Category Archives: Original Research

Going the Full Circle: Upgrading the Patient Field Chart and Tag for Electronic Mass Casualty Incidents Solutions in Romania

Adrian Stănescu1, Sanda Maria Copotoiu2, Cristian Marius Boeriu3

1. Sibiu Clinical Pediatric Hospital, Sibiu, Romania
2. University of Medicine, Pharmacy, Sciences and Technology of Târgu Mureş, Târgu Mureș Clinical Emergency County Hospital, Târgu Mureş, Romania
3. University of Medicine, Pharmacy, Sciences and Technology of Târgu Mureş, Romania

DOI: 10.2478/amma-2018-0025

Objective: Mass casualty incidents and disasters require functional and efficient patient data management systems, as well as smart interconnections with patient tracking applications. Various initiatives developed and tested patient field charts for large-scale events but there is no one definite general format accepted. The current research proposes an upgraded model of the official patient field chart issued by the Romanian Department for Emergency Situations in 2015 to be used for large-scale events.
Measures: An upgraded model is created after a thorough content analysis, physical analysis, design upgrade and optimization process. Differences between the official and the upgraded model are measured and compared, and statistical computations are carried out.
Results: The main distinctive features of the patient field chart are dynamic triage, unique code identification, QR visual codes, wireless tags and irreversible clear contamination status highlighting. The upgrade process results in almost doubling the available active area without the need to change the document size format of the product. Visual elements and features are included to optimize operation workflow.
Conclusions: The upgraded model offers a variety of improvements for both the overall rescue effort as well as the end user of the product. It allows for previously unavailable features like unlimited dynamic triage and enables the use of electronic management solutions.

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Eating Behaviour and Food Preferences of Tîrgu Mures High School Students

Maria Salcudean1, Victoria Rus1, Florina Ruta1, Catalin Moise Dogar2, Iustinian Simion1, Levente Nemes1

1. Department of Community Nutrition and Food Hygiene, University of Medicine and Pharmacy of Tirgu Mures, Romania
2. Department of Information and Public Relations, University of Medicine and Pharmacy of Tirgu Mures, Romania

DOI: 10.2478/amma-2018-0014

Introduction. Due to a busy and exhausting urban lifestyle parents do not always have the necessary time to pay sufficient attention to the quality of the dietary habits of their children.
Objective. Starting from the premise that teenagers have insufficient information about healthy eating, the present study aimed to highlight eating behaviours and nutrition knowledge deficits in a group of 427 high school students from Tîrgu Mures.
Methods. An observational study based on lifestyle and food frequency consumption was conducted. In 2017, students in fifteen classes from several High School Institutions from Targu Mures, Romania, were asked to complete a questionnaire with questions relating to the current state of health, lifestyle characteristics, anthropometric indicators, frequency of daily meal consumption, significance and intake of food additives, leisure activities performed and also teenagers’ preferences for food products.
Results. The average age of the respondents was 16.1 years old, 72.6% were boys, and 82% lived in the city. 43.6% of respondents stated that food is a necessity, while 22% asserted that food characterizes a pleasure for them. Concerning the calorific value of foods, 32.8% stated that they have no interest in the calorie content of different food products while only 26%, mainly girls, took notice of these. 31.10% of respondents indicated that they include the recommended amount of vegetables in their daily diet, 22% prefer to eat preserved foods while increased consumption of sweets was observed in 39.80%. 55.50% of respondents ate breakfast on a regular basis, and 37% read food labels.
Conclusions. The results emphasize the necessity to develop more effective educational programs designed to create necessary background information for a young generation, change adolescent dietary behaviours for the better, and thus prevent dietary related diseases.

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Effect of Food on the Pharmacokinetics of Gliclazide 60 mg Modified Release Tablet in Healthy Caucasian Volunteers

Diana Pop1, Ana-Maria Gheldiu1, Monica Oroian1,2, Adriana Marcovici2, Sandeep Bhardwaj2, Arshad Khuroo3, Ravi Kochhar4, Laurian Vlase1

1. Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, University of Medicine and Pharmacy “Iuliu Hatieganu”, Cluj-Napoca, Romania
2. Clinical Pharmacology and Pharmacokinetics Department, Terapia S.A-Sun Pharma Company, Cluj-Napoca, Romania
3. Clinical Pharmacology and Pharmacokinetics Department, Gurugram, India
4. R&D Formulation Development, Gurugram, India

DOI: 10.2478/amma-2018-0022

Objective: To evaluate the food effect on glicazide disposition in clinical trials conducted on healthy Caucasian volunteers who were given a new modified release oral formulation of Gliclazide 60 mg developed by Sun Pharmaceutical Industries, India.
Methods: The studies were designed as open-label, randomized, single-dose, crossover studies that consisted of two periods. During each study, venous blood samples were taken before and after drug administration up to 96 hours. Subsequently, individual plasma profiles were determined and non-compartmental method was employed for the assessment of food effect on the pharmacokinetic profile of gliclazide. The statistical significance of differences for the main pharmacokinetic parameters was evaluated by ANOVA test, for p < 0.05 statistical significance was decided. The relative profiles of absorption of gliclazide were obtained by mathematical deconvolution. All calculations were performed by Phoenix WinNonlin®.
Results: High-fat, high-calorie meal decreased gliclazide exposure. The mean maximum plasma concentration decreased with 14%, while the mean total area under the plasma concentration-time profile registered a 17% decrease. The elimination half-lives under fasted and fed conditions were comparable and the time to maximum plasma concentration was shortened under fed condition. Safety evaluation showed that overall gliclazide was well tolerated under both fasted and fed condition.
Conclusions: The statistical analysis revealed the lack of food effect on the new modified release tablets of Gliclazide 60 mg. However, before stating a definite conclusion regarding the food effect on gliclazide pharmacokinetic profile, additional studies on patients with type 2 diabetes mellitus should be conducted.

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New Insights in Growth Hormone Stimulation Tests Protocols

Iulia Armean1, Raluca Pop2, Iuliana Gherlan3, Ionela Pașcanu2

1. Emergency Clinical County Hospital Clinic, Tirgu Mures, Romania
2. Endocrinology Departament, University of Medicine and Pharmacy Târgu Mureș, Romania
3. CI Parhon Institute, Bucharest, University of Medicine and Pharmacy “Carol Davila”, Bucharest, Romania

DOI: 10.2478/amma-2018-0021

Objective: The objective of this study was to analyze the performance of 2 stimulation tests used in the diagnosis of growth hormone deficiency.
Method: A retrospective study was conducted on a non-random sample of 310 patients, between 2 and 20 years old, who were hospitalized in the Mureș County Hospital’s Endocrinology Department and in the National Institute of Endocrinology C.I. Parhon with short stature between 2009-2015. Inclusion criteria: all subjects who underwent growth hormone stimulation tests in accordance with the national protocol. Microsoft Office Excel was used for data collection and MedCalc v 12.5 was used for statistical analysis.
Results: From the total of 310 patients, 102 were diagnosed in Târgu Mureș and 208 in Bucharest. Sex ratio favored boys (boys:girls 1.64:1). In 173 subjects growth hormone deficiency was confirmed. For both tests the percentage of maximum response was the highest for the 60 minutes blood sample regardless if the test were positive or not. Both tests have 100% sensitivity and negative predictive value, with the highest specificity for the 60 minutes clonidine and 30 minutes insulin. The false positive rate was 60% for the insulin test and 27.2% for clonidine for Târgu Mureș sample and 86.9% for the insulin test and 62.5% for clonidine for Bucharest sample. The concordance of the 2 tests was 49.36%.
Conclusions: Stimulating growth hormone testing has a number of limitations but is still needed in some auxological circumstances. We recommend performing the clonidine test first to exclude idiopathic short stature and then the insulin tolerance test for the diagnosis of growth hormone deficiency.

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General Characteristics and Quality of Stroke-Related Online Information – A Cross-Sectional Assessment of the Romanian and Hungarian Websites

Septimiu Daniel Popescu1, Alex Otniel Popescu2, Mihaela Dănilă3, Mihaela Dobria2, David Maior2, Valentin Nădăşan4

1. Department of Radiology and Imaging, Emergency County Hospital Tirgu Mures, Romania
2. University of Medicine and Pharmacy of Tirgu Mures, Romania
3. Cardiovascular and Transplant Emergency Institute, Tirgu Mures, Romania
4. Department of Hygiene, University of Medicine and Pharmacy of Tirgu Mures, Romania

DOI: 10.2478/amma-2018-0023

Background: The quality of online health-related information may affect users’ understanding and medical decision-making with dramatic impact, particularly in case of stroke.
Objective: The objective of this study was to assess the quality of information about stroke on the Romanian and Hungarian websites in terms of completeness and accuracy.
Methods: The research was designed as an observational cross-sectional study. The sample included 25 Romanian and 25 Hungarian websites presenting information about stroke for the general public. General characteristics such as website ownership, main goal, website genre and medical approach were identified by the evaluators using a predetermined set of common instructions. The completeness and accuracy of the information were assessed by two independent assessors against a quality benchmark.
Results: Overall, most of the websites were owned by private commercial companies (42%), had educational goal (66%), were designed as medical web-portals (46%) and had a conventional medicine approach (72%). Mean completeness score was 5.6 points (SD± 1.9) for Romanian sites and 4.1 points (SD ± 2.4) for Hungarian sites (p = 0.017). Mean accuracy score was 6.2 points (SD ± 1.1) for Romanian sites and 7.0 points (SD ± 0.7) for Hungarian sites (p = 0.02).
Conclusions: The information about stroke on the Romanian and Hungarian websites had poor quality. Although we found statistically significant differences between the quality scores of the two language sub-samples and two site characteristics associated with significantly higher quality, the practical relevance of these findings for online health information seekers should be interpreted with caution.

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Predictors of Progression of Coronary Atherosclerosis after Percutaneous Coronary Intervention

Violeta Dinesch1, Mihail Dinesch2, Ileana Voichita Sirbu3, Cosmin Macarie3, Bogdan Vasile Halatiu4, Mircea Buruian­5

1. University of Medicine and Pharmacy Tirgu Mures, Romania
2. Department of Cardiology, Institute for Cardiovascular Disease and Heart Transplant, Tirgu Mures, Romania
3. Department of Internal Medicine M3, University of Medicine and Pharmacy, Department of Cardiology, Institute for Cardiovascular Disease and Heart Transplant, Tirgu Mures, Romania
4. Department of Physiology, University of Medicine and Pharmacy, Tirgu Mures, Romania
5. Department of Morphologic Sciences M1, University of Medicine and Pharmacy, Tirgu Mures, Romania

DOI: 10.10.2478/amma-2018-0020

Objective: This study investigated predictors of progression of coronary atherosclerosis after percutaneous coronary intervention. Their identification may be useful in clinical practice.
Methods: We retrospectively reviewed the database of the Cardiology Department of the Cardiovascular Disease and Heart Transplant Institute in Tirgu Mures from January 2012 to December 2015 and identified 180 patients readmitted after successful percutaneous coronary intervention. The t-test, chi-square test, Fisher’s exact test, and mono- and multivariate analyses were used to evaluate associations between the patients’ clinical and angiographic characteristics and the progression of coronary atherosclerosis.
Results: The pre-percutaneous coronary intervention atherosclerotic burden was associated with a higher number of new coronary lesions at readmission. Hypertension and the placement of more than one bare-metal stent in the right coronary artery were associated with increased odds of the progression of coronary atherosclerosis. The use of drug-eluting stents at the index percutaneous coronary intervention and a greater number of drug-eluting stents in the left anterior descending artery were associated with a decreased chance of the progression of coronary atherosclerosis.
Conclusions: A massive atherosclerotic load at index percutaneous coronary intervention and hypertension were predictors of the progression of coronary artery atherosclerosis. The number, type, and localization of the stent at the index percutaneous intervention could influence the progression of coronary atherosclerosis. Further research is needed to identify other potential predictors and to determine how to optimize the treatment of known predictors.

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Impact of a One Day Crisis Resource Management Training on the Work Satisfaction among Emergency Department Healthcare Staff

Teodora Sorana Truta1, Irina Ban2, Cristian Boeriu1, Marius Petrisor1, Diana Aniela Moldovan3, Sanda Maria Copotoiu1

1. University of Medicine and Pharmacy Tirgu-Mures, Romania
2. Universita degli Studi di Padova Dipartimento di Medicina Padova, Italy
3. Tirgu-Mures Emergency Clinical County Hospital, Tirgu Mures, Romania

DOI: 10.2478/amma-2018-0019

Objective: To evaluate the impact of a single day Crisis Resource Management (CRM) oriented team training, combining didactic and simulation sessions, on work satisfaction of the healthcare staff working in an Emergency Department.
Methods: Seventy health professionals with different qualifications, working in an emergency department, were enrolled in the study. After enrollment, participants were asked to complete a work satisfaction questionnaire and to choose a day for the training session according to their availability. Each training session took place in the simulation center and consisted of several elements: didactic session and simulation session, followed by instructor facilitated debriefing. The lecture was focused on medical errors and CRM principles. Two months after, they were asked to complete again the work satisfaction questionnaire.
Results: There were no significant improvements on the items evaluated through the work satisfaction questionnaire for none of the professional categories involved, except for ‘the possibility to refer the patient to a specialist whenever was considered necessary’ for the doctors. Improvements were seen for the same professional category on the following items: workload, leisure time, level of stress at work, time and energy spent on administrative tasks.
Conclusions: The findings of this study do not support the effectiveness of a single day CRM training as a tool to improve the work satisfaction among medical staff in ED. Further research is necessary.

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Risk of Contrast-Induced Nephropathy after Repeated Contrast Medium Administration

Violeta Dinesch1, Mihail Dinesch2, Cosmin Macarie3, Ileana Voichita Sirbu3, Mircea Buruian­4

1. University of Medicine and Pharmacy Tirgu Mures, Romania
2. Department of Cardiology, Institute for Cardiovascular Disease and Heart Transplant, Tirgu Mures, Romania
3. Department of Internal Medicine M3, University of Medicine and Pharmacy, Department of Cardiology, Institute for Cardiovascular Disease and Heart Transplant, Tirgu Mures, Romania
4. Department of Morphologic Sciences M1, University of Medicine and Pharmacy, Tirgu Mures, Romania

DOI: 10.2478/amma-2018-0017

Objective: Non-invasive coronary computed tomography angiography is frequently used to exclude coronary artery disease in patients with low-to-intermediate pre-test probability because of the high negative predictive value. The strategy of coronary computed tomography angiography and subsequent invasive coronary angiography in case of positive findings has risks owing to repeated contrast medium administration and the possibility of contrast-induced nephropathy.
Methods: We retrospectively evaluated the changes in the serum creatinine level and estimated glomerular filtration rate (at baseline, 24 h, and 48 h after contrast administration) in patients with repeated contrast medium administration in order to evaluate contrast-induced nephropathy development. All patients were intravenously hydrated with 1000 ml sodium chloride (0.9%) per day during hospitalization.
Results: The study included 17 patients. Of these patients, 7 (41.2%) had prior impaired renal function (estimated glomerular filtration rate <60 ml/min/1.73 m2). The mean coronary computed tomography angiography contrast medium (iopromide 769 mg/ml) volume was 114.11 ± 7.75 ml and the mean invasive coronary angiography contrast medium (iohexol 755 mg/ml) volume was 129.7 ± 19.24 ml. The serum creatinine level was significantly higher and the estimated glomerular filtration rate was significantly lower at 48 hours after the second contrast medium administration than at baseline (p = 0.05 and p = 0.03, respectively). None of the patients had contrast-induced nephropathy.
Conclusion: Repeated contrast medium administration was not associated with contrast-induced nephropathy development at 48 hours after the second contrast medium administration, even in patients with prior impaired renal function.

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LC-MS Method for Determining Amiodarone and Desethylaminodarone in Rat Plasma Used in Endogenous Overdosing Conditions Following Lipolysis

George Jîtcă, Bianca-Eugenia Ősz, Szende Vancea, Amalia Miklos, Amelia Tero-Vescan

University of Medicine and Pharmacy of Tîrgu Mureș, Romania

DOI: 10.2478/amma-2018-0016

Objective: The purpose of this study was to develop a LC-MS method to determine amiodarone (AMI) and its major metabolite desethylamiodarone (DEA) from rat plasma released from the adipose tissue of AMI treated rats subjected to a weight gain/weight loss cycle.
Methods: Separation of the compounds was performed on a Kinetex 2.6 μm C18 100 x 4.6 mm column under isocratic conditions using a mixture of acetonitrile: 0.1% formic acid 65:35 at a flow rate of 0.5 ml/min. Detection of the analyte was performed by electrospray positive ionization, the monitored ions being 135 m/z from 646 for AMI and 135 m/z of 618 for DEA. Analytes were extracted after plasma protein precipitation with methanol.
Results: The developed method presented specificity and linearity on the concentration range of 25-2500 ng/ml plasma for AMI and 2.5-1250 ng/ml plasma for DEA and the precision and accuracy of the method at all of quality control concentration levels including LLOQ were according to official guidelines for validating analytical methods.
Conclusions: A sensitive and accurate LC-MS method has been developed with a much lower LLOQ than literature data to detect the plasma concentration differences of the studied analytes that result from forced lipolysis and mobilization from the adipose tissue.

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Characterization of Inclusion Complexes between Miconazole and Different Cyclodextrin Derivatives

Hajnal Kelemen1, Gabriel Hancu1, Serban Andrei Gâz-Florea2, Eniko Nemes-Nagy3, Lajos Attila Papp1, Eleonora Mircia4

1. Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Medicine and Pharmacy, Tîrgu Mureş, Romania
2. Department of Organic Chemistry, Faculty of Pharmacy, University of Medicine and Pharmacy, Tîrgu Mureş, Romania
3. Department of Biochemistry, Faculty of Pharmacy, University of Medicine and Pharmacy, Tîrgu Mureş, Romania
4. Department of Pharmaceutical Industry, Faculty of Pharmacy, University of Medicine and Pharmacy, Tîrgu Mureş, Romania

DOI: 10.2478/amma-2018-0012

Objective: Miconazole, an imidazole antifungal derivative, is a very hydrophobic compound, a major drawback in obtaining topical pharmaceutical formulations with optimal bioavailability. Cyclodextrins (CDs) may increase local drug delivery by enhancing the drug release and/or permeation. The aim of the study is the characterization of inclusion complexes between miconazole and different CD derivatives.
Methods: Several CD derivatives were tested in the experiments. The binary systems between miconazole and different CDs were prepared in 1:1 molar ratios by physical-mixture and kneading methods. Differential scanning calorimetry (DSC) and Fourier transformed-infrared spectroscopy (FT-IR) methods were used to characterize solid state interactions between miconazole and CDs in their binary systems.
Results: The FT-IR analysis suggests the formation of a new solid phase, indicating a molecular interaction between the components. The DSC analysis sustains the hypothesis of formation of partial inclusion complexes between miconazole nitrate and CD. Conclusion: The thermic behaviour of the complexes depends both on the preparation method and the composition of the products.

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