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PubMed1990

[Evaluation of norfloxacin in the pediatric field. Pediatric Study Group for Norfloxacin].

Norfloxacin (NFLX, AM-715), a new quinolone antibiotic agent, was evaluated clinically and bacteriologically for its efficacy and safety in pediatrics by a study group organized with pediatricians from all over the country. A summary of the results of the evaluation is as follows. 1. Incidence of NFLX-resistant strains (MIC over 12.5 micrograms/ml) isolated from children with various infections was 1.6% (8/512). One resistant strain was observed among 45 isolates of Staphylococcus aureus, and none among 30 isolates of Pseudomonas aeruginosa. 2. After single oral administration of 1.5-2.9, 3.0-4.8 and 5.1-6.1 mg/kg NFLX in tablet form at fasting, mean peak values of serum concentration of 0.37, 0.56, 0.92 micrograms/ml, T1/2 of 2.5, 2.6, 2.6 hours and urinary recovery rates in 8 hours at 25.3, 25.3, 27.1% were observed, respectively. 3. Clinical effects were studied chiefly in intestinal and urinary tract infections. Among 317 patients from whom pathogens had been isolated, responses to the treatment were excellent in 187, good in 79, fair in 9, poor in 7, and unknown in 35 cases. The overall efficacy rate was 94.3% (266/282) and the efficacy rate for excellent responses was 70.3% (187/266). Among all the 406 patients treated, including those with undetermined pathogens, responses were excellent in 233, good in 106, fair in 11, poor in 11, and unknown in 45 cases. The overall efficacy rate was 93.9% (339/361). 4. Clinical effects of NFLX classified by diseases with identified pathogens were 81.8% (9/11) for acute pneumonia, 80.8% (21/26) for other respiratory infections, 95.8% (23/24) for bacillary dysentery, 98.6% (70/71) for Campylobacter enteritis, 100% (24/24) for Salmonella enteritis, 100% (6/6) for other acute enteritis and 98.1% (104/106) for urinary tract infections. Including other infections as high as 94.3% (266/282) of efficacy rate was obtained in total. There was no significant difference in NFLX efficacies between unidentified and identified pathogens. Thus, the total clinical efficacy rate was 93.9% (339/361). 5. The total eradication rate of 325 pathogens evaluable was 84.3%, with identical eradication rates for Gram-positive cocci (GPC) (43/51) and for Gram-negative rods (GNR) (231/274). 6. The optimal daily dose of NFLX seemed to be in a range between 6.0 and 12.0 mg/kg, and the optimal duration of treatment to be 7 days for children over 5 years old. 7. The clinical efficacy in treating P. aeruginosa infections in 12 patients was 100% (11/11) and the eradication rate was 83.3% (10/12).(ABSTRACT TRUNCATED AT 400 WORDS)

Administration, Oral↗
PubMed1989

[Bacteriological, pharmacokinetic and clinical studies on clarithromycin in the pediatric field. Pediatric Study Group of Clarithromycin].

Clarithromycin (TE-031, A-56268), a new macrolide antibiotic agent, was evaluated bacteriologically and clinically for its efficacy and safety in pediatrics by a study group organized with pediatricians from all over the country. A summary of the results of the evaluation is as follows. 1. Absorption and excretion Pharmacokinetics of TE-031 was examined by single oral administration of 10% granules and 50 mg tablets at doses of 1, 5, 10 and 15 mg/kg. There were no significant differences between 10% granules and 50 mg tablets, and between administrations before and after meal. Peaks and half-life periods of blood level of TE-031 given once at doses of 5, 10 and 15 mg/kg (10% granules) before meal were 1.58, 4.37 and 3.79 micrograms/ml, and 2.53, 3.17 and 2.20 hours, respectively, and the urinary excretion in 6 hours after the administration were about 20-30%. 2. Antibacterial effects TE-031 was proved to have excellent antibacterial effect, i.e., inhibiting growth over 80% of strains of Streptococcus pneumoniae and Streptococcus pyogenes at 0.10 micrograms/ml, Branhamella catarrhalis at 0.39 micrograms/ml, and Campylobacter jejuni at 0.78 micrograms/ml. Against Staphylococcus aureus, TE-031 showed very similar activity spectrum to EM, and EM resistant strains were also resistant to TE-031. 3. Clinical results A total of 764 cases was studied. Clinical effects of TE-031 were evaluated in 717 cases out of the 764, excluding drop-outs and cases which did not meet specified protocols. Clinically, efficacies of TE-031 were "excellent" in 265 cases and "good" in 161 cases out of 453 cases of Group A in which causal agents were identified, with an efficacy rate of 94.0%, and out of 264 cases of Group B in which pathogens were not detected, clinical effects of TE-031 were "excellent" in 115 cases and "good" in 124 cases, with an efficacy rate of 90.5%. In terms of clinical effects of TE-031 classified by diseases when Group A and B were combined, efficacy rates were 91.6% for upper respiratory tract infection (217/237), 90.0% for bacterial pneumonia (108/120), 97.4% for Mycoplasma pneumonia (111/114), 100% for Chlamydia pneumonia (4/4), 85.0% for pertussis (34/40), 100% for scarlet fever (16/16), 83.9% for skin and soft tissue infection (26/31), and 98.9% for Campylobacter enteritis (87/88).(ABSTRACT TRUNCATED AT 400 WORDS)

Adolescent↗
PubMed1989

[Pharmacokinetic studies on oral antibiotics in pediatrics. II. A pharmacokinetic study on cefteram pivoxil in pediatrics].

A pharmacokinetic study on cefteram pivoxil (CFTM-PI) granules and tablets for pediatric use was performed, and pharmacokinetic parameters were calculated using the one-compartment open model with a time lag. 1. Twelve school children were administered orally with CFTM-PI granules at a dose level of 3 mg/kg either at 30 minutes before meal or 30 minutes after meal on a crossover design, and serum concentrations and urinary excretion rates of CFTM were determined. Tmax, Cmax, T 1/2 and urinary excretion rate following the administration before meal were 1.3 +/- 0.1 hours, 1.35 +/- 0.11 micrograms/ml, 1.21 +/- 0.07 hours and 13.4 +/- 1.5%, respectively. Tmax, Cmax, T 1/2 and urinary excretion rate following the administration after meal were 2.9 +/- 0.3 hours, 1.08 +/- 0.09 microgram/ml, 1.72 +/- 0.26 hours and 23.3 +/- 2.2%, respectively. Earlier Tmax, higher Cmax and lower urinary excretion rate were observed when the drug was administered before meal than when administered after meal. 2. Six school children were administered orally with CFTM-PI granules at 30 minutes after meal at a dose level of either 3 mg/kg or 6 mg/kg on a crossover design, and serum concentrations and urinary excretion rates of CFTM were determined. Cmax at a dose level of 3 mg/kg was 1.50 +/- 0.26 microgram/ml, Cmax at a dose level of 6 mg/kg was 2.58 +/- 0.29 micrograms/ml. There existed dose response. 3. Eighteen school children, 10 younger children and 6 infants were administered orally with CFTM-PI granules at a dose level of 3 mg/kg at 30 minutes after meal, and serum concentrations and urinary excretion rates of CFTM were determined. Tmax in school children, younger children and infants were 2.8 +/- 0.3, 3.4 +/- 0.3 and 2.0 +/- 0.4 hours, respectively. Slightly earlier Tmax's were observed in infants than in other children. Cmax in school children, younger children and infants were 1.22 +/- 0.11, 1.03 +/- 0.12 and 0.94 +/- 0.15 micrograms/ml, respectively. It seemed slightly high in the older school children, younger children, infants. Although T 1/2 were nearly the same in all age groups, it seemed somewhat longer in school children than in others. Urinary excretion rates in school children, younger children and infants were 21.5 +/- 1.8, 19.3 +/- 2.0 and 7.6 +/- 0.1%, respectively. Obviously low excretion rates were observed in infants.(ABSTRACT TRUNCATED AT 400 WORDS)

Adolescent↗
PubMed1986

The decision in pediatrics to go ahead with bone marrow transplant for a pediatric malignancy.

Bone marrow transplantation in pediatrics has become an accepted modality of therapy for a variety of malignant diseases. This sophisticated approach is now being used worldwide in a large number of centers for children who fail to respond to conventional therapy. In this review I have addressed the questions of when we should offer a bone marrow transplant, what medical issues impact on this decision, when such treatment is in the child's best interests and who acts for the patient during the transplant procedure. The decision to proceed with a bone marrow transplant is a complex one and requires frank discussions on a regular basis between family members and professional staff since, for many of these questions, there are no set responses.

Bone Marrow Transplantation↗
PubMed1986

[Pharmacokinetic and clinical studies with imipenem/cilastatin sodium in the pediatric field. Pediatric Study Group for Imipenem/Cilastatin Sodium].

Pharmacokinetic and clinical studies of imipenem/cilastatin sodium (MK-0787/MK-0791), a new carbapenem antibiotic and a dehydropeptidase-I inhibitor, respectively, were carried out in a joint study in the pediatric field by a study group consisting of investigators at 16 institutions. The results were summarized below. Pharmacokinetic studies Peak plasma concentrations of MK-0787/MK-0791 were 27.7-190.0/28.3-216.4 micrograms/ml at doses of 10/10-50/50 mg/kg administered by a 30 or 60-minute drip infusion. The above findings proved that dose response was clearly observed. Over a period of 6 or 7 hours, the urinary excretion of MK-0787 and MK-0791 totaled 54.2-88.0% and 53.6-89.0% of the dose administered, respectively. Plasma half-lives of MK-0787 and MK-0791 in the beta-phase were 0.87-1.05 hours and 0.59-0.95 hour, respectively. The cerebrospinal fluid (CSF) levels of MK-0787 in patients with purulent meningitis were 2.0-14.4 micrograms/ml; however, the penetration rate of the drug into the CSF was relatively poor in patients with normal meninges. Clinical study Clinical efficacy was evaluated in 283 patients. In 112 patients the daily dosage ranged from 30/30 mg/kg to 59/59 mg/kg, and in 138 patients it ranged from 60/60 mg/kg to 99/99 mg/kg. The maximum dose administered was 222/222 mg/kg. The drug was administered either 3 or 4 times per day. The clinical efficacy rate was 92.5% among 187 patients with identified etiologic pathogens. The drug was effective in 3 out of 4 patients with purulent meningitis and in 7 out of 10 patients with septicemia. The clinical efficacy rate was 96.7% in 90 patients with respiratory tract infection (pneumonia, lung abscess, etc.), 96.5% in 57 patients with urinary tract infection, 90.9% in 11 patients with SSTI. The clinical efficacy rate in those with no identified etiologic pathogen was 97.0% among 101 patients. Bacteriologically, the eradication rate for S. aureus was 87.9% of 33 isolates. Comprehensively, the eradication rate for Gram-positive bacteria was 94.7% of 75 isolates. The eradication rate for P. aeruginosa was 87.5% of 8 isolates. Including these strains, the eradication rate for Gram-negative bacteria was 90.3% of 134 isolates. The MK-0787/MK-0791 exhibited an eradication rate of 91.9% among a total of 211 Gram-positive and Gram-negative bacteria including anaerobes.(ABSTRACT TRUNCATED AT 400 WORDS)

Bacterial Infections↗
PubMed1986

Clinical experience and results of treatment with suprofen in pediatrics. 5th communication: a single-blind study on antipyretic effect and tolerability of suprofen syrup versus metamizole drops in pediatric patients.

In a single-blind study, 60 children in two age groups (30 patients: 6 months to 3 years; 30 patients: 3 years to 12 years), were orally treated with either alpha-methyl-4-(2-thienyl-carbonyl)phenylacetic acid (suprofen, Suprol), syrup 10 mg/ml or metamizole drops 50% for a maximum period of 4 days, up to 4 times a day. The children presented with high fever due to bacterial or virus infections. Body temperature, pulse rate, and respiratory rate were evaluated at the beginning and then 30 min, 1, 1 1/2, 2, 3, 4, 5, and 6 h after the first administration of the respective drug. Significant differences between the drugs were found for all variables; this demonstrated that with suprofen the antipyretic effect set in more rapidly than with the reference drug. No side-effects were observed in children treated with suprofen syrup. Two patients showed adverse effects, i.e. sweating and hypotension, during the treatment with metamizole. Due to its good antipyretic effect and good tolerability, suprofen appears to be particularly useful for symptomatic treatment of pediatric patients with fever caused by bacterial or virus infections.

Adolescent↗
PubMed1986

[Bacteriological, pharmacokinetic and clinical evaluations of ceftriaxone in the pediatric field. Pediatric study group of ceftriaxone].

UNLABELLED: Ceftriaxone (CTRX), a new injectable cephem antibiotic agent, was evaluated bacteriologically and clinically for its efficacy and safety in the pediatric field by a study group organized with pediatricians from all over the country. The following are a summary of the results of the evaluation. Antibacterial effects: The inhibition of growth was attained for over 90% of strains of K. pneumoniae, H. influenzae and Salmonella spp. at the concentration of 0.10 micrograms/ml and of strains of S. pneumoniae and E. coli at the concentration of 2.0 micrograms/ml. The CTRX was proved to have excellent antibacterial effects. Absorption and excretion: Thirty minutes after one shot intravenous administration with 10, 20, 40 and 50 mg/kg of CTRX, its serum levels were 73, 124, 169 and 190 micrograms/ml, respectively, a clear tendency of dose-response relationship being noticed. The serum levels decreased only gradually and stayed as high as 10 to 20 micrograms/ml even after 12 hours. The half-lives of the drug were 5.5, 6.3, 6.0 and 4.7 hours for the 4 different dose levels, respectively. Following the intravenous injection with 10, 20 and 40 mg/kg, the urinary excretion rates were 55, 52 and 54%, respectively. Following the one shot intravenous administration or by the drip infusion for 30 minutes with about 50 mg/kg, CTRX levels in the cerebrospinal fluid ranged from 1 to 20.3 micrograms/ml in case of purulent meningitis (5 to 10 micrograms/ml in most cases). CLINICAL RESULTS: A total of 322 cases was enrolled. The efficacy of CTRX was evaluated in 295 cases out of the 322, excluding drop-outs and the cases which did not meet the protocols. The clinical efficacy rate was 94% of 191 cases where the causative bacteria were identified, CTRX being "excellent" in 108 cases and "effective" in 72. In the remaining 104 cases where the causative bacteria were not identified, the efficacy rate was 92%, CTRX being "excellent" in 42 cases and "effective" in 54. Furthermore, the efficacy rate was 89% of 18 cases infected with more than one kind of bacteria. The drug showed "excellent" or better effectiveness in 88% of 75 cases which had not responded to other antibiotics. Bacteriologically, 174 out of 216 strains (93%) which were judged to be causative bacteria disappeared with the use of CTRX. Eighty-five percent of 53 strains which had not responded to other antibiotics disappeared by the CTRX treatment.(ABSTRACT TRUNCATED AT 400 WORDS)

Adolescent↗
PubMed1985

[Bacteriological, pharmacokinetic and clinical studies on aztreonam in the pediatric field. Pediatric Study Group of Aztreonam].

This report summarizes the results of joint studies in pediatrics on aztreonam, the first monobactam antibiotic for practical use. Pharmacokinetics was studied in 53 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. T1/2 was in a relatively fixed range of 1.35-1.56 hours in intravenous injection cases and 1.30-1.55 hours in drip infusion. One hour after commencing administration of standard 20 mg/kg, the serum concentrations were 50.18 +/- 4.24 micrograms/ml in intravenous injection and 116.33 +/- 10.18 micrograms/ml in drip infusion and even 6 hours after the end of the administration, they were 5.80 +/- 1.16 micrograms/ml and 3.38 +/- 0.58 micrograms/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 E. coli and H. influenzae. Amount of the penetration decreased as the cases were improved. 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 N. meningitidis meningitis and "good" for 1 case of 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%. 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 P. aeruginosa cases. 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%. 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 X 3 approximately 4 times a day was recommendable.(ABSTRACT TRUNCATED AT 400 WORDS)

Age Factors↗
PubMed1977

[Clinical experience with sustained release cefalexin (S-6437) for pediatric use in pediatrics (author's transl)].

S-6437 is a preparation of sustained release cefalexin consisting of non-enteric coated granules and enteric coates ones and it is reported that the drug shows good effectiveness with b.i.d. regimen. Various infections in pediatrics were treated with S-6437 and the following results were obtained. Dose used was 40 approximately 100 mg/kg/day at 2 divided doses after breakfast and dinner. 1) Twenty patients (87.0%) of the 23 with respiratory tract infections and 3 (60.0%) of the 5 with the other infections responded to the drug. Overall effectiveness was 82.1% (23/28 cases). 2) As for side effects, tentative diarrhea was observed in 5 patients (17.2%) of the 29 but no other severe side effects were found. 3) S-6437 is considered to be a drug which overcomes inconvenience of giving regular cefalexin four times a day.

Age Factors↗
PubMed1994

[Clinical studies on clarithromycin dry syrup in the pediatric field. Pediatric Study Group of TE-031 Dry Syrup].

Clarithromycin dry syrup, a new drug preparation, was clinically evaluated in the pediatric field and the following results were obtained: 1. Absorption and excretion In infants administered with single oral dose of 5 mg (potency)/kg and 10 mg/kg, the Cmax was 2.26 +/- 0.42 and 3.23 micrograms/ml; Tmax, 1.6 +/- 0.1 and 2.0 hours; T 1/2, 3.89 +/- 0.52 and 2.06 hours; AUC (0-infinity), 13.48 +/- 1.93 and 13.84 micrograms.hr/ml, respectively. Urinary concentrations peaked in 2-4 hours after administration at 5 mg/kg and 0-2 hours at 10 mg/kg. Urinary recovery rates in the first 6 hours were 25.8 +/- 3.9% at 5 mg/kg and 20.7% at 10 mg/kg. 2. Clinical results The clinical efficacy of the drug was evaluated in 150 patients with various infections. Clarithromycin dry syrup was administered to all the patients at daily doses of 10-15 mg/kg divided into 2-3 equal doses. The overall clinical efficacy rate was 98.0%, and this drug was effective in 98.9% of 90 patients for whom the causative pathogens were identified and in 96.7% of the other 60 patients for whom the causative pathogens were unknown. The bacteriological eradication rate was 88.5%. The efficacy and eradication rates for 19 patients who had not responded to previous chemotherapy that lasted for more than three days were 94.7% (18/19) and 75.0%, respectively. Side effects occurred in 4 (2.4%) of 169 patients subjected to safety analyses, but none was serious. As to abnormal laboratory test results, moderate increases of eosinophils and elevations of transaminases were observed in 5.9% of the cases. No particular and serious problems were associated with administration of this drug. Based on the above results, clarithromycin dry syrup is considered to be very useful and have a good compliance at a daily dose of 10-15 mg/kg divided into 2-3 doses.

Administration, Oral↗
PubMed1994

[Neuroblastoma IV-S. A multicenter study. Work Group of Pediatric Oncology. Spanish Society of Pediatric Surgery].

A retrospective multicentric study of 23 patients with stage IV-S neuroblastoma treated in 10 national Pediatric Surgery Departments between January 1988 and December 1992, is presented. All cases were classified as stage IV-S following staging criteria proposed by Evans et al. The age diagnosis was an average of 3 months. An acute clinical course was seen in 7 patients. Primary sites of the tumor were: adrenal gland in 6 patients (30.5%), abdominal paravertebral in 3 (13%) and unknown in 2 (9%). Distant tumor sites were: liver in 20 patients, bone marrow in 9, and skin in 5. There were not systematic therapeutic approach, in 16 cases (69%) the primary tumor was resected, 18 (78%) received chemotherapy, the liver was irradiated in 3 (13%), and 1 case (4%) received no treatment at all. One children died. The overall disease-free survival is 95.6% at 43 months post-diagnosis. A common treatment protocol is proposed, with systematic determination of N-myc oncogene which will indicate the appropriate therapy.

Abdominal Neoplasms↗
PubMed1994

[Pharmacokinetic and clinical studies with L-627 (biapenem) in the pediatric field. Pediatric study group of L-627].

To conduct pharmacokinetic and clinical studies on newly developed L-627 (biapenem) against various infections in pediatrics, a study group was organized and a joint research by 15 institutions and their related hospitals was undertaken. Informed consents of subjects were obtained prior to the study. The obtained results are as follows. 1. Plasma concentrations and urinary excretion Pharmacokinetics of L-627 in children was studied in 29 subjects using 30 minutes intravenous drip infusion of 6 mg/kg and 12 mg/kg. Maximum plasma levels of L-627 was observed at the completion of drip infusion and were 25.1 micrograms/ml with administration of 6 mg/kg and 39.2 micrograms/ml with administration of 12 mg/kg on average. Dose dependency was noted in Cmax and AUC with these doses. Maximum blood levels in all of the 5 participated sucklings under the age of one year were similar to the average. As for urinary excretion, L-627 was excreted 66.0% with administration of 5 mg/kg and 62.3% with 12 mg/kg. 2. Cerebrospinal fluid concentrations Cerebrospinal fluid concentrations ranged from 0.76 to 8.54 micrograms/ml in 30-240 minutes after the completion of drip infusion with dose of 20-40 mg/kg in 9 subjects with purulent meningitis, when they were measured within 3 days after the initiation of the treatment with L-627. 3. Clinical results Thirty-three cases of exclusion and drop-out were deducted from a total of 330 cases, hence 297 cases were evaluated as the subjects in the study for analysis of clinical effects. As for clinical effects in group A where pathogenic bacteria were detected, 166 out of 173 were rated as effective or above, hence the efficacy rate of 96.0% was obtained. In group B where pathogenic bacteria were not detected, 114 out of 124 cases were rated as effective or above, thus the efficacy rate was 91.9%, which is similar to that of the group A. The overall efficacy rate was 94.3% in the entire 297 cases. The rates of "excellent" responses out of the cases rated as effective or above were 62.7% (104/166) in the group A and 55.3% (63/114) in the group B, thus the rate was markedly high in the former group. Efficacy rate for each pathogenic strain was also high, and that in subjects infected by a single pathogenic strain was 96.7% (145/150) and that in subjects infected by two or more pathogenic strains was 91.3% (21/23).(ABSTRACT TRUNCATED AT 400 WORDS)

Age Factors↗
PubMed1994

[Pharmacokinetic and clinical studies with cefozopran in the pediatric field. Pediatric Study Group of Cefozopran].

We investigated pharmacokinetics and clinical effectiveness of a newly developed cephem antibiotic cefozopran (SCE-2787, CZOP) against various pediatric infections in 18 institutions and their affiliates. We obtained the following results. 1. Serum concentration and urinary excretion rates Pharmacokinetics of CZOP in children was examined after intravenous injection and 30-minute drip infusion of 10, 20 and 40 mg/kg of CZOP. Peak serum concentrations of CZOP in 30 minutes after intravenous injection were 21.7, 51.5 and 77.8 micrograms/ml, respectively, showing a clear dose response. Half-lives were 1.99, 1.85 and 1.67 hours, respectively. In the first 6 hours after administration, urinary excretion rates of CZOP were 87.3, 67.4 and 84.1%, respectively. In the cases of 10, 20 and 40 mg/kg administration of CZOP 30-minute drip infusion, peak serum concentration of CZOP in 30 minutes, when the infusion was completed, were 38.1, 72.8 and 95.6 micrograms/ml, respectively. Again, there was a clear dose response. Half-lives were 1.67, 1.69 and 1.43 hours, respectively. In the first 6 hours after administration, urinary excretion rates of CZOP were 53.9, 59.7 and 77.3%, respectively. Cerebrospinal fluid concentrations of CZOP administered by intravenous injection of 50 mg/kg to patients with purulent meningitis were 1.6 to 43.4 micrograms/ml in 1 to 1.5 hours after administration. 2. Clinical study Clinical efficacy was evaluated in 337 cases. The largest number of cases, 138 cases, were found in 2 to < 6-year olds. The majority of the patients were under age 9, and 70 cases were of less than 1-year old infants. 183 cases were males and 154 cases were females. In terms of illness, a majority, or 185 cases, suffered from pneumonia, followed by 39 cases of UTI and 23 infections of the skin and soft tissue. There were 7 cases of purulent meningitis. In 218 cases, CZOP was administered at a daily dose of 60- < 80 mg/kg. The drug was administered for 6-10 days, the most frequent duration, in 188 cases. In the cases where causative organisms were identified (group A), the efficacy rates ("excellent" and "good") obtained were 100% (5/5) against purulent meningitis, 100% (2/2) against sepsis, 98.3% (119/121) against pneumonia, 100% (13/13) against acute bronchitis, 100% (11/11) against upper respiratory tract infection, 96.3% (26/27) against UTI. Overall, "excellent" and "good" responses were observed in 97.5% (197/202) of cases with known causative organisms.(ABSTRACT TRUNCATED AT 400 WORDS)

Adolescent↗
PubMed1994

[Pharmacokinetic and clinical studies of SY5555 in the pediatric field. Pediatric Study Group of SY5555].

SY5555, a new oral penem, was pharmacokinetically and clinically evaluated in the pediatric field and the following results were obtained: 1. Pharmacokinetics Pharmacokinetics of SY5555 dry syrup (powder which is dissolved before use) was investigated in 64 children. At a dose level of 3 mg (potency)/kg, Cmax and T1/2 were 0.33 micrograms/ml and 0.95 hours (n = 1), respectively, in the non-fasting state. At a dose level of 5 mg/kg Cmax and T1/2 were 2.09 +/- 1.25 micrograms/ml and 1.20 +/- 1.07 hours, respectively, in the fasting state, and were 1.21 +/- 0.70 micrograms/ml and 1.33 +/- 0.90 hours, respectively, in the non-fasting state. At a dose level of 10 mg/kg, Cmax and T1/2 were 2.96 +/- 1.89 micrograms/ml and 0.89 +/- 0.43 hours, respectively, in the fasting state, and were 2.45 +/- 1.37 micrograms/ml and 1.17 +/- 0.53 hours, respectively, in the non-fasting state. At a dose level of 15 mg/kg, Cmax and T1/2 were 4.30 +/- 2.15 micrograms/ml and 0.82 +/- 0.09 hours, respectively, in the non-fasting state. Data of Cmax and AUC showed that plasma concentration of the drug depended on dose levels. Urinary recovery rates in the first 6 hours were 1.71% (n = 1) in the non-fasting state at a dose level of 3 mg/kg, 4.13 +/- 1.40% in the fasting state and 4.17 +/- 3.29% in the fasting and the non-fasting state, respectively at a dose level of 5 mg/kg, and 6.02% (n = 1) and 4.64 +/- 2.81%, respectively, at a dose level of 10 mg/kg. At a dose level of 15 mg/kg, urinary recovery rate in the first 6 hours was 7.97% (n = 2) in the non-fasting state. 2. Clinical results 1) Dry syrup The clinical efficacy of the SY5555 dry syrup was evaluated in 506 cases. SY5555 was administered at daily doses of 15-30 mg/kg divided into 3 equal doses to most patients. Daily doses of 12- < 18 mg/kg were given to 46.6% of the patients. The overall clinical efficacy rate was 92.9%, and this drug was effective in 93.0% of the 301 patients for whom the causative pathogens were identified, and in 92.7% of the 205 patients with infections for whom the causative pathogens were unknown. The efficacy rate at daily doses of 12 - < 18 mg/kg was 94.5% similar to those obtained at daily doses of 18- < 27 mg/kg (91.7%) or 27- < 33 mg/kg (91.3%). The bacteriological eradication rate was 82.3%.(ABSTRACT TRUNCATED AT 400 WORDS)

Absorption↗
PubMed1993

Analysis of complications in a chronic peritoneal dialysis pediatric patient population. The Italian Registry of Pediatric Chronic Peritoneal Dialysis.

During the period 1986-1991, the Italian Registry of Pediatric Chronic Peritoneal Dialysis collected data from 140 patients younger than 15 years at the start of chronic peritoneal dialysis (CPD). In this study we review the Registry's complications and patient hospitalization data. A total of 395 complications directly related to CPD were registered during 2722 dialysis-months. There were 176 episodes of peritonitis (44.5%), 161 catheter-related complications (40.7%) (103 exit-site infections, 17 leakages, 15 obstructions, 15 cuff extrusions, 5 hemoperitoneum, and 6 other complications), and 58 technique-related complications (14.8%) (39 abdominal hernias, 10 hydroceles, 5 with abdominal pain, 4 hydrothorax complications). The patient hospitalization rate during the period 1989-1991 was evaluated; the analysis referred to 106 patients who underwent treatment for a total of 1520.5 dialysis-months. Patients starting CPD in the year and patients already on CAPD spent 5.8 and 2.1 days per patient-month in the hospital, respectively; the difference was not statistically significant. The evaluation of complications (both technical and systemic) causing patient hospitalization showed that peritonitis was responsible for 43.2% of patient admissions and 36.3% of days hospitalized, catheter-related complications for 22% and 19.8%, technique-related complications for 8.3% and 5.1%, and other clinical complications for 26.5% and 38.8%, respectively.

Catheters, Indwelling↗
PubMedDate not supplied

The Japanese National Registry data on pediatric CAPD patients: a ten-year experience. A report of the Study Group of Pediatric PD Conference.

OBJECTIVE: Over the past 10 years, we have collected data on pediatric patients less than 16 years of age from the National Registry of CAPD (continuous ambulatory peritoneal dialysis). We present our experience with this population. DESIGN: The database details the patient number, age, weight, height, outcome, cause of death, reason for terminating CAPD therapy, peritonitis, and catheter survival. PATIENTS: Of the 434 patients (239 males, 195 females), 37 patients (8.5%) were under 1 year of age and 164 patients (37.8%) were under 6 years of age. About half of the patients were less than 20 kg in weight, clearly indicating that CAPD was the treatment of choice in young children. The duration on CAPD for these patients was less than 2 years for 233 patients (54%), and was 5 years or more in 48 patients (11%). RESULTS: The outcome of the total patient population of 434 as of May, 1991, is as follows: 229 patients (52.8%) were being successfully treated with CAPD, 47 patients (10.8%) died, and 78 patients (18.0%) received a kidney transplantation. The patient survival rate was 85.6% at 3 years and 81.7% at 5 years. The technique survival rate was 74.9% at 3 years and 63.5% at 5 years. The rate of peritonitis was one episode over 28.6 patient-months. The mean catheter duration was 1.68 years. Peritonitis rate, catheter survival rate, and the rate of tunnel infection were worse in children less than 6 years of age than in older children. CONCLUSION: The excellent patient and technique survival rates indicate that CAPD is an effective treatment for children with end-stage renal disease in Japan. The high infection rates in younger children indicate that extra careful management is needed for this young age group.

Cause of Death↗
PubMed1998

Prevention of medication errors in the pediatric inpatient setting. American Academy of Pediatrics. Committee on Drugs and Committee on Hospital Care.

Medication errors that occur on a pediatric medical/surgical inpatient care unit are usually avoidable. Several steps are recommended to reduce these errors, beginning with the physician and including every member of the health care team. Pediatricians should help hospitals develop effective programs for safely providing treatment with medications to hospitalized children.

Child↗