Volume 66, Number 1, 2020
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Category Archives: AMM 2020, Volume 66, Number 1
Patient Positioning in Neurosurgery, Principles and Complications
DOI: 10.2478/amma-2020-0007
Patient positioning is a crucial step in neurosurgical interventions This is the responsibility of both the neurosurgeon and the anesthesiologist.
Patient safety, surgeon’s comfort, choosing an optimal trajectory to the lesion, reducing brain tension by facilitating venous drainage, using gravitation to maintain the lesion exposed and dynamic retraction represent general rules for correct positioning. All bony prominences must be protected by silicone padding. The head can be positioned using a horseshoe headrest or three pin skull clamp, following the general principles: avoiding elevating the head above heart more than 30 degrees, avoiding turning the head to one side more than 30 degrees and maintaining 2 to 3 finger breaths between chin and sternum. Serious complications can occur if the patient is not properly positioned so this is why great care must be paid during this step of the surgical act.
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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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The First International Western and Chinese & Thai Medicine Workshop on Pain Therapy & Management, Targu Mures, Romania. November 25 – 28, 2019
DOI: 10.2478/amma-2020-0005
The First International Workshop on using combined Western and Traditional Medicine for Pain Therapy was successfully held in Romania, 2018. Medical doctors from Romania, China and Thailand participated as lecturers and demonstrators to more than 40 participants. At the conclusion of the workshop, the organizers, lecturers and participants overwhelmingly endorsed the proposals to organize the second workshop and to organize a clinical trial in developing a combined protocol for innovative pain therapy.
Keywords: western and traditional medicine, pain therapy, acupuncture, therapeutic massage, osteoarthritis
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Cardiac Autonomic Neuropathy in Diabetes Mellitus Patients – Are We Aware of the Consequences?
DOI: 10.2478/amma-2020-0003
Cardiovascular autonomic neuropathy is the most frequent clinical form of autonomous diabetic neuropathy and appears secondary to cardiac autonomous fibre involvement, actively involved in cardiac rhythm impairment. Type 2 diabetes mellitus patients can present cardiac autonomic neuropathy early in the disease. Autonomous nerve function in DM patients should be assessed as early as the diagnosis is set in order to establish the optimal therapeutic strategy. The most frequent cardio-vagal test used is heart rate variability. An abnormal heart rate variability in the presence of orthostatic arterial hypotension indicates a severe cardiac autonomic neuropathy diagnosis. The development of cardiac autonomic neuropathy is subjected to glycaemic control, duration of the disease and associated risk factors. The glycaemic control is extremely important, especially early in the disease. Therefore, a poor glycaemic control carries unfavourable long-term effects, despite an ulterior optimal control, a phenomenon named “hyperglycaemic memory”. In type 2 diabetes mellitus patients, the association of cardiac autonomic neuropathy with intensive glycaemic control increases the mortality rate, due to the fact, that, secondary to autonomous impairment, the patients do not present the typical symptoms associated with hypoglycaemia. Stratifying the cardiac autonomic neuropathy aids the clinician in assessing the morbidity and mortality risk of diabetes mellitus patients, because it is an independent risk factor for mortality, associated with silent myocardial infarctions and the risk of sudden death.
Keywords: cardiac autonomic neuropathy, diabetes mellitus, diabetic neuropathy, hyperglycaemia, hyperglycaemic memory
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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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Factors Involved in the Pathogenesis of Acne and Its Psycho-Social Impact
DOI: 10.2478/amma-2020-0001
With acne as one of the most common and frequent conditions of young adult patients, we looked for significant associations, associated conditions with influence on the skin condition with the idea of outlining a different approach of the acne patient. With a multifactorial, multidisciplinary etiopathogeny, the purpose of this study was to highlight the factors involved in the pathogenesis of this condition and to identify those that should be taken into account when prescribing the treatment.
Keywords: associated conditions, acne
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