Category Archives: Original Research

Fatal Road Traffic Accidents in Mureș County, Romania – A Retrospective Autopsy Based Study

DOI: 10.2478/amma-2019-0024

Objective: The main objective of this study is to evaluate the medico-legal aspects of fatal road traffic accidents.
Methods: This is a retrospective study consisting of 80 forensic autopsies performed at the Institute of Legal Medicine – Tîrgu Mureș, Romania during a two years period, between January 1st, 2016 to December 31st, 2017. The information obtained was based on the medical records and the evaluation of autopsy reports.
Results: Male victims involved in road traffic accidents were nearly three times more numerous than women (72.5% vs. 27.5%). Divided into 3 age groups (under 35 years old, 36-59 years old and over 60 years old) we noticed a relatively uniform distribution of the victims, with a slight dominance of the 36-59 age group and the over 60 years of age group. The highest number of victims was among the pedestrians (36.25%), followed in decreasing order by the drivers (33.75%), passengers (17.5%), cyclists (7.5%) and motorcyclists (5%). Positive alcohol testing was found in 14 of drivers (81 %). The analysis of lesions found during necropsies of the deceased at the scene of the accident highlights some particularly life-incompatible injuries that resemble any rescue effort on the part of the medical crew moved to the scene of the accident.
Conclusion: Inappropriate road conditions and indiscipline in traffic of both drivers and pedestrians contribute to unacceptably high mortality.

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The Association between Various Lifestyle Patterns and the Body Mass Index in Adolescents

DOI: 10.2478/amma-2019-0023

Objective: The study aims to analyze obesogenic behavioral patterns of adolescents living in Mureş County, Romania, as well as to establish a relationship between these behaviors and their Body Mass Index (BMI), in an attempt to provide effective prevention strategies for obesity.
Material and Methods: 153 students between 9th to 12th grade, aged between 14 and 19 years old, from the Vocational and Art Highschool of Târgu Mureş were included in the study. All the candidates filled out an evaluation questionnaire of lifestyle and risky behaviors. The analyzed data were sex, age, residence, BMI and risky eating behavior defined as the consumption of carbohydrates (bread, potatoes, sweets), sodas, junk food, alcohol (wine, distilled beverages, beer), beer separately, level of physical activity (school and extra-school sports activities), sedentary behaviors (≥2 hours/day in front of a screen: personal computer-PC and television-TV), and spending ≥2 hours/day separately on the PC and on the TV.
Results: A statistically significant association was observed between BMI and consumption of fast-food, tobacco, beer, sedentary behavior and spending ≥2 hours/day in front of the PC. Moreover, there was a statistically significant difference between the BMI values of adolescents presenting all studied risk behaviors compared to those who did not.
Conclusions: Obesity among adolescents from Mureș County is influenced by lifestyle choices like fast-food, tobacco, beer, sedentary behavior and spending ≥2 hours/day in front of the PC.

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Clinical Study on the Perception of Patients with Orthodontic Appliances Regarding the Periodontal Change

DOI: 10.2478/amma-2019-0021

Introduction: The orthodontic treatment helps in reestablishing a functional occlusion, improving the aesthetics and functionality of the dento-facial complex. A correct alignment of the teeth, through the correction of some dental or skeletal anomalies, enhances the possibilities of dental hygiene, thus reducing the risk of periodontal affections. Nevertheless, the presence of orthodontic appliances in the oral cavity may reduce the efficacy of the means of oral hygiene by creating retentive areas for food, thus producing damages at the level of the marginal periodontium.
Objective: The evaluation of oral hygiene practices for patients in the course of fixed orthodontic therapy and the identification of changes appeared at the level of the marginal periodontium caused by the orthodontic appliances.
Material and methods: A questionnaire with 20 questions was distributed to a number of 129 patients undergoing the active phase of orthodontic treatment in the Orthodontic and Dentofacial Clinic of the Medical Dental School Tîrgu Mureș or in some private practices in the Bucharest metropolitan area.
Results: The majority of patients surveyed are aware of the means of dental hygiene and practice a daily brushing, associated with auxiliary means. The iatrogenic effects of the fixed therapy are represented by gingival recession, gingival overgrowth and bleeding during brushing but these were visible only in the case of a small number of patients.
Conclusions: The fixed orthodontic treatment must be started only after a thorough evaluation of the marginal periodontium, with a close orthodontist – periodontist collaboration and avoidance of jiggling-like movements.

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Markers of Atherosclerosis in Hypertensive Patients with Less Advanced Chronic Kidney Disease

DOI: 10.2478/amma-2019-0022

Objective: Our study aimed to validate the neutrophil-to-lymphocyte ratio (NLR) as a marker for aortic arch calcification in hypertensive patients with less advanced chronic kidney disease (CKD).
Methods: A number of forty-four hypertensive patients with chronic kidney disease (categories G3a and G3b – 2012 KDIGO nomenclature) were included in the study. Considering the presence of aortic arch calcification (AAC) on chest X-ray, the study population was divided into two groups: 27 patients AAC present and seventeen without aortic arch calcification. Laboratory data were collected for each patient and NLR was computed. Comorbidities were also recorded: stable coronary artery disease, lower extremity arterial disease and hypertensive heart disease.
Results: A positive correlation between neutrophil-to-lymphocyte ratio and aortic arch calcification in hypertensive CKD patients was identified. Furthermore, advanced age, increased alkaline phosphatase and increased erythrocyte sedimentation rate had a positive association with aortic arch calcification. We found no statistical correlation between neutrophil-to-lymphocyte ratio and other laboratory features in both groups of patients.
Conclusions: Neutrophil-to-lymphocyte ratio may be viewed as a potential risk factor for vascular calcification in patients with moderate chronic kidney disease; nevertheless, future extensive studies are necessary. In the management of hypertensive patients, general medicine might particularly benefit of this simple, readily available inflammatory marker.

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Evaluation of the Apical Seal after Root Canal Cleaning and Shaping with Two Nickel-Titanium Systems

DOI: 10.2478/amma-2019-0019

Objective: The aim of our study is to compare the ability of two nickel-titanium systems that use different rotation motions to create preparations that could promote a complete filling of the apical third of root canals.
Methods: We used 36 freshly extracted teeth, randomly divided in two groups, as follows: in Group A we used ProTaper Next, a system characterized by a continuous rotary motion and in Group B the teeth were instrumented with Wave-One, in which the files have a reciprocating motion. All teeth were root filled based on the same protocol, using gutta-percha and AH Plus. The teeth were further prepared for microleakage evaluation based on dye penetration technique, as follows: immersion in 2% methylene blue, longitudinally sectioned and examination of the apical thirds with an operating microscope. The distance of dye penetration along dentin walls was measured using the ImageJ program.
Results: The comparison between rotational and reciprocating systems showed that reciprocating files significantly promoted a reduced apical microleakage, as demonstrated by unpaired t test, Welch corrected (p=0.0346).
Conclusion: The use of Wave-One Reciprocating system was considered more effective in the shaping of root canals, as they demonstrating better conditions for the hermetic, tridimensional sealing of apical third of the roots canals.

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Atomoxetine and Duloxetine: Evaluation of a Potential Pharmacokinetic Drug-Drug Interaction

DOI: 10.2478/amma-2019-0017

Objective: The present research aimed to investigate whether a pharmacokinetic drug interaction exists between atomoxetine, a substrate of CYP2D6 and duloxetine, an enzymatic inhibitor of the same metabolic pathway.
Methods: Twenty-three healthy volunteers were enrolled in an open-label, non-randomized, sequential, 2-period clinical study. During the trial, they received a single dose of atomoxetine 25 mg (Period 1:Reference) followed by a combination of atomoxetine 25 mg and duloxetine 30 mg, after a pretreatment regimen with duloxetine 30-60 mg/day for 4 days (Period 2:Test). The pharmacokinetic parameters of atomoxetine and its main metabolite (4-hydroxyatomoxetine-O-glucuronide) were estimated using a non-compartmental approach and statistical tests were used to compare these parameters between study periods.
Results: A total of 22 subjects, extensive metabolizers (EMs), were considered for the final report of the study findings. Duloxetine influenced the plasma concentration-time profile of both parent drug and its glucuronidated metabolite. The pharmacokinetic and statistical analysis revealed that pretreatment with the enzymatic inhibitor increased the mean atomoxetine AUC0–t (from 1151.19±686.52 to 1495.54±812.40 [ng*h/mL]) and AUC0–∞ (from 1229.15±751.04 to 1619.37±955.01 [ng*h/mL]) while kel was decreased and the mean t1/2 was prolonged. With regard to 4-hydroxyatomoxetine-O-glucuronide, Cmax was reduced from 688.76±270.27 to 621.60±248.82 [ng/mL] after coadministration of atomoxetine and duloxetine.
Conclusions: Duloxetine had an impact on the pharmacokinetics of atomoxetine as it increased the exposure to the latter by ~30%. Although the magnitude of this pharmacokinetic interaction is rather small, a potential clinical relevance cannot be ruled out with certainty without further investigation.

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The Statistical Analysis of Pharmacokinetic Parameters in the Context of Bioequivalence Testing of Two Anthelmintic Formulas Based on Ivermectine and Triclabendazole in Sheep

DOI: 10.2478/amma-2019-0015

Conducting bioequivalence studies is an essential step during the market authorization process of generic pharmaceutical formulations, for both human or veterinary use. The aim of the present study was to evaluate the pharmacokinetics of triclabendazole sulphoxide, the main metabolite of triclabendazole, and ivermectin in order to evaluate the bioavailability and bioequivalence of a novel sheep anthelmintic formulation of oral suspension for sheep treatment containing triclabendazole 50 mg/mL and ivermectin 1 mg/mL compared to the reference product. In order to determine relative bioavailability of the test product with respect to the reference product the study was conducted on 36 clinically healthy sheep, following an unicentric, randomized, cross-over, two-sequence, two-treatment and 14-day wash-out study design. For the determination of triclabendazole sulphoxide and ivermectin sheep plasma concentrations, two rapid, selective high performance liquid chromatography coupled with mass spectrometry (LC-MS/MS) methods were developed and validated. The measured plasma concentrations of triclabendazole sulphoxide and ivermectin were used for the pharmacokinetic analysis and the determination of bioequivalence between the test product with regards to the reference product. The noncompartmental analysis of the pharmacokinetic data for both triclabendazole sulphoxide and ivermectin showed similarities between first-order kinetics of the test and reference product. The relevant pharmacokinetic parameters (Cmax, AUClast, AUCtot) were determined and the bioequivalence between the test and reference product could be concluded.

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The Complication Rates of Oral Anticoagulation Therapy in Deep Venous Thrombosis

DOI: 10.2478/amma-2019-0012

The objective of the current study is to evaluate the complication rates (embolic and hemorrhagic events) in deep venous thrombosis (DVT) patients on different types of oral anticoagulation therapy (OAC): direct oral anticoagulant therapy and vitamin K antagonist therapy.
Methods: A number of 62 DVT patients were included and divided in two groups, depending on the type of oral anticoagulation therapy administered. The first group was composed of patients treated with direct oral anticoagulant treatment (Dabigatran, Rivaroxaban) and the second group was composed of patients treated with vitamin K antagonist (Acenocumarol). General data, including BMI and comorbidities were noted. Embolic and hemorrhagic events were noticed.
Results: in the first group of patients (DOAC therapy), a number of 34 patients were included (14 of them with BMI higher than 25 kg/m2 and 14 with concomitant atrial fibrillation), while the second group comprised of 28 patients treated with VKA (21 of them with a high BMI and only 3 of them with atrial fibrillation). After a mean period of 36 months of anticoagulant therapy, complications were present in 17 patients, hematuria (8 episodes) and pulmonary embolism (4 cases) were the most frequent, with no difference regarding the treatment applied. Conclusion: No statistically significant difference was encountered regarding embolic and hemorrhagic event rates in our deep vein thrombosis patients.

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Development and Validation of an UV-Spectrophotometric Method for the Assay of Strontium Ranelate and HPLC Stability Testing from Bulk and Pharmaceutical Dosage Form

DOI: 10.2478/amma-2019-0014

Objective: The present work offers a fast, reliable and easy UV spectrophotometric method for the assay of strontium ranelate from bulk samples and pharmaceutical dosage form.
Methods: The proposed method uses 0.1% V/V trichloroacetic acid as dissolution medium for spectrophotometric analysis, by signal detection at 321 nm. The method was validated according to the currently in-force international guidelines for linearity, accuracy, precision, robustness, limit of detection and quantification.
Results: The method was found to be linear in the range of 5-100 µg mL-1 (R2 > 0.999). Method accuracy was found in-between 98.87-100.41%, showing good linear correlation as well (R2 = 0.9997). The concentrations for limit of detection and limit of quantitation were found 1.13 µg mL-1 and 3.77 µg mL-1, resp. The proposed method showed good intra- and interday precision, with low RSD values of 0.53-1.24% and 1.11%, resp.
Conclusions: Stability studies performed by both HPLC and UV spectrophotometric methods revealed that the active substance is highly susceptible to acidic hydrolysis, oxidation and exposure to high temperature.

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Development and Validation of an UHPLC Method for Ostarine Determination in Dietary Supplements

DOI: 10.2478/amma-2019-0008

Objective: The purpose of this study was to develop a low-cost, yet sensitive and precise UHPLC method for the quantitative determination of ostarine from dietary supplements (DS) for athletes. The analytical performance of the method was verified on a DS legally acquired from a specialized website for athletes. The uniformity of mass and content of the ostarine DS was also verified.
Methods: For the quantitative determination of ostarine a UHPLC method was developed and validated. The separation was performed using a reversed-phase C18 column, using a mixture of 75% methanol: 25% formic acid 0.1% in isocratic elution, at a flow rate of 0.5 ml/min. The uniformity of mass and content of DS was performed following the methodology described in the European Pharmacopoeia 7th Edition.
Results: The validated method was specific and linear on the concentration range of 1-25 µg/ml and was precise and accurate at all concentration levels, according to the official guidelines for validating analytical methods. An average mass of 510 mg content was obtained for the ostarine capsules, with an RSD of 2.41%. Regarding the uniformity of the content, an average of 4.65 mg ostarine/capsule was obtained with an RSD of 1.05%.
Conclusions: The developed UHPLC method was suitable, rapid, sensitive and allowed quantitative determination of active substance content in a DS with ostarine (92.91% ostarine/capsule from 5 mg ostarine/capsule declared by the manufacturer).

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