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Background: In March 2020, the world health organization declared COVID-19 a world wide pandemic. Countries introduced public health measures to contain and reduce its spread. The effect of mandated societal lockdown to reduce the transmission of corona virus disease 2019 (COVID-19) on road traffic accidents is not known. For this we performed an in-depth analysis singdata of emergency and trauma centre UPUMS, Saifai. As most of the manpower was involved in managing Covid patients directly or indirectly, it was a challenge to manage these mass casualty patients who require intensive care as well as Medicolegal documentation, record keeping, Consent for life saving procedures in absence of Relatives. Material(s) and Method(s): We reviewed data on total 2876 road traffic accident records in UPUMS, Saifai from January 1, 2020 through September 30, 2020. We treated March 20th as the first day of mandated societal lock down and 1st July as the first day of re-opening. Result(s): We have found that the reis increase in road traffic accidents resulting in serious or fatal injuries during lockdown and post-lockdown period. There was increased Medicolegal burden in spite of the decreased medical resources, manpower as most of manpower and resources were being utilized for covid patients. Conclusion(s): Road traffic accidents are a prominent contributor to hospitalization and may negatively impact the existing hospital resources directed towards COVID-19.Copyright © 2023, World Informations Syndicate. All rights reserved.
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Aim - the discutability of existing scientific publications prompted a retrospective analysis of COVID-19 risk factors among the working population using the example of Russian Railways. Material and methods. Based on the archival documentation of medical institutions of Russian Railways, an analysis of the incidence of employees of the holding was carried out. Data from 2452 cases were analysed, for which full medical documentation was available. The comparison group randomly included 2911 workers who did not have COVID-19, comparable in sex, age, and area of residence. Results. Significant factors of difference between the groups of patients and those who were not ill were: sex, the presence of influenza vaccination, smoking and established diabetes mellitus. There was a trend towards an association of COVID-19 incidence and the presence of cardiovascular disease. In the comparison group, unlike the group of COVID-19 cases, there are 23% more persons who were vaccinated against influenza. In the group of patients with diabetes mellitus was found 3 times more often than in the group of non-patients. In both groups, the incidence rates of cardiovascular disease did not differ. However, as the severity of the disease increased, there was a tendency to increase the incidence of cardiovascular diseases. Meanwhile, the presence of other cardiovascular risk factors (male sex, smoking, diabetes mellitus, obesity) was significantly associated with a higher incidence in the disease group compared to non-patients. Multifactorial analysis also revealed other significant combinations of risk factors with COVID-19 risk: lack of influenza vaccination and the presence of diabetes mellitus;lack of vaccination, smoking and the presence of diabetes mellitus. Conclusion. For the working population, male sex and diabetes may be a significant risk factor for developing COVID-19. Influenza vaccination should be considered as a factor in anti- COVID-19 protection. Cardiovascular diseas e and smoking may serve as additional risk factors.Copyright © 2021 Infectious Diseases: News, Opinions, Training. All rights reserved.
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Introduction & Objectives: The incidence of prostate cancer, both in the world and in the Russian Federation, tends to increase. In the Republic of Bashkortostan in 2021, 699 patients with this diagnosis were registered. 19.6% of patients had stage IV disease at the time of diagnosis. 5818 patients were registered, of which 361 died within a year. The effectiveness of hormonal treatment of common prostate cancer has time limitations, after which there is a development of resistance to castration and progression of the disease. To date, drugs such as kabazitaxel, sipuleucel-T vaccine, abiraterone, enzalutamide and radium-223 have been approved for use in metastatic CRPC. The purpose of the work: analysis of the experience of systemic radiotherapyand Radium - 223 patients with mCRPC in the Republic of Bashkortostan in 2021. Material(s) and Method(s): Analysis of patients who received systemic radiotherapy Radium - 223 in the Republic of Bashkortostan according to medical documentation and research data. In 2021, Radiy-223 radiotherapy was performed on 7 patients diagnosed with mCRPC. Median age 63.14 years. All patients met the criteria for treatment, i.e. had castration-resistant prostate cancer with bone metastases, without visceral metastases. All patients had concomitant pathology from the cardiovascular system, respiratory tract, endocrine system. According to the previous surgical treatment, patients were distributed as follows: orchidectomy - 4, prostatectomy - 1 and 2 patients underwent tumor biopsy. By morphology: Glisson 6 - 2 patients, Glisson 7 - 1, Glisson 8 - 3, Glisson 10 - 1. 4 patients were referred to Xofigo for radiologically confirmed progression, 3 patients were progressingin height at PSA levels. Result(s): 1 patient previously received 1 line of systemic therapy, 5 patients received 2 lines, 1 patient received 3 lines of therapy. 6 patients received all 6 courses of radiotherapy, 1 patient did not complete treatment due to COVID 19. He is expected to complete therapy. All patients are currently alive with no signs of disease progression. Serious side effects were not registered. Conclusion(s): The "therapeutic window" for the prescription of radium-223 is the period before the appearance of visceral metastases and decline of the somatic status. To achieve the maximum benefit from the appointment of radium-223, it is necessary to conduct >=5 cycles of therapy, which is possible in 1-2 treatment lines. It is necessary to select patients carefully for radiotherapy - Radium 223.Copyright © 2022 European Association of Urology. Published by Elsevier B.V.
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The pandemic of coronavirus infection is characterized by a low percentage of complications and severe forms in sick children compared to the adult population. However, there have been described cases of severe clinical course of COVID-19 in children with comorbidities among which is obesity. The aim of this study was to analyze the severe course of a new coronavirus infection paralleled with morbid obesity in a pediatric patient. Materials and methods. All accompanying patient medical documentation was examined. Results and discussion. From the anamnesis of life it is known that the patient was long time complained of intensively increased body weight, on which she repeatedly underwent examinations. In 2018, hypothalamic pubertal syndrome was diagnosed for the first time, for which the patient received hypoglycemic and antihypertensive drugs, hepatoprotectors on an ongoing basis. In the epidemiological anamnesis, the intrafamilial COVID-19 contact with mother was established. The main disease began acutely with a rise in body temperature up to 39-39.5degreeC, cough and weakness. During the first week of illness, the patient did not seek medical help and receive self-treatment, but the positive effect was not achieved. Saturation measurement showed low oxygen level (SpO2 71%). In this regard, the patient underwent chest computed tomography, which revealed a bilateral interstitial polysegmental lung lesion with signs of consolidation. After emergency hospitalization, the patient was prescribed empiric antibiotic therapy, anti-inflammatory and antithrombotic treatment, as well as respiratory support. A positive PCR result of a throat and nasal swab for SARS-CoV-2 was obtained in the hospital. Due to a poor response to therapy, the patient was transferred to a respiratory hospital. At the time of hospitalization, the condition was considered severe due to severe respiratory failure and premorbidity. The range of treatments included oxygenotherapy, antibacterial and anticoagulation therapy, as well as surfactant and the nucleoside analogue Remdesivir. During treatment, the clinical picture gained a positive trend, and after 6 days of hospitalization the patient no longer needed respiratory support. According to the results of repeated computed tomography, bilateral interstitial polysegmental pneumonia was diagnosed with damage to the lung tissue up to 95%. The patient remained stable and showed no signs of respiratory failure during the following days of hospitalization. On the 20th day of ilness, the patient was discharged from hospital with full clinical recovery. Conclusion. This clinical case demonstrates the role of premorbid background in aggravating the clinical picture of a new coronavirus infection in a child. Careful study of anamnestic characteristics is necessary in patients of any age, even with an uncomplicated disease course.Copyright © 2023 Saint Petersburg Pasteur Institute. All rights reserved.
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Background: Months after the initial report of an unknown cause of pneumonia outbreak in Wuhan, China, the SARS-COV-2 continues its rampant spread globally. This novel corona virus has been known to cause severe respiratory illness. It is important to be wary of the complications that would soon present at the Out-patient centers after being cured from the infection. Case: This is a case of a 59-year-old, female who came in at the Out-Patient Clinic with progressive bilateral pins and needles sensation of the feet after recovering from COVID-19 infection followed by a sensory level on T7-T10. Case Report: Here we present a case of transverse myelitis as a complication of COVID-19 infection, the first to have occurred after recovery from the virus. With the success of treatments and recoveries, possible post infectious sequelae could be the next wave that could come into the present picture of the pandemic. Conclusion(s): Post infectious transverse myelitis after recovering from COVID-19 is a possibility and that documentation of such cases and other complications must be reported.Copyright © 2022
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The post-COVID-19 recovery period is characterized by persistence of some symptoms, with immunological alterations being of great importance. Development of preventive measures to normalize mucosal immunity after a coronavirus infection determines the relevance of the current study. The aim was to study dynamics of clinical symptoms and level of secretory immunoglobulin A in individuals after a novel coronavirus infection as well as evaluate effectiveness of using IFNalpha-2b. Materials and methods. A study was conducted with patients aged 18 to 60 years old (n = 130), surveyed 1 to 9 months after post-infection, as well as in apparently healthy individuals lacking COVID-19 (n = 15). Previous novel coronavirus infection and post-COVID manifestations were verified based on medical documentation, complaints, anamnesis data, physical examination and questionnaires. The concentration of salivatory and nasopharyngeal mucosal sIgA was measured dynamically prior to and after administration of local therapy with IFNalpha-2b (gel applied intranasally twice a day for 30 days). Results. The acute period of COVID-19 was characterized by fever, anosmia, severe asthenia (fatigue and weakness), muscle and joint pain. Among the post-COVID manifestations at early period (1-3 months), pain in the joints and muscles (75.0%) as well as elevated body temperature (21.2%) were reliably detected, whereas in the long period (6-9 months) there were revealed dominance with the same frequency of shortness of breath, muscle and joint pain (75.8%, respectively). Based on examination data in healthy subjects, there was determined an arbitrary normal range of secretory IgA in saliva - 6.45+/-1.81 mg/ml and nasal swabs - 13.43+/-3.24 mg/ml. In the group of patients 1-3 months post-infection, therapy with IFNalpha-2b one month later resulted in significantly increased level of secretory IgA in saliva (from 1.84+/-0.28 to 5.78+/-1.96 mg/ml) and in nasal swabs (from 28.61+/-3.0 to 39.83+/-3.85 mg/ml) by more than 3- and 1.5-fold, respectively. In the group of patients without therapy was featured with stably sustained decline in sIgA level up to 9 months after COVID-19. In particular, the level of saliva sIgA ranged from 2.36+/-0.56 down to 2.16+/-0.66 mg/ml, and in nasal smears - from 15.66+/-1.32 to 10.23+/-1.07 mg/ml that differed insignificantly compared to baseline level. The rate of respiratory diseases prevailed in this group (27.6% of cases), which fully lacked in the group of topically administered IFNalpha-2b. Conclusion. In the post-COVID period, multiple organ disorders persist and reduced sIgA level is registered. Intranasally applied IFNalpha-2b made possible to normalize sIgA level and prevent accumulation of respiratory infectious pathologies.Copyright © 2022 Saint Petersburg Pasteur Institute. All rights reserved.
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The post-COVID-19 recovery period is characterized by persistence of some symptoms, with immunological alterations being of great importance. Development of preventive measures to normalize mucosal immunity after a coronavirus infection determines the relevance of the current study. The aim was to study dynamics of clinical symptoms and level of secretory immunoglobulin A in individuals after a novel coronavirus infection as well as evaluate effectiveness of using IFNα-2b. Materials and methods. A study was conducted with patients aged 18 to 60 years old (n = 130), surveyed 1 to 9 months after post-infection, as well as in apparently healthy individuals lacking COVID-19 (n = 15). Previous novel coronavirus infection and post-COVID manifestations were verified based on medical documentation, complaints, anamnesis data, physical examination and questionnaires. The concentration of salivatory and nasopharyngeal mucosal sIgA was measured dynamically prior to and after administration of local therapy with IFNα-2b (gel applied intranasally twice a day for 30 days). Results. The acute period of COVID-19 was characterized by fever, anosmia, severe asthenia (fatigue and weakness), muscle and joint pain. Among the post-COVID manifestations at early period (1–3 months), pain in the joints and muscles (75.0%) as well as elevated body temperature (21.2%) were reliably detected, whereas in the long period (6–9 months) there were revealed dominance with the same frequency of shortness of breath, muscle and joint pain (75.8%, respectively). Based on examination data in healthy subjects, there was determined an arbitrary normal range of secretory IgA in saliva — 6.45±1.81 mg/ml and nasal swabs — 13.43±3.24 mg/ml. In the group of patients 1–3 months post-infection, therapy with IFNα-2b one month later resulted in significantly increased level of secretory IgA in saliva (from 1.84±0.28 to 5.78±1.96 mg/ml) and in nasal swabs (from 28.61±3.0 to 39.83±3.85 mg/ml) by more than 3- and 1.5-fold, respectively. In the group of patients without therapy was featured with stably sustained decline in sIgA level up to 9 months after COVID-19. In particular, the level of saliva sIgA ranged from 2.36±0.56 down to 2.16±0.66 mg/ml, and in nasal smears — from 15.66±1.32 to 10.23±1.07 mg/ml that differed insignificantly compared to baseline level. The rate of respiratory diseases prevailed in this group (27.6% of cases), which fully lacked in the group of topically administered IFNα-2b. Conclusion. In the post-COVID period, multiple organ disorders persist and reduced sIgA level is registered. Intranasally applied IFNα-2b made possible to normalize sIgA level and prevent accumulation of respiratory infectious pathologies.
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The COVID-19 pandemic is a worldwide problem. The clinical spectrum of SARS-CoV-2 infection varies from asymptomatic or paucity-symptomatic forms to conditions such as pneumonia, acute respiratory distress syndrome and multiple organ failure. Objective was to describe a clinical case of SARS-CoV-2 infection in the patient with sarcoidosis and cardiovascular pathology developing acute respiratory syndrome and lung edema. Material and methods. There were analyzed accompanying medical documentation (outpatient chart, medical history), clinical and morphological histology data (description of macro- and micro-preparations) using hematoxylin and eosin staining. Results. Lung histological examination revealed signs of diffuse alveolar damage such as hyaline membranes lining and following the contours of the alveolar walls. Areas of necrosis and desquamation of the alveolar epithelium in the form of scattered cells or layers, areas of hemorrhages and hemosiderophages are detected in the alveolar walls. In the lumen of the alveoli, a sloughed epithelium with a hemorrhagic component, few multinucleated cells, macrophages, protein masses, and accumulated edematous fluid were determined. Pulmonary vessels are moderately full-blooded, surrounded by perivascular infiltrates. Signs of lung sarcoidosis were revealed. Histological examination found epithelioid cell granulomas consisting of mononuclear phagocytes and lymphocytes, without signs of necrosis. Granulomas with a proliferative component and hemorrhage sites were determined. Giant cells with cytoplasmic inclusions were detected - asteroid corpuscles and Schauman corpuscles. Non-caseous granulomas consisting of clusters of epithelioid histiocytes and giant Langhans cells surrounded by lymphocytes were detected in the lymph nodes of the lung roots. Hamazaki-Wesenberg corpuscles inside giant cells were found in the zones of peripheral sinuses of lymph nodes. In the lumen of the bronchi, there was found fully exfoliated epithelium, mucus. Granulomas are mainly observed subendothelially on the mucous membrane, without caseous necrosis. Histological examination of the cardiovascular system revealed fragmentation of some cardiomyocytes, cardiomyocyte focal hypertrophy along with moderate interstitial edema, erythrocyte sludge. Zones of small focal sclerosis were determined. The vessels of the microcirculatory bed are anemic, with hypertrophy of the walls in small arteries and arterioles. Virological examination of the sectional material in the lungs revealed SARS-CoV-2 RNA. Conclusion. Based on the data of medical documentation and the results of a post-mortem examination, it follows that the cause of death of the patient R.A., 50 years old, was a new coronavirus infection COVID-19 that resulted in bilateral total viral pneumonia. So-morbidity with competing diseases such as lung sarcoidosis and cardiovascular diseases aggravated the disease course, led to the development of early ARDS and affected the lethal outcome. Copyright © 2022 Saint Petersburg Pasteur Institute. All rights reserved.
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The post-COVID-19 recovery period is characterized by persistence of some symptoms, with immunological alterations being of great importance. Development of preventive measures to normalize mucosal immunity after a coronavirus infection determines the relevance of the current study. The aim was to study dynamics of clinical symptoms and level of secretory immunoglobulin A in individuals after a novel coronavirus infection as well as evaluate effectiveness of using IFNalpha-2b. Materials and methods. A study was conducted with patients aged 18 to 60 years old (n = 130), surveyed 1 to 9 months after post-infection, as well as in apparently healthy individuals lacking COVID-19 (n = 15). Previous novel coronavirus infection and post-COVID manifestations were verified based on medical documentation, complaints, anamnesis data, physical examination and questionnaires. The concentration of salivatory and nasopharyngeal mucosal sIgA was measured dynamically prior to and after administration of local therapy with IFNalpha-2b (gel applied intranasally twice a day for 30 days). Results. The acute period of COVID-19 was characterized by fever, anosmia, severe asthenia (fatigue and weakness), muscle and joint pain. Among the post-COVID manifestations at early period (1-3 months), pain in the joints and muscles (75.0%) as well as elevated body temperature (21.2%) were reliably detected, whereas in the long period (6-9 months) there were revealed dominance with the same frequency of shortness of breath, muscle and joint pain (75.8%, respectively). Based on examination data in healthy subjects, there was determined an arbitrary normal range of secretory IgA in saliva - 6.45+/-1.81 mg/ml and nasal swabs - 13.43+/-3.24 mg/ml. In the group of patients 1-3 months post-infection, therapy with IFNalpha-2b one month later resulted in significantly increased level of secretory IgA in saliva (from 1.84+/-0.28 to 5.78+/-1.96 mg/ml) and in nasal swabs (from 28.61+/-3.0 to 39.83+/-3.85 mg/ml) by more than 3- and 1.5-fold, respectively. In the group of patients without therapy was featured with stably sustained decline in sIgA level up to 9 months after COVID-19. In particular, the level of saliva sIgA ranged from 2.36+/-0.56 down to 2.16+/-0.66 mg/ml, and in nasal smears - from 15.66+/-1.32 to 10.23+/-1.07 mg/ml that differed insignificantly compared to baseline level. The rate of respiratory diseases prevailed in this group (27.6% of cases), which fully lacked in the group of topically administered IFNalpha-2b. Conclusion. In the post-COVID period, multiple organ disorders persist and reduced sIgA level is registered. Intranasally applied IFNalpha-2b made possible to normalize sIgA level and prevent accumulation of respiratory infectious pathologies. Copyright © 2022 Saint Petersburg Pasteur Institute. All rights reserved.
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The new EU regulations for medical device and in vitro diagnostic devices called for additional expert reviews for novel and high-risk devices. These newly formed committees have published three opinions for medical devices and fifteen opinions for IVDs. The opinions offer a detailed and critical review of data from both the manufacturer and notified body, which give insight into the nature of their review processes. In 2022, Regulation (EU) 2022/123 gave responsibility for the oversight of those expert panels to the EMA. This move suggests a more active role for the EMA in the approval of medical devices in ways that will impact future device submissions. The additional review will bring a new level of complexity and criticism into an already strained review process. Copyright © 2022, TOPRA. All rights reserved.
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Aim: Surgical handover aims to convey accurate, appropriate & concise clinical information that is correct and up to date. It is essential in providing continuity of care, ensuring patient safety, and avoiding clinical errors. This process should be led by the Consultant on call. In this audit we aimed to compare our handover documentation practice against guidelines formulated by RCS England. Method: Surgical Handover sheets from September 2020 and March 2021 were used for data collection. A total of 66 & 41 new patients were included in the initial and re audit respectively. Essential and desirable criteria guidelines by RCS England were used to compare our documentation. Essential criteria documentation should be 100% as per RCS guidelines. Results: Initial audit showed room for improvement in documentation of both essential & desirable criteria. A new handover template was introduced, we displayed posters and sent email reminders of the RCS guidelines. Re audit showed significant improvement in essential criteria: date of admission 47% to 60%, responsible consultant 0 to 100%, current diagnosis 83% to 100% and investigations 84% to 100%. In desirable criteria: Past medical documentation improved from 42 to 62%, management plans from 96 to 100% and COVID status from 52 to 79%, VTE was documented in 58% of patients. Conclusions: Surgical Handover documentation improved after implementation of changes. Busy ward rounds, multiple clinicians leading rounds, frequent relocation of patients and patients in non-surgical wards can make the process complex.
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Background: It is assumed that patients with immuno-infammatory rheumatic diseases (IIRDs) in old age are susceptible to a more severe course of COVID-19 both due immunological disorders (autoimmune disease and its activity, immuno-suppressive therapy, immunosenescence leading to systemic subclinical chronic infammation with increased secretion of IL-6, IL-1, IL-18, TNF-α) and due to the presence of comorbid pathology. There are no Russian data on the course of COVID-19 in elderly patients with IIRDs. Objectives: To study the features of the course of COVID-19 in elderly patients with IIRDs. Methods: The study included 93 patients with IIRDs: 72 women, 21 men, average age 67.5±6.1 years. Of them, 62 patients suffered from rheumatoid arthritis, 9-systemic sclerosis, 5-ankylosing spondylitis, 4-Sjogren's disease, 4-systemic vasculitis, 3-psoriatic arthritis, 2-osteoarthritis, 1 systemic lupus erythematosus, 1-polymyositis, 1-rheumatic polymyal-gia, 1-gout. At the moment of COVID-19, 10 patients had high activity of IIRDs, 26-moderate, 40-low, 17-remission. 69 patients were treated with disease-modifying antirheumatic drugs-DMARDs (40-methotrexate, 12-lefunomide, 8-sulfasalazine, 7-hydroxychloroquine), 45-glucocorticoids (34-low doses, 11-medium or high doses). 36 patients received biologic or target DMARDs: 24-rituximab (the interval from the last administration to the development of COVID-19 symptoms averaged 7 months), 4-TNF-α inhibitors, 3-abatacept, 2-secukinumab, 1-tofacitinib, 1-baricitinib, 1 ustekinumab. Comorbidities included hypertension (n=74), coronary artery disease (n=27), obesity (n=17), diabetes mellitus (n=8), bronchial asthma (n=5), chronic obstructive pulmonary disease (n=4), chronic kidney disease (n=3). The patients were interviewed by a research doctor, additional information was obtained from medical documentation. Results: The most common symptoms of COVID-19 were fever-67.7%, weakness/drowsiness-53.7%, cough-48.4%, as well as anosmia and dyspnea-35.5% each, headache-20.4%, body aches-16.1%, congestion nose-8.6%, chest pain-7.5%, dysgeusia-5.4%, diarrhea/vomiting-3.2%. According to CT chest scan, 8 patients had 0% of lung damage, 31-25%, 32-50%, 12-75%, in other cases the study was not carried out (n=9) or data are not available (n=1). In 2 patients the course of COVID-19 was complicated by bacterial pneumonia, in 1-bacterial-fungal. An asymptomatic course was noted only in 2 patients (PCR+/IgM +, CT 0, close contact with a confrmed case of COVID-19). Recovery was noted in 90 patients, fatal outcome-in 3. Exacerbation of IIRDs after COVID-19 was noted in 48.4% of patients, which required intensifying antirheu-matic therapy. Conclusion: Preliminary data indicate that COVID-19 is characterized by moderate and severe course in elderly patients with IIRDs. Further studies are required to identify risk factors for severe course and complications in order to provide timely qualifed care.
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Background: Patients with spondyloarthritis (SpA) probably have a high incidence of COVID-19. Vaccination remains one of the most effective methods of preventing infectious diseases. However, data on the safety of vaccines against COVID-19 in patients with SpA are few and relate to foreign vaccines that are not licensed in Russia. Objectives: To study the safety of COVID-19 vaccines in patients with SpA in real clinical practice. Methods: The study included 47 SpA patients (25-ankylosing spondylitis, 13-psoriatic arthritis, 9-undifferentiated SpA, 19 women, 28 men, age 42.3±11.6 years, duration of the disease 11.8±9.2 years)-the main group and 97 people without any immuno-infammatory rheumatic diseases (67 women, 30 men, age 43.7±13.1 years)-the control group. 20 patients received disease-modifying antirheumatic drugs (12-methotrexate, 8-sulfasalazine), 10-biological drugs (8-TNF-α inhibitors, 2-IL-17 inhibitors), 6-glucocorticoids, 1-tofacitinib, 12-only nonsteroidal anti-infammatory drugs, 8-did not receive therapy. In the main group, 40 patients were vaccinated with Gam-COVID-Vac (Sputnik V), 3-Covi-Vac and Sputnik Light, 1-EpiVacCorona (both components of the vaccine were received by 44 patients). In the control group 69 were vaccinated with Sputnik V, 15-CoviVac, 5-Sputnik Light and BNT162b2, 2-EpiVacCorona, 1-mRNA-1273. (91 participants received both components of the vaccine). All participants were interviewed by a research doctor with a unifed questionnaire, additional information was obtained from medical documentation. Results: The data obtained are refilected in the Table 1. Local adverse events (AEs) occurred relatively less frequently in patients with SpA than in the control group. After the introduction of the first component of the vaccine, there was a significant increase in the frequency of pain without restriction of movement and edema/hyperemia in the control group (p<0.001 and p=0.049, respectively), while after the introduction of the second component, a significant difference was registered only for the first indicated symptom (p<0.001). The most frequent systemic AEs were weakness, fever, arthralgia or myalgia, headache, and chills, which were significantly less common (p=0.008) in the main group after immunization with the first component. The proportion of SpA patients without any reactions was significantly higher after the introduction of the first component of the vaccine (59.6% and 29.9%, p<0.001), while after immunity with the second component there were no differences (59.1% and 44.0%, p>0.05). After complete immunization, the percentage of patients without any AEs was significantly higher in the main group than in the control (50.0% and 17.6%, p<0.001). There was no exacerbation of SpA or development of new autoimmune phenomena in the main group after full vaccination. Conclusion: According to preliminary data, the tolerability of vaccines against COVID-19 in patients with SpA is satisfactory. Further studies with an increased sample are needed to study the safety, immunogenicity and clinical efficacy of immunization against COVID-19 in patients of this cohort.
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Background: The Covid-19 pandemic has changed many aspects of our lives. Perhaps the biggest changes have been in medical services. Institutes specializing in RMD in Serbia were part of the covid system and patients only had access in emergency cases, there was no regular examinations. Objectives: The paper will show how the 'Online Counselling for Arthritis Patients (OCAP)' worked during the pandemic, how many rheumatologists and patients were involved and were patients satisfed with the service provided. Methods: Through the platform 'Lekarinfo' ORS,1 in cooperation with pharmaceutical companies, organized an OCAP. Patients were informed about the possibility of using online consultations with rheumatologists via social networks, viber groups. email. and they were given instructions how to use it, they were advised to send medical documentation before, so the doctor has time to look at it, which gives more time for conversation. Consultations were held by phone or online, depending of patient's wishes and abilities. The time set aside with a rheumatol-ogist was 20 minutes and with a psychologist 30 minutes. One psychologist and 23 rheumatologists were available. The ORS distributed cards to rheumatogists with all necessary data about OCAP to inform their patients. Results: ORS conducted a Survey about OCAP. It was completed by 100 respondents, aged 20 to 75 of whom 75% were women. The 44% of respondents were from Belgrade, but it also included respondents from all over the country. RA have 61% of respondents, but patients with other types of arthritis were also included. 4/5 of patients are non-smokers and half of them are on biological therapy. All but one respondents are ORS's members. The results of Survey are the following: OCAP was used by 27% of respondents and all of them were satisfed except one. Everyone would use it again and would advise others to do so. Online consultation can replace live examination, when the disease is in remission, thinks 62% of respondents. The majority (90%) found it technically easy to use it, but also the majority of respondents felt that there is a space for improvement (70%). One third prefers to have online consultations with their rheumatologist, Half of them understand the importance of telemedicine, 61% think that C-19 pandemic has increased the need for it and 64% think that digital solutions are our perspectives and it should be further developed. Conclusion: It is desirable to continue with this kind of telemedicine. Patients and their families should be encouraged and educated about using digital platforms, aim is to explain them the benefts of telemedicine and that consultations do not necessarily have to be with their rheumatologists. Regardless of the pandemic, digitalization is in every aspect of our life, it is inevitable, but also it is a great advantage that should not be missed. Investments in the development of online platforms, that will facilitate patients access to doctors are an investment in self-control of chronic diseases in extraordinary circumstances, but also in normal conditions when because of the overscheduled doctors, lack of time for employed patients or other reasons, it is not possible for frequent examinations. Telemedicine is an investment not only in physical health but also in mental health of patients, having a doctor 'just a step from you' has calming and positively affects for patients. And without positive attitude it's hard to keep a chronic disease under control.
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Background: Patients with rheumatoid arthritis (RA) are at high risk of developing COVID-19. Vaccination should be an effective method of preventing this disease. However, vaccination may be unsafe in RA patients. At present, data on the safety of vaccines against COVID-19 in RA patients are few and relate to foreign vaccines that are not licensed in Russia. Objectives: To study the safety of COVID-19 vaccines in patients with RA in real clinical practice. Methods: The study included 131 RA patients (120 women, 11 men, age 53.8±13.9 years, duration of disease 11.5±9.2 years)-the main group and 121 people without any immuno-infammatory rheumatic diseases (87 women, 34 men, age 39.8±14.2 years)-the control group. 103 patients received disease-modifying antirheumatic drugs (54-methotrexate, 30-lefunomide, 10-hydroxychloroquine, 8-sulfasalazine, 1-mofetil mycophenolate), 68-biological drugs (58-rituximab, 5-TNF-α inhibitors, 4-abatacept, 1-tocilizumab), 64-glucocorticoids, 10-did not receive therapy. In the main group, 92 patients were vaccinated with Gam-COVID-Vac (Sputnik V), 21 with Sputnik Light, 16 with CoviVac, 2 with EpiVacCorona (110 patients received two components of the vaccine). In the control group, 91 were vaccinated with Sputnik V, 16 with Covi-Vac, 6 with BNT162b2, 5 with Sputnik Light, 2 with EpiVacCorona, 1 with mRNA-1273 (114 participants received two components of the vaccine). All participants were interviewed by a research doctor with a unifed questionnaire, additional information was obtained from medical documentation. Results: Local and systemic adverse events (AEs) were observed both in the main group and in the control group. After the introduction of the frst component of the vaccine, local AEs (pain/hyperemia/edema) were noted in 12.2% of RA patients and in 10.7% of the control group, after the introduction of the second component of the vaccine-in 9.1% and 11.4% of respondents, respectively (in both groups p>0.05). There was a signifcant difference between the main group and the control group in the frequency of pain at the injection site without restriction of movements both after the frst (24.4% and 40.5%, p=0.007) and after the second component (18.2% and 31.6%, p=0.021). The most frequent systemic AEs were weakness, fever, muscle or joint pain, headache, chills, which were observed in both groups after administration of both the frst and second components of the vaccine. There was a signifcant difference between the main group and the control group in the frequency of fever (16.8% and 39.7%, p<0.001), weakness (26.0% and 38.8%, p=0.029), muscle and joint pain (9.2% and 25.6%, p<0.001) after administration of the frst (but not the second) component of the vaccine. A signifcant difference was revealed between the main group and the control group in the number of patients with local and systemic AEs both after the introduction of the frst component of the vaccine (19.1% and 43%, p<0.001) and after the second (15.5% and 30.7%, p=0.007). After administration of the two components of the vaccine, a higher number of patients without any AEs were detected in the main group compared to the control group (32.7% and 18.4%, p=0.014). Exacerbation of RA and the emergence of new autoimmune phenomena in main group are not marked. Conclusion: According to preliminary data, the tolerance of vaccines against COVID-19 in RA patients is satisfactory. Further studies are needed to study the safety, immunogenicity and clinical efficacy of immunization against COVID-19 in patients of this cohort.
ABSTRACT
Background: Based on given legislation (ŞŞ 33a and 139e SGB V, Social Code Book V) the German approach to digital health applications (Digitale Gesundheitsanwendungen, DiGA) allows reimbursed prescription of approved therapeutic software products (listed in the DIGA directory https://diga.bfarm.de/de/verzeichnis) for patients since October 6th, 2020. Objectives: To evaluate the level of knowledge on DiGA among members of the German Society for Rheumatology (DGRh) after one year of DiGA under the conditions of the COVID-19 pandemic using the DiGA Toolbox of the 'health innovation hub' (hih), a think tank and sparrings partner of the German Federal Ministry of Health. Methods: Anonymous cross-sectional online survey using LimeSurvey (https://limesurvey.org). The survey was promoted by newsletters sent out to DGRh newsletter recipients and Twitter posts. Ethical approval was obtained. Results: 75 valid participants reported that they care more than 80% of their working time for patients with rheumatic diseases. Most were working in outpatient clinics (54%) and older than 40 years of age (84%). Gender distribution was balanced (50%). 70% were aware of the possibility to prescribe DiGA. Most were informed on this for the frst time via trade press (63%), and only 8% via the professional society. 46% expect information on DiGA from professional societies and the medical chambers (36%) but rarely from the manufacturer (10%) and the responsible ministry (4%). Respondents would like to be informed about DIGA via continuing education events (face-to-face 76%, online 84%), trade press (86%), and manufacturers test accounts (64%). Only 7% have already prescribed a DiGA, 46% planned to do so, and 47% did not intend DiGA prescriptions. Relevant aspects for prescription are given in Figure 1. 86% believe that using DiGA/medical apps would at least partially be feasible and understandable to their patients. 83% thought that data collected by the patients using DiGA or other digital solutions could at least partially influence health care positively. 51% appreciated to get DiGA data directly into their patient documentation system resp. clinical electronic health record (EHR) and 29% into patients' owned EHR. Conclusion: DiGA awareness was high whereas prescription rate was low. Mostly, physician-desired aspects for DiGA prescriptions were proven efficacy and efficiency for physicians and patients, risk of adverse effects and health care costs were less important. Evaluation of patients' barriers and needs are warranted. Our results will contribute to the implementation and dissemination of DIGA.
ABSTRACT
The dominance of reliably immunized population is a fundamental factor in prevention of COVID-19 pandemia, with immune prophylaxis taking a dominant position. Due to lack of clear data on the intensity of specific immunity after a new coronavirus infection, consolidation of immunological memory by vaccination becomes the urgent task, in order to exclude the risk of re-involvement of previously ill patients into the epidemic process. Meanwhile, many questions related to vaccination of COVID-19 survivors do not get distinct answers. To study the features of immune response, using a vaccine based on SARS-CoV-2 peptide antigens (EpiVacCorona), we monitored 81 participants. The inclusion criteria were data confirming COVID-19 in the anamnesis (medical documentation), low levels or absence of antibodies to the SARS-CoV-2 nucleocapsid protein, and negative PCR tests for SARS-CoV-2. When assessing the data of post-vaccinal immunity checked 21 days after 1st dose of the vaccine, the patients were divided into 2 groups: those who did not respond, and those who developed the immune response. In order to identify possible reasons for different phenotypic patterns of humoral response to vaccination, a comparative analysis of B lymphocyte indexes was carried out in these groups. Absolute counts, subpopulation composition and activation potential of peripheral blood B lymphocytes were determined by flow cytofluorometry using appropriate labeled monoclonal antibodies purchased from Beсkman Coulter. Comparative analysis of B lymphocyte indexes on the day of first vaccination showed that the persons who did not respond to the vaccine had smaller counts of circulating B cells, i.e., both percentage and absolute cell numbers, than in comparison group, as well as changed ratio of B1-to-B2 subpopulations. After administration of the first vaccine dose (by day +21), in alternative variant of the antibody response to V1, the differences in the parameters of B cells were presented as a smaller percentage and absolute numbers of regulatory B lymphocytes in non-responding participants. Moreover, the contents of minor B cell subpopulations were decreased in the non-responding group than in the comparison group, thus affecting the values of the B1:B2 ratio. In general, the presented data demonstrate that the absence of secondary immune response to antigens of the SARS-CoV-2 peptide vaccine could be is associated with altered differentiation of B1 and B2 subpopulations, B regulatory lymphocytes, B memory cells.
ABSTRACT
Introduction: In setting of global pandemic of coronavirus disease 19 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), cases resembling Kawasaki disease (KD) were repeatedly reported. Soon afterwards it began to be considered as separate entity named multisystem inflammatory syndrome in children (MIS-C). In addition to this newly recognized syndrome which has overlapping features with KD and is still occasionally described as its from, during COVID-19, a high incidence of Kawasaki-like syndrome (KLS) with mild to moderate symptoms was also noted. Recently, it was proposed that even such cases should, in clinical context, be treated as MIS-C if appropriate criteria are met. On the other hand, clear distinction of the two entities can help researchers to answer the question of its etiology and pathogenesis and could direct the clinicians what to expect during the course of the disease. Objectives: The aim was to describe main epidemiologic and clinical characteristics of KLS during the first year of COVID-19 pandemic. Methods: This retrospective study included analysis of medical documentation of patients treated for KLS at Clinic of Pediatrics, University Clinical Center Niš, between March 2020 and 2021. Inclusion criteria was fulfillment of KD or KLS criteria, based on CDC1 or WHO2 recommendation. Severe form of the disease with signs of a shock was exclusion criteria. The results were elaborated with the statistical method of descriptive and quantitative analysis. Results: A total of 21 subjects fulfilled the criteria for KLS during the study period. The cumulative incidence was 8.48 per 105 minors. Male to female ratio was 2:1 and mean age at diagnosis was 6.5 years (min. 8 months;max. 17 years). In fourteen cases current or recent COVID-19 infection or confirmed COVID-19 exposure was observed. When only these patients are analyzed average age was 8.2 years. Antibodies against SARS-CoV-2 were confirmed in seven patients, three had positive PCR test for COVID-19 and one had close contact with someone who has COVID-19 but COVID-19 was not proved. Interestingly, three patients that were antigen positive had respiratory organ involvement. In the reaming seven cases all the other possible causes of symptoms were ruled out and possible contact with SARS-CoV-2 was assumed. In addition to prolonged fever, that was present in all patients, polymorphous rash (95%) was the most common clinical feature flowed by bilateral nonpurulent conjunctivitis (47%). Gastrointestinal tract involvement was the most common internal organ manifestation. Treatment included corticosteroids (15 patients), intravenous immunoglobulin (1 patient) and two patients received nonsteroidal anti-inflammatory drug in anti-inflammatory dose, while the rest were only treated symptomatically. Favorable outcome was achieved in all patients with no morphological changes observed on echocardiography during the hospitalization and 2 weeks after discharge. Conclusion: Our findings suggest connection between infection and occurrence of the disease in susceptible children. Yet, a large portion of the population had contact with SARS-CoV-2, thus the exact role of infectious agent and pathophysiological mechanisms have to be determined. Gender distribution with male dominance among our patients is expected. Still, average age at diagnosis was bit higher than what is usually observed in classic KD and is more in line with characteristics of MIS-C. Further research are to be done in order to define what determine progression of the disease and are there any signs that may point in which way it will develop. Only in that way the clinicians would made right choices regarding the patients treatment.