Teclistamab in combination with daratumumab and lenalidomide in multiple myeloma (MajesTEC-2 study)

Introduction: Combination of daratumumab (Dara) and lenalidomide (Len) may enhance the function of teclistamab (Tec), potentially resulting in improved antimyeloma activity in a broader population. We present initial safety and efficacy data of Tec-Dara- Len combination in patients with multiple myeloma (MM) in a phase 1b study (MajesTEC-2;NCT04722146). Method(s): Eligible patients who received 1-3 prior lines of therapy (LOT), including a proteasome inhibitor and immune-modulatory drug, were given weekly doses of Tec (0.72-or- 1.5 mg/kg with step-up dosing) + Dara 1800 mg + Len 25 mg. Responses per International Myeloma Working Group criteria, adverse events (Aes) per CTCAE v5.0, and for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) per ASTCT guidelines, were assessed. Result(s): 32 patients received Tec-Dara- Len (0.72 mg/kg, n = 13;1.5 mg/kg, n = 19). At data cut-off (11 July 2022), median follow-up (range) was 5.78 months (1.0-10.4) and median treatment duration was 4.98 months (0.10-10.35). Median age was 62 years (38-75);87.5% were male. Median prior LOT was 2 (1-3), 18.8% were refractory to Dara and 28.1% refractory to Len. CRS was most frequent AE (81.3% [n = 26], all grade 1/2), 95% occurred during cycle1. Median time to onset was 2 days (1-8), median duration was 2 days (1-22). No ICANS were reported. Frequent Aes (>=25.0% across both dose levels) were neutropenia (75.0% [n = 24];grade 3/4: 68.8% [n = 22]), fatigue (43.8% [n = 14];grade 3/4: 6.3% [n = 2]), diarrhoea (37.5% [n = 12];all grade 1/2), insomnia (31.3% [n = 10];grade 3/4: 3.1% [n = 1]), cough (28.1% [n = 9];all grade 1/2), hypophosphatemia (25.0% [n = 8];all grade 1/2), and pyrexia (25% [n = 8];grade 3/4: 6.3% [n = 2]). Febrile neutropenia frequency was 12.5% (n = 4). Infections occurred in 24 patients (75.0%;grade 3/4: 28.1% [n = 9]). Most common were upper respiratory infection (21.9% [n = 7]), COVID-19 (21.9% [n = 7]), and pneumonia (21.9% [n = 7]). Three (9.4%) had COVID-19 pneumonia. One (3.1%) discontinued due to COVID-19 infection and this patient subsequently died of this infection. Overall response rate (ORR, median follow-up) was 13/13 (8.61 months) at 0.72 mg/kg and 13/16 evaluable patients (less mature at 4.17 months) at 1.5 mg/kg. 12 patients attained very good/better partial response at 0.72 mg/kg dose, and response was not mature for 1.5 mg/kg group. Median time to first response was 1.0 month (0.7-2.0). Preliminary pharmacokinetic concentrations of Tec-Dara- Len were similar as seen with Tec monotherapy. Tec-Dara- Len- treatment led to proinflammatory cytokine production and T-cell activation. Conclusion(s): The combination of Tec-Dara- Len has no new safety signals beyond those seen with Tec or Dara-Len individually. Promising ORR supports the potential for this combination to have enhanced early disease control through the addition of Tec. These data warrant further investigation.

Space-time risk clusters of COVID-19 in a tourism area in the northeastern Brazil: an epidemiological overview after two years of pandemic

The world is facing a serious viral infection caused by the new Severe Acute Respiratory Syndrome Coronavirus 2. We aimed to evaluate and map the high-risk clusters of COVID-19 in the State of Alagoas, a touristic area in northeastern Brazil, after two years of pandemic by a population-based ecological study, using COVID-19 cases reported in the State of Alagoas, between March, 2020 and April, 2022. We performed a descriptive and statistical analysis of epidemiological data. We then map high-risk areas for COVID-19, using spatial analysis, considering the incidence rate by municipality. 297,972 positive cases were registered;56.9% were female and 42.7% aged between 20 and 39 years old. Men (OR = 1.59) and older than 60 years old (OR = 29.64) had a higher risk of death, while the highest incidence rates of the disease occurred in the metropolitan region. Our data demonstrate the impact of COVID-19 in the State of Alagoas, through the two years of pandemic. Although the number of cases were greater among women and young adults, the chance of death was greater among men and older adults. High-risk clusters of the disease initially occur in metropolitan cities and tourist areas.

Trauma: a stress during pandemic?

Introduction: Coronavirus disease 2019 pandemic significantly impacted on trauma systems, since emergency departments (ED) suddenly were overwhelmed by patients requiring intensive care unit (ICU) admission. Once, trauma volume was supposed to decrease due to lockdown policies, we aimed to describe ICU trauma admissions during this period. Method(s): Retrospective observational study of all trauma patients admitted to the ICU of a Portuguese Trauma Center between January 2020 and December 2021. Data were collected from clinical hospital records. Result(s): 437 trauma patients (15% of all admissions), mostly male (71%), with a median age of 59 years-old (42-74) were included. At least one comorbidity was present in 71% of the patients. Median severity scores were: SAPS II 26 (19-38), SOFA 3 (1-6), ISS 13 (9-22), RTS 8 (6-8) and TRISS 96,75 (81.1-98.6). The most frequent mechanisms of injury were falls (59%) and road traffic accidents (25%). The majority consisted of blunt trauma (88%), 65% of brain trauma and 35% of musculoeskeletal trauma. Trauma Team assessment was started in < 3 min in all cases and median length of stay (LOS) in the ED was 261 min (154-418). Surgical intervention was performed in < 4 h in 56% of surgical brain trauma injuries, in < 6 h in 67% of extremity open fractures and in < 1 h in 6% of a penetrating trauma. Shock, mainly hemorrhagic, was present in 8% of the patients on hospital admission. 38% were submitted to invasive mechanical ventilation and 34% to vasopressors. The most common complication was nosocomial infection (18%). The median LOS in the UCI was 12 days (5-24). Only 8% of the patients died in the ICU and 11% in the hospital. Conclusion(s): During pandemic, trauma persisted a major health problem with a significant consumption of time and critical care resources. The high influx of patients may have influenced the LOS in the ED before ICU admission and the time until the surgical intervention. Despite it, mortality remained low.

Interpersonal violence in a city of Parana: a study about the epidemiological profile of victims and characterization of dental trauma

The socioeconomic context and population vulnerability are directly associated with violence in the country. In Brazil, the Criminal Code provides the illicit act and punishes the aggressor who offends the physical aggression from a person. Interpersonal violence is an illegal act and is associated with the vulnerability of victims. Therefore, the study of the epidemiological profile of victims of interpersonal violence is needed to alert the population about their susceptibility. The present study aimed to design the epidemiological profile of victims of bodily injury from interpersonal violence in the region of Maringa, in the state of Parana, and to study the characterization of dental injuries in terms of permanent weakness and deformity. Four thousand nine hundred sixty-two reports performed between 2018 and 2020 were analyzed using descriptive statistics. Data collected included: sex, age, marital status, the region affected by the bodily injury, type of dental trauma, and responses to "weakness" or/and "permanent deformity". During the period studied, there was a prevalence of female victims (57.8%), white skin color (80.2%), aged between 21 and 30 years (24.9%), single (54.9%), and the most affected region was the upper limbs (32.1%). Regarding bodily injuries with dental involvement, 67 cases were reported, male victims were prevalent (60.3%), and dental fracture was highlighted with 54.4% of examined injuries. The implementation of the Forensic Dentistry Centre took place in August 2019 at the Medico-Legal Institute of Maringa. Also, with the interruption of expert activities in 2020 - due to the COVID-19 pandemic - relevant outcomes regarding permanent weakness were observed. The epidemiological profile of victims is characterized by the female sex, white skin color, the age group from 21 to 30 years old, and singles. Regarding dental trauma, male victims, and dental fractures were prevalent. Furthermore, there was an increase in the classification of "permanent weakness", as well as a slight increase in cases of "further assessment required" for permanent deformity.Copyright © 2023 Faculdade de Medicina de Ribeirao Preto - U.S.P.. All rights reserved.

Identification of Synthetic 2-Mercaptobenzimidazole Derivatives as Inhibitors of Spike Protein of SARS-CoV-2 by Virtual Screening

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spread worldwide and caused the COVID-19 pandemic. Despite countless efforts in searching for repositioned drugs to treat this disease, the results are still modest. Thus, searching for new compounds as promising drugs to treat this disease is crucial. 2-Mercaptobenzimidazole, a scaffold found in many biologically relevant compounds, has been extensively studied due to its range of biological activities. Using in silico tools, this study aimed to identify 2-mercaptobenzimidazole derivatives as potential drugs to inhibit SARS-CoV-2 infection by blocking spike protein – human angiotensin-converting (hACE2) enzyme interaction. 61 compounds were screened to evaluate their absorption, distribution, metabolism, and excretion (ADME) properties. The compounds that did not violate any Lipinski or Veber rules were subjected to molecular docking interactions to verify their ability to inhibit spike glycoprotein from binding to the hACE2 enzyme. The docking scores for these compounds were superior to the antiviral drugs Remdesivir and Umifenovir, proven to be potential drugs against COVID-19. Furthermore, 2-mercaptobenzimidazole derivatives have been shown to interfere in amino acids involved in key contact sites between SARS-CoV-2-CTD and hACE2 subdomain I. Finally, some toxicological properties were predicted, and the compounds exhibited few (or none) alerts for toxic endpoints as well as low predicted acute oral toxicity (LD50). In this way, the results presented in this work should contribute to discovering new drugs against SARS-CoV-2. © 2022 by the authors.

Inactivation of Pathogenic Microorganisms on Polymeric Materials through Ozonation

Ozone-based technologies have been evaluated to inactivate the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on surfaces. However, the vast diversity of information makes it difficult to establish common ground for determining the best practices for using this technology. The objective of this work is to evaluate the success of N95 mask decontamination by ozonation, determining the specific parameters for process control. To quantify the effectiveness of the process, a disinfection protocol was initially developed based on two bacterial species (Escherichia coli and Staphylococcus pseudintermedius), followed by another disinfection assay using the murine hepatitis coronavirus (MHV-3), in a laboratory-scale prototype. Ozone is an effective candidate for use against SARS-CoV-2 or other viruses to disinfect personal protection equipment (PPE). © 2023 Wiley-VCH GmbH.

Physical therapy follow-up before and during COVID-19 pandemic of patients with amyotrophic lateral sclerosis

Introduction: Amyotrophic lateral sclerosis (ALS) is marked by a gradual decline in functional capacity and increased morbidity from respiratory infections due to progressive loss of muscle strength. The regular monitoring by a multidisciplinary team, adjustments in ventilatory parameters, and maintenance of NIV are essential for disease management. This study aimed to monitor functional progression of patients with ALS during COVID-19 pandemic using telemedicine. Method(s): This is longitudinal case series with patients with ALS. Five assessments were performed, being two occurred in-person and three were performed remotely during the COVID-19 pandemic. First assessments included pulmonary function, respiratory muscle strength, functionality (ALSFRS-R), rate of disease progression, and disease staging. The further assessments included a clinical evaluation form, use and parameters of NIV. Result(s): We followed 11 patients for 30 months. Most patients had spinal onset ALS (72.7%), were male (72.7%), had a median age of 51 years. Total ALSFRS-R (P < 0.01) and motor domain (P < 0.01) scores reduced during the pandemic. However, total and domain scores were not different between patients with spinal and bulbar onset. According to ALSFRS-R, 90.9% of patients presented a slow disease progression. Most patients used NIV at night and during a half-day shift. Conclusion(s): The telemedicine facilitates monitoring clinical and seems to influence functional progression of patients with ALS during COVID-19 pandemic. Patients with ALS have a slow rate of disease progression and a functional decrease during 14 months follow-up period.

Staying Connected with Aged Populations in Times of COVID-19: An Interview Study of the Role of Portuguese Institutions and Municipalities

In times of social confinement frequently associated with COVID-19 pandemics, an increasing dependence of aged populations on digital media to maintain social interactions and participation in society was observed. Although courses for action on the access to digital media by aged populations and the potential harms of digital inclusion have been acknowledged in the literature, far too little attention has been devoted to the challenges and in situ measures undertaken by local entities targeted to aged populations. The purpose of this study is to analyze the strategies adopted by Portuguese Universities of the Third Age, Municipalities, among other Institutional Care for Aged Populations to ensure communication and active participation of older adults in society and the role of digital media in that process. A total of 72 Portuguese entities developing initiatives addressed to aged populations were interviewed, including Municipalities and Universities of the Third Age, aiming at gathering their perspectives on the challenges and practices of using digital media to involve the ageing population in the community. Data was collected employing a semi-structured interview and content analysis was performed. Findings indicate that although participants found difficulty in adhering to activities owing to the financial and social consequences of the pandemic, most had to restructure their activities to maintain connections and routines. Conclusions offer some important insights into practices to foster participation within the communities using digital platforms. © 2022, Interaction Design and Architecture(s). All Rights Reserved.

COVID-19 induced stress among dentists affecting pediatric cooperation and alter treatment of choice

Objectives: To assess the effect of the COVID-19 pandemic on self-rated stress levels among dentists who treated children during the outbreak and pediatric patient cooperation during dental treatments. Methods and materials: This cross-sectional study was assessed by enrolling an online questionnaire among dental practitioners treated children during April 2020. Result(s): Dentists with higher COVID-19-induced distress reported a lower degree of pediatric patient cooperation during dental treatments than dentists with lower reported stress (p value < 0.01). Additional factors negatively impacting patient cooperation were degree of professional practitioner seniority in pediatric dentistry, and perceived knowledge about the COVID-19 disease infectivity and feeling protective against viral transmission with Personal Protective Equipment (PPE). Also, stress levels among dentists treating children influenced medical decisions, such as the selected treatment approach influenced by COVID-19 considerations. Conclusion(s): The COVID-19 pandemic has adverse effects on clinicians and pediatric patients. Educational programs should be developed to advance dental staff.Copyright © 2021 The Authors

Psychological Impact of the Covid-19 Pandemic and Mothers' Conflict Resolution Styles: The Mediating Role of Well-Being

The new coronavirus pandemic (COVID-19) brought considerable changes to families' routines, with the implementation of social isolation and quarantine measures, possible financial insecurity, and care overload. Since all these changes represent potential stressors for family dynamics, this study aimed to assess the relationship between the psychological impact of the COVID-19 pandemic and conflict resolution styles that mothers use with their children, both directly and indirectly via mothers' well-being. A sample of 316 Brazilian mothers participated in the study, through an online survey. Mediation models of mothers' well-being were tested on the relationship between the psychological impact of the COVID-19 pandemic and conflict resolution styles with their children. Results indicated that mothers' well-being mediates the relation between the psychological impact of the COVID-19 pandemic and conflict engagement, withdrawal, and compliance styles. Theoretical and practical implications are discussed. © 2022 Taylor & Francis Group, LLC.

A rare fungi, Candida Krusei implicated in Ludwig's angina and deep neck necrotising infection- a case report and review of literature

Introduction/Aim: Ludwig's angina is potentially life-threatening, polymicrobial infection of bilateral submandibular and sublingual spaces. Most common organisms isolated from deep neck infections are viridans streptococci, streptococcus anginosus group of oral flora. We describe a previously un-reported case of Ludwig's angina associated with an unusual fungus, Candida Krusei. Case Description: 35-year-old, fit and healthy, non-smoking male patient presented with ludwig's angina and sepsis, previously diagnosed with parotitis following telephone consultation with his GP due to the COVID-19 pandemic. CT scan showed periapical pathology of both carious lower third molars with involvement of deep neck tissue spaces including the prevertebral space. The patient underwent multiple theatre visits for neck exploration and had prolonged hospital stay and subsequently recovered and discharged. Tissue samples grew Candida Krusei on multiple occasions. Discussion(s): This is a rare and previously unreported case of Ludwig's angina related to Candida Krusei. Literature search was carried out using MeSH terms Candida krusei, dental infection, neck infection, cervicofacial infection and Ludwig's angina using EMBASE, Medline, PubMed and Google Scholar. Candida Krusei has low disease-causing potential when compared to commonly found candida, with poor adhesive properties to oral cavity. It is not well-studied with regards to its virulence but has high resistance to azoles and other antifungal medications. Conclusion/Clinical Relevance: This report emphasises keeping an open mind when considering potential pathogens in cervico-dentofacial infections, to test tissue for fungi as well as bacteria, and to seek timely advice from microbiologists. The authors also counsel caution when carrying out telephone consultations during the ongoing COVID-19 pandemic. Copyright © 2022

Impact de l'infection par le SARS-CoV-2 sur l'activité de la maladie des patients atteints de rhumatisme psoriasique sous bDMARD : données réelles

Introduction L'infection par le SARS-CoV-2 peut entraîner une inflammation sévère et il a été suggéré d'induire des poussées de rhumatisme psoriasique (RP). Cependant, l'impact sur l'activité de la maladie et la réponse aux DMARD biologiques modificateurs de la maladie (bDMARD) reste inconnu. Patients et méthodes Nous avons réalisé une analyse rétrospective incluant tous les patients atteints de RP, répondant aux critères CASPAR et sous biothérapie, suivis dans le service de rhumatologie d'un CHU universitaire tertiaire. Les données démographiques et cliniques, y compris la survenue d'une infection par le SARS-CoV-2, ont été collectées à partir de notre base de données nationale (reuma.pt). L'activité de la maladie (CDAI, SDAI, DAS28 4v, BASDAI, ASDAS) et les réponses aux bDMARD (réponses EULAR, ASDAS, ASAS, ACR et PsARC) ont été évaluées avant et après l'infection par le SARS-Cov-2. Résultats Au total, 102 patients atteints de RP ont été inclus. Cinquante-deux étaient des femmes (51 %). L'âge moyen était de 53 ± 11,09 ans et la durée médiane de la maladie était de 15 ans [min 2, max 47]. Au total, 54 (53 %) patients avaient une atteinte axiale prédominante, 26 (26 %) périphérique et 36 (37 %) enthésopathique. Le bDMARD le plus utilisé était l'étanercept (n = 28, 27,5 %) suivi de l'adalimumab (n = 22, 21,6 %) et du sécukinumab (n = 18, 17,6 %). La prévalence de l'infection par le SARS-CoV-2 était de 15,7 % (n = 16). Soixante-trois pour cent ont reçu le vaccin BNT162b2 (Pfizer/BioNtech), 31 % ont reçu l'ARNm-1273 (Moderna), 13 % ont reçu l'AZD1222 (AstraZeneca) et 13 % ont reçu l'AD26.COV2.S (Janssen/Johnson & Johnson). Soixante-trois pour cent étaient infectés avant toute vaccination, 13 % après la première dose et 25 % après la seconde. Les symptômes les plus fréquents étaient l'anosmie (65 %), la dysgueusie (56 %) et la toux (56 %). Tous les patients se sont complètement remis de l'infection, sans nécessiter d'hospitalisation. Quel que soit le score utilisé, la différence entre l'activité moyenne de la maladie après l'infection par le SARS-CoV-2 et celle au départ n'a pas atteint la signification statistique. Au départ et après l'infection, les paramètres moyens de l'activité de la maladie étaient respectivement : CDAI 8,6 ± 5,7 vs 8,6 ± 5,7, p = 0,997 ;SDAI 9,3 ± 6,6 contre 9,2 ± 6,1, p = 0,928 ;DAS 28 4v 2,9 ± 1,2 contre 2,9 ± 1,2, p = 0,818 ;BASDAI 3,6 ± 2,6 contre 3,2 ± 2,7, p = 0,506 ;ASDAS 2,2 ± 1,2 contre 2,2 ± 1, p = 0,721. Le nombre de patients ne répondant pas aux bDMARD (selon EULAR, ASDAS, ASAS, ACR et PsARC) avant l'infection n'était pas différent de celui post-infection. Conclusion Notre étude suggère que l'infection par le SARS-CoV-2 n'a aucun impact négatif sur l'activité de la maladie PSA et les réponses bDMARD. Cependant, d'autres études sont encore nécessaires pour mieux comprendre les effets à long terme de l'infection par le SARS-CoV-2.

ALTERAÇÕES HEMATOLÓGICAS EM PACIENTES COM COVID-19: REVISÃO SISTEMÁTICA E METANÁLISE

Objetivo Realizar uma revisão sistemática com metanálise sobre as manifestações hematológicas da COVID-19, comparando as alterações entre os grupos de gravidade clínica: doença leve ou moderada versus doença grave ou crítica. Material e Métodos Foi realizada uma revisão sistemática baseada no protocolo PRISMA 2020, nas bases de dados Pubmed, Embase, LILACS e SciElo, usando os seguintes descritores do MeSH: COVID-19 ou SARS-CoV-2;hematological tests;erythrocyte count, red blood cell count, leukocyte count, platelet count, ferritin, coagulopathy, prothrombin time, partial thromboplastin time, c-reactive protein e fibrinogen. Foram excluídos artigos não disponíveis na íntegra, revisões de literatura, revisões sistemáticas, opiniões de experts e artigos que não faziam a comparação dos parâmetros entre os grupos de gravidade. O software Stata versão 14.0 foi utilizado para a análise estatística e foi feito cálculo de risco relativo com Intervalo de Confiança de 95% para avaliar as diferenças entres os grupos. A heterogeneidade foi calculada com o teste do ꭓ2 e o teste do I2. A heterogeneidade significativa foi definida com p<0,10 ou I2 >50%. Resultados A pesquisa sistemática identificou um total de 2.682 artigos, sendo que ao final da triagem, 55 foram selecionados para a revisão e 18 para metanálise. Os artigos selecionados arrolaram um total de 13.289 participantes, sendo 10.312 com quadro clínico leve a moderado e 3.977 com quadro clínico grave a crítico. As médias de idade foram de 49,8 anos para participantes com doença leve a moderada e de 61,3 anos para o grupo de doença grave a crítica. As mulheres representaram 44,5% dos indivíduos do grupo com doença leve e 32,94% dos indivíduos do grupo grave. Identificou-se que os valores médios de leucócitos (SMD=0,47;95% IC 0,24‒0,70;I2=86,2%), neutrófilos (SMD=1.44;95% IC 0,92‒1,96;I2=0,0%), PCR (SMD=3,98;95% IC 2,6‒5,80;I2=98,2%), ferritina (SMD=1,13;95% IC 0,57‒1,69;I2=72,6%), fibrinogênio (SMD=0,55;95% IC 0,16‒0,93;I2=40,5%) e TP (SMD=0,53;95% IC 0,24‒0,82;I2=55,0%) foram significativamente mais elevados e a contagem de linfócitos (SMD = -1,25;95% IC -1,67 ‒ -0,83;I2=95,7%) foi significativamente reduzida no grupo de doença grave. Discussão A infecção por SARS-CoV-2 induz uma série de mudanças nos exames laboratoriais e algumas delas podem ser usadas para monitorar a gravidade e prever o prognóstico. Diversos trabalhos demonstraram que casos graves são mais propensos a níveis elevados de leucócitos, neutrófilos, aumento da ferritina e alargamento do TP. Apesar de o presente trabalho não demonstrar associação entre níveis de plaquetas e gravidade da doença, vários estudos sugerem que a trombocitopenia também está significativamente associada à doença grave. Neste estudo também não foram observadas diferenças significativas entre os níveis de D-dímero dos grupos avaliados, mas outros trabalhos apontam que a elevação do D-dímero é um fator de risco independente para morte. Conclusão Os indivíduos com COVID-19 grave apresentaram redução da contagem de linfócitos e elevação de leucócitos, neutrófilos, PCR, ferritina, fibrinogênio e TP.

Acute necrotizing pancreatitis and disconnected pancreatic duct syndrome associated with COVID-19

Disconnected pancreatic duct syndrome (DPDS) is a rare but important complication of acute necrotizing pancreatitis (ANP). This syndrome presents as a circumferential discontinuity of the ductal anatomy between the pancreatic secreting tissue and the gastrointestinal tract. Most cases do not respond to conservative therapy and require surgical intervention. This condition is a challenge for the medical team, given the delay in diagnostic suspicion and the need for multimodal therapeutical approach. Acute pancreatitis has been reported in patients with COVID-19, although a direct cause and effect relationship has not yet been established. Whether infection with new Coronavirus can contribute as worsen-ing factor in acute pancreatitis due to viral tropism to pancreatic cells is not known. We present the case of a 44-year-old male patient with a diagnosis of acute necrotizing pancreatitis who evolved with disconnected duct syndrome due to necrosis of the central region of the pancreas. He performed multiple drainages of the collections and necrosectomy, with persistent pancreatic fistula, eventually requiring caudal pancreatec-tomy. This patient had a diagnosis of COVID-19 and thromboembolic events during hospitalization, constituting a challenge for treatment. He presented a good postoperative clinical evolution, being discharged 5 months after admission. Disconnect duct syndrome frequently presents as a treatment challenge. These patients are severe and an overlapping COVID infection acts as an important aggravating factor. Whether the infection is related to pancreatitis, either in its genesis or acting as a worsening factor has not yet been established.(Cite this article as: Capaverde LH, Hinrichsen LB, Fetzner B, Pieta MP, Cardoso AM, Costa LB, et al. Acute necrotizing pancreatitis and discon-nected pancreatic duct syndrome associated with COVID-19. Chirurgia 2022;35:241-5. DOI: 10.23736/S0394-9508.21.05347-X)

ETHNOGRAPHY WITH CHILDREN IN TIMES OF PANDEMIC: AN ETHICAL AND METHODOLOGICAL REFLECTION

This article is concerned with the ethical and methodological aspects of research carried out during 2020, which investigated the children’s representation of Covid-19 in the Brazilian state of Maranhão. It queries the fabrication of an ethnography at a distance (with the children’s parents as mediators), taking digital technologies as a means to access children and their narratives through short interviews, audio recordings, and drawings. Adhering to social distancing rules, without access to direct observation, it raises issues regarding the process of obtaining information and transforming it into data through systematization and analysis. © 2022, Fundacao Carlos Chagas. All rights reserved.

Efficacy of hydrogen peroxide wipes for decontamination of AZD1222 adenovirus COVID-19 vaccine strain on pharmaceutical industry materials.

This study aimed to evaluate the performance of accelerated hydrogen peroxide® wipes (HPW) for decontamination of the chimpanzee adenovirus AZD1222 vaccine strain used in the production of recombinant COVID-19 vaccine in a pharmaceutical industry. Two matrices were tested on stainless-steel (SS) and low-density-polyethylene (LDP) surfaces: formulated recombinant COVID-19 vaccine (FCV) and active pharmaceutical ingredient (API). The samples were spiked, dried and the initial inoculum, possible residue effect (RE) and titre reduction after disinfection with HPW were determined. No RE was observed. The disinfection procedure with HPW resulted in complete decontamination the of AZD1222 adenovirus strain in FCV (≥7·46 and ≥7·49 log10 infectious unit [IFU] ml-1 for SS and LDP carriers respectively) and API (≥8·79 and ≥8·78 log10 IFU ml-1 for SS and LDP carriers respectively). In conclusion, virucidal activity of HPW was satisfactory against the AZD1222 adenovirus strain and can be a good option for disinfection processes of SS and LPD surfaces in pharmaceutical industry facilities during recombinant COVID-19 vaccine production. This procedure is simple and can be also applied on safety unit cabins and sampling bags made of LDP as well.

IMPACT of SARS-COV-2 INFECTION on the DISEASE ACTIVITY of PATIENTS with PSORIATIC ARTHRITIS under BDMARDS: REAL LIFE DATA

Background: SARS-CoV-2 infection can lead to severe infammation and has been suggested to induce Psoriatic Arthritis (PsA) fares.1 However, the impact on disease activity and response to biological disease modifying anti-rheumatic drugs DMARDs (bDMARDs) remains unknown. Objectives: To evaluate the effect of SARS-CoV-2 infection on disease activity and bDMARDs responses in patients with PsA. Methods: We performed a retrospective analysis including all the patients with PsA, meeting the CASPAR criteria and under biologic therapy, followed in the Rheumatology department of a tertiary university hospital. Demographic and clinical data, including occurrence of SARS-CoV-2 infection, were collected from our national database (reuma.pt). Disease activity (CDAI, SDAI, DAS28 4v, BASDAI, ASDAS) and bDMARDs responses (EULAR, ASDAS, ASAS, ACR and PsARC responses) were evaluated before and after SARS-Cov-2 infection. Statistical analysis was performed with SPSS. Continuous variables were compared through paired samples t-test. Results: A total of 102 patients with PsA were included. Fifty-two were females (51%).The mean age was 53 ± 11.09 years and the median disease duration was 15 years [min 2, max 47]. Overall, 54 (53%) patients had predominant axial involvement, 26 (26%) peripheric and 36 (37%) enthesopathic. The most used bDMARD was etanercept (n=28, 27.5%) followed by adalimumab (n=22, 21.6%) and secukinumab (n=18, 17.6%). The prevalence of SARS-CoV-2 infection was 15.7% (n=16). Sixty-three per cent received the BNT162b2 (Pfzer/BioNtech) vaccine, 31% received mRNA-1273 (Moderna), 13% received AZD1222 (AstraZeneca) and 13% received AD26. COV2.S (Janssen/Johnson & Johnson). Sixty-three percent were infected before any vaccination, 13% after the frst dose and 25% after the second. The most common symptoms were anosmia (65%), dysgeusia (56%) and cough (56%). All patients fully recovered from the infection, with no need for hospitalization. Regardless of the score used, the difference between the mean disease activity after SARS-CoV-2 infection and that at baseline did not reach statistical significance. At baseline and after infection, mean (SD) disease activity parameters were, respectively: CDAI 8.6±5.7 vs 8.6±5.7, p=0.997;SDAI 9.3±6.6 vs 9.2±6.1, p=0,928;DAS 28 4v 2.9±1.2 vs 2.9 ±1.2, p= 0.818;BASDAI 3.6 ±2.6 vs 3.2±2.7, p=0.506;ASDAS 2.2±1.2 vs 2.2±1, p=0.721. The number of patients unresponsive to bDMARDs (according EULAR, ASDAS, ASAS, ACR and PsARC) before the infection wasn't different from post-infection. Conclusion: Our study suggests that SARS-CoV2 infection has no negative impact on PsA disease activity and bDMARD responses. However, more studies are still needed to better understand the long-term effects of SARS-CoV2 infection.

THE IMPACT of SARS-COV-2 INFECTION on DISEASE ACTIVITY and CLINICAL RESPONSE to BIOLOGICAL DMARDS in PATIENTS with RHEUMATOID ARTHRITIS

Background: Infections are a known trigger for Rheumatoid Arthritis (RA) fares.1 It is still unclear whether SARS-Cov-2 infection affects RA disease activity and the clinical response to biological disease-modifying antirheumatic drugs (bDMARDs). Objectives: To evaluate the effect of SARS-Cov-2 infection on disease activity and bDMARD responses in patients with RA. Methods: A retrospective study was carried out in a cohort of RA patients treated with bDMARDs from a tertiary hospital centre. Demographic and clinical data, including occurrence of SARS-Cov-2 infection, were obtained through medical records. Disease activity (DAS28, DAS28-CRP, CDAI and SDAI) and ACR and EULAR bDMARD responses were evaluated at four time points: baseline (t1-last evaluation before Covid-19 pandemic), before (t2) and after (t3) SARS-Cov-2 infection and at the end of follow-up (t4-last appointment of 2021). In patients with no record of SARS-Cov-2 infection the middle evaluations were obtained from two random consecutive appointments during Covid-19 pandemic. Statistical analysis (signifcance at p<0.05) was performed using paired t-test, Wilcoxon and McNemar tests for paired samples and unpaired t-test, Mann-Whitney, Fisher and χ2 tests for independent samples according to the type of variable and the presence of normal distribution. Results: Of the 237 patients included, most of them was women [n = 195 (82.3%)], with a mean age of 59.6 ± 10.1 years old and a median [min, max] disease duration of 18 [2, 50] years. The majority presented rheumatoid factor (RF) and/or anti-citrullinated protein antibodies (ACPA) positivity [n = 204 (87.9%)] and radiographic erosions [n = 119 (72.6%)]. The prevalence of SARS-Cov-2 infection was 11.4% (n=27). Mean disease activity was lower after SARS-Cov-2 infection compared to the previous evaluation on all scores used;however, this difference was not statistically signifcant. Nevertheless, when compared to the mean disease activity at the end of follow-up, there were statistically signifcant differences in DAS28-CRP (t2 3.2±1.0 vs. t4 2.8±1.1, p=0.017) and CDAI (t2 11.1±8.1 vs. t4 8.7±6.2, p=0.05) scores. The relative number of patients with no ACR or EULAR bDMARD responses before SARS-Cov-2 infection wasn't different from post infection and at the end of follow-up. At baseline, the infected and uninfected groups were similar regarding gender, age, RF and/or ACPA positiv-ity, erosive disease, disease and biologic treatment durations, baseline disease activity and ACR and EULAR response. The variation in disease activity and the relative number of patients with worsening or improving EULAR and ACR bDMARD responses between t2 and t3 were not signifcantly different in the two groups, as well as between t2 and t4. The prevalence of patients who switched to another bDMARD was signifcantly higher in the group of patients who had Covid-19 [n=4 (14.8%) vs. 9 (4.3%), p=0.047]. The main reason for switching was the ineffectiveness of the therapy (n=11). Conclusion: No worsening of disease activity or ACR and EULAR bDMARD responses was found after SARS-Cov-2 infection in RA patients under bDMARD. However, the later can be explained by the small sample size. Indeed, these patients exhibited a higher rate of switch due to ineffectiveness of therapy, suggesting a negative impact of SARS-Cov2 infection on the disease course.

COVID19 in SPONDYLOARTHRITIS PATIENTS under BDMARD-A COMPREHENSIVE ASSESSMENT

Background: SARS-Cov-2 infection had a major impact on patients with infam-matory rheumatic diseases. Spondyloarthritis (SpA) patients were one of the most affected groups of these patients. Objectives: To assess the impact of Covid19 in spondyloarthritis patients under biological disease modifying anti-rheumatic drugs (bDMARDs). Methods: A retrospective observational study was conducted using registry data of patients with SpA under bDMARD therapy, followed at a tertiary level hospital, that have been diagnosed with COVID19 from March 2019 to December 2021. At least one evaluation previous (t0) and two evaluations after SARS-CoV-2 infection (t1, t2) were included in our analysis. Sociodemographic, clinical, disease activity, therapeutic response, function and general health status data were collected. Statistical analysis (signifcance at p < 0.05) was performed using paired T-test, Wilcoxon test and McNemar tests for paired samples. Linear and logistic regression models were performed to assess direction and strength of association Results: Thirty-two patients with SpA under bDMARD had COVID19, mostly women (20, 62.5%), with a disease course time averaged 18.65 (± 9.69) years, mainly with axial involvement (19, 59.4%) and positive for HLA-B27 antigen (11, 64.7%). The majority were under TNF inhibitors (30, 93.75%), with golimumab being the most common (9, 28.1%), and with a median bDMARD persistence of 2.63 (5.09) years. Seven (21.9%) were under a cDMARD, 3 (9.4%) under NSAID and 18 (56.3%) under corticosteroids. Three (9.4%) were already vaccinated against SARS-CoV-2, 2 (66.6%) with the mRNA-1273 vaccine, presenting a medium time since inoculation of 240 (± 234.01) days. Arterial hypertension was the most common comorbidity (5, 15.6%) and one patient (3.1%) had a previous diagnosis of type 2 diabetes. Most were never-smokers (17, 53.1%) and never-drinkers (29, 90.6%). The average age at infection was 40.97 (± 6.15) years and the most common symptom was cough (22, 68.8%), followed by headache (20, 62.5%) and myalgia (19, 59.4%). Event tree analysis didn't show association with SpA subtype, education level, work status, tobacco or alcohol consumption. Only one patient needed hospital admission but without needing of oxygen, therapy, ventilator or ECMO. Only one patient had an overlaid bacterial infection and no thromboembolic complications were observed. Two patients needed specific SARS CoV-2 infection treatment, one with hydroxychloroquine and another with azithromycin. Twelve (37.5%) patients suspended bDMARD at the time of infection, with only 2 (6.3%) maintaining suspension at the time of the first post-infection visit. When comparing clinical variables, higher disease activity was seen at t1 only for BASDAI mean values, without statistical signifcance. Higher all domains VAS scores were also observed at t1, but not at t2, also without statistical signifcance;moreover, physical function didn't change signifcantly. No differences were observed according to gender or SpA subtype, nor with the use of cDMARDs, NSAIDs or corticosteroids. The only statistically signifcant difference concerned MASES score between t0 and t1 (1 ± 4 vs. 2 ± 6, p=0.04), but not between t0 and t2. Higher baseline tender joint score (p < 0.01) and higher baseline LEI (p=0.03) negatively correlated with MASES score variation. Several baseline variables correlated positively with MASES at t1, including female gender (p < 0.01), corticosteroid use (p = 0.04), BASDAI (p < 0.01), ASDAS-ESR (p < 0.01), ASDAS-CRP (p < 0.01), DAS28 (p < 0.01), SPARCC (p = 0.04), physician VAS (p = 0.03) and total spine VAS (p = 0.01). Working status varied signifcantly after SARS-Cov-2 infection (at least part-time-29, 90.6% vs. 22, 68.8%, p= 0.016). Conclusion: SpA patients on bDMARD had a mild course of SARS-CoV-2 infection, with slight changes in enthesitis score in the short term, the latter particularly in those with higher disease activity in the pre-infection period. Long-term effects on work status could represent confounding factors related to the e onomic constraints of the pandemic.

Sleep quality in healthcare workers during the COVID-19 pandemic: a cross-sectional study

Introduction: The COVID-19 pandemic appears to affect the sleep quality of healthcare workers, according to recent studies. Objective: To evaluate health personnel sleep quality, at a tertiary hospital reference in COVID-19 patient's care in southern Brazil, when its resources were under clear overload, and 25% of these workers had already contracted the virus. Methods: This cross-sectional study took place between November 2020 and January 2021. All 7500 healthcare workers received an online questionnaire with sociodemographic, and occupational information, as well as questions on the subjective perception of sleep quality according to the Pittsburgh Sleep Quality Index (PSQI). Data were analyzed using SPSS version 18.0. Descriptive data are presented as absolute and relative frequencies (n, n%) and mean and standard deviation. For factors associated with sleep quality, we used the chi-square test and multivariate robust Poisson regression. Study was approved by Research Ethics Committee by the number 200502. Results: Of the 1441 participants answering the questionnaire, 995 were included in the sample. The mean age was 44.1±10.6 years, 764 (76.8%) were women, and 739 (74.3%) were married/ in a stable relationship. Personnel distribution according to occupation area: 483 (48.5%) administrative, 230 (23.1%) surgical unit/obstetrics, 176 (17.7%) emergency/intensive care unit, and 106 (10.7%) outpatient clinics. Most reported working 20 to 40 hours a week (53.6%), and 486 (48.8%) reported having contact with COVID-19 patients. According to PSQI individual components, healthcare workers in contact with COVID-19 patients showed higher sleep latency (p=0.038), less habitual sleep efficiency (p=0.024), more sleep medication use (p=0.011), and more daytime dysfunction (p=0.036). According to overall PSQI score, those in contact with COVID-19 had worse sleep quality (p=0.013), as well as from the total sample, 689 (70.7%) had poor sleep quality. In the multivariate analysis, younger age and female gender were aggravating factors for poor sleep quality (p=0.039;p<0.001). Conclusion: Most participants reported poor sleep quality, including those who had direct contact with COVID-19 patients during the work. Age was an important factor, in other words, the younger the healthcare worker, worse is the sleep quality, as well as be female sex.