Category Archives: Original Research

Physical and Chemical Study of Lovastatin Inclusion Complexes. Bioavailability Improvement

Rédai Emőke1,Tőkés B2, Sipos Emese1

1 Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Medicine and Pharmacy, Tîrgu Mureș, Romania
2 Department of Physical Chemistry, Faculty of Pharmacy, University of Medicine and Pharmacy, Tîrgu Mureș, Romania

Background: Lovastatin is an inhibitor of hydroxy-methyl-glutaryl-coenzyme A reductase, used in the treatment of hypercholesterolemia. To enhance its bioavailability through inclusion complexation, as host molecule hydroxypropyl-b-cyclodextrin had been used.
Methods: Complexes were prepared by kneading in molecular ratio 1:1 and compared also with a physical mixture in molecular ratio 1:1. The complex was studied by performing dissolution tests and differential scanning calorimetry.
Results: Mixing the drug with the host molecule the soluble amounts were increased to 1.55 mg in artificial gastric juice and 2.99 mg in artificial intestinal juice. Kneading also improved the solubility of lovastatin to 1.94 mg in artificial gastric juice and 2.78 mg in artificial intestinal juice. In the thermograms a sharp endotherm peak was observed at the same position of lovastatin.
Conclusions: Dissolution studies showed an improvement of the drug release both in artificial gastric and intestinal juice. The sharp endotherm peak on the DSC curves indicates the untrapped lovastatin.

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The Frequency of Adverse Prognostic Features Detected with Ambulatory Blood Pressure Monitoring in the Practice of a Preventive Ambulatory System from Tîrgu Mureș

Preg Z1, Kikeli P1, Germán-Salló Márta3, Hubatsch Mihaela1, Bocicor Andreea-Elena1, László MI2

1 Department of Family Medicine, Faculty of Medicine, University of Medicine and Pharmacy, Tîrgu Mureş, Romania
2 Procardia Medical Society, Tîrgu Mureş, Romania
3 Department of Medical Semiology, Faculty of Medicine, University of Medicine and Pharmacy, Tîrgu Mureş, Romania

Background: Twenty four hour ambulatory blood pressure monitoring (24-H ABPM) plays an important role in the management of hypertensive patients. The aim of our study was to determine the frequency of seven known adverse prognostic features in an ambulatory assisted hypertensive patient population.
Methods: The study included all the 957 hypertensive patients with a performed 24-H ABPM, examined in the 2008–2011 period in a preventive ambulatory cardiology system. The studied adverse prognostic features were: daytime systolic blood pressure (BP) >140 mmHg, daytime diastolic BP >90 mmHg, nighttime systolic BP >125 mmHg, nighttime diastolic BP >75 mmHg, nocturnal dipping <10%, early morning hypertension >140/90 mm Hg, pulse pressure >53 mm Hg. Patient data were introduced in an integrated patient data management system as an electronic health record. The frequency of adverse prognostic features was compared in type 2 diabetic versus non-diabetic patients, and in patients with or without manifest cardiovascular complications (ischemic heart disease, stroke, lower extremity arterial disease).
Results: The frequency of the studied adverse prognostic features was as follows: high daytime systolic BP 38.1%, high daytime diastolic BP 21.4%, high nighttime systolic BP 45.5%, high nighttime diastolic BP 31.3%, absent nocturnal dipping 59.9%, morning hypertension 33.6%, high pulse pressure 51.5%, morning surge 5.1%. A large proportion of subjects (86.2%) had one or more adverse features reported on the 24-H ABPM.
Conclusions: In clinical practice there is a frequent association of multiple adverse prognostic features of ambulatory blood pressure monitoring. The presence of some prognostic features is associated with the presence of diabetes, stroke history, ischemic heart disease or lower extremity arterial disease.

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Schizophrenia: Social Cognition as a Predictive Factor of Social Performance?

Popovici Zs1, Bredicean Cristina2, Papavă I2, Cristanovici Mădălina1, Giurgi Oncu Cătălina1, Roşu M1, Durla Anca3

1 Psychiatry Clinic, Timişoara, Romania
2 Department of Psychiatry, University of Medicine and Pharmacy Timişoara, “Mara” Mental Health Center, Timişoara, Romania
3 Clinical Ambulatory of Psychiatry, Satu-Mare, Romania

Objectives: Schizophrenia is one of the conditions that affect social cognition and social functioning. These aspects are particularly important when assessing the prognosis and evolution of the disease. The main objective of the present study was to examine the role of social cognition for social functioning. We hypothesized that social cognition influences directly social functioning in schizophrenia.
Material and method: We assessed 31 subjects who have been admitted for the first time to the Timișoara Psychiatric Clinic between 1998 and 2007 and who have had within the last five years a stable diagnosis of schizophrenia according to ICD-10. The following parameters were analyzed: socio-demographic (gender, age of onset, level of schooling, marital and professional status), clinical symptoms (Brief Psychiatric Rating Scale), social cognition (Social Cognition Rating Scale for Psychosis) and social functioning (Social Functioning Scale).
Results: The analysis of socio-demographic features show values similar to those cited in the international literature (gender distribution approximately equal, mean age of onset of 26.2 years, mean level of schooling of 11.77; 22.6% were married and all of the subjects were retired). BPRS scores indicated average values. Most of the subjects also had a social cognition and social functioning deficit. There is a direct correlation between social cognition and social functioning (r=0.46).
Conclusions: The deficit of social cognition in schizophrenia generates a decrease of social functioning.

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Correlation of APC and MLH1/MSH2 Expression in Colon Adenomas/Polyps

Pap Zsuzsanna1, Dénes L1, Szántó Annamária1, Şipoş R1, Mocan Simona2, Brînzaniuc Klara1, Jung I2, Pávai Z1

1 Department of Anatomy and Embryology, University of Medicine and Pharmacy, Tîrgu Mureş, Romania
2 Department of Pathology, University of Medicine and Pharmacy, Tîrgu Mureş, Romania

Background: Adenomatous polyposis coli (APC) gene is thought to play a key role in the majority of sporadic colorectal cancers developed through the chromosomal instability pathway. In 10–15% of CRC the defect of the mismatch repair genes (MLH1, MSH2), the microsatellite instability is the underlying mechanism for carcinogenesis. The aim of this study was the correlation of APC, MLH1 and MSH2 immunoexpression in different types of colon adenomas/polyps (A/P).
Materials and methods: We processed biopsies and surgical pieces of colon A/P and carcinoma developed in adenoma (CC). The APC, MLH1, MSH2 expression were graded, and used for establishing different immune phenotypes that have been compared by statistical tests. Results: The majority of tubular and tubulovillous adenomas have the MLH1+/MSH2+/APC+ immune phenotype, and the ratio of MLH1–/MSH2–/APC+ cases increases in case of hyperplastic polyps and serrated adenomas. A/P developing in the right colon and in patients below 40 years were more frequently MLH1–/MSH2–/APC+.
Conclusions: APC immunoexpression decreases in adenomas/polyps with dysplasia, and MLH1 and MSH2 expression is altered especially in hyperplastic polyps and serrated adenomas.

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Terlipressin Use in the Emergency Treatment of Patients with Variceal Bleeding in Hepatic Cirrhosis

Molnar C1, Roșca C1, Panțiru A1, Tudor A1, Nicolescu C1, Copotoiu R2, Voidăzan S3, Copotoiu C1

1 Surgery Clinic 1, County Emergency Clinical Hospital, Tîrgu Mureș, Romania
2 Anesthesia and Intensive Care Clinic, County Emergency Clinical Hospital, Tîrgu Mureș, Romania
3 Department of Epidemiology, University of Medicine and Pharmacy, Tîrgu Mureș, Romania

Background: Treatment of variceal rupture from portal hypertension remains a therapeutic problem with implications and socio-economic challenge, still insufficient crystallized from a practical point of view, therefore, we considered it necessary to research new therapeutic options.
Methods: We conducted a single center non-interventional observational study on a group of 20 patients in the 2010–2011 period, with the diagnosis of esophageal varices in portal hypertension. We analyzed cases based on physical and laboratory examinations collected from observation sheets, intraoperatory or endoscopic examination, terlipressin efficiency being quantified postterapeutically.
Results: Out of the 20 patients, 75% had ethanol cirrhosis, while a viral etiology was recognized in 25% of cases, class Child-Pugh A and B being the most common. Control of bleeding was achieved in 85% of cases within 12 hours, in 10% of cases the bleeding stopped at intervals over 12 h after the first administration, and only in one case the bleeding persisted despite therapy with terlipressin.
Conclusions: Use of terlipressin is an important option in obtaining hemostasis of upper gastrointestinal bleeding due to variceal rupture. Pharmacologic therapy with terlipressin can save cirrhotic patients with severe or moderate bleeding, requiring transfusion with two units.

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Myocardial Protection with Sevoflurane in Patients with Cardiac Risk Undergoing Non-cardiac Surgery

Manolescu R1, Duțu M1, Negoiță S1, Popescu M2, Calu V3, Corneci D1, Azamfirei L4

1 Anaesthesia and Intensive Care Clinic, Elias University Emergency Hospital, Bucharest, Romania
2 Cardiology Clinic, Elias University Emergency Hospital, Bucharest, Romania
3 Surgery Clinic, Elias University Emergency Hospital, Bucharest, Romania
4 Anaesthesia and Intensive Care Clinic, County Emergency Clinical Hospital, Tîrgu Mureș, Romaina

Objective: Evaluation of cardioprotective effects of sevoflurane compared with propofol in high-risk cardiac patients undergoing non-cardiac surgery.
Material and methods: Prospective study enrolling 14 patients with cardiac risk Lee’s score > 3 points, undergoing abdominal elective surgery. The patients were divided into two groups: Group S (sevoflurane) – 8 patients who received balanced anesthesia with sevoflurane; Group P (propofol) – 6 patients receiving total intravenous anesthesia – target control infusion (TIVA-TCI). All patients were monitored hemodynamically, cardiac biomarkers (troponine I – TnI, the precursor of brain natriuretic peptide – proBNP, myocardial creatine kinase – CKMB) and inflammatory tests (high sensitive C-reactive protein – CRP, fibrinogen – FBG, interleukin 6 – IL6) were registered perioperatively.
Results: All patients had a decrease of mean arterial pressure (MAP) after induction, with significant values in Group P (48.4±3.82 mmHg). There were no acute cardiac perioperative events and the concentration of TnI after surgery was significantly lower in patients with sevoflurane anesthesia ( 0.017±0.01 ng/ml vs. 0.2±0.18 ng/ml) at 12 h and 24 h respectively (p <0.05). CKMB had lower postoperative values in Group S vs. Group P. ProBNP was elevated preoperatively in all patients and it is correlated with increased cardiac risk. In postoperative period the patients have lower levels in Group S compared with Group P (p <0.05). IL6 showed a significant decrease in patients in Group P at 12–48 h after surgery.
Conclusion: Anesthesia with sevoflurane, in patients with increased cardiac risk undergoing non-cardiac surgery, was accompanied by decreased values of TnI, proBNP and CKMB postoperatively, compared with propofol anesthesia.

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Four Years Experience in Retinopathy of Prematurity

Maki Cristina¹, Rusu Monica-Blanka¹, Moldovan M², Baghiu Maria Despina³

1 Department of Ophthalmology, University of Medicine and Pharmacy, Tîrgu Mureș, Romania
2 Department of Biophysics, University of Medicine and Pharmacy, Tîrgu Mureș, Romania
3 Department of Paediatrics, University of Medicine and Pharmacy, Tîrgu Mureș, Romania

Purpose: Analysis of the results of screening and treatment for retinopathy of prematurity (ROP) in a sample of prematurely born babies evaluated in the Neonatal Intensive Care Unit and Neonatology Prematures Clinic of Targu Mures, between January 2008 and January 2012.
Material and method: We conducted a prospective study on all premature infants born with less than 34 weeks gestational age (GA) and lower than 2000 g birth weight (BW). The first ophthalmoscopic examination was performed between 4 and 6 weeks after birth, regardless of gestational age. The treatment was needed in threshold (or prethreshold) disease.
Results: Different stages of ROP were found in 24.1% from the total 503 infants: stage 1 in 34 eyes (28.1%), stage 2 in 65 eyes (53.7%), stage 3 in 16 eyes (13.2%) and stage 5 in 6 eyes (5%). We didn’t have cases with stage 4 ROP. Statistical analysis showed that GA and BW are highly significant risk factors for the development of ROP, with a risk reduction as the values of gestational age and birth weight were higher. The indication for laser treatment was set at 3.97% of all premature, respectively in 16.53% of children with ROP. Favorable evolution after laser treatment was observed in 80% of cases. From the others, who had no positive response to laser treatment, 75% had aggressive posterior ROP (APROP). We recorded a statistically significant association between BW and the incidence of cases which required laser therapy (p=0.0058), but no statistically association was found between GA and grades of diseases that needed laser (p=0.0789).
Conclusions: Screening for retinopathy of prematurity requires an experienced paediatrician-ophthalmologist, recognition of severe disease that requires treatment being crucial. Performed strictly and in accordance with international protocols, screening remains the first step in the detection and management of retinopathy of prematurity.

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Development of a Dissolution Method for Modified Release Tablets Containing an Insoluble Active Substance

Kelemen Éva Katalin1, Kelemen LJ1, Gyéresi Á2, Imre Silvia3, Obreja Mona1

1 Gedeon Richter Romania S.A., Tîrgu Mureș, Romania
2 Department of Pharmaceutical Chemistry, University of Medicine and Pharmacy, Tîrgu Mureș, Romania
3 Department of Analytical Chemistry and Drug Control, University of Medicine and Pharmacy, Tîrgu Mureș, Romania

Objective: The aim of the present work is to develop a discriminative dissolution method for a practically insoluble pharmaceutical active substance such as indapamide.
Methods: Dissolution testing was performed in compliance with USP, using USP apparatus 2. The proper dissolution medium and the optimal rotation per minutes of the apparatus were optimized. In order to quantify the dissolution of indapamide from modified release tablets, a high liquid chromatographic method was developed and validated.
Results: An HPLC method was developed in order to provide adequate specificity trying several column types and different mobile phases. We selected the proper dissolution medium based on indapamide solubility, we determined the optimal speed of rotation of the dissolution tester for the indapamide in the selected medium, then we proved the discriminating power of the developed dissolution method.
Conclusions: A robust and discriminating HPLC method for analyzing dissolution samples containing indapamide was developed and successfully validated.

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Benzene Determination in Soft Drinks

Fülöp Ibolya, Pădureanu Anca, Kincses Ajtay Mária, Croitoru MD

Department of Toxicology, Biopharmacy and Pharmacokinetics, University of Medicine and Pharmacy, Tîrgu Mureș, Romania

Objectives: Benzene is a known human carcinogen. We are exposed to benzene mainly through inhalation and a lesser extent through the ingestion of food and water. Benzene is formed in beverages when ascorbic acid coexists with benzoate salts. Certain additional conditions (heat, UV light, metallic ions) are required for detectable levels of benzene to be formed. The aim of this study was to investigate soft drinks for the presence of benzene.
Methods: A GC method was developed to identify and quantify benzene in beverages. Fifteen samples containing benzoate sodium and ascorbic acid were analyzed.
Results: The benzene concentration ranged between the limit of quantification and 8.81 µg/l. The EU guideline limits the benzene concentration at 1 µg/l in drinking water; 6 of the products tested were above this admitted level.
Conclusion: Based on the presented data, the safety of benzene as a preservative agent should be reconsidered.

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Quality of Life in Elderly Patients with Cluster C Personality Disorder

Echim Iulia1, Nireştean A1,2

1 Psychiatric Clinic No II, Tîrgu Mureş, Romania
2 University of Medicine and Pharmacy, Tîrgu Mureş, Romania

Introduction: Epidemiological studies have found reduced health-related quality of life (QoL) in patients with personality disorders (PDs), but few clinical studies have examined QoL in elderly patients with cluster C PDs. Our objective was to evaluate QoL in elderly patients with cluster C PDs admitted to the Psychiatric Clinic No II Tîrgu Mureș in all four domains related to QoL: physical health, psychological health, social relationships and environment.
Material and method: Elderly patients with cluster C PDs filled in the World Health Organization Quality of life (WHOQoL-Bref). An independent psychiatrist diagnosed cluster C PDs and Axis-I disorders by structured interviews (SCID II) and rated the Global Assessment of Functioning (GAF).
Results: Cluster C PD patients showed high co-morbidity with Axis I mental disorders, and they scored significantly lower on all the WHOQol dimensions. The WHOQoL physical health and social functioning were significantly associated with the GAF.
Conclusions: Elderly people with a cluster C PD have globally poor QoL and were more vulnerable to late-life distress, especially those with more than one diagnosis. In keeping with the results, widowhood, divorce hood, and living alone appear to be variables able to negatively influence QoL in this population.

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