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1.
Lima; Perú. Ministerio de Salud; 20201000. 12 p. ilus.
Monografia em Espanhol | LILACS, MINSAPERU | ID: biblio-1122245

RESUMO

El documento contiene los lineamientos técnicos operativos de validación de los procedimientos de seguridad, calidad y desempeño de los dispositivos médicos en etapa de investigación en el contexto de la autorización sanitaria excepcional.


Assuntos
Pesquisa , Segurança , Gestão da Qualidade , Estudo de Validação , Equipamentos e Provisões
3.
Biomed Res Int ; 2020: 2606058, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33029499

RESUMO

On March 11th, 2020, the World Health Organization declared COVID-19 infection as a pandemic. Since it is a novel virus, there are basically no proven drugs or therapies; although many laboratories in different countries are working to develop a vaccine, it will take time to make it available. Passive immunization is the therapy born from the intuition of Behring and Kisato in the late 19th century. It was widely used for the treatment of bacterial infections until the discovery of antibiotics, as well as during the viral pandemics of the 20th century and of the beginning of the 21st; it still has clinical applications (e.g., tetanus prevention). This paper summarizes the basic principles of passive immunization, with particular reference to convalescent plasma. The literature concerning its use during past epidemics and the results of the first clinical studies concerning its use during the current pandemic are discussed too. A large section is dedicated to the analysis of the possible, although rare, side effects. Recently, in 2017, the WHO Blood Regulators Network (BRN) published a position paper, recommending convalescent plasma as the first-choice treatment to be tested in the absence of authorized drugs; however, this strategy has not been followed. In the current epidemic, the principle of passive immunization through convalescent plasma has been applied in several circumstances and particularly in patients with serious complications. The first reported results are encouraging and confirm the effectiveness of plasma therapy and its safety. Also, the FDA has proposed plasma treatment in order to face the increasingly complex situation and manage patients with serious or immediately life-threatening COVID-19 disease. Several studies and clinical programs are still ongoing.


Assuntos
Infecções por Coronavirus/terapia , Pneumonia Viral/terapia , Betacoronavirus/imunologia , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/imunologia , Humanos , Imunização Passiva/efeitos adversos , Imunização Passiva/métodos , Pandemias , Pneumonia Viral/epidemiologia , Pneumonia Viral/imunologia , Segurança , Resultado do Tratamento , Estados Unidos , United States Food and Drug Administration , Organização Mundial da Saúde
4.
Biomed Res Int ; 2020: 3292916, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33029503

RESUMO

In December of 2019, there was an outbreak of a severe acute respiratory syndrome caused by the coronavirus 2 (SARS-CoV-2 or COVID-19) in China. The virus rapidly spread into the whole world causing an unprecedented pandemic and forcing governments to impose a global quarantine, entering an extreme unknown situation. The organizational consequences of quarantine/isolation are absence of organized training and competition, lack of communication among athletes and coaches, inability to move freely, lack of adequate sunlight exposure, and inappropriate training conditions. The reduction of mobility imposed to contain the advance of the SARS-Cov-2 pandemic can negatively affect the physical condition and health of individuals leading to muscle atrophy, progressive loss of muscle strength, and reductions in neuromuscular and mechanical capacities. Resistance training (RT) might be an effective tool to counteract these adverse consequences. RT is considered an essential part of an exercise program due to its numerous health and athletic benefits. However, in the face of the SARS-Cov-2 outbreak, many people might be concerned with safety issues regarding its practice, especially in indoor exercise facilities, such as gyms and fitness centers. These concerns might be associated with RT impact in the immune system, respiratory changes, and contamination due to equipment sharing and agglomeration. In this current opinion article, we provide insights to address these issues to facilitate the return of RT practices under the new logistical and health challenges. We understand that RT can be adapted to allow its performance with measures adopted to control coronavirus outbreak such that the benefits would largely overcome the potential risks. The article provides some practical information to help on its implementation.


Assuntos
Infecções por Coronavirus/epidemiologia , Pandemias , Pneumonia Viral/epidemiologia , Treinamento de Resistência/efeitos adversos , Treinamento de Resistência/métodos , Betacoronavirus , China/epidemiologia , Infecções por Coronavirus/fisiopatologia , Infecções por Coronavirus/transmissão , Desinfecção/métodos , Humanos , Sistema Imunitário/fisiopatologia , Pandemias/prevenção & controle , Pneumonia Viral/fisiopatologia , Pneumonia Viral/transmissão , Treinamento de Resistência/instrumentação , Sistema Respiratório/fisiopatologia , Fatores de Risco , Segurança
5.
Int Marit Health ; 71(3): 184-190, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33001430

RESUMO

BACKGROUND: Work-related stress among seafarers is well known but a suspected excess of work-related stress due to the COVID-19 so far has not been published. The aim of the study was to evaluate the well- -being of the seafarers during the outbreak of COVID-19 pandemic and their evaluation of the precautions taken by the shipping companies. MATERIALS AND METHODS: Seventy-two seafarers completed the General Health Questionnaire (GHQ12) with three extra questions on how the COVID-19 precautions were taken on board. RESULTS: The mean Likert score was 13.9 for the whole sample, corresponding to "no problems" while a subgroup of 40% had mean Likert sum scores of 16.1 (level 15-23) corresponding to "starting problems." In response to the extra items, 50% of the seafarers did not feel safe doing their job in relation to the epidemic and 60% did not think everything has been done to ensure their health at work in relation to the epidemic. Thirty per cent suffered of insomnia to the extent of becoming concerned and 26% had been unhappy and depressed during the latest tours of duty. CONCLUSIONS: The hypothesis that excess work-related stress has been put on the seafarers in this specific situation was confirmed and calls for prevention. A combination of person-focused and organisation-focused prevention approaches has been advocated as the most promising for alleviation of job stress in the workplaces at sea.


Assuntos
Infecções por Coronavirus/psicologia , Medicina Naval , Estresse Ocupacional/epidemiologia , Pneumonia Viral/psicologia , Adolescente , Adulto , Betacoronavirus , Criança , Infecções por Coronavirus/prevenção & controle , Estudos Transversais , Humanos , Masculino , Mar Mediterrâneo , Pessoa de Meia-Idade , Estresse Ocupacional/psicologia , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Segurança , Distúrbios do Início e da Manutenção do Sono , Estresse Psicológico/epidemiologia , Inquéritos e Questionários
6.
ScientificWorldJournal ; 2020: 7945309, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33029109

RESUMO

As early as December 2019 in the province of Hubei, China, contamination of patients with pneumonia of an unknown etiology occurred. These patients presented with symptoms such as coughing, sore throat, malaise, diarrhea, high fever, and dyspnea. This emerging disease was named COVID-19 due to being part of the group of coronaviruses (CoVs) belonging to the subfamily Orthocoronavirinae, in the Coronaviridae family and in the Nidovirales order. COVID-19 is most commonly transmitted through speech, coughing, sneezing, and salivary sputum. Because dental professionals work closely with the oral cavity, it is imperative that infection prevention controls are strictly adhered to. It is important that the dental profession treats patients while also limiting the possible contamination through the production of aerosol in the dental environment. Furthermore, the dental professional also has a key role in raising awareness and guidance amongst the population concerning COVID-19 related biosafety measures. This literature review aims to inform dental professionals about the COVID-19 pandemic and to present the implications of the virus to the dentist. Dental professionals are considered to be at high risk for contracting SARS-CoV-2.


Assuntos
Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/transmissão , Odontólogos , Procedimentos Cirúrgicos Bucais , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Pneumonia Viral/transmissão , Papel Profissional , Segurança , Infecções por Coronavirus/epidemiologia , Humanos , Segurança do Paciente , Pneumonia Viral/epidemiologia , Medição de Risco
7.
Medicine (Baltimore) ; 99(40): e22547, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019465

RESUMO

BACKGROUND: chronic low back pain (CLBP) are common symptoms bothering people in daily life. Traditional Chinese medicine (TCM) nonpharmacological interventions are gaining an increasing popularity for CLBP. Nevertheless, the evidence of efficacy and safety of random controlled trials (RCTs) remains controversial. This study aims to evaluate the efficacy and acceptability of different TCM nonpharmacological therapies by systematic review and network meta-analysis. METHODS: According to the strategy, The authors will retrieve a total of 7 electronic databases by September 2020, including PubMed, the Cochrane Library, EMbase, China National Knowledge Infrastructure, China Biological Medicine, Chongqing VIP, and Wan-fang databases After a series of screening, 2 researchers will use Aggregate Data Drug Information System and Stata software to analyze the data extracted from the randomized controlled trials of TCM nonpharmacological interventions for CLBP. The primary outcome will be the improvement of Pain intensity and functional status/disability and the secondary outcomes will include lobal improvement, health-related quality of life, satisfaction with treatment, and adverse events. Both classical meta-analysis and network meta-analysis will be implemented to investigate direct and indirect evidences on this topic. The quality of the evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation instrument. RESULTS: This study will provide a reliable evidence for the selection of TCM nonpharmacological therapies in the treatment of CLBP. CONCLUSION: This study will generate evidence for different TCM nonpharmacological therapies for CLBP and provide a decision-making reference for clinical research. ETHICS AND DISSEMINATION: This study does not require ethical approval. The results will be disseminated through a peer-reviewed publication. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/4H3Y9.


Assuntos
Dor Lombar/terapia , Medicina Tradicional Chinesa/métodos , Metanálise em Rede , Acupressão/métodos , Terapia por Acupuntura/métodos , Tomada de Decisão Clínica , Ventosaterapia/métodos , Bases de Dados Factuais , Humanos , Dor Lombar/psicologia , Medicina Tradicional Chinesa/efeitos adversos , Medicina Tradicional Chinesa/tendências , Moxibustão/métodos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Segurança , Tai Ji/métodos , Resultado do Tratamento
8.
Medicine (Baltimore) ; 99(40): e22564, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019468

RESUMO

BACKGROUND: At present, the prevalence of type 2 diabetes mellitus (T2DM) has become a major public health issue throughout the world, especially in developing countries. Notably, traditional Chinese patent medicines (TCPMs) are of great significance in the treatment of T2DM combined with conventional Western medicine therapy. However, there is a lack of comparison among all the current common TCPMs for treating T2DM. Therefore, this study intends to explore the efficacy and safety of different TCPMs against T2DM through the Bayesian network meta-analysis (NMA). METHODS: We will conduct a comprehensive and systematic search for randomized controlled trials (RCTs) of TCPM for the treatment of T2DM in both Chinese and English databases published till August 2020. Two researchers will be responsible for screening eligible literature, extracting data, and assessing the risk of bias of included studies independently. Then, pairwise meta-analyses and Bayesian network meta-analyses will be conducted to assess all available evidence. In the end, data will be analyzed using STATA15.0 and WinBUGS1.4.3 software. CONCLUSION: This study will compare the efficacy and safety of different TCPMs against T2DM in detail. Our findings will provide a reliable evidence for selecting clinical treatment program and guideline development of T2DM.


Assuntos
Diabetes Mellitus Tipo 2/terapia , Medicina Tradicional Chinesa/métodos , Medicamentos sem Prescrição/efeitos adversos , Teorema de Bayes , Diabetes Mellitus Tipo 2/epidemiologia , Feminino , Humanos , Masculino , Metanálise em Rede , Medicamentos sem Prescrição/uso terapêutico , Prevalência , Ensaios Clínicos Controlados Aleatórios como Assunto , Segurança , Resultado do Tratamento
9.
Medicine (Baltimore) ; 99(40): e22586, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019475

RESUMO

BACKGROUND: Neurodermatitis is a common inflammatory and allergic disease, characterized by itching and lichenification plaque. Some studies have reported cupping therapy (CT) for the treatment of neurodermatitis. However, the effectiveness and safety are still uncertain. This study aims to evaluate the efficacy and safety of CT for the treatment of patients with neurodermatitis. METHODS: We will retrieve the following electronic databases systematically: Pubmed, Web of Science, Embase, the Cochrane Library, Chinese Scientific Journal Database, China National Knowledge Infrastructure Database, Chinese Biomedical Literature Database, and Wanfang database from their inception to December 2020. Other literature resources will be manually searched. Published randomized controlled trials (RCTs) and quasi-randomized controlled trials (q-RCTs) on the topic will be retrieved by 2 investigators independently. We will apply a fixed-effect model or random effect model basis on the heterogeneity test and employ with RevMan 5.3 software for data synthesis. The total clinical effective rate will be selected as the primary outcome, skin disease quality of life index score, recurrence rate, and adverse events as secondary outcomes. RESULTS: This study will comprehensively summarize the high-quality trials to determine the efficacy and safety of CT for the treatment of patients with neurodermatitis. CONCLUSION: Our systematic review will present evidence for the efficacy and safety of CT to neurodermatitis patients. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/6DCM3.


Assuntos
Ventosaterapia/métodos , Medicina Tradicional Chinesa/métodos , Neurodermatite/terapia , Prurido/etiologia , Protocolos Clínicos , Ventosaterapia/efeitos adversos , Feminino , Humanos , Erupções Liquenoides/etiologia , Erupções Liquenoides/patologia , Masculino , Medicina Tradicional Chinesa/efeitos adversos , Neurodermatite/patologia , Neurodermatite/psicologia , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Segurança , Resultado do Tratamento
10.
Medicine (Baltimore) ; 99(40): e22588, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019476

RESUMO

BACKGROUND: The objective of this meta-analysis was to summarize and identify the available evidence from studies to estimate the clinical value of traditional Chinese medicine (TCM) in the treatment of recurrent aphthous stomatitis (RAS) and provides clinicians with evidence on which to base their clinical decision making. METHODS: This review will include all studies comparing clinical efficacy of TCM in the treatment of RAS. The search strategy will be performed in 9 databases. We will not establish any limitations to language and publication status, published from inception to the August 2020. Two reviewers will screen, select studies, extract data, and assess quality independently. Outcome is clinical efficacy, pain relief, duration of wound healing, effect on wound healing, rate of recurrence, adverse events, and safety. The methodological quality including the risk of bias of the included studies will be evaluated. We will carry out statistical analysis using RevMan 5.3 software. RESULTS: This study will summarize current evidence to assess the efficacy and safety of TCM in the treatment of RAS. CONCLUSION: The findings of this study will provide helpful evidence for the clinician, and will promote further studies, as well as studying the value of TCM. REGISTRATION NUMBER: INPLASY202080126 (DOI number: 10.37766/inplasy2020.8.0126).


Assuntos
Medicina Tradicional Chinesa/métodos , Medição da Dor/estatística & dados numéricos , Estomatite Aftosa/terapia , China/epidemiologia , Tomada de Decisão Clínica , Feminino , Humanos , Incidência , Masculino , Medicina Tradicional Chinesa/efeitos adversos , Estudos Observacionais como Assunto , Medição da Dor/efeitos dos fármacos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Segurança , Estomatite Aftosa/epidemiologia , Resultado do Tratamento , Cicatrização/efeitos dos fármacos
11.
Medicine (Baltimore) ; 99(40): e22589, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019477

RESUMO

BACKGROUND: Trigeminal neuralgia (TN) is a disease accompanied by severe facial pain, which seriously affects the daily life of patients. Acupuncture is widely used by Traditional Chinese Medicine doctors to treat various painful diseases. Acupuncture combined with the treatment of trigeminal neuralgia can increase the analgesic effect and reduce side effects. However, there is still a lack of more quality multi-center clinical controlled trials and comprehensive meta-analysis, and a lack of more comprehensive and stronger evidence-based medical evidence. METHODS: The 2 reviewers used the same search strategy to search CNKI, PubMed, Web of Science, Cochrane Library, Scopus, EBSCO, and the search date is until July 19, 2020. Two people read the retrieved literatures independently, and then delete duplications. Then, use the "risk of bias" tool in Cochrane Handbook 5.2 to score. Only documents with a score greater than 5 can be included. Make a table of literature characteristics, extract baseline patient data, research methods and possible risks of bias in the literature, interventions in treatment and control groups, outcome evaluation indicators (BNI, VAS, ER and AE), and research funding support. Use Review Manager 5.3.5 for meta-analysis, use Stata 15 for regression analysis to find the source of heterogeneity, and then perform subgroup analysis to resolve the heterogeneity based on the corresponding source. RESULTS: The analysis of BNI, VAS, ER and AE data can provide high-quality evidence for high-quality synthesis and/or descriptive analysis of the effectiveness and safety of acupuncture treatment of various causes of urinary retention. CONCLUSION: This study can provide more comprehensive and strong evidence to prove whether acupuncture is effective and safe in the treatment of TN patients. REGISTRATION: The research has been registered and approved on the PROSPERO website. The registration number is CRD42019119606.


Assuntos
Terapia por Acupuntura/métodos , Medicina Tradicional Chinesa/métodos , Neuralgia do Trigêmeo/terapia , Terapia por Acupuntura/efeitos adversos , Estudos de Avaliação como Assunto , Dor Facial/etiologia , Dor Facial/terapia , Feminino , Humanos , Masculino , Medicina Tradicional Chinesa/efeitos adversos , Avaliação de Resultados em Cuidados de Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Segurança , Resultado do Tratamento , Neuralgia do Trigêmeo/patologia , Retenção Urinária/etiologia , Escala Visual Analógica
12.
Medicine (Baltimore) ; 99(40): e22596, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019479

RESUMO

BACKGROUND: The pathophysiologic of vascular malformations is still unclear, and the treatment of vascular malformations is a challenge. With improvement in the understanding of pathogenesis of vascular malformations, sirolimus has been a promising and effective treatment. As so far, there is absent convincing evidence to confirm the efficacy of sirolimus for vascular malformations. The purpose of this study was to evaluate the effectiveness and safety of sirolimus in the treatment of vascular malformations. METHODS: The literatures about the management of vascular malformations with sirolimus would be searched from databases of MEDLINE, EMBASE, PubMed, Web of Science, Clinicaltrials.org., Cochrane Library, China Biology Medicine Database (CBM), Wan Fang Database, China National Knowledge Infrastructure Database (CNKI), and VIP Science Technology Periodical Database. We will search each database from inception or 1995 to August 20, 2020. Two researchers worked independently on literature selection, data extraction and quality assessment. The efficacy and safety of sirolimus in the treatment of vascular malformations were the main outcomes. Adverse events after sirolimus were evaluated as the secondary outcomes. The included studies will be analyzed by Review Manager 5.3. If the results are applicable, meta-analysis would also be performed. RESULTS: The study will evaluate the efficacy and safety of sirolimus in the treatment of vascular malformations based on current evidence. CONCLUSION: The conclusion of this study will provide more reliable, evidence-based data for the use of sirolimus in the treatment of vascular malformations. PROSPERO REGISTRATION NUMBER: CRD42020167881.


Assuntos
Imunossupressores/uso terapêutico , Sirolimo/uso terapêutico , Malformações Vasculares/tratamento farmacológico , Gerenciamento de Dados , Feminino , Humanos , Imunossupressores/efeitos adversos , Masculino , Projetos de Pesquisa , Segurança , Sirolimo/efeitos adversos , Serina-Treonina Quinases TOR/efeitos dos fármacos , Serina-Treonina Quinases TOR/metabolismo , Resultado do Tratamento , Malformações Vasculares/fisiopatologia
13.
Medicine (Baltimore) ; 99(40): e22598, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019480

RESUMO

BACKGROUND: Early diagnosis and treatment of the osteonecrosis of the femoral head (ONFH), a refractory disease, is imperative to prevent femoral head collapse; however, the existing solutions remain controversial. This study assessed the safety and efficacy of extracorporeal shock wave therapy (ESWT) combined with multiple drilling and intramedullary drug injection, a novel cocktail therapy, as a randomized controlled trial (RCT) model to postulate an alternative therapy for patients with early-stage ONFH. METHODS: Femoral head necrosis patients aged 20 to 60 years with stage ARCO I-II were recruited. One hundred twenty eligible participants were randomized into four groups in a 1:1:1:1 ratio: extracorporeal shock wave therapy combined with multiple drilling and intramedullary drug injection (group EMI), extracorporeal shock wave therapy (group E), multiple drilling combined with intramedullary drug injection (group MI), and multiple drilling ("positive" control group; group M). The primary outcomes included effective rate, subchondral collapse rate of the femoral head, lesion size, and grade of bone marrow edema. Secondary outcomes included the Harris Hip Score and the visual analog scale. All outcomes were measured at the screening visit (baseline) and at the planned time intervals during treatment and follow-up, and the efficacy was statistically analyzed according to the intention-to-treat sub-populations and per-protocol sub-populations. OBJECTIVES: To examine the clinical efficacy of ESWT combined with multiple drilling and intramedullary drug injection to provide a safe and more effective method for treating early-stage ONFH. TRIAL REGISTRATION NUMBER: ChiCTR1900020888; Pre-results.


Assuntos
Tratamento por Ondas de Choque Extracorpóreas/métodos , Necrose da Cabeça do Fêmur/terapia , Cabeça do Fêmur/patologia , Infusões Intraósseas/instrumentação , Adulto , Artroplastia Subcondral/efeitos adversos , Artroplastia Subcondral/métodos , Doenças da Medula Óssea/patologia , Protocolos Clínicos , Terapia Combinada/métodos , Diagnóstico Precoce , Edema/induzido quimicamente , Feminino , Cabeça do Fêmur/efeitos dos fármacos , Necrose da Cabeça do Fêmur/classificação , Seguimentos , Humanos , Infusões Intraósseas/métodos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Segurança , Resultado do Tratamento , Escala Visual Analógica
14.
J Breath Res ; 14(4): 040202, 2020 10 06.
Artigo em Inglês | MEDLINE | ID: mdl-33021207

RESUMO

In contrast to blood and urine samples, breath is invisible and ubiquitous in the environment. Different precautions are now necessary beyond the usual 'Universal Precautions'. In the era of COVID-19, breath (especially the aerosol fraction) can no longer be considered as harmless in the clinic or laboratory. As Journal of Breath Research is a primary resource for breath-related research, we (the editors) are presently developing safety guidance applicable to all breath research , not just for those projects that involve known COVID-19 infected subjects. We are starting this process by implementing requirements on reporting safety precautions in research papers and notes. This editorial announces that authors of all new submissions to JBR henceforth must state clearly the procedures undertaken for assuring laboratory and clinical safety, much like the existing requirements for disclosing Ethics Committee or Institutional Review Board protocols for studies on human subjects. In the following, we additionally make some recommendations based on best practices drawn from our experience and input from the JBR Editorial Board.


Assuntos
Pesquisa Biomédica/tendências , Testes Respiratórios , Controle de Doenças Transmissíveis , Infecções por Coronavirus/epidemiologia , Pneumonia Viral/epidemiologia , Aerossóis , Betacoronavirus , Pesquisa Biomédica/normas , Humanos , Pandemias , Equipamento de Proteção Individual , Saúde Pública , Risco , Segurança
15.
Lima; Perú. Ministerio de Salud; 20200900. 27 p.
Monografia em Espanhol | LILACS, MINSAPERU | ID: biblio-1118679

RESUMO

El documento contiene los criterios de calidad, seguridad y eficiencia de vacunas en investigación, destinadas a la prevención de enfermedades infecciosas.


Assuntos
Pesquisa , Segurança , Vacinas , Saúde , Doenças Transmissíveis , Eficiência , Prevenção de Doenças , Normas Técnicas
16.
Undersea Hyperb Med ; 47(3): 405-413, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32931666

RESUMO

Objective: Given the high mortality and prolonged duration of mechanical ventilation of COVID-19 patients, we evaluated the safety and efficacy of hyperbaric oxygen for COVID-19 patients with respiratory distress. Methods: This is a single-center clinical trial of COVID-19 patients at NYU Winthrop Hospital from March 31 to April 28, 2020. Patients in this trial received hyperbaric oxygen therapy at 2.0 atmospheres of pressure in monoplace hyperbaric chambers for 90 minutes daily for a maximum of five total treatments. Controls were identified using propensity score matching among COVID-19 patients admitted during the same time period. Using competing-risks survival regression, we analyzed our primary outcome of inpatient mortality and secondary outcome of mechanical ventilation. Results: We treated 20 COVID-19 patients with hyperbaric oxygen. Ages ranged from 30 to 79 years with an oxygen requirement ranging from 2 to 15 liters on hospital days 0 to 14. Of these 20 patients, two (10%) were intubated and died, and none remain hospitalized. Among 60 propensity-matched controls based on age, sex, body mass index, coronary artery disease, troponin, D-dimer, hospital day, and oxygen requirement, 18 (30%) were intubated, 13 (22%) have died, and three (5%) remain hospitalized (with one still requiring mechanical ventilation). Assuming no further deaths among controls, we estimate that the adjusted subdistribution hazard ratios were 0.37 for inpatient mortality (p=0.14) and 0.26 for mechanical ventilation (p=0.046). Conclusion: Though limited by its study design, our results demonstrate the safety of hyperbaric oxygen among COVID-19 patients and strongly suggests the need for a well-designed, multicenter randomized control trial.


Assuntos
Betacoronavirus , Infecções por Coronavirus/terapia , Oxigenação Hiperbárica/métodos , Pneumonia Viral/terapia , Pontuação de Propensão , Síndrome do Desconforto Respiratório do Adulto/terapia , Adulto , Idoso , Pressão Atmosférica , Estudos de Casos e Controles , Infecções por Coronavirus/complicações , Infecções por Coronavirus/mortalidade , Feminino , Humanos , Oxigenação Hiperbárica/efeitos adversos , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/complicações , Pneumonia Viral/mortalidade , Respiração Artificial/mortalidade , Síndrome do Desconforto Respiratório do Adulto/etiologia , Síndrome do Desconforto Respiratório do Adulto/mortalidade , Fatores de Risco , Segurança , Análise de Sobrevida , Fatores de Tempo , Resultado do Tratamento
17.
Nat Microbiol ; 5(10): 1185-1191, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32908214

RESUMO

Antibody-based drugs and vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are being expedited through preclinical and clinical development. Data from the study of SARS-CoV and other respiratory viruses suggest that anti-SARS-CoV-2 antibodies could exacerbate COVID-19 through antibody-dependent enhancement (ADE). Previous respiratory syncytial virus and dengue virus vaccine studies revealed human clinical safety risks related to ADE, resulting in failed vaccine trials. Here, we describe key ADE mechanisms and discuss mitigation strategies for SARS-CoV-2 vaccines and therapies in development. We also outline recently published data to evaluate the risks and opportunities for antibody-based protection against SARS-CoV-2.


Assuntos
Anticorpos Facilitadores , Betacoronavirus , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/terapia , Pneumonia Viral/imunologia , Pneumonia Viral/terapia , Vacinas Virais/efeitos adversos , Animais , Anticorpos Monoclonais/administração & dosagem , Anticorpos Neutralizantes/administração & dosagem , Anticorpos Antivirais/administração & dosagem , Anticorpos Antivirais/imunologia , Anticorpos Facilitadores/imunologia , Betacoronavirus/imunologia , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/prevenção & controle , Humanos , Imunização Passiva/efeitos adversos , Técnicas In Vitro , Modelos Imunológicos , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Doenças Respiratórias/etiologia , Doenças Respiratórias/imunologia , Fatores de Risco , Segurança , Vacinas Virais/imunologia
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