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Introduction: Regulatory T cells (Treg) play a central role in the immunopathogenesis of psoriasis. Immunoregulatory T cells (Tregs) are involved in important homeostatic mechanism for maintaining tolerance and preventing autoimmunity, and autoimmune diseases. The aim of this study was to examine the role of Tregs cells in the pathogenesis of psoriasis, and determine the range value for Treg cells (CD4+ CD25+) in the peripheral blood of patients with psoriasis compared to the severity of disease. Material and methods: The study included 51 patients diagnosed with psoriasis and 25 healthy individuals. Phenotype profile of peripheral blood lymphocytes was determined by flow cytometry, and assessment of severity of disease was determined on the basis of PASI score (e.g. Psoriasis Area and Severity Index). Results: Proportion of CD4+CD25+T cells in the control group was significantly higher than in the patients with psoriasis [6,4% ±(5,4-7,6) vs. 4,1% (3,1 -5,8)–Mann–Whitney U test, p <0.001]. In the present study we did not find a statistically significant correlation between the levels of CD4+CD25+cells, in patients with psoriasis, compared to the severity of disease–PASI. (i.e. Pearson correlation, r = 0.197, p = 0.194). Conclusion: The stratification of patients, according to the severity of the clinical course was not possible on the basis of Treg cells’ level. ROC curve analysis of the optimal cutoff (PASI=10) and the CD4+CD25+, which distinguishes between patients and healthy individuals was 5% of CD4+CD25+ of the total number of CD4+ lymphocytes with specificity of 69% and sensitivity of 84%.

J. Ćorić, Lejla Hasanbegović, Aleksandar Bodulović, Jasminka Mujić

Introduction: Whey-acidic protein human epididymis protein 4 (HE4) is a new promising biomarker for epithelial ovarian cancer. The measured HE4 values may depend on the testing procedure used. The aim of this study was to evaluate the Methods : We evaluated a HE4 method on Elecsys 2010 analyzer. The method for quantitative determination of HE4 is direct, competitive chemiluminescent immunoassay. For quality control we use Elecsys PreciControl HE4 1 and 2. HE4 was measure on sera obtained from 56 women ( 20 healthy and 36 with epithelial ovarian cancer). Results: The Roche HE4 assays showed a good linearity (r=0.99) and precision (intrassayed total CV<5%). The median HE4 serum concentrations was significantly higher among EOC patients than healthy females (p<0,05). Elevated levels HE4 were found in 78 % patients with epithelial ovarian cancer. Conclusions : The presented results of the analytical evaluation methods for the determination of HE4 on the Elecsys 2010 analyzer showed an acceptable accuracy and precision.

Introduction: The U.S. pharmaceutical industry is defined by the U.S. Census Bureau as “companies engaged in researching, developing, manufacturing and marketing of medicines and biological for human or veterinary use”. Besides its main role in improving human health, the US pharmaceutical industry represents one of the most critical, key decision makers’ lobbying prone and competitive sectors in the economy. The cost in the environment of very limited government price regulation remains one of the major problems fuelling aggregate health care cost inflation. Pharmaceuticals have created huge benefits for public health and economic productivity by the means of saving lives, increasing life expectancy, reducing illness related suffering, preventing surgeries and decreasing hospital stays. Purpose: The goal of this review paper is to show the present conditions and future trends of the pharmaceutical industry in the U.S. Methodology: This paper represents a thorough literature review of the multifaceted sources including: studies, books, peer reviewed journals, U.S. government sources (i.e. U.S. Census Bureau, U.S. Bureau of Economic Analysis, etc.). Discussion: In the thirty years pharmaceutical companies have consistently developed and launched new medicines, bringing hope to sick or – at risk patients. They also usually provide above the average financial returns for its shareholders. U.S. pharmaceutical companies had as their goal to discover blockbuster drugs. Blockbuster drugs are generally defined as drugs that solve medical problems common to hundreds of millions of people and, at the same time generate large sales increases and profits for the pharmaceutical companies. The main approach of these companies includes huge investments in research and development (R&D), innovation, marketing and sales. The trend analysis shows that for the most part the era of blockbuster drugs is nearing an end. Conclusion: Numerous blockbuster drugs will be coming off patent in the next few years, opening the way to generics and eliminating a major source of the industry’s profits. Still, there is plenty of room for improvement in the medications people take while there is no shortage of human suffering to alleviate. It is doubtful whether big pharmaceutical firms will be able to pursue these goals within the old model of developing exclusive new drugs that can be sold further in the future. In the past, medicines for the ailments that were never before addressed, like anti-cholesterol or anti-depression drugs were developed. Currently, and in the future, it is expected that only blockbuster modifications will be developed. This phenomenon is expected to create market saturation, which will significantly reduce profits. The business model that drove the major drug makers’ success is not working anymore. Pharmaceutical companies must create new ways and to bring new ideas. The survivors will be those that market strategies supported by innovative approaches and winning capabilities.

Introduction: Low sensitivity and specificity in traditional laboratory tests became insufficient for accurate diagnostics and initiation of proper treatment of patients infected with bacterial meningitis. High sensitivity Creactive protein (hsCRP) may be an appropriate supplement for rapid diagnosis of bacterial meningitis. The subject of our investigation was the determination of C- reactive protein in cerebrospinal fluid (CSF) during acute bacterial meningitis. Methods: HsCRP was analysed by a sensitive immunoturbidimetric assay using the Dimension RxL analyser (Siemens). Cerebrospinal fluid concentrations of C-reactive protein have been measured in 20 patients (age range,1 to 50 years) presenting with acute bacterial meningitis and also in a non-infected, non-inflamed control group (n=25). Results: The accuracy and precision of the method proved to be satisfactory. Repeatability of serial sampling for hsCRP described by coefficient of variation were CV=2.1-4.5%. This assay hsCRP in cerebrospinal fluid demonstrates adequate performance characteristics for routine clinical use. Elevated levels of CRP were found in 95% patients with bacterial meningitis. The mean CRP value in 25 uninfected control group was 0.25 mg/L (range 0.10-0.55). The mean CRP for patients with bacterial meningitis was 21.4 mg/L (range 0.40-100). Conclusions: A sensitive assay for CRP in CSF would be an useful adjunct to conventional investigation of acute infective meningitis.

In this paper we would like to briefly introduce readers to the situation in the field of laboratory medicine in Bosnia and Herzegovina, with a focus on training in the field of medical biochemistry. As in some of neighboring countries, term Medical biochemist is the usual name for the Clinical biochemist or Clinical chemist in Bosnia and Herzegovina. Despite the difficult period through which the profession had passed in the last two decades, laboratory work, particularly clinical biochemistry, has managed to retain the necessary quality and keep pace with the developed world. In post war period, Society of Medical Biochemists of Bosnia and Herzegovina held regular meetings each year as a part of "life long learning" process, where both scientific and vocational lecturers presented their work. A single law on the state level would provide us with more defined and precise answers, such as: who can get a specialization, how long should last the training for medical biochemistry specialists (duration in years). This law should be in consent with the program described in EC4 or other documents given by the EFCC (European Federation of Clinical Chemistry and Laboratory Medicine) and IFCC (International Federation of Clinical Chemistry and Laboratory Medicine).

E. Suljević, Muhamed Fazlić, J. Ćorić, Jozo Corić i Emina Kiseljaković

Research on the parameters of full blood count and differential white blood count is included in the program of all medical laboratories of primary, secondary and tertiary health care levels. Today, all haematological tests are exclusively performed on the haematology analyzers. Automation of haematology laboratories is a result of the huge requires for haematological test performing, timely issuing of the haematological findings, and possibility of the usage of modern techniques. This work is an evaluation of laser haematology analyzer Cell-Dyn 3700 SL. It investigates the reliability of test results throughout the following parameters: precision, accuracy, sensitivity and specificity of determination methods. It also explores the influence of sample transferring and correlation with haematology analyzer MAXM Retti. Haematology parameters that have been investigated are: white blood cell (WBC), neutrophils (NEU), lymphocytes (LXM), monocytes (MONO), eosinophils (EOS), basophils (BASO), red blood cells (RBC), haemoglobin (HGB), haematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCHC) red cell distribution width (RDW), platelet (PLT), mean platelet volume (MPV), plateletocrit (PCT), and platelet distribution width (PDW). The results confirms that precision of analyzer fulfils the reproducibility of testing parameters: WBC, RBC, HGB, MCV, MCH, MCHC, and PLT. Correlation coefficient values (r) gained throughout the statistical analysis, that is linear regression results obtained throughout the comparison of two analyzers are adequate except for MCHC (r = 0.64), what is in accordance with literature data. Accuracy is tested by haematology analyzer method and microscopic differentiating method. Correlation coefficient results for granulocytes, lymphocytes and monocytes point the accuracy of methods. Sensitivity and specificity parameters fulfil the analytical criteria. It is confirmed that haematology analyzer Cell-Dyn 3700 SL is reliable for the determination of full blood count in everyday work. Analyzer and its program for differential white blood count can be used for the research and separation of normal and pathological blood counts with addition of microscopic methods confirming distribution or morphologic changes of leukocytes.

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