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Median raphe cyst in the scrotum, mimicking a serous borderline tumor, associated with cryptorchidism after orchiopecxy.

Median raphe cyst (MRC) is a benign lesion occurring predominantly in the ventral surface of the penises of young men and is an embryological developmental anomaly of the male genitalia. Serous borderline tumors (SBT) are found most frequently in the female ovary and only several cases with SBT of the male genitalia have been reported. We describe a case of MRC with features of SBT, which appeared in the scrotum of a 9-year-old boy after orchiopexy and was associated with surgery for cryptorchidism. The cyst arose on the right testicular tunica and consisted of cystic components with intracystic papillae lined by stratified epithelial cells, some of which showed mild cytological atypia and sporadic mitosis. These epithelial cells expressed CA 125, CA 19-9, carcinoembryonic antigen, estrogen receptor and progesterone receptor. Although no cases of MRC with characteristics of SBT in association with the rete testis has been described, the current report gives additional information for follow-up of cryptorchidism.

Child↗

Clock completion: an objective screening test for dementia.

OBJECTIVE: To develop a simple, readily administered and scored screening test for dementia utilizing the clock-drawing task. DESIGN: Retrospective analysis of clock-drawing errors and prospective validations. SETTING: Hospital-based outpatient geriatric assessment clinic, rehabilitation service, apartment building for older adults, and long-term care facility. PARTICIPANTS: Convenience sample of patients attending the geriatric assessment clinic, patients on the rehabilitation service, or residents of the above sites. MEASUREMENTS: Sensitivity and specificity of a clock-scoring system in identifying patients with dementia and the comparison of this system with the Short Blessed Test (SBT) in the diagnosis of dementia and in the prospective validation of the test. RESULTS: Of the 10 clock-drawing errors evaluated, placement of digits in a pre-drawn circle had the greatest sensitivity and specificity in distinguishing patients with irreversible dementia from patients with other disorders who did not meet NINCDS-ADRDA criteria for probable dementia. The derived scoring system had a sensitivity of 87% and a specificity of 82%, compared with a sensitivity of 82% and a specificity of 88% for the SBT in identifying dementia. Test-retest reliability for the distinction between demented and non-demented was 82%, with a Kappa of 0.63 for the clock completion, and 82%, with a Kappa of 0.62 for the SBT. Inter-rater reliability for clock completion was 0.90 to 0.93. CONCLUSION: A simple, completely objective scoring system for a clock completion test has been developed which involves only the number of digits placed in the fourth quadrant of a pre-drawn circle. This readily administered test is as effective in screening for dementia as the longer six-item SBT.

Aged↗

Whole gut transit scintigraphy in the clinical evaluation of patients with upper and lower gastrointestinal symptoms.

OBJECTIVE: In a single noninvasive, quantitative test, whole gut transit scintigraphy (WGTS) measures gastric emptying (GE), small bowel transit (SBT), and colonic transit (CT). The aim of this study was to investigate the clinical utility of WGTS in patients with functional gastrointestinal (GI) symptoms. METHODS: A total of 108 patients with either dyspeptic upper GI symptoms (n = 35) or constipation (n = 73) underwent WGTS. Patients consumed a meal of 99 m-Tc egg sandwich with 111-In DTPA in water. They were imaged every 30 min for 6 h to measure GE and SBT, and at 24, 48, and 72 h to measure CT. RESULTS: Of 108 studies, 104 were analyzable. In patients with upper GI symptoms, 14/35 (40%) had delayed GE of solids, 4/35 (11%) delayed SBT, and 11/35 (31%) delayed CT. Of those with constipation, 13/69 (19%) had delayed GE, 5/69 (7%) delayed SBT, and 43/69 (65%) delayed CT. WGTS changed the initial clinical diagnosis in 47/104 (45%) and altered patient management in 70/104 (67%) of the patients. CONCLUSIONS: Transit abnormalities of the upper GI tract and colon are common in patients with functional GI symptoms. Patients with upper GI symptoms frequently have delayed GE, whereas those with constipation tend to have predominantly delayed CT. In many patients with functional GI symptoms, there was evidence of a diffuse GI motility disorder. Whole gut transit scintigraphy is a simple, clinically useful test, as it frequently leads to a change in diagnosis and, therefore, patient management.

Adult↗

Predicting successful extubation of very low birthweight infants.

OBJECTIVE: To determine the accuracy of three tests used to predict successful extubation of preterm infants. STUDY DESIGN: Mechanically ventilated infants with birth weight <1250 g and considered ready for extubation were changed to endotracheal continuous positive airway pressure (ET CPAP) for three minutes. Tidal volumes, minute ventilation (V e), heart rate, and oxygen saturation were recorded before and during ET CPAP. Three tests of extubation success were evaluated: (a) expired V e during ET CPAP; (b) ratio of V e during ET CPAP to V e during mechanical ventilation (V e ratio); (c) the spontaneous breathing test (SBT)-the infant passed this test if there was no hypoxia or bradycardia during ET CPAP. The clinical team were blinded to the results, and all infants were extubated. Extubation failure was defined as reintubation within 72 hours of extubation. RESULTS: Fifty infants were studied and extubated. Eleven (22%) were reintubated. The SBT was the most accurate of the three tests, with a sensitivity of 97% and specificity of 73% and a positive and negative predictive value for extubation success of 93% and 89% respectively. CONCLUSION: The SBT used just before extubation of infants <1250 g may reduce the number of extubation failures. Further studies are required to establish whether the SBT can be used as the primary determinant of an infant's readiness for extubation.

Continuous Positive Airway Pressure↗

Absorptive capacity of the transplanted small bowel.

Small bowel transplantation (SBT) has been carried out in man in several cases without success, because immunologic problems were unsolved. In experimental SBT a 'two step' model was developed, which enables long term observation of immunologic phenomena. In this model the graft is in a heterotopic position to the recipient's own small bowel. After 35 days the recipient's own bowel is removed and replaced by the graft, now in orthotopic position and again in contact with luminal chymus. To investigate functional and morphological changes, which result from the procedure, the resorption of glucose and water was measured in syngeneic transplanted rats by an in vivo recirculation system and the mucosa was evaluated three dimensionally. The graft mucosa showed a significant reduction in villus height, crypt length and villus surface and a corresponding decrease in glucose and water absorption during heterotopic position. If the graft came into the orthotopic position, the mucosa did regenerate which was expressed by the significant longer crypts of the graft compared with those of the controls, although the graft's villus height and surface are still smaller. Glucose and water absorption increased and were higher in orthotopic transplanted animals, when absorption was expressed per unit intestinal length. The results indicate that in the 'two step' model of SBT the absorption of water and glucose is influenced to such an extent, that recovery is possible after three weeks, thus enabling orthotopic SBT. This almost complete recovery of the mucosa is further evidence of the regeneratory capacity of the small bowel, which enables clinical small bowel transplantation.

Animals↗

Effect of pulmonary perfusion on the slopes of single-breath test of CO2.

The objective of this study was to evaluate the effects of lung perfusion on the slopes of phases II (S(II)) and III (S(III)) of a single-breath test of CO(2) (SBT-CO(2)). Fourteen patients submitted to cardiac surgery were studied during weaning from cardiopulmonary bypass (CPB). Pump flow was decreased in 20% steps, from 100% (total CPB = 2.5 l.min(-1).m(-2)) to 0%. This maneuver resulted in a progressive and opposite increase in pulmonary blood flow (PBF) while maintaining ventilator settings constant. SBT-CO(2), respiratory, and hemodynamic variables remained unchanged before and after CPB, reflecting a constant condition at those stages. S(III) was similar before and after CPB (19.6 +/- 2.8 and 18.7 +/- 2.1 mmHg/l, respectively). S(III) was lowest during 20% PBF (8.6 +/- 1.9 mmHg/l) and increased in proportion to PBF until exit from CPB (15.6 +/- 2.2 mmHg/l; P < 0.05). Similarly, S(II) and the CO(2) area under the curve increased from 163 +/- 41 mmHg/l and 4.7 +/- 0.6 ml, respectively, at 20% PBF to 313 +/- 32 mmHg/l and 7.9 +/- 0.6 ml (P < 0.05) at CPB end. When S(II) and S(III) were normalized by the mean percent expired CO(2), they remained unchanged during the protocol. In summary, the changes in PBF affect the slopes of the SBT-CO(2). Normalizing S(II) and S(III) eliminated the effect of changes in the magnitude of PBF on the shape of the SBT-CO(2) curve.

Aged↗

Sudden blastic transformation in patients with chronic myeloid leukemia treated with imatinib mesylate.

Sudden blastic transformation (SBT) has been reported in 0.5% to 2.5% of patients treated with interferon-alpha (IFN-alpha) during the first 3 years of therapy. Imatinib is now standard therapy for patients with chronic myeloid leukemia in chronic phase. We investigated the occurrence of SBT among patients treated with imatinib. Among 541 patients treated with imatinib in chronic phase, 23 developed blast phase, which was of sudden onset (ie, occurring in patients previously in complete cytogenetic remission) in 4 patients (17%; 0.7% of the total), 2 lymphoid and 2 myeloid. Patients with SBT were found to have low-risk features more often at the time of presentation and had achieved optimal response with imatinib. Three of the 4 patients underwent allogeneic stem cell transplantation and achieved a molecular remission. SBT is still a rare event, probably less common than that observed with IFN-alpha therapy. Continuous monitoring of patients treated with imatinib is mandatory.

Adult↗

Predictors of extubation outcome in patients who have successfully completed a spontaneous breathing trial.

BACKGROUND: After patients recovering from respiratory failure have successfully completed a spontaneous breathing trial (SBT), clinicians must determine whether an artificial airway is still required. We hypothesized that cough strength and the magnitude of endotracheal secretions affect extubation outcomes. METHODS: We conducted a prospective study of 91 adult patients treated in medical-cardiac ICUs who were recovering from respiratory failure, had successfully completed an SBT, and were about to be extubated. A number of demographic and physiologic parameters were recorded with the patient receiving full ventilatory support and during the SBT, just prior to extubation. Cough strength on command was measured with a semiobjective scale of 0 to 5, and the magnitude of endotracheal secretions was measured as none, mild, moderate, or abundant by a single observer. In addition, patients were asked to cough onto a white card held 1 to 2 cm from the endotracheal tube; if secretions were propelled onto the card, it was termed a positive white card test (WCT) result. All patients were then extubated from T-piece or continuous positive airway pressure breathing trials. If 72 h elapsed and patients did not require reintubation, they were defined as successfully extubated. RESULTS: Ninety-one patients with a mean (+/- SE) age of 65.2 +/- 1.6 years, ICU admission APACHE (acute physiology and chronic health evaluation) II score of 17.7 +/- 0.7, and duration of mechanical ventilation of 5.0 +/- 0.5 days were studied over 100 extubations. Sixteen patients could not be extubated, and 2 patients underwent two unsuccessful extubation attempts, for a total of 18 unsuccessful extubations. Age, severity of illness, duration of mechanical ventilation, oxygenation, rapid shallow breathing index, and vital signs during SBTs did not differ between patients with successful extubations vs patients with unsuccessful extubations. The WCT result was highly correlated with cough strength. Patients with weak (grade 0 to 2) coughs were four times as likely to have unsuccessful extubations, compared to those with moderate-to-strong (grade 3 to 5) coughs (risk ratio [RR], 4.0; 95% confidence interval [CI],1.8 to 8.9). Patients with moderate-to-abundant secretions were more than eight times as times as likely to have unsuccessful extubations as those with no or mild secretions (RR, 8.7; 95% CI, 2.1 to 35.7). Patients with negative WCT results were three times as likely to have unsuccessful extubations as those with positive WCT results (RR, 3.0; 95% CI, 1.3 to 6.7). Poor cough strength and endotracheal secretions were synergistic in predicting extubation failure (Rothman synergy index, 3.7; RR, 31.9; 95% CI, 4.5 to 225.3). Patients with PaO(2)/fraction of inspired oxygen (P:F) ratios of 120 to 200 (receiving mechanical ventilation) were not less likely to be successfully extubated than those with P:F ratios of > 200, but those with hemoglobin levels < or = 10 g/dL were more than five times as likely to have unsuccessful extubations as those with hemoglobin levels > 10 g/dL. CONCLUSIONS: After patients recovering from respiratory failure have successfully completed an SBT, factors affecting airway competence, such as cough strength and amount of endotracheal secretions, may be important predictors of extubation outcomes. Also, a majority (89%) of medically ill patients with P:F ratios of 120 to 200 (four of five patients with P:F ratios from 120 to 150), values sometimes used to preclude weaning, were extubated successfully.

Adult↗

Automatic tube compensation-assisted respiratory rate to tidal volume ratio improves the prediction of weaning outcome.

OBJECTIVE: To assess whether the respiratory rate to tidal volume ratio (RVR) measured while receiving automatic tube compensation (ATC) [RVRATC] would have a better predictive value as a weaning measure than unassisted RVR. DESIGN: Prospective cohort study. SETTING: General ICU of a tertiary-care university hospital. PATIENTS: Forty-three patients who received mechanical ventilation for > 24 h and were considered ready for weaning. INTERVENTIONS: All patients underwent a 60-min spontaneous breathing trial (SBT) [positive end-expiratory pressure of 5 cm H(2)O; ATC, 100%]. Patients tolerating the trial (n = 35) were extubated immediately. The following parameters were measured at the onset and end of the SBT: RVR, RVRATC, peak airway pressure (Paw), airway occlusion pressure, and minute ventilation. The outcome measure was successful extubation (ability to maintain spontaneous breathing for > 48 h). MEASUREMENTS AND RESULTS: Median age was 55 years (range, 25 to 88 years), median APACHE (acute physiology and chronic health evaluation) II score was 15.5 (range, 3 to 29), and median duration of mechanical ventilation prior to the SBT was 7 days (range, 1 to 40 days). Extubation was successful in 25 patients (72%). There were no significant differences in baseline characteristics between patients successfully extubated (group 1) and those requiring reintubation. On multivariate analysis, RVRATC measured at 60 min (RVR(60)ATC) was most predictive of successful extubation (p = 0.03). The area under the receiver operator characteristic curve was also highest for RVR(60)ATC (0.81 +/- 0.03) as compared to RVR (0.77 +/- 0.03), RVRATC (0.75 +/- 0.04), and RVR measured at 60 min (0.69 +/- 0.05). The ratio of RVR(60)ATC to Paw was the best predictor (0.84 +/- 0.02). CONCLUSIONS: RVRATC measured at the end of the SBT was the best predictor of successful extubation. A new ratio (ratio of RVRATC to Paw) was most predictive and deserves further study.

Adult↗

Monitoring the treatment of sepsis with vancomycin in term newborn infants.

UNLABELLED: A prospective study was conducted to determine if standardized vancomycin doses could produce adequate serum concentrations in 25 term newborn infants with sepsis. PURPOSE: The therapeutic response of neonatal sepsis by Staphylococcus sp. treated with vancomycin was evaluated through serum concentrations of vancomycin, serum bactericidal titers (SBT), and minimum inhibitory concentration (MIC). METHOD: Vancomycin serum concentrations were determined by the fluorescence polarization immunoassay technique, SBT by the macro-broth dilution method, and MIC by diffusion test in agar. RESULTS: Thirteen newborn infants (59.1%) had adequate peak vancomycin serum concentrations (20 - 40 mg/mL) and one had peak concentration with potential ototoxicity risk (>40 microg/mL). Only 48% had adequate trough concentrations (5 - 10 mg/mL), and seven (28%) had a potential nephrotoxicity risk (>10 microg/mL). There was no significant agreement regarding normality for peak and trough vancomycin method (McNemar test : p = 0.7905). Peak serum vancomycin concentrations were compared with the clinical evaluation (good or bad clinical evolution) of the infants, with no significant difference found (U=51.5; p=0.1947). There was also no significant difference between the patients' trough concentrations and good or bad clinical evolution (U = 77.0; p=0.1710). All Staphylococcus isolates were sensitive to vancomycin according to the MIC. Half of the patients with adequate trough SBT (1/8), also had adequate trough vancomycin concentrations and satisfactory clinical evolution. CONCLUSIONS: Recommended vancomycin schedules for term newborn infants with neonatal sepsis should be based on the weight and postconceptual age only to start antimicrobial therapy. There is no ideal pattern of vancomycin dosing; vancomycin dosages must be individualized. SBT interpretation should be made in conjunction with the patient's clinical presentation and vancomycin serum concentrations. Those laboratory and clinical data favor elucidation of the probable cause of patient's bad evolution, which would facilitate drug adjustment and reduce the risk of toxicity or failing to achieve therapeutic doses.

Anti-Bacterial Agents↗

The effect of short periods of caloric restriction on weight loss and glycemic control in type 2 diabetes.

OBJECTIVE: To determine whether an intermittent very-low-calorie diet (VLCD) improves weight loss and glycemic control more than moderate caloric restriction alone. RESEARCH DESIGN AND METHODS: Individuals with type 2 diabetes (n = 54) who were > or = 20% over ideal body weight participated in a 20-week behavioral weight control program. Subjects were randomized to either a standard behavioral therapy (SBT) group or to one of two VLCD groups. SBT subjects received a 1,500-1,800 kcal/day diet throughout. Both VLCD groups followed a VLCD for 5 consecutive days during week 2, followed by either intermittent VLCD therapy for 1 day/week for 15 weeks (1-day) or for 5 consecutive days every 5 weeks (5-day), with a 1,500-1,800 kcal/day diet at other times. RESULTS: Both VLCD groups lost more weight than the SBT group over the 20 weeks (P = 0.04). Although the groups did not differ in fasting plasma glucose (FPG) changes at 20 weeks, more subjects in the 5-day group attained a normal HbA1c when compared with the SBT group (P = 0.04). This benefit was independent of the effects of weight loss. The best predictor of overall change in FPG and HbA1c was the FPG response during the first 3 weeks of the program. CONCLUSIONS: Periodic VLCDs improved weight loss in diabetic subjects. A regimen with intermittent 5-day VLCD therapy seemed particularly promising, because more subjects in this group attained a normal HbA1c. Moreover, the glucose response to a 3-week period of diet therapy predicted glycemic response at 20 weeks, and it was a better predictor of the 20-week response than initial or overall weight loss.

Adult↗

[Bacterial translocation in intestinal transplant].

OBJECTIVE: To analyse the influence of ceftriaxone on bacterial translocation and survival after small bowel transplantation in an experimental model with large animals. DESIGN: We performed 21 small bowel transplantation in pigs. Group 1 (n = 5): small bowel transplantation (SBT). Group 2 (n = 5): SBT and immunosuppression with cyclosporine, azathioprine and prednisolone. Group 3 (n = 5): SBT and ceftriaxone. Group 4 (n = 6): SBT, ceftriaxone and immunosuppression. SUBJECTS: Minipig of 25-45 Kg body weight. MEASURES: Blood, spleen, liver, and mesenteric lymph nodes for bacterial culture and biopsy of ileum on postoperative days POD 0.3 and 7. RESULTS: Cultures were positive for bacteria in 22% (10/41) before perfusion, and 43% (28/67) post-reperfusion. Groups 1 and 2: cultures were positive for bacteria in 93% (28/30) on POD 3 degrees, and in 100% (30/30) on POD 7 degrees. Cultures were positive for enterobacteria in 80% (24/30) on POD 3 degrees. Groups 3 and 4: cultures were positive for bacteria in 79.5% (33/41) on POD 3 degrees and in 100% (31/31) on POD 7 degrees. Cultures were positive for enterobacteria in 36.5% (15/41) on POD 3 degrees. Early mortality (before POD 7 degrees), not related with technical complications was 50% (5/10) in groups 1 and 2 and 0% (0/11) in groups 3 and 4. There were no differences with the use of immunosuppression. CONCLUSIONS: Ceftriaxone could decrease bacterial translocation (especially enterobacteria), and early mortality post-small bowel transplantation in pigs.

Animals↗

Bioinformatics: analysis of HLA sequence data.

High resolution HLA typing is a requirement for the selection of matched donors in hematopoietic cell transplantation. The high resolution typing method that provides the most accurate and complete identification of HLA genotypes is sequencing-based typing (SBT). For each sample being tested, SBT defines the exact nucleotide sequence of the coding regions of both alleles at a given HLA locus. Identification of the underlying genotype of the sample can then be made by computerized sequence comparison with all possible HLA allele combinations at that locus. The use of SBT to identify the complete nucleotide sequence of a given HLA gene also enables the direct detection of previously undefined alleles. Since different HLA alleles may differ by a single nucleotide, the accurate assignment of an HLA genotype by SBT is absolutely dependent on the correct identification of the nucleotide at each position for a given sample. However, automated sequence analysis of heterozygous samples may result in the ambiguous assignment of nucleotides at a given position. In addition, ambiguous assignments may result from the sequencing of two different samples that express different HLA alleles but whose sequence profiles appear exactly the same. Both of these ambiguous situations can be resolved by the application of the multi-sequence analysis (MSA) method described here.

Alleles↗

[Selective immunosuppression with monoclonal antibodies against ICAM-1 and LFA-1 with FK 506 after experimental small intestine transplantation in the rat].

Prevention of allograft rejection remains a major problem after small bowel transplantation (SBT) and requires potent immunosuppressive regimens. In a variety of transplant models, e.g. liver or heart transplantation, the supplementary application of monoclonal antibodies (mabs) against adhesion molecules is effective in both prolonging graft survival and inducing long-term graft acceptance or tolerance in some cases. In this study anti ICAM-1 (1A29) and anti LFA-1 (WT1) mabs were used in combination with a subtherapeutic dose of FK 506 for 13 days after allogeneic SBT in the rat. The results of this study indicate that in contrast to the induction of allospecific tolerance after liver transplantation, the addition of anti ICAM-1 and/or of anti LFA-1 mabs after SBT reverses the FK 506 effect and results in early graft rejection. It has been shown that higher dosages of these mabs, given alone or in combination with CsA or FK 506, result in long-term survival of cardiac allografts in both, rats and mice [4-8]. Graft survival after pancreas transplantation is prolonged [6]. However, these negative therapeutic effects of the mabs 1A29 and WT1 after SBT have to be critically reevaluated and further analysed.

Animals↗

[The effect of sulbactam on the in vitro activity of mezlocillin, piperacillin and cefotaxime].

The in vitro activity of mezlocillin (MZL, CAS 51481-65-3), piperacillin (PIP, CAS 61477-96-1) and cefotaxim (CTX, CAS 63527-52-6) alone and in combination with sulbactam (SBT; CAS 68373-14-8) against mezlocillin-resistant pathogens was determined in a multicenter study. A total of 870 strains were investigated (481 Enterobacteriaceae, 57 Pseudomonas aeruginos, 41 Acinetobaster spp., 194 Bacteroides fragilis, and 97 Staphylococcus spp.). Determinations of MIC were performed according to DIN-guidelines (agar-dilution method for aerobes and microbroth-dilution method for anaerobes). Sulbactam was added in fixed concentrations of 5 mg/l and 10 mg/l. In all sulbactam-combinations examined mean MIC as well as MIC50 and MIC90 were reduced compared to the respective values for the antibiotics alone. Consequently, percentages of susceptible strains increased significantly: i.e. for Enterobacteriaceae: MZL 1% vs. MZL + 10 mg/l SBT 53%; PIP 4% vs. PIP + 10 mg/l SBT 54%; CTX 52% vs. CTX + 10 mg/l SBT 68%. The effect of sulbactam was most pronounced in Bacteroides spp. with an increase in susceptible strains from 2% to 97% for MZL, from 6% to 95% for PIP and from 7% to 98% for CTX. The results indicate that by adding sulbactam the in vitro activity of mezlocillin, piperacillin and cefotaxim against resistant pathogens is augmented significantly. In addition, the spectrum of antibacterial activity is extended to anaerobic pathogens such as Bacteroides spp. The availability of sulbactam as a monosubstance for combination with various beta-lactam-antibiotics thus represents a useful improvement of therapeutic options in bacterial infections.

Acinetobacter↗

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

The clinical efficacy and the safety of sultamicillin (SBTPC) fine granules, which is a semisynthetic beta-lactam antibiotic for oral use with ester linked ampicillin (ABPC) and sulbactam (SBT), a beta-lactamase inhibitor, in a ratio of 1:1, were evaluated in 31 patients with ages from 6 months old to 10 years and 4 months old with various bacterial infections. The results obtained are summarized as follows. 1. In a pharmacokinetic study with a dose level of 10 mg/kg SBTPC, serum levels reached a peak in 1 hour after oral administration, with peak levels of 3.94 micrograms/ml for ABPC and 4.08 micrograms/ml for SBT. Half-lives of ABPC and SBT were 64.8 minutes and 63.6 minutes, respectively. The urinary excretion of ABPC over 6 hours was 66.2% and that of SBT was 60.4%. 2. SBTPC fine granules were administered orally to 1 patient with bronchitis, 9 patients with bronchopneumonia, 7 patients with tonsillitis, 4 patients with scarlet fever, 1 patient each with pharyngitis, otitis media, purulent parotitis, and urinary tract infection and 6 patients with skin and soft tissue infections at daily dosage levels of 26.1-31.6 mg/kg divided into 3 or 4. Clinical evaluations of these 31 patients were as follows, excellent: 20 patients, good: 10 patients, poor: 1 patient. The efficacy rate was 96.8%. 3. Diarrhea was observed in a patient with otitis media on the fifth day of SBTPC administration. No other clinical adverse reaction was observed in any of the remaining 30 patients. No abnormal laboratory data was found in any of 23 patients who were subjected to laboratory examinations for safety.(ABSTRACT TRUNCATED AT 250 WORDS)

Age Factors↗

[Laboratory and clinical studies of sultamicillin in pediatric field].

We have carried out laboratory and clinical studies on sultamicillin (SBTPC). The results are summarized as follows. SBTPC was given by oral administration to 2 children in a single dose at 5 mg/kg and to 3 children in a single dose at 10 mg/kg. After the oral administration, mean peak serum levels of ampicillin (ABPC) and sulbactam (SBT) obtained for the 2 dose levels were 1.91 +/- 1.34 and 2.06 +/- 1.06 micrograms/ml and 2.43 +/- 0.68 and 2.96 +/- 0.77 micrograms/ml at 1 hour, respectively, and mean half-lives were 0.80 +/- 0.10 and 0.98 +/- 0.46 hour and 1.57 +/- 0.57 and 2.01 +/- 0.70 hours, respectively. SBTPC was given to 2 children in a single dose at 15 mg/kg. After oral administration, the mean serum levels of ABPC and SBT at 30 minutes were 6.55 +/- 1.63 and 6.00 +/- 1.00 micrograms/ml, and the mean half-lives were 0.90 +/- 0.13 and 0.82 +/- 0.16 hour. SBTPC was given to 1 child at a single dose of 20 mg/kg. The peak serum levels of ABPC and SBT were 11.3 and 8.64 micrograms/ml, and the half-lives were 0.87 and 0.92 hour. Mean urinary excretion rates of ABPC and SBT were 38.4 +/- 2.7 and 34.6 +/- 4.7%, 43.0 +/- 3.6 and 41.6 +/- 5.8%, 47.7 +/- 5.2 and 51.6 +/- 3.5% in 6 hours and 66.1 and 59.2% in 8 hours after oral administration of 5 mg/kg, 10 mg/kg, 15 mg/kg and 20 mg/kg, respectively. Treatment with SBTPC was made in 34 cases of pediatric bacterial infections; 2 cases of pharyngitis, 19 cases of tonsillitis, 2 cases of bronchitis, 3 cases of impetigo, 2 cases of staphylococcal skalded skin syndrome, 4 cases of urinary tract infection and 1 case each of pneumonia and scarlet fever. Results obtained were excellent in 20 cases, good in 13 cases and poor in 1 case. No significant side effect due to the drug was observed in any cases.

Age Factors↗

[Pharmacokinetic and clinical studies of sultamicillin fine granules in children].

Sultamicillin (SBTPC) is a semi-synthesized beta-lactam antibiotic consisted of ampicillin (ABPC) and a beta-lactamase inhibitor, sulbactam (SBT), linked with an ester linkage. Pharmacokinetic and clinical studies using SBTPC 10% fine granules were performed in pediatric patients with a variety of infections. 1. Pharmacokinetic investigation: SBTPC was given at 30 minutes after meal at a dose of 10 mg/kg. Peak serum levels were attained at 1 hour after dosing with average levels of 3.83 +/- 0.27 micrograms/ml for ABPC and 2.73 +/- 0.30 micrograms/ml for SBT. The average half-life of ABPC was 1.52 +/- 0.25 hours and that of SBT was 1.13 +/- 0.09 hours. The urinary recovery rate of ABPC during 6 hours after dosing was 58.2 +/- 4.9% and that of SBT was 59.7 +/- 6.4%. 2. Clinical investigation: Enrolled in the study were a total of 26 patients including 12 with tonsillitis, 6 with pharyngitis, 5 with urinary tract infections, and 1 each with bronchitis, with Salmonella enteritis and a case with fever of unknown case. Responses were excellent in 15 patients, good in 8, fair in 2 and poor in 1 with an efficacy rate of 88.5%. In the assessment of the bacteriological efficacy, 11 out of 14 strains of organisms isolated previous to the treatment were eradicated, 1 strain was found reduced in number and 2 strains remained unchanged with an eradication rate of 78.6%. One patient (3.8%) out of the 26 had diarrhea as side effects and 3 patients (16.7%) of 18 showed eosinophilia in laboratory examinations.

Adolescent↗