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Handzhiev D.D.,Anna University | Kalevski S.K.,Anna University | Handzhieva S.V.,University Hospital St Marina | Dzhenkov D.L.,Medical University-Varna | Salieva- Badi S.,Anna University
Journal of Clinical Neuroscience | Year: 2017

This case report describes destruction of overlying dura and calvaria by a low grade glioma in the absence of prior surgery or radiation. Bone and dural involving is known to occur with some malignant tumors, but due to low grade glioma is very rare.The initial radiologic examinations demonstrated a heterogeneous mass in the right parietal region with both extra- and intra-axial components. No inward displacement of the adjacent dura was observed. Initial consideration for extra-axial lesions includes metastatic lesions, lymphoma, or an aggressive meningioma. The pathologic findings demonstrated a glial cell origin.To our knowledge, destruction of the dura and calvaria from a low-grade glioma, without prior surgery or radiation, has not been well documented previously. Calvarial destruction with associated intra-axial lesions on imaging may prompt the diagnosis of extra-axial tumors such as aggressive meningiomas, metastasis and lymphoma.We report an unusual case of parietal low-grade glioma with destruction of the dura and calvaria in the absence of prior surgery or radiation. The erosion probably is due to pressure atrophy of the dura and inner table and thinning of the diploe.The mechanism of skull erosion in these superficial gliomas relates to their chronic mass effect (8). The mass displaces the CSF, which normally cushions and diffuses brain pulsations over a wide area. Once the CSF space is effaced, the brain may directly transmit these pulsations to the inner table. Over time, this localized elevated pressure may erode the cortical bone of the inner table. © 2017 Elsevier Ltd.


PubMed | Wojewodzki Szpital Zespolony, NZOZ Osteo Medic, Rush University Medical Center, Ivano Frankivsk Regional Clinical Hospital and 8 more.
Type: | Journal: Arthritis research & therapy | Year: 2016

CT-P13 (Remsima, Inflectra) is a biosimilar of the infliximab reference product (RP; Remicade). The aim of this study was to compare the 54-week efficacy, immunogenicity, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of CT-P13 and RP in patients with active rheumatoid arthritis (RA).In this multinational phase III double-blind study, patients with active RA and an inadequate response to methotrexate (MTX) were randomized (1:1) to receive CT-P13 (3 mg/kg) or RP (3 mg/kg) at weeks 0, 2, 6 and then every 8 weeks to week 54 in combination with MTX (12.5-25 mg/week). Efficacy endpoints included American College of Rheumatology (ACR)20, ACR50 and ACR70 response rates, Disease Activity Score in 28 joints (DAS28), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), European League Against Rheumatism (EULAR) response rates, patient-reported outcomes and joint damage progression. Immunogenicity, safety and PK/PD outcomes were also assessed.Of 606 randomized patients, 455 (CT-P13 233, RP 222) were treated up to week 54. At week 54, ACR20 response rate was highly similar between groups (CT-P13 74.7 %, RP 71.3 %). ACR50 and ACR70 response rates were also comparable between groups (CT-P13 43.6 % and 21.3 %, respectively; RP 43.1 % and 19.9 %, respectively). DAS28, SDAI and CDAI decreased from baseline to week 54 to a similar extent with CT-P13 and RP. Radiographic progression measured by Sharp scores as modified by van der Heijde was also comparable. With both treatments, patient assessments of pain, disease activity and physical ability, as well as mean scores on the Medical Outcomes Study Short Form Health Survey (SF-36), improved markedly at week 14 and remained stable thereafter up to week 54. The proportion of patients positive for antidrug antibodies at week 54 was similar between the two groups: 41.1 % and 36.0 % with CT-P13 and RP, respectively. CT-P13 was well tolerated and had a similar safety profile to RP. PK/PD results were also comparable between CT-P13 and RP.CT-P13 and RP were comparable in terms of efficacy (including radiographic progression), immunogenicity and PK/PD up to week 54. The safety profile of CT-P13 was also similar to that of RP.ClinicalTrials.gov identifier: NCT01217086 . Registered 4 Oct 2010.


Park W.,Inha University | Yoo D.H.,Hanyang University | Jaworski J.,Linea Corporis | Brzezicki J.,Wojewodzki Szpital Zespolony w Elblagu | And 11 more authors.
Arthritis Research and Therapy | Year: 2016

Background: CT-P13 (Remsima®, Inflectra®) is a biosimilar of the infliximab reference product (RP; Remicade®) and is approved in Europe and elsewhere, mostly for the same indications as RP. The aim of this study was to compare the 54-week efficacy, immunogenicity, pharmacokinetics (PK) and safety of CT-P13 with RP in patients with ankylosing spondylitis (AS), with a focus on patient-reported outcomes (PROs). Methods: This was a multinational, double-blind, parallel-group study in patients with active AS. Participants were randomized (1:1) to receive CT-P13 (5mg/kg) or RP (5mg/kg) at weeks 0, 2, 6 and then every 8weeks up to week 54. To assess responses, standardized assessment tools were used with an intention-to-treat analysis of observed data. Anti-drug antibodies (ADAs), PK parameters, and safety outcomes were also assessed. Results: Of 250 randomized patients (n = 125 per group), 210 (84.0%) completed 54weeks of treatment, with similar completion rates between groups. At week 54, Assessment of Spondylo Arthritis international Society (ASAS)20 response, ASAS40 response and ASAS partial remission were comparable between treatment groups. Changes from baseline in PROs such as mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI; CT-P13 -3.1 versus RP -2.8), Bath Ankylosing Spondylitis Functional Index (BASFI; -2.9 versus -2.7), and Short Form Health Survey (SF-36) scores (9.26 versus 10.13 for physical component summary; 7.30 versus 6.54 for mental component summary) were similar between treatment groups. At 54weeks, 19.5% and 23.0% of patients receiving CT-P13 and RP, respectively, had ADAs. All observed PK parameters of CT-P13 and RP, including maximum and minimum serum concentrations, were similar through 54weeks. The influence of ADAs on PK was similar in the two treatment groups. Most adverse events were mild or moderate in severity. There was no notable difference between treatment groups in the incidence of adverse events, serious adverse events, infections and infusion-related reactions. Conclusions: CT-P13 and RP have highly comparable efficacy (including PROs) and PK up to week 54. Over a 1-year period, CT-P13 was well tolerated and displayed a safety profile comparable to RP; no differences in immunogenicity were observed. © 2016 Park et al.


PubMed | Chungnam National University, University of Latvia, Hospital Central Dr Ignacio Morones Prieto, Linea Corporis and 10 more.
Type: | Journal: Arthritis research & therapy | Year: 2016

CT-P13 (Remsima, Inflectra) is a biosimilar of the infliximab reference product (RP; Remicade) and is approved in Europe and elsewhere, mostly for the same indications as RP. The aim of this study was to compare the 54-week efficacy, immunogenicity, pharmacokinetics (PK) and safety of CT-P13 with RP in patients with ankylosing spondylitis (AS), with a focus on patient-reported outcomes (PROs).This was a multinational, double-blind, parallel-group study in patients with active AS. Participants were randomized (1:1) to receive CT-P13 (5mg/kg) or RP (5mg/kg) at weeks 0, 2, 6 and then every 8weeks up to week 54. To assess responses, standardized assessment tools were used with an intention-to-treat analysis of observed data. Anti-drug antibodies (ADAs), PK parameters, and safety outcomes were also assessed.Of 250 randomized patients (n=125 per group), 210 (84.0%) completed 54weeks of treatment, with similar completion rates between groups. At week 54, Assessment of Spondylo Arthritis international Society (ASAS)20 response, ASAS40 response and ASAS partial remission were comparable between treatment groups. Changes from baseline in PROs such as mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI; CT-P13-3.1 versus RP -2.8), Bath Ankylosing Spondylitis Functional Index (BASFI; -2.9 versus -2.7), and Short Form Health Survey (SF-36) scores (9.26 versus 10.13 for physical component summary; 7.30 versus 6.54 for mental component summary) were similar between treatment groups. At 54weeks, 19.5% and 23.0% of patients receiving CT-P13 and RP, respectively, had ADAs. All observed PK parameters of CT-P13 and RP, including maximum and minimum serum concentrations, were similar through 54weeks. The influence of ADAs on PK was similar in the two treatment groups. Most adverse events were mild or moderate in severity. There was no notable difference between treatment groups in the incidence of adverse events, serious adverse events, infections and infusion-related reactions.CT-P13 and RP have highly comparable efficacy (including PROs) and PK up to week 54. Over a 1-year period, CT-P13 was well tolerated and displayed a safety profile comparable to RP; no differences in immunogenicity were observed.ClinicalTrials.gov identifier: NCT01220518 . Registered 4 October 2010.


Bliznakova D.,University Hospital St Marina
Pediatriya | Year: 2013

Proteinuria is one of the main clinical markers of renal disease. It is associated with the progression of the disease. The knowledge of the causesfor the proteinuria allowsto determine the approach and design an algorithm for management of a child with proteinuria. For deciphering this symptom it is necessary to differentiate between the transient and the permanent proteinuria and to have detailed knowledge of the conditions and diseases that can cause them. The present work is an example of analgorithm for management of children with proteinuria. The need for its elaboration is driven by the fact the chronic renal disorders become more common world wide and proteinuria, as one of the leading symptoms of their progression, deserves special attention.


Shivachev P.,University Hospital St Marina
Pediatriya | Year: 2013

Critical congenital heart malformation (CCHM) are a group of diseases with high morbidity and mortality and early diagnosis is crucial for treatment outcome. The low sensitivity of prenatal ultrasonography and neonatal clinical examination, require necessary of introduction universal newborn screening for early recognition of these diseases before dehospitalisation and onset of severe organ damage in newborns. In recent years the pulse oximetry screening (POS) is established in many countries in Europe and America as highly specific, moderate sensitive and reasonable cost method for early detection of CCHM.


Chervenkov T.,University Hospital St Marina | Shishkov R.,Medical University-Varna | Tonchev A.B.,Medical University-Varna
Neurochemistry International | Year: 2013

A gene known as Cyclon (cytokine-induced protein with coiled-coil domain) or CCDC86 (coiled-coil domain-containing protein 86) is known for its expression in leukocytes in mice, where it regulates the immune response. We investigated whether Cyclon/CCDC68 is expressed in leukocytes of schizophrenia patients and whether it might be used as a biological marker for the disease endophenotype segregation. We examined the level of mRNA of Cyclon/CCDC68 in white blood cells obtained from schizophrenia patients in relapse and remission as well as in healthy controls. The mRNA of Cyclon/CCDC68 was expressed by white blood cells of both schizophrenia patients and healthy controls. There was a dichotomous change in the levels of Cyclon/CCDC68 of relapsed patients before and after treatment. High Cyclon/CCDC68 levels were associated with a recent disease and presence of psychotic symptoms, while low levels were associated with a long duration of the disease and an absence of psychotic symptoms. These data indicate that Cyclon/CCDC68 levels correlate with the clinical presentation of relapsed schizophrenia. Cyclon/CCDC68 might be involved in the immune system disturbances observed in schizophrenia. © 2013 Elsevier Ltd. All rights reserved.


Shivachev P.,University Hospital St Marina
Pediatriya | Year: 2014

Critical congenital heart diseases (CCHD) are group of malformations, which are connected to high morbidity and mortality rate, and early diagnosis is extremely important. The aim of this study was to assess the possibilities of the routine clinical examination for early determination of patients with CCHD. Patients and methods. Retrospectively are investigated 272 newborns and infants till three months of age with CCHD from the region of North-East Bulgaria for a period of 25 years (1987-2011). They were divided, according to a hemodynamic principle into three separate groups: obstructive lesions of the systemic circulation (OLSC)-103 children, obstructive lesions of the pulmonary circulation (OLPC) - 64 children and non-obstructive mixing cardiopathies (NOMC)-105 children. An analysis of the early clinical symptoms had been made, together with the location and the method of diagnosis, number of discharged newborns without an established cardiac malformation, and those with incorrect diagnosis. Results. The frequency of CCHD is 12.5 % out of all the congenital heart diseases (CHD). The mean time of initial clinical manifestation was 3.45 days, the mean age of which diagnosis was being made was 8.5 days. The most common first clinical symptom was cyanosis - 65%. In 21 % of the cases there was no audible heart murmur. Newborns with clinically manifested symptoms till the 4th day after birth (81.7%), had been diagnosed in 54% of the cases, which means that 27.7 % of the children remained undiagnosed. Latest clinical manifestation and diagnosis was established in children with OLSC and NOMC. The initial diagnosis was set most commonly in children's hospitals - 60%, and only 30% of the cases were diagnosed in Neonatology Departments. Without established heart disease are discharged 15.8% of newborns, and in 22% of the cases the initial diagnosis was incomplete or incorrect, mostly in patients with OLSC or NOMC. Conclusion. Clinical examination of newborns with CCHD is with unsatisfactory sensibility and often diagnosis is delayed, especially in cases with OLSC or NOMC. Screening programs are necessary for early identification of these patients and improving their prognosis.


Zheleva E.,University Hospital St Marina | Platikanov V.,University Hospital St Marina
Anaesthesiology and Intensive Care | Year: 2015

Introduction: The cannulation of central venous access is an important aspect of the treatment of patients regardless of age. In practice, the routine performance of this invasive manipulation is based on the presumptive location of the vessels, which is deemed to correspond to the identification of the anatomical markers known as the landmark technique. Despite the similarity of the vascular anatomy in different age groups the success rate of cannulation VJI using landmark technique in children under 1 year is 77%. The introduction of ultrasound technology in clinical practice allows a noninvasive way to visualize the target vein and cannulate undercontroll in real time. Objective: To analyze the benefit of the using ultrasound in cannulation jugular internal vein/JIV/by Seldinger technique in children under 5 years. Material and method: In 15 children aged from 20 days to 2years and 11 months, weighing from 2kg to 13 kg, ASA physical status III-IV were cannulated right JIV under Ultrasound control. Record: number of punctures made to achieve success, the success rate in the group, the time from the puncture to the aspiration of blood first in the syringe and subsequently through one of the ports of the catheter, as well as the complications. Record: the position of the vein in relation to the artery and it there's a match between the puncture point determined on the basis of Ultrasound and this of landmark technique at the level cartilage cricoideus. Results: The ultrasound-guided cannulationof JIV in real time was successful in all children. Conclusion: The Ultrasound-guided cannulation of JIV can increase saffety when cannulating children by improving the effectiveness and quality and reducing the risk of complications.


Bazdarska Y.R.,University Hospital St Marina | Bazdarska Y.R.,Medical University-Varna | Ribarov R.S.,University Hospital St Marina
Endokrinologya | Year: 2016

In the last two decades, continuous subcutaneous insulin infusion (CSII) became the gold standard for optimal control and improved quality of life in children and adolescents with type 1 diabetes mellitus (TI DM) and their families. The aim of this review paper is to summarize and highlight the benefits of insulin pump therapy (IPT) and future trends in the treatment of T1D in children and adolescents. The benefits of pump therapy are associated with the individualized approach to insulin regiments and lifestyle of patients. CSII achieved better metabolic control compared to basal-bolus regimen with pens in patients with T1D. The results of various studies show reduction of HbAlc, reducing the time spent in a state of hypoglycemia and episodes of acute complications requiring hospitalization. Continuous subcutaneous insulin infusion provides greater flexibility in the diet and daily routine of patients, active participation and greater responsibility of the patient towards the diabetes control. In that way it provides a reduction of future chronic complications and disability.

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