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Introduction: Overweight and obesity in youth with serious emotional disturbance (SED) is exceedingly common. In 2015 the AHA called attention to mental illnesses in youth as important risk conditions for early CVD and the need for transformational change in management of overweight and obesity in this group. Our objective was to test a 12-month, innovative healthy weight intervention in youth with SED.Hypothesis: The active intervention is more effective than control in decreasing BMI Z-score compared at 12 m. Method(s): We conducted a two-arm randomized trial in 2 outpatient pediatric mental health settings in 112 youth, ages 8-18 yrs. The active intervention group was offered 12m of in-person and virtual individual weight management sessions led by health coaches who provided guidance on improving diet and increasing physical activity, and engaged parents. Result(s): At baseline, mean (SD) age was 13.0 (2.7) yrs with 46% ages 8-12 and 54% 13-18;55% were male, 46% Black, 39% had household income less than $50K/yr and 31% lived in a single-parent household. Primary diagnoses were ADHD (41%), major depression (23%), and anxiety (23%). Mean BMI Z-score (SD) was 2.0(0.4), BMI 30.4 (6.4) kg/m2.Mean(SD) psychotropic medications were 2.1(1.4).At 12m, 111 (99%) had a follow-up weight;42 were collected after the onset of the COVID pandemic). The intervention group compared to the control group had 0.15 decrease in BMI Z-Score (95% CI 0.26 to 0.04), p<0.007) between baseline and 12 m (Figure) and a 1.43 kg/m2 decrease in BMI (95% CI 2.43, 0.42, p<0.006). Estimated net effect on BMI Z-score for intervention vs. control was enhanced during the pandemic but not statistically different from net effects pre-pandemic (p=0.06). Conclusion(s): A weight control intervention designed for children with SED decreased BMI Z-score substantially over 12 months, including during the COVID-19 pandemic. These results provide empirical evidence in support of weight control programs in a population at high risk for early development of CVD risk factors.
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Therapeutically, new oral anticoagulants (NOACs) are considered to be non-inferior or superior to vitamin K antagonists (warfarin). NOACs are included in current guidelines for the treatment of various cardiovascular diseases. Rivaroxaban medicinal products have been shown to effectively fight thrombotic complications of the new coronavirus infection, COVID-19. The wide clinical use of rivaroxaban products motivates the development of generics. The aim of the study was to compare the pharmacokinetics and safety of rivaroxaban medicinal products in a single-dose bioequivalence study in healthy volunteers under fasting conditions. Material(s) and Method(s): the bioequivalence study compared single-dose oral administration of Rivaroxaban, 10 mg film-coated tablets (NovaMedica Innotech LLC, Russia), and the reference product Xarelto, 10 mg film-coated tablets (Bayer AG, Germany), in healthy volunteers under fasting conditions. The open, randomised, crossover trial included 46 healthy volunteers. Each of the medicinal products (the test product and the reference product) was administered once;blood samples were collected during the 48 h after the administration. The washout between the study periods lasted 7 days. Rivaroxaban was quantified in plasma samples of the volunteers by high performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS). Result(s): no adverse events or serious adverse events were reported for the test and reference products during the study. The following pharmacokinetic parameters were obtained for Rivaroxaban and Xarelto, respectively: Cmax of 134.6 +/- 58.0 ng/mL and 139.9 +/- 49.3 ng/mL, AUC0-48 of 949.7 +/- 354.5 ngxh/mL and 967.6 +/- 319.9 ngxh/mL, AUC0- of 986.9 +/- 379.7 ngxh/mL and 1003.6 +/- 320.4 ngxh/mL, T1/2 of 8.2 +/- 3.2 h and 7.8 +/- 3.3 h. The 90% confidence intervals for the ratios of Cmax, AUC0-48, and AUC0- geometric means were 88.04-108.67%, 89.42-104.92% and 89.44-104.81%, respectively. Conclusion(s): the test product Rivaroxaban and the reference product Xarelto were found to have similar rivaroxaban pharmacokinetics and safety profiles. The study demonstrated bioequivalence of the medicinal products.Copyright © 2022 Obstetrics, Gynecology and Reproduction. All rights reserved.
ABSTRACT
Therapeutically, new oral anticoagulants (NOACs) are considered to be non-inferior or superior to vitamin K antagonists (warfarin). NOACs are included in current guidelines for the treatment of various cardiovascular diseases. Rivaroxaban medicinal products have been shown to effectively fight thrombotic complications of the new coronavirus infection, COVID-19. The wide clinical use of rivaroxaban products motivates the development of generics. The aim of the study was to compare the pharmacokinetics and safety of rivaroxaban medicinal products in a single-dose bioequivalence study in healthy volunteers under fasting conditions. Material(s) and Method(s): the bioequivalence study compared single-dose oral administration of Rivaroxaban, 10 mg film-coated tablets (NovaMedica Innotech LLC, Russia), and the reference product Xarelto, 10 mg film-coated tablets (Bayer AG, Germany), in healthy volunteers under fasting conditions. The open, randomised, crossover trial included 46 healthy volunteers. Each of the medicinal products (the test product and the reference product) was administered once;blood samples were collected during the 48 h after the administration. The washout between the study periods lasted 7 days. Rivaroxaban was quantified in plasma samples of the volunteers by high performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS). Result(s): no adverse events or serious adverse events were reported for the test and reference products during the study. The following pharmacokinetic parameters were obtained for Rivaroxaban and Xarelto, respectively: Cmax of 134.6 +/- 58.0 ng/mL and 139.9 +/- 49.3 ng/mL, AUC0-48 of 949.7 +/- 354.5 ngxh/mL and 967.6 +/- 319.9 ngxh/mL, AUC0- of 986.9 +/- 379.7 ngxh/mL and 1003.6 +/- 320.4 ngxh/mL, T1/2 of 8.2 +/- 3.2 h and 7.8 +/- 3.3 h. The 90% confidence intervals for the ratios of Cmax, AUC0-48, and AUC0- geometric means were 88.04-108.67%, 89.42-104.92% and 89.44-104.81%, respectively. Conclusion(s): the test product Rivaroxaban and the reference product Xarelto were found to have similar rivaroxaban pharmacokinetics and safety profiles. The study demonstrated bioequivalence of the medicinal products. Copyright © 2022 Obstetrics, Gynecology and Reproduction. All rights reserved.
ABSTRACT
This paper focuses on metaphorical representation of coronavirus in medical myths on the example of the British media. To attain this goal, the descriptive metaphor theory is used for the analysis of metaphorical models for the conceptualization of coronavirus. The information about the virus transmitted by the media correlates with background knowledge of the recipient, acquires new conceptual characteristics. Our hypothesis is that metaphorical actualization of coronavirus in medical myths is represented by the descriptive metaphor, the content of which changes depending on the specifics of the spread of the virus over the country as well as the political situation in the country. The research is based on the assumption that metaphorical implications in medical myths influence the representation of the disease, which reflects not only general beliefs about this disease, but also molds the public opinion on political situation in the linguocultural society. The objective of this research is to analyze the titles and leads of the British press about coronavirus and interpret the metaphorical models for the conceptualization of coronavirus, used in medical myths. The objective of the research determined the choice of research methods: content analysis of titles and leads that contain metaphorical models for the conceptualization of coronavirus in medical myths;sampling analysis aimed at identifying and describing the functions of metaphorical models in the representation of the disease in medical myths. The notions of metalanguage such as the signification descriptor and the denotation descriptor are used to describe the functioning of metaphors. The research findings reveal that for the conceptualization of coronavirus in medical myths the following metaphorical models are used: ‘Coronavirus-military rival’, ‘Coronavirus-natural disaster’ and ‘Coronavirus-silver lining’. © Stepanova E.S., 2022.
ABSTRACT
In 2020-2021, the world was engulfed by the pandemic of a new coronavirus infection (COVID-19) caused by the SARS-CoV-2 virus. The low population coverage with vaccination against COVID-19 and the lack of herd immunity result in the need to find an effective and safe etiotropic treatment. Medicinal agents for treatment of COVID-19, approved while preparing this publication, have several limitations related to the conditions of their use and/or population category. In this situation, interferon-containing drugs widely used in Russia and the CIS for prevention and treatment of viral infectious diseases, i.e. ARVI and influenza, may hold promise. This study aims to confirm in vitro antiviral activity against SARS-CoV-2 for the preparation VIFERON (R) containing recombinant human interferon alpha-2b (IFN alpha-2b). Materials and methods. Vero CCL-81 cells were infected with hCoV-19/StPetersburg-RII3524VR4/2020 strain of SARS-CoV-2 at doses of 10 TCID50 or 100 TCID50 per well. The suppressive effect of IFN alpha-2b, extracted from VIFERON (R) in dosage form of rectal suppositories, was evaluated by qRT-PCR at 24 h and 48 h after the infection of cells in two schemes, simulating preventive (24 h before infection) and therapeutic (2 h after infection) use of drugs. Results. IFN alpha-2b at concentrations of 800, 400, 200, 100 and 50 IU/ml, extracted from rectal suppositories of VIFERON (R), showed high biological activity, displayed as inhibition of SARS-CoV-2 strain replication in both infectious doses evaluated either at 24 h or at 48 h after cell infection. The "preventive" vs. "therapeutic" scheme was found to be more effective. In the "preventive" scheme the virus titre decreased by more than 3 lg TCID50 at 24 hours post-infection and by 5-6 lg TCID50 at 48 hours post-infection after administration of 800 IU/ml IFN alpha-2b. Conclusion. The study results evidence that VIFERON (R) in dosage form of rectal suppositories may be promising for prevention and treatment of new coronavirus infection in clinical practice.
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OBJECTIVE: to assess the level of anxiety and characterize the quality of sleep in children living in radioactively con-taminated areas in comparison with children who were not affected by the Chornobyl-affected contingents that werequarantined in connection with the COVID-19 pandemic. MATERIALS AND METHODS: The indicators of the level of anxiety were studied using the scale of self-assessment of thelevel of anxiety Ch.D. Spielberger, sleep quality was assessed using a standardized questionnaire for self-completionof PSQI and 137Cs content was measured in children. The main group consisted of 96 children who were quarantineddue to the COVID-19 pandemic and permanently lived in radioactively contaminated areas of Zhytomyr and Rivneregions with a soil contamination density of 137Cs from 18 kBq/m2 to 235 kBq/m2. The age of children ranged from10 to 17 years. Among them were 33 boys and 63 girls. The comparison group consisted of 52 children of similar age,including 26 boys and 26 girls. These children lived permanently in Kyiv and were not victims of the Chornobyl dis-aster. RESULTS: It was found that children who were quarantined for COVID-19 (both residents of radioactively contami-nated areas and children who do not belong to the contingents affected by the Chornobyl disaster) had an increasedlevel of reactive (RA) and personal anxiety (PA). The comparative analysis showed that children of the same sex ofthe main group and the comparison group did not differ in terms of PA and RA. At the same time, studies have shownthat girls, both in the main group and in the comparison group, were characterized by higher levels of PA and RAthan boys. It was determined that poor sleep quality was common in both children living in radioactively contami-nated areas (42.71 %) and children in the comparison group (42.44 %). Among the sleep disorders in children ofboth observation groups, «day dysfunction¼ was most often detected. CONCLUSIONS: There was a direct correlation between the overall PSQI score and the level of reactive, personal anx-iety and the overall PSQI score. Using regression analysis, the presence of a linear association of the level of incorporated 137Cs (Bq) with the indicator of personal anxiety of children living in radioactively contaminated territory (b = -0.716, p < 0.001) was proved.
Subject(s)
Anxiety/etiology , COVID-19/psychology , Quarantine/psychology , Radiation Exposure , Sleep Quality , Social Isolation/psychology , Adolescent , Chernobyl Nuclear Accident , Child , Female , Humans , Male , Pandemics , SARS-CoV-2 , UkraineABSTRACT
Purpose. Analyze and identify the features of the course of the new coronavirus infection (COVID-19) in HIV-infected patients. Materials and methods. An analysis of the course of coronavirus infection (COVID-19) was carried out in 16 patients with HIV infection who were hospitalized at the St. Petersburg State Budgetary Healthcare Institution Center for the Prevention and Control of AIDS and Infectious Diseases from April to October 2020. All patients underwent a study of biological material from the oropharynx and nasopharynx for COVID-19 and diagnosed based on a positive PCR result. Results. In HIV-infected patients with diagnosed coronavirus infection caused by COVID-19, signs of progression of HIV infection, clinical, immunological, virological (75%), opportunistic diseases and comorbidities (chronic viral hepatitis in the cirrhotic decompensated stage, cardiovascular diseases and others) (94%). A small sample of patients did not allow to determine with reliable accuracy the mutual influence of existing diseases and pathologies, but, of course, multiple comorbid pathologies play a role in the development of severe conditions and unfavorable outcomes. A clinical case is presented. Conclusion. The provoking factors have been identified that play a role in the development of infection and more severe forms of coronavirus infection caused by COVID-19 in HIV-infected patients (injecting drug use, alcohol abuse, late stage of HIV infection (4B, 4C) and progression of earlier stages (4A), a low number of CD4 lymphocytes (less than 200 cells / μl), multiple comorbid pathology (HIV infection, opportunistic diseases, comorbidities, especially chronic liver damage in the stage of decompensated cirrhosis), absence, interrupted antiretroviral therapy, multiple changes of regimens, absence prevention of opportunistic diseases). A patient with HIV infection at ART. 4B with multiple comorbidity, the possibility of long-term persistence of the COVID-19 virus coronavirus with positive and negative results for more than 2 months and later development of lung damage caused by COVID-19 was established.
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The authors of the paper present the result of risk and perspective analysis of genetic technologies introduction into agricultural sector of national economies. In the context of high level mistrust in GMO, research results due to the interest of multinational corporations in obtaining ‘super profits’ and high potential of genetic technologies for national food security, it has been concluded that it is necessary to expand governmental overview powers and participation level in the development and introduction of GM technologies into agriculture and other spheres of economy in order to guarantee safety and ensure higher accessibility standards to the population. The results of the study are supported by the data of the survey among certain age groups of Russian, Egyptian, Bulgarian and American population conducted by the authors of the paper. As a solution, we suggest establishing a new Governmental Department related to the FAO GM foods in order to determine quantities, safety assessment standards and facilitate deals between countries enabling GM foods production. In the future, this may change the policy of some countries, which now have a strict ban on GMOs, allowing them to open up to genetic technologies development. There are both direct positive effects to the Government from support of research and introduction of genetic technologies in agriculture and indirect ones. They include new jobs creation, affordability of the market basket or commodity bundle, poverty reduction and national scientific potential increase. In the conclusion, it should be specified that the demand for genetic technologies in agriculture during the post -COVID period is justified due to decrease in living standards of global population, unemployment increase, change in production and consumption structure of national and world economy. Besides, a set of measures should be adopted aimed at implementing government policy of support and development of GM foods and services production at the global and national levels.