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1.
Med Sci Monit ; 27: e934949, 2021 Oct 04.
Artigo em Inglês | MEDLINE | ID: mdl-34602605

RESUMO

There have been five viral pandemics in the past century, four were due to influenza, and the ongoing COVID-19 pandemic is due to SARS-CoV-2 infection. During the COVID-19 pandemic, there has been a 99% global reduction in the diagnosis of influenza. Also, from 2020, global mortality rates from influenza fell to record levels during the influenza seasons in the southern and northern hemispheres. However, as social restrictions become lifted and the winter season begins in the northern hemisphere, it is expected that influenza will re-emerge. The World Health Organization (WHO) FluNet surveillance platform provides global surveillance data on influenza, and the US Centers for Disease Control and Prevention (CDC) records national weekly infection rates. Both surveillance programs have identified zoonotic avian and swine influenza variants in humans. The WHO Pandemic Influenza Preparedness (PIP) Framework requires WHO Member States to share data on cases of emerging influenza viruses with pandemic potential in a regular and timely way. The WHO PIP Framework organizes the Global Influenza Surveillance and Response System (GISRS), a global network of public health laboratories developing candidate virus vaccines. This Editorial aims to present the reasons for concern regarding the emergence of pandemic influenza viruses driven by the social and public health responses to the COVID-19 pandemic and highlights the importance of global influenza surveillance at this time.


Assuntos
COVID-19/epidemiologia , Influenza Humana/epidemiologia , Orthomyxoviridae/imunologia , Pandemias , COVID-19/imunologia , Humanos , Influenza Humana/imunologia , SARS-CoV-2
2.
Med Sci Monit ; 27: e935005, 2021 Oct 11.
Artigo em Inglês | MEDLINE | ID: mdl-34629462

RESUMO

Recent studies on the pathogenesis and clinical spectrum of human disease following infection with the new human pathogen, SARS-CoV-2, have identified the varied presentations and sequelae of COVID-19. Acute 'cytokine storm' in severe COVID-19 results in multiorgan damage due to vascular hyperpermeability, edema, and hypercoagulation. The long-term consequences of infection from SARS-CoV-2 include long COVID. or post-COVID syndrome, and multisystem inflammatory syndrome in children (MIS-C). Several case reports of multisystem inflammatory syndrome in adults (MIS-A) have shown the presentation at more than four weeks after initial infection with SARS-CoV-2 in adults more than 21 years of age. In September 2021, a published systematic review of the literature identified 221 patients with MIS-A, representing the most comprehensive clinical study to date. MIS-A occurs in the post-acute COVID-19 period. The pathogenesis may involve a dysregulated antibody-mediated immune response, similar to MIS-C. Therefore, patients with MIS-A may respond to supportive therapies that control hyperinflammation. This Editorial aims to describe MIS-A and discuss COVID-19 as a spectrum of hyperinflammatory disease in terms of severity, extent, duration, and patient age.


Assuntos
COVID-19/complicações , Síndrome de Resposta Inflamatória Sistêmica/etiologia , COVID-19/genética , COVID-19/imunologia , Síndrome da Liberação de Citocina/etiologia , Síndrome da Liberação de Citocina/genética , Síndrome da Liberação de Citocina/imunologia , Humanos , Síndrome de Resposta Inflamatória Sistêmica/genética , Síndrome de Resposta Inflamatória Sistêmica/imunologia
3.
Med Sci Monit ; 27: e934766, 2021 Sep 20.
Artigo em Inglês | MEDLINE | ID: mdl-34538868

RESUMO

During the past two years, clinical studies have attempted to identify risk factors to predict clinical outcomes following infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In July 2021, a study using a high-throughput technique detected autoantibodies to chemokines, cytokines, and complement components in patients with symptomatic coronavirus disease 2019 (COVID-19). In August 2021, a study identified pre-existing autoantibodies to type 1 interferons (IFNs) in 10% of patients with severe COVID-19 but not asymptomatic individuals. Autoantibodies may be the long-awaited markers of clinical risk for severe COVID-19 in patients with SARS-CoV-2 infection. This Editorial aims to present some recent findings of autoantibodies to components of the immune system, including type 1 IFNs, and the risk of severe COVID-19.


Assuntos
Autoanticorpos/imunologia , COVID-19/imunologia , Interferon Tipo I/imunologia , SARS-CoV-2/imunologia , COVID-19/virologia , Humanos , Interferon Tipo I/genética , SARS-CoV-2/genética
4.
Med Sci Monit ; 27: e934625, 2021 Sep 06.
Artigo em Inglês | MEDLINE | ID: mdl-34483336

RESUMO

In the past 18 months, accelerated vaccine development to prevent or reduce the severity of coronavirus disease 2019 (COVID-19) has resulted in rapid global emergency regulatory approvals, including the US Food and Drug Administration (FDA) emergency use authorization (EUA) approvals. On August 23, 2021, the US FDA gave the first full regulatory approval for a COVID-19 vaccine and approved the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) for individuals 16 years and older. In the US, there is a continued EUA for individuals aged 12-15 years of age. Also, the EUA includes the administration of a third or booster dose in immunocompromised individuals at increased risk for severe COVID-19. This Editorial aims to present an update on the first COVID-19 vaccine to receive full regulatory approval, the Pfizer-BioNTech vaccine, and the implications for real-world public health during the global COVID-19 pandemic and increasing concerns for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concern.


Assuntos
Vacinas contra COVID-19 , COVID-19/prevenção & controle , Política de Saúde , Imunização , Pandemias/prevenção & controle , Humanos
5.
Med Sci Monit ; 27: e934676, 2021 Sep 13.
Artigo em Inglês | MEDLINE | ID: mdl-34511592

RESUMO

Malaria affects more than 3 billion people in 95 countries, with an estimated mortality rate of 400,000 per year. The female Anopheles spp mosquito most commonly transmits malaria, and the main burden of disease is due to Plasmodium falciparum. The most abundant antigen on the sporozoite surface is the Plasmodium falciparum circumsporozoite protein (PfCSP). PfCSP is required for parasite development and attachment to host hepatocytes. The first potential protein vaccine, RTS,S/ASO1, consists of a recombinant fusion antigen based on PfCSP. Initial findings from a phase 3 trial of RTS,S/ASO1 were promising but resulted in recommendations for further evaluation in large-scale trials. R21, a circumsporozoite protein-based vaccine, combined with an adjuvant, Matrix-M (MM), was recently evaluated in a phase 2 investigational study in children between 5-17 months of age in Burkina Faso. The R21/MM candidate vaccine resulted in high titers of malaria-specific antibodies. On August 26, 2021, the findings from a phase 1 trial on a new monoclonal antibody to PfCSP, CIS43LS, showed that a single dose of the CIS43LS monoclonal antibody resulted in protection against malaria. These new findings have implications for the seasonal control of malaria in endemic regions and a possible future role in public health strategies to eliminate malaria. This Editorial aims to provide the background to developing and evaluating the new malaria vaccines that target PfCSP, including the first monoclonal antibody vaccine to malaria.

6.
Med Sci Monit ; 27: e934854, 2021 Sep 27.
Artigo em Inglês | MEDLINE | ID: mdl-34565792

RESUMO

The coronavirus disease 2019 (COVID-19) pandemic has affected the number of completed clinical trials, particularly in oncology. Between 80-85% of all lung cancers are non-small cell lung cancer (NSCLC), and of these, between 2-3% have an EGFR exon 20 insertion, which is associated with increased cell proliferation, metastasis, and a lack of response to chemotherapy and epidermal growth factor receptor (EGFR) inhibitors. Until this year, there were no available targeted therapies for advanced NSCLC with this genetic subtype. However, in May 2021, the US Food and Drug Administration (FDA) granted accelerated approval for amivantamab-vmjw (Rybrevant®), a bispecific monoclonal antibody, targeting activating and resistant EGFR and MET mutations and amplifications. This FDA approval was for adult patients with locally advanced metastatic NSCLC, with disease progression on or following platinum-based chemotherapy. The FDA also approved the Guardant360® companion diagnostic, a next-generation sequencing platform for circulating tumor DNA (ctDNA), which is a liquid biopsy assay. In 2019, Project Orbis was launched by the FDA Oncology Center of Excellence as a global collaborative review program to facilitate rapid global access for patients to innovative cancer therapies. This Editorial aims to highlight how global regulatory initiatives from the FDA have delivered accelerated approval of the first bispecific therapeutic monoclonal antibody, amivantamab-vmjw (Rybrevant®), and a companion diagnostic for patients with advanced NSCLC with an EGFR exon 20 insertion.


Assuntos
Anticorpos Biespecíficos/administração & dosagem , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Aprovação de Drogas , Neoplasias Pulmonares/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/diagnóstico , Carcinoma Pulmonar de Células não Pequenas/genética , Carcinoma Pulmonar de Células não Pequenas/metabolismo , Receptores ErbB/genética , Receptores ErbB/metabolismo , Sequenciamento de Nucleotídeos em Larga Escala , Humanos , Mutação , Proteínas Proto-Oncogênicas c-met/genética , Proteínas Proto-Oncogênicas c-met/metabolismo , Estados Unidos , United States Food and Drug Administration
7.
Med Sci Monit ; 27: e934514, 2021 Aug 30.
Artigo em Inglês | MEDLINE | ID: mdl-34456331

RESUMO

During 2020 and 2021, the COVID-19 pandemic has resulted in interruptions and cancellations of clinical trials and has delayed drug development in all areas except SARS-CoV-2 vaccine development. A further concern is the need to rapidly share anonymized datasets and improve opportunities to conduct randomized clinical trials (RCTs) in low-resource developing countries, particularly for oncology trials and for other infectious diseases. The Consolidated Standards of Reporting Trials (CONSORT) 2010 and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 currently guide the reporting of trial protocols and completed RCTs, respectively. Extenuating circumstances or unavoidable situations may occur that are beyond the control of study sponsors and investigators. On June 21, 2021, the CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstance (CONSERVE) was published. The scope of CONSERVE 2021 includes modifications that have substantive implications for the feasibility, ethical conduct, scientific content, and study analysis. This Editorial aims to provide the background to CONSERVE 2021 and show how these guidelines may reduce the number of clinical trials currently being paused or discontinued due to the COVID-19 pandemic, particularly in poorly resourced and developing countries.


Assuntos
COVID-19/epidemiologia , Protocolos Clínicos/normas , Guias como Assunto , Editoração/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Relatório de Pesquisa/normas , SARS-CoV-2/fisiologia , COVID-19/virologia , Humanos , Estados Unidos/epidemiologia
8.
Med Sci Monit ; 27: e934292, 2021 Aug 09.
Artigo em Inglês | MEDLINE | ID: mdl-34366429

RESUMO

The World Health Organization (WHO) estimated that in 2019, 10.0 million people worldwide developed tuberculosis (TB), with 1.4 million deaths from TB in that year. Infection with Mycobacterium tuberculosis that is resistant to at least isoniazid and rifampin and an additional chemotherapeutic agent is known as multidrug-resistant TB (MDR TB). Until recently, the prevalence of drug resistance in patients with TB has been poorly understood due to a lack of infection surveillance and molecular testing. Countries with the highest prevalence of TB, including MDR TB, are also those most affected by the COVID-19 pandemic. The identification of MDR TB requires careful monitoring and resources for molecular testing. Previous treatment regimens have required intravenous treatments of long duration and high cost. The 2020 and 2021 recommendations from the WHO for the management of drug-susceptible TB and MDR TB have included oral treatment regimens and reduced treatment duration. This Editorial aims to present the rationale for the 2020 and 2021 recommendations from the WHO for the management of drug-susceptible TB and MDR TB.


Assuntos
Tuberculose Resistente a Múltiplos Medicamentos/tratamento farmacológico , Tuberculose Pulmonar/tratamento farmacológico , Tuberculose/tratamento farmacológico , Antituberculosos/uso terapêutico , Protocolos Clínicos/normas , Saúde Global , Humanos , Mycobacterium tuberculosis/isolamento & purificação , Tuberculose/epidemiologia , Tuberculose Resistente a Múltiplos Medicamentos/epidemiologia , Tuberculose Pulmonar/epidemiologia , Organização Mundial da Saúde
9.
Med Sci Monit ; 27: e934129, 2021 Jul 27.
Artigo em Inglês | MEDLINE | ID: mdl-34366427

RESUMO

This manuscript has been retracted at the author's request due to possible conflict of interest.Reference:Dinah V. Parums. Editorial: mRNA Vaccines and Immunotherapy in Oncology: A New Era for Personalized Medicine. Med Sci Monit 2021;27:e933088. DOI: 10.12659/MSM.933088.

10.
Med Sci Monit ; 27: e934393, 2021 Aug 16.
Artigo em Inglês | MEDLINE | ID: mdl-34393218

RESUMO

Regulatory authorities, including the US Food and Drug Administration (FDA), have accelerated diagnostic and therapeutic approvals during the coronavirus disease 2019 (COVID-19) pandemic. Accelerated clinical development and approvals have resulted in vaccine programs for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, some individuals remain at high risk for the progression of COVID-19. In the US, the FDA has given Emergency Use Authorization (EUA) for two neutralizing therapeutic monoclonal antibody 'cocktails,' casirivimab and imdevimab (REGEN-COV), bamlanivimab and etesevimab, and one monotherapy, bamlanivimab, for prophylactic post-exposure therapy in individuals at high risk of progressing to severe COVID-19. Preclinical and clinical studies showed consistent effectiveness of REGEN-COV against current variants of SARS-CoV-2. On 21st November 2020, the FDA approved an initial EUA for REGEN-COV to treat mild to moderate COVID-19 in adults and in children 12 years or older with exposure to SARS-CoV-2 at high risk for progression to severe COVID-19. On 30th July 2021, the FDA updated its EUA for REGEN-COV for emergency use as post-exposure prophylactic to prevent COVID-19 progression in adults and children aged 12 years or older. This Editorial aims to provide an update on accelerated regulatory authorization for post-exposure prophylactic neutralizing monoclonal antibodies to SARS-CoV-2 for individuals at high risk for COVID-19.


Assuntos
Anticorpos Monoclonais/uso terapêutico , COVID-19/tratamento farmacológico , Humanos , Risco , SARS-CoV-2 , Estados Unidos , United States Food and Drug Administration
11.
Med Sci Monit ; 27: e934171, 2021 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-34334785

RESUMO

Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes coronavirus disease 2019 (COVID-19) commonly presents with pneumonia. However, COVID-19 is now recognized to involve multiple organ systems with varying severity and duration. In July 2021, the findings from a retrospective population study from the National COVID Cohort Collaborative (N3C) Consortium were published that included analysis by machine learning methods of 174,568 adults with SARS-CoV-2 infection from 34 medical centers in the US. The study stratified patients for COVID-19 according to the World Health Organization (WHO) Clinical Progression Scale (CPS). Severe clinical outcomes were identified as the requirement for invasive ventilatory support, or extracorporeal membrane oxygenation (ECMO), and patient mortality. Machine learning analysis showed that the factor most strongly associated with severity of clinical course in patients with COVID-19 was pH. A separate multivariable logistic regression model showed that independent factors associated with more severe clinical outcomes included age, dementia, male gender, liver disease, and obesity. This Editorial aims to present the rationale and findings of the largest population cohort of adult patients with COVID-19 to date and highlights the importance of using large population studies with sophisticated analytical methods, including machine learning.


Assuntos
COVID-19 , Aprendizado de Máquina , Adulto , COVID-19/classificação , COVID-19/diagnóstico , COVID-19/epidemiologia , COVID-19/mortalidade , Diagnóstico por Computador , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Estatísticos , Saúde da População , Fatores de Risco , SARS-CoV-2 , Índice de Gravidade de Doença
12.
Med Sci Monit ; 27: e934475, 2021 Aug 23.
Artigo em Inglês | MEDLINE | ID: mdl-34421116

RESUMO

Subjective narrative review articles have an educational and informative role in medical and scientific journals. Systematic review of the literature requires an objective and complete review of all available publications on an identified topic. Systematic review that undergoes meta-analysis aims to provide a complete and objective evaluation of all the published data. Data from systematic review and meta-analysis publications support evidence-based medical practice and are prepared as original research articles. These studies require a clear aim and detailed planning with registration and approval of the study protocol before the study commences. Systematic review and meta-analysis studies are designed, conducted, and reported according to mandatory guidelines. The number of these publications has continued to rise during the past decade. However, concerns with the quality of the studies have resulted in more stringent study guidelines. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement, guidelines, reporting checklist, and study flow diagram from 2009 were updated and published in March 2021 as PRISMA 2020. The Editorial aims to present the roles and requirements of subjective narrative review articles, systematic review of the literature, and systematic review and meta-analysis, and introduces the revisions and aims of the PRISMA 2020 guidelines.

13.
Med Sci Monit ; 27: e933973, 2021 Jul 19.
Artigo em Inglês | MEDLINE | ID: mdl-34276042

RESUMO

Vaccinated, non-vaccinated, and immunosuppressed individuals will continue to be infected with SARS-CoV-2. Therefore, there is a priority to develop treatments that reduce the severity of COVID-19 in patients who require hospital admission. Interleukin-6 (IL-6) is a proinflammatory cytokine. In 2011, a humanized monoclonal antibody to the IL-6 receptor (IL-6R), tocilizumab, was approved by the US Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, giant cell arteritis, and Castleman's disease. In 2017, tocilizumab was approved to treat chimeric antigen receptor (CAR) T-cell therapy-induced cytokine release syndrome (CRS). In 2021, the results of the REMAP-CAP clinical trial (NCT02735707) and the COVID-19 Therapy (RECOVERY) clinical trial (NCT04381936) supported FDA Emergency Use Authorization (EUA) for tocilizumab to treat hospitalized patients with moderate and severe COVID-19. Monoclonal antibodies are currently in clinical development or undergoing clinical trials to treat COVID-19. Further clinical trials will provide safety and efficacy data on targeting IL-6 and IL-6R and provide rationales for more personalized combination treatments to control the systemic effects of SARS-CoV-2 infection in hospitalized patients with moderate and severe COVID-19. This Editorial aims to present the background to the recent authorization of tocilizumab, a humanized therapeutic monoclonal antibody to the IL-6 receptor (IL-6R), for hospitalized patients with moderate and severe COVID-19 and future combination therapies.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , COVID-19/terapia , Interleucina-6/imunologia , Terapia Combinada , Humanos
14.
Med Sci Monit ; 27: e933831, 2021 Jul 05.
Artigo em Inglês | MEDLINE | ID: mdl-34219126

RESUMO

During the global COVID-19 pandemic, data from clinical studies, systematic review, and population registry data have shown that when compared with non-pregnant women, SARS-CoV-2 infection in pregnancy is associated with a small increase in risk to the mother. Large cohort studies and registry data collected from 2020 have included the US Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET), COVI-PREG, the UK and Global Pregnancy and Neonatal Outcomes in COVID-19 (PAN-COVID) study, the American Academy of Pediatrics (AAP) Section on Neonatal-Perinatal Medicine (SONPM) National Perinatal COVID-19 Registry, the Swedish Pregnancy Register, and the Canadian Surveillance of COVID-19 in Pregnancy (CANCOVID-Preg) registry. Recently published data have shown that most maternal infections with SARS-CoV-2 occur during the third trimester and result in a small increase in hospital admission, admission to the intensive care unit (ICU), mechanical ventilation, preterm birth, and increased cesarean sections in mothers infected with SARS-CoV-2. However, currently approved vaccines given in pregnancy result in an immune response to current SARS-CoV-2 variants. Transplacental transmission of SARS-CoV-2 to the fetus can occur, but the immediate and long-term effects on the newborn infant remain unclear. Therefore, women who are pregnant or planning a pregnancy should be managed according to current clinical guidelines with timely vaccination to prevent infection with SARS-CoV-2. This Editorial summarizes what is currently known about maternal SARS-CoV-2 infection and pregnancy outcomes from multinational studies.


Assuntos
COVID-19/epidemiologia , Complicações Infecciosas na Gravidez/epidemiologia , Nascimento Prematuro/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/uso terapêutico , Cesárea/estatística & dados numéricos , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Transmissão Vertical de Doenças Infecciosas , Unidades de Terapia Intensiva/estatística & dados numéricos , Gravidez , Complicações Infecciosas na Gravidez/prevenção & controle , Resultado da Gravidez , Respiração Artificial/estatística & dados numéricos , SARS-CoV-2
15.
Med Sci Monit ; 27: e934077, 2021 Jul 26.
Artigo em Inglês | MEDLINE | ID: mdl-34305135

RESUMO

Current treatments for patients with Alzheimer's disease aim to improve behavioral, cognitive, and non-cognitive symptoms. There have been no new drug approvals for preventing or treating Alzheimer's disease for more than two decades. Drug development in Alzheimer's disease aims to identify disease-modifying therapies that will delay or slow the clinical course of this disease. More than 50% of the current Alzheimer's disease drug pipeline now involves immunotherapies or oral small molecule agents. The most promising disease-modifying drug targets are amyloid ß and tau protein. In June 2021, aducanumab, a humanized recombinant monoclonal antibody to amyloid ß, was the first potential disease-modifying therapy approved by the US Food and Drug Administration (FDA) to treat Alzheimer's disease and mild cognitive impairment. Accelerated approval of aducanumab was based on the results of only one of two phase 3 clinical trials. Several clinical trials of targeted disease-modifying immunotherapies to the tau protein and amyloid ß that commenced before the current COVID-19 pandemic have been delayed. This Editorial aims to provide an update on past, present, and future disease-modifying therapies in Alzheimer's disease, including targeted therapies for amyloid ß and tau protein.


Assuntos
Doença de Alzheimer/tratamento farmacológico , Doença de Alzheimer/metabolismo , Peptídeos beta-Amiloides/metabolismo , Proteínas tau/metabolismo , Anticorpos Monoclonais Humanizados/uso terapêutico , Disfunção Cognitiva/tratamento farmacológico , Disfunção Cognitiva/imunologia , Humanos , Imunoterapia/métodos , Imunoterapia/tendências , Tauopatias/tratamento farmacológico
16.
Med Sci Monit ; 27: e933675, 2021 Jun 28.
Artigo em Inglês | MEDLINE | ID: mdl-34176921

RESUMO

Artificial intelligence (AI) in clinical medicine includes physical robotics and devices and virtual AI and machine learning. Concerns have been raised regarding ethical issues for the use of AI in surgery, including guidance for surgical decisions, patient confidentiality, and the need for support from controlled clinical trials to use these methods so that clinical guidelines can be developed. The most common applications for virtual AI include disease diagnosis, health monitoring and digital patient consultations, clinical training, patient data management, drug development, and personalized medicine. In September 2020, the CONSORT-A1 extension was developed with 14 additional items that should be reported for AI studies that include clear descriptions of the AI intervention, skills required, study setting, inputs and outputs of the AI intervention, analysis of errors, and the human and AI interactions. This Editorial aims to present current applications and challenges of AI in clinical medicine and the importance of the new 2020 CONSORT-AI study guidelines.

17.
Med Sci Monit ; 27: e933446, 2021 Jun 07.
Artigo em Inglês | MEDLINE | ID: mdl-34092779

RESUMO

During 2020, increasing numbers of case reports, case series, and small observational studies reported long-term complications of coronavirus disease 2019 (COVID-19) in patients who had recovered from acute infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Long COVID has a prevalence of between 10-30% in patients with a recent history of SARS-CoV-2 infection. Pulmonary, hematologic, cardiovascular, neuropsychiatric, renal, endocrine, gastrointestinal and hepatobiliary, and dermatologic involvement, and chronic multisystem inflammatory syndrome in children (MIS-C) highlights the requirement for a multidisciplinary approach to the management of patients with long COVID. This Editorial aims to present the current status of long COVID, or post-COVID syndrome, and its global impact on health and the provision of health care.


Assuntos
COVID-19/complicações , COVID-19/epidemiologia , COVID-19/economia , COVID-19/metabolismo , COVID-19/terapia , Convalescença , Atenção à Saúde , Humanos , Pandemias , Recuperação de Função Fisiológica , SARS-CoV-2/isolamento & purificação
18.
Med Sci Monit ; 27: e933554, 2021 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-34149048

RESUMO

Patient registries include data on patient diagnosis, demographics, treatment, and outcomes and are now fundamental to the provision of successful global health systems. Patient registries include mainly local, regional, and national patient data on general or specific patient groups. Global registries currently exist mainly for rare diseases. Some of the most studied registries include the national Surveillance, Epidemiology, and End Results (SEER) program and the hospital-based Medical Information Mart for Intensive Care (MIMIC-III) dataset. The limitations of registry databases have included lack of feedback from clinical studies to the clinical center, the lack of patient involvement, and limited findings on patient-reported outcomes (PROs). In September 2020, the European Medicines Agency (EMA) published its draft guidelines on registry-based clinical studies. Guidelines for the development and analysis of registry data will improve the quality and registry-based studies and increase the role of registry data to support clinical trials. This Editorial aims to present the current status of registries and population databases in clinical research and practice.

19.
Med Sci Monit ; 27: e933369, 2021 May 31.
Artigo em Inglês | MEDLINE | ID: mdl-34075014

RESUMO

In early 2020, at the beginning of the coronavirus disease 2019 (COVID-19) pandemic due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), rare cases were reported in children and adolescents of multisystem inflammatory syndrome in children (MIS-C). MIS-C is characterized by fever, systemic inflammation, and multiorgan dysfunction and usually presents late in SARS-CoV-2 infection. Since May 2020, the Centers for Disease Control and Prevention (CDC) has recorded all reported cases of COVID-19 and MIS-C in children and adolescents in the USA. In April 2021, the American College of Rheumatology (ACR) revised its clinical guidelines for diagnosing and managing hyperinflammation and MIS-C. There are several challenges ahead for preventing, diagnosing, and managing MIS-C, particularly following the rapid emergence of new strains of SARS-CoV-2. This Editorial aims to present an update on the current status of the clinical presentation, diagnosis, and management of MIS-C and includes some updates from population studies and clinical guidelines.


Assuntos
COVID-19/diagnóstico , COVID-19/terapia , Síndrome de Resposta Inflamatória Sistêmica/diagnóstico , Síndrome de Resposta Inflamatória Sistêmica/terapia , Adolescente , Teste para COVID-19 , Criança , Gerenciamento Clínico , Humanos , SARS-CoV-2/isolamento & purificação
20.
Med Sci Monit ; 27: e932986, 2021 May 05.
Artigo em Inglês | MEDLINE | ID: mdl-33947822

RESUMO

The Oxford-AstraZeneca vaccine, ChAdOx1 nCoV-19 (AZD1222), uses double-stranded DNA, while the Pfizer-BioNTech and Moderna vaccines include single-stranded RNA to encode the SARS-CoV-2 spike protein.Reference:Parums DV. Editorial: SARS-CoV-2 mRNA Vaccines and the Possible Mechanism of Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT). Med Sci Monit 2021; 27:e932899; 10.12659/MSM.932899.

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