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1.
Eur J Pharm Biopharm ; : 114383, 2024 Jun 25.
Article in English | MEDLINE | ID: mdl-38936783

ABSTRACT

Compounded medicines are widely used, especially for pediatric patients. The aim of this study was to evaluate children's acceptability of compounded preparations and to provide information regarding compounding practices' characteristics in a Romanian hospital setting. An observational, cross-sectional, and retrospective study was conducted in three Clinical Pediatric Departments (Emergency Clinical Hospital for Children, Cluj-Napoca). The study population comprised patients under 18 years old taking at least one compounded medication. Study data was collected mainly through an interviewer-administered questionnaire and medicine acceptability was assessed based on the children's first reaction to the preparations using a 3-point facial hedonic scale. A total of 162 compounded medications were evaluated. A positive/negative reaction was reported for 20.83%/58.33%, 20.63%/49.21%, and 66.67%/7.41% of oral, oromucosal and cutaneous dosage forms. Although patient disapproval was recorded for various reasons, medication administration was successful in over 75% of cases. Factors such as fewer steps required for intake of a dose, capsule dosage form, no additional food/drink immediately after drug intake, medication perceived as "easy/very easy" to swallow, were correlated with a better acceptability of oral preparations. This study highlights the importance of identifying factors that can improve the acceptability of compounded preparations and, subsequently, treatment outcomes in pediatric patients.

2.
J Clin Med ; 12(8)2023 Apr 12.
Article in English | MEDLINE | ID: mdl-37109167

ABSTRACT

Electronic nose (e-nose) is a new technology applied for the identification of volatile organic compounds (VOC) in breath air. Measuring VOC in exhaled breath can adequately identify airway inflammation, especially in asthma. Its noninvasive character makes e-nose an attractive technology applicable in pediatrics. We hypothesized that an electronic nose could discriminate the breath prints of patients with asthma from controls. A cross-sectional study was conducted and included 35 pediatric patients. Eleven cases and seven controls formed the two training models (models A and B). Another nine cases and eight controls formed the external validation group. Exhaled breath samples were analyzed using Cyranose 320, Smith Detections, Pasadena, CA, USA. The discriminative ability of breath prints was investigated by principal component analysis (PCA) and canonical discriminative analysis (CDA). Cross-validation accuracy (CVA) was calculated. For the external validation step, accuracy, sensitivity and specificity were calculated. Duplicate sampling of exhaled breath was obtained for ten patients. E-nose was able to discriminate between the controls and asthmatic patient group with a CVA of 63.63% and an M-distance of 3.13 for model A and a CVA of 90% and an M-distance of 5.55 for model B in the internal validation step. In the second step of external validation, accuracy, sensitivity and specificity were 64%, 77% and 50%, respectively, for model A, and 58%, 66% and 50%, respectively, for model B. Between paired breath sample fingerprints, there were no significant differences. An electronic nose can discriminate pediatric patients with asthma from controls, but the accuracy obtained in the external validation was lower than the CVA obtained in the internal validation step.

3.
Materials (Basel) ; 15(22)2022 Nov 09.
Article in English | MEDLINE | ID: mdl-36431389

ABSTRACT

The present research is focused on three different classes of orthodontic cements: resin composites (e.g., BracePaste); resin-modified glass ionomer RMGIC (e.g., Fuji Ortho) and resin cement (e.g., Transbond). Their mechanical properties such as compressive strength, diametral tensile strength and flexural strength were correlated with the samples' microstructures, liquid absorption, and solubility in liquid. The results show that the best compressive (100 MPa) and flexural strength (75 Mpa) was obtained by BracePaste and the best diametral tensile strength was obtained by Transbond (230 MPa). The lowestvalues were obtained by Fuji Ortho RMGIC. The elastic modulus is relatively high around 14 GPa for BracePaste, and Fuji Ortho and Transbond have only 7 GPa. The samples were also subjected to artificial saliva and tested in different acidic environments such as Coca-Cola and Red Bull. Their absorption and solubility were investigated at different times ranging from 1 day to 21 days. Fuji Ortho presents the highest liquid absorption followed by Transbond, the artificial saliva has the best absorption and Red Bull has the lowest absorption. The best resistance to the liquids was obtained by BracePaste in all environments. Coca-Cola presents values four times greater than the ones observed for artificial saliva. Solubility tests show that BracePaste is more soluble in artificial saliva, and Fuji Ortho and Transbond are more soluble in Red Bull and Coca-Cola. Scanning electron microscopy (SEM) images evidenced a compact structure for BracePaste in all environments sustaining the lower liquid absorption values. Fuji Ortho and Transbond present a fissure network allowing the liquid to carry out in-depth penetration of materials. SEM observations are in good agreement with the atomic force microscopy (AFM) results. The surface roughness decreases with the acidity increasing for BracePaste meanwhile it increases with the acidity for Fuji Ortho and Transbond. In conclusion: BracePaste is recommended for long-term orthodontic treatment for patients who regularly consume acidic beverages, Fuji Ortho is recommended for short-term orthodontic treatment for patients who regularly consume acidic beverages and Transbond is recommended for orthodontic treatment over an average time period for patients who do not regularly consume acidic beverages.

4.
Front Bioeng Biotechnol ; 9: 703268, 2021.
Article in English | MEDLINE | ID: mdl-34368097

ABSTRACT

Here we show that surface-enhanced Raman scattering (SERS) analysis captures the relative hypomethylation of DNA from patients with acute leukemia associated with Down syndrome (AL-DS) compared with patients diagnosed with transient leukemia associated with Down syndrome (TL-DS), an information inferred from the area under the SERS band at 1005 cm-1 attributed to 5-methycytosine. The receiver operating characteristic (ROC) analysis of the area under the SERS band at 1005 cm-1 yielded an area under the curve (AUC) of 0.77 in differentiating between the AL-DS and TL-DS groups. In addition, we showed that DNA from patients with non-DS myeloproliferative neoplasm (non-DS-MPN) is hypomethylated compared to non-DS-AL, the area under the SERS band at 1005 cm-1 yielding an AUC of 0.78 in separating between non-DS-MPN and non-DS-AL. Overall, in this study, the area of the 1005 cm-1 DNA SERS marker band shows a stepwise decrease in DNA global methylation as cells progress from a pre-leukemia to a full-blown acute leukemia, highlighting thus the potential of SERS as an emerging method of analyzing the methylation landscape of DNA in the context of leukemia genesis and progression.

5.
Vaccine ; 39(19): 2643-2651, 2021 05 06.
Article in English | MEDLINE | ID: mdl-33858718

ABSTRACT

BACKGROUND: We assessed the 10-year efficacy, immunogenicity and safety of two doses of a combined measles-mumps-rubella-varicella vaccine (MMRV) or one dose of a monovalent varicella vaccine (V) in children from Czech Republic, Lithuania, Poland, Romania and Slovakia. METHODS: This was a phase IIIB follow-up of an observer-blind, randomized, controlled trial (NCT00226499). In phase A, healthy children aged 12-22 months from 10 European countries were randomized in a 3:3:1 ratio to receive two doses of MMRV (MMRV group), one dose of MMR followed by one dose of V (MMR + V group), or two doses of MMR (MMR; control group), 42 days apart. Vaccine efficacy (VE) against varicella (confirmed by viral DNA detection or epidemiological link and clinical assessment) was calculated with 95% confidence intervals using Cox proportional hazards regression model. Immunogenicity was assessed as seropositivity rates and geometric mean concentrations (GMCs). Solicited and unsolicited adverse events (AEs) and serious AEs (SAEs) were recorded. RESULTS: A total of 3705 children were vaccinated (1590, MMRV group; 1586, MMR + V group; 529, MMR group). There were 663 confirmed varicella cases (47, MMRV group; 349, MMR + V group; 267, MMR group). VE ranged between 95.4% (Lithuania) and 97.4% (Slovakia) in the MMRV group and between 59.3% (Lithuania) and 74% (Slovakia) in the MMR + V group. At year 10, seropositivity rates were 99.5%-100% in the MMRV group, 98%-100% in the MMR + V group and 50%-100% in the MMR control group, and the anti-VZV antibody GMCs were comparable between MMRV and MMR + V groups. The occurrence of solicited and unsolicited AEs was similar across groups and no SAE was considered as vaccination-related. No new safety concerns were identified. CONCLUSIONS: Our results indicated that two doses of varicella zoster virus-containing vaccine provided better protection than one dose against varicella and induced antibody responses that persisted 10 years post-vaccination.


Subject(s)
Measles , Mumps , Rubella , Antibodies, Viral , Chickenpox Vaccine/adverse effects , Child , Czech Republic , Europe , Follow-Up Studies , Humans , Infant , Measles-Mumps-Rubella Vaccine , Poland , Romania , Rubella/prevention & control , Slovakia , Vaccines, Combined/adverse effects
6.
Med Ultrason ; 23(2): 153-160, 2021 May 20.
Article in English | MEDLINE | ID: mdl-33626119

ABSTRACT

AIM: To evaluate the value of abdominal ultrasonography (US) in the follow-up of paediatric patients with ulcerative colitis (UC) compared to faecal calprotectin (FC) and colonoscopy. MATERIAL AND METHOD: In this retrospective study we enrolled 30 paediatric patients previously diagnosed with UC, examined by abdominal US and colonoscopy within the same week. FC was also determined during the same week. Disease activity was established using the paediatric ulcerative colitis activity index (PUCAI). The global endoscopic activity was evaluated using the Mayo endoscopic subscore. RESULTS: Endos-copy revealed pathological findings of active disease in 27 out of 30 patients; 3 patients were in endoscopic remission. Only 18 of them had clinical active disease (PUCAI >10), [sensitivity (Se) 66.7% and specificity (Sp) 33% of PUCAI in detecting endoscopic active disease). Twenty-three (76.7%) patients had FC >250 mcg/g, but in 2 of these cases the colonoscopy was normal (Se 77.8% and Sp 33.3% in detecting active disease). At US examination, pathological findings (increased bowel wall thickness, hypervascularity, lymphadenopathies, and/or mesenteric inflammatory fat) were found in 27 patients (90%), all with endoscopic active disease (agreement US - colonoscopy, at patient level, k=1.0, p<0.001, Se 100% and Sp 100%). At seg-ment level (totally 180 bowel segments examined by US), the overall agreement between US and colonoscopy was k=0.767, p<0.001, Se 86.5%, Sp 90.1%. Of the 27 patients with US pathological findings in any of colonic segments, 23 had FC >250 mcg/g (85.1%). The inter-observer agreement for the US measurements had an overall ICC of 0.926 with p<0.001. CONCLUSION: Abdominal US findings demonstrate a good to excellent concordance with endoscopic examination and are correlated with elevated FC levels. Therefore, US appears as an accurate technique in assessing activity in patients with UC and might replace colonoscopic evaluation for the follow-up.


Subject(s)
Colitis, Ulcerative , Abdomen , Biomarkers/analysis , Child , Colitis, Ulcerative/diagnostic imaging , Colonoscopy , Feces , Humans , Leukocyte L1 Antigen Complex , Retrospective Studies , Severity of Illness Index , Ultrasonography
7.
Pediatr Res ; 89(7): 1798-1803, 2021 05.
Article in English | MEDLINE | ID: mdl-32937648

ABSTRACT

BACKGROUND: Assessing the inflammation is important in the follow-up of paediatric patients with inflammatory bowel disease (IBD). We aim to evaluate the value of B cell-activating factor (BAFF) in paediatric IBD as a potential biomarker for follow-up. METHOD: We determined BAFF in serum and faeces and faecal calprotectin (CP) in 32 IBD children-16 Crohn's disease (CD) and 16 ulcerative colitis (UC). Twenty-six healthy children and 10 children with irritable bowel syndrome (IBS) were included as controls. RESULTS: No differences were found in serum BAFF between IBD, IBS, and healthy group: 1037.35, 990.9 and 979.8 pg/ml, respectively, all p > 0.05, but faecal BAFF was higher in the IBD group: 15.1, 8.5 and 8.2 pg/ml, respectively, p < 0.05, and higher in the UC group (55.975 pg/ml) compared to the CD group (10.95 pg/ml), p = 0.015. Splitting the IBD group in relation to the CP level, the serum BAFF had no significantly different values between the subgroups, but the faecal BAFF was significantly higher in the >250 µg/g subgroup. Cut-off values of BAFF were calculated. CONCLUSION: Faecal BAFF is a promising marker for monitoring the children with IBD, higher levels of BAFF being correlated with high CP. IMPACT: Faecal BAFF is a promising marker in monitoring the children with IBD, higher levels of BAFF being correlated with high faecal calprotectin. To our knowledge, this is the first paediatric study concerning BAFF evaluation in IBD. Faecal BAFF levels could be considered a potential non-invasive marker in monitoring IBD activity in paediatric population with clinically mild or inactive disease.


Subject(s)
B-Cell Activating Factor/metabolism , Inflammatory Bowel Diseases/metabolism , Adolescent , Biomarkers/metabolism , Case-Control Studies , Child , Child, Preschool , Female , Humans , Male , Prospective Studies
8.
Environ Geochem Health ; 43(1): 585-599, 2021 Jan.
Article in English | MEDLINE | ID: mdl-33070230

ABSTRACT

It is well known and proven that heavy metal contamination of the soils can severely affect the health of the people living in the contaminated areas given the ease with which trace elements can enter the human body. In addition-to agricultural crop depreciation as well as soil erosion, soil pollution can negatively affect the natural function of ecosystems. While certain heavy metals in high doses can be harmful to the body, others such as cadmium, mercury, lead, chromium, silver and arsenic in minimal amounts have delusional effects on the body, causing acute and chronic intoxication. Our research is focused on the identification of heavy metals from the soil (O, Al, Ca, Cu, Fe, K, Mg, Na, P, Pb, Si, Ti, Zn) in 3 areas in Transylvania where factories were in operation, using 4 methods: UV-VIS spectrometry, AAS, SEM-EDAX and X-ray diffractions. High levels of very toxic trace elements such as lead, aluminum, cadmium were found near the studied areas, especially using SEM-EDAX and AAS methods. Knowledge on the soil concentration of TEs, the time exposure and the side effects can lead us to predict the health status of the exposed population. In our study, by determinating the concentration of TEs we set out to formulate a prediction on the health status of the exposed population using literature data.


Subject(s)
Environmental Exposure/analysis , Health Status , Metals, Heavy/analysis , Soil Pollutants/analysis , Ecosystem , Environmental Exposure/adverse effects , Environmental Monitoring/methods , Humans , Metals, Heavy/toxicity , Romania , Soil/chemistry , Soil Pollutants/toxicity , Trace Elements/analysis , Trace Elements/toxicity
9.
Cell Physiol Biochem ; 54(5): 994-1012, 2020 Oct 03.
Article in English | MEDLINE | ID: mdl-33006449

ABSTRACT

BACKGROUND/AIMS: Down syndrome associated disorders are caused by a complex genetic context where trisomy 21 is a central component in relation to other changes involving epigenetic regulators and signaling molecules. This unique genetic context is responsible for the predisposition of people with Down syndrome to acute leukemia. Although, the research in this field has discovered some important pathogenic keys, the exact mechanism of this predisposition is not known. METHODS: In this study we applied functional enrichment analysis to evaluate the interactions between genes localized on chromosome 21, genes already identify as having a key role in acute leukemia of Down syndrome, miRNAs and signaling pathways implicated in cancer and cell development and found that miR-155 has a high impact in genes present on chromosome 21. Forward, we performed next generation sequencing on DNA samples from a cohort of patients diagnosed with acute leukemia of Down syndrome and in vitro functional assay using a CMK-86 cell line, transfected with either mimic or inhibitor of the microRNA-155-5p. RESULTS: Our results show that the epigenetic alteration of the TNF superfamily receptors in Down syndrome, which can be correlated to microRNA-155-5p aberrant activity, may play an important role in cell signaling and thus be linked to acute myeloid leukemia. CONCLUSION: Some genes, already shown to be mutated in AML-DS, are potential targets for miR-155. Our results show that the epigenetic alteration of the TNF superfamily receptors in Down syndrome may play an important role in cell signaling and thus be linked to acute myeloid leukemia.


Subject(s)
Down Syndrome/complications , Epigenesis, Genetic , Gene Expression Regulation, Leukemic , Leukemia, Myeloid, Acute/pathology , Leukemoid Reaction/pathology , MicroRNAs/genetics , Receptors, Tumor Necrosis Factor/genetics , Cell Differentiation , Cohort Studies , Down Syndrome/etiology , Down Syndrome/genetics , Down Syndrome/metabolism , Down Syndrome/pathology , Female , High-Throughput Nucleotide Sequencing , Humans , Leukemia, Myeloid, Acute/etiology , Leukemia, Myeloid, Acute/metabolism , Leukemoid Reaction/etiology , Leukemoid Reaction/metabolism , Male , Receptors, Tumor Necrosis Factor/metabolism
10.
Article in English | MEDLINE | ID: mdl-32916790

ABSTRACT

Even though vitamin D is widely acknowledged as having a potential immunomodulatory role in asthma, its exact beneficial mechanisms are yet to be clarified. An optimal serum 25-hydroxy-vitamin D (25-OH-VitD) level in pediatric asthma patients might not rely solely on the effect of dose-dependent vitamin D3 intake, but might also be influenced by factors related to insufficient asthma control. We aimed to survey the prevalence of serum 25-OH-VitD deficiency and analyze whether suboptimal levels were associated with asthma severity factors. The current cross-sectional study enrolled 131 pediatric asthma or asthma-suggestive recurrent wheezing patients, for whom serum 25-OH-VitD, IgE, and eosinophil count were assessed. The prevalence of suboptimal serum 25-OH-VitD was 58.8%. A suboptimal vitamin D status was associated with asthma exacerbation in the previous month (p = 0.02). Even under seasonal oral vitamin D3 supplementation, patients with a positive history of asthma attack in the previous four weeks presented significantly lower serum 25-OH-VitD concentrations, compared to their peers with no disease exacerbation. In conclusion, sequential measurements of serum 25-OH-VitD might prove useful for future studies evaluating the dynamic changes in vitamin D3 status in regard to asthma, especially in symptomatic patients.


Subject(s)
Asthma , Vitamin D Deficiency , Asthma/drug therapy , Asthma/epidemiology , Child , Child, Preschool , Cross-Sectional Studies , Disease Progression , Female , Humans , Male , Respiratory Sounds , Risk , Vitamin D , Vitamin D Deficiency/epidemiology
11.
J BUON ; 25(6): 2737-2746, 2020.
Article in English | MEDLINE | ID: mdl-33455121

ABSTRACT

PURPOSE: Down syndrome (DS) or trisomy 21, brings together some unique aspects from clinical pediatrics. Among the hematological disorders present in DS, by far the most important is the predisposition for developing acute leukemia. Acute myeloid leukemia (AML) of DS has a preleukemic state with the onset in the neonatal period, rarely symptomatic but with the presence of blasts in peripheral blood smear and apparently a spontaneous remission. The unique tumor profile of DS underlines the importance of chromosome 21 in hematopoiesis and it can help understanding leukemogenesis in general. The purpose of this study was to present the very rare cases with DS and transient leukemia and/or acute leukemia that were found in a nationwide survey of Romania, in three centers of pediatric hematology and oncology. METHODS: A nationwide analysis of the very rare cases of transient leukemia of DS are described, involving the three major pediatric hematology centers of Romania: Cluj Napoca, Bucharest and Timisoara. Data analysis was performed using R 3.5.3. Categorical variables were presented as absolute value (percent). Contingency tables were analyzed using the Fisher test. Normality of the distribution was assessed using the Shapiro test and histogram visualization, but also took into consideration the sample size. Non-normally distributed variables were presented as median (quartile 1, quartile 3). Wilcoxon test was used to determine the differences between two non-normally distributed groups. A p value under 0.05 was considered statistically significant. RESULTS: It appears that the more aggressive entity at presentation is represented by CD45 positive leukemia, which is the more frequent of the myeloid lineage and has lower counts at diagnosis. CONCLUSION: We address this manuscript to pediatricians and neonatologists in order to emphasize the importance of diagnosing hematological disorders in children with DS, especially neonates, even if they are asymptomatic.


Subject(s)
Down Syndrome/complications , Leukemia, Myeloid, Acute/etiology , Child, Preschool , Cohort Studies , Female , Humans , Leukemia, Myeloid, Acute/physiopathology , Male
12.
World J Clin Cases ; 7(18): 2666-2674, 2019 Sep 26.
Article in English | MEDLINE | ID: mdl-31616683

ABSTRACT

Irritable bowel syndrome (IBS) is a lifelong condition with a high prevalence among children and adults. As the diet is a frequent factor that triggers the symptoms, it has been assumed that by avoiding the consumption of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP), the symptoms might be improved. Therefore, in the past decade, low FODMAP diet has been intensively investigated in the management of IBS. The capacity of FODMAPs to trigger the symptoms in patients with IBS was related to the stimulation of mechanoreceptors in the small and large intestine. This stimulation appears as a response to a combination of increased luminal water (the osmotic effect) and the release of gases (carbon dioxide and hydrogen) due to the fermentation of oligosaccharides and malabsorption of fructose, lactose and polyols. Numerous studies have been published regarding the efficacy of a low FODMAP diet compared to a traditional diet in releasing the IBS symptoms in adults, but there are only a few studies in the juvenile population. The aim of this review is to analyze the current data on both low FODMAP diet in children with IBS and the effects on their nutritional status and physiological development, given the fact that it is a restrictive diet.

13.
J Clin Med ; 8(8)2019 Aug 06.
Article in English | MEDLINE | ID: mdl-31390838

ABSTRACT

During recent decades, understanding of the molecular mechanisms of acute lymphoblastic leukemia (ALL) has improved considerably, resulting in better risk stratification of patients and increased survival rates. Age, white blood cell count (WBC), and specific genetic abnormalities are the most important factors that define risk groups for ALL. State-of-the-art diagnosis of ALL requires cytological and cytogenetical analyses, as well as flow cytometry and high-throughput sequencing assays. An important aspect in the diagnostic characterization of patients with ALL is the identification of the Philadelphia (Ph) chromosome, which warrants the addition of tyrosine kinase inhibitors (TKI) to the chemotherapy backbone. Data that support the benefit of hematopoietic stem cell transplantation (HSCT) in high risk patient subsets or in late relapse patients are still questioned and have yet to be determined conclusive. This article presents the newly published data in ALL workup and treatment, putting it into perspective for the attending physician in hematology and oncology.

14.
Crit Rev Clin Lab Sci ; 56(4): 247-259, 2019 06.
Article in English | MEDLINE | ID: mdl-31043105

ABSTRACT

Childhood leukemia is mostly a "developmental accident" during fetal hematopoiesis and may require multiple prenatal and postnatal "hits". The World Health Organization defines transient leukemia of Down syndrome (DS) as increased peripheral blood blasts in neonates with DS and classifies this type of leukemia as a separate entity. Although it was shown that DS predisposes children to myeloid leukemia, neither the nature of the predisposition nor the associated genetic lesions have been defined. Acute myeloid leukemia of DS is a unique disease characterized by a long pre-leukemic, myelodysplastic phase, unusual chromosomal findings and a high cure rate. In the present manuscript, we present a comprehensive review of the literature about clinical and biological findings of transient leukemia of DS (TL-DS) and link them with the genetic discoveries in the field. We address the manuscript to the pediatric generalist and especially to the next generation of pediatric hematologists.


Subject(s)
Down Syndrome/complications , Leukemoid Reaction/complications , Down Syndrome/genetics , Down Syndrome/therapy , Genetic Predisposition to Disease , Humans , Leukemoid Reaction/genetics , Leukemoid Reaction/therapy
15.
Lancet Infect Dis ; 19(3): 287-297, 2019 03.
Article in English | MEDLINE | ID: mdl-30765242

ABSTRACT

BACKGROUND: The duration of protection provided by varicella vaccines is unclear. We assessed the 10-year vaccine efficacy of two doses of a combined measles-mumps-rubella-varicella vaccine (MMRV), one live attenuated varicella vaccine (V) dose given after one measles-mumps-rubella vaccine (MMR) dose (MMR + V), versus two MMR doses (control vaccine) for the prevention of confirmed varicella. METHODS: This was a phase 3b follow-up of an observer-blinded, randomised, controlled trial. In phase a, children aged 12-22 months (at first vaccination) from Czech Republic (Czechia), Greece, Italy, Lithuania, Norway, Poland, Romania, Russia, Slovakia, and Sweden were randomly assigned by computer-generated randomisation list (3:3:1) to receive two doses of MMRV, one dose of MMR and one dose of varicella vaccine, or two doses of MMR, 42 days apart. Varicella cases were confirmed by detection of viral DNA, or epidemiological link and clinical assessment, by an independent data monitoring committee; disease severity was based on a modified Vázquez scale. Hazard ratios for MMRV and MMR + V versus MMR estimated in the per-protocol cohort using a Cox proportional hazards regression model were used to calculate vaccine efficacy and 95% CI. Serious adverse events were recorded throughout the study in all vaccinated children. Study objectives were secondary and descriptive. The trial is registered at ClinicalTrials.gov, number NCT00226499. FINDINGS: Between Sept 1, 2005, and May 10, 2006, 5803 children (mean age 14·2 months, SD 2·5) were vaccinated. The per-protocol cohort included 2279 children from the MMRV group, 2266 from the MMR + V group, and 744 from the MMR group. From baseline to a median follow-up of 9·8 years, 76 (3%) children in the MMRV group, 469 (21%) in the MMR + V group, and 352 (47%) in the MMR group had varicella. Vaccine efficacy against all varicella was 95·4% (95% CI 94·0-96·4) for MMRV and 67·2% (62·3-71·5) for MMR + V; vaccine efficacy against moderate or severe varicella was 99·1% (97·9-99·6) for MMRV and 89·5% (86·1-92·1) for MMR + V. During phase b, serious adverse events were reported by 290 (15%) of 1961 children in the MMRV group, 317 (16%) of 1978 in the MMR + V group, and 93 (15%) of 641 in the MMR group. There were no treatment-related deaths. INTERPRETATION: The 10-years vaccine efficacy observed, suggests that a two-dose schedule of varicella vaccine provided optimum long-term protection for the prevention of varicella by offering individual protection against all severities of disease and leading to a potential reduction in transmission, as observed in the US experience with universal mass vaccination. FUNDING: GlaxoSmithKline Biologicals.


Subject(s)
Chickenpox Vaccine/immunology , Chickenpox/prevention & control , Chickenpox Vaccine/administration & dosage , Chickenpox Vaccine/adverse effects , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/pathology , Europe , Female , Follow-Up Studies , Humans , Immunization Schedule , Infant , Male , Single-Blind Method , Treatment Outcome , Vaccines, Combined/administration & dosage , Vaccines, Combined/adverse effects , Vaccines, Combined/immunology
16.
Expert Rev Vaccines ; 18(3): 281-293, 2019 03.
Article in English | MEDLINE | ID: mdl-30810402

ABSTRACT

INTRODUCTION: Vaccination against varicella rapidly reduces disease incidence, resulting in reductions in both individual burden and societal costs. Despite these benefits, there is no standardization of varicella immunization policies in Europe, including countries in Central and Eastern Europe (CEE). AREAS COVERED: This systematic literature review identified publications on the epidemiology of varicella, its associated health and economic burden, and vaccination strategies within the CEE region, defined as Albania, Bosnia-Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Serbia, Slovakia, and Slovenia. Twenty-six studies were identified from a search of PubMed, Embase®, and MEDLINE® biomedical literature databases, supplemented by gray literature and country-specific/global websites. EXPERT COMMENTARY: Limited information exists in published studies on the burden of varicella in CEE. The wide variability in incidence rates between countries is likely explained by a lack of consistency in reporting systems. Funded universal varicella vaccination (UVV) in CEE is currently available only in Latvia as a one-dose schedule, but Hungary together with Latvia are introducing a two-dose strategy in 2019. For countries that do not provide UVV, introduction of vaccination is predicted to provide substantial reductions in cases and rates of associated complications, with important economic benefits.


Subject(s)
Chickenpox Vaccine/administration & dosage , Chickenpox/epidemiology , Vaccination/statistics & numerical data , Chickenpox/economics , Chickenpox/prevention & control , Cost of Illness , Europe/epidemiology , Europe, Eastern/epidemiology , Health Policy , Humans , Incidence
17.
Cardiovasc J Afr ; 29(5): 322-330, 2018.
Article in English | MEDLINE | ID: mdl-29750230

ABSTRACT

Peripheral arterial disease (PAD) represents a major public health problem due to its high and increasing prevalence, worldwide distribution, and significant morbidity and mortality rate. Female gender is a risk factor for PAD globally and especially in low-income countries. In this review, we summarise the present knowledge regarding the role of novel atherosclerosis markers in the development of PAD in women. We discuss inflammatory markers, cytokines, cellular adhesion molecules, markers of oxidative stress and other circulating markers, and their role in the prediction of presence, severity and complications of PAD, with particular emphasis on gender. Although many PAD biomarkers are indicative of PAD in both males and females, some are strongly correlated with the disease in females. These gender differences could be useful for the early identification and management of PAD in women.


Subject(s)
Biomarkers/blood , Peripheral Arterial Disease/blood , Plaque, Atherosclerotic , Cell Adhesion Molecules/blood , Cytokines/blood , Female , Humans , Inflammation Mediators/blood , Male , Oxidative Stress , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/epidemiology , Peripheral Arterial Disease/therapy , Predictive Value of Tests , Prevalence , Prognosis , Risk Factors , Severity of Illness Index , Sex Factors
18.
Int Orthop ; 42(10): 2437-2442, 2018 10.
Article in English | MEDLINE | ID: mdl-29732492

ABSTRACT

PURPOSE: The aim of the study was to evaluate the role of joint hyperlaxity (by Beighton score) as a protective factor for clubfoot relapse. METHODS: Patients with idiopathic clubfoot treated with the Ponseti method between January 2004 and December 2012, without other congenital foot deformity, and not previously treated by open surgery were included in either the Relapse group (n = 23) if it was a clubfoot relapse or the Control group (n = 19) if no relapse was noted. Joint laxity was evaluated using the Beighton score at the latest follow-up against the Normal group (n = 22, children matched by sex and age without clubfoot deformity). RESULTS: We found a significantly higher joint laxity in the Control group (4.58, 95% confidence interval [CI]: 2.1-7.06) as compared to the Relapse (3.17, 95% CI: 1.53-4.81, p = 0.032) and Normal (3.14, 95% CI: 1.78-4.5, p = 0.03) groups. The univariate logistic regression showed a 5.28-times increase in the risk of relapse for a Beighton score lower than 4/9 points (odds ratio = 5.28; 95% CI = 1.29-21.5; p = 0.018). CONCLUSIONS: Joint hyperlaxity could be a protective factor for clubfoot relapse.


Subject(s)
Clubfoot/therapy , Joint Instability/epidemiology , Orthopedic Procedures/methods , Braces/adverse effects , Child , Child, Preschool , Clubfoot/complications , Female , Humans , Infant , Joint Instability/complications , Joint Instability/therapy , Male , Orthopedic Procedures/adverse effects , Prospective Studies , Recurrence , Treatment Outcome
19.
Clujul Med ; 91(1): 53-57, 2018.
Article in English | MEDLINE | ID: mdl-29440952

ABSTRACT

BACKGROUND AND AIMS: Community-acquired pneumonia (CAP) is a both common and serious childhood infection. Antibiotic treatment guidelines help to reduce inadequate antibiotics prescriptions. METHODS: We conducted a retrospective study at the Clinical Emergency Hospital for Children, 3rd Pediatric Clinic, Cluj-Napoca and Dr. Gavril Curteanu Clinical City Hospital, in Oradea. All patients discharged with a diagnosis of CAP between December 1, 2014 and February 28, 2015, were included in the study. RESULTS: There were 146 cases discharged with pneumonia in Cluj-Napoca center (mean age 4 years; range: 1 month - 16 years), and 212 cases in Oradea center (mean age 0.9 years; range: 2 weeks - 8 years). All cases were analyzed. The analysis made in Clinical Emergency Hospital for Children, 3rd Pediatric Clinic, Cluj-Napoca, showed that the antibiotics used in children hospitalized with community-acquired CAP are cefuroxime (43%), ceftriaxone (23%), macrolides (16%), ampicillin in association with an aminoglycoside (6%) and other antibiotics. The same antibiotics were used in Dr. Gavril Curteanu Clinical City Hospital of Oradea, where ampicillin in association with aminoglycoside was utilized in younger children (mean age 1.3 years), while ceftriaxone in older children (5.7 years) and children with high inflammation markers (ESR, CRP). From 11 pleurisy cases, 9 received cefuroxime or ceftriaxone. CONCLUSIONS: There was a wide variability in CAP antibiotic treatment across university hospitals, regarding antibiotic choice and dosing. Antibiotic selection was not always related to the clinical and laboratory characteristics of the patient. The national guideline was not followed, especially in children aged one to three months.

20.
Med Ultrason ; 19(4): 451-453, 2017 Nov 29.
Article in English | MEDLINE | ID: mdl-29197924

ABSTRACT

AL-amyloidosis is a rare, but complex disease, with a severe prognosis, cardiac involvement being found in half of the patients. The rapid increase of the LV wall thickness predicts an unfavorable evolution. We report the case of a 63-year-old man diagnosed with AL-amyloidosis, with cardiac involvement, associated with multiple site thrombosis.  Specific echocardiographic methods like tissue Doppler imaging and speckle tracking provided crucial diagnostic and prognostic information.


Subject(s)
Disease Progression , Echocardiography/methods , Immunoglobulin Light-chain Amyloidosis/complications , Immunoglobulin Light-chain Amyloidosis/diagnostic imaging , Thrombosis/complications , Humans , Male , Middle Aged
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