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Third Dose (third + dose)
Selected AbstractsClarithromycin-induced hypomania in a child , a case reportACTA PSYCHIATRICA SCANDINAVICA, Issue 3 2010W. J. Baranowski Baranowski WJ. Clarithromycin-induced hypomania in a child , a case report. Objective:, We report here a child developing hypomania while treated with clarithromycin. Method:, Case report. Results:, A 3-year-old boy was treated for pneumonia with oral clarithromycin in monotherapy. The boy became somewhat hyperactive and irritable after the second dose. After the third dose he presented with psychomotor agitation, pressured speech, irritability, aggressive behaviour and insomnia. The antibiotic was identified as the only possible cause of the described clinical picture and was discontinued immediately. The hypomanic symptoms subsided gradually over 36 h. Conclusion:, Commonly-used medications can produce uncommon adverse reactions. Clinicians, especially general practitioners, pediatricians, as well as child and adolescent psychiatrists ought to be aware of such a possibility when evaluating a child with suddenly changed behaviour. [source] Development and Evaluation of a DNA Vaccine Based on Helicobacter pylori urease B: Failure to Prevent Experimental Infection in the Mouse ModelHELICOBACTER, Issue 6 2006Livania Zavala-Spinetti Abstract Background:, The development of a vaccine against Helicobacter pylori has become a priority to prevent major morbidity and mortality associated with this infection. Our goal was to prepare and evaluate a DNA vaccine based on the urease B gene (ureB). Methods:, The ureB gene of H. pylori was amplified and cloned into the eukaryotic expression vector pcDNA3.1/TOPO. Plasmid DNA was purified from transformed Escherichia coli cells and used to immunize mice by the intragastric, intramuscular, intrarectal (40 µg each) and intranasal (16 µg) route, three doses every 2 weeks, with CpG oligodeoxynucleotide (ODN) as adjuvant. Four weeks after the third dose, animals were orally challenged with Helicobacter felis and were sacrificed 6 weeks later. The stomach was stained to detect the presence of infection. Results:, Despite in vitro confirmation of successful cloning and functionality of the ureB gene with expression of a protein morphologically and antigenically identical to urease B, the DNA vaccine did not perform well in vivo. Immunization of mice produced a weak immune response. Overall, intrarectal and intranasal administration seemed more immunogenic than other routes. Protection against challenge was modest and nonsignificant, and slightly better on animals immunized by the intramuscular and intranasal route. Conclusion:, A DNA vaccine based on H. pylori urease B was poorly immunogenic and nonprotective at the conditions evaluated. Higher doses, better adjuvants or a prime-boost approach may circumvent these limitations. [source] Hepatitis B vaccination is effective for babies weighing less than 1800 gJOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 5 2006Wee-Bin Lian Aim: This trial studied the effectiveness of early hepatitis B (HepB) immunisation in babies weighing less than 1800 grams, born of HepB surface-antigen-negative mothers. Methods: The first vaccine dose was given once clinical stability was achieved, with second and third doses given 1 and 6 months later, respectively. HepB serology, done using Abbott ElA (phase 1) and Abbott Axsym (phase 2) before and after June 2001, respectively, was checked at birth (Sero1), prior to (Sero2) and 6 months after (Sero3) the third dose. A booster dose was recommended when Sero3 showed a non-immune status (<10 mIU/mL). Results: Median birth weight and gestational age (n = 118) were 1295 [range 475, 1780] g and 31 [range 24, 37] completed weeks, respectively. Sero1 (median age of 4 [range 1, 34] days) showed 64% (n = 113) to be non-immune. The first dose of vaccine was administered at a median weight of 1268 [range 530, 1790] g, median age of 6 [range 1,63] days and median post-menstrual age of 32 [range 24,37] completed weeks. Sero2 (median age of 179 [range 112,260] days), for 110 babies (93.2%) showed immunity in 48.2% (median titres , Phase 1: 26 [range 10, 150] mIU/mL; Phase 2: 34 [range 10, 1000] mIU/mL). Sero3 revealed seroprotection in 77.8% (median titres , Phase 1: 102 [range 12, 150] mIU/mL; Phase 2: 162 [range 16, 1000] mIU/mL). The more mature the bady at time of first dose, the more likely he is to achieve seroprotection (85% amongst those administered at and beyond 33 weeks; 91% among those administered at and beyond Day 10 at Sero3). Conclusions: Early HepB immunisation in infants <1800 g can be safely recommended, with booster doses necessary at 1 year for some infants. [source] Comparison of effects and plasma concentrations of opioids between elderly and middle-aged patients after cardiac surgeryACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 1 2009A. PESONEN Background: In elderly patients, opioids may cause prominent postoperative sedation and respiratory depression. We evaluated the influence of age on the effects of opioids and plasma concentrations of fentanyl and oxycodone in cardiac surgery patients. Methods: Thirty (,75 years, gender M9/F21) and 20 (,60 years, gender M20/F0) patients scheduled to undergo cardiac surgery. A standard anesthesia with fentanyl as an opioid was used. Fentanyl plasma concentrations were measured at the end of surgery and 2 h later. After tracheal extubation, when the pain intensity was at least moderate, blood samples for fentanyl and oxycodone plasma concentration measurements were taken. Thereafter, oxycodone hydrochloride 0.05 mg/kg i.v. was administered. After 15 and 45 min, pain intensity, sedation and oxycodone plasma concentration were determined. This test protocol was repeated twice. Results: The elderly had a higher plasma concentration of fentanyl at the end of surgery than younger patients (5.7±2.2 vs. 3.8±1.2 ng/ml, P=0.001). The plasma concentrations of oxycodone were comparable between the groups. The interval between the second and the third oxycodone dose was longer in the elderly patients (P=0.036). Pain intensity on the verbal rating scale was lower at the 45-min assessment point after all three oxycodone test doses (P=0.008) and sedation scores were significantly higher after the third dose in the elderly patients (P=0.035). Conclusions: In elderly patients, the plasma concentration of fentanyl was higher but plasma levels of oxycodone were at a similar level compared with middle-aged patients. However, the elderly patients had less pain and were more sedated after doses of oxycodone. [source] Should fimbriae be included in pertussis vaccines?APMIS, Issue 9 2009Studies on ELISA IgG anti-Fim2/3 antibodies after vaccination, infection The anti-Fim response and long-term persistence after vaccination and infection may be of importance in understanding population immunity. Longitudinal serum samples (n = 1330) from 542 non-infected children related to a Swedish vaccine trial showed that the post vaccination (DTPa5) antibody decay curve for pertussis ELISA IgG anti-fimbriae2/3 (anti-Fim2/3) was bi-phasic. A slower one followed an initial rapid decay approximately 5,6 months after the third dose at 12 months of age. After 71 months, however, 60% still had concentrations above ,5 EU/ml, a level that had been shown to correlate with decreased risk of disease. Booster responses after re-vaccination with DTPa5 at 4, 5 and 6 years of age were strong and appeared within 1 week after vaccination, indicating immune memory. Ninety-six young children with verified pertussis infection, for whom we had serum samples both before, during and after the infection, showed a high response if they had been primed with fimbriae (either DTPa5 or DTPwc). In contrast, 76% of infected children not primed with fimbriae (a DTPa2 or DT group) only had concentrations below the minimum level of detection in all samples taken during and after the infection. In two Swedish seroepidemiological surveys, one from 1997 just after reintroduction of universal childhood vaccination against pertussis and one from 2007, the proportion of children 2,3 years with anti-Fim2/3 concentrations <5 EU/ml was similar and above 90%. This reflects that the two- or three-component pertussis vaccines (DTPa2 and DTPa3) that were introduced in Sweden in 1996 do not induce anti-Fim2/3 antibodies. In previous studies it was shown in multivariate analyses that levels of IgG anti-Fim2/3 ,5 EU/ml reduced short-term risk of pertussis in small children. As the antibody response to Fim2/3 after infection is poor in children who have not been primed earlier in life, inclusion of immunogenic Fim2/3 in future pertussis vaccines should be considered. [source] Estimation and Inference for a Spline-Enhanced Population Pharmacokinetic ModelBIOMETRICS, Issue 3 2002Lang Li Summary. This article is motivated by an application where subjects were dosed three times with the same drug and the drug concentration profiles appeared to be the lowest after the third dose. One possible explanation is that the pharmacokinetic (PK) parameters vary over time. Therefore, we consider population PK models with time-varying PK parameters. These time-varying PK parameters are modeled by natural cubic spline functions in the ordinary differential equations. Mean parameters, variance components, and smoothing parameters are jointly estimated by maximizing the double penalized log likelihood. Mean functions and their derivatives are obtained by the numerical solution of ordinary differential equations. The interpretation of PK parameters in the model and its flexibility are discussed. The proposed methods are illustrated by application to the data that motivated this article. The model's performance is evaluated through simulation. [source] Desmopressin in elderly patients with nocturia: short-term safety and effects on urine output, sleep and voiding patternsBJU INTERNATIONAL, Issue 7 2003A. Rembratt OBJECTIVE To investigate the short-term safety of desmopressin in elderly patients with nocturia, with special focus on the risk of hyponatraemia, and to assess the short-term effects on urine output, sleep and voiding patterns. PATIENTS AND METHODS Patients (72) were recruited from a study using frequency-volume charts, which in turn was preceded by a questionnaire study. Each patient took one 0.2 mg desmopressin tablet at bedtime for three consecutive nights and kept a frequency-volume chart. Serum sodium was assessed in the morning after the first and the third dose. Patients with a mean serum sodium level during treatment deviating more than five units from baseline were considered sensitive to change in serum sodium. Potential predictors for sodium sensitivity and response were investigated with logistic and multiple regression. RESULTS All 72 enrolled patients completed the trial; no serious adverse events occurred and no adverse events of severe intensity were recorded. Six patients were sensitive to change in serum sodium. The risk (odds ratio, 95% confidence interval) increased with increasing age (1.3, 1.1,1.6), concomitant cardiac disease (10.0, 0.9,105.8) and increasing baseline 24-h urine output (1.2, 1.0,1.5). Patients sensitive to change in serum sodium were pharmacological responders and desmopressin had a greater effect on their 24-h diuresis, indicating that the drug effect was not limited to the night only. CONCLUSION Desmopressin was well tolerated in elderly patients with nocturia, but the results suggest that serum sodium should be measured before and after a few days of treatment. [source] Decrease of adenosine deaminase activity and increase of the lipid peroxidation after acute methotrexate treatment in young rats: protective effects of grape seed extractCELL BIOCHEMISTRY AND FUNCTION, Issue 1 2010F. V. Pinheiro Abstract The methotrexate (MTX) is an anti-folate used to treat cancer and some inflammatory diseases. The efficacy of MTX is often limited by its severe toxicity. The present study was undertaken to determine whether Grape seed (Cabernet Sauvignon) extract (GSE) could ameliorate the MTX-induced oxidative injury and the effect on adenosine deaminase activity (ADA) in rats. The rats were pretreated with 50,mg/kg of GSE, i.p., prior to MTX administration (10,mg/kg, i.p.) with a second dose given 4,h and a third dose 16,h after MTX administration. Biochemical parameters were investigated 48,h after the last MTX administration. The administration of MTX increased thiobarbituric acid reactive species (TBARS) levels in hippocampus, kidney and liver, whereas induced a significant decreased in the ADA activity in the cerebral cortex, kidney and liver tissues. MTX administration significantly increased the activity of ALT(alanine aminotransferase) and urea levels and decreased uric acid levels in the serum. Urinary uric acid levels decreased in the MTX group when compared to those of the control group. The GSE along with MTX-administration significantly reversed these parameters toward to near normal. These results indicated that GSE could reduce hepatic and nephritic damage induced by MTX-treatment in young rats therefore having free radical scavenging. Copyright © 2009 John Wiley & Sons, Ltd. [source] Once daily dose gentamicin in neonates , is our dosing correct?ACTA PAEDIATRICA, Issue 7 2009Tiroumourougane V Serane Abstract Aim:, The aim of this paper is to study the safety and efficacy (measured by therapeutic level) of once daily gentamicin in neonates ,32 weeks of gestation and ,7 days of age. Setting:, Level II neonatal intensive care unit. Subjects:, Neonates ,32 weeks of gestation and ,7 days of age treated with gentamicin for presumed sepsis. Methods:, Gentamicin was administered by intravenous injection at 4 mg/kg/day once daily. Peak and trough gentamicin levels were measured at the third dose. Results:, In neonates with gestational age between 32 and 36 weeks, 14 out of 65 (22%) had trough serum concentration >2 mg/L. Only 39 (60%) had peak and trough levels within the therapeutic range. All babies who had audiometric evaluation (62 out of 65) had normal hearing. Out of the 65 babies, 60 had paired serum creatinine levels estimated and none had evidence of renal dysfunction. Among term neonates, only 2 out of 50 had the trough serum concentration of >2 mg/L. In 38 (76%) of the 50 neonates, the trough serum gentamicin concentration was <2.0 mg/L and the peak level was <10 mg/L. Forty-eight babies had audiometric evaluation which was normal. Conclusion:, A dose of 4 mg/kg/day produces serum gentamicin levels outside the therapeutic range in two-fifths of neonates between 32 and 36 ± 6 weeks. A single dose of 4 mg/kg/day of gentamicin is appropriate for term babies and probably excessive for 32,36 weeks' neonates. [source] Hepatitis B vaccination is effective for babies weighing less than 1800 gJOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 5 2006Wee-Bin Lian Aim: This trial studied the effectiveness of early hepatitis B (HepB) immunisation in babies weighing less than 1800 grams, born of HepB surface-antigen-negative mothers. Methods: The first vaccine dose was given once clinical stability was achieved, with second and third doses given 1 and 6 months later, respectively. HepB serology, done using Abbott ElA (phase 1) and Abbott Axsym (phase 2) before and after June 2001, respectively, was checked at birth (Sero1), prior to (Sero2) and 6 months after (Sero3) the third dose. A booster dose was recommended when Sero3 showed a non-immune status (<10 mIU/mL). Results: Median birth weight and gestational age (n = 118) were 1295 [range 475, 1780] g and 31 [range 24, 37] completed weeks, respectively. Sero1 (median age of 4 [range 1, 34] days) showed 64% (n = 113) to be non-immune. The first dose of vaccine was administered at a median weight of 1268 [range 530, 1790] g, median age of 6 [range 1,63] days and median post-menstrual age of 32 [range 24,37] completed weeks. Sero2 (median age of 179 [range 112,260] days), for 110 babies (93.2%) showed immunity in 48.2% (median titres , Phase 1: 26 [range 10, 150] mIU/mL; Phase 2: 34 [range 10, 1000] mIU/mL). Sero3 revealed seroprotection in 77.8% (median titres , Phase 1: 102 [range 12, 150] mIU/mL; Phase 2: 162 [range 16, 1000] mIU/mL). The more mature the bady at time of first dose, the more likely he is to achieve seroprotection (85% amongst those administered at and beyond 33 weeks; 91% among those administered at and beyond Day 10 at Sero3). Conclusions: Early HepB immunisation in infants <1800 g can be safely recommended, with booster doses necessary at 1 year for some infants. [source] Effects of feeding probiotics during weaning on infections and antibody responses to diphtheria, tetanus and Hib vaccinesPEDIATRIC ALLERGY AND IMMUNOLOGY, Issue 1 2008Christina E. West Microbial exposure is necessary for the development of normal immune function, which has driven the idea of using probiotics for treatment and prevention of immune-mediated diseases in infancy and childhood. Mounting evidence indicates that probiotics have immunomodulatory effects. However, the mechanisms are still poorly understood. Specific antibody response is a valuable proxy for immune system maturation status in infancy. We aimed at determining the impact of Lactobacillus F19 (LF19) during weaning on infections and IgG antibody responses to routine vaccines. In a double-blind, placebo-controlled randomized intervention trial, infants were fed cereals with (n = 89) or without LF19 (n = 90) from 4 to 13 months of age. Infants were immunized with DTaP (diphtheria and tetanus toxoid and acellular pertussis), polio and Hib-conjugate vaccines at (3), 5 and 12 months of age. We assessed the number of days with infections, antibiotic prescriptions and antibody concentrations to Hib capsular polysaccharide (HibPS), diphtheria toxin (D) and tetanus toxoid (T) before and after the second and third doses. Days with infectious symptoms did not differ between the groups. Days with antibiotic prescriptions were fewer in the LF19 group (p = 0.044). LF19 enhanced anti-D concentrations when adjusting for breastfeeding duration and colonization with LF19 (p = 0.024). There was an interaction of the intervention and colonization with LF19 on anti-T concentrations during the course of vaccination (p = 0.035). The anti-HibPS concentrations were higher after the first and second dose of Hib vaccine in infants breastfed <6 months compared with those breastfed ,6 months (p < 0.05), with no effect by LF19. In conclusion, feeding LF19 did not prevent infections, but increased the capacity to raise immune responses to protein antigens, with more pronounced effects in infants breastfed <6 months. [source] Comparison of a 3-day with a 1-day regimen of an extended-release formulation of ciprofloxacin as antimicrobial prophylaxis for patients undergoing transrectal needle biopsy of the prostateBJU INTERNATIONAL, Issue 1 2007Anthony J. Schaeffer OBJECTIVE To compare the clinical and bacteriological efficacy and the clinical safety of a 1-day with a 3-day regimen of an extended-release formulation of ciprofloxacin (ciprofloxacin XR) given as antimicrobial prophylaxis to men undergoing transrectal needle biopsy of the prostate (TRNBP). PATIENTS AND METHODS This was a multicentre, prospective, international, double-blind study in patients who required TRNBP. Patients were randomized to receive oral ciprofloxacin XR 1000 mg as either a 1-day or a 3-day regimen. Single doses were given at 24 h before, 2,3 h before, and 24 h after TRNBP. Patients in the 1-day regimen had placebo instead of the first and third doses of ciprofloxacin. RESULTS Of 497 patients enrolled, 247 were randomized to 1-day ciprofloxacin XR and 250 to the 3-day regimen. In the population valid for microbiological efficacy, the final assessment identified bacteriological success (primary efficacy endpoint) in more patients who had the 3-day regimen (98%) than in those who received the 1-day regimen (94.8%, 95% confidence interval, CI, ,,6.1%, 0.8%), although the difference was not statistically significant. In this population, the clinical response at the final visit was 98.5% and 96.7% for patients receiving the 3-day and the 1-day regimens, respectively (95% CI ,,5.2%, 0.8%). However, in the clinical efficacy population the clinical success rate was significantly greater for the 3-day (99.0%) than for the 1-day regimen (95.8%; 95% CI ,,6.4%, ,,0.3%). In a multivariate analysis, patients with diabetes mellitus and patients with a history of prostatitis had higher microbiological and clinical failure rates, respectively, than those without such conditions. For these patients, all failures occurred among those treated with the 1-day regimen. CONCLUSION As defined by bacteriological success in the population assessed for microbiological efficacy, prophylaxis with one dose of ciprofloxacin XR was statistically no worse than a 3-day regimen. However, in all efficacy analyses, bacteriological and clinical success rates were consistently lower for the 1-day than for the 3-day treatment. Thus, for selected patients undergoing TRNBP, there might be a role for 3-day preventive therapy with ciprofloxacin XR. [source] |