Radosevic B.,University of Banja Luka |
Bukara-Radujkovic G.,Clinical Center Banja Luka |
Miljkovic V.,Clinical Center Banja Luka |
Pejicic S.,University of Banja Luka |
And 2 more authors.
Pediatric Diabetes | Year: 2013
Objective: To establish and compare the incidence and trends of type 1 diabetes mellitus (T1DM) in Republic of Srpska and Slovenia in age group 0-18 yr from 1998 to 2010. Methods: The subjects (413 newly diagnosed T1DM patients in the Republic of Srpska and 664 in Slovenia) were grouped into the age groups: 0-4, 5-9, 10-14, and 15-18 yr. Confidence intervals (CI) for crude incidence rates were estimated assuming numbers of cases were counts from the Poisson distribution. Gender and age-specific standardization was done according to the EURODIAB criteria. Statistical analysis used Poisson-regression models to analyze difference rate between countries and to investigate the incidence trend. Results: Case ascertainment was estimated to be 99.95% for the Republic of Srpska and 100% for Slovenia by using the capture-recapture method. The standardized incidence of T1DM for age group 0-18 yr in the Republic of Srpska was 7.5/100 000/yr (95% CI: 6.8-8.3). For the same period and the same age group incidence in Slovenia was 12.5/100 000/yr (95% CI: 11.5-13.5). Annual increase in the incidence in the Republic of Srpska was 2.3% (95% CI: -0.3 to 5.0%), whereas in Slovenia 4.3% (95% CI: 2.2-6.5%). Conclusion: The incidence for age group 0-18 yr standardized to the world population is remarkably higher in Slovenia than in the Republic of Srpska. Further follow-up and investigations are needed to explain the high difference in incidence of T1DM between the two geographically related countries. © 2012 John Wiley & Sons A/S.
A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: The PLANETRA study
Yoo D.H.,Hanyang University |
Hrycaj P.,Poznan University of Medical Sciences |
Ramiterre E.,Brokenshire Memorial Hospital |
Piotrowski M.,Reumed |
And 12 more authors.
Annals of the Rheumatic Diseases | Year: 2013
Objectives To compare the efficacy and safety of innovator infliximab (INX) and CT-P13, an INX biosimilar, in active rheumatoid arthritis patients with inadequate response to methotrexate (MTX) treatment. Methods Phase III randomised, double-blind, multicentre, multinational, parallel-group study. Patients with active disease despite MTX (12.5-25 mg/week) were randomised to receive 3 mg/kg of CT-P13 (n=302) or INX (n=304) with MTX and folic acid. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 30. Therapeutic equivalence of clinical response according to ACR20 criteria was concluded if the 95% CI for the treatment difference was within ±15%. Secondary endpoints included ACR response criteria, European League Against Rheumatism (EULAR) response criteria, change in Disease Activity Score 28 (DAS28), Medical Outcomes Study Short-Form Health Survey (SF-36), Simplified Disease Activity Index, Clinical Disease Activity Index, as well as pharmacokinetic (PK) and pharmacodynamic (PD) parameters, safety and immunogenicity. Results At week 30, ACR20 responses were 60.9% for CT-P13 and 58.6% for INX (95% CI -6% to 10%) in the intention-to-treat population. The proportions in CT-P13 and INX groups achieving good or moderate EULAR responses (C reactive protein (CRP)) at week 30 were 85.8% and 87.1%, respectively. Low disease activity or remission according to DAS28-CRP, ACR-EULAR remission rates, ACR50/ACR70 responses and all other PK and PD endpoints were highly similar at week 30. Incidence of drug-related adverse events (35.2% vs 35.9%) and detection of antidrug antibodies (48.4% vs 48.2%) were highly similar for CT-P13 and INX, respectively. Conclusions CT-P13 demonstrated equivalent efficacy to INX at week 30, with a comparable PK profile and immunogenicity. CT-P13 was well tolerated, with a safety profile comparable with that of INX.
PubMed | University of Belgrade, Society of Young Serbian Neurologists and Clinical Center Banja Luka
Type: Journal Article | Journal: Journal of the peripheral nervous system : JPNS | Year: 2016
The aim of the study was to analyze specific features of Guillain-Barr syndrome (GBS) in old people. The study included 403 GBS patients (62% young [<60 years], 35% young-old [60-80 years], and 3% old-old [>80 years]). Diagnosis of GBS was made according to the National Institute of Neurological Disorders and Stroke (NINDS criteria). Severe disability (GBS disability score of >3) at nadir was more common in old compared with young patients (p = 0.0001) as was mortality (9% vs. 2%, respectively). Acute motor and sensory axonal neuropathy and hyponatremia were more common in old compared with young patients (12% vs. 6% and 27% vs. 18%, respectively, p = 0.04). A positive history for malignancy was more than three times more common in old than young patients (11% vs. 3%, respectively, p = 0.01). Disability on nadir was similar in young-old and old-old subjects with disability on discharge being more severe in old-old (p = 0.04) suggesting slower recovery in this subgroup. Bulbar symptoms were more common in old-old compared with young-old (50% vs. 19%, respectively, p = 0.01). Comorbidities were present in virtually all old-old patients compared with 66% of young-old patients (p = 0.04). In conclusion, Elderly patients, and especially old-old patients, with GBS have more severe disease with slower recovery than do younger patients.
Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study
PubMed | Ternopil State Medical University, Clinical Center Banja Luka, University of Chile, Lithuanian University of Health Sciences and 9 more.
Type: Journal Article | Journal: Annals of the rheumatic diseases | Year: 2016
To assess the efficacy and safety of switching from the infliximab reference product (RP; Remicade) to its biosimilar CT-P13 (Remsima, Inflectra) or continuing CT-P13 in patients with rheumatoid arthritis (RA) for an additional six infusions.This open-label extension study recruited patients with RA who had completed the 54-week, randomised, parallel-group study comparing CT-P13 with RP (PLANETRA; NCT01217086). CT-P13 (3mg/kg) was administered intravenously every 8weeks from weeks 62 to 102. All patients received concomitant methotrexate. Endpoints included American College of Rheumatology 20% (ACR20) response, ACR50, ACR70, immunogenicity and safety. Data were analysed for patients who received CT-P13 for 102weeks (maintenance group) and for those who received RP for 54weeks and then switched to CT-P13 (switch group).Overall, 302 of 455 patients who completed the PLANETRA study enrolled into the extension. Of these, 158 had received CT-P13 (maintenance group) and 144 RP (switch group). Response rates at week 102 for maintenance versus switch groups, respectively, were 71.7% vs 71.8% for ACR20, 48.0% vs 51.4% for ACR50 and 24.3% vs 26.1% for ACR70. The proportion of patients with antidrug antibodies was comparable between groups (week 102: 40.3% vs 44.8%, respectively). Treatment-emergent adverse events occurred in similar proportions of patients in the two groups during the extension study (53.5% and 53.8%, respectively).Comparable efficacy and tolerability were observed in patients who switched from RP to its biosimilar CT-P13 for an additional year and in those who had long-term CT-P13 treatment for 2years.NCT01571219; Results.
Grubor P.,Clinical Center Banja Luka
Medicinski arhiv | Year: 2012
Developmental hip disorder (DHD) is a disorder in development of the acetabulum which remains abrupt (dysplasia) and probably consequential cranialisation of the femur head (luxation). The aim of this paper is to establish the total number of DHD and its subtypes at the first clinical and ultrasound exam of newborns in a retrospective-prospective study made in the period from 1st Jan 2006 through to 31 Dec 2010 at the Clinic for orthopaedics and traumatology in Banja Luka. In total 6132 patients were examined and 99 cases diagnosed with DHD (dysplasia and luxation). Ultrasonic exam was done by means of electronic probe of 5-12 MHz according to standard method after Graph. Girls were significantly more present (96%). Positive family anamnesis on DHD was present with 7.8% examinee, mainly with primiparas, and/ or with 77.8% children with DHD. Dominant intrauterine risk factors for DHD were: mal position of foetus in uterus (78.6%), oligoamnion (17.9%), malformation of the spinal column of the pregnant woman (3.6%), whereas with 38.4% of children with a certain form of DHD the following were found: breech presentation, caesarean section or twin pregnancy. The clinical exam indicated DHD with 8.87% examinee, out of which hip looseness was found with 5% examinees. Ultrasonic finding was positive with 99 examinee, that is with 1.61% of them (deficient and badly formed acetabulum, sleeked protrusion; 8 luxations and 91 dysplasia). Prophylactic measures were requested by 58.6% children (abductive bending and exercises), whereas 41.4 % needed non-intervention therapeutic measures (traction, Pavlik's straps, Graph's knickers, plastering), after which there were no children needing surgical correction of DHD. These data indicate that clinical exam is unreliable for DHD diagnostics, and that Ultrasonic diagnostics and treatment of DHD should start as early as possible applying atraumatic helping devices and procedures in the period when all structures are elastic, flexible and adaptable.
Grubor P.,Clinical Center Banja Luka
Medicinski arhiv | Year: 2011
The pelvis is the central part of the body that receives the weight from the vertebral column and transfers it to the lower extremities. It protects the internal organs with its specific structure and shape. The study aims to compare the clinical outcomes of emergency non-surgical and surgical treatment of such patients, to analyze the types and severity of complications and final functional outcome. We present a series of 47 patients treated in the period between 1999 and 2009 at the Traumatology Clinic, CHC Banja Luka. According to Marvin Tile's classification, fractures were distributed as follows: Type A fractures occurred in 19 patients (40.6%), Type B in 18 (38.1%) and Type C in 10 (21.3%). 30 patients (63.8%) were polytraumatised, with craniocerebral injuries in 12 patients (25.5%), chest cavity injuries in 5 (10.6%) and abdominal organ injuries in 13 patients (27.6%). 27 patients (57.4%) had clinical and laboratory signs of hemorrhagic shock on admission, while 26 patients (56.2%) received conservative treatment and 21 patients (43.8%) were treated using surgical methods of stabilization of the pelvic ring. The analysis of the outcomes of treating pelvic ring fractures in our series of patients by using radiography (x-rays according to Slatis) showed that out of 47 treated patients, the outcomes were excellent in 28 (60%), good in 7 (15%), fair in 5 (12%) and poor in 7 (14%). The functional outcomes in all patients were evaluated according to the D'Aubigne-Postel scale, on average 18 months after the trauma. The outcomes were excellent in 22 patients (45%), good in 15 (31%), fair in 4 (9%) and poor in 6 (14%). The chi-square test showed that there was no significant statistical difference between the outcomes monitored using x-rays and functional outcomes monitored using the D'Aubigne-Postel scale (p = 0.097). The surgical treatment efficiency coefficient was introduced for the purpose of comparative evaluation of treatment outcomes. The surgical treatment efficiency coefficient, compared with conservative treatment, showed that all evaluated parameters were between 1.56 and 16.33 times lower in surgical treatment, which represents the more favorable outcome. We can conclude that conservative treatment is the treatment of choice for Tile's Type A fractures, external fixator for treating Type B fractures (including all subtypes), and internal fixation, as mono therapy or in combination with external fixator, for treating Type C2 and Type C3 fractures. Surgical treatment, compared with conservative treatment, allows faster mobilisation of the patient and it shortens the recovery period, which in turn lowers the total treatment costs.
Spiric S.,Clinical Center Banja Luka
Medicinski pregled | Year: 2011
Transient-evoked otoacoustic emissions are transmitted through the middle ear. The purpose of this study was to investigate the effects of dynamic properties of the transmission system on the measurability of transient otoacoustic emissions. The authors analyzed the presence of transient otoacoustic emissions in 48 children with serous otitis media regarding the tympanogram, presence and type of effusion and pure tone average findings. The results obtained in this research show the predominant absence of transient otoacoustic emissions in patients with type B tympanogram (69.1%) especially if the effusion is mucoid (77.5%) with the hearing loss of 15 decibel hearing level. This research shows that disorders in dynamic characteristics of the middle ear in patients with serous otitis obstruct the transmission of acoustic energy and affect the measurability of transient otoacoustic emissions, especially if the effusion is mucoid and hearing loss of 15 decibel hearing level.
Prodanovic N.,Clinical Center Banja Luka
European review for medical and pharmacological sciences | Year: 2012
Digital clubbing is a rare clinical finding and usually represents a sign of underlying disease.There are only few cases of digital clubbing in patients with primary hyperparathyroidism or with secondary hyperparathyroidism (SHPT) during long-term hemodialysis. We haven't come across papers dealing with the relation of digital clubbing and SHPT caused by vitamin D deficiency. In this article, we report a case of 43 year-old female patient with prominent clubbing of the fingers and toes, and 22 year history of SHPT caused by vitamin D deficiency. Current radiographic findings of the hands and feet are actually uncommon, and they show massive osteolytic lesions of numerous phalanges, which is the consequence of long-time untreated SHPT. Besides, our patient has a rare case of neutrophils with bilobed nuclei and decreased cytoplasmic granularity. This paper for the first time describes digital clubbing as an unusual complication of the SHPT caused by vitamin D deficiency associated with atypical neutrophils.
Pascual T.N.B.,Diagnostic Imaging International |
Chhem R.,International Atomic Energy Agency |
Wang S.-C.,University of Sydney |
Vujnovic S.,Clinical Center Banja Luka
European Journal of Radiology | Year: 2011
Radiology undergraduate curriculum has undergone a tremendous transformation in the decades reflecting a change in the structure, content and delivery of instruction. These changes are not unique to the discipline, but rather a response in the cycle of the re-engineering process in the medical curriculum in order to ensure its proper role into the ever-changing context. Radiology education is now more integrated across the curriculum than ever. The diversity of how radiology is being taught within the medical undergraduate curriculum is extensive and promising with the expanding role of the radiologist in the spectrum within the medical curriculum. A strong interface between the medical student and the clinicians must always be integrated in the learning process in order to convey the essential and practical use of the different aspects of radiology essential to the student's career as a future clinician. With the recent advancement in educational and technological innovations, radiology education is mobilized in the most pioneering ways, stimulating a rekindled interest in the field of medical imaging. This paper describes the increasing interest in current role of undergraduate radiology education in the context of constant medical curriculum innovations and in the digital age. © 2010 Elsevier Ireland Ltd. All rights reserved.
PubMed | University of Novi Sad, University of Banja Luka and Clinical Center Banja Luka
Type: Journal Article | Journal: Hippokratia | Year: 2016
Cutaneous melanoma has the propensity to early metastatic spread via the lymphatic vessels. Recent studies have found a positive correlation between an increased number of tumor-associated lymphatics and lymph node metastasis. The aim of this study was to determine whether there was a difference in the lymphatic vessel density (LVD) when cutaneous metastasizing melanomas were compared with nonmetastasizing melanomas and nevi.Ninety-five melanoma specimens (45 with lymph node metastasis, 50 nonmetastasizing) and 22 nevi specimens (7 compound, 5 intradermal, 4 blue, and 6 dysplastic) were investigated by immunostaining for the lymphatic endothelial marker D2-40. The quantification of lymphatics was conducted by computer-assisted morphometric analysis. Metastasizing and nonmetastasizing melanoma specimens were matched according to their thickness into three classes 2.0 mm, 2.01 - 4.0 mm, >4.0 mm.Metastasizing melanomas thick 2.01-4.0 mm and thicker than 4.0 mm, showed a significantly higher intratumoral and peritumoral LVD compared with nonmetastasizing melanomas (2.01-4.0 mm, p =0.006 and p =0.032, respectively; >4.0 mm, p =0.045 and p =0.026, respectively). No significant difference in intratumoral and peritumoral LVD was found between metastasizing and nonmetastasizing melanomas of thickness 2.0 mm. Metastasizing melanomas showed a significantly higher intratumoral LVD compared with compound, intradermal, blue and dysplastic nevi p <0.001, p =0.002, p =0.002 and p <0.001, respectively), and significantly higher peritumoral LVD compared with compound nevi (p=0.039). Total average LVD was significantly higher in metastasizing melanomas than in nonmetastasizing melanomas (p <0.001), compound, intradermal, blue and dysplastic nevi (p <0.001, p <0.001, p =0.001 and p <0.001, respectively).This study shows higher LVD in metastasizing melanomas compared with nonmetastasizing melanomas and nevi. In melanomas with intermediate thickness and in thick melanomas, higher intratumoral and peritumoral LVD are significantly associated with lymph node metastasis. This finding suggests that LVD can be a useful marker for identifying melanomas which are at a higher risk for the metastasis development. Hippokratia 2015; 19 (3): 210-215.