Economic evaluation of a school-based strategy to prevent overweight and obesity in French adolescents: insights from the PRALIMAP randomised trial.

OBJECTIVES: This study aimed to provide cost-effectiveness and budget impact analyses of a school-based overweight/obesity screening and care prevention strategy among adolescents. STUDY DESIGN: Cost-effectiveness and budget impact analyses. METHODS: Data from 3538 adolescents who participated in a school-based randomised controlled trial in the Northeast of France were used. Costs (from a public payer's perspective) included screening for overweight and obesity and subsequent care. Effectiveness was measured as the change in body mass index (kilogram per square metre), prevalence of overweight/obesity, moderate physical activity energy expenditure, duration and frequency and total sitting time. The incremental cost-effectiveness ratio was calculated, and a budget impact analysis was conducted. RESULTS: The screening and care strategy resulted in an incremental cost-effectiveness ratio of €1634.48 per averted case of overweight/obesity and €255.43 per body mass index unit decrease. The costs for increasing moderate physical activity by 1000 metabolic equivalent of task-min/week, duration by 60 min/week and frequency 1 day/week were €165.28, €39.21 and €93.66 per adolescent, respectively. Decreasing total sitting time by 60 min/week had a cost of €8.49 per adolescent. The cost of implementing the strategy nationally was estimated to be €50.1 million with a payback period from 3.6 to 7.3 years. CONCLUSIONS: The screening and care strategy could be an efficient way to prevent overweight and obesity among adolescents. Future studies should investigate how the current results could be achieved in schools with different settings and thus justify its relevance for overweight and obesity prevention to policy-makers.

Proportionate universalism intervention is effective for tackling nutritional social gradient in adolescents: the PRALIMAP-INÈS mixed randomised trial.

OBJECTIVE: This study aimed to investigate the effectiveness of proportionate universalism intervention to reduce the slope of the nutritional social gradient in adolescents. STUDY DESIGN: A mixed (experimental and quasi-experimental) multicentre trial. METHODS: Data from 985 adolescents of the PRALIMAP-INÈS trial (North-eastern France, 2012-2015) were analysed. For this, adolescents were split into five social classes according to the Family Affluence Scale: Highly Less Advantaged (H.L.Ad; n = 33), Less Advantaged (L.Ad; n = 155), Intermediate (Int; n = 404), Advantaged (Ad; n = 324) and Highly Advantaged (H.Ad; n = 69). The overweight care management was a standard care for all and a strengthened one adapted to the social class of adolescents. The main outcome was the 1-year change of the body mass index z-score (BMIz) slope. Other nutritional outcomes were BMI, ΔBMIp95 (BMI minus 95th percentile of the WHO reference), %BMIp95 (percent of 95th percentile of the WHO reference), leisure-time sport, consumption of fruits and vegetables and consumption of sugary foods and drinks. RESULTS: The inclusion data confirmed a weight social gradient expressed by a significant BMIz linear regression coefficient (ß = -0.09 [-0.14 to -0.04], P < 0.0001). The higher the social class, the lower the BMIz. The 1-year BMIz linear regression coefficient was -0.07 [-0.12 to -0.02], corresponding to a significant weight social gradient reduction of 23.3% (ß = 0.021 [0.001 to 0.041]; P = 0.04). Consistent results were found for other nutritional outcomes. CONCLUSIONS: PRALIMAP-INÈS shows that proportionate universalism intervention is effective to reduce the adolescents' nutritional social gradient and suggests that equitable health programmes and policies are a realistic goal.

The effect of vehicle on skin absorption of Mg2+ and Ca2+ from thermal spring water.

OBJECTIVE: Thermal spring waters (TSW) are commonly used as active ingredients in cosmetics. Their biological activities directly depend on the ionic composition of the spring. However, in order to exhibit beneficial properties, the minerals need to reach viable skin layers. The present study addresses the incorporation of marketed TSW in model cosmetic formulations and the impact of the formulation on skin absorption of magnesium and calcium ions that are known to improve skin barrier function. METHODS: Marketed TSW was introduced into five formulations. Liposomes were prepared using saturated or unsaturated phospholipids mixed with cholesterol by the thin layer evaporation technique. Emulsions water-in-oil (W/O), oil-in-water (O/W) or double: water-in-oil-in-water (W/O/W) were prepared by high-shear mixing. Skin absorption of Mg2+ and Ca2+ from those formulations was studied in vitro using static Franz diffusion cells under infinite dose condition and under occlusion of the apparatus. RESULTS: Mg2+ and Ca2+ penetrate skin samples from TSW. Encapsulating TSW into double emulsion (TSW/O/W) increased skin absorption of both cations of interest and kept the Ca2+ /Mg2+ ratio equal to that of TSW in each skin layer. The dermal absorption of Mg2+ from the double emulsion departs from both single emulsions. Application of liposome suspension improved the skin absorption of Ca2+ while keeping constant that of Mg2+ , leading to unbalanced Ca2+ /Mg2+ ratio inside skin. CONCLUSION: The beneficial effects of TSW are not only due to their action on the skin surface. Their active components, especially Ca2+ and Mg2+ cations, reach viable skin layers in a formulation-dependent manner. The distribution of ions inside skin depends on the type of formulation.

OBJECTIFS: Les eaux thermales sont couramment utilisées comme substances actives dans les formulations cosmétiques. Leurs activités biologiques dépendent directement de leur composition en ions. L'action des ions s'exerce à différents niveaux dans la peau, mais bien souvent dans les couches profondes, au-delà du stratum corneum, qu'ils doivent donc atteindre. L'objectif de cet article est d'étudier l'absorption des ions magnésium et calcium, reconnus pour leur effet bénéfique sur la fonction barrière de la peau, depuis différentes formes galéniques formulées avec une eau thermale. METHODES: Une eau thermale commerciale a été utilisée comme phase aqueuse dans 5 formulations différentes : des liposomes formulés avec des phospholipides saturés et insaturés et du cholestérol ; des émulsions de différents sens, eau thermale/huile (TSW/O) et huile/eau thermale (O/TSW) ; une émulsion multiple eau thermale/huile/eau (TSW/O/W). L'absorption cutanée du calcium et du magnésium a été étudiée depuis ces différentes formulations, en utilisant la méthode des cellules de Franz, en dose infinie, et en fermant les cellules pour prévenir toute évaporation. RESULTATS: Les ions magnésium et calcium pénètrent dans la peau depuis l'eau thermale, utilisée comme contrôle. L'encapsulation de l'eau thermale dans les gouttelettes internes de l'émulsion double (TSW/O/W) permet de promouvoir la pénétration des deux ions d'intérêt dans chaque couche de la peau tout en respectant le rapport Ca2+ /Mg2+ obtenu avec l'eau thermale, contrairement aux émulsions simples. Les liposomes augmentent la pénétration cutanée des ions calcium, tandis que celle des ions magnésium reste constante, ce qui conduit à des rapports Ca2+ /Mg2+ élevés dans la peau. CONCLUSION: Les effets thérapeutiques des eaux thermales ne sont pas seulement dus à une action de surface. Les ions comme le calcium et le magnésium pénètrent dans la peau et exercent une action en profondeur qui dépend de la formulation dans laquelle ils sont formulés. En effet, leur distribution ions dépend de la formulation qui les contient.

Obesity phenotype and patient-reported outcomes in moderate and severe chronic kidney disease: a cross-sectional study from the CKD-REIN cohort study.

PURPOSE: To evaluate the association between obesity phenotypes and health-related quality of life (HRQoL) in non-dialysis-dependent CKD patients. METHODS: Data from the national CKD-REIN cohort which included 3033 patients with stage 3-4 CKD were used. Patients were divided into three groups: non-obese (NO) patients (BMI < 30 kg/m2), metabolically healthy obese (MHO) (BMI ≥ 30 kg/m2 and ≤ 1 criterion NCEP/ATP III), and metabolically unhealthy obese (MUO) (BMI ≥ 30 kg/m2 and ≥ 2 criteria NCEP/ATP III). HRQoL was measured by the KDQOL-36™ which comprised three disease-specific dimensions: symptoms, effects, and burden and two summaries scores: physical (PCS) and mental (MCS). We used a mixed effect model with adjustment on sociodemographic characteristics and comorbidities. RESULTS: A total of 2693 patients completed the self-administered questionnaires. MHO patients accounted for 3.4% of the cohort and for 12% of obese patients. In the NO group, average HRQoL scores were 77.2 ± 15.9 for symptoms, 83.5 ± 16.5 for effects, 76.8 ± 22.7 for burden, 43.5 ± 9.7 for PCS, and 47.9 ± 7.0 for MCS. In the multivariate analysis, scores were similar in MHO and NO patients, but significantly different with those in MUO patients: symptoms (- 0.7; p = 0.71 vs. - 3.0; p = 0.0025), effects (+ 1.2; p = 0.57 vs. - 4.3; p < 0.0001), burden (+ 2.7; p = 0.31 vs. - 3.6; p = 0.0031), and PCS (- 0.6; p = 0.58 vs. - 4.3; p < 0.0001). MCS was not associated with obesity phenotypes. CONCLUSIONS: This study demonstrated an association between obesity phenotypes and QoL in non-dialysis-dependent CKD patients. MUO patients had worse QoL than NO and MHO patients even after adjustment on comorbidities.

Formulation of survival acceptor medium able to maintain the viability of skin explants over in vitro dermal experiments.

OBJECTIVE: In vitro assessments of skin absorption of xenobiotics are essential for toxicological evaluations and bioavailability studies of cosmetic and pharmaceutical ingredients. Since skin metabolism can greatly contribute to xenobiotic absorption, experiments need to be performed with skin explants kept viable in suitable survival media. Existing protocols for non-viable skin are modified to consider those conditions. The objective was to design a survival medium used as an acceptor fluid in Franz cells for testing cutaneous penetration of hydrophilic or lipophilic molecules. Their metabolism inside skin may be investigated under the same conditions. The determining factors involved in survival mechanisms in vitro are discussed. The consequences of short-term skin preservation at 4°C were also evaluated. METHODS: The metabolic activity of fresh skin samples mounted in Franz cells was studied by measurement of lactate release over 24 h in order to assess the impacts of pH, buffering, osmolality, ionic strength, initial glucose supply and the addition of ethanol or non-ionic surfactant in the acceptor part of Franz cells. CONCLUSION: Survival media must maintain physiological pH (>5.5) be isotonic with skin cells (300 mOsm kg-1 ) and contain at least 0.5 g L-1 glucose. Several compositions able to preserve skin metabolism are reported. Storage of skin explants overnight at 4°C impairs skin metabolic activity. The present work provides guidelines for designing survival media according to constraints related to the scientific requirements of the experiments.

OBJECTIFS: Les études d'absorption cutanée sont indispensables pour les évaluations toxicologiques et les études de biodisponibilité des ingrédients cosmétiques et pharmaceutiques. Etant donné que le métabolisme cutané peut contribuer à l'absorption cutanée des xénobiotiques, les études doivent être parfois menées sur les explants cutanés maintenus en survie à l'aide d'un milieu adapté. Les protocoles classiques utilisés avec des explants congelés non viables sont souvent modifiés pour prendre en compte ces conditions particulières. L'objectif de cette étude est d'étudier les conditions nécessaires à appliquer au milieu receveur des cellules de Franz pour maintenir la viabilité des explants, dans les études de pénétration cutanée de molécules hydrophiles et lipophiles. Leur métabolisme dans la peau peut être étudié dans ces mêmes conditions. Les facteurs déterminants à prendre en compte pour assurer la viabilité des explants in vitro sont discutés. Les conséquences de la conservation des explants cutanés durant une courte durée à 4°C, avant utilisation, ont été également évaluées. METHODES: L'activité métabolique des échantillons de peau, montés en cellules de Franz, a été évaluée grâce aux mesures du lactate produit durant 24h, durée de l'expérience. L'impact du pH, de solutions « tampon ¼, de l'osmolalité, de la force ionique, de la concentration initiale en glucose et de l'addition d'éthanol ou de tensioactifs non-ioniques, dans le milieu receveur de la cellule de Franz, a été étudié. CONCLUSION: Le milieu de survie doit maintenir un pH physiologique (>5.5), être isotonique par rapport aux cellules de la peau (300 mOsm kg-1 ) et contenir au moins 0.5 g L-1 de glucose. Plusieurs compositions capables de maintenir le métabolisme cutané sont décrites. La conservation des explants cutanés à 4°C, durant une nuit, perturbe l'activité métabolique de la peau. Ces travaux permettent de mettre en évidence des prérequis pour la formulation de milieux de survie adaptés aux expériences.

The role of anxiety in the perception of technological hazards - a cross-sectional study on cell phones and masts.

BACKGROUND: Risk perception is determined by parameters related to the nature of the risk, as well as inherent to the individual perceiving this risk. This study was designed to provide a better understanding of the role of personality, especially anxiety traits, on risk perception. It compared representations of two different risks, smoking (with known and generally accepted adverse health effects) and cell phones (whose hazardous potency is still controversial), each presented in two different forms of exposure, active (smokers and cell phone users) and passive (passive smoking and exposure to cell phone masts). METHODS: A self-administered questionnaire sent to volunteer subjects collected sociodemographic and exposure data. It measured the perceived risk as well as 11 psychometric properties of risk using visual analogue scales (values ranging from 0 to 10). An anxiety trait was evaluated by the Spielberger questionnaire. RESULTS: In all, 72% of the questionnaires sent were returned. Mean declared risk scores attributed to passive and active smoking were higher (8.75 and 8.31 respectively) than those attributed to cell phones and masts (4.44 and 4.73 respectively). However, scores for the 11 psychometric properties of the risk attributed to cell phones were higher than those associated with smoking, especially for dissatisfaction with information (6.71 and 7.36 respectively for cell phones and masts versus 1.75 and 2.18 for passive and active smoking) and the capacity of authorities to master the risk (6.45 and 6.65 for cell phones and masts versus 4.72 and 4.40 for passive and active smoking). Anxiety did not directly influence the risk scores attributed to these 4 forms of exposure but was predictive of the way in which subjects perceived the risk in terms of two essential properties: uncertainty concerning the effects on health and the potential to trigger health catastrophes. Indeed anxious subjects are more certain about the hazards of cell phones and masts than non-anxious subjects (P=0.008 et P≤0.001) and attributed a higher catastrophic potential (P=0.02 and P=0.004). CONCLUSION: This study suggests that subjects with an anxious profile are affected by the destabilizing nature of uncertain knowledge concerning the hazardous potency of new technologies and of the controversies concerning this hazard.

Confocal Raman microspectroscopy for evaluating the stratum corneum removal by 3 standard methods.

BACKGROUND/AIMS: Stratum corneum (SC) removal is needed in biopharmaceutical studies or in evaluating the barrier function. The most common technique is the tape stripping method. However, it results in neither a homogeneous nor a complete removal. METHODS: The removal qualities of tape stripping, cyanoacrylate skin surface biopsy and trypsinization were estimated in vitro via histological imaging and confocal Raman microspectroscopy (CRM) and compared. In addition, the potential of the noninvasive CRM as a replacement method is discussed. RESULTS: Comparison between the 3 methods showed, as expected, that the tape stripping method did not result in a uniform removal over the whole surface even after 28 strips. The trypsinization and cyanoacrylate skin surface biopsies allowed a complete and uniform removal of the SC after defining a standard protocol (2 cyanoacrylate strips with a polymerization time of 15 min). CONCLUSION: The feasibility of CRM to control SC removal was demonstrated in vitro. Tape stripping is a simple method, but it is influenced by many extrinsic factors and axial drug quantification is difficult. With trypsinization and cyanoacrylate methods, the entire SC is removed so that quantification over the whole SC is possible but not an axial drug screening.

rhEGF microsphere formulation and in vitro skin evaluation.

An optimized process for protein encapsulation was applied to formulate epidermal growth factor (rhEGF)-poly-epsilon-caprolactone microspheres. Microparticles mean size was 3.8 microm +/- 0.2 and the encapsulation efficiency was 41.9% +/- 2.6. rhEGF recovery after the encapsulation process was approximately 70% (41.9% inside the microspheres and 30% still active in the external phase). In vitro release experiments in McIlvaine buffered solution showed a rhEGF sustained release over 4 days. Skin absorption studies conducted on full-thickness human skin using the Franz cell method showed that 20% rhEGF was released from the microspheres after 24 h exposure. Microspheres accumulated in the stratum corneum where they may act as a rhEGF reservoir. Therefore, rhEGF-PCL microparticles seemed to be promising systems due to their ability to provide locally a sustained release of rhEGF in skin layers.

The WHOQOL-BREF questionnaire: French adult population norms for the physical health, psychological health and social relationship dimensions.

BACKGROUND: Medical and scientific committees need validated instruments to assess quality of life, but the lack of general population norms limits their full use in research and clinical practice. This study aimed to determine norms for the French general population for the physical and psychological health and social relationship dimensions of the abbreviated version of WHOQOL-BREF questionnaire in a large representative community sample. METHODS: A sample of 16,450 randomly selected subjects 18-75 years old, in two steps: households and individuals, was drawn from the National Health Barometer 2005, a periodic study by the French National Institute for Preventive and Health Education. Quality of life and other characteristics were collected using a computer-assisted telephone interview by use of a booklet. RESULTS: Internal consistency was good. Normative data for the French population are analyzed by age, sex and self-reported chronic disease. CONCLUSIONS: Our data provide normative scores for the general French population for three of four dimensions of the WHOQOL-BREF that can be useful to researchers using this measure of health-related quality-of-life assessment and to clinical practitioners.

Agreement between children with cancer and their parents in reporting the child's health-related quality of life during a stay at the hospital and at home.

BACKGROUND: Although parent-child agreement is widely studied in the paediatric clinical sample, no study has compared parent-child agreement during home and hospital stays. We aimed to determine the level of agreement in reports of health-related quality of life (HRQoL) between parents of children with cancer and the children themselves during a stay in the hospital and a stay at home. METHODS: The sample consisted of 28 children, aged 9-18 years old, hospitalized and treated for cancer in a Children's University Hospital in France. The child's HRQoL was assessed by the parent and child versions of the Child Health Questionnaire. Parent-child agreement was estimated by the intraclass correlation coefficient. Potential predictors influencing the parent-child agreement were investigated. RESULTS: For both locations of stay, parent scores from the HRQoL survey were lower than those for their children for all domains, except for the general behaviour during the home stay. Scores for both parents and children, for all domains, were lower during the hospital than the home stay. The parent-child agreement was better for mental health, self-esteem, general health and family activities during the hospital stay (range 0.32-0.66), but was better for physical function, role/physical and general behaviour during the home stay (range 0.45-0.71). Few predictors of parent-child agreement were found. CONCLUSIONS: Agreement between parents and their children who have cancer in reporting the child's HRQoL differed by location of stay. For the home stay, the agreement was better for domains related to the child's physical life, but for the hospital stay, it was better for domains related to the child's behaviour/psychological life.

[Incidence of chronic kidney disease in general population, EPIRAN study]. / Incidence de l'insuffisance rénale chronique en population générale, étude EPIRAN.

AIMS: To assess incidence of chronic kidney disease in general population and to describe baseline characteristics of incident patients. METHODS: Between 1st/01/04 and 30/06/06 all incident cases of chronic kidney disease in the Nancy district were prospectively identified. New cases were identified from all medical laboratories in this area and determined by a persistently increased serum creatinine level (> or = 150micromol/l, or paediatric levels) for 3 months after the 1st/01/04, and by living in Nancy area. RESULTS: The annual incidence rate of detected chronic kidney disease was 1 per thousand inhabitants (1,3 per thousand for men and 0,7 per thousand for women). Incidents patients were old (mean age: 77 years) and with numerous comorbidities (diabetes: 34 %, cardiac failure: 23 %). More than 30% of incident patients were diagnosed at sever stage of chronic kidney disease (<30ml/min/1,73m(2)). CONCLUSIONS: The annual incidence of diagnosed chronic kidney disease is common: 10 times more than end-stage renal disease in France. Most of these patients are diagnosed in a severe stage of chronic kidney disease whereas they could be detected earlier and benefit from adequate, appropriate and multidisciplinary take care.

Impact of sex and glucose-lowering treatments on hypoglycaemic symptoms in people with type 2 diabetes and chronic kidney disease. The French Chronic Kidney Disease - Renal Epidemiology and Information Network (CKD-REIN) Study.

AIM: To describe current practices of glucose-lowering treatments in people with diabetes and chronic kidney disease (CKD), the associated glucose control and hypoglycaemic symptoms, with an emphasis on sex differences. METHODS: Among the 3033 patients with CKD stages 3-5 recruited into the French CKD-REIN study, 645 men and 288 women had type 2 diabetes and were treated by glucose-lowering drugs. RESULTS: Overall, 31% were treated only with insulin, 28% with combinations of insulin and another drug, 42% with non-insulin glucose-lowering drugs. In CKD stage 3, 40% of patients used metformin, 12% at stages 4&5, similar for men and women; in CKD stage 3, 53% used insulin, similar for men and women, but at stages 4&5, 59% of men and 77% of women used insulin. Patients were reasonably well controlled, with a median HbA1c of 7.1% (54mmol/mol) in men, 7.4% (57mmol/mol) in women (P=0.0003). Hypoglycaemic symptoms were reported by 40% of men and 59% of women; they were not associated with the estimated glomerular filtration rate, nor with albuminuria or with HbA1c in multivariable analyses, but they were more frequent in people treated with insulin, particularly with fast-acting and pre-mixed insulins. CONCLUSION: Glucose-lowering treatment, HbA1c and hypoglycaemic symptoms were sex dependent. Metformin use was similar in men and women, but unexpectedly low in CKD stage 3; its use could be encouraged rather than resorting to insulin. Hypoglycaemic symptoms were frequent and need to be more closely monitored, with appropriate patient-education, especially in women.

Percutaneous release of caffeine from microemulsion, emulsion and gel dosage forms.

The transport of caffeine to the hypodermis by an alcohol-free o/w microemulsion was investigated and compared with an aqueous gel and an o/w emulsion. The microemulsion was well characterized and in vitro diffusion measurements through pig skin having the hypodermis either kept or removed were performed in static Franz cells. The microemulsion allowed delivery of a large fraction of the caffeine in the hypodermis: 23% of caffeine reached the hypodermis after 24h diffusion, 1.3-fold larger than from the emulsion and gel dosage forms. Half this amount was stored in the hypodermis, the other half continuing its diffusion to the receptor compartment of the Franz cell.

Actinide-contaminated Skin: Comparing Decontamination Efficacy of Water, Cleansing Gels, and DTPA Gels.

Skin contamination by alpha-emitting actinides is a risk to workers during nuclear fuel production and reactor decommissioning. Also, the list of items for potential use in radiological dispersal devices includes plutonium and americium. The actinide chemical form is important and solvents such as tributyl phosphate, used to extract plutonium, can influence plutonium behavior. This study investigated skin fixation and efficacy of decontamination products for these actinide forms using viable pig skin in the Franz cell diffusion system. Commonly used or recommended decontamination products such as water, cleansing gel, diethylenetriamine pentaacetic acid, or octadentate hydroxypyridinone compound 3,4,3-LI(1,2-HOPO), as well as diethylenetriamine pentaacetic acid hydrogel formulations, were tested after a 2-h contact time with the contaminant. Analysis of skin samples demonstrated that more plutonium nitrate is bound to skin as compared to plutonium-tributyl phosphate, and fixation of americium to skin was also significant. The data show that for plutonium-tributyl phosphate all the products are effective ranging from 80 to 90% removal of this contaminant. This may be associated with damage to the skin by this complex and suggests a mechanical/wash-out action rather than chelation. For removal of americium and plutonium, both Trait Rouge cleansing gel and diethylenetriamine pentaacetic acid are better than water, and diethylenetriamine pentaacetic acid hydrogel is better than Osmogel. The different treatments, however, did not significantly affect the activity in deeper skin layers, which suggests a need for further improvement of decontamination procedures. The new diethylenetriamine pentaacetic acid hydrogel preparation was effective in removing americium, plutonium, and plutonium-tributyl phosphate from skin; such a formulation offers advantages and thus merits further assessment.

Factors associated with anemia among incident pre-dialysis patients managed within a French care network.

BACKGROUND AND AIMS: Despite guidelines concerning the management of renal anemia, the international literature reports that a large proportion of pre-dialysis patients have hemoglobin values lower than the recommended level. The present study analyzed the evolution of pre-dialysis Hb levels and erythropoietin use over a 4-year period and investigated factors associated with anemia. METHODS: A total of 1315 patients initiating dialysis in Lorraine, France, were enrolled since 2001-2004. For each year, anemia, defined by Hb <11 g/dl, and erythropoietin use were investigated in three groups: all patients, patients whose dialysis was planned and patients whose dialysis was unplanned. RESULTS: At initiation of dialysis, all groups showed increases over time in mean hemoglobin levels, proportion of patients without anemia and with erythropoietin therapy. Among patients whose first dialysis was planned in 2004, 43.8% had anemia and 67.9% had received erythropoietin, compared with 75.4% and 29.4%, respectively, when dialysis was unplanned. Patients receiving unplanned dialysis were more likely to have anemia (odds ratio (OR) = 2.6), as were those with a serum albumin level < 3.5 g/dl (OR = 2.1), body mass index < 30 kg/m2 (OR = 1.9) (all p < 0.001) or glomerular filtration rate < 10 ml/min/1.73 m2 (OR = 1.4, p = 0.04). The year of dialysis initiation was also associated with anemia (p = 0.024). CONCLUSION: The proportion ofpatients starting dialysis with anemia might be reduced by earlier nephrology referral leading to erythropoietin administration, planned first dialysis while residual renal function remains, and greater attention to nutritional status.

The effect of monomers on the formulation of polymeric nanocapsules based on polyureas and polyamides.

Formulation of nanocapsules based on polyureas and polyamides have been tested using a patented process. This method based on polycondensation reaction of two complementary monomers and spontaneous formation of oil in water emulsion, is an alternative concept to the known technique based on the same type of reaction used for the formulation of microcapsules, and in which the lipophilic monomer was emulsified in the organic phase before the formation of the polymeric membrane. Nanocapsules can be prepared from different monomers. Wall based on cross-linked polymer contributes to the stability of nanocapsules during and after formulation. The permeability of the polymeric wall is related to its crystallinity and contributes to the growth of nanocapsule membrane by the diffusion of the hydrophilic monomers to get stable colloidal suspensions.

Improvement of a bovine serum albumin microencapsulation process by screening design.

The first objective of this study was to prepare microspheres containing a model protein by double emulsion-solvent evaporation/extraction method. This method was modified to consider the fragile nature of proteins. These modifications related to the reduction of polymer loss, of agitation duration and of contact time between protein and solvent. The polymer used was poly(epsilon-caprolactone) and the model protein was bovine serum albumin. The control of the microsphere properties constituted a second objective of this project. A screening design methodology was used to evaluate the effects of the process and formulation variables on microsphere properties. Twelve operating factors were retained, and the particle properties considered were the mean size, the encapsulation efficiency, and the surface state. The statistical analysis of the results allowed determining the most influent factors. Considering the whole results, it appeared that the polymer concentration, the osmotic pressure equilibrium and the volume of the inner, outer and organic phases were the most important parameters. Following this screening study, it was possible to produce particles of small size with high entrapment efficiency (near to 80%) and smooth surface. A good batch to batch reproductibility was obtained.

Degradation of paraoxon (VX chemical agent simulant) and bacteria by magnesium oxide depends on the crystalline structure of magnesium oxide.

In this work, our goal was to study the capability of a single metallic oxide to neutralize a chemical agent and to exhibit an antibacterial effect. We tested two types of magnesium oxides, MgO. The first MgO sample tested, which commercial data size characteristic was -325 mesh (MgO-1) destroyed in 3 h, 89.7% of paraoxon and 93.2% of 4-nitrophenol, the first degradation product. The second MgO sample, which commercial data size was <50 nm (MgO-2) neutralized in the same time, 19.5% of paraoxon and 10.9% of 4-nitrophenol. For MgO-1 no degradation products could be detected by GC-MS. MgO-1 had a bactericidal activity on Escherichia coli (6 log in 1 h), and showed a decrease of almost 3 log on a Staphylococcus aureus population in 3 h. MgO-2 caused a decrease of 2 log of a E.coli culture but had no activity against S. aureus. Neither of these two products had an activity on Bacillus subtilis spores. Analytical investigations showed that the real sizes of MgO nanoparticles were 11 nm for MgO-1 and 25 nm for MgO-2. Moreover, their crystalline structures were different. These results highlighted the importance of the size of the nanoparticles and their microscopic arrangements to detoxify chemical products and to inhibit or kill microbial strains.

Penetration and decontamination of americium-241 ex vivo using fresh and frozen pig skin.

Skin contamination is one of the most probable risks following major nuclear or radiological incidents. However, accidents involving skin contamination with radionuclides may occur in the nuclear industry, in research laboratories and in nuclear medicine departments. This work aims to measure the penetration of the radiological contaminant Americium (241Am) in fresh and frozen skin and to evaluate the distribution of the contamination in the skin. Decontamination tests were performed using water, Fuller's earth and diethylene triamine pentaacetic acid (DTPA), which is the recommended treatment in case of skin contamination with actinides such as plutonium or americium. To assess these parameters, we used the Franz cell diffusion system with full-thickness skin obtained from pigs' ears, representative of human skin. Solutions of 241Am were deposited on the skin samples. The radioactivity content in each compartment and skin layers was measured after 24 h by liquid scintillation counting and alpha spectrophotometry. The Am cutaneous penetration to the receiver compartment is almost negligible in fresh and frozen skin. Multiple washings with water and DTPA recovered about 90% of the initial activity. The rest remains fixed mainly in the stratum corneum. Traces of activity were detected within the epidermis and dermis which is fixed and not accessible to the decontamination.

Estimated risk of endocarditis in adults with predisposing cardiac conditions undergoing dental procedures with or without antibiotic prophylaxis.

BACKGROUND: Although antibiotic prophylaxis for infective endocarditis (IE) has been recommended for persons with predisposing cardiac conditions (PCCs) for many years, its efficacy, which has not been demonstrated, has been recently challenged. To assess its usefulness, we estimated the risk of developing IE after undergoing a dental procedure for which subjects would be eligible for prophylaxis, both in subjects having (protected procedure) or not having (unprotected procedure) received antibiotic prophylaxis. METHODS: The number of French persons with PCCs, the annual number of dental procedures in which subjects would be eligible for antibiotic prophylaxis, and the number of procedures that were unprotected were estimated on the basis of a survey performed on a sample of 2805 subjects aged 25-84 years. The annual number of IE cases possibly due to an unprotected procedure was estimated on the basis of a 1-year epidemiological study of IE conducted in an area inhabited by 16 million people. RESULTS: After standardization, extrapolation of results to the age-equivalent general population (39 millions subjects) indicated the following: first, 3.3% (95% confidence interval [CI], 2.6%-4%) of the subjects had PCC, 2.7 million (95% CI, 2.3-3.2 million) of whom had undergone at least 1 at-risk dental procedures within the survey year, and the procedures were unprotected in 62% of cases; second, 37 (95% CI, 18-68; 2.7%) of the 1370 annual IE cases in France were possibly related to unprotected procedures. Thus, the risks of developing IE were estimated to be 1 in 46,000 for unprotected procedures (1 in 10,700 and 1 in 54,300 for subjects with prosthetic and native valve PCC, respectively) and 1 in 150,000 for protected procedures. CONCLUSIONS: A huge number of prophylaxis doses would be necessary to prevent a very low number of IE cases.