].

Pharmacokinetical, bacteriological and clinical studies of flomoxef (FMOX, 6315-S), a new cephem antibiotic, were conducted in the pediatric field. 1. Mean drug concentrations in the blood after intravenous one shot injection of FMOX 20 mg/kg to 5 children (aged 5-8 years) were 39.7 micrograms/ml at 1/4 hour, 24.1 micrograms/ml at 1/2 hour, 12.2 micrograms/ml at 1 hour, 4.7 micrograms/ml at 2 hours, 1.1 microgram/ml at 4 hours, and 0.3 microgram/ml at 6 hours. The mean half-life in blood was 0.65 hour. Mean concentrations in urine was 3,558 micrograms/ml during 0-2 hours after intravenous injection, 568 micrograms/ml during 2-4 hours, and 117 micrograms/ml during 4-6 hours. The mean 6-hour urinary recovery rate was 72.8%. 2. Clinically, FMOX was administered to 32 children (5 months to 9 years) with infections, i.e. 29 with pneumonia, 1 each with acute purulent tonsillitis, acute purulent lymphadenitis and cellulitis. The treatment was excellent in 24 cases and good in 8. Thus, the efficacy rate was 100%. 3. The bacteriological effect of FMOX was investigated using 11 clinical isolates which were considered to be causative organisms, i.e. 1 strain of Staphylococcus aureus, 1 strain of Streptococcus pneumoniae, 8 strains of Haemophilus influenzae and 1 strain of Haemophilus parainfluenzae. Except one strain (H. influenzae) which was just decreased, all the bacteria were eliminated. 4. No side effect was found at all. As abnormal laboratory findings, elevation of GOT was found in 1 case, thrombocytosis in 2, and eosinophilia in 1 but all the changes were slight and were normalized by the time of re-examination. The above results suggest that FMOX is a useful and safe drug for the pediatric practice just as in the adult field.

Age Factors↗
PubMed1987

[Pharmacokinetic and clinical studies of cefuzonam in pediatrics].

Pharmacokinetic and clinical studies were conducted to evaluate cefuzonam (L-105, CZON), a new cephem type antibiotic, in the pediatric field. A total of 9 pediatric patients (2-14 years) was treated with intravenous injection of CZON: 4 cases with one shot of 20 mg/kg, 2 cases with one shot of 40 mg/kg and 3 cases with drip infusion over 1 hour of 40 mg/kg. CZON concentrations in serum and the excretion in urine were determined. Mean serum concentrations of CZON after one shot intravenous injection of 20 mg/kg were 49.0, 22.7, 9.03, 2.13, 0.37, and 0.09 micrograms/ml at 15, 30 minutes, 1, 2, 4 and 6 hours, respectively. With 40 mg/kg one shot intravenous injections, mean serum concentrations were 117.5, 68.0, 26.2, 8.80, 0.63 and 0.19 micrograms/ml at 15, 30 minutes, 1, 2, 4 and 6 hours, respectively. With 40 mg/kg intravenous drip infusions over 1 hour, mean concentrations were 57.1, 78.8, 12.9, 1.12 and 0.23 micrograms/ml at 30 minutes, 1, 2, 4 and 6 hours, respectively. Mean half-lives were 0.69 hour for 20 mg/kg one shot injections, 0.44 hour for 40 mg/kg one shot injections, and 0.58 hour for 40 mg/kg 1 hour drip infusions. Urinary recovery rates in 6 hour after administration were 70.8% (mean) for the 20 mg/kg one shot injection, 44.1% (1 case) for the 40 mg/kg one shot injection, and 60.0% (mean) for the 40 mg/kg 1 hour drip infusion. CZON was administered in 26 cases of pediatric infections, and the clinical efficacy, antibacterial activity, and side effects were evaluated. Of the 26 cases 2 were excluded for the reason of not having bacterial infection, and the remaining 24 cases were assessed. Included in the 24 cases were 16 cases of acute pneumonia, 2 cases of acute purulent lymphadenitis, and 1 case each of acute bronchitis, acute purulent otitis media, acute apical periodontitis, staphylococcal scalded skin syndrome (SSSS), acute pyelonephritis, and acute enteritis. Clinical efficacy evaluation showed 19 excellent cases and 5 good cases, with an efficacy rate of 100%. Bacteriologically, Staphylococcus aureus 1 strain, Streptococcus pneumoniae 1 strain, beta-Streptococcus 1 strain, Haemophilus influenzae 10 strains, Haemophilus parainfluenzae 1 strain, Proteus mirabilis 1 strain, and Campylobacter jejuni 1 strain were determined or assumed as pathogens, but all of them were eradicated.(ABSTRACT TRUNCATED AT 400 WORDS)

Acute Disease↗
PubMed1986

[Studies on imipenem/cilastatin sodium in the field of pediatrics].

Pharmacokinetic and clinical studies on imipenem (MK-0787)/cilastatin sodium (MK-0791), a combined drug of carbapenem antibiotics (MK-0787) and renal depeptidase inhibitor (MK-0791) in a 1:1 ratio, were performed in the field of pediatrics. Absorption and excretion Serum levels and urinary excretion of MK-0787/MK-0791 were determined in 7 children aged 4 to 11 years. Four cases were administered with a single dose of MK-0787/MK-0791 at 10 mg/10 mg/kg by intravenous drip infusion and the other 3 cases were given a single dose of 20 mg/20 mg/kg. Serum concentrations of MK-0787 reached their peaks at the end of drip infusion where the mean level was 17.5 +/- 1.0 micrograms/ml for the group given 10 mg/10 mg/kg, and 43.6 +/- 2.1 micrograms/ml for the group given 20 mg/20 mg/kg. Concentrations decreased with half-lives of 0.82 +/- 0.10 hour and 0.74 +/- 0.04 hour for the low and high doses, respectively, and serum levels at 6 hours after administration were 0.3 +/- 0.1 microgram/ml and 0.4 +/- 0.1 microgram/ml, respectively. Peak concentrations of MK-0791 were 22.6 +/- 4.8 micrograms/ml in the 10 mg/10 mg/kg group and 52.9 +/- 4.7 micrograms/ml in the 20 mg/20 mg/kg group at the end of the drip infusion. Half-lives were 0.56 +/- 0.17 hour and 0.46 +/- 0.11 hour for the 2 doses, respectively while MK-0791 levels were below detection limit at 6 hours after administration. Mean urinary recovery rates in 6 hours after administration were 54.0 +/- 15.3% and 49.3 +/- 7.8% for MK-0787 and MK-0791, respectively, in the group of 10 mg/10 mg/kg, and 62.0 +/- 7.4% and 65.3 +/- 9.2%, respectively, in the group of 20 mg/20 mg/kg. These results showed that pharmacokinetics of MK-0787 and MK-0791 in children were similar to that in adults. Clinical study MK-0787/MK-0791 was used for treatment in a total of 22 pediatric patients to evaluate clinical effectiveness, bacteriological efficacy and adverse reactions. Each of patients was treated 3 or 4 times per day at a single dose of 11.4-22.8 mg/kg (of MK-0787). Duration of treatment ranged from 2.5 to 18 days and total doses ranged from 1.36 to 19.92 g. Clinical efficacy in cases including 2 with acute purulent tonsillitis, 1 with acute purulent otitis media, 9 with acute pneumonia, 1 with pythorax, 3 with acute purulent lymphadenitis, and 6 with acute pyelonephritis were judged excellent in 20 cases and good in 2 cases; an efficacy rate of 100%.(ABSTRACT TRUNCATED AT 400 WORDS)

Bacterial Infections↗
PubMed1985

Treatment of subacute sclerosing panencephalitis with human leukocyte interferon.

In five patients with subacute sclerosing panencephalitis (SSPE), human leukocyte interferon (IFN) therapy was tried. IFN was administered intramuscularly, intravenously, and intrathecally. The total dose of administered IFN ranged from 13 X 10(6) to 116.92 X 10(6) IU. There were no severe side effects except for temporary high fever and vomiting. Observation of the clinical course were made for 26-60 months. At the beginning of the treatment, one of the patients was at the first stage of Jabbour's classification and the other four at the second stage. No clinical improvement was observed and the clinical course was progressive in all patients. At present, one of the patients was at the second stage and the other four were at the fourth stage. EEGs showed progressive deterioration, and cranial CT scan demonstrated progressive cortical atrophy and ventricular enlargement. Measles antibody titers in the serum and CSF also unchanged. On the other hand, permeability of IFN at blood-brain barrier (BBB) was relatively good.

Child↗