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216 results on '"Naumovska, Zorica"'

2. AKR1D1*36 C>T (rs1872930) allelic variant is associated with variability of the CYP2C9 genotype predicted pharmacokinetics of ibuprofen enantiomers – a pilot study in healthy volunteers

Author

Kapedanovska Nestorovska Aleksandra, Jakjovski Krume, Naumovska Zorica, Sterjev Zoran, Geskovska Nadica Matevska, Mladenovska Kristina, Suturkova Ljubica, and Dimovski Aleksandar

Subjects
ibuprofen, enantiomers, pharmacokinetics, akr1d1, cyp2c9, pharmacogenetics, Pharmaceutical industry, HD9665-9675
Abstract

The relative contribution of CYP2C9 allelic variants to the pharmacokinetics (PK) of ibuprofen (IBP) enantiomers has been studied extensively, but the potential clinical benefit of pharmacogenetically guided IBP treatment is not evident yet. The role of AKR1D1*36C>T (rs 1872930) allelic variant in interindividual variability of CYP450 mediated drug metabolism was recently elucidated. A total of 27 healthy male subjects, volunteers in IBP single-dose two-way cross-over bioequivalence studies were genotyped for CYP2C9*2, CYP2C9*3 and AKR1D1*36 polymorphisms. The correlation between CYP2C9 and AKR1D1 genetic profile and the PK parameters for S-(+) and R-(−)-IBP was evaluated. Remarkable changes in the PK values pointing to reduced CYP2C9 enzyme activity were detected only in the CYP2C9*2 allelic variant carriers. Statistically significant association between the AKR1D1*36 allele and the increased IBP metabolism (low AUC0-t and 0–∞, high Cltot and short tmax values for both enantiomers) was observed in subjects carrying the CYP2C9 *1/*3 or CYP2C9*1/*1 genotype. The clinical value of concomitant CYP2C9 and AKR1D1 genotyping has to be further verified.

Published
2019
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3. REGULATORY FRAMEWORK FOR ADVERTISING OF MEDICINAL PRODUCTS IN THE REPUBLIC OF NORTH MACEDONIA AND THE EUROPEAN UNION.

Author

Zerde, Stefana Georgievska, Mihajloska, Evgenija, Dimkovski, Aleksandar, Naumovska, Zorica, Sterjev, Zoran, and Netkovska, Katerina Anchevska

Subjects
PHARMACEUTICAL industry, DRUG advertising, GOVERNMENT regulation
Abstract

Pharmaceutical companies frequently engage in drug advertising to connect with potential buyers. In the competitive pharmaceutical market, where patients are highly sensitive to various forms of advertising, manufacturers aim to reach a broad audience. This rapid dissemination of information in the advertising of medicinal products leads to some details being unverified and inaccurate, which emphasizes the critical importance of establishing and enforcing legislation. This paper aims to evaluate the current legislation for advertising of medicinal products in Republic of North Macedonia, as well as the regulations in European Union member states, namely Germany, Slovenia and Spain. The basic legal act that regulates the advertising of medicinal products in the European Union is Directive 2001/83/EC of the European Parliament and of the Council of Europe of 6 November 2001 on the Community code relating to medicinal products for human use such as amended by Directive 2004/27/EC of 31 March 2004. By reviewing relevant literature and conducting a comparative analysis of regulations in the Republic of North Macedonia and European Union, it can be concluded that the European Directive serves as a foundational framework. Each country has transposed the European Directive in domestic laws and regulatory guidelines with local adaptations and all Member States have therefore adopted further specific measures concerning the advertising of medicinal products. Depending on the member state, pharmaceutical promotion can be monitored and controlled by the government, by a national competent authority or not, this approach is called “self-regulation.Upon examining the regulatory structures in each specific country, there are five key components that must be implemented: development and adoption of national laws and regulations; implementation of the regulation, codes and other standards; monitoring the pharmaceutical promotion to ensure compliance with legal regulations; enforcement of the law through suitable sanctions to prevent violations; and evaluation of regulatory efficiency. Drawing parallels between the practices of established European member states and the regulatory framework of the Republic of North Macedonia, it becomes evident that there is an opportunity for the Republic of North Macedonia to leverage positive experiences from the European countries. By incorporating successful elements of European member states' regulations, the Republic of North Macedonia could enhance its own pharmaceutical regulatory environment. Based on this evaluation of established practices and experiences in European countries, direction will be provided for harmonizing and improving the regulatory framework for advertising od medicinal products in the Republic of North Macedonia. [ABSTRACT FROM AUTHOR]

Published
2024

4. Bioactive compounds profiling in cultivated medical Cannabis

Author

Serafimovska, Tijana, Tonic Ribarska, Jamina, Naumovska, Zorica, Darkovska-Serafimovska, Marija, Keskoski, Zlatko, and Stefkov, Gjoshe

Subjects
Other medical sciences
Abstract

Cannabis sativa is plant used to treat various painful and pathogenic conditions. The main carriers of pharmacological effects in cannabis flowers are cannabinoids and terpenes. Cannabinoids have been used in the treatment of chronic pain, spasticity, seizure disorders, nausea, anorexia. Terpenes itself have a wide range of pharmacological actions, such as antifungal, antiviral, anti-inflammatory, antimicrobial, and act synergistically with cannabinoids in exhibiting a pharmacological effect. The aim of this study was to determine cannabinoids content and terpenoid profile in dry cannabis flowers obtained from different THC-rich varieties of cannabis plant. For that purpose, a verification of HPLC/UV method for quantification of cannabinoids and GC/MS method for determination of terpenes in cannabis flowers was done to demonstrate that the analytical methods are suitable for intended analysis. Content of THC in Strawberry glue variety Lot.080322, Lot.110322 and Lot.040222 is 21.46%, 20.99% and 21.96%, respectively. Most common terpenes are beta-Myrcene, d-Limonene, beta-Caryophyllene and alpha-Terpineol. Content of THC in French Cookies variety Lot.060222, Lot.120322 and Lot.140422 is 22.17%, 23.05% and 22.55%, respectively. Most dominant terpenes are beta-Myrcene, d-Limonene, beta-Caryophyllene and alpha-Humulene. Content of THC in La Sage variety Lot.070222, Lot.090322 and Lot.110322 is 21.34%, 23.36% and 21.99%, respectively. Its unique aroma is a mixture of the dominant Terpinolene and beta-Caryophyllene and less represented, D-Limonene and beta Myrcene. The results obtained indicate that dry flowers derived from different cannabis varieties can be distinguished only by a terpenoid profile which is at the same time a fingerprint or a specificity that is characteristic of each variety.

Published
2023

19. Correlation of Vitamin D and Zinc concentration with therapy outcome in epilepsy patients from Republic of North Macedonia

Author

Georgievski, Damjan, primary, Lutovska, Kosara, additional, Sokoloski, Petar, additional, Rexhepi, Arbana, additional, Mihajloska, Evgenija, additional, Dimkovski, Aleksandar, additional, Kapedanovska Nestorovska, Aleksandra, additional, Naumovska, Zorica, additional, Cvetkovska, Emilija, additional, and Sterjev, Zoran, additional

Published
2022
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30. Improving the safety of prescribing and using antibiotics in the treatment of exacerbations of COPD in hospitalized patients in tertiary care

Author

K. Nakovska, Olivera, primary, Dokic, Dejan, additional, Karkinski, Dimitar, additional, Nechevski, Vangel, additional, Janeva, Elena, additional, M. Gjorevska, Milena, additional, Debreslioska, Angela, additional, Bogoeva, Ksenija, additional, Naumovska, Zorica, additional, Kapedanovska Nestorovska, Aleksandra, additional, and Suturkova, Ljubica, additional

Published
2022
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33. COVID-19 vaccination in rituximab-treated patients with rheumatic disorders

Author

Mihajloska, Evgenija, primary, Dimkovski, Aleksandar, additional, Antova, Dubravka, additional, Vasilevska, Ana, additional, Grozdanova, Aleksandra, additional, Naumovska, Zorica, additional, Kapedanovska Nestorovska, Aleksandra, additional, Sterjev, Zoran, additional, Osmani, Bashkim, additional, and Suturkova, Ljubica, additional

Published
2022
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39. Concomitant influence of CYP2D6 phenotype and ABCB1 overall haplotype/genotype on pharmacokinetics of risperidone and 9-hydroxyrisperidone in healthy volunteers

Author

Dimkovski, Aleksandar, primary, Mihajloska, Evgenija, additional, Jakovski, Krume, additional, Sterjev, Zoran, additional, Matevska Geskovska, Nadica, additional, Naumovska, Zorica, additional, Kapedanovska Nestorovska, Aleksandra, additional, Suturkova, Ljubica, additional, and Dimovski, Aleksandar, additional

Published
2022
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40. D-dimer levels as a biomarker for disease severity and mortality in Covid-19 critically ill patients

Author

Lazarova, Biljana, Eftimova, Biljana, Gazepov, Strahil, and Naumovska, Zorica

Subjects
Health sciences
Abstract

Purpose As the critically ill patients with COVID-19 pneumonia suffered from high thrombotic risk and the effect of COVID-19 on coagulation is still not well determined, the aim of our study was to evaluate the risk factors associated with mortality in COVID-19 patients and assess the use of D-dimer as a biomarker for disease severity and clinical outcome. Methodology We conducted a retrospective study of critically ill patients admitted to an intensive care unit (ICU) because of severe COVID-19 pneumonia Fifty five critical COVID-19 patients in the intensive care unit of the Clinical Hospital in Stip-The Republic of North Macedonia in three mounths period December, 2020 - Fevruary, 2021 were enrolled in the study and were divided into survivors and non-survivors. The diagnosis of severe COVID-19 pneumonia was according to World Health Organization (WHO) interim guidance and it was confirmed by RNA detection of the SARS-CoV-2 in clinical laboratory. The demographic and clinical information were collected. Peripheral venous blood sample was taken and routine blood examination with platelet counts and D�dimers was performed on day of admission and at the time of discharged the ICU unit for the survivor group of the patients and the day of death of the non-survivor group. All patients receive appropriate supportive therapies during the hospital stay and tromboprophylaxis with low molecular weight heparin (LMWH, 40-60mg enoxaparin/day) in line with adopted guidelines. Statistical analysis of the data was performed and appropriate parametric and non-parametric test were conducted. Continuous variables were expressed as median (interquartile range) and compared with the Mann-Whitney U test. A p-value of < 0.05 was considered statistically significant. Stat Graphics centurion 19 was used for statistical analysis. Results Fifty five patients were enrolled into the study. The mean age was 67 ± 10 years; most of them were male (63.6%). Seventeen patients (31%) survived and 38 patient (69%) have died during the treatment in the ICU in the clinical hospital in Stip. The mean age in the survived group of patients was 66 ± 9 years; most of them were male (76.5%), whereas in the group of non-survivors mean age of patients was 68 ± 10 years with 42.1% women. Our results have suggested that the age does not influents the rate of survival (p=0.4). Our results have suggested that the D-dimer values depend on the gender. Our result have confirmed statistically significant higher D-dimer value on the admission in the ICU in female patients (p=0.05) and on the leave of ICU unit (p=0.024). The present study shows that abnormal coagulation results, especially markedly elevated D‐dimer are common in deaths with NCP. Conclusions Recent clinical experience suggests that severe COVID-19 is commonly complicated with coagulopathy with elevated D-dimer values and severe disease is accompanied with higher D-dimer values in comparison with patients with mild Covid-19 clinical form of disease. In severe cases hypercoagulability is accelerated and disseminated intravascular coagulation is possible clinical outcome. The effect of Coid-19 infection on hemostatic function remains still unknown. Recommendations Abnormal coagulation results, especially markedly elevated D‐dimer may have the potential to guide therapy and prognosis evaluation in criticaly ill patients with confirmed Covid-19 infection.

Published
2021

41. Prognostic value of lactate dehydrogenase for in-hospital mortality in critically ill patients with Covid-19

Author

Eftimova, Biljana, Lazarova, Biljana, Gazepov, Strahil, and Naumovska, Zorica

Subjects
Health sciences
Abstract

Purpose It is well known that COVID-19 patients may have increased serum lactate dehydrogenase (LDH) levels in the early stage, so LDH has been proved to be a prognostic factor for the severity and poor outcomes of coronavirus disease (COVID-19). The aim of the study was to evaluated the association of LDH and CRP with in-hospital mortality in critically ill patients with COVID-19 and their predictive value for prognosis. Methodology A retrospective study was conducted in order to analyzed the clinical data of 55 critical COVID-19 patients. The patients were diagnosed with PCR test and critical cases met any one of the following criteria: respiratory failure and required mechanical ventilation, the occurrence of shock, and the combined failure of other organs that required intensive care unit monitoring and treatments, according to the diagnostic criteria of critical COVID-19. Clinical data including symptoms, detection of SARS-CoV-2, chest computed tomography (CT) images, CRP and LDH levels in serum were collected. According to chest CT images, we observed the fibrosis stages in all critical patients in this study. Most non-survivors died in the fibrosis stage. Statistical analysis of the data was performed and appropriate parametric and non-parametric test were conducted. Continuous variables were expressed as median (interquartile range) and compared with the Mann-Whitney U test. A pvalue of < 0.05 was considered statistically significant. Stat Graphics centurion 19 was used for statistical analysis. Results Fifty five patients were enrolled into the study. The mean age was 67 ± 10 years; most of them were male (63.6%). Seventeen patients (31%) survived and 38 patient (69%) have died during the treatment in the ICU in the clinical hospital in Stip. The mean age in the survived group of patients was 66 ± 9 years; most of them were male (76.5%), whereas in the group of non-survivors mean age of patients was 68 ± 10 years with 42.1% women. Our results have suggested that the age does not influents the rate of survival (p=0.4). The obtained results confirmed that the LDH values depend on the gender. Our result have not reached statistical significance but there was evident tendency in higher values in LDH values in female patients on the admission in the ICU with p=0.068. Also the same tendency was confirmed for the influence of the LDH levels on survival of the Covid-19 patients in ICU with p=0.07. Limited number of enrolled patients may explain the tendency and higher number of patients included in the study is expected to confirm the statistical significance in influence of gender on LDH level, as well as influence of the LDH level on severe patient survival in ICU. In all patient population higher CRP values were confirmed (178±132) mg/L in the non-survivors group and (250±103) mg/L in the group of survivors. Our results have confirmed that there was statistically significant difference in the CRP values and rate of survival in ICU Covid-19 patients. There were statistically significant higher CRP values in the group on non-survivors in comparison to the group of survivors (p=0.03). Additionally, non-survivors had fewer days of hospitalization, shorter disease duration, shorter duration of fibrosis, and had dyspnea symptoms at disease onset (P = 0.05). Conclusions LDH is a prognostic biomarker with acceptable accuracy for predicting in-hospital mortality in critically ill patients with COVID-19. This may help the physicians in the process of effective in identification of patients at high risk of death and rational prioritization of resources it order to initiate more aggressive treatments at an earlier phase to save patients' lives. Recommendations LDH may play significant role as a biomarker for identification of COVID-19 patient population at high mortality risk and could help physicians in selection of patients eligible for more aggressive treatment initiation at early stage of ICU-admission.

Published
2021

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