Search

Aim: Contrast-enhanced harmonic endoscopic ultrasound (CEH-EUS) parameters may be used to predict prognosis of pancreatic ductal adenocarcinoma (PDAC) and pancreatic neuroendocrine tumors (pNET). The aim of this study was to investigate the association between several perfusion parameters on CEH-EUS performed before treatment and survival outcome in patients with PDAC or pNET., Material and Methods: Thirty patients with PDAC or pNET who underwent CEH-EUS and EUS-guided fine needle aspiration (EUS-FNA) were included. Quantitative analysis of tumor vascularity was performed using time-intensity curve (TIC) analysis-derived parameters, obtained from processing CEH-EUS recordings with a commercially available software (VueBox). Cox proportional hazards models were used to determine associations with survival outcome., Results: Median overall survival (OS) for PDAC patients was 9.61 months (95% CI: 0.1-38.7) while the median OS for pNET patients was 15.81 months (95% CI: 5.8-24.75. In a multivariate model for OS, a lower peak enhancement (HR=1.76, p=0.02) and a lower wash-in area under the curve (HR=1.06, p=0.001) were associated with worse survival outcome for patients with PDAC., Conclusions: CEH-EUS parameters may be used as a surrogate to predict PDAC aggressiveness and survival before treatment. After validation by large-scale studies, CEH-EUS perfusion parameters have the potential to be used in pretreatment risk stratification of patients with PDAC and in evidence-based clinical decision support.

This cross-sectional study aimed to determine the use of neuroenhancers, the motivations and factors associated with their use in French and Romanian university students. Students from two universities in France (Rouen and Opal Coast University) and one in Romania (Cluj-Napoca) were asked to complete a self-administered anonymous questionnaire, either online or on paper, about the use of three different categories of substance: Prescription drugs (methylphenidate, modafinil, and beta-blockers), drugs of abuse (alcohol, cannabis, cocaine, and amphetamines), and soft enhancers (coffee, vitamins, caffeine tablets, and energy drinks). In total, 1110 students were included: The users were 2.2% for prescription drugs, 4.3% for drugs of abuse, and 55.0% for soft enhancers. Students used neuroenhancement to stay awake for study (69.3%), to improve concentration (55.5%), to decrease stress (40.9%), and to improve memory (39.6%). Neuroenhancement was considered to meet expectations by 74.4% of users. The factors associated with the use of drugs of abuse were frequent binge drinking (Adjusted Odds Ratio-AOR: 6.49 [95% CI: 2.53-16.6]), smoking (AOR: 5.50 [95% CI: 2.98-10.14]), having a student job (AOR: 2.42 [95% CI 1.13-5.17]), and being male (AOR: 2.23 [95% CI:1.21-4.11]). No significant associations with eating disorders were detected for any of the three categories of substances. University students reported neuroenhancement with prescription drugs, drugs of abuse, and mainly soft enhancers. These substances were used mainly to increase the waking hours. Educational programs in universities seem to be required in order to increase student awareness of the problems caused by neuroenhancements, and to decrease the associated risks by changing students' attitudes and beliefs.

Background and Aims: Due to the increasing number of hepatitis C virus (HCV)-infected patients being treated with direct antiviral agents (DAAs) in Romania, we aimed to conduct a pharmacovigilance study in order to comprehensively evaluate the safety profile for the ombitasvir/paritaprevir/ritonavir and dasabuvir (Om/Pa/Ri+Da) regimen., Methods: A retrospective analysis was conducted on the individual case safety reports (ICSRs), extracted from VigiBase® on 1 st February 2018, which included the Om/Pa/Ri+Da regimen as suspected for causing adverse drug reactions (ADRs). Potential drug-drug interactions (DDIs) were checked for all concomitant medication using the IBM Micromedex® tool., Results: Among the 1,102 ICSRs retrieved, 260 were serious (23.5%). Ribavirin was significantly associated with more ADRs reported per case (on average 5.1 vs. 3.2 ADRs/case, p<0.001). Most commonly reported ADRs were pruritus (6.8%), fatigue (5.4%), dizziness (4.3%) and headache (3.8%). For the serious ICSRs, a significant relationship was found between age and renal and urinary disorders, and between gender and neoplasms, injury, poisonings and procedural complications. Hepatotoxicity was identified in six ICSRs, four of them being serious. Potential contraindicated DDIs were identified in 1.9% of all ICSRs and major DDIs in 20.4%., Conclusions: About a third of the ICSRs related to Om/Pa/Ri+Da regimen were serious. Pruritus, fatigue, dizziness and headache were the most commonly reported ADRs. The frequent use of multiple co- medications in HCV-infected patients requires the consideration of potential DDIs when using the Om/ Pa/Ri+Da regimen.

Background: In Romania, colorectal cancer does not benefit yet from a national screening program. In order to decrease the harm and burden of colorectal cancer (CRC), opportunistic programs relying on endoscopy has been adopted by each centre according to its capacity. A colorectal cancer (CRC) screening programme based on faecal immunochemical test (FIT) was launched at Ponderas Academic Hospital (PAH) in 2019. Aim: The present study analyses the outcomes after the first 1500 tests in the PAH-FIT-CRC Screening Program. We have also aimed to compare the efficiency of the FIT testing program with the screening colonoscopies performed in our Center, withing the same time interval (2019). Methods: The test was recommended in asymptomatic patients over 45 years, and it was followed by a colonoscopy when the test results were positive. Furthermore, we performed a retrospective observational study gathering data from all the consecutive patients prospectively included in the respective databases of our hospital, comparing the efficacy of the two colorectal cancer screening methods (FIT versus colonoscopy). Results: Between 01.01.2019 and 01.01.2020, 1524 screening colonoscopies were performed, and the resulting data were compared with those obtained in the FIT group (1500 FIT tests freely distributed). In the screening colonoscopy group, the polyp detection rate was 38.98% and 22 (1.44%) adenocarcinomas were identified. In the FIT group, the FIT uptake rate was 71% with a positivity rate of 21.7%. The colonoscopy compliance rate for positive FIT patients was 29.4%, with only 2 adenocarcinomas detected. Conclusions: Following data analysis, the need for improvement of uptake rate and colonoscopy compliance rate was suggested, due to the lower acceptance of FIT tests and colonoscopies, especially among men. Moreover, special efforts should be made in order to improve quality indicators for screening colonoscopies (especially adenoma detection rate) with the purpose of decreasing interval CRC., (Celsius.)

Background and Aims: The nutritional disorders are modifiable predisposing factors of the current leading causes of morbidity and premature mortality, such as cardiovascular diseases, diabetes and cancers. An early recognition of appropriate interventions could decrease the burden of medical costs and increase the healthy life expectancy. The aims of our study were the description of nutritional status, its associated factors, and the detection of eating disorders among Romanian medical students of the "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca., Methods: A cross-sectional study was conducted during the 2015-2016 academic year, including medical students from all study years, by an online questionnaire. The statistics, both descriptive and inferential, were calculated using EpiInfo., Results: A total of 222 students from the University Romanian section were included, with a sex-ratio (men:women) of 0.22. The average body mass index of the medical students included was 21.3±3.3 kg/m2, for females it was 20.7±3 kg/m2 and for males 23.9±3.1 kg/m2. For the nutritional disorders such as overweight, the prevalence among males (30%) had a net predominance (p<0.001) over females (4.4%), while for underweight, it was prevalent only for female students (20.3%). Overweight was associated with low academic performance (odds ratio (OR)=7.2; 95% confidence interval (95% CI): 1-53.94), smoking (OR=2.4; 95% CI: 1-5.76) and binge drinking (OR=3; 95% CI: 1.26-7.25). Eating disorders were reported by 25.7% of the students and were significantly more prevalent in students in the second academic study cycle (47.4%; 95% CI: 34.7-60.3%) and in students with jobs (7%; 95% CI: 2.3-16.1%)., Conclusions: In this survey, two different distribution models of nutritional disorders for both genders were identified, with the predominance of overweight among men. Eating disorders were more prevalent among students in the second study cycle and those with jobs at the same time.

Introduction: Carcinomas of the thyroid gland represent 3% of all malignancies, with 1.3 to 9.8% corresponding to anaplastic thyroid carcinomas (ATC). Metastases are present in 50% of patients when ATC is diagnosed. Gastrointestinal metastases are a rare finding in patients with thyroid carcinoma., Case Report: A 68-year old gentleman with a history of papillary thyroid carcinoma (PTC) underwent surgery and radiopharmaceutical therapy. Restaging studies nine months later suggested wall thickening localizing to the distal stomach. Endoscopy results showed a large, infiltrative, subepithelial, and ulcerated gastric mass and biopsies revealed anaplastic thyroid carcinoma Conclusion. Incidental thickening or other findings in the stomach in a patient with ATC without gastrointestinal symptoms should be further investigated with endoscopy and biopsies to rule out gastric metastases from anaplastic thyroid carcinoma.

The results of national safety studies are essential for decision-making at the regulatory level and have also educational implications for prescribing patterns. The aim of this study was to analyze the adverse drug reactions (ADRs) of analgesic medicines spontaneously reported to Pharmacovigilance and Risk Management Service of the Romanian National Agency for Medicines and Medical Devices between 2011 and 2015. For the 71 reports, patients had a mean age of 39.8 years; 60.6% of patients were female, and 38% male and 1.4% were unknown. Reporters were mainly physicians (74.7%), and 52.1% of ADR reports were transmitted through marketing authorization holders. Of the serious ADRs (32.4%), 34.7% led to hospitalization or prolonged hospitalization. The most frequent ADRs reported were skin and subcutaneous tissue disorders (25.8%) and general disorders and administration site conditions (19.2%). Metamizole, alone or in combination, was the main analgesic suspected in almost 15.5% of the cases and remains one of the most popular analgesics in Romania. Ten cases were assessed as preventable or potentially preventable (14%), of which two cases were serious. Even if the level of reporting is still low, this study conducted on ADRs of analgesics reported to the national pharmacovigilance center represents an essential step toward promoting the rational use of analgesics in Romania., (© 2018 Société Française de Pharmacologie et de Thérapeutique.)

We report a rare case of seronegative autoimmune pancreatitis (AIP) that presented as a pancreatic focal lesion and was considered to be pancreatic cancer based on the clinical presentation and imaging findings. The endoscopic ultrasound-guided biopsies of the pancreatic mass revealed no malignant cells and the pancreatic swelling had become diffuse on repeat imaging. AIP was suspected and a trial of steroids was considered as a diagnostic and therapeutic method. The patient responded dramatically to corticosteroid treatment with resolution of symptoms and normal imagining and laboratory parameters. This case highlights the challenge in the diagnostic approach of a pancreatic mass.

Purpose: Platinum derivatives play a very important role in cancer therapy. Despite their outstanding results in the treatment of tumors with different locations, the occurrence of hypersensitivity reactions raises issues when it comes to therapy decision, because the changing of chemotherapy line could influence the tumor's evolution. Over the years the scientific community has paid particular attention to the mechanism by which this occurs and to identification of predictive factors. The purpose of this case-control, retrospective study was to find new predictive markers for the occurrence of allergic reactions to platinum derivatives., Methods: We identified 59 cases of allergic reactions to platinum derivatives in the Oncology Institute "Prof. Dr. Ion Chiricuta" from Cluj-Napoca city in 2013. Blood tests data were analyzed before the administration of the cycle on which the allergic reaction occurred, along with the mandatory analyses for the patients and we focused on the values of neutrophils, lymphocytes, monocytes, eosinophils and basophils., Results: When these values were compared with the values of the control group (,which was made at a ratio of 1:2 or 1:3, matched for age, tumor location and chemotherapy cycle) we found that each increase of lymphocytes or doses of platinum and each drop in monocytes number increased the risk for allergic reactions to occur., Conclusion: These findings are of a great value for the physicians and represent a starting point for more detailed studies.

Objectives: The aims of this study were to determine the patterns of analgesic adverse drug reactions (ADRs) and to assess their preventability and contributing factors., Methods: This is a retrospective, descriptive study conducted on ADRs of analgesics and other drugs indicated as analgesics, spontaneously reported to the Bordeaux pharmacovigilance center from January 2011 to June 2012., Results: The 141 cases selected for the analysis included 16 cases of medication errors (11.3%) and 15 addiction cases (10.6%). In total, 214 ADRs were registered, for which 173 analgesic medicines were suspected. The most frequent ADRs reported were nervous system disorders (26.6%), psychiatric disorders (15.0%), and skin and subcutaneous tissue disorders (12.1%). Tramadol alone or in combination (17.3%), followed by morphine (15%), fentanyl (9.8%), and paracetamol (8.7%) were the most frequently involved analgesics. More than half of the cases (54.6%) were serious and led to hospitalization or prolonged hospitalization. Preventability was determined for 134 cases (95%): 51.5% were considered as preventable, 26.1% not preventable, and 22.4% not assessable. The main contributing factors for the preventable cases included negligence of recommendations for analgesic use and failure to consider patients' risk factors when prescribing., Conclusions: A significant number of analgesic ADRs could be prevented, and being aware of their contributing factors promotes efficient analgesia with minimum risks to the patients.

Pain represents a complex experience which can be approached by various medicines. Non-opioid and opioid analgesics are the most common drugs used to manage different types of pain. The increased attention nowadays to pain management entailed concomitantly more frequent adverse drug reactions (ADRs) related to analgesic use. Drug-drug interactions can be sometimes responsible for the adverse effects. However, a significant proportion of analgesic ADRs are preventable, which would avoid patient suffering. In order to draw the attention to analgesics risks and to minimize the negative consequences related to their use, the present review comprises a synthesis of the most important safety issues described in the scientific literature. It highlights the potential risks of the most frequently used analgesic medicines: non-opioid (paracetamol, metamizole, non-steroidal anti-inflammatory drugs) and opioid analgesics. Even if there is a wide experience in their use, they continue to capture attention with safety concerns and with potential risks recently revealed. Acknowledging potential safety problems represents the first step for health professionals in assuring a safe and efficient analgesic treatment with minimum risks to patients. Taking into consideration all medical and environmental factors and carefully monitoring the patients are also essential in preventing and early detecting analgesic ADRs.

Background: Potential drug-drug interactions (DDIs) are frequent in drug prescription but clinically significant are the ones which can result in changes of therapeutic effect of one of the two drugs or in adverse drug reactions (ADRs). The aim of this study was to assess the potential DDIs as well as the DDIs which cause adverse drug reactions (ADRs) in an internal medicine department hospitalized patients., Methods: The prospective study included all patients admitted between November 2010 and January 2011 in an internal medicine ward. Information on patients' demographics and their medication use history was obtained from each patient by interview. In addition, medical history, medication use during hospitalization, and relevant laboratory and clinical data were obtained from medical records. Potential DDIs were identified using the Thomson Micromedex program. Each patient was monitored during the hospitalization period in order to detect the ADRs resulting from DDI's if present., Results: Three hundred and five patients were enrolled in this study during 3 months. Of 1279 potential DDIs, Fourteen led to 13 ADRs out of which 8 were serious and caused hospital admission or prolongation of hospitalization. There was a statistically significant association between ADRs related to DDIs and the presence of ATC (Anatomical Therapeutic Chemical) C medication during hospitalization and the length of hospital stay, in the multivariate analysis., Conclusion: Awareness of the most commonly occurring DDIs should be raised by the utilization of drug-drug interaction guides in the Romanian clinical practice which can help prescribers and pharmacists prevent DDI related ADRs., (Copyright © 2012 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.)