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1.
Eur J Paediatr Neurol ; 51: 79-83, 2024 May 28.
Article in English | MEDLINE | ID: mdl-38880066

ABSTRACT

OBJECTIVE: This retrospective study aimed to describe a cohort of 38 pediatric patients with MOGAD and to investigate the clinical differences between patients with CSF-negativity and CSF-positivity for MOG-abs. METHODS: The clinical and laboratory characteristics of pediatric patients with MOGAD were retrospectively studied. Demographics, clinical characteristics, CSF analysis, treatments and prognosis of patients were recorded. All patients' serums and CSF were tested for MOG-IgG by live cell-based assays (CBA). The data were statistically analysed. RESULTS: A total of 38 pediatric MOGAD patients were enrolled in the study, including 22 (57.9 %) females and 16 male (42.1 %) with a mean age of 8.4 ± 4.0 years at disease onset. Twenty-seven (71.7 %) patients were CSF-positive for MOG-abs while 11 (28.9 %) patients were CSF-negative for MOG-abs. The median follow-up was 25.5 months (IQR 5.5-73.25). Seventeen (44.7 %) patients presented a relapsing disease course, and the majority of these patients was CSF positive with a significant difference between the two groups (p = 0.038) in terms of recurrent diseases. CSF-positive patients presented more often an increased white cell count (p = 0.043), and in this cohort clinical phenotypes with spinal involvement were more frequent while encephalitis-like phenotypes were more frequent in the CSF negative cohort (p = 0.019). CONCLUSIONS: CSF-status appears to identify two subgroups in this pediatric MOGAD population; thus, CSF-status requires further studies in pediatric patients with MOGAD.

3.
Clin Ter ; 172(6): 517-519, 2021 Nov 22.
Article in English | MEDLINE | ID: mdl-34821342

ABSTRACT

ABSTRACT: Couple infertility constitutes a major source of concern and even distress for those involved, affecting roughly 50-80 million people in the world, according to World Health Organization data. There is no denying that medical and technological advancements in the field of as-sisted reproductive technology (ART) are among the greatest and most beneficial achievements of modern medicine. Countless couples have been able to achieve parenthood who in the past could not have, thanks to ART. Infertility itself used to be deemed insurmountable, especially when arising from uterine conditions (referred to as absolute uterine factor infertility, AUFI), neoplastic conditions or major complications affecting reproductive organs during previous pregnancies. The inability to have children is often considered by couples as a failure severely impacting their relationships, due to the unfulfilled biological potential in regard to parenting. However, in addition to its significance as a social problem, infertility is a medical issue which requires a strict and clearly defined path of diagnosis and treatment, particularly in times of COVID-19, when access to essential care has often been delayed with potentially harmful repercussions for patients seeking to achieve parenthood or to keep their fertility.


Subject(s)
COVID-19 , Infertility , Child , Female , Humans , Parenting , Pregnancy , Reproductive Techniques, Assisted , SARS-CoV-2
4.
J Biol Regul Homeost Agents ; 34(5 Suppl. 3): 97-110. Technology in Medicine, 2020.
Article in English | MEDLINE | ID: mdl-33386039

ABSTRACT

There are different treatment options that employ a bone conduction transmission of the sound, for different types of hearing loss, as well as hearing aids, medical intervention via prostheses and surgically implanted medical devices. A middle ear disease causes a decline in the conductive mechanism of hearing. The current possibilities of compensating Conductive Hearing Loss (CHL) solutions include both surgical and no surgical Bone Conduction Devices (BCDs). Due to the invasiveness of the implantable devices and their specific requirements in terms of the temporal bone anatomy, non-implantable BCDs are in some cases preferred in the clinical routine. The goal of this review is to investigate the beneficial effects and safety of non-implantable BC devices, analysing the different type of solutions found so far. A systematic review was performed to identify all the clinical studies evaluating the use of non-invasive BCDs. A qualitative analysis based on data extracted was conducted. From 37 articles, 11 prospective studies and 1 retrospective study were selected for a full analysis, for a total of 173 patients from 4- to 77-years-old. Eight of these studies included adult patients, while the other four are paediatric studies. All the studies analyse non-implantable BCDs commonly used in case of CHL, sensorineural HL and single side deafness. Three of them analyse an adhesive device, six compare the adhesive device with a sound processor mounted on a support fitted on the head, one compare it also with an implant, one analyse the sound processor mounted on different type of support, and one compare different type of sound processor. All the studies showed advantages from the use of non-invasive BCDs, both on adults and children. The non-invasive BCDs analysed in this review show good results both from the audiological and subjective point of view and could be considered a safe and effective solution for patients suffering from conductive hearing loss, sensorineural hearing loss or single-side deafness. More studies are required to confirm these promising results.


Subject(s)
Hearing Aids , Hearing Loss , Adolescent , Adult , Aged , Bone Conduction , Child , Child, Preschool , Humans , Middle Aged , Prospective Studies , Prostheses and Implants , Retrospective Studies , Young Adult
5.
Clin Exp Immunol ; 197(3): 263-275, 2019 09.
Article in English | MEDLINE | ID: mdl-31194881

ABSTRACT

Interleukin (IL)-10 plays a key role in controlling intestinal inflammation. IL-10-deficient mice and patients with mutations in IL-10 or its receptor, IL-10R, show increased susceptibility to inflammatory bowel diseases (IBD). Protein tyrosine phosphatase, non-receptor type 22 (PTPN22) controls immune cell activation and the equilibrium between regulatory and effector T cells, playing an important role in controlling immune homoeostasis of the gut. Here, we examined the role of PTPN22 in intestinal inflammation of IL-10-deficient (IL-10-/- ) mice. We crossed IL-10-/- mice with PTPN22-/- mice to generate PTPN22-/- IL-10-/- double knock-out mice and induced colitis with dextran sodium sulphate (DSS). In line with previous reports, DSS-induced acute and chronic colitis was exacerbated in IL-10-/- mice compared to wild-type (WT) controls. However, PTPN22-/- IL-10-/- double knock-out mice developed milder disease compared to IL-10-/- mice. IL-17-promoting innate cytokines and T helper type 17 (Th17) cells were markedly increased in PTPN22-/- IL-10-/- mice, but did not provide a protctive function. CXCL1/KC was also increased in PTPN22-/- IL-10-/- mice, but therapeutic injection of CXCL1/KC in IL-10-/- mice did not ameliorate colitis. These results show that PTPN22 promotes intestinal inflammation in IL-10-deficient mice, suggesting that therapeutic targeting of PTPN22 might be beneficial in patients with IBD and mutations in IL-10 and IL-10R.


Subject(s)
Colitis/immunology , Inflammatory Bowel Diseases/immunology , Interleukin-10/deficiency , Protein Tyrosine Phosphatase, Non-Receptor Type 22/deficiency , Th17 Cells/immunology , Animals , Chemokine CXCL1/genetics , Chemokine CXCL1/immunology , Colitis/chemically induced , Colitis/genetics , Colitis/pathology , Dextran Sulfate/toxicity , Disease Models, Animal , Female , Gene Knockdown Techniques , Inflammatory Bowel Diseases/chemically induced , Inflammatory Bowel Diseases/genetics , Inflammatory Bowel Diseases/pathology , Interleukin-10/immunology , Interleukin-17/genetics , Interleukin-17/immunology , Male , Mice , Protein Tyrosine Phosphatase, Non-Receptor Type 22/immunology , Receptors, Interleukin-10/genetics , Receptors, Interleukin-10/immunology , Th17 Cells/pathology
6.
Spectrochim Acta A Mol Biomol Spectrosc ; 219: 504-508, 2019 Aug 05.
Article in English | MEDLINE | ID: mdl-31078817

ABSTRACT

We present a multi-analytical in situ non-invasive study of a series of emblematic paintings by Alessandro Milesi (1856-1945) from the collection of the International Gallery of Modern Art Ca' Pesaro in Venice. Eight paintings dated from 1897 to 1910 were studied with imaging and spectroscopic techniques. White pigments were characterized by a combination of X-ray fluorescence spectroscopy which traced the presence of zinc-based pigments in Milesi's paintings, Raman Spectroscopy, Laser Induced Fluorescence (LIF) Spectroscopy and Time-resolved Luminescence Imaging. Time-resolved analysis of luminescence emissions revealed the nanosecond emission from organic compounds and the slower emission from the luminescent inorganic pigment Zinc Oxide that varied between 1.1 and 1.6 microseconds. In this work, data regarding the distribution of luminescent pigments was acquired with a time-gated imaging detector. Furthermore, differences in emission decay kinetics recorded from different paintings can be ascribed to different paint formulations or origins of the Zinc white in paint.

7.
Spectrochim Acta A Mol Biomol Spectrosc ; 219: 530-538, 2019 Aug 05.
Article in English | MEDLINE | ID: mdl-31078820

ABSTRACT

A complementary multi-analytical in-situ approach has been adopted for the investigation of a corpus of ten paintings dating from 1889 and 1940 by the Venetian painter Alessandro Milesi (1856-1945), from the collection of the International Gallery of Modern Art Ca' Pesaro in Venice. Analyses were performed in situ with digital imaging, elemental and spectroscopic analysis. The analysis of pigments and binding media and their possible deterioration patterns were studied with a combination of X-Ray Fluorescence (XRF) Spectroscopy, External Reflection- Fourier Transform Infrared Spectroscopy (ER-FTIR) and Raman Spectroscopy. These analytical methods provide information regarding the evolution of the artist's palette and the painting techniques adopted in painting. Data suggest the widespread detection of zinc carboxylates, with implications for conservation and display.

8.
Ultrastruct Pathol ; 40(2): 83-5, 2016.
Article in English | MEDLINE | ID: mdl-26886841

ABSTRACT

Juvenile dermatomyositis (JDM), an autoimmune idiopathic myositis, is characterized by rash and proximal muscle weakness. Immunohistopathology typically shows perivascular inflammatory infiltrate with predominance of CD4+ T lymphocytes, perifascicular atrophy, and upregulation of major histocompatibility complex class I. JDM has been attributed to a humoral-driven muscle microangiopathy probably implicating the type I interferon pathway. Tubulo-reticular inclusions present in endothelial cell of muscle are biomarkers of interferon exposure, and so may be an indirect data of this myopathy especially in the absence of rash and inflammatory infiltrate. We report on three patients in which electron microscopy solves the differential diagnosis among infantile myositis showing peculiar inclusions.


Subject(s)
Dermatomyositis/pathology , Endothelial Cells/ultrastructure , Muscle, Skeletal/ultrastructure , Biopsy , Child , Child, Preschool , Diagnosis, Differential , Early Diagnosis , Female , Humans , Male , Microscopy, Electron , Predictive Value of Tests
9.
J Hazard Mater ; 306: 115-123, 2016 Apr 05.
Article in English | MEDLINE | ID: mdl-26705888

ABSTRACT

We studied the strategy of an Aspergillus fumigatus strain able to grow on metal cyanide wastes to cope with silver. The tolerance test revealed that the Minimum Inhibitory Concentration of Ag(I) was 6mM. In 1mM AgNO3 aqueous solution the fungus was able to reduce and sequestrate silver into the cell in the form of nanoparticles as evidenced by the change in color of the biomass and Electron Microscopy observations. Extracellular silver nanoparticle production also occurred in the filtrate solution after previous incubation of the fungus in sterile, double-distilled water for 72h, therefore evidencing that culture conditions may influence nanoparticle formation. The nanoparticles were characterized by UV-vis spectrometry, X-ray diffraction and Energy Dispersion X-ray analysis. Atomic absorption spectrometry revealed that the optimum culture conditions for silver absorption were at pH 8.5.The research is part of a polyphasic study concerning the behavior of the fungal strain in presence of metal cyanides; the results provide better understanding for further research targeted at a rationale use of the microorganism in bioremediation plans, also in view of possible metal recovery. Studies will be performed to verify if the fungus maintains its ability to produce nanoparticles using KAg(CN)2.


Subject(s)
Aspergillus fumigatus/drug effects , Cyanides/metabolism , Metal Nanoparticles/toxicity , Silver Nitrate/toxicity , Aspergillus fumigatus/metabolism , Aspergillus fumigatus/ultrastructure , Metal Nanoparticles/ultrastructure , Microscopy, Electron, Scanning , Microscopy, Electron, Transmission
10.
Opt Express ; 23(12): 16196-208, 2015 Jun 15.
Article in English | MEDLINE | ID: mdl-26193592

ABSTRACT

Sub-Nyquist time frequency packing technique was demonstrated for the first time in a super-channel field trial transmission over long-haul distances. The technique allows a limited spectral occupancy even with low order modulation formats. The transmission was successfully performed on a deployed Australian link between Sydney and Melbourne which included 995 km of uncompensated SMF with coexistent traffic. 40 and 100 Gb/s co-propagating channels were transmitted together with the super-channel in a 50 GHz ITU-T grid without additional penalty. The super-channel consisted of eight sub-channels with low-level modulation format, i.e. DP-QPSK, guaranteeing better OSNR robustness and reduced complexity with respect to higher order formats. At the receiver side, coherent detection was used together with iterative maximum-a-posteriori (MAP) detection and decoding. A 975 Gb/s DP-QPSK super-channel was successfully transmitted between Sydney and Melbourne within four 50GHz WSS channels (200 GHz). A maximum potential SE of 5.58 bit/s/Hz was achieved with an OSNR = 15.8 dB, comparable to the OSNR of the installed 100 Gb/s channels. The system reliability was proven through long term measurements. In addition, by closing the link in a loop back configuration, a potential SE∙d product of 9254 bit/s/Hz·km was achieved.

11.
Acta Neurol Scand ; 131(5): 341-6, 2015 May.
Article in English | MEDLINE | ID: mdl-25659828

ABSTRACT

BACKGROUND: Zonisamide has been associated with weight loss in children and adults. AIMS OF THE STUDY: To assess the effects of adjunctive zonisamide on weight and body mass index (BMI) in children with partial epilepsy. METHODS: A subanalysis was conducted of a Phase III trial and extension study, in which children with partial epilepsy received adjunctive zonisamide (target dose 8 mg/kg/day; maximum 500 mg/day). Changes in weight were correlated with skeletal development and sexual maturation. RESULTS: Overall, 179 children (93 male, 86 female; age 6-18 years) received zonisamide (mean duration 370.6 days). Weight loss ≥ 5% was reported for 64 of 179 (35.8%) zonisamide-treated children. Of these, 46.9% were overweight/obese at study entry, compared with 23.4% at study end (P = 0.0007); 48.4% had normal weight at study entry, compared with 65.6% at study end (P = 0.03). Three patients were underweight at study entry, and four more became underweight by study end. No consistent correlations between weight loss and skeletal development or sexual maturation were observed. CONCLUSIONS: Approximately one-third of children treated with zonisamide experienced ≥ 5% weight loss. Weight loss was most apparent in children with high baseline BMI values and did not appear to be associated with any consistent effects on growth and development.


Subject(s)
Anticonvulsants/adverse effects , Epilepsies, Partial/drug therapy , Isoxazoles/adverse effects , Weight Loss/drug effects , Adolescent , Body Mass Index , Child , Female , Humans , Male , Zonisamide
12.
Prev. tab ; 16(1): 21-27, ene.-mar. 2014. graf, tab
Article in Spanish | IBECS | ID: ibc-121068

ABSTRACT

Objetivos. Realizar una evaluación comparativa de la condición de tabaquismo en el personal de planta del Hospital del Carmen (provincia de Mendoza) con encuestas nacionales de la población general (Argentina) durante un período de 15 años. Material y métodos. Estudio observacional y retrospectivo, comprendido entre 1997 y 2012. Se realizó una encuesta sobre tabaquismo en tres períodos puntuales (1997-2004-2012), fueron comparadas entre sí y a su vez con las encuestas nacionales. Resultados. Se observó una disminución en el porcentaje de fumadores actuales, tanto en el personal de salud como en la población general (13,5 y 17,7% respectivamente);a su vez se observó un reducción del porcentaje de extabaquistas en el personal de salud (8,3%) y la población general (10,1%). En el personal de salud se observó un aumento del número de personas que nunca fumaron estadísticamente significativo (p=0,0067) del 21,8% y en la población general del 27,8%. Conclusiones. Se ha producido un cambio generacional positivo, observándose un aumento del número de personas que nunca fumaron; por lo tanto, se deben mantener las políticas de prevención para que los cambios sean perdurables en el tiempo (AU)


Goals. Perform a comparative evaluation on the smoking condition on the house staff of the Carmen Hospital (province of Mendoza) with national surveys of the general population (Argentina) during a 15-yearperiod.Equipment and methods. Observational and retrospective study, between 1997 and 2012. A survey regarding smoking was performed in three specific periods (1997-2004-2012). They were compared with each other and also with national surveys. Results: A decrease in the percentage of Current Smokers was observed in the health care staff as well as in the general population (13.5 and 17.7, respectively). A decrease in the percentage of former smoker was also observed in the health care staff (8.3%) as well as the general population (10.1%). Among health care workers, a statistically significant increase in the number of people who never smoked was noted (p=0.0067), at 21.8%, and in the general population it was 27.8%.Conclusions. A positive generation change was noted in the increase of the number of people who have never smoked, reason why the prevention policies should be maintained, so the changes will endure over time (AU)


Subject(s)
Humans , Smoking/epidemiology , Health Personnel/statistics & numerical data , Argentina/epidemiology , Morbidity Surveys , Retrospective Studies
13.
Acta Neurol Scand ; 128(6): 422-8, 2013 Dec.
Article in English | MEDLINE | ID: mdl-23773051

ABSTRACT

OBJECTIVES: To assess the safety/tolerability of zonisamide in elderly patients. MATERIALS & METHODS: A pooled analysis of clinical study data from elderly (≥65 years) patients receiving add-on/monotherapy zonisamide for partial seizures was compared with pooled adult (18-65 years) study data. Assessments included treatment-emergent adverse events (TEAEs), clinical laboratory parameters and weight change. RESULTS: Data were analyzed from 95 elderly and 1389 adult patients. Incidence of total TEAEs was similar (elderly, 78/95 [82%] vs adult, 1165/1389 [84%]); but lower in elderly versus adult patients for treatment-related TEAEs (53/95 [56%] vs 1010/1389 [73%]), severe TEAEs (11/95 [12%] vs 289/1389 [21%]), serious TEAEs (12/95 [13%] vs 230/1389 [17%]) and TEAEs leading to withdrawal (17/95 [18%] vs 312/1389 [23%]). Most TEAEs were of mild-to-moderate intensity. TEAEs reported more frequently by elderly versus adult patients included fatigue (11/95 [12%] vs 135/1389 [10%]), nasopharyngitis (8/95 [8%] vs 100/1389 [7%]), constipation (7/95 [7%] vs 67/1389 [5%]) and pruritus (6/95 [6%] vs 29/1389 [2%]). The only serious TEAEs reported by ≥2% of elderly patients were 'convulsions' (4/95 [4%] vs 49/1389 [4%]). Three elderly patients died; one death was considered treatment-related. TEAEs leading to discontinuation of ≥2% of elderly patients were dizziness (4/95 [4%]), headache (2/95 [2%]), somnolence (2/95 [2%]) and confusional state (2/95 [2%]). For elderly patients, there were minimal changes in clinical laboratory parameters, no reports of respiratory alkalosis or metabolic acidosis and no significant weight changes. CONCLUSIONS: Zonisamide demonstrated a favourable safety/tolerability profile in elderly patients. No new or unexpected safety findings were identified.


Subject(s)
Anticonvulsants/therapeutic use , Epilepsy/drug therapy , Isoxazoles/therapeutic use , Aged , Aged, 80 and over , Databases, Bibliographic , Dose-Response Relationship, Drug , Female , Humans , Male , Treatment Outcome , Zonisamide
15.
Opt Express ; 20(26): B507-12, 2012 Dec 10.
Article in English | MEDLINE | ID: mdl-23262895

ABSTRACT

We report enhanced 10 Gb/s operation of directly modulated bandwidth-limited reflective semiconductor optical amplifiers. By using a single suitable arrayed waveguide grating we achieve simultaneously WDM demultiplexing and optical equalization. Compared to previous approaches, the proposed system results significantly more tolerant to seeding wavelength drifts. This removes the need for wavelength lockers, additional electronic equalization or complex digital signal processing. Uniform C-band operations are obtained experimentally with < 2 dB power penalty within a wavelength drift of 10 GHz (which doubles the ITU-T standard recommendations).

16.
Acta Neurol Scand Suppl ; (194): 19-28, 2012.
Article in English | MEDLINE | ID: mdl-23106522

ABSTRACT

Zonisamide is a benzisoxazole derivative, chemically unrelated to other antiepileptic drugs, that appears to have multiple mechanisms of action, including inhibition of Na(+) channels and reduction of T-type Ca(2+) currents. It is currently licensed in Europe and the USA for adjunctive treatment of partial seizures in adults, and in Europe as monotherapy for treatment of partial seizures in adults with newly diagnosed epilepsy. Zonisamide displays predictable, dose-dependent pharmacokinetics and has a half-life of ~60 h, allowing once- or twice-daily administration. It has a low potential for interactions with other medications, including oral contraceptives. The clinical efficacy of adjunctive zonisamide therapy has been established in four pivotal, phase III, randomized, double-blind, placebo-controlled trials, which together included approximately 850 patients, aged 12-77 years, with refractory partial epilepsy. In all four trials, zonisamide 300-600 mg/day resulted in significant reductions in median total seizure rates vs placebo, and zonisamide was generally well tolerated; the most frequently reported adverse events being somnolence, dizziness and anorexia/weight loss. Subanalysis of the primary European trial indicated that zonisamide was effective when administered as first-line adjunctive treatment, and a long-term extension to the same trial demonstrated that the efficacy and safety/tolerability of adjunctive zonisamide was sustained for up to 36 months. Once-daily monotherapy with zonisamide (200-500 mg/day) has been shown to be non-inferior to, and as well tolerated as, twice-daily monotherapy with controlled-release carbamazepine (400-1200 mg/day) in adults with newly diagnosed partial epilepsy. Zonisamide has also been shown to have favourable long-term retention rates, an important indication of its overall effectiveness.


Subject(s)
Anticonvulsants/pharmacology , Epilepsy/drug therapy , Isoxazoles/pharmacology , Animals , Anticonvulsants/adverse effects , Anticonvulsants/chemistry , Clinical Trials as Topic , Dose-Response Relationship, Drug , Humans , Isoxazoles/adverse effects , Isoxazoles/chemistry , Treatment Outcome , Zonisamide
17.
Eur J Neurol ; 19(1): 105-13, 2012 Jan.
Article in English | MEDLINE | ID: mdl-21699627

ABSTRACT

BACKGROUND: The 24-week, double-blind Efficacy and Safety Evaluation in PD-Adjunct (EASE-PD Adjunct) study randomized patients with advanced Parkinson's disease (PD) suboptimally controlled with levodopa to once-daily placebo or adjunctive ropinirole prolonged release (2-24 mg/day). We investigated the effect of ropinirole prolonged release on nocturnal symptoms in these patients. METHODS: Total and grouped item PD Sleep Scale (PDSS) scores were analyzed post hoc in patients with baseline PDSS total scores ≤ 100 (troublesome nocturnal symptoms) and >100. RESULTS: Baseline PDSS total score was ≤ 100 in 93 of 198 (47%) and 89 of 189 (47%) patients receiving ropinirole prolonged release and placebo, respectively; this subgroup displayed evidence at baseline of greater daily awake 'off' time, reduced night-time sleep and worse quality of life, than the PDSS >100 subgroup. Significant improvements with ropinirole prolonged release versus placebo in PDSS score from baseline to Week 24 last observation carried forward were observed for those with baseline PDSS ≤ 100 [adjusted mean treatment difference 9.0 (95% CI: 2.76, 15.33; P = 0.0051)], but not >100. The PDSS ≤ 100 subgroup demonstrated treatment benefits for PDSS groupings of motor symptoms on waking and global quality of sleep. Changes in daytime sleepiness were similar between treatment groups. The PDSS >100 subgroup demonstrated significant treatment benefit for global quality of sleep. The unadjusted odds ratio for a positive response with ropinirole prolonged release relative to placebo, for the PDSS ≤ 100 subgroup, was 2.90 (95% CI: 1.42, 5.95, P = 0.004). CONCLUSIONS: Once-daily ropinirole prolonged release improves nocturnal symptoms in patients with advanced PD not optimally controlled with levodopa who suffer troublesome nocturnal disturbance.


Subject(s)
Antiparkinson Agents/therapeutic use , Indoles/therapeutic use , Parkinson Disease/drug therapy , Sleep Wake Disorders/drug therapy , Aged , Delayed-Action Preparations , Double-Blind Method , Female , Humans , Male , Parkinson Disease/complications , Quality of Life , Sleep Wake Disorders/etiology
18.
Vaccine ; 30(6): 1170-80, 2012 Feb 01.
Article in English | MEDLINE | ID: mdl-22178096

ABSTRACT

BACKGROUND: Although influenza vaccination is widely recommended for immunosuppressed people, the same immune dysfunction that can increase the risk of contracting influenza might also compromise vaccine effectiveness, especially during pandemics. Clinical data have highlighted the role of adjuvants in improving vaccine efficacy. As uremic patients are especially vulnerable to infections, it is recommended that they should be vaccinated yearly against influenza. This paper presents the results of a pilot clinical trial, conducted in hemodialyzed patients with an adjuvated pandemic H1N1v influenza vaccine alone and combined with Thymosin-alpha 1. METHODS: Subjects were subdivided into 3 treatment groups receiving: the adjuvated pandemic influenza vaccine (Focetria) only (first treatment group), and the Vaccine+Thymosin alpha 1 (Zadaxin) at a dose of 3.2 and 6.4 mg (second and third treatment groups respectively). The immunoresponse was assessed on days 0, 21, 42, 84 and 168 after vaccine administration by means of Hemagglutination Inhibition (HI), Microneutralization (MN) and Single Radial Hemolysis (SRH) assays. The CHMP regards HI as the gold standard test to evaluate the immune response to influenza vaccines before influenza vaccines are licensed. The CHMP criteria are slightly different in adults (18-60-year-old subjects) and the elderly (>60 years old). Indeed, 40% of seroconversion, 70% of subjects seroprotected 21 days after vaccination, and a 2.5-fold increase in GMR (Geometric Mean Ratio) are required in adults, while in the elderly, the corresponding threshold values are: 30%, 60% and a 2-fold increase. All these criteria must be met for the licensing of a pandemic influenza vaccine. Safety evaluation was performed by means of Adverse Event (AE) recording, laboratory assays (hematology and chemistry), electrocardiogram, and assessment of vital signs. RESULTS: Three populations were considered: Intention-To-Treat (ITT) (94 patients), Per Protocol (PP) (82 patients), and Safety population (99 patients). With regard to the Geometric Mean Titer (GMT) and the Geometric Mean Ratio (GMR) of HI on Day 21 in the ITT population, both "Vaccine+Thymosin alpha 1" groups presented better results than the "Vaccine only" group. A large proportion of ITT patients in the two Vaccine+Thymosin alpha 1 groups achieved seroconversion by Day 21. On Day 42, the decrease in the GMT of HI was greater in the Vaccine+Thymosin alpha 1 groups than in the vaccine only group. Similar results were obtained in the PP population. The CHMP criteria were fully met in the groups treated with Vaccine+Thymosin alpha 1. No AE was found to be related to Thymosin alpha 1 nor to the Focetria vaccine. CONCLUSIONS: Although further studies in larger hemodialyzed populations are necessary, it can be concluded that Thymosin alpha 1 enhanced the immunogenicity of the pandemic influenza vaccine used. Moreover, it proved safe and well tolerated, and did not affect hematology or blood-chemistry values.


Subject(s)
Adjuvants, Immunologic/administration & dosage , Influenza A Virus, H1N1 Subtype/immunology , Influenza Vaccines/immunology , Influenza, Human/prevention & control , Thymosin/analogs & derivatives , Adjuvants, Immunologic/adverse effects , Adolescent , Adult , Aged , Aged, 80 and over , Antibodies, Neutralizing/blood , Antibodies, Viral/blood , Female , Humans , Immunoassay , Influenza Vaccines/administration & dosage , Influenza Vaccines/adverse effects , Male , Middle Aged , Pilot Projects , Renal Dialysis , Thymalfasin , Thymosin/administration & dosage , Thymosin/adverse effects , Uremia/immunology , Uremia/therapy , Young Adult
19.
J Nanosci Nanotechnol ; 11(10): 8804-11, 2011 Oct.
Article in English | MEDLINE | ID: mdl-22400263

ABSTRACT

Nanosized platinum-gold alloys clusters have been deposited on gas diffusion electrode by sputter deposition. The deposits were characterized by FE-SEM, TEM and XPS in order to verify the formation of alloy nanoparticles and to study the influence of deposition technique on the nanomorphology. The deposition by sputtering process allowed a uniform distribution of metal particles on porous surface of carbon supports. Typical island growth mode was observed with the formation of a dispersed metal nanoclusters (mean size about 5 nm). Cyclic voltammetry was used to determine the electrochemical active surface and the electrocatalytic performance of the PtAu electrocatalysts for methanol oxidation reaction. The data were re-calculated in the form of mass specific activity (MSA). The sputter-catalyzed electrodes showed higher performance and stability compared to commercial catalysts.

20.
J Nanosci Nanotechnol ; 11(10): 8812-7, 2011 Oct.
Article in English | MEDLINE | ID: mdl-22400264

ABSTRACT

New carbon nanomaterials, i.e., carbon nanotubes and nanofibers, with special physico-chemical properties, are recently studied as support for methanol oxidation reaction electrocatalysts replacing the most widely used carbon black. Particularly, carbon fibrous structures with high surface area and available open edges are thought to be promising. Platelet type carbon nanofibers, which have the graphene layers oriented perpendicularly to the fiber axis, exhibit a high ratio of edge to basal atoms. Different types of carbon nanofibers (tubular and platelet) were grown by plasma enhanced chemical vapour deposition on carbon paper substrates. The process was controlled and optimised in term of growth pressure and temperature. Carbon nanofibers were characterised by high resolution scanning electron microscopy and X-ray photoelectron spectroscopy to assess the morphological properties. Then carbon nanofibers of both morphologies were used as substrates for Pt electrodeposition. High resolution scanning electron microscopy images showed that the Pt nanoparticles distribution was well controlled and the particles size went down to few nanometers. Pt/carbon nanofibers nanocomposites were tested as electrocatalysts for methanol oxidation reaction. Cyclic voltammetry in H2SO4 revealed a catalyst with a high surface area. Cyclic voltammetry in presence of methanol indicated a high electrochemical activity for methanol oxidation reaction and a good long time stability compared to a carbon black supported Pt catalyst.

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