Category Archives: AMM 2015, Volume 61, Number 4

Risk Management in Clinical Laboratory: from Theory to Practice

David Remona Eliza1*, Dobreanu Minodora2

1 Department of Medical Biochemistry, University of Medicine and Pharmacy Tîrgu Mureș, Romania
2 Department of Laboratory Medicine University of Medicine and Pharmacy Tîrgu Mureş, Romania

DOI: 10.1515/amma-2015-0086

Clinical laboratory tests ensure approximately 70% of the medical decisions, so that the time until the release of the results and its accuracy are critical for the diagnosis and the efficiency of the treatment [1]. Risk management involves both the anticipation of what could happen erroneous and the assessment of errors’ frequency as well as the consequences or the severity of the effects caused by it, and finally to decide what can be done in order to reduce the risk to an acceptable clinical level. For this reason, organizations should not see the risk management as a compliance issue, but as an integral part of the decision-making process. EP23-A is a guideline of CLSI that introduces the risk management principles in the clinical laboratory and encourages the laboratories to develop plans of risk management which are addressed to the risks of each laboratory. EP18-A2 proposes 2 techniques for identifying and controlling the errors in the laboratory: FMEA (Failure Mode and Effects Analysis) and FRACAS (Failure Reporting, Analysis and Corrective Action System). The European Committee of Experts and Management of Safety and Quality in Health Care proposed to use the quality indicators to identify the critical stages of each process, thus being possible to assess continuously the medical processes with the aim of identifying the errors when they occur. This review summarizes the principles of the risk management in the clinical laboratory, thus it can achieve its aims to report valid, accurate and reliable test results.

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Tissue Integration of Synthetic Grafts and the Impact of Soft-Tissue Infection – An Experimental Model

Russu Eliza1*, Mureșan Adrian Vasile1, Cordoș Bogdan Andrei2, Cotoi Ovidiu Simion3, Copotoiu Constantin1

1 Department of Surgery, University of Medicine and Pharmacy of Tirgu Mures, Romania
2 Experimental Research Station, University of Medicine and Pharmacy of Tirgu Mures, Romania
3 Pathophysiology Department, University of Medicine and Pharmacy of Tirgu Mures, Romania

DOI: 10.1515/amma-2015-0097

Objective: Starting with the ‘Vinyon-N-revolution’ of the 50’s, there has been a constant interest in understanting tissue integration, or the so-called graft healing process, as well as its relationship with infection. In this study we present an experimental animal model designed to assess tissue integration of different graft materials, and their reaction to the presence of infection. Methods: Synthetic grafts (knitted Dacron®, woven Dacron®, silver-impregnated Dacron® and Gore-Tex®) were implanted subfascially in the interscapular region of Wistar rats. Animals were divided into a control group and an infected group, with infection induced using bacterial suspensions of standard strains of Staphylococcus aureus, Staphylococcus epidermidis, and Escherichia coli. Implants were retrieved at 2 and 4 weeks postoperatively in the control group and at 1, 2 and 3 weeks postoperatively in theinfected group. Retrieved grafts were assessed bacteriologically and morpho-pathologically. Results: All microorganisms produced clinically evident infections, with positive blood cultures in case of E. coli. Staphylococci produced more massive infections on Dacron® grafts, except for the silver-impregnated version, while E. coli produced more significant infections on Gore-Tex® grafts. Morpho-pathologically Dacron® grafts behaved poorly, with ocassional complete structural compromise, and no difference between the conventional and the silver-impregnated type. The Gore-Tex® graft showed a consistent structural resistance throughout the study period. Conclusions: Although the silver-impregnated graft inhibited bacterial growth, it was poorly tolerated by the host tissue. In contrast, Gore-Tex® grafts showed more massive infection, especially with E. coli, but kept their structural integrity surprisingly well.

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Determination of Secondary Bile Acids in the Mice Feces. Controversies on their Involvment in the Pathogenesis of Colorectal Cancer

Saracut Claudiu1,2, Molnar Calin1,2, Farczádi L3, Vlase L4,5, Tero-Vescan Amelia6,1, Todoran Nicoleta7,1, Copotoiu Constantin1,2

1 University of Medicine and Pharmacy Tirgu Mures, Romania
2 Surgical Clinic 1, Tirgu Mures Emergency County Hospital, Romania
3 Vim Spectrum SRL, Romania,
4 Department of Pharmaceutical Technology and Biopharmaceutics Faculty of Pharmacy, Cluj-Napoca, Romania
5 University of Medicine and Pharmacy “Iuliu Hatieganu”, Cluj-Napoca, Romania
6 Department of Pharmaceutical Biochemistry and the chemistry of environmental factors, Tirgu Mures, Romania
7 Department of Pharmaceutical Technology, Tirgu Mures, Romania

DOI: 10.1515/amma-2015-0096

Objectives: The aim of the study was to determine the level of secondary bile acids (SBA) in the diets and feces of mice and the variation of amount ingested/excreted if these SBA are administered as monotherapy or in 1:1 dose. Methods: The mice were divided into 4 groups and fed for 140 days with different diets. The control lot received a normal diet and the others received diets supplemented with 0.25% deoxycholic acid (DCA), 0.25% lithocholic acid (LCA) and 0.125% DCA+0.125% LCA. After 140 days, the mice feces were collected and homogenized to obtain a mixture for each lot from which the determinations of the studied SBA were performed. For the mice food evaluation, portions of 10 g from each of the 4 diets were subjected to the SBA determination. Results: The daily ingestion over more than 4 months of DCA or LCA added to the diet and administered as monotherapy determine a significantly increase of the SBA eliminated into the feces (the DCA level was 11x higher, and of the LCA 233x higher). If half of the LCA dose is replaced with DCA, the level of LCA in the feces gets comparable with that of the DCA (their combined amounts represents only 13x higher increase of these two bile acids in feces). Conclusions: The simultaneous ingestion and excretion of DCA and LCA can be considered as a particular situation ruled by endogenous mechanisms. This behavior represents an important observation, knowing that the bile acids effects in the colorectal cancer are dose dependent.

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Ambulatory Blood Pressure and Arterial Stiffness in Obese Children and Adolescents

Duicu Carmen1*, Mărginean Cristina Oana1, Pitea Ana Maria1, Melit Lorena Elena2

1 University of Medicine and Pharmacy Tirgu Mureș, Romania, 1st Department of Pediatrics
2 Emergency Clinical County Hospital of Tirgu Mureș, Romania, Pediatrics Clinic 1

DOI: 10.1515/amma-2015-0090

The aim of the present study was to investigate differences regarding 24-hour blood pressure and arterial stiffness in a cohort of office normotensive obese and non-obese children and adolescents, and to evaluate correlations of these parameters with some anthropometric indices.
We retrospectively evaluated ABPM records in 71 children (42 boys); 31 obese compared with 40 normal-weight children.
Results: Mean 24-hour, day-time and night-time SBP was significantly higher in the obese group than in the control group (p <0.01 during the entire period). Significantly higher AASI values were found in obese children compared to controls (0.45 vs. 0.41, p <0.05), the difference being more obvious for day-time AASI (p <0.001). Conclusions: This research confirms that SBP and AASI are increased in obese children. AASI is a useful index of arterial stiffness that can be easily measured under ambulatory circumstances in children.

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The Assessment of Reperfusion Inflammatory Injury in Ischemic Preconditioned Diabetic Rats

Grigorescu Bianca-Liana1, Fodor Raluca Ştefania2, Scridon Alina3, Perian Marcel3, Badea Iudita2, Cioc Adrian Dan1, Cotoi Ovidiu Simion4, Copotoiu Sanda-Maria2, Azamfirei Leonard2

1 Department of Anaesthesiology and Intensive Care, Emergency County Hospital, Tirgu-Mures, Romania
2 Department of Anaesthesiology and Intensive Care, University of Medicine and Pharmacy, Tirgu-Mures, Romania
3 Department of Physiology, University of Medicine and Pharmacy, Tirgu-Mures, Romania
4 Department of Pathophysiology, University of Medicine and Pharmacy, Tirgu-Mures, Romania

DOI: 10.1515/amma-2015-0087

Objective: The assessment of systemic reperfusion injury and the contractile force of the peripheral muscles post-acute ischemia of the hind limbs in healthy versus diabetic ischemic preconditioned rats. Method: The study included 16 Wistar rats divided into two groups: the control group and the diabetic ischemic preconditioned group. Acute ischemia was induced, followed by reperfusion. The assessment of reperfusion injury used biochemical, histopathological and functional determinations (peak tetanic tension-PTT, specific tension-ST). Results: Ischemia-reperfusion injury was more severe in control group regarding creatine-kinase (CK) (CK1=470.13 IU/L versus CK2=230.88 IU/L, p=0.0001) and myoglobin (390.25 ng/mL versus 47.99 ng/mL, p=0.025). Cytolysis enzymes were significantly increased in diabetic preconditioned rats (Alanine aminotransferase ALAT1=46 IU/L, ALAT2=167.8 IU/L, p=0.02; Aspartate aminotransferase ASAT1=106 IU/L, ASAT2=237.5 IU/L, p=0.016). Functional assessment (PTT and ST) highlighted roughly equal values. A paradoxical response occurred in diabetic rats (the contractile force increased during the period of the stimulation). Histopathological findings showed that rhabdomyolysis was more severe in the control group, while inflammatory systemic response due to reperfusion injury was less expressed in diabetic ischemic preconditioned rats. Conclusions: Ischemic preconditioning reduces the severity of reperfusion injury and allows the preservation of contractile muscle function in diabetic rats.

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Efficacy of Fine Needle Aspiration Cytology in Diagnosis of Salivary Gland Tumors

Iacob Alina*, Sin Anca, Mezei Tibor, Mocan Simona, Ormenisan Alina, Tilinca Mariana

University of Medicine and Pharmacy, Tîrgu Mureş, România

DOI: 10.1515/amma-2015-0085

Introduction: Masses of the head and neck comprise a variety of benign and malignant tumors and tumor-like conditions, which may present diagnostic challenges to the surgeon and pathologist as well. Fine needle aspiration cytology is considered to be a valuable diagnostic tool used for preoperative evaluation of various masses in the head and neck region. However, its role is quite controversial for salivary gland tumour evaluation. This study was aimed to evaluate salivary gland fine-needle aspiration cytology for sensitivity, specificity and diagnostic accuracy in our medical center.
Material and method: The present study included 58 patients with different salivary gland lesions who underwent preoperative fine-needle aspiration procedure followed by surgical procedure and histological examination. The cytological findings were compared with the final histological diagnosis and concordance assessed.
Results: Of the 58 cases with salivary gland lesions, most of them involved parotid gland (72.41%), 91.38% were neoplasms and 8.62% were non-neoplastic lesions. Out of 53 neoplasms, 39 were benign and 14 were malignant salivary gland tumors. The sensitivity and a specificity of fine-needle aspiration cytology in differentiation malignancies from benign lesions was 100% and 97.73% respectively. In some situations cytological features could not provide correct tumor characterization.
Conclusions: Fine-needle aspiration cytology is a simple and reliable technique for preoperative evaluation of salivary gland tumors with a high sensitivity diagnosis of malignant tumors, but a lower tumor type characterization. Due to the minimally invasive nature of the technique, fine-needle aspiration cytology offers valuable information for planning of subsequent therapeutic management.

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Quinolone Antibacterials: Commentary and Considerations Regarding UV Spectra and Chemical Structure

Rusu Aura1*, Imre Silvia2, Mircia Eleonora3, Hancu Gabriel1

1 Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Medicine and Pharmacy, Tîrgu Mureş, România
2 Department of Analytical Chemistry and Drug Analysis, Faculty of Pharmacy, University of Medicine and Pharmacy, Tîrgu Mureş, România
3 Department of Organic Chemistry, Faculty of Pharmacy, University of Medicine and Pharmacy, Tîrgu Mureş, România

DOI: 10.1515/amma-2015-0084

Objective: Antibacterial quinolones represent an important class of pharmaceutical compounds that are widely used in therapy. Analytical methods that rely on their property to absorb light in the UV range are commonly used for their analysis. In the current study we present an interpretation of the relationship between chemical structure – UV spectra based on the comparative examination of UV spectral behavior of the eighteen quinolone derivatives and four model compounds.
Methods: Eighteen quinolone derivatives and four model compounds were selected and their UV spectra were recorded in different solvents (methanol, 0.1M HCl, 0.1M NaOH).
Results: The studied compounds show three absorption maximum values located around 210-230 nm, 270-300 nm and 315-330 nm values. A general characteristic was observed as the absorption bands exhibited both hypsochrome and bathochrome shifts, by comparison in different solvents. Most commonly we observed a slight hypsochrome shift at acidic pH (protonated form prevails) and basic pH (anionic form prevails). The structural differences are reflected in changes of UV spectra only when there are auxochrom substituents or different basic substituents are present in the quinolones structure.
Conclusions: The correlations between the chemical structure of quinolone derivatives and their UV spectra using model compounds were established. This study provides useful information that can be used successfully in various UV spectrophotometric analysis methods or in more complex analytical methods using UV detection, and also in pharmacodynamic and kinetic studies.

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Surgical Management of Renal Hyperparathyroidism: Case Series and Review of the Literature

Neagoe Radu Mircea1, Mureșan Mircea1*, Văcar Smaranda2, Hossu Ioan3, Pașcanu Ionela4, Borda Angela5, Sala Daniela1

1 Second Department of General Surgery, University of Medicine and Pharmacy Tîrgu Mureş, Romania
2 Centrul de Dializă B Braun Avitum Tîrgu Mures
3 Nephrology Department, University of Medicine and Pharmacy Târgu Mureş, Romania
4 Endocrinology Department, University of Medicine and Pharmacy Târgu Mureş, Romania
5 Department of Histology, University of Medicine and Pharmacy Târgu Mureş, Romania

DOI: 10.1515/amma-2015-0083

Secondary hyperparathyroidism (sHPT) occurs most commonly in the setting of chronic renal failure (CRF) being frequently referred to as “renal” hyperparathyroidism The “classical” medical treatment with oral calcium and vitamin D supplementation is generally sufficient to lower parathyroid hormone levels in the majority of these patients. However, we frequently encounter cases of severe refractory sHPT, a state in which even recently available therapeutic agents, i.e. calcimimetics, new phosphate binders, vitamin D analogues, remain inefficient, thus parathyroidectomy and/ or renal transplant becoming necessary. Three types of surgeries have been proposed in sHPT: two of them are grouped as remnant-conserving techniques, i.e. subtotal parathyroidectomy (sPtx) and total parathyroidectomy with autotransplantation (tPtx+AT), the third one being total parathyroidectomy without autotransplantation (tPtx). There was a continuous debate concerning the best surgical approach in renal hyperparathyroidism, starting very soon after those techniques were described; without pretending to solve these controversies, this paper aims to review the surgical treatment options in sHPT, based on our 5-year experience in dealing with the disease.

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The Monitoring of Immunosuppressive Therapy with Tacrolimus in Patients with Kidney Transplant, Based on the Pharmacokinetic Criteria

Stoica Ciprian Mihai1, Căldăraru Carmen Denise2*, Vari Camil Eugen3, Tarța Dorin Ionuț1, Dogaru Maria Titica3, Carașca Emilian4, Dogaru Grigore Aloiziu1

1 Department of Nephrology, University of Medicine and Pharmacy, Târgu-Mureş, România
2 Department of Physiology, University of Medicine and Pharmacy, Târgu-Mureş, România
3 Department of Pharmacology and Clinical Pharmacy, University of Medicine and Pharmacy, Târgu-Mureş, România
4 Department of Internal Medicine IV, University of Medicine and Pharmacy, Târgu-Mureş, România

DOI: 10.1515/amma-2015-0082

Background: Therapeutic drug monitoring (TDM) in patients with Chronic Kidney Disease (CKD) with kidney transplant, represents a major post transplant concern due to the characteristics of this special category of patients, particularities which can generate changes of the pharmacokinetic profile of the administered medication.
Material and methods: The current study is a retrospective pharmacokinetic study, over a period of 50 months, including a group of 36 kidney transplanted patients with CKD. Tacrolimus blood concentration was determined by a validated high-performance liquid chromatography method (HPLC), at a 12 hour time interval from the last administration of the immunosuppressive medication and before the following dose (Residual concentration, Cmin(trough)).
Results: During the monitoring of therapy, based on the pharmacokinetic criteria, 252 measurements of blood concentration were determined, 58 of these being outside the therapeutic window.
Conclusions: The results obtained show that it is mandatory to continue to monitor closely medical therapy based on the pharmacokinetic criteria in view of improving drug administration. The other ways of monitoring therapy: the clinical and biochemical criteria should not be overlooked. In addition, the interindividual variability of patients should be considered, as well as drug interaction which can alter the pharmacokinetics of tacrolimus.

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Prevalence of Physiological, Pathological and Behavioral Risk Factors in Patients Treated with Antidiabetic Sulfonylureas

Confederat Luminita*, Stefan Roxana, Constantin Sandra, Hăncianu Monica, Profire Lenuta

University of Medicine and Pharmacy “Grigore T. Popa”, Iași , Romania

DOI: 10.1515/amma-2015-0080

Diabetes mellitus is an important public health problem because of its increased incidence and its devastating complications. In addition to this, it was observed an increase in prevalence for diabetes risk factors. The aim of this study was to evaluate the frequency of the pathophysiological and behavioral risk factors among patients treated with oral hypoglycemic sulfonylureas.
Material and methods: It were analyzed the observation sheets of 200 patients ambulatory treated at the “Providența” Medical Center.
Results and discussions: Most of the patients were aged over 65 years, being 48.5% women and 51.5% men. The obesity was the most frequent (88%) risk factor in patients; the majority of them were included in the “overweight” and “first- degree obesity” class (72%). Regarding associated comorbidities, hypertension was found in 77% of cases, followed by dyslipidemia. In terms of physiological and behavioral aspects, age and alcohol consumption were predominant.
Conclusions: A significant percentage of diabetic patients treated with hypoglycemic sulfonylureas present a high prevalence of the risk factors and even two or three factors associated.

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