Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 25
Filter
1.
Int J Angiol ; 32(4): 243-247, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37927846

ABSTRACT

D-dimer and fibrinogen are nonspecific diagnostic biomarkers for venous thromboembolism (VTE). The aim of this article was to present the values of D-dimer and fibrinogen in relation to the anatomical localization of deep vein thrombosis (DVT). This was an observational study, which included 1,142 patients hospitalized from 2010 to 2019 at the Department of Angiology, Clinical Center University of Sarajevo. Data on gender, age, and thrombosis location were collected of all patients. Fibrinogen and D-dimer values were available for 983 and 500 patients, respectively. Thrombosis location was classified as iliofemoral (521-45.6% patients), femoral-popliteal (486-42.6% patients), isolated calf DVT (63-5.5% patients), and upper extremity DVT (UEDVT in 72-6.3% patients). A majority, 448 (89.6%), of patients had high D-dimer (the cutoff is 0.55 mg/L) and 662 (67.3%) patients had high fibrinogen (reference range: 1.8-3.8 g/L). The highest D-dimer was detected in patients with iliofemoral DVT (mean: 10.48 mg/L), χ2 = 50.78, p = 0.00. The highest fibrinogen was detected in patients with iliofemoral DVT as well (mean 4.87 g/L), χ2 = 11.1, p = 0.01. D-dimer and fibrinogen values are significantly higher in patients iliofemoral DVT than femoral-popliteal and isolated calf DVT, and D-dimer values are significantly higher in lower extremity DVT than UEDVT, but these biomarkers cannot be used alone to discriminate between thrombosis locations. Further imaging is required.

2.
Int J Appl Basic Med Res ; 12(4): 269-276, 2022.
Article in English | MEDLINE | ID: mdl-36726657

ABSTRACT

Aim: The study aimed to evaluate the acute effect of ultrafiltration on the mechanical properties of the aorta using brachial-ankle pulse wave velocity (PWV) before and after hemodialysis (HD). Patients and Methods: This study included 80 patients who were on a long-term HD program. The input variables were anamnestic data, body composition monitor (BCM) parameters, and echocardiography findings. The assessment of hydration status was determined by BCM, whose work is based on the principle of multifrequency bioimpedance spectroscopy. Another diagnostic procedure was the use of an arteriograph apparatus to assess PWV and Augmentation Index (AIx). All measurements were performed before and after dialysis on the middle dialysis day of the week. Results: The participants were divided into two groups based on hydration status: the experimental group consisted of 40 overhydrated participants and the control group consisted of 40 normovolemic participants. Statistically, the following BCM parameters correlated significantly positively with PWV: total body fat (r = 0.222; P < 0.05), overhydration (r = 0.290; P < 0.001), and relative overhydration (r = 0.290; P < 0.001). From echocardiography findings, only left atrial diameter correlated statistically significantly positively with PWV (r = 0.359; P < 0.001). Comparison of the mean PWV values within the experimental group before and after HD showed a statistically significant decrease from 14.32 ± 2.34 m/s to 8.72 ± 1.52 m/s (Z = 3.254; P = 0.0001). Mean PWV values within the control group did not decrease significantly from 13.39 ± 1.32 m/s to 10.39 ± 1.18 m/s (Z = 0.524; P = 0.742). If we compare the mean values of PWV between groups, then before HD treatment, there was no statistically significant difference between groups with PWV values in the experimental group of 14.32 ± 2.34 m/s and the control group of 13.39 ± 1.32 m/s (Z = 0.762; P = 0.852). According to the results of univariate regression analysis before and after HD treatment, only overhydration showed an absolute effect on PWV before and after HD. Conclusion: Overhydration showed an effect on brachial-ankle PWV before and after HD, and brachial-ankle PWV should be followed in HD patients.

3.
Med Glas (Zenica) ; 18(2): 468-474, 2021 08 01.
Article in English | MEDLINE | ID: mdl-34308619

ABSTRACT

Aim To investigate a profile of patients with peripheral artery disease (PAD) in Bosnia and Herzegovina. Methods This observational study included 1022 patients hospitalized at the Clinical Centre University of Sarajevo in a 5-year period, 2015 to 2019. Results Disease prevalence rises sharply after the age of 50. Most patients, 797 (78%) had proximal PAD; 658 (64.4%) were males. The death occurred in 73 (7.1%) patients, more often in females (66- 10%), and in patients with chronic kidney disease (10- 23.8%). Amputation occurred in 153 (15%) patients, where 102 (66.7%) patients had diabetes. Other surgical procedures were more common in males and smokers. Necrosis and phlegmon on lower extremities were found in 563 (55.1%) and 43 (4.2%) patients, respectively. History of tobacco use was noted in 620 (60.2%) patients, and 414 (40.8%) patients were current smokers. More than a half of patients had hypertension and diabetes, 596 (58.3%) and 513 (50.2%), respectively. One in 10 patients had a history of myocardial infarction or stroke. Most patients had high fibrinogen and blood glucose and low high-density lipoprotein (HDL). Conclusion Patients with PAD have multiple comorbidities and risk for various complications. Primary and secondary prevention of risk factors is the mainstay of treatment.


Subject(s)
Diabetes Mellitus , Myocardial Infarction , Peripheral Arterial Disease , Bosnia and Herzegovina/epidemiology , Female , Humans , Male , Peripheral Arterial Disease/epidemiology , Risk Factors
4.
Int J Appl Basic Med Res ; 11(1): 50-52, 2021.
Article in English | MEDLINE | ID: mdl-33842298

ABSTRACT

Churg-Strauss syndrome (CCS) or eosinophilic granulomatosis with polyangiitis is a rare condition, which is a challenge for both diagnosis and treatment in clinical work. Occurrences of cardiac complications represent a negative predictor of treatment outcome for these patients. The aim of this article is to present the diagnostic and therapeutic modality of a 33-year-old male diagnosed with? CCS. Treatment of these patients should be multidisciplinary, with a comprehensive therapeutic modality, while early diagnosis is imperative.

5.
Med Arch ; 74(3): 183-186, 2020 Jun.
Article in English | MEDLINE | ID: mdl-32801432

ABSTRACT

INTRODUCTION: Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease, with more frequent occurrence in the female gender, it primarily affects the lining of the synovial joints, and is associated with lower quality of life, inability to work, progressive disability, and all of these patients are more likely to develop other comorbidities. AIM: To display the role of anti-cyclic citrullinated peptide antibody (anti-CCP) in evaluating RA complications during a one-year follow-up, and compare its values with values of rheumatoid factor (RF). METHODS: The study included 40 patients with RA, out of which 6 were excluded during the 1-year follow-up. All patients were treated with anti-rheumatics, methothrexate 15-25mg, occasionally corticosteroids at the same doses. RESULTS: Anti-CCP values were also significantly higher during the second examination and were 5.0 ± 1.9 (range 0.5-7.6) compared to the first examination when they were 4.2 ± 1.3 (range 0.4-6.2) indicating a higher sensitivity of Anti-CCP in detecting of disease progression (t = -2.064; p = 0.043). Anti-CCP values were statistically significant in patients with complications compared to those without during the first examination and at follow-up after one year (t = 5,382; p = 0.0001). CONCLUSION: The positivity of anti-CCP antibodies is a useful marker in terms of predicting the course and prognosis of the RA. A higher titer of anti-CCP antibodies represents a poorer prognosis for the disease. Determination of the presence of anti-CCP antibodies should be performed as a routine examination in all patients with suspected rheumatoid arthritis.


Subject(s)
Arthritis, Rheumatoid/blood , Arthritis, Rheumatoid/complications , Autoantibodies/blood , Peptides, Cyclic/immunology , Adult , Arthritis, Rheumatoid/drug therapy , Biomarkers/blood , Disease Progression , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prognosis , Rheumatoid Factor/blood
6.
Med Glas (Zenica) ; 17(2): 335-340, 2020 Aug 01.
Article in English | MEDLINE | ID: mdl-32153154

ABSTRACT

Aim To determine a status of systolic function in patients with diabetes mellitus (DM) type 2 with ST-segment elevation acute myocardial infarction (STEMI), to determine values of cardiac biomarkers in patients with DM type 2 with STEMI and correlate the parameters with ejection fraction of left ventricle (EFLV). Methods A total of 80 patients were divided into two groups, the study group (group I) consisting of 40 patients admitted with the diagnosis of DM type 2 and STEMI, and a control group (group II) with 40 patients with STEMI without diagnosed DM type 2. Cardiac biomarkers - creatine kinase MB fraction (CKMB), and troponin I were monitored. The EFLV was evaluated echocardiographically (using Simpson method) five days after primary percutaneous coronary intervention (pPCI). Results In the group I the EFLV five days after pPCI was significantly correlated with troponin values (with a minimum r = -0.47; p=0.002, a maximum r = -0.339; p = 0.032, as well as with an average value of r = -0.389; p=0.013), and with an average CK value (r = -0.319; p=0.045). In the group II there was a significant negative correlation of EFLV with the maximum value of troponin (r = -0.309; p=0.05). Conclusion Troponin values have an effect on the EFLV after STEMI, and thus on the left ventricular status, as well as on the pharmacological modality itself.


Subject(s)
Diabetes Mellitus, Type 2 , Myocardial Infarction , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Biomarkers , Diabetes Mellitus, Type 2/complications , Humans , Ventricular Function, Left
7.
Mater Sociomed ; 32(3): 172-176, 2020 Sep.
Article in English | MEDLINE | ID: mdl-33424444

ABSTRACT

INTRODUCTION: Rheumatoid arthritis (RA) is a chronic, inflammatory, systemic rheumatic disease, very complex, with many different forms, progressive course, with pronounced changes in the joints, still unknown etiology and poorly understood pathology. Assessing of structural change can be done with proposed scores which observe changes on wrist and wrist joints, as a Sharp score. AIM: To examine the correlation between Anti-Citrullinated Protein Antibodies (Anti-CCP) values and Sharp score, and to determine the importance of Sharp score in the progression of RA. METHODS: The study had prospective character and followed patients in the period from January 1, 2017 to December 31, 2017. The study included 40 patients with RA. At the beginning of the follow-up of patients, X-ray of hands and feet were performed. RESULTS: Out of total of 40 patients, 34 or 85% had a follow-up examination after one year. Of these, 14 patients (41.2%) were reported to have complications. The subjects were divided into two groups according to Anti-CCP values. First group included patients with Anti-CCP values <4 and second those who had Anti-CCP> 4. Statistical analysis of the number of patients with complications at first and repeated examination indicated that there were no significant differences and that the sample was consistent between the first and repeated results (p> 0.05). Patients with higher Anti-CCP values also had a higher Sharp score with statistically significant differences during repeated examination (p <0.05). Correlation analysis shows that there was statistically significant (p <0.05) positive correlation with Anti-CCP values, and that an increase in values leads to an increase in the Sharp score (first measurement rho = 0.193, p> 0.05; repeated measurement rho = 0.645, p <0.0001). No statistically significant differences in Sharp score values at the first examination were compared with the repeated examination, but there was a statistically significant difference after one year in patients with complications (X2 = 13,388; p = 0.001), indicating that the Sharp score reflects disease progression. CONCLUSION: Anti-CCP values are also directly correlated with the Sharp score, which should be routine in both initial and repeated examination of a patient with RA. Sharp's score represents a marker of progression as well as of therapeutic modality of RA.

8.
Med Arch ; 73(1): 23-27, 2019 Feb.
Article in English | MEDLINE | ID: mdl-31097855

ABSTRACT

INTRODUCTION: By development of the medicine, control of the risk factors for acute myocardial infarction (AMI), became the foundation of cardiology. AIM: To investigate the association of the age with presence of risk factors in patients with acute myocardial infarction. METHODS: The study had a prospective, comparative and descriptive character, and it was done on a sample of 80 patients (n=80; 55 male and 25 female) Clinic for Heart, Blood Vessel and Rheumatic Diseases, Clinical Center University of Sarajevo from January 2016 to August 2018. All patients were hospitalized under the diagnosis of myocardial infarction and were divided into two main groups, which were divided into two subgroups according to age. Group A, group of patients under 45 years of age at the moment of diagnosis of AMI (n = 40; men = 29; women = 11) was divided into group A1 (n = 20; patients aged 25-35 years) and group A2 (n = 20; patients aged between 35-45 years). Group B, patients older than 45 years at the time of diagnosis of AMI (n = 40; men = 26, women = 14) was divided into group B1 (n = 20; patients aged between 45-55 years) and group B2 (n = 20; patients aged 55-65 years of age). RESULTS: According to gender distribution, there is a significantly higher incidence of hypertension in male patients aged 25-35 years and between 35-45 years (p = 0.01; p = 0.01). Increased cholesterol values were significantly more common in men aged 25-35 years (p = 0.0121). Increased triglyceride values were significantly more common in men aged 25-35 years, in comparison to female respondents of the same age (86.67% vs. 13.33%, p = 0.0001). There was a significant significance between the two groups in the occurrence of anteroseptal (p = 0.04) and in the diaphragmatic myocardial infarction (p = 0.01), while in other infarction localities no significant significance was observed. CONCLUSION: Male sex is a predisposing risk factor for the development of a cardiovascular incident in the younger age. The post infarction ejection fraction of the left ventricle was significantly reduced in younger patients. The potential for prevention should be of paramount importance. The localization of the incident itself, and the involvement of a certain blood, represents, regardless of all the research, still a fact that is hard to stratify and directly correlated with a certain risk factor.


Subject(s)
Myocardial Infarction/etiology , Adult , Age Factors , Aged , Bosnia and Herzegovina/epidemiology , Female , Humans , Male , Middle Aged , Myocardial Infarction/epidemiology , Myocardial Infarction/physiopathology , Risk Factors , Sex Factors , Stroke Volume
9.
Med Glas (Zenica) ; 16(1): 28-34, 2019 Feb 01.
Article in English | MEDLINE | ID: mdl-30680982

ABSTRACT

Aim To assess triglyceride - to high-density lipoprotein cholesterol (TG/HDL)-C ratio in patients with acute coronary syndrome (ACS) and to verify its association with renal dysfunction. Methods A cross sectional study included 85 ACS patients divided in two groups with (ACS - RD) and without (ACS-nRD) presence of renal dysfunction, and 35 healthy subjects. Blood pressure, blood glucose, C-reactive protein, urea, creatinine, eGFR and serum lipids levels (total cholesterol, triglycerides, LDL-C, HDL-C) was measured in all participants. Based on the values of the measured lipid fractions TG/HDLc ratio was calculated. Results Patients in ACS group had significantly lower HDL-C level (p<0.0005) but significantly higher TG level (p=0.046) and TG/HDL-C ratio (p<0.0005) than controls. There was a significant increase (p<0.0005) in TG/HDL-C ratio in ACS-RD group compared to ACS-nRD group. The ACS-RD group had significantly higher level of TG (p=0.001), serum urea (p=0.02) and creatinine (p<0.0005) compared to the ACS-nRD group. With a cut-off level of 1.135 TG/HDL-C ratio had a sensitivity of 77.6% and a specificity of 62.9% in distinguishing between ACS patients and healthy subjects. With cut-off value of 1.905 TG/HDL-C ratio had a sensitivity of 75.9% and a specificity of 78.6% in distinguishing between ACS patients with and without renal dysfunction. Conclusion This study confirms the reliability of the TG/HDLC ratio as a simple, low cost and useful marker in distinguishing between patients with ACS and healthy subjects and ACS patients with and without renal dysfunction.


Subject(s)
Acute Coronary Syndrome/blood , Lipoproteins, HDL/blood , Renal Insufficiency/blood , Triglycerides/blood , Acute Coronary Syndrome/complications , Acute Coronary Syndrome/physiopathology , Aged , Biomarkers/blood , Blood Glucose/analysis , Blood Pressure , C-Reactive Protein/analysis , Creatinine/blood , Cross-Sectional Studies , Female , Glomerular Filtration Rate , Humans , Kidney/physiopathology , Male , Middle Aged , Reference Values , Renal Insufficiency/etiology , Renal Insufficiency/physiopathology , Reproducibility of Results , Sensitivity and Specificity , Urea/blood
10.
Med Arch ; 73(6): 374-377, 2019 Dec.
Article in English | MEDLINE | ID: mdl-32082002

ABSTRACT

INTRODUCTION: Lately, the use of biological therapy in various autoimmune diseases is increasing. The ideal marker for monitoring the effects of modern therapy is still non-existent. AIM: To investigate early response biomarkers of SLE and RA patients under the rituximab treatment are in research phase and each new investigations offer new and original useful data. MATERIAL AND METHODS: Immunophenotyping of cells was carried out by a standard method of sample preparation. We investigated by flow cytometric analyses expression of NK and CD19+ cells at ten SLE and five RA patients before and after treatment with rituximab, in laboratory of Department of Clinical immunology in the Clinical Centre University of Sarajevo. RESULTS: In both cases, SLE and RA patients, reduced number of CD16+ parameter indicates lower cytotoxic activity of NK cells. Increased number of B cells indicates higher pathological activity leading to severe autoimmune disease allegation. CONCLUSION: Determining the proportion of NK and B will be useful diagnostic tool in therapeutic strategy, and also in monitoring of effect of biological therapy.


Subject(s)
Antirheumatic Agents/therapeutic use , Arthritis, Rheumatoid/drug therapy , B-Lymphocytes/immunology , Killer Cells, Natural/immunology , Lupus Erythematosus, Systemic/drug therapy , Rituximab/therapeutic use , Antigens, CD19/immunology , Biomarkers , CD56 Antigen/immunology , Flow Cytometry , GPI-Linked Proteins/immunology , Humans , Immunophenotyping , Receptors, IgG/immunology , Treatment Outcome
11.
Med Glas (Zenica) ; 15(2): 168-173, 2018 Aug 01.
Article in English | MEDLINE | ID: mdl-29722771

ABSTRACT

Aim To demonstrate the effects of early diagnosis of overuse syndrome in the wrist on healing, pain intensity and quick recovery to daily work and sport activities. Methods This clinical retrospective study included 60 patients of both sexes aged from 22 to 44 years, with pain in the wrist and clinical signs of creeping tenosynovitis. Patients were divided into two groups: the first group - persons doing sports activity, and the second group - patients who did not deal with sports activities. Results Females in 31 (51.7%) cases compared to males with 29 (48.3%) were slightly more represented in the total sample. Patients with injuries due to sports activities had previously reported to the physician and the diagnosis was set at an average of 3.1±0.9 days after the first symptoms (the range of 2-5 days), compared to the patients of the second group whose diagnosis was set at an average of 4.7±1.1 days after the first symptoms (p<0.05). Conclusion Patients involved in sports activities were more motivated for faster recovery, they had earlier doctor's examination with rapid reduction of subjective symptoms during intensive physical therapy.


Subject(s)
Cumulative Trauma Disorders/diagnosis , Pain/diagnosis , Tenosynovitis/diagnosis , Wrist Joint/pathology , Wrist/pathology , Adult , Cumulative Trauma Disorders/pathology , Cumulative Trauma Disorders/therapy , Early Diagnosis , Female , Humans , Male , Pain/etiology , Patient Acceptance of Health Care , Retrospective Studies , Sports , Tenosynovitis/pathology , Tenosynovitis/therapy , Young Adult
12.
Ann Rheum Dis ; 77(2): 234-240, 2018 02.
Article in English | MEDLINE | ID: mdl-29042358

ABSTRACT

OBJECTIVES: Efficacy, safety and immunogenicity results from the phase III study of SB2, a biosimilar of reference infliximab (INF), were previously reported through 54 weeks. This transition period compared results in patients with rheumatoid arthritis (RA) who switched from INF to SB2 with those in patients who maintained treatment with INF or SB2. METHODS: Patients with moderate to severe RA despite methotrexate treatment were randomised (1:1) to receive SB2 or INF at weeks 0, 2 and 6 and every 8 weeks thereafter until week 46. At week 54, patients previously receiving INF were rerandomised (1:1) to switch to SB2 (INF/SB2 (n=94)) or to continue on INF (INF/INF (n=101)) up to week 70. Patients previously receiving SB2 continued on SB2 (SB2/SB2 (n=201)) up to week 70. Efficacy, safety and immunogenicity were assessed up to week 78. RESULTS: Efficacy was sustained and comparable across treatment groups. American College of Rheumatology (ACR) 20 responses between weeks 54 and 78 ranged from 63.5% to 72.3% with INF/SB2, 66.3%%-69.4% with INF/INF and 65.6%-68.3% with SB2/SB2. Treatment-emergent adverse events during this time occurred in 36.2%, 35.6% and 40.3%, respectively, and infusion-related reactions in 3.2%, 2.0% and 3.5%. Among patients who were negative for antidrug antibodies (ADA) up to week 54, newly developed ADAs were reported in 14.6%, 14.9% and 14.1% of the INF/SB2, INF/INF and SB2/SB2 groups, respectively. CONCLUSIONS: The efficacy, safety and immunogenicity profiles remained comparable among the INF/SB2, INF/INF and SB2/SB2 groups up to week 78, with no treatment-emergent issues or clinically relevant immunogenicity after switching from INF to SB2. TRIAL REGISTRATION NUMBER: NCT01936181; EudraCT number: 2012-005733-37.


Subject(s)
Antirheumatic Agents/administration & dosage , Arthritis, Rheumatoid/drug therapy , Biosimilar Pharmaceuticals/administration & dosage , Infliximab/administration & dosage , Adolescent , Adult , Aged , Antibodies/blood , Antirheumatic Agents/adverse effects , Arthritis, Rheumatoid/immunology , Biosimilar Pharmaceuticals/adverse effects , Double-Blind Method , Drug Therapy, Combination , Female , Humans , Infliximab/adverse effects , Infliximab/immunology , Male , Methotrexate/therapeutic use , Middle Aged , Severity of Illness Index , Treatment Outcome , Young Adult
13.
Rheumatology (Oxford) ; 56(10): 1771-1779, 2017 10 01.
Article in English | MEDLINE | ID: mdl-28957563

ABSTRACT

Objectives: SB2 is a biosimilar to the reference infliximab (INF). Similar efficacy, safety and immunogenicity between SB2 and INF up to 30 weeks were previously reported. This report investigates such clinical similarity up to 54 weeks, including structural joint damage. Methods: In this phase III, double-blind, parallel-group, multicentre study, patients with moderate to severe RA despite MTX were randomized (1:1) to receive 3 mg/kg of either SB2 or INF at 0, 2, 6 and every 8 weeks thereafter. Dose escalation by 1.5 mg/kg up to a maximum dose of 7.5 mg/kg was allowed after week 30. Efficacy, safety and immunogenicity were measured at each visit up to week 54. Radiographic damage evaluated by modified total Sharp score was measured at baseline and week 54. Results: A total of 584 patients were randomized to receive SB2 (n = 291) or INF (n = 293). The rate of radiographic progression was comparable between SB2 and INF (mean modified total Sharp score difference: SB2, 0.38; INF, 0.37) at 1 year. ACR responses, 28-joint DAS, Clinical Disease Activity Index and Simplified Disease Activity Index were comparable between SB2 and INF up to week 54. The incidence of treatment-emergent adverse events and anti-drug antibodies were comparable between treatment groups. Such comparable trends of efficacy, safety and immunogenicity were consistent from baseline up to 54 weeks. The pattern of dose increment was also comparable between SB2 and INF. Conclusion: SB2 maintained similar efficacy, safety and immunogenicity with INF up to 54 weeks in patients with moderate to severe RA. Radiographic progression was comparable at 1 year. Trial registration: ClinicalTrials.gov (http://clinicaltrials.gov; NCT01936181) and EudraCT (https://www.clinicaltrialsregister.eu; 2012-005733-37).


Subject(s)
Antirheumatic Agents/administration & dosage , Arthritis, Rheumatoid/drug therapy , Biosimilar Pharmaceuticals/administration & dosage , Infliximab/administration & dosage , Adult , Aged , Antirheumatic Agents/adverse effects , Arthritis, Rheumatoid/diagnostic imaging , Biosimilar Pharmaceuticals/adverse effects , Disease Progression , Double-Blind Method , Drug Administration Schedule , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/etiology , Female , Humans , Male , Middle Aged , Radiography/methods , Severity of Illness Index , Treatment Outcome , Young Adult
14.
Ann Rheum Dis ; 76(1): 58-64, 2017 Jan.
Article in English | MEDLINE | ID: mdl-26318384

ABSTRACT

OBJECTIVES: To compare the efficacy, safety, immunogenicity and pharmacokinetics (PK) of SB2 to the infliximab reference product (INF) in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate therapy. METHODS: This is a phase III, randomised, double-blind, multinational, multicentre parallel group study. Patients with moderate to severe RA despite methotrexate therapy were randomised in a 1:1 ratio to receive either SB2 or INF of 3 mg/kg. The primary end point was the American College of Rheumatology 20% (ACR20) response at week 30. Inclusion of the 95% CI of the ACR20 response difference within a ±15% margin was required for equivalence. RESULTS: 584 subjects were randomised into SB2 (N=291; 290 analysed) or INF (N=293). The ACR20 response at week 30 in the per-protocol set was 64.1% in SB2 versus 66.0% in INF. The adjusted rate difference was -1.88% (95% CI -10.26% to 6.51%), which was within the predefined equivalence margin. Other efficacy outcomes such as ACR50/70, disease activity score measured by 28 joints and European League against Rheumatism response were similar between SB2 and INF. The incidence of treatment-emergent adverse events was comparable (57.6% in SB2 vs 58.0% in INF) as well as the incidence of antidrug antibodies (ADA) to infliximab up to week 30 (55.1% in SB2 vs 49.7% in INF). The PK profile was similar between SB2 and INF. Efficacy, safety and PK by ADA subgroup were comparable between SB2 and INF. CONCLUSIONS: SB2 was equivalent to INF in terms of ACR20 response at week 30. SB2 was well tolerated with a comparable safety profile, immunogenicity and PK to INF. TRIAL REGISTRATION NUMBER: NCT01936181.


Subject(s)
Antirheumatic Agents/pharmacokinetics , Antirheumatic Agents/therapeutic use , Arthritis, Rheumatoid/drug therapy , Biosimilar Pharmaceuticals/pharmacokinetics , Biosimilar Pharmaceuticals/therapeutic use , Infliximab/pharmacokinetics , Infliximab/therapeutic use , Adult , Aged , Antibodies/blood , Antirheumatic Agents/adverse effects , Biosimilar Pharmaceuticals/adverse effects , Double-Blind Method , Female , Humans , Infliximab/adverse effects , Infliximab/immunology , Male , Methotrexate/therapeutic use , Middle Aged , Severity of Illness Index , Therapeutic Equivalency , Treatment Outcome
15.
Med Arch ; 70(6): 419-424, 2016 Dec.
Article in English | MEDLINE | ID: mdl-28210012

ABSTRACT

INTRODUCTION: Cardiovascular diseases are the leading cause of death in most countries. The aim was to examine the quality of life and to determine the differences in the quality of life in patients one year after myocardial infarction and the relationship between quality of life and echocardiographic parameters in these patients. MATERIAL AND METHODS: The research was a prospective, clinical, epidemiological study and was conducted at the Clinic of Cardiology, University Clinical Center Sarajevo (UCCS). The research was conducted on a sample of 160 patients who had acute myocardial infarction, which are based on the therapeutic procedures divided into four groups. The average age in the total sample was 54.9±8.8 years (range 37-76 years). The research was conducted one year after myocardial infarction (I group of subjects) or 12 months after PCI therapeutic procedures (II and III group of respondents) or coronary artery bypass surgery (IV group of respondents). RESULTS: Comparison of the mean scores of scales in SF-36 questionnaire showed that the highest total score had patients in the group II 67.3±15.2, and the lowest in the group I 57.8±21.4. The increase in ejection fraction leads to a statistically significant increase in quality of life scores at all subscales, in all groups, so that EF has the greatest impact on the quality of life in all respondents. Statistically significant differences in the effects of mitral regurgitation in particular groups have been recorded only in the case of the mental health scale. CONCLUSIONS: Ejection fraction has the greatest impact on the quality of life in all patients, regardless of the type of medical treatment.


Subject(s)
Echocardiography , Myocardial Infarction/diagnostic imaging , Quality of Life , Adult , Aged , Coronary Artery Bypass , Echocardiography/methods , Female , Hospitals, University , Humans , Male , Middle Aged , Myocardial Infarction/therapy , Percutaneous Coronary Intervention/methods , Postoperative Care , Predictive Value of Tests , Prospective Studies , Sensitivity and Specificity , Surveys and Questionnaires , Treatment Outcome
16.
Med Arch ; 68(1): 22-6, 2014.
Article in English | MEDLINE | ID: mdl-24783906

ABSTRACT

INTRODUCTION: Non-alcoholic (NAFLD) encompasses a spectrum of disease states, from steatosis (fatty liver) to non-alcoholic steatohepatitis (also called NASH steatosis with inflammatory changes) followed by progression to fibrosis and cirrhosis and hepatocellular carcinoma Excess liver fat is believed to be a manifestation of the metabolic syndrome and not surprisingly NASH is associated with obesity, insulin resistance, dyslipidemia and type 2 diabetes in humans. AIM OF THE STUDY: Is to establish anthropometric and biochemical specificities in patients with non-alcoholic steatohepatitis diagnosed with non-invasive diagnostic methods. MATERIAL AND METHODS: Study enrolled 170 participants, 130 with NASH steatosis. The non-alcoholic group (control), consisted of 40 normal weight patients without metabolic syndrome. Alcohol intake was estimated with established protocol. Routine biochemistry analysis were performed by standard laboratory procedures; serum levels of serum levels of fasting cholesterol and triglycerides, fasting glucose and insulin, insulin resistance estimated by HOMA index (Homeostasis model assessment), biochemistry tests and a liver ultrasound examination. RESULTS: In study participants group, patients were more obese comparing with controls p < 0.01, waist line extent also was of greater statistical significance in the non-alcoholic group fatty liver (p < 0, 01). Comparing biochemical parameter values, significant statistical deference has been noted in glaucosis and insulin levels, total cholesterol and gama-glutamil transferase levels, between groups (p < 0.01). Fasting glucose and insulin levels, HOMA-IR were significantly greater in study cohort group patients, as was significantly positive correlation between BMI and waist line extent. CONCLUSION: Patients with non-alcoholic fatty liver are excessively obese, have greater waist line extent, consequently insulin resistance and impaired glucose metabolism, insulin resistance, dyslipidemia, risk factors known to be associated with the development of cardiovascular disease.


Subject(s)
Fatty Liver/diagnosis , Blood Glucose/analysis , Body Mass Index , Case-Control Studies , Cholesterol/blood , Female , Humans , Insulin/blood , Male , Middle Aged , Non-alcoholic Fatty Liver Disease , Prospective Studies , Waist Circumference
17.
Med Arch ; 67(4): 260-2, 2013.
Article in English | MEDLINE | ID: mdl-24520748

ABSTRACT

GOAL: The goal of this study is to determine the effect of the hemodialysis durations on the concentration of inflammatory agents C-reactive protein concentration, fibrinogen and ferritin in hemodialysis patients. There is not enough reliable research data about the primary causes of the increase of these agents levels in the serum. The role of inflammatory agents in the development of primary renal disease, pathogenesis and morphogenesis and in particular the development of complications and comorbidities is unclear. PATIENTS AND METHODS: The study included 114 chronic hemodialysis patients who were on dialysis three times a week for 4 hours, according to the regular protocol of hemodialysis at the Cantonal Hospital Zenica, Department for hemodialysis. RESULTS AND DISCUSSION: Patients were analyzed according to the hemodialysis duration (years) and on the basis of duration of hemodialysis are divided into 3 groups: According to the average values of fibrinogen in all three groups was p < 0.05 which is not statistically significant difference according to the hemodialysis duration. Average values of ferritin in group 1 (patients less than 1 year on hemodialysis) was 612 +/- 543 in group 2 (patients with hemodialysis duration between 1-10 years) was 1056 +/- 852, and in group 3 (patients with hemodialysis duration over 10 years) was 610 +/- 700. According to the average values of ferritin in all three groups we see that p < 0.05. In the second group ferritin concentrations were highest. In the third group of patients the results were the same as in the first group. CONCLUSION: It was found that the duration and type of hemodialysis does not affect the concentration of inflammatory agents in the blood.


Subject(s)
C-Reactive Protein/metabolism , Ferritins/blood , Fibrinogen/metabolism , Inflammation/blood , Renal Dialysis , Aged , Female , Humans , Inflammation/etiology , Male , Middle Aged , Renal Dialysis/adverse effects , Renal Insufficiency, Chronic/therapy , Time Factors
18.
Med Arch ; 67(5): 318-21, 2013.
Article in English | MEDLINE | ID: mdl-24601160

ABSTRACT

OBJECTIVE: Our objective was the comparison of combined utility of two-dimensional (2D) transthoracic echocardiography (TTE) and three-dimensional (3D) TTE versus 2D and 3D transesophageal echocardiography (TEE) in evaluation of anatomy of the left atrium appendage (LAA) and for clot formation in LAA. BACKGROUND: 2DTEE as semi-invasive method has been for a long time used to visualize the LAA. Improved echocardiography technology has increasingly improved visualization of LAA by 2DTTE and 3DTTE in many patients and decreased the need for TEE performance. METHODS: We compared combined 2DTTE and 3DTTE with 2DTEE and 3DTEE in evaluating the LAA for anatomical features and thrombus. Eighty-six patients underwent 2DTTE, 3DTTE, 2DTEE and 3DTEE. RESULTS: LAA could be visualized in all patients. 31 % of patients had one lobe, 43% had 2 lobes and 26% had > 2 lobes. Of 86 patients studied, 79 had no thrombus and 7 had thrombus in the LAA by all modalities. Six patients, 3 with atrial fibrillation (AF), and 4 in sinus rhythm (SR) had a suspected thrombus by 2DTEE. Only in one patient 3DTEE cropping has been needed to clearly show thrombus which was suspected in short axis view on 2DTEE as rounded echo dense mass. CONCLUSIONS: Our preliminary study suggests that combined 2DTTE and 3DTTE has comparable accuracy to TEE in evaluating the LAA anatomy and pathology in terms of thrombus. Only in inappropriate (obese) patients 2TTE, but not 3DTTE, may misdiagnose pectinate musculature as thrombus.


Subject(s)
Atrial Appendage/diagnostic imaging , Echocardiography, Three-Dimensional/methods , Echocardiography, Transesophageal/methods , Heart Diseases/diagnostic imaging , Thrombosis/diagnostic imaging , Adult , Aged , Aged, 80 and over , Cohort Studies , Echocardiography/methods , Female , Humans , Male , Middle Aged , Retrospective Studies
19.
Med Arch ; 67(5): 361-4, 2013.
Article in English | MEDLINE | ID: mdl-24601173

ABSTRACT

UNLABELLED: The aim of this study was to determine the influence of inflammatory markers, predictive values of CRP and target hemoglobin (Hb) in patients on chronic hemodialysis. MATERIAL AND METHODS: Made is a cross-sectional study of inflammatory agents serum levels-CRP, fibrinogen and ferritin before hemodialysis in 114 patients divided into two groups according to the achieved or unachieved target hemoglobin level in the Cantonal Hospital in Zenica. RESULTS: The 57 patients (test group) did not reached the target hemoglobin in the range from 10-12 g/dl and CRP values were significantly higher compared to the control group (57 patients) who had reached targeted hemoglobin values. Levels of fibrinogen and ferritin were not significantly different between the control and the test group. CRP values are in negative correlation with the Hb concentration, while fibrinogen and ferritin values had a positive correlation. Significant negative correlation was only found in case of CRP, respectively, higher CRP was at lower levels of blood Hb. It was found that the predictive value of CRP is 6.5 mg/L to achieve target Hb level. If the CRP increases by 1 mg/L, possibilities to achieve the target Hb level in dialysis patients is reduced by 7.5%, with a sensitivity of 51% and specificity of 77%. Ferritin was elevated due to iatrogenic iron saturation, because all patients received intravenous iron and was treated with erythropoietin. By identification and analysis of inflammatory agents and duration ofhemodialysis, are explored the primary influence on hematopoiesis, of course, with the primary application of erythropoietin and adjuvant agents. It has been shown that CRP alone has an impact on the target Hb level, depending on the hemodialysis duration. CONCLUSION: The research results show how what looks as routine findings may be helpful in the timely detection of threatening complications and their treatment, and provide extended and improved quality of life for patients on hemodialysis.


Subject(s)
Anemia/diagnosis , C-Reactive Protein/metabolism , Ferritins/metabolism , Fibrinogen/metabolism , Hemoglobins/metabolism , Kidney Failure, Chronic/therapy , Aged , Anemia/drug therapy , Anemia/etiology , Biomarkers/metabolism , C-Reactive Protein/immunology , Case-Control Studies , Cross-Sectional Studies , Erythropoietin/therapeutic use , Female , Ferric Compounds/therapeutic use , Ferric Oxide, Saccharated , Ferritins/immunology , Fibrinogen/immunology , Glucaric Acid , Humans , Inflammation/metabolism , Kidney Failure, Chronic/complications , Male , Middle Aged , Predictive Value of Tests , ROC Curve , Renal Dialysis/adverse effects , Sucrose/therapeutic use
20.
Med Arch ; 66(5): 336-9, 2012.
Article in English | MEDLINE | ID: mdl-23097974

ABSTRACT

The highly specific biomarkers for monitoring of SLE disease activity are not yet defined up to date, due to existing of different clinical SLE phenotypes caused by individual genetic variation. Basically, numerous clinical complications follow SLE patients such as nephritis, atherosclerosis and cardial, CNS, gastrointestinal and ophthalmological complications, as well. Their monitoring in clinical SLE management can be evaluated by analysing of specific biochemical parameters and require permanent clinical observation. The presence of ANAs and anti-ds-DNAs are usual diagnostic SLE autoimmunity parameters, while SLE disease activity biomarkers are C3 and C4 level, anticardiolipin antibodies, anti-Sm/RNPs and, recently level of CD4 and CD8 lymphocytes. However, the number of TCR molecules on the T-cells surface at SLE patients is lower then in normal condition, and otherwise for these receptors CD molecules make specific connection. On the other hand, the T lymphocytes can be also, therapeutical targets at SLE patients, because of their clear direct involving in SLE pathogenesis. The SLE phenotypes are characterized by double CD negativity ( CD3 +/-, CD4-) caused by abnormal level of IL-2 and IL-17. T-lymphocytes have usually alpha-beta and gamma-delta TCR receptors, but for SLE patients is characteristic lower number gama-delta TCR molecules, detected in the peripheral blood specimens. Taking into account all of the facts, we investigated the level of specific usual SLE activity biomarkers (anti-ds-DNAs, C3, C4, anticardiolipin antibodies (beta-2-IgG, beta-2-IgM, ACA-G, ACA-M, CD4 and CD8 level) in serum specimens of SLE patients who underwent to the corresponding chemotherapy in combination with other biochemical and clinical parameters. Once again proved to be, that SLE biomarker monitoring, could be useful aproach for SLE activity disease and prediction organ damage, as well. In our investigation we used the following methods: immunofluorescence microscopy (IFA-ANA), and nephelometry, Hycor ELISA system and Flow cytometry, for precisely quantitative measurements. We determined correlation between C3 and C4 complement components level, CD3 (T-Ly), CD3+/HLA-DR and total HLA-DR with regard to SLE disease activity. Also, CD4 (Th), CD4:CD8 ratio, beta-2-G, beta-2-M not proved to be useful biomarkers in this sense, despite some results specific for some special SLE phenotypes. Anti-Sm/ RNPs proved to be better in SLE diagnostic process.


Subject(s)
Biomarkers/analysis , Immunophenotyping , Lupus Erythematosus, Systemic/diagnosis , Antibodies, Antinuclear/analysis , Enzyme-Linked Immunosorbent Assay , Flow Cytometry , Fluorescent Antibody Technique , Humans , Lupus Erythematosus, Systemic/immunology , Lupus Erythematosus, Systemic/therapy , Nephelometry and Turbidimetry
SELECTION OF CITATIONS
SEARCH DETAIL