Biomedical subjects
Publications and source records attributed to H Sakata.
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Twenty nine children were treated with cefpodoxime proxetil (CPDX-PR, CS-807) and the clinical efficacy and side effects were evaluated. Ages of the patients ranged from 2 months to 10 years. Dose levels of CPDX-PR ranged from 7.5 to 12.0 mg/kg/day for 5 to 12.7 days. The 29 patients included 9 tonsillitis, 2 otitis media, 5 scarlet fever, 3 bronchopneumonia, 1 lymphadenitis, 8 urinary tract infections and 1 staphylococcal scalded skin syndrome, and they were evaluated for the clinical efficacy of CPDX-PR. Results were excellent in 21 and good in 8 patients. Out of the 29 patients, 3 cases showed diarrhea and 2 cases showed elevated GOT and GPT. The pharmacokinetics of CPDX-PR was studied in 9 patients whose ages ranged from 1 to 9 years. The serum peak concentrations of CPDX in 5 patients were between 1.37 and 4.10 micrograms/ml (mean: 2.53 micrograms/ml) at 1 to 6 hours after dosing 3 mg/kg before meals. Those of 4 patients ranged 3.29 to 4.88 micrograms/ml (mean: 4.36 micrograms/ml) at 2 hours after administering 6 mg/kg before meals. Portions of CPDX excreted into urine within 6 hours ranged from 20.3 to 34.3% (mean 27.1%) in 5 patients who were given 3 mg/kg, and ranged from 24.1 to 65.7% (mean 41.1%) in 4 patients given 6 mg/kg.
Twenty-six children were treated with cefteram pivoxil (CFTM-PI) and the clinical efficacy and side effects were evaluated. Ages of the patients ranged from 8 months to 9 years. Doses of CFTM-PI ranged 7.5-20.1 mg/kg/day for 4 to 19 days. The twenty-six patients including 10 patients with tonsillitis, 1 pharyngitis, 3 otitis media, 2 scarlet fever, 1 bronchopneumonia, 1 lymphadenitis, 6 urinary tract infections, 1 vaginitis and 1 staphylococcal scalded skin syndrome were evaluated for clinical efficacy. Results were excellent in 11, good in 13, and fair in 2 patients. Out of the 26 patients, one case showed elevated GOT and GPT, and another case showed elevated GOT. The pharmacokinetic study of CFTM-PI was performed in 9 fasting patients whose ages ranged from 2 to 11 years. Serum peak concentrations of CFTM were 0.92 to 1.05 micrograms/ml (mean 0.99 microgram/ml) at 1 to 2 hours after a dose of 1.5 mg/kg each to 3 patients, 1.12 to 1.38 micrograms/ml (mean 1.25 micrograms/ml) after a dose of 3 mg/kg each to 3 patients and 0.66 to 2.1 micrograms/ml (mean 1.17 micrograms/ml) after a dose of 6 mg/kg each to 3 patients. The portions of the drug excreted into urine within 8 hours were 8.9% and 14.7% in 2 patients, each given a dose of 1.5 mg/kg, from 13.0 to 23.1% (mean 18.4%) in 3 patients, each given a dose of 3 mg/kg, and 6.3% and 8.7% in 2 patients, each given a dose of 6 mg/kg.
Twenty neuroblastoma and 4 nonneuroblastoma patients were studied by 131I-MIBG imaging. The primary tumor was detected in 89% of patients (8/9) before therapy. Bone marrow metastasis was also visualized in 4 of the 8 patients with primary positive scan. True negative results were obtained in 4 nonneuroblastoma patients. After therapy, of 10 tumor-bearing patients, eight showed positive scans and 9 of 12 lesions (75%) were visualized. The accuracies of presence or absence of neuroblastoma were compared between 131I-MIBG imaging and several tumor markers. The accuracies before and after therapy were as follows: 131I-MIBG imaging; 92% (12/13), 88% (15/17), serum NSE; 80% (4/5), 93% (13/14), serum LDH; 92% (11/12), 76% (13/17), urinary VMA; 54% (7/13), 56% (9/16), and urinary HVA; 77% (10/13), 56% (9/16). It appears that 131I-MIBG imaging is useful for both locating and excluding neuroblastoma. In addition, 131I-MIBG imaging appears to be the most efficient diagnostic and follow up study for neuroblastoma when it is combined with measurements of serum NSE.
The incidence of tuberculosis is very high in patients treated by hemodialysis particularly in the early stage of hemodialysis. The diagnosis of tuberculosis in dialysis patients was obscured as symptoms were nonspecific and extrapulmonary involvement was seen frequently. We investigated cell mediated immunity in dialysis patients in relation to the period of dialysis. The data indicate that dialysis patients show the following immunological impairments; 1) lymphopenia, 2) decreased B cell, 3) alteration of T cell subset, 4) decreased reaction of PPD skin test, 5) decreased T cell activity, 6) decreased IL-2 production, 7) decreased PHA induced lymphocyte blastogenesis, 8) decreased NK cell. Decreased immunologic host defence mentioned above may contribute to the high incidence of tuberculosis in the early stage as well as in the maintenance phase of dialysis.
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A passive hemagglutination (PHA) test for measles was evaluated in comparison with hemagglutination inhibition (HI) and neutralization (NT) tests. The PHA test determines exclusively the level of antibody directed to the hemagglutinin protein of measles virus. The ratio of PHA to HI titer was 1 to 32 (geometric mean, 6.5) for the first 5 weeks of infection but declined to near unity thereafter. It gradually increased again to 4 to 32 (geometric mean, 11.7) over several years. The initial high PHA titer relative to the HI titer was most likely due to the presence of the immunoglobulin M antibody known to be efficient in agglutination, because 2-mercaptoethanol (2ME) treatment of sera reduced the PHA titer to a level similar to that of the HI titer. The PHA titer in sera obtained after the convalescent phase was insensitive to 2ME, and the relative increase in the PHA over the HI titer was presumably a result of increased antibody avidity. In some individuals, the HI titer fell to below detectable levels several years after either natural infection or vaccination, but the PHA as well as the NT titer remained positive. The PHA titer was therefore a more reliable and more sensitive indicator of immune status against measles than the HI titer. The decrease in PHA titer by 2ME treatment provided evidence of a current or very recent infection. PHA was found to be useful both for assessing immunity status and for serodiagnosis.
Adult patients who had experienced sudden deafness were examined for possible presence of subclinical mumps infection, using a new method of detecting mumps IgM antibody. Three of 53 patients demonstrated a positive reaction, indicating a strong correlation of sudden deafness with recent mumps infection. Mumps vaccination is recommended for those who have one deaf ear, in order to protect the better ear from mumps infection.
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The biodistribution and in vivo kinetics of [131I]lipiodol infused into the hepatic artery were studied to estimate the potential of internal radiotherapy of hepatic cancer in five patients. It accumulated only in the vascular tumors and adjacent hepatic tissue (AHT) supplied by the infused artery, and to a lesser extent in the lung throughout 8 days imaging sequence. Iodine-131 lipiodol appeared to lead to oil embolization of the tumor and AHT followed by secondary embolization to the lungs and finally the activity was mainly excreted into urine. Four tumors had rapidly and slowly decreasing components, while the AHT activity decreased exponentially from the beginning. The effective half life in tumors was longer with the slow component (mean +/- s.d.: 5.7 +/- 1.2 days) than the AHT (3.7 +/- 0.6 days). The tumor/AHT concentration ratio in three patients at 2 hr was estimated to be 7.5-21. The activity was lower in the lungs than in the AHT in four patients. Iodine-131 lipiodol thus may be used as an intra-arterial infusion agent to treat certain vascular hepatic cancers.
Twelve oral antimicrobial agents were tested for their antimicrobial activities against causative organisms isolated from pediatric infections. Activities of these antimicrobial agents against Streptococcus pyogenes were also examined in relation to T-antigen typing of the species. The results of the investigation are summarized as follows. 1. Against Staphylococcus aureus, rokitamycin (RKM), josamycin, ofloxacin, minocycline exhibited strong antimicrobial activities, and few strains of S. aureus showed resistance to these antimicrobial agents. More strains exhibited resistance to erythromycin (EM) than to other macrolide antibiotics (MLs) examined. Amoxicillin (AMPC)-resistance was often observed also. 2. Against S. pyogenes, beta-lactam antibiotics (beta-lactams) and RKM had MIC80 of 0.20 microgram/ml or below, and no resistant strains of this organism were observed against these antibiotics. Only 2 resistant strains (2.0%) of S. pyogenes to MLs were detected, but resistance to tetracyclines (TCs) was observed at a high frequency, with 71.4% or more strains among T-4, T-6, T-12 and T-28 antigen types exhibited resistance to TCs. Among the 21 strains of T-12 antigen type examined, only one strain (4.8%) was found resistant to MLs. These observations suggested that the reduction in the frequency of ML-resistant strains was not due to the reduction in the number of T-12 antigen type strains but due to losses of resistance factors against MLs of plasmids. 3. Antibacterial activities of beta-lactams and MLs against Streptococcus pneumoniae strains were good, similarly to activities against S. pyogenes. But many strains of S. pneumoniae were resistant to TCs. 4. New quinolone antimicrobial agents (quinolones) showed excellent activities against Branhamella catarrhalis strains with EM and RKM showing the next best activities. The number of resistant strains against quinolones, however, seemed to be on an increase. 5. Quinolones had strong antimicrobial activities against Haemophilus influenzae, few strains of which showed resistance to quinolones. AMPC had the next best activity, but approximately 10% of H. influenzae exhibited resistance to this antibiotic. 6. Against Campylobacter spp., quinolones and MLs showed the best activities with MIC80 values at or below 0.25 microgram/ml, and no resistant strains of the species against these antimicrobial agents were observed. Fosfomycin and TCs showed somewhat inferior activities to quinolones and MLs, with beta-lactams showing still lower activities. 7. Only few strains of Mycoplasma pneumoniae and Chlamydia trachomatis were examined, but MLs and TCs appeared to be effective against these organisms.(ABSTRACT TRUNCATED AT 400 WORDS)
Thirteen neonates and young infants, including 5 infants with very low birth weight, were treated with ceftizoxime (CZX) and its clinical efficacy and side effects were evaluated. The ages of the patients ranged from 0 to 96 days, and their body weights ranged from 580 to 5,050 g. Doses given were 20-54 mg/kg every 6 to 12 hours for 2.5 to 7.5 days. Two infants with sepsis, one with urinary tract infection, one with sepsis and urinary tract infection, and 1 with fetal infection were considered to have responded satisfactorily to the CZX treatment. The drug was well tolerated and side effects was not apparent. Pharmacokinetic studies were done on CZX in 8 patients including 4 infants with very low birth weight. Their ages ranged from 2 to 91 days, and body weights from 545 to 5,050 g. Serum concentrations at 2 hours after single 20 mg/kg intravenous bolus injections were 19.2 to 44.2 micrograms/ml and the levels were 2.11 to 26.3 micrograms/ml at 8 hours. Elimination half-lives of CZX ranged 1.90 to 9.57 hours in these patients. In 2 infants with very low birth weights with ages 7 and 91 days, half-lives were as long as 9.57 and 8.24 hours, respectively. Urinary recovery in 6 hours was 31.9-66.9% in 5 patients. Urine concentrations of the drug in 24 samples collected at various time from the 7 patients ranged from 130 to 3,219 micrograms/ml. Influence of CZX on the fecal flora was studied in 1 patient given 20 mg/kg X 4/day of the drug.(ABSTRACT TRUNCATED AT 250 WORDS)
A parenteral cephem antibiotic ceftriaxone (CTRX) was studied for its pharmacokinetic features and clinical efficacy and safety in various infections in neonates including premature infants at 11 institutions associated with Japan Perinatal Infection Research Group. The following results obtained are summarized as follows. 1. Following single intravenous bolus injections with 10 and 20 mg/kg of CTRX, serum levels of the drug at 30 minutes post-dose 36-42 micrograms/ml and 46-76 micrograms/ml, respectively, and those at 12 hours post-dose were 10-14 micrograms/ml and 13-21 micrograms/ml, respectively, in a total of 105 neonates. Serum levels detected were on very gentle descending curves. 2. Half-lives (T 1/2) of the drug in serum were significantly prolonged in 0-3 day age groups of both mature and premature infants: it was especially long in premature infants with age of 0-3 days; i.e., 17.1 hours. There was no difference in T 1/2 between the 4-7 day and 8-28 day age groups. 3. Urinary excretion rates were 20-30% in the first 6 hours post-dose and 30-40% in 12 hours post-dose, in 80 neonates examined. 4. Clinical efficacy: Clinical efficacies were evaluated in 112 of 168 enrolled excluding infants with 90 days of age or older, who were treated for prophylaxis and unevaluable cases. The safety was evaluated in 161 of the 168. (1) Demographic background of the 112 cases: The 112 cases were composed of 89 neonates with ages of 28 days or younger, 21 premature infants, 57 males and 55 females. The drug was given to 102 of the cases by intravenous bolus injection, with 81 cases administered twice a day and 97 cases receiving 10-50 mg/kg a day. (2) Efficacy rate in the 112 cases: In 60 cases for whom causative pathogens were identified the efficacy rate was 90.0% in total (excellent: 31/60; good: 23/60); efficacy rates of 87.5% were obtained in 8 cases with purulent meningitis and 90.9% in 11 with septicemia. In 52 with causative pathogen not identified, the efficacy rate was 96.2% in total (excellent: 21/52; good: 29/52). (3) Adverse reaction: Adverse reactions were noted in 14 of the 161 cases where the safety was evaluated (8.7%). These reactions included diarrhea in 11, vomiting in 2 and exanthema in 1. Abnormalities in laboratory test values were observed in 25 of the 152 cases (16.4%). They included eosinophilia in 14, elevated GOT in 4 and thrombocytosis in 3 etc.(ABSTRACT TRUNCATED AT 250 WORDS)
Twenty three neonates and young infants were treated with imipenem/cilastatin sodium (IPM/CS) and its clinical efficacy and side effects were evaluated. Ages of the patients ranged from 0 to 83 days, and their body weights ranged from 750 to 4,760 g. Doses of IPM/CS ranged from 17.4 to 21.5 mg/kg as IPM every 6 to 12 hours for 3 to 12 days. Sixteen patients with infections including sepsis, meningitis and pneumonia, appeared to have responded to the IPM/CS treatment. Among them, clinical results were excellent in 2, good in 12 and fair in 2 patients. The drug was well tolerated, but 1 patient had diarrhea, 1 had redness of body during infusion, 1 had elevated GOT and GPT, and 2 patients showed only elevated values of GOT only among the 23 patients. The pharmacokinetics of IPM/CS were studied in 7 patients. Their ages ranged from 0 to 9 days, and body weights ranged from 2.5 to 4.0 kg. Serum concentrations of IPM were between 18.0 and 96.9 micrograms/ml and those of CS ranged 31.7 and 144.5 micrograms/ml in 6 patients at the end of intravenous drip infusion 20 mg/20 mg/kg during 30 or 60 minutes. Elimination half-lives of IPM ranged from 1.2 to 2.0 hours, and those of CS ranged from 1.4 to 2.7 hours. Serum concentrations of IPM was 14.7 micrograms/ml and that of CS was 32.4 micrograms/ml in 1 patient at the end of 30 minute-drip infusion 10 mg/10 mg/kg. The elimination half-lives of IPM was 1.5 hours, and that of CS was 2.9 hours.(ABSTRACT TRUNCATED AT 250 WORDS)
A multiclinic study of gentamicin (GM) given by intravenous drip infusion was carried out by the Gentamicin Pediatric Study Group. The results are summarized as follows: 1. Upon intravenous drip infusion of GM at a dose range of 2.0-2.5 mg/kg over a period of 0.5-1 hour, therapeutically effective serum concentrations of 4-12 micrograms/ml were obtained. These values are similar to reported values in previous studies using GM intramuscular injection. 2. High urinary concentrations were observed up to 6 hours after administration, and the urinary recovery rate was approximately 60%. 3. Of a total of 142 cases collected, 117 cases were evaluated. Efficacy rates by diseases were: 100% in pneumonia (30/30), 98.3% in urinary tract infections (59/60), and 92.3% in other infections (skin and soft tissue) (12/13), with an overall efficacy rate of 94.9% (including 77 "excellent" cases). 4. Bacteriological examinations showed high eradication rates with the use of GM; i.e., 80% with Staphylococcus aureus (8/10), 60% with Pseudomonas aeruginosa (3/5), 100% with Haemophilus influenzae (7/7) and 97.8% with Escherichia coli (44/45), achieving an overall eradication rate of 92.4%. In mixed infections, the eradication rate was 85.7% (6/7). 5. No ototoxicity, nephrotoxicity or allergic reactions was observed. Abnormal laboratory findings observed were: GOT elevation in 3.1% of cases, GPT elevation in 3.9%, platelet increase in 1.5% and eosinophil increase in 0.8%, thus an overall rate of the appearance of abnormality was 5.6%. The above results indicate that an intravenous drip infusion of GM is a useful method for treating infections in pediatrics.
Eighteen children with urinary tract infection were treated with intravenous drip infusion of gentamicin (GM), and clinical efficacy and pharmacokinetics were studied. Ages of the patients ranged from 2 months to 12 years. Doses of GM ranged 1.0 to 2.5 mg/kg every 8 to 12 hours, and treatment continued for 4 to 10 days. Among 18 patients treated, clinical results were excellent in 12, and good in 6. Values of BUN and creatinine remained within normal range in all patients during and after the GM treatment. One child had an eosinophilia. There were no cases that showed signs and symptoms of oto- and nephrotoxicity. Twenty eight time-serum level curves were studied in 16 patients during and after intravenous infusion of GM over 30 minutes. Doses were 1.0 mg/kg in 4, 1.9-2.0 mg/kg in 14, and 2.2-2.5 mg/kg in 10. Peak serum levels at 30 minutes after the start of infusion were 2.66-7.38 micrograms/ml (average 5.45 micrograms/ml) in cases receiving 1.0 mg/kg, 4.67-10.8 micrograms/ml (7.26 micrograms/ml) in 1.9-2.0 mg/kg, and 6.16-16.5 micrograms/ml (8.86 micrograms/ml) in 2.2-2.5 mg/kg. Elimination half-lives were 1.75-2.48 hours (average 2.10 hours) in cases with ages less than 1 year, 1.58-2.58 hours (2.01 hours) with 1 to 6 years, and 1.20-3.07 hours (1.66 hours) with 7 to 12 years who were given doses of 1.9-2.5 mg/kg. There were no significant differences in pharmacokinetic parameters between first and last administration in these patients, suggesting that no accumulation occurred with above mentioned doses. Urinary recovery of GM ranged from 21.9 to 99.2 percent (average 62.48%) within 6.5 hours after the initiation of drip infusion.
In a study of rokitamycin (RKM) dry syrup for its usefulness in pediatric infections, the following results were obtained: 1. Frequencies of RKM-resistant strains among fresh isolates from sick children were very low, and 4.4% of 68 isolates of Staphylococcus aureus, 4.2% of 48 isolates of Streptococcus pneumoniae, and none of 96 isolates of Streptococcus pyogenes were found to be RKM-resistant. 2. Hypo- to achlorhydria was found in 2 (3.77%) of 53 children. 3. When children were administered once orally with 5, 10 and 15 mg/kg of RKM dry syrup at fasting, mean peak values of plasma concentration were 0.25, 0.55 and 0.74 micrograms/ml with a T1/2 (beta) of 2.18, 1.97 and 2.00 hours, respectively. Urinary recovery rates during the first 0-6 hours were quite low, and values were 1.21, 1.38 and 2.23%, respectively. 4. The clinical efficacy of RKM dry syrup was studied on children chiefly with acute pneumonia, mycoplasmal pneumonia and tonsillitis. Among 379 children from whom pathogens had been determined, responses to the treatment were excellent in 186, good in 144, fair in 24, poor in 20 and unknown in 5 patients, the overall efficacy rate being 88.2%. Among all 598 treated patients, including those with undetermined pathogens, responses were excellent in 247, good in 269, fair in 42, poor in 35 and unknown in 5 patients, the efficacy rate being 87.0%. 5. The clinical efficacy of the drug in treating Chlamydia infection in 12 patients including a Chlamydia carrier and the clinical efficacy in treating Campylobacter enteritis in 36 patients were studied. All the cases showed "good" responses. Among 66 patients with mycoplasmal pneumonia, responses were excellent in 33 and good in 27 patients, with an efficacy rate of 90.9%. 6. The optimal dose of RKM dry syrup seemed to be in the range between 20 and 40 mg/kg. It appeared, however, that a dose of about 40 mg/kg would be required to eradicate the pathogen from the pharynx in S. pyogenes infection. 7. Adverse reactions to RKM dry syrup were found in 9 (1.45%) of 622 patients. The reactions were gastrointestinal symptoms except eruption occurred in 1 patient, but they were all mild. Laboratory examinations revealed eosinophilia in 19 and abnormal hepatic enzyme activities in 8 of 455 patients studied, but such abnormalities were all transient and mild.