Category Archives: Original Research

The Anti-tobacco Legislation’s Impact on Air Pollution in Romanian Foster Care Homes

DOI: 10.2478/amma-2020-0019

Objective: The research aimed to investigate the impact of the anti-tobacco legislation (2016) on air quality in Romanian foster care homes.
Methods: The measurements took place in foster care homes situated in three Romanian counties. We recorded data three times (in 2014, in 2016 – six months after the implementation of the anti-tobacco legislation, in 2019). In 41 foster care homes were measured the indoor and outdoor Particulate Matter (PM2.5) level in the air, using the TSI SidePak™ Personal Aerosol Monitor device. Descriptive statistics and t-test were used for data analysis (significant difference if p < 0.05).
Results: The indoor PM2.5 values were higher in every year than outdoor values. Analyzing the anti-tobacco legislation’s impact on air quality, we found no difference between the indoor data measured in 2014 and in 2016, but there was a significant difference in the outdoor values (they were higher in 2016). Comparing the values measured after the implementation of the legislation (2016 vs. 2019) we found no difference in either indoor or outdoor values.
Conclusions: The anti-tobacco legislation has not influenced the indoor air pollution (PM2.5) level. The increased outdoor PM2.5 values suggest that the residents of the foster care homes are smoking more in front of the house after the introduction of the anti-tobacco legislation in 2016.

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Establishing the Diagnostic and Prognostic Value of Serum Interleukin 6 Levels in Sepsis

DOI: 10.2478/amma-2020-0014

Objective: Establishing a serological profile of interleukin 6 (IL-6) in order to evaluate its usefulness as a biological marker for the diagnosis and early prognosis in sepsis.
Materials and Methods: The study included 246 individuals, divided into 2 groups: 131 in the septic subgroup (S) and 115 in the septic shock (SS) subgroup. Inflammatory markers, bacteriological examinations and laboratory samples were determined within 24 hours of the first signs of infection. Severity scores were also calculated within the first day of the onset of sepsis.
Results: The SS subgroup (median 121.2 pg/ml, 18.59-10235 pg/ml; SD = 1920) shows significantly higher values of IL-6, compared to the S subgroup (median 43.49 pg/ml, 13, 27-6566 pg/ml; SD = 1367) (p = 0.0026). The SS subgroup has a significantly higher death rate than S subgroup (p = 0.001). The cut-off values of the mortality prediction degree were 184.74 pg/ml. The area under the curve of the cytokine IL-6 for the differentiation of sepsis from septic shock was 0.693 (95% CI 0.582-0.790, p = 0.002). The optimal value of the cut-off that allows the differentiation of the septic subgroup from the one with organ dysfunction, was 52.72 pg / ml.
Conclusion: Serum IL-6 values are significantly higher in the septic shock group. All deceased patients had higher IL-6 serum values.

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Effect of Isoflurane Anesthesia on the Heart Rate and Blood Pressure Response to Autonomic Nervous System Stimulation and Inhibition in Rats

DOI: 10.2478/amma-2020-0016

Objective: Many experimental studies aim to assess the autonomic nervous system (ANS), but this is often hampered by interactions with anesthetic drugs. We aimed to evaluate whether isoflurane anesthesia is suitable for ANS evaluation in rats.
Methods: Six Wistar rats were anesthetized with isoflurane (4 L/min, 2.5%). Systolic blood pressure (SBP) and heart rate (HR) were measured at baseline and 20 min after sympathetic inhibition (propranolol, 5 mg/kg) and stimulation (isoproterenol, 2.5 mg/kg), and parasympathetic inhibition (atropine nitrate, 2 mg/kg) and stimulation (carbamylcholine, 0.4 mg/kg; acetylcholine, 0.1 mg/kg). Six additional rats were used to assess the effects of isoproterenol, carbamylcholine, and atropine nitrate in the absence of anesthesia.
Results: Propranolol significantly decreased the HR and the SBP, whereas isoproterenol significantly increased the HR (all p≤0.01) in the isoflurane-anesthetized rats. However, the HR response to sympathetic stimulation was significantly reduced in the anesthetized compared to the non-anesthetized rats (p=0.03). Carbamylcholine and acetylcholine significantly decreased both the HR and SBP (all p<0.05) in the anesthetized rats, but the response to carbamylcholine administration was significantly more pronounced in the non-anesthetized rats (p=0.03). Atropine nitrate significantly increased the HR (p<0.001) in the non-anesthetized rats, but it had no effect on either the HR or the SBP in the presence of isoflurane anesthesia (both p>0.05).
Conclusions: Isoflurane anesthesia appears to interfere with both components of the ANS and is therefore not an optimal approach for experimental ANS evaluation. Our data indicate autonomic receptors and/or post-receptor mechanisms as the most likely site for isoflurane-ANS interactions.

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Left Ventricular Function and Morphology after Cardiac Surgery for Severe Mitral Insufficiency – A Single Center Experience

DOI: 10.2478/amma-2020-0015

Introduction: Mitral insufficiency is a common valvular disease affecting 10% of the general population. The main treatment of the severe mitral regurgitation is surgical. We have analyzed the impact of cardiac surgery on the left ventricular performance and morphology, in patients treated for severe mitral insufficiency accordingly to the type of intervention, ischemic time and type of cardioplegia.
Methods: Ninety patients diagnosed with isolated severe mitral insufficiency that benefited from mitral valvular replacement or mitral valvuloplasty were retrospectively enrolled. The left ventricle, the left atrium, the right ventricle diameters and the left ventricle ejection fraction were measured by two-dimensional (2D) echocardiography before and after surgery. The influence of the myocardial ischemia time and the type of cardioplegia administered on the ventricular systolic function were also analyzed.
Results: Regardless the surgical technique chosen, after surgery we noticed a decreased size of the left ventricle (preoperative mean 54.91mm ±8.18 vs postoperative mean 51.94mm±8.15, p=0.035), right ventricle (preoperative mean 33.49mm±5,87 vs postoperative mean 32.41mm±6.03, p=0.0001), as well as the ejection fraction (preoperative mean 51.29%±8.51 vs postoperative mean 46.57%±8.71, p=0.0001).
Conclusions: Immediately after surgery, a decrease in the size of cardiac cavities as well as a decrease of the left ventricle ejection fraction is noticed.

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Correlation Study of Serum Zinc Concentration and Retina Layer Thickness in Hypertensive Patients

DOI: 10.2478/amma-2020-0017

Objective: The aim of our study was to evaluate whether blood serum zinc concentration correlates with the thickness of human retina layers, in hypertensive patients with microvascular damage.
Methods: Retinas of elderly patients with arterial hypertension and microvascular damage were imaged using a swept-source ocular coherence tomography from Topcon. Automatic retinal segmentation was applied on a 6mm X 6mm scan protocol and average thickness for 5 examined layers was used for statistical analysis. Serum zinc concentration was measured using the Zinc Assay kit from Sentinel Diagnostics in a spectrophotometric method.
Results: The average age of the twenty-three enrolled patients was 70 years, varying between 62 and 76. The mean zinc value was 9.9 µmol/l ±1.62 (SD). All five examined layers of the retina presented inverse correlation with serum zinc concentration. The complex including the inner plexiform layer and ganglion cell layer indicated the Spearman’s (rho) correlation coefficient -0.42 and a significance level of p=0.04. Patients in high-Zn group (≥ 9.87 µmol/l) had thinner macular retina layers, most importantly in the inner-plexiform layer-ganglion cell layer complex (p=0.006).
Conclusions: Our study has found that serum zinc concentration is inversely correlated with the thickness of retina layers with statistical relevancy in the inner plexiform layer – ganglion cell layer complex. This finding emerges experimental studies in order to elucidate its clinical significance and to evaluate whether the fine architecture of the inner retina has the potential to benefit from oral zinc supplementation through modulating serum levels of zinc in patients with microvascular-damaging diseases.

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A Study of Heat Generation in Orthopaedic Bone Drilling Process

DOI: 10.2478/amma-2020-0009

Reconstruction and repair of a complete bone fracture requires surgical drilling of bone in order to create holes which support easy insertion of screws. The objective of the research is to optimize kinematic parameters when drilling bone in order to avoid bone necrosis and increase the capacity of bones to retain the surgical screws. In literature there are presented attempts to measure the temperature of bones by introducing thermocouples into bone near the drill path which is not a satisfactory method. In this research it is proposed a new method for measuring temperature by means of a digital infrared thermometer oriented on bone surface where holes are made. We have drilled animal bones and represented the experimental curves of temperature for a wide range of kinematic parameters that are supposed to be used during orthopaedic operations. It is concluded speeds ranges that can be used when drilling bone holes, which ensures good cutting conditions and temperatures at a level which does not affect the quality of the assembly.

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Enumerating the Yield and Purity of PfDNA from Archived, Newly Used mRDTs and Comparison with DBS from a Malaria-Endemic Focus

DOI: 10.2478/amma-2020-0008

Objective: Archived malaria rapid diagnostic test strips (mRDTs) serves as an important source of plasmodium Deoxyribose Nucleic Acid (DNA) in epidemiological studies. The presence of Plasmodium falciparum DNA (PfDNA) in mRDTs (yr. 2016-2017) and newly used ones (yr. 2018) were enumerated with a view to establish the parasite’s optimum genomic DNA volume. Methods: A retrospective study to determine the yield and purity of used mRDTs was carried out on randomly selected mRDTs (2016 – 2018). Both positive and negative mRDTs samples were analyzed with nested Polymerase chain reaction (nPCR). Dried blood spots (DBS) were obtained from study enrolments and analyzed molecularly. nPCR and Agarose gel electrophoresis were used to determine P. falciparum DNA. Results: Agarose gel electrophoresis results showed that only 26 out of the 50 samples eligible for screening were PCR positive for P. falciparum. The following was observed; yrs.: 2016 – 17(34%) with 2.06 X 103 yield, 1.7235 purity; 2017 – 16(32%) with 1.03 X 103 yield, 1.7619 purity and 2018 – 17(34%) with 1.42 X 103 yield, 1.6194 purity. Molecular analysis (P.f. 18Ss rRNA) was determined to ascertain positive result that appeared negative using mRDTs or microscopy. The DNA yield of the DBS for 2018 was 1.66 X 103 and a purity (Optical Density 260/280) of 1.69. The purity was higher than that of the mRDTs with a DNA yield of 1.42 X 103 and 1.62 purity. Conclusion: PfDNA extraction is an important process for malaria PCR screening and the reliability is dependent on pureness and concentration.

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The relative bioavailability of two formulations containing 10 mg Dapagliflozin assessed under fasting conditions in a randomized crossover study in healthy Caucasian subjects

DOI: 10.2478/amma-2020-0006

Objective: The aim of the present study was to evaluate the relative bioavailability of two formulations containing 10 mg dapagliflozin in healthy Caucasian subjects under fasting conditions.
Materials and Methods: Forty-eight healthy Caucasian subjects were enrolled in a single-dose, crossover, balanced, open label, randomized clinical trial, with two treatment, two periods and two sequences. The wash-out period was of 7 days and thirty-eight subjects completed both study periods. Each subject received a single dose of 10 mg dapagliflozin as the reference product Farxiga® (AstraZeneca Pharmaceuticals LP, USA) and the test product developed by Sun Pharmaceutical Industries, India. Dapagliflozin plasma levels were determined from blood samples collected in both study periods before and after dosing until 48 hours by using a validated LC-MS/MS method. For pharmacokinetic analysis of data, the non-compartmental method was used (Phoenix® WinNonlin 6.3). The statistical analysis was performed by SAS software 9.1.3 for the logarithmically transformed values of maximum plasma concentration and area under the curve.
Results: The 90% confidence intervals for the evaluated pharmacokinetic parameters were found to be in the accepted interval for bioequivalence (80.00-125.00%).
Conclusion: The 10 mg dapagliflozin immediate release tablet newly developed by Sun Pharmaceutical Industries, India, is bioequivalent with the reference product Farxiga® under fasted state of the subjects.

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Thin layer chromatographic compatibility study in preformulation of new transdermal therapeutic systems

DOI: 10.2478/amma-2020-0004

Objective: The compatibility of four binary active substances combinations adapalene – levofloxacin (ADP-LFX), adapalene – miconazole nitrate (ADP-MCZ), levofloxacin – meloxicam (LFX-MLX) and levofloxacin – miconazole nitrate (LFX-MCZ) was analysed to be comprised in new transdermal therapeutic systems. Also, the compatibility of selected active substances and four polymeric excipients (hydroxypropyl methylcellulose – HPMC 15000, hydroxypropyl methylcellulose – HPMC E5, ethyl cellulose – EC 10, and hydroxyethyl cellulose – HEC) was studied.
Methods: Thin layer chromatographic method (TLC) and four selected mobile phases were used. On the plate (in situ) were obtained the binary combinations (active substances and active substance-polymer).
Results: A good compatibility of ADP-LFX was found using ammonia : methanol : acetonitrile : methylene chloride 2:4:1:4 mobile phase. Using chloroform : acetone : glacial acetic acid 34:4:3 on the chromatogram of ADP-MCZ, only ADP spots appeared but without changes in the shape of the spots and Rf values. Any modifications of LFX and MLX spots (from LFX-MLX mixture) had been observed using toluene : glacial acetic acid : methanol 11:1:0.5 mobile phase, although LFX spots have remained on the baseline. Only LFX spots were visible from LFX-MLX and LFX-MCZ mixtures (ammonia : methanol : acetonitrile : methylene chloride 2:4:1:4 mobile phase). Distinctive spots were observed for ADP, LFX and MLX with variable results from no chemical interactions to limited chemical interactions when the compatibility with polymers was verified.
Conclusions: ADP-LFX and LFX-MLX mixtures were found to be compatible. ADP with HPMC polymers and LFX with HPMC E5 and HEC had presented excellent compatibility; for the other binary combinations, different analytical methods will be necessary.

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Comparative study of Clinical Characteristics in Patients with Mild and Severe Reflux Esophagitis

DOI: 10.2478/amma-2020-0002

Objective: This study aims to determine the correlation between risk factors and erosive esophagitis development. Methods: We conducted a retrospective observational study on a consecutive series of 19.672 patients who underwent upper gastrointestinal endoscopy between 01.01.2011-31.12.2017. A total of 3005 patients, diagnosed with erosive esophagitis, were included in the present study and stratified according to Los Angeles classification. Results: During the studied period we found 3005 patients with erosive esophagitis, sex ratio male to female was 1.3/1, the most common forms of esophagitis being grade A and B: 74.54% patients with esophagitis grade A, 14.80% patients with grade B; 5.29% patients were with grade C and 5.35% patients with esophagitis grade D. In severe esophagitis the male predominance was more prevalent (249 males, 71 female), with a sex ratio 3.50/1. The correlation of male gender with severe esophagitis was highly statistically significant (p < 0.0001, OR 2.97; 95% CI 2.25-3.91). Hiatal hernia was diagnosed in 1171 patients, the presence of large hiatal hernias, being an important predictor, with statistical significance (p < 0.0001, OR 3.41; 95% CI 2.22-5.21), for severe esophagitis development. Incidence of Helicobacter pylori infection was 11.51%, in the entire study group, with no statistical significant difference between patients with mild or severe esophagitis (12.02% vs 7.18%). Conclusion: Erosive esophagitis is a frequent disease, the most common forms being grade A and B. Male gender and the presence of hiatal hernia are the most important risk factors for erosive esophagitis development, in our study group.

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