Oral valganciclovir treatment in newborns with symptomatic congenital cytomegalovirus infection.

This study was performed to assess oral valganciclovir V-GCV (GCV pro-drug), 15 mg/kg bid for 6 weeks to 13 neonates with symptomatic congenital cytomegalovirus (CMV). We monitored plasma levels of GCV within 30 days of therapy: C(trough), and C(2h) (before and the 2 hours after administration), we performed viral assessment in plasma and urine and tolerability at baseline, and every fortnight. Pharmacokinetics showed GCV stable and effective plasma concentrations: mean C(trough) = 0.51 +/- 0.3 and C(2h) : 3.81 +/- 1.37 microg/ml. No significant variability was seen neither intra-patient nor inter-patients. One newborn discontinued therapy because of thrombocytopenia, another finished with a neutrophils count of 1,000/microl. At the end of therapy 6 out of 12 and 8 out of 12 newborns were negative for CMV in urine and plasma. The 4 newborns positive for CMV DNA showed a 90% reduction of pre-therapy values. Clinically, the 4 patients reporting hepatic disease and the 3 with thrombocytopenia recovered after 6 weeks of therapy. Eight newborns suffered from SNHL; at the 6-month follow-up no patients had worsened, 2 had improved, and no deterioration was reported in 3 newborns with chorioretinitis scarring. The paucity of adverse events, and the effectiveness and stability of drug plasma concentrations are the important findings of our study.

The effect of aging on the pharmacokinetics of nizatidine.

A single oral dose of 300 mg of nizatidine was administered to two groups of volunteers: a first group of 12 young healthy subjects and a second group of 12 elderly patients, in order to compare the pharmacokinetic parameters and to verify a possible influence of the age on nizatidine's kinetics. Blood samples were collected periodically and plasma concentrations of the drug were determined by a specific HPLC method. The results evidenced differences among the pharmacokinetic parameters of the two groups: the mean of Cmax was higher in the elderly than in the young (3.28 mg/ml against 2.23 mg/ml), the peak time was prolonged in the elderly (2.1 h against 1.00 h) and the AUC values were higher too (12.17 in the elderly and 7.99 in the young). Only the elimination half-life t1/2 was slightly higher in the elderly (1.8 h against 1.7 h in the young).

[Genotoxicity of surface water treated with different disinfectants using in situ plant tests]. / Valutazione della genotossicità di acque superficiali trattate con diversi disinfettanti mediante test su vegetali.

Disinfection of surface drinking water, in particular water chlorination, produces many by-products with genotoxic and/or carcinogenic activity. The aim of this research was to evaluate the genotoxicity of surface water after treatment with different disinfectants by means of in situ plant genotoxicity assays. The study was carried out in a pilot plant using lake water after sedimentation and filtration, which supplied four stainless steel basins: three basins were disinfected with sodium hypochlorite, chlorine dioxide and peracetic acid, respectively, and the fourth basin contained untreated lake water and was used as a control. The study was carried out using water collected in different seasons over a period of about one year in order to assess the treatments under different physical and chemical lake water conditions. Plant genotoxicity tests were performed by exposing plant bioindicators directly to raw and disinfected water. The Tradescantia micronucleus test in pollen cells of the flowers of an hybrid of Tradescantia and the Allium cepa test, a chromosome aberration test in root cells of Allium cepa, showed genotoxic effects only in some disinfected samples and revealed genotoxicity also in raw water in one experiment. The Vicia faba test, a micronucleus test in root cells of Vicia faba, revealed genotoxicity in many samples of disinfected water. The results of the study indicated that the Vicia faba/MCN test was the most sensitive plant assay for disinfected water, and that peracetic acid disinfection produced lower genotoxicity than sodium hypochlorite or chlorine dioxide treatment.

Bioequivalency of three tableted gallopamil products.

A three cross-study was conducted in 12 healthy male volunteers to evaluate the relative bioavailability of three different gallopamil tablets: Product A-Galcan 25 mg, Product B-Galcan 50 mg and Product C-Procorum 50 mg. Each dose was administered as a single tablet after an overnight fast, and blood samples were obtained for 12 hours. There was no statistically significant differences among the three products for the mean area under the plasma concentration-time curves (when corrected for the different doses). The relative bioavailability of Product A and B to Product C was respectively 96.3% (ESM = 12.4%) and 103.1% (ESM = 10.2%). Statistically significant (p less than 0.05) differences were found in Tmax between Product C (1.0 hr) and both Product A (2.1 hr) and Product B (2.4 hr). A longer-lasting absorption should always diminish peak to trough fluctuations during multiple dosing and to this extent Product B has some advantage over Product C.

New technique for inter-implant papilla reconstruction between two or more implants in patients with variably reabsorbed ridges and flat anatomy. Preliminary results of a 9 consecutive clinical case series.

THE AIM OF THE WORK: Interimplant papilla reconstruction is difficult because the biologic width around an implant is apical to the implant-abutment connection and because the biologic width creates subcrestally. The aim of this study is to investigate whether the reconstruction of the interimplant papilla can be achieved by the use of an innovative surgical technique combined with scalloped implants, in the most severe surgical conditions, i.e. in variably reabsorbed ridges with flat anatomy. MATERIALS AND METHOD: Nine surgical sites, in eight consecutive patients, were treated with at least two adjacent scalloped implants and fixed prosthesis. 23 scalloped implants were placed using this new surgical technique on bone and soft tissue structures. One flat platform implant was also placed between two other scalloped implants. A total of 15 interimplant papillae were examined. RESULTS: 100% of papilla reconstruction at first prosthesis insertion. 13.3% failed to maintain interimplant papillae after 6 months and 20% after 12 months. Also, papilla reconstruction was maintained for 12 months in the mesial and distal embrasure spaces of the flat platform implant. CONCLUSION: The combination of the use of adjacent scalloped implants with this surgical approach, even in reabsorbed ridges with flat anatomy, may reform inter-implant bone peaks as support for the papillae.

Modeling vaccination campaigns and the Fall/Winter 2009 activity of the new A(H1N1) influenza in the Northern Hemisphere.

The unfolding of pandemic influenza A(H1N1) for Fall 2009 in the Northern Hemisphere is still uncertain. Plans for vaccination campaigns and vaccine trials are underway, with the first batches expected to be available early October. Several studies point to the possibility of an anticipated pandemic peak that could undermine the effectiveness of vaccination strategies. Here, we use a structured global epidemic and mobility metapopulation model to assess the effectiveness of massive vaccination campaigns for the Fall/Winter 2009. Mitigation effects are explored depending on the interplay between the predicted pandemic evolution and the expected delivery of vaccines. The model is calibrated using recent estimates on the transmissibility of the new A(H1N1) influenza. Results show that if additional intervention strategies were not used to delay the time of pandemic peak, vaccination may not be able to considerably reduce the cumulative number of cases, even when the mass vaccination campaign is started as early as mid-October. Prioritized vaccination would be crucial in slowing down the pandemic evolution and reducing its burden.

Pharmacokinetics of omeprazole in cirrhotic patients.

Omeprazole (CAS 73590-58-6), an H+, K+ ATPase inhibitor, is a potent suppressor of gastric acid secretion and a very active substance in the treatment of duodenal and gastric ulcers. The kinetic profile of omeprazole is well defined for healthy volunteers and for some high-risk population, but not so far for patients with liver disease. As the substance is mainly metabolized in the liver, changes in liver circulation and/or function might lead to changes in the pharmacokinetics of omeprazole. Aim of the study was to evaluate the kinetic profile in patients with liver disease and compare the results obtained in healthy volunteers, 16 subjects were included in the study: 8 patients with liver cirrhosis and 8 healthy volunteers. A single oral dose of omeprazole 20 mg was administered: plasma samples were collected for 24 h since omeprazole administration. The principal pharmacokinetic parameters were estimated for the two studied populations.