Myostatin and Activin A as Biomarkers of Sarcopenia in Inflammatory Bowel Disease Patients.

The prevalence of sarcopenia in inflammatory bowel disease patients has received increasing attention. The aim of this study is to assess the usefulness of determining levels of myostatin (MSTN) and activin A (Act A) as potential markers of disease activity and occurrence of sarcopenia in Crohn's disease and ulcerative colitis patients. The case-control study included 82 patients with Inflammatory Bowel Disease. The control group consisted of 25 healthy volunteers. The serum levels of myostatin and activin A were determined by the quantitative sandwich enzyme-linked immunosorbent assay. Sarcopenia was diagnosed based on the EWGSOP2 criteria. The study found lower levels of myostatin and activin A in the IBD patients. There were significantly lower levels of myostatin (80.6 pg/mL vs. 186.2 pg/mL; p = 0.0364) as well as activin A (32.1 pg/mL vs. 35.2 pg/mL; p = 0.0132) in the IBD patients with sarcopenia compared to those without sarcopenia. Positive correlations were found between MSTN levels and Muscle Mass Index (rho = 0.31; p < 0.005) and hand grip strength (rho = 0.34, p < 0.05) in the IBD patients. The determination of serum levels of MSTN and Act A may be useful in the early diagnosis of sarcopenia in IBD patients.

An Evaluation of the Usefulness of Selected Screening Methods in Assessing the Risk of Malnutrition in Patients with Inflammatory Bowel Disease.

The aim of this study was to assess the prevalence of malnutrition risk in patients with IBD using different scales to evaluate their usefulness as first-step screening tools for the diagnosis of malnutrition using the GLIM criteria in patients with inflammatory bowel disease. This study included 82 patients with IBD. The Mini Nutritional Assessment, Malnutrition Universal Screening Tool, Saskatchewan IBD-Nutrition Risk and Malnutrition Screening Tool were used to assess malnutrition risk in the study group. In order to diagnose malnutrition, the GLIM criteria were used. According to the GLIM recommendations, malnutrition was diagnosed in 60 patients with IBD (73.17%). Depending on the applied screening tools, the prevalence of moderate and/or high-risk malnutrition in patients with IBD ranged from 20.25% to 43.59%. The highest level of accuracy (ACC) was noted for the MST and MUST questionnaires (92.50% and 90%, respectively), followed by the SASKIBD-NR test (89.97%) and the MNA questionnaire (83.33%). The results of our study indicate a high prevalence of malnutrition in patients with IBD. Thus, there is a need to conduct routine assessments of malnutrition risk using validated scales. The MUST scale seems promising in the assessment of malnutrition risk in patients with IBD as a first step in the assessment of malnutrition using the GLIM criteria.

Role of Serum Interleukin-6, Interleukin-1ß and Interleukin-10 in Assessment of Disease Activity and Nutritional Status in Patients with Inflammatory Bowel Disease.

Inflammatory bowel diseases (IBD) are characterised by multifactorial and chronic inflammation. Much attention has been paid to immune dysfunction in inflammatory bowel diseases. The aim of this study was to assess the usefulness of serum IL-6, IL-1ß and IL-10 in determining the activity and nutritional status in IBD patients. The case-control study was carried out on 82 patients with IBD; the control group consisted of 25 clinically healthy subjects. The serum concentrations of IL-6, IL-1 ß and IL-10 were determined by the quantitative sandwich enzyme-linked immunosorbent assay. There were no significant differences in IL-6 and IL-1ß levels in UC and CD patients according to disease activity as assessed by the Montreal classification, Partial Mayo Score and CDAI. Significantly higher IL-6 levels were found in patients with low body fat in comparison to patients with normal body fat. Furthermore, significantly higher mean IL-6 levels were observed in patients with excess body fat in comparison to patients with normal body fat, and also in comparison to patients with deficient body fat. IL-6 and IL-1ß may provide extra information regarding the nutritional status of IBD patients. IL-10 can be considered a non-invasive biomarker of IBD activity.

Indirect and Direct 65+ Patient Reporting of Non-Steroidal Anti-Inflammatory Drug-Induced Adverse Drug Reactions as a Source of Information on Polypharmacy and Polypharmacy-Related Risk.

Background and Objectives: Non-steroidal anti-inflammatory drugs (NSAIDs), which have anti-inflammatory and analgesic properties, are commonly used in the treatment of various, particularly frequent, as well as chronic, conditions in older patients. Due to common polypragmasia in these patients and a high risk of adverse drug reactions (ADRs) and drug interactions, pain management poses a therapeutic challenge. This study describes the importance of ADR reports in the identification of polypharmacy and the ensuing interactions. Materials and Methods: Both healthcare professionals (HPs) and non-healthcare professionals (non-HPs) reports collected in the EudraVigilance database of NSAIDs, including most commonly co-reported medications and reported reactions, were analysed and differences between HPs and non-HPs reports were identified. Results: In the analysed period and group, non-HPs reported more reactions but indicated fewer drugs as suspect or concomitant. The outcomes of our analysis indicate more HP engagement and more detailed reports of serious ADRs when compared to non-serious individual case safety reports (ICSRs) by non-HPs, which appeared more detailed. Such reactions as kidney failure and increased risk of bleeding are known adverse reactions to NSAIDs and common symptoms of their interactions, which were described in the available literature. They were much more frequently reported by HPs than by non-HPs. Non-HPs more frequently reported reactions that may have been considered less significant by HPs. Conclusions: The differences between healthcare professionals' (HPs) and non-healthcare professionals' (non-HPs) reports may result from the fact that the reports from patients and their caregivers require a professional medical diagnosis based on symptoms described by the patient or additional diagnostic tests. This means that when appropriately classified, medically verified, and statistically analysed, the data may provide new evidence for the risks of medication use or drug interactions.

Clostridioides difficile Infections among Pediatric Patients Hospitalized at an Oncology Department of a Tertiary Hospital in Poland.

Background and Objectives: Gastrointestinal tract infections caused by Clostridioides difficile bacteria are diagnosed in pediatric patients with increasing frequency. Children treated at pediatric units are a group of patients at high risk of this infection; therefore, appropriate differential diagnostics and an individual approach to every case are of particular importance. The goal of the study was to assess the clinical parameters of patients with a confirmed CD infection and colonization. Materials and Methods: Every positive case was subjected to a retrospective analysis based on medical history and an infection notification note. Results: Positive results were obtained for 30 patients, among whom the results of 18 patients were considered to justify the diagnosis of an infection. In the remaining patients, treatment was not initiated in only three cases. Cases were detected where treatment was initiated despite the lack of sufficient clinical evidence. Conclusions: This study demonstrates that there are many factors that result in a high risk of the occurrence of CDI in oncology patients, such as antibiotic therapy, multiple hospitalizations, and myelosuppression.

Evaluation of Albumin, Transferrin and Transthyretin in Inflammatory Bowel Disease Patients as Disease Activity and Nutritional Status Biomarkers.

Inflammatory bowel disease (IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC), is often accompanied by malnutrition that manifests itself as nutrient deficiencies and body mass loss or deficit. The purpose of this study is to evaluate the utility of albumin, transferrin and transthyretin levels in the assessment of nutritional status and IBD activity. The case-control study included 82 IBD patients. The serum concentrations of albumin, transferrin and transthyretine were determined by a quantitative sandwich enzyme-linked immunosorbent assay (ELISA). Significantly lower median concentrations of albumin were found in the IBD patients vs. controls and in CD patients compared to the UC patients. Significantly higher median transthyretin concentrations were found in the IBD patients compared to the healthy subjects. There were no significant differences in median transferrin concentrations between the IBD patients and the healthy subjects. Significantly higher albumin levels were found in IBD patients in remission compared to patients with moderate and severe exacerbation of IBD symptoms. There were no significant differences in the median transferrin or transthyretin levels in patients with IBD depending on disease activity. No differences were identified in the median transferrin or transthyretin levels in the IBD patients according to nutritional status. The median albumin concentrations in the IBD subjects were significantly higher in patients with normal body fat, normal BMI and normal waist circumferences compared to those with an abnormal nutritional status. The albumin levels reflect both nutritional status and disease activity and therefore cannot be considered a prognostic marker of malnutrition in IBD. As regards the utility of transferrin and transthyretin as markers of activity and nutritional status in IBD patients, further studies are required.

Dietary Behaviors and Beliefs in Patients with Inflammatory Bowel Disease.

INTRODUCTION: Due to a lack of clear dietary guidelines, patients with inflammatory bowel disease (IBD) self-impose dietary restrictions based on their own nutritional experiences. The aim of this study was to investigate dietary perceptions and behavior in IBD patients. MATERIALS AND METHODS: A total of 82 patients (48 with Crohn's disease and 34 with ulcerative colitis) participated in this prospective, questionnaire-based study. Based on a literature review, the questionnaire was developed to investigate dietary beliefs, behaviors and food exclusions during IBD relapses and remission. RESULTS: The majority of patients (85.4%) believed that diet can be a trigger factor for IBD relapses, and 32.9% believed that diet initiates the disease. The majority of patients (81.7%) believed that they should eliminate some products from their diets. The most often-pointed-out products were spicy and fatty foods, raw fruits and vegetables, alcohol, leguminous foods, cruciferous vegetables, dairy products and milk. Most patients (75%) modified their diets after diagnosis, and 81.7% imposed food restrictions to prevent IBD relapses. CONCLUSIONS: The majority of patients avoided certain foods during relapses as well as to maintain remission of IBD, basing this on their own beliefs, inconsistently with current scientific knowledge. Patient education should be a key determinant in IBD control.

The Hospital Environment as a Potential Source for Clostridioides difficile Transmission Based on Spore Detection Surveys Conducted at Paediatric Oncology and Gastroenterology Units.

Clostridioides difficile is an anaerobic, Gram-positive bacterium widely present in the hospital environment due to its ability to generate spores. The transfer of spores to patients through the hands of medical personnel is one of the most frequent paths of C. difficile transmission. In paediatric patients burdened with a serious primary illness requiring long-term hospitalisation and antibiotic therapy, C. difficile may be a significant risk factor for antibiotic-associated diarrhoea. The goal of the study was to assess the state of hospital environments as a potential source of C. difficile spores and to establish the share of hyperepidemic strains at the two paediatric units. The survey for C. difficile was conducted with a C. diff Banana BrothTM medium, used to detect spores and to recover vegetative forms of the bacteria. Environmental samples (n = 86) and swabs from the clothing of medical personnel (n = 14) were collected at two units of a paediatric hospital, where the cases of antibiotic-associated diarrhoea with a C. difficile aetiology constitute a significant clinical problem. In 17 samples, a change in the broth's colour was observed, indicating the presence of spores. Out of seven samples, C. difficile strains were cultured. The pathogenic isolates of C. difficile were obtained from swabs collected from elements of beds, a toilet, a door handle and a doctor's uniform. In our study, we indicated points of increased risk of pathogen transmission, which could constitute a source of infection. The clothing of medical personnel may be a dangerous carrier of pathogenic spores. Periodical surveys of hospital environments with the use of specialist microbiological mediums successfully indicate the direction of corrective actions to be undertaken by the medical facility in order to increase patient safety.

Dietary Behaviors, Serum 25(OH)D Levels and Quality of Life in Women with Osteoporotic Disorders.

Data obtained in recent years clearly demonstrate the aging process of European populations. Consequently, the incidence of osteoporosis has been rising. The aim of this study is to assess the quality of life (QoL) of women with osteoporosis. A total of 260 women participated in this study. The patient group consisted of 170 women with osteoporotic disorders. The control group consisted of 90 healthy women. Participants' quality of life was measured with the Qualeffo-41 Questionnaire. The total 25(OH)D concentration level was assessed with an assay using the chemiluminescent immunoassay. To assess the pain level, the Visual Analogue Scale (VAS) was used. To assess dietary behaviors, data were obtained by a 13-item Food Frequency Questionnaire. To assess the nutrition knowledge of participants, the Beliefs and Eating Habits Questionnaire was used. Based on the frequency of food intake, participants were classified into three patterns of behavior, i.e., Prudent, Western, and Not Prudent-Not Western. The patients assessed their quality of life as average (36.6 ± 19.9 points). The most favorable scores were obtained in the domains of "Ability to do jobs around the house" and "Mobility". The worst rated domain among the respondents was "Mental function". There were significant differences identified in quality of life depending on diet, nutritional knowledge, comorbidities and occurrence of fractures in the subjects. The individuals in the "Prudent" group reported a significantly higher quality of life as compared to the "Not Prudent-Not Western" and "Western" groups and those with high nutritional knowledge as compared to those with moderate and low. Lower quality of life was also observed among women with comorbidities and with bone fractures. Depending on serum 25(OH)D levels, poorer quality of life was characterized women with vitamin D deficiency. Patient education, implementation of effective methods aimed at alleviating pain and maintaining the optimal concentration of vitamin D can help improve the quality of life in patients with osteoporotic disorders.

Dietary Interventions in Inflammatory Bowel Disease.

Inflammatory bowel disease, which primarily includes ulcerative colitis and Crohn's disease, is a group of chronic diseases of the gastrointestinal tract. Mainly affecting young people, it is characterized by periods of exacerbation and remission. In recent years, there has been an increase in the prevalence of inflammatory bowel disease worldwide, including Poland. The potential impact of nutrition and selected dietary components that are directly or indirectly involved in the pathogenesis of intestinal lesions in IBD is not fully clear. Evaluating the impact of diet on the course of IBD is very complex due to the fact that regardless of a dietary model adopted, each one is based on consumption of many different food groups which affect one another. However, the growing need to produce dietary recommendations for these patients has prompted the International Organization for the Study of Inflammatory Bowel Disease (IOIBD) to develop nutrition guidelines for the patients. The present paper characterizes the dietary models most commonly discussed in research studies and their potential impact on IBD activity.

Relationship between Dietary Behaviors and Physical Activity and the Components of Metabolic Syndrome: A Case-Control Study.

Poor diet and low physical activity play an important role in the etiopathogenesis of metabolic syndrome. The aim of this study was to analyze the association between nutrient intake, groups of food products and physical exercise undertaken and the components of metabolic syndrome (MS). The study included 330 patients with MS, and the control group comprised of 270 subjects without MS. The food intake was assessed using 24-h dietary recall, and a 13-item Food Frequency Questionnaire. To assess nutrition knowledge, a Beliefs and Eating Habits Questionnaire was used. The level of physical activity was assessed using the International Physical Activity Questionnaire. Three patterns of behavior were identified: Prudent-Active, Western-Sedentary, and NotPrudent-notWestern-lowActive. In the Prudent-Active group, as compared to the NotPrudent-notWestern-lowActive subjects, the risk of central obesity, hypertension, hypertriglyceridemia, low HDL cholesterol and hyperglycemia occurrence was lower. There was also a lower proportion of patients with MS. As compared to the NotPrudent-notWestern-lowActive subjects, in the Prudent-Active group there was more than a two times higher chance of subjects with a high level of nutrition knowledge. Western diets have been proven to exert a detrimental effect on the components of MS. When designing intervention programs, education of patients with MS on dietary habits and physical activity should be considered.

The Scale of Intoxications with New Psychoactive Substances over the Period 2014-2020-Characteristics of the Trends and Impacts of the COVID-19 Pandemic on the Example of Lódz Province, Poland.

Legal highs are new psychoactive substances (NPSs) which pose a high risk for human health, and the spread of the SARS-CoV-2 pandemic has changed peoples' behaviours, including the demand for NPS. The aim of the study was to assess both the frequency of intoxication with NPS in Lódz province over the period 2014−2020, and the impact of the COVID-19 pandemic on developing this trend. An analysis was carried out of data on intoxications in Lódz province in the years 2014−2020 reported by hospitals. The medical interventions rate (MI) per 100,000 people in the population was calculated. The frequency of intoxications was compared taking sociodemographic variables into account, and the effect of seasonal influence on intoxications was calculated using the Holt−Winter multiplicative seasonal method. In the period considered, there were 7175 acute NPS poisonings in the Lódz province and 25,495 in Poland. The averaged MI rate between 2014−2020 was 9.45 for Poland and 38.53 for the Lódz province, and the lowest value was found during the COVID pandemic in the year 2020 (respectively, 2.1 vs. 16.94). NPS users were mainly young men of 19−24 years old from a big city. Most cases were registered at weekends and in summer months. The majority of intoxications were caused by unidentified psychoactive substances of legal highs (chi2 = 513.98, p < 0.05). The actual number of NPS-related poisonings in the Lódz province in 2020 was lower than the value extrapolated from trend analysis of data between 2014−2019. NPS use in Poland decreased during the pandemic. It should be noted that a decrease in the number of drug-related incidents can have more than one reason, e.g., preventive programs, increased awareness, or changes in the law. This paper advocates that, in addition to monitoring NPS-related intoxications, there is further investigation into the social, cultural, and behavioural determinants of NPS to facilitate targeted prevention programmes and the development of new medical treatments.

Resting Metabolic Rate in Women with Endocrine and Osteoporotic Disorders in Relation to Nutritional Status, Diet and 25(OH)D Concentration.

There are speculations that vitamin D may be an important regulator of the energy metabolism. The aim of this study was to evaluate the influence of serum 25(OH)D concentration and nutritional status on the resting metabolic rate. The study group consisted of 223 women with endocrine and/or osteoporotic disorders. The control group consisted of 108 women, clinically healthy. The total 25(OH)D concentration level was measured with an assay using chemiluminescent immunoassay technology. Indirect calorimetry was applied to assess the resting metabolic rate. The mean resting metabolic rate was significantly lower in the group of women with metabolic disorders than in the control group. A correlation was found between serum 25(OH)D levels in healthy subjects and the resting metabolic rate. Significantly higher resting metabolic rate was found in women with normal serum 25(OH)D levels in comparison to subjects with deficient vitamin D levels. The control group demonstrated a relationship between body fat tissue and fat-free body mass and the resting metabolic rate. Both 25(OH)D concentration and body composition were factors influencing the resting metabolic rate in the group of healthy subjects. More research is needed to clarify the relationship between vitamin D status and metabolic rate in individuals with endocrine and osteoporotic disorders.

Vitamin D status in Polish women with endocrine and osteoporotic disorders in relation to diet, supplement use and exposure to ultraviolet radiation.

BACKGROUND: In Europe, the rate of 25(OH)D deficiency is considered high. Thus, it seems necessary to conduct population-based studies to fully assess vitamin D deficiency in various groups of patients. OBJECTIVES: To evaluate serum 25(OH)D levels and the frequency of deficiency in women in Poland with endocrine and osteoporotic disorders. The influences of diet, use of vitamin/mineral supplementation and exposure to ultraviolet (UVB) radiation on vitamin D status in women with metabolic disorders were also examined. MATERIAL AND METHODS: The patient group consisted of 223 women aged 19-81 years diagnosed with endocrine and/or osteoporotic disorders. The control group consisted of 108 clinically healthy women aged 26-72 years. Serum 25(OH)D concentration was assessed using a chemiluminescent immunoassay (CLIA). An ad hoc questionnaire was used to assess the participants' exposure to UVB radiation. Food intake was assessed using a three-day 24-hour questionnaire interview. RESULTS: The following groups showed significantly higher 25(OH)D levels: women taking vitamin D supplements compared to women not taking vitamin D supplements (29.3 ±3.2 compared to 19.5 ±3.7 ng/mL, p = 0.0024); premenopausal women compared to postmenopausal women (28.9 ±5.2 compared to 21.5 ±4.5 ng/mL, p = 0.0021); women who visited sunny countries in the last 6 months compared to women who did not (28.1 ±3.1 ng/mL compared to 24.5 ±5.3 ng/mL, p = 0.0031); and normal weight or overweight women (according to body mass index (BMI)) compared to obese women (27.4 ±4.5 ng/mL compared to 22.3 ±4.7 ng/mL, p = 0.0431). In addition, 25(OH)D concentration correlated with total dietary vitamin D intake in the patient group (R = 0.17, p = 0.0021). Of all examined food groups, fish consumption affected serum 25(OH)D levels in patients (R = 0.20, p = 0.0421) and controls (R = 0.29, p = 0.0002). Consumption of fish products contributed to statistical differences between the patient group (R = 0.17, p = 0.0072) and healthy subjects (R = 0.19, p = 0.0032). CONCLUSIONS: The most crucial factors influencing vitamin D status in the studied women were regular fish consumption, spending holidays in sunny destinations and regular intake of vitamin D preparations.

Assessment of cardiovascular risk in patients with metabolic syndrome working in the agricultural sector.

INTRODUCTION: Cardiovascular diseases are the main death cause in Poland. Several clinical studies showed association between metabolic syndrome and higher prevalence of diabetes mellitus, cardiac events and mortality. The aim of the study was to estimate cardiovascular complications and death risk in subjects with metabolic syndrome (MS) working in agriculture. MATERIAL AND METHODS: The study included 332 people working in agriculture in Lodz voivodeship, 231 with MS and 101 healthy ones. Increased risk of cardiovascular complications was determined for pulse pressure (pp) >63 mmHg. Based on the SCORE index, 10-year death risk due to cardiovascular complications was estimated taking into account sex, age, smoking, systolic blood pressure and total cholesterol concentration. A value ≥5% was accepted as high risk of death within 10 years. RESULTS: Increased risk of cardiovascular complications (pulse pressure >63 mmHg) was found in 31.60% subjects with MS and 6.93% healthy ones. CONCLUSIONS: High risk of cardiovascular complications and death occurs statistically more frequently in subjects with MS than in the rest of the population.

[Surgery first as an alternative approach in patients treated for dentofacial deformities]. / Chirurgia jako pierwsza ­ alternatywne podejscie do leczenia chirurgiczno-ortodontycznego pacjentów z wadami zgryzowotwarzowymi.

Recently surgery first became more popular alternative for treatment of dentofacial deformities. In this approach treatment starts from orthognathic surgery. Immediately after othognathic surgery facial aesthetics and oral function are improved. Thus main complaints of the orthognathic patients are resolved early during treatment period. Indications for surgery first approach are wider than years ago and include: skeletal Class II and III malocclusion, skeletal open bite, bimaxillary protrusion, even cases with severe facial asymmetry are reported. The key point for gaining stable results and total treatment time shortening is an appropriate surgical occlusion. For higher precision of treatment 3D virtual planning is recommended. Total treatment time depends on: number of contact points in surgical occlusion, number of extracted teeth and postsurgical midline deviation. Surgery first is a good alternative approach in some patients treated for dentofacial deformities. Stability in this approach is similar to conventional method of treatment and both methods result in quality of life improvement. As there is lack of presurgical orthodontics in surgery first approach patients avoid transient deterioration in facial aesthetics and oral function that results in higher satisfaction and shorter total treatment time.

[An assessment of the antioxidant vitamins concentration in people with metabolic syndrome working in agriculture]. / Ocena stezenia witamin antyoksydacyjnych u osób z zespolem metabolicznym pracujacych w rolnictwie.

BACKGROUND: Vitamins A, C and E are important parts of the antioxidant barrier. Polish data on antioxidant vitamins deficiency in the population are rare, especially among physically active people with metabolic disorders. The aim of this study was to evaluate the serum concentrations of vitamins A, C and E in people with metabolic syndrome (MS) working in agriculture, the prevalence of their deficiency in these workers, and the correlation between antioxidant vitamins concentration and traditional biomarkers of cardiovascular diseases. MATERIAL AND METHODS: The study included 332 residents of the Lódz Voivodeship working in agriculture: 231 people with MS and 101 healthy ones. The serum concentrations of vitamins A, C and E were assessed using the chemiluminescent immunoassay technology. The antioxidant vitamins intake was assessed by means of a 24-h recall questionnaire using Diet 5.0 software. RESULTS: The mean serum concentrations of vitamins A, C and E were significantly lower in the MS workers than in the healthy ones No correlation was found between the antioxidant vitamins concentration and the dietary intake but there was a correlation between the antioxidant vitamins concentration and high-density lipoprotein cholesterol (HDL-C). A correlation was found between the serum concentrations of vitamins A and C, and vitamins A and E, in the MS workers. CONCLUSIONS: The serum concentrations of antioxidant vitamins in the MS workers were significantly lower than in the healthy controls, despite the similar physical activity level. The dietary intake had no impact on the serum concentrations of these vitamins. The HDL-C concentration in the MS workers correlated with the concentrations of all antioxidant vitamins. Med Pr. 2021;72(2):123-9.

The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process.

All medicinal products authorized in the European Union are subjects of constant drug-safety monitoring processes. It is organized in a pharmacovigilance system that is designed to protect human health and life by the detection, analysis and prevention of adverse drug reactions (ADRs) and other drug-related problems. The main role of the aforementioned system is to collect and analyze adverse drug reaction reports. Legislation introduced several years ago allowed patients, their legal representatives and caregivers to report adverse drug reactions, which caused them to be an additional source of safety data. This paper presents the analysis of EudraVigilance data related to adverse drug reactions provided by patients, their representatives, as well as those obtained from healthcare professionals related to medicines which belong to M01A anti-inflammatory and antirheumatic products, a non-steroid group. The objective of the study was to identify the changes in the number and structure of adverse reaction reporting after the introduction of pharmacovigilance (PV) obligations in EU. A review of scientific literature was also conducted to assess the differences in adverse reactions reported by patients or their representatives and by healthcare professionals. We also identified other factors which, according to literature review, influenced the number of adverse reaction reports provided by patients. Analysis of data collected from the EudraVigilance showed that from 2011 to 2013 the number of reports made by patients and their caregivers increased by approx. 24 percentage points, and then, from 2014, it constituted around 30% of the total of reported reactions every year, so patient reporting is an important part of pharmacovigilance system and a source of drugs' safety information throughout their use in healthcare practice. Additionally, there was no interrelationship between the seriousness of reported adverse reactions and the overall number of patient reports when compared to reports form healthcare professionals.

[Assessment of 25(OH)D concentration in people with metabolic syndrome working in agriculture]. / Ocena stezenia 25(OH)D u osób z zespolem metabolicznym pracujacych w rolnictwie.

BACKGROUND: Polish data on vitamin D deficiency in the population are incomplete. Vitamin D deficiency seems to be common, but there is a lack of studies concerning the concentration of 25(OH)D in people with high UV exposure. The aim of this study was to evaluate the plasma concentration of 25(OH)D in people with and without metabolic syndrome (MS), working in agriculture, the prevalence of its deficiency in these workers, and the correlation between the plasma concentration of 25(OH)D and traditional biomarkers of cardiovascular diseases. MATERIAL AND METHODS: The study included 332 people working in agriculture in the Lódz voivodeship, including 231 people with MS and 101 healthy ones. The plasma concentration of 25(OH)D was assessed using the chemiluminescent immunoassay technology. The vitamin D intake was assessed using a 24-h recall questionnaire using Diet 5.0 software. RESULTS: The mean plasma concentration of 25(OH)D was 13.64±8.01 ng/ml in MS workers, and it was significantly lower than in the healthy ones (26.61±10.12 ng/ml, p < 0.00001); the highest concentration of 25(OH)D was noted in summer months. Deficient plasma concentrations of 25(OH)D were found significantly more often in MS workers than in the controls (81.82% and 20.79%, respectively, p < 0.00001). No correlation was found between the plasma vitamin D concentration and its dietary intake. The plasma concentration of 25(OH)D correlated with age of the examined workers (r = -0.28, p = 0.023), high density lipoprotein concentration (r = 0.19, p = 0.036) and glucose concentration (Rho = -0.24, p = 0.02). A multivariate analysis of variance demonstrated that the body mass index affected significantly the mean value of the 25(OH)D concentration in MS workers. CONCLUSIONS: The concentration of vitamin D in the plasma of workers with MS was significantly lower than in the healthy controls despite the same high UV exposure; these workers also manifested significantly higher 25(OH)D deficiency than the control subjects. This study indicates the need for further research on the concentration of 25(OH)D in people with metabolic disorders regardless of UV exposure and vitamin D intake with a diet. Med Pr. 2021;72(1):9-18.

Circumstances and Structure of Occupational Sharp Injuries among Healthcare Workers of a Selected Hospital in Central Poland.

(1) Background: An analysis of work-related sharp injuries in Healthcare Workers (HCWs) based at a selected hospital in Central Poland by presenting the frequency of accidents, injury rates, and identifying circumstances of Needle Sticks and Sharp Injuries (NSSI) and giving Post-Exposure Procedures (PEP). (2) Methods: A retrospective analysis of medical documentation regarding work-related NSSI at a district hospital located in central Poland; over the period 2010⁻2017. The study group included HCWs who had an accident while on duty. (3) Results: Most injuries were reported by nurses and staff over 40, on the morning shift. The most common injuries were using a needle. The most exposed part of the body were fingers. The average annual injury rates were: 1.22/100 Nurses; 2.02/100 doctors; 1.34/100 hospital beds; and 8.59/100,000 inpatient days. The rates for 3-year periods, after the implementation of legal regulations were higher than before. CONCLUSION: Injuries rates are more reliable for comparison than frequency. Legislation on the need to register injuries seems to be necessary. In the supervision of work safety of personnel, reliable reporting of all injuries by the respective HCWs plays a key role.