Prevention Of Complications In Patients Research Articles

Study of mathematical models of type 2 diabetes mellitus and its complications

The rapid increase in type 2 diabetes mellitus (DM) cases in Indonesia, driven by hereditary factors and unhealthy lifestyles, poses significant health challenges. This study develops a compartmental model to analyze the progression of type 2 DM and the onset of complications, classifying individuals into susceptible, patients without complications, patients with complications, and those disabled due to complications. The model examines the influence of two key factors on the recovery from complications: habitual factors, including medication adherence, physical activity, dietary habits, smoking history, and environmental factors, such as stress levels, environmental support, patient trust, and compliance. The results indicate that habitual factors have a more substantial impact on mitigating complications compared to environmental factors, suggesting that lifestyle interventions are crucial in improving patient outcomes. The model also shows that an increase in behavioral interactions leading to disease progression results in instability, emphasizing the need for early and consistent behavioral interventions. This research offers valuable insights for healthcare providers and policymakers. By identifying the most influential factors in managing complications, the model can guide the development of targeted interventions that prioritize habitual changes, such as medication adherence and physical activity. Public health strategies can be tailored to emphasize the importance of these habitual factors, potentially reducing the burden of type 2 DM complications. Overall, this study highlights the critical role of personalized, behavior-focused interventions in the management and prevention of complications in patients with type 2 DM, offering a practical framework for improving patient care.

From wernicke-korsakoff to central pontine myelinolysis: the potentially irreversible risks of alcohol use

Introduction Sustained alcohol intake, when combined with incomplete treatment, can result in chronic structural changes in the Central Nervous System, including generalized cortical and cerebellar atrophy, amnesic syndromes like Korsakoff’s syndrome, and white matter disorders such as Central Pontine Myelinolysis and Marchiafava-Bignami syndrome. It is crucial to prevent these complications due to their potential for irreversible and debilitating consequences. For Wernicke-Korsakoff syndrome, early recognition and thiamine administration for prevention are paramount, as it arises from thiamine deficiency due to malnutrition caused by persistent alcohol use. In the case of Central Pontine Myelinolysis, which is caused by abrupt fluctuations in serum osmolality, controlled sodium correction is essential.ObjectivesThrough a clinical case and a review of published literature, this study aims to reflect on the importance of preventing neurological injuries associated with chronic alcohol consumption, specifically Wernicke-Korsakoff Syndrome and Central Pontine Myelinolysis.Methods A literature review was conducted by searching for articles on PubMed using the terms “Alcohol Use Disorder,” “Wernicke-Korsakoff syndrome,” and “Central pontine myelinolysis.” A clinical case is presented, featuring a 50-year-old patient with alcohol use disorder who developed Wernicke-Korsakoff syndrome and Central Pontine Myelinolysis. Considering this case, we reflect on the primary approaches that could have been beneficial in preventing these complications and propose a straightforward method for doing so.Results A 50-year-old patient presented with poor general condition, characterized by low weight, significant loss of strength in the limbs and arms, and incoherent speech with anterograde amnesia and confabulation. This condition had progressed to a point where the patient could no longer walk, perform basic self-care tasks such as bathing, dressing, and eating independently, underscoring the severity of his condition. The diagnoses of Wernicke-Korsakoff syndrome and Central Pontine Myelinolysis were established based on clinical manifestations and the presence of hyperintense lesions observed in the central pons on T2/FLAIR axial MRI scans. This clinical case highlights the importance of proper and precocious prevention of complications in patients with alcohol use disorder. The foremost step in preventing these complications is to treat alcohol dependence effectively, even when faced with patient resistance. It’s vital to remain vigilant about potential complications and implement suitable prophylactic measures.ConclusionsThe devastating effects of complications arising from Alcohol Use Disorder, such as Wernicke-Korsakoff syndrome and Central Pontine Myelinolysis, underscore the importance of enhanced attention that clinicians should provide when approaching these patients at all clinical interactions.Disclosure of InterestNone Declared

Bilateral Renal Cortical Necrosis following Snake Envenomation: A Comprehensive Case Report and Analysis of the Underlying Pathophysiological Mechanisms and Treatment Approaches

Acute bilateral renal cortical necrosis (RCN) is a rare but potentially lethal form of renal injury that poses a diagnostic and therapeutic challenge for clinicians. The causes of renal cortical necrosis are multi-factorial. Renal cortical necrosis shows a higher incidence in men than women in non-obstetric cases, and its clinical presentation is heterogeneous, ranging from asymptomatic to severe renal failure. In this case report, we describe the clinical course of a patient who presented with acute renal failure following a venomous snake bite and was subsequently diagnosed with renal cortical necrosis. Despite aggressive management, the patient ultimately succumbed to death on the 24th day of admission. The present case highlights the importance of early diagnosis, prompt initiation of appropriate management, and effective prevention of complications in patients with renal cortical necrosis to improve patient outcomes and reduce morbidity and mortality. A timely and accurate diagnosis of renal cortical necrosis is critical for initiating appropriate interventions, and management should aim to address the underlying cause and prevent potential complications.

Factors associated with glycemic control and diabetes complications in a group of Saudi patients with type 2 diabetes.

Poor glycemic control is a risk factor for micro and macrovascular complications of diabetes. The aim of this study was to assess the prevalence and factors related to suboptimal glycemic control and diabetes complications in a group of patients with type 2 diabetes mellitus (T2DM). This cross-sectional descriptive study conducted in Al Qassim region, Saudi Arabia. Two hundred patients with T2DM were enrolled. Demographic, social, and self-care behavior data were collected. A thorough clinical evaluation was done. Glycated hemoglobin, lipid, and kidney profile results were recorded. Mann-Whitney test was used to compare different groups. For comparing categorical data, Chi-square (χ2) test was performed. Multivariate logistic regression analyses used to detect predictors of poor glycemic control and macrovascular and microvascular complications. The median age of patients was 58 years, and 62% of them were males. Only 22.5% of patients had glycated hemoglobin <7%. Forty-four patients (22%) had evidence of macrovascular complications. Retinopathy, neuropathy, and nephropathy were found in 42.5%, 32.5%, and 12%, respectively. Longer diabetes duration was significantly associated with poor glycemic control (OR = 1.006, P < .005). The age of the patients was independently associated with macrovascular complications (OR = 1.050, P = .029). Hyperlipidemia was significantly associated with neuropathy (OR = 0.229, P = .043) and retinopathy (OR = 12.887, P = .003). Although physical activity was lower in patients with suboptimal glycemic levels (P = .024), cardiovascular disease (P = .030), neuropathy (P < .001), retinopathy (P < .001), and nephropathy (P = .019), multivariate analysis showed that it was only independently associated with neuropathy (OR = 0.614, P = .001). The prevalence of suboptimal glycemic control is high in the studied population. Effective health measures are urgently needed to stop diabetes complications, especially retinopathy and neuropathy. Elderly people with long durations of diabetes, and lower physical activity should be the focus of the interventions. Tailored exercise programs are particularly needed for better diabetes control and for the prevention of complications in patients with T2DM.

Sporotrichosis: A Comprehensive Review on Epidemiology, Clinical and Treatment of an Emerging Mycosis

Sporotrichosis is an emerging subcutaneous mycosis caused by the fungus Sporothrix schenckii. In this article, a comprehensive review of the epidemiology, clinical and treatment of this disease is presented. Relevant aspects of its geographical distribution, risk factors, zoonotic transmission and epidemic outbreaks are discussed. In addition, the clinical variability of sporotrichosis is analyzed in detail, describing its various forms of presentation, including cutaneous, lymphangitic and systemic. Diagnostic challenges associated with its similarity to other mycoses and skin diseases are highlighted, and guidelines for its microbiological diagnosis are provided. Therapeutic options are also discussed, with emphasis on the use of systemic antifungals and the consideration of surgical treatment in selected cases. Finally, the importance of comprehensive knowledge of sporotrichosis to improve early detection, effective clinical management and prevention of complications in patients affected by this fungal infection is highlighted.

Perioperative prevention of complications in surgery of ventral hernias

To improve perioperative algorithm of prevention of complications in patients with ventral and incisional hernias via differentiated choice of mesh implants and hernia repair technique. The study included 144 patients with abdominal wall hernia, who were divided into two representative groups. Original algorithms for choosing the method of hernia repair depending on type and position of mesh implant, as well as methods of perioperative prevention of complications are proposed. These algorithms significantly reduced the incidence of postoperative wound complications after sublay hernia repair and posterior separation with TAR.

The Refinement of Home Exercise Program for Children and Adolescents With Muscular Dystrophy in the Present COVID-19 Pandemic Scenario: A Scoping Review.

Muscular dystrophies (MDs) are a category of hereditary illnesses characterized by the gradual malfunction and/or weakening of the skeletal muscles. This disease of the muscles also results in hypotonia and joint contracture, along with raised serum creatine kinase (CK) levels. To prevent complications, continuous physiotherapy is advised for children with muscular dystrophy, which is even asked to perform at home as a home exercise program (HEP). As a result, the home exercise program (HEP) is critical in maintaining the optimal health of children with Duchenne muscular dystrophy (DMD). The present coronavirus (COVID-19) pandemic has adversely affected these children as there was very little scope to get direct help from a physiotherapist. Meanwhile, the home program was continued by many to compensate for the direct benefit. However, because of the lack of specific guidelines and structured methodology to follow for a home program, there was a deterioration in the health status of many children. There is a need to understand how the children are getting affected and the way the home program can be refined to help needy children with muscular dystrophy. Our scoping review aims to identify the present home program patterns being followed for children with DMD and their scope for refinement. The data were collected from electronic databases including PubMed, ProQuest, Cochrane, and Web of Science. We searched four electronic databases until September 2021. We included the published case studies, observational and experimental studies that described the positive impact of home exercise programs, and the methodology they followed as an alternative to institution-based physiotherapy. One hundred thirty-eight titles were screened, and 58 met the inclusion criteria. Along with regular physiotherapy, the incorporation of HEP helped in early complication prevention in patients with muscular dystrophy. The HEP was found to be a successful adjunct in the COVID-19 scenario. This review presents different therapeutic measures that can be taken for the prevention of complications in patients with MD and how the HEP plays an important role in removing the gaps on how HEP is beneficial in the COVID-19 scenario and a scope to refine the present methodologies for more accurate management.

Нарушение углеводного обмена после перенесенной новой коронавирусной инфекции (COVID-19): акцент на контроль уровня гликемии

Diabetes mellitus (DM) is one of the most important comorbidities associated with the severity of all three known pathogenic human coronavirus infections, including the SARS-CoV-2 (COVID-19) virus. The implementation of regular monitoring of plasma glucose is important during a pandemic for patients with type I and type II diabetes. Less studied within the framework of COVID-19 is the problem of developing diabetes after a coronavirus infection. The first part of the review discusses the etiopathogenesis of DM in the post-COVID syndrome and presents clinical observations indicating an increased risk of developing diabetes after SARS-CoV-2 infection, which predetermines the need for glycometabolic control in the post-COVID syndrome. Hyperglycemia is a leading factor in the development of complications of DM. Glycated hemoglobin is the "gold standard" for monitoring glycemic control, but this indicator does not provide complete information about daily and intraday changes in glucose levels. An important place in the prevention of complications in patients with DM, especially during the pandemic of a new coronavirus infection, is occupied by regular self-monitoring of glucose levels. An important aspect of the technical impact on the adherence of patients to self-control and treatment of DM is the availability of convenient communication between the patient and the doctor, in particular, the possibility of contact remotely via a computer and mobile phone. In the second part of the review, the capabilities of the new model of the Contour glucometer line, the Contour Plus One glucometer, are considered.

Perioperative prevention of thrombohemorrhagic complications in patients with calculous cholecystitis and obstructive jaundice

The OBJECTIVE was to improve the effectiveness of prevention of thrombohemorrhagic disorders in patients with calculous cholecystitis and obstructive jaundice.METHODS AND MATERIALS. The clinic examined 537 patients operated on for obstructive jaundice. From 2010 to 2015, the prevention of thrombohemorrhagic complications consisted in the determination of risk factors, elastic compression of the lower extremities and the appointment of anticoagulants (1st comparative group). Since 2015, all medical measures have also been carried out taking into account the stages of obstructive jaundice (2nd study group).RESULTS. When comparing the results, the number of subhepatic abscessed hematomas decreased from 4 (1.6 %) patients in the first group to 2 (0.8 %) in the second, the number of gastric bleedings-from 6 (2.4 %) to 3 (1.2 %), metrorrhagia – from 3 (1.2 %) to 1 (0.4 %), pancreatic necrosis – from 8 (3.2 %) to 5 (1.9 %), pulmonary embolism – from 7 (2.8 %) to 5 (2.0 %), the number of strokes and transient disorders of cerebral circulation – from 5 (2.0 %) to 3 (1.2 %), the number of cardiac arrhythmias in the form of atrial fibrillation-from 3 (1.2 %) to 2 (0.8 %). The incidence of myocardial infarction decreased from 5 (2.0 %) patients to 3 (1.2 %), and the incidence of mesenteric vascular thrombosis decreased from 3 (1.2 %) to 1 (0.4 %). In group 1, 2 (0.8 %) patients had hemobilia.CONCLUSION. In addition to protocols and standards, the prevention of thrombohemorrhagic complications should take into account the stages of obstructive jaundice. During the period of cholestasis, the prevention of thrombohemorrhagic complications should be used in the same volume as in the absence of jaundice. In hepatocytolysis, it should be performed using the CHA2DS2-VASc scale with the HEMORR2HAGESscale as a safety net. In cholangitis, on the contrary, the main role is assigned to the HEMORR2HAGESscale.

Atrial fibrillation in old age: current treatment options

In older age, patients with atrial fibrillation (AF) have a high risk of stroke, bleeding, and death, but such patients have been underrepresented in randomized clinical trials. A search and analysis of 4 176 literature sources from the MEDLINE/ PubMed and eLIBRARY databases was carried out for the keywords «atrial fibrillation», «old age», «older», «elderly». The review includes the most important studies reflecting the current understanding of risk factors for development, complications and treatment of AF in old age. The results of therapy to control the ventricular rate, to control sinus rhythm in AF with drugs and catheter ablation are discussed. The data of studies on the prevention of thromboembolic complications in patients with AF by the use of anticoagulants and implantable devices are considered.

Еще раз о COVID-19 (клиническая лекция)

The paper summarizes current research data on the nature, spread, clinical course, pathogenesis of complications and sequelae of coVId-19. The developing cognitive disorders, erectile and endothelial dysfunctions, oxidative stress, and hormone imbalances are discussed. The role of using antioxidants, vitamins, and micronutrients for treatment and prevention of complications in patients with coVId-19 and post-coVId syndrome is clarified by the example of the Selzinc Plus premix.

A Study to Evaluate the Effectiveness of Health-Care Package on Self-care Management and Prevention of Complications in Patients with Type-2 Diabetes Mellitus in Terms of the Knowledge and Practices in Diabetic Clinic of Selected Hospitals in Delhi

Introduction: The aim of this study were to prevent, control, and manage diabetes mellitus (DM) and its further consequences, it is essentially required that the diabetic patients should have adequate knowledge and adopt healthy lifestyle practices. Objectives: The objectives of this study were to evaluate the effectiveness of the health-care package on self-care management and prevention of complications in type 2 DM patients in terms of the knowledge and practices. Materials and Methods: The present study was conducted with evaluative research approach and non-randomized control group design at Safadarjung Hospital, Delhi. Sample was selected through non-probability purposive sampling technique and sample size consisted of 60. The tools for data collection included structured interview schedule and expressed practice questionnaire. The health-care package included – planned teaching program, self-care diary cum information booklet, diabetic identification card, diet chart, and pictorial/flash cards. Results: There was a significant “t” value of 15.882, df (29), P &lt; 0.05 and “t” value of 9.86, df (29), P &lt; 0.05 for mean pre- and post-test, knowledge and practice scores of experimental group and, significant “t” value of 9.1, df (58), P &lt; 0.05 and “t” value of 11.45, df (58), P &lt; 0.05 for mean post-test, and knowledge and practice scores of experimental and control group. There was also found a positive correlation r = 0.948, P &lt; 0.05 between post-test knowledge and practice scores of experimental group. Study findings also conclude significant association of post-test, knowledge scores with educational level (χ² = 16.533*, df=6, P &lt; 0.05), per capita income (χ² = 10.093*, df=3, P &lt; 0.05), practice scores with educational level (χ² = 17.2*, df=6, P &lt; 0.05), and per capita income (χ² = 8.422*, df=3, P &lt; 0.05) of type 2 diabetic patients. Conclusion: The study findings revealed that health-care package was found to be effective in enhancing the knowledge and improving the practices of the type 2 diabetic patients.

Anticoagulant therapy for stroke prevention in patients with severe COVID-19

During the pandemic of the new coronavirus infection, there is increasing evidence of neurological complications associated with COVID-19. There is no doubt that stroke can be a major complication in patients with severe disease course.Objective: to determine the safest and most effective anticoagulant for stroke prevention in patients with severe COVID-19.Patients and methods. A prospective study enrolled 520 patients with severe COVID-19. We used the following criteria for severe COVID-19: SpO2 &lt;92% on room air at sea level, PaO2 /FiO2 &lt;300 mm Hg, respiratory rate &gt;30 breaths/min, lung infiltrates &gt;50% on computed tomography. The study included 509 patients, divided into three groups depending on the type of anticoagulant therapy: patients of the 1st group received 24–36 thousand IU of heparin, patients of the 2nd group – enoxaparin at a dose of 1 mg/kg per day, patients of the 3rd group – rivaroxaban at a dose of 20 mg/day. The duration of anticoagulant administration depended on the severity of the patient's condition, dynamics of laboratory parameters (D-dimer, fibrinogen, international normalized ratio, activated partial thromboplastin time, platelet count), and varied from 2 to 6 weeks. In addition, we studied the incidence of ischemic and hemorrhagic strokes and transient ischemic attacks during a 6-week follow-up period. The article also presents a clinical case of large artery thrombosis in a young patient with severe COVID-19 without stroke risk factors.Results and discussion. Even against the background of active primary prevention, stroke incidence was 2.6% (0.6% for ischemic stroke, 1.4% for venous stroke, and 0.6% for hemorrhagic stroke). The highest stroke incidence was observed in the group of patients receiving heparin. In contrast, the prevention of thrombotic complications in patients receiving low-molecular-weight anticoagulants or rivaroxaban showed the best results with minimal morbidity and mortality in severe COVID-19.Conclusion. Stroke can be a complication of COVID-19, and preventive anticoagulant therapy using low-molecular-weight heparin or a factor X inhibitor effectively prevents this complication.

Применение озоно-кислородной смеси у больных острым билиарным панкреатитом с желчной гипертензией

Цель: усовершенствовать хирургическое лечение больных острым билиарным панкреатитом с желчной гипертензией путем применения индивидуального подхода к выбору декомпрессионной технологии в ранней фазе заболевания и ранней профилактики инфекционных осложнений с использованием озоно-кислородной смеси. Материалы и методы. В исследование были привлечены 70 пациентов (22 мужчины и 48 женщин) с острым билиарным панкреатитом и желчной гипертензией разных возрастных групп (средний возраст — 57,2 года). У всех пациентов билиарное происхождение панкреатита диагностировано в соответствии с критериями, предложенными Голландской исследовательской группой по изучению панкреатита. Во всех случаях применен усовершенствованный алгоритм хирургического лечения, который предусматривал индивидуальный подход к выбору декомпрессионной технологии в первые 72 ч после первичного приступа абдоминальной боли независимо от срока госпитализации в клинику. Больных распределили на две группы. В первой группе (n = 32) после устранения билиарной гипертензии проводили профилактику инфекционных осложнений путем эндобилиарного введения озоно-кислородной смеси, растворенной в 0,9 NaCl, с концентрацией озона 2–4 мкг/мл, во второй группе (n = 38) профилактику не применяли. Для выявления возможного повреждающего действия озоно-кислородной смеси на желчный проток нами исследован пузырный проток у 12 больных острым билиарным панкреатитом с желчной гипертензией, у которых удалили желчный пузырь в острый период заболевания. Результаты. Проведены 49 фибро­гастродуоденоскопий с эндоскопической папиллосфинктеротомией и лито­экстракцией, 10 перкутанных чреспеченочных пункционных дренирований, 13 лапароскопических холецистэктомий с внешним дренированием внепеченочных желчных протоков (у 5 пациентов выполнена лапароскопическая холедохоскопия с литоэкстракцией). Некротические формы острого панкреатита развились у 11 (34,37 %) пациентов первой группы, из них у 5 (45,45 %) произошло инфицирование. Средняя длительность лечения составила 14,5 суток, летальность — 6,25 %. Во второй группе некротические формы острого панкреатита развились у 15 (39,47 %) пациентов, из них у 7 (46,6 %) произошло инфицирование. Средняя длительность лечения составила 16,46 суток, летальность — 10,5 %. Выводы. Применение ранней профилактики инфекционных осложнений у больных острым билиарным панкреатитом с желчной гипертензией в сочетании с выполнением декомпрессионных оперативных вмешательств для ликвидации желчной гипертензии в первые 72 ч от начала заболевания позволяет уменьшить частоту развития некротических и инфицированных форм, тяжесть заболевания, уровень летальности и длительность пребывания в стационаре, in vitro не вызывает альтеративных, дистрофических или дегенеративных изменений как на клеточном, так и на тканевом уровне во всех структурах стенки ductus cysticus.

Analysis of the Effect of Advanced Nursing on the Quality of Life and the Prevention of Complications in Patients with Breast Cancer Undergoing PICC Chemotherapy

Objective: To investigate the effect of advanced nursing on the quality of life and the prevention of complications in patients with breast cancer undergoing PICC (Peripherally Inserted Central Catheter) chemotherapy. Methods: From January 2017 to January 2020, 98 patients with breast cancer undergoing PICC chemotherapy in our hospital were divided into control group and study group by random sampling. The patients were given routine nursing and advanced nursing intervention on the basis of routine nursing. The psychological status, complications and quality of life of the patients were compared. Results: There was no significant difference in HAMA, HAMD score and QLQ-30 score before nursing (P &gt; 0.05). The scores of HAMA and HAMD in the study group after nursing were lower than those in the control group (P &lt; 0.05), the scores of QLQ-30 were higher than those in the control group (P &lt; 0.05), and the complication rate was lower than that in the control group (P &lt; 0.05). Conclusion: The intervention of advanced nursing mode in patients with breast cancer treated with PICC chemotherapy can effectively alleviate the influence of negative emotion on chemotherapy, reduce the occurrence of complications and improve the quality of life. This mode has high clinical value.

Analysis of the effect of advanced nursing on the quality of life and the prevention of complications in patients with breast cancer undergoing PICC chemotherapy

Objective: To investigate the effect of advanced nursing on the quality of life and the prevention of complications in patients with breast cancer undergoing PICC (Peripherally Inserted Central Catheter) chemotherapy. Methods: From January 2017 to January 2020, 98 patients with breast cancer undergoing PICC chemotherapy in our hospital were divided into control group and study group by random sampling. The patients were given routine nursing and advanced nursing intervention on the basis of routine nursing. The psychological status, complications and quality of life of the patients were compared. Results: There was no significant difference in HAMA, HAMD score and QLQ-30 score before nursing (P &gt; 0.05). The scores of HAMA and HAMD in the study group after nursing were lower than those in the control group (P &lt; 0.05), the scores of QLQ-30 were higher than those in the control group (P &lt; 0.05), and the complication rate was lower than that in the control group (P &lt; 0.05). Conclusion: The intervention of advanced nursing mode in patients with breast cancer treated with PICC chemotherapy can effectively alleviate the influence of negative emotion on chemotherapy, reduce the occurrence of complications and improve the quality of life. This mode has high clinical value.

Habitual Miso (Fermented Soybean Paste) Consumption Is Associated with Glycemic Variability in Patients with Type 2 Diabetes: A Cross-Sectional Study.

Glycemic control, including glycemic variability, is important for the prevention of diabetic vascular complications in patients with type 2 diabetes mellitus (T2DM). There was an association between miso soup intake and insulin resistance. However, the relationship between habitual miso consumption and glycemic control, including glycemic variability, in patients with T2DM remains unknown. We defined people without habitual miso consumption if they did not consume miso soup at all in a day. The average, standard deviation (SD), and coefficient of variation (CV), calculated as CV = (SD/average HbA1c) × 100 (%), of hemoglobin (Hb) A1c levels were evaluated. The proportions of habitual miso consumption of male and female were 88.1% and 82.3%, respectively. The average (7.0 [6.4–7.5] vs. 7.3 [6.8–8.4] %, p = 0.009), SD (0.21 [0.12–0.32] vs. 0.37 [0.20–0.72], p = 0.004), and CV (0.03 [0.02–0.04] vs. 0.05 [0.03–0.09], p = 0.005) of HbA1c levels in female with habitual miso consumption were lower than those of female without. Moreover, habitual miso consumption correlated with average (β = −0.251, p = 0.009), SD (β = −0.175, p = 0.016), and CV (β = −0.185, p = 0.022) of HbA1c levels after adjusting for covariates. However, no association between habitual miso consumption and any glycemic parameters was shown among male. This study clarified the association between habitual miso consumption and good glycemic control, including glycemic variability, in female, but not in male.

Regulatory delays in a multinational clinical stroke trial.

IntroductionThe initiation and conduct of randomised clinical trials are complicated by multiple barriers, including delays in obtaining regulatory approvals. Quantitative data on the extent of the delays due to national or local review in randomised clinical trials is scarce.Materials and methodsWe assessed the times needed to obtain regulatory approval and to initiate a trial site for an academic, EU-funded, phase III, randomised clinical trial of pharmacological prevention of complications in patients with acute stroke in over 80 sites in nine European countries. The primary outcome was the time from the first submission to a regulatory authority to initiation of a trial site. Secondary outcomes included time needed to complete each individual preparatory requirement and the number of patients recruited by each site in the first 6 and 12 months.ResultsThe median time from the first submission to a regulatory authority to initiation of a trial site was 784 days (IQR: 586–1102). The single most time-consuming step was the conclusion of a clinical trial agreement between the national coordinator and the trial site, which took a median of 194 days (IQR: 93–293). A longer time to site initiation was associated with a lower patient recruitment rate in the first six months after initiation (B = –0.002; p = 0.02).DiscussionConclusionIn this EU-funded clinical trial, approximately 26 months were needed to initiate a trial site for patient recruitment. The conclusion of a contract with a trial site was the most time-consuming activity. To simplify and speed up the process, we suggest that the level of detail of contracts for academic trials should be proportional to the risks and commercial interests of these trials.

Реалии применения антикоагулянтной терапии при COVID-19

Введение. Поступление вируса SARS-CoV-2 в организм человека сопровождается развитием COVID-19-ассоциированной коагулопатии, часто реализующейся в различных тромботических осложнениях. Актуальные клинические рекомендации описывают основные подходы к лечению и профилактике венозных тромбоэмболических осложнений (ВТЭО), однако реализация их не всегда представляется возможной. В реальной практике встречается значительное количество отклонений и нарушений, в том числе носящих системный характер, связанных как с ограниченностью представлений клиницистов о патогенетических аспектах развития инфекционного процесса, так и с избыточным желанием предотвратить отдельные из них. Цель исследования: изучение состояния реальной клинической практики в области лечения и профилактики развития тромботических осложнений у пациентов c новой коронавирусной инфекцией COVID-19 (НКИ COVID-19). Материалы и методы. В основе работы лежит анонимный опрос 223 врачей-специалистов, занимающихся лечением пациентов с хроническими и острыми заболеваниями сосудов. В опросник включено 18 вопросов, описывающих отношение врачей к проблеме в целом, а также касающихся выбора тактики лечения, применения антикоагулянтных препаратов и методов контроля системы гемостаза. Результаты. Подавляющее большинство участников опроса информированы и озадачены увеличением риска тромботических осложнений при НКИ COVID-19. При этом приоритетной целью антикоагулянтной терапии (АКТ) в острой фазе заболевания участники назвали лечение COVID-19-ассоциированной коагулопатии, а в стадии реконвалесценции — профилактику ВТЭО. Максимальную степень доверия при назначении АКТ имеют низкомолекулярные гепарины. Прямые оральные антикоагулянты, несмотря на отсутствие качественных рандомизированных исследований, подтверждающих их эффективность, большая часть врачей использует на амбулаторном этапе. Вызывает озабоченность значительный разброс вариантов и невысокий процент корректных ответов в вопросах, посвященных лабораторному контролю за системой гемостаза при АКТ. Заключение. Выполненный нами анализ свидетельствует о существенном расхождении реального применения антикоагулянтных препаратов у пациентов с НКИ COVID-19 с действующими клиническими рекомендациями. Кроме того, полученные результаты свидетельствуют о необходимости повышения уровня образованности практикующих специалистов в вопросах свертывания крови. Background. The SARS-CoV-2 virus invasion lead to COVID-19-associated coagulopathy accompanied with increased incidence of thrombotic complications. Current clinical guidelines give the main approaches to the treatment and prevention of them; however their implementation is not always possible in practice. In fact, there are a lot of violations including with a systemic genesis and associated either with the low understanding of infectious process pathogenesis aspects by clinicians or with their excessive desire to prevent coagulation disturbances. the revealing of real clinical practice conditions in the treatment and prevention of thrombotic complications in patients with coronavirus infection COVID-19. Materials/Methods. We provided an anonymous poll for 223 experts treating patients with chronic and acute vascular diseases. The questionnaire included 18 questions to identify as the experts attitude to this challenge as a whole as well as to their choice of treatment tactics, and anticoagulant drugs, and methods of laboratory monitoring of blood coagulation. Results. Most participants know the increased risk of thrombotic complications in COVID-19 and they are puzzled by it The treatment of COVID-19-associated coagulopathy is considered as the priority goal of anticoagulant therapy in the acute phase of COVID-19 whereas the prevention of venous thromboembolic complications is noted as main goal in convalescences. Low molecular weight heparins have gotten the highest confidence in the administration among anticoagulants. In turn, the most of experts use direct oral anticoagulants in outpatients even despite no confirmation is for DOAC’s effectiveness from randomized trials in this time. Besides it was revealed wide spread of opinions and low count of correct responses about laboratory control of the hemostatic system and anticoagulants. Conclusion. The analysis showed a serious inconsistency between the real anticoagulants administration in patients with COVID-19 and the recommendations of clinical guidelines. This circumstance obviates the need to raise educational level of physicians and surgeons in the field of blood coagulation.

Atherosclerotic Cardiovascular Diseases and Type 2 Diabetes Mellitus - new Developments in the Treatment

Despite obvious success in the management of patients with type 2 diabetes mellitus, incidence of myocardial infarction, stroke, critical ischemia, and lower extremity amputation remains high. Results of clinical studies of new hypoglycemic drugs have demonstrated their high efficacy in decreasing mortality, incidence of cardiovascular complications, and progression of chronic heart failure. At the same time, prevention of atherothrombotic complications is essential for this patient category. Traditionally, the antiaggregant therapy with acetylsalicylic acid (ASA) is administered to patients with stable atherosclerotic diseases to reduce the risk. Attempts of reducing additionally the risk with ASA combinations with other antiplatelet drugs did not produce an expected result. Theoretical prerequisites suggested that anticoagulant supplements would increase the treatment efficacy in prevention of atherothrombotic complications in patients with cardiovascular diseases. Recently emerged oral anticoagulants can be administered at a considerably lower dose. In the COMPASS study, a combination of rivaroxaban 2.5 mg twice a day and ASA 100 mg/day compared to ASA 100 mg/day significantly reduced the total risk of stroke and cardiovascular death by 24 % and incidence of stroke and cardiovascular death by 42% and 22 %, respectively. Patients with peripheral artery disease showed for the first time improvement of prognosis, decreased number of amputations, major complications of lower extremity disease. Results of the COMPASS study confirmed the validity of influencing simultaneously the platelet and the coagulation components of hemostasis in patients with stable atherosclerotic cardiovascular diseases.