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BACKGROUND: Trimodulin (human polyvalent immunoglobulin [Ig] M ~ 23%, IgA ~ 21%, IgG ~ 56% preparation) has previously been associated with a lower mortality rate in a subpopulation of patients with severe community-acquired pneumonia on invasive mechanical ventilation (IMV) and with clear signs of inflammation. The hypothesis for the ESsCOVID trial was that trimodulin may prevent inflammation-driven progression of severe coronavirus disease 2019 (COVID-19) to critical disease or even death. METHODS: Adults with severe COVID-19 were randomised to receive intravenous infusions of trimodulin or placebo for 5 consecutive days in addition to standard of care. The primary efficacy endpoint was a composite of clinical deterioration (Days 6-29) and 28-day all-cause mortality (Days 1-29). RESULTS: One-hundred-and-sixty-six patients received trimodulin (n = 84) or placebo (n = 82). Thirty-three patients died, nine during the treatment phase. Overall, 84.9% and 76.5% of patients completed treatment and follow-up, respectively. The primary efficacy endpoint was reported in 33.3% of patients on trimodulin and 34.1% of patients on placebo (P = 0.912). No differences were observed in the proportion of patients recovered on Day 29, days of invasive mechanical ventilation, or intensive care unit-free days. Rates of treatment-emergent adverse events were comparable. A post hoc analysis was conducted in patients with early systemic inflammation by excluding those with high CRP (> 150 mg/L) and/or D-dimer (≥ 3 mg/L) and/or low platelet counts (< 130 × 109/L) at baseline. Forty-seven patients in the trimodulin group and 49 in the placebo group met these criteria. A difference of 15.5 percentage points in clinical deterioration and mortality was observed in favour of trimodulin (95% confidence interval: -4.46, 34.78; P = 0.096). CONCLUSION: Although there was no difference in the primary outcome in the overall population, observations in a subgroup of patients with early systemic inflammation suggest that trimodulin may have potential in this setting that warrants further investigation. ESSCOVID WAS REGISTERED PROSPECTIVELY AT CLINICALTRIALS.GOV ON OCTOBER 6, 2020.: NCT04576728.
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Tratamiento Farmacológico de COVID-19 , COVID-19 , Humanos , Masculino , Femenino , Método Doble Ciego , Persona de Mediana Edad , Anciano , COVID-19/mortalidad , COVID-19/terapia , Resultado del Tratamiento , SARS-CoV-2 , Adulto , Combinación de Medicamentos , Inmunoglobulina A , Inmunoglobulina G , Inmunoglobulina MRESUMEN
Meplazumab, a humanized CD147 antibody, has shown favourable safety and efficacy in our previous clinical studies. In DEFLECT (NCT04586153), 167 patients with severe COVID-19 were enroled and randomized to receive three dosages of meplazumab and a placebo. Meplazumab at 0.12 mg/kg, compared to the placebo group, showed clinical benefits in significantly reducing mortality by 83.6% (2.4% vs. 14.6%, p = 0.0150), increasing the proportion of patients alive and discharged without supplemental oxygen (82.9% vs. 70.7%, p = 0.0337) and increasing the proportion of patients who achieved sustained clinical improvement (41.5% vs. 31.7%). The response rate in the 0.2 mg/kg group was relatively increased by 16.0% compared with the placebo group (53.7% vs. 46.3%). Meplazumab also reduced the viral loads and multiple cytokine levels. Compare with the placebo group, the 0.3 mg/kg significantly increased the virus negative rate by 40.6% (p = 0.0363) and reduced IL-8 level (p = 0.0460); the 0.2 mg/kg increased the negative conversion rate by 36.9%, and reduced IL-4 (p = 0.0365) and IL-8 levels (p = 0.0484). In this study, the adverse events occurred at a comparable rate across the four groups, with no unexpected safety findings observed. In conclusion, meplazumab promoted COVID-19 convalescence and reduced mortality, viral load, and cytokine levels in severe COVID-19 population with good safety profile.
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COVID-19 , Humanos , Adulto , SARS-CoV-2 , Interleucina-8 , CitocinasRESUMEN
The hospital environment can be considered a high risk for the occurrence of SARS-CoV-2 transmission outbreaks, either for health professionals who are directly involved in the care of suspected or confirmed cases of the disease, or for patients, for being in an environment more vulnerable to the acquisition of nosocomial infections. In this molecular epidemiology study, we aimed to analyze the occurrence and transmission dynamics of SARS-CoV-2 in outbreaks and local chains of transmission in a large tertiary teaching hospital in southern Brazil, in addition to verifying circulating strains and their epidemiological relation in the local context, from September 21, 2020 to October 5, 2021. Positive samples involved in COVID-19 clusters or outbreaks were analyzed using clinical, epidemiological and genomic data. Different lineages and sublineages among patients in the same room were observed. Most patients had their first clinical manifestation, evidence of suspicion, and diagnostic confirmation within 7-14 days or >14 days after hospital admission. The patients who have contact with confirmed cases of COVID-19 spent, on average, 6.28 days in the same environment until the positive test. There was a significant association between the outcome and the number of vaccine doses (p < 0.05), where those who received two doses presented a lower occurrence of death. There was a total replacement of variant of concern (VOC) Gamma by VOC Delta from August 2021 at the study site. Although the epidemiological analysis indicates nosocomial infections, through genomic sequencing, it was established that most of the hospital outbreaks had different origins. These findings highlight the utility of integrating epidemiological and genomic data to identify possible routes of viral entry and dissemination.
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COVID-19 , Infección Hospitalaria , Humanos , SARS-CoV-2 , Brasil , Infección Hospitalaria/epidemiología , Centros de Atención TerciariaRESUMEN
Resumo Objetivo Comparar taxas de infecção de sítio cirúrgico em cirurgia limpa antes e após implantação do checklist proposto pela Organização Mundial de Saúde. Métodos Estudo observacional, descritivo, retrospectivo do tipo correlacional, realizado em um hospital geral. Amostra constituída por 15.319 registros de cirurgias limpas das especialidades traumato-ortopedia, cardiovascular, plástica, geral e urologia monitoradas pelo Serviço de Controle de Infecção Hospitalar. Antes da implantação do checklist foram avaliados 5.481 registros e após 9.838. Análise realizada com Software SPSS 22.0 e aplicação do teste qui-quadrado de Pearson, considerando-se significativo p<0,05. Resultados A taxa geral de infecção em cirurgia limpa foi 4.17% no período pré-implantação do checklist e 1.10% pós (p<0.05), com redução estatisticamente significativa nas cirurgias de coluna, aneurisma e by-pass, abdominoplastia, mamoplastia, herniorrafia e prostatectomia. Conclusão Observou-se redução significativa da taxa de infecção de sítio cirúrgico nas cirurgias limpas quando comparados os períodos pré e pós-implantação do checklist proposto pela Organização Mundial de Saúde.
Resumen Objetivo Comparar tasas de infección de sitio quirúrgico en cirugía limpia antes y después de implantación del checklist propuesto por Organización Mundial de la Salud. Métodos Estudio observacional, descriptivo, retrospectivo, tipo correlacional, realizado en hospital general. Muestra de 15.319 registros de cirugías limpias de traumatología-ortopedia, cardiovascular, plástica, general y urología, monitoreadas por Servicio de Control de Infección Hospitalaria. Antes de implantarse el checklist fueron evaluados 5.481 registros, y 9.838 después. Análisis realizado aplicando Software SPSS 22.0 y test de Chi-cuadrado, considerándose significatividad de p<0,05. Resultados La tasa general de infección en cirugía limpia fue 4,17% en período preimplantación del checklist, y 1,10% en el posterior (p<0,05), con reducción estadísticamente significativa en cirugías de columna, aneurismas y by-pass, abdominoplastía, mamoplastía, herniorrafia y prostatectomía. Conclusión Observada significativa reducción de tasa de infección del sitio quirúrgico en cirugías limpias al compararse períodos pre y post implantación del checklist propuesto por la OMS.
Abstract Objective To compare surgical site infection rates in clean surgery before and after implementation of the checklist proposed by the World Health Organization. Methods Observational, descriptive, retrospective correlational study performed in a general hospital. Sample consisting of 15,319 records of clean surgeries monitored by the hospital Infection Prevention and Control Service, in the trauma, orthopedics, cardiovascular, plastic, general, and urology specialties. Before implementing the checklist, 5,481 records were evaluated; 9,838 records were reviewed after. Analysis was performed with SPSS 22.0 software and application of the Pearson's chi-square test, considering p <0.05. Results The overall infection rate in clean surgery was 4.17% in the pre-implementation period of the checklist and 1.10% post-implementation (p<0.05), with statistically significant reductions in spine, aneurysm and bypass, abdominoplasty, mammoplasty, herniorrhaphy and prostatectomy surgeries. Conclusion A significant reduction was identified in the rate of surgical site infection in clean surgeries when comparing the pre- and post- implementation periods of the checklist proposed by the World Health Organization.
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Humanos , Infección de la Herida Quirúrgica , Control de Infecciones , Lista de Verificación , Seguridad del Paciente , Pausa de Seguridad en la Atención a la Salud , Epidemiología Descriptiva , Estudios Retrospectivos , Estudio Observacional , Correlación de DatosRESUMEN
O diagnóstico da infecção pelo HIV, em uma faixa etária mais avançada, traz importantes consequências para a qualidade de vida do paciente. O objetivo deste trabalho foi investigar a qualidade de vida dos pacientes HIV+, com mais de 50 anos, através do instrumento HAT-QoL. Métodos: Foi realizado um estudo transversal, composto por 86 pacientes soropositivos, com mais de 50 anos, cadastrados no Ambulatório do Serviço de Atendimento Especializado em DST/AIDS do Centro de Saúde IAPI de Porto Alegre, RS, de junho a outubro de 2010. Para avaliar a qualidade de vida, foi feita a aplicação verbal do instrumento HAT-QoL. Resultados: Verificaram-se baixos índices de renda e de escolaridade. Na escala HAT-QoL, constatou-se que as maiores preocupações eram quanto aos aspectos financeiros, ao sigilo, à saúde e à atividade sexual. Observou-se alto índice de confiança no médico, com a mediana no máximo da escala (100). A média de todos os domínios da escala HAT-QoL foi de 66,5 e o desvio padrão, 18,5. Conclusão: Os domínios com maior comprometimento foram "Preocupações Financeiras", "Preocupações com o Sigilo", "Preocupações com a Saúde" e "Função Sexual".
The diagnosis of HIV infection in an older age has important consequences for the patients quality of life. The objective of this study was to investigate the quality of life of HIV+ patients over 50 years of age through instrument HAT-QoL. Methods: We performed a cross-sectional study comprising 86 HIV-positive patients who were over 50 years of age and enrolled in the STD/AIDS Specialized Outpatient Service of the Health Care Center IAPI in Porto Alegre, from June to October 2010. The HAT-QoL questionnaire was adminstered verbally to assess the Quality of Life. Results: Low levels of income and education were found. The HAT-QoL showed that the patients greatest concerns were about financial aspects, confidentiality, health and sexual activity. There was a high level of confidence in the physician, with a median at the top of the scale (100). The mean of all domains in the HAT-QoL scale was 66.5 and standard deviation 18.5. Conclusion: The domains that were more highly compromised were "Financial Concerns", "Confidentiality Concerns", "Health Concerns" and "Sexual Function".
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Humanos , Persona de Mediana Edad , Anciano de 80 o más Años , VIH , Calidad de Vida , Síndrome de Inmunodeficiencia AdquiridaRESUMEN
JUSTIFICATIVA E OBJETIVOS: Há uma preocupação crescente das instituições de saúde com a satisfação dopaciente no seu atendimento. O objetivo deste estudo foi avaliar a satisfação dos pacientes em pós-operatório, em hospital de médio porte quanto ao controle da dor, após implantar o conceito dor como quinto sinal vital, vista a importância do tema e a escassez de estudos prospectivos sobre o assunto.MÉTODO: Ensaio clínico aleatório aberto. Os pacientes em pós-operatório foram divididos em dois grupos. No grupo com intervenção, as escalas de dor foram disponibilizadas para a equipe assistencial e informadas verbalmente no momento da aplicação. Já no grupo sem intervenção,as escalas de dor não estiveram disponíveis.Foram então avaliadas as medidas de satisfação uma vez ao dia até, no máximo, o quinto dia de pós-operatório.RESULTADOS: Ocorreu predomínio do sexo feminino (83,5%) e a média de idade da amostra foi de 36,7 anos. A maioria das cirurgias foi cesariana (57,1%). Os pacientes referiram dor em 75,6% das medições e a consideraram de moderada a intensa em 23% das medições. Quanto ao grau de satisfação, a maioria (54%) considerou ótimo o controle álgico. Comparando os grupos, não houve diferença significativa quanto ao grau de satisfação. CONCLUSÃO: Observou-se que não houve diferença na satisfação dos pacientes quando colocada em prática a dor como quinto sinal vital. O estudo sugere que vários componentes contribuem para a satisfação do paciente, embora tenha sido avaliado apenas o aspecto fisiológico da dor.
BACKGROUND AND OBJECTIVES: There is an increasing concern of health institutions with patients' satisfaction. This study aimed at evaluating patients' satisfactionin the postoperative period of a medium-size hospital in terms of controlling pain and implementing the concept of pain as the fifth vital sign, faced to the importanceof the theme and the lack of prospective studies on the subject.METHOD: Open randomized clinical trial. Postoperative patients were divided in two groups. In the group with intervention, pain scales were made available to the assisting team and verbally informed when applied. For thegroup with no intervention, there were no pain scales. Satisfaction measurements were evaluated once a day until,at the utmost, the fifth postoperative day.RESULTS: There has been predominance of females (83.5%) and mean sample age was 36.7 years. Most surgeries were C-sections (57.1%). Patients referred pain in 75.6% of measurements and considered it from moderate to severe in 23% of measurements. As to satisfaction,most (54%) have considered pain control excellent. In comparing groups there has been no significant differencein the level of satisfaction.CONCLUSION: There has been no difference in patients' satisfaction when pain as the fi fth vital sign was implemented. The study suggests that several components contribute to patients' satisfaction, although we have just evaluated the physiological aspect of pain.
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Hospitalización , Dimensión del Dolor , Dolor Postoperatorio , Satisfacción del PacienteRESUMEN
JUSTIFICATIVA E OBJETIVOS: Em 1996 foi reconhecida a necessidade de considerar a dor como o quinto sinal vital. Desde então muito se discute sobre a melhor forma de tratá-lo. O estudo é um projeto piloto de um ensaio clínico randomizado para adequação metodológica de uma pesquisa que avaliará a eficácia da mensuração da dor pós-operatória através da escala numérica verbal. A metodologia poderá posteriormente ser estendida a diferentes instituições, ainda que o perfil dos pacientes ou procedimentos seja diferente.MÉTODO: Ensaio clínico randomizado aberto realizado entre 2009 e 2010. Quarenta e dois pacientes foram randomizados em dois grupos. A dor foi aferida duas vezes ao dia em cada um deles, porém apenas no grupo com intervenção o resultado da aferição era disponibilizado no prontuário. Desta forma, apenas esse grupo esteve sujeito às adequações analgésicas à dor referida. O restante dos participantes da pesquisa foi submetido à rotina de cuidados da instituição. Os grupos foram comparados por intenção de tratar através do teste de Mann-Whitney, sendo considerado significativo quando p < 0,05. RESULTADOS: O procedimento cirúrgico predominante foi a cesariana (75%). A mediana da dor foi maior no grupo com intervenção, tanto na medida basal quanto no seguimento (4,5), no entanto sem significância estatística.CONCLUSÃO: Como a aferição álgica se trata da mensuração quantitativa de um evento subjetivo, realizou-se este estudo para certificação do instrumento de pesquisa. Os resultados demonstrados objetivam definir a validade do método usado para comparação da aferição da dor no pós-operatório como quinto sinal vital.
BACKGROUND AND OBJECTIVES: The need to consider pain as the fifth vital sign was recognized in 1996. Since then, a lot has been discussed about the best way to do it. This study is a pilot project of a randomized clinical trial for methodological adaptation of a research to evaluate the efficacy of measuring postoperative pain through verbal numerical scale. The methodology shall be afterwards expanded to different institutions, although patients or procedures profile may be different.METHOD: Open randomized clinical trial carried out between 2009 and 2010. Forty-two patients were randomized in two groups. Pain was measured twice a day in all of them, however only in the group with intervention measurement results were made available in their medical records. This way, only this group was subject to analgesic adaptations to referred pain. Other participants were submitted to routine care of the institution. Groups were compared by intention to treat with Mann-Whitney's test, considering significant p < 0.05. RESULTS: Predominant surgical procedure was Cesarean section (75%). Pain median was higher in the group with intervention both in baseline and follow-up measurements (4.5), however without statistical significance.CONCLUSION: Since pain measurement is a quantitative measurement of a subjective event, this study was carried out to certify the research tool. Results aimed at defining the validity of the method used to compare postoperative pain measurement as the fifth vital sign.
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Os autores desenvolvem uma revisão abrangente da literatura disponível sobre o tema, permitindo a obtenção de informações atualizadas e úteis para a prática clínica. Abordam-se aspectos epidemiológicos, clínicos, diagnósticos e terapêuticos da doeça causada pelo Histoplasma capsulatum, alertando para o risco de doença disseminada em pacientes imunodeprimidos, especialmente com HIV, como infeção oportunista
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Humanos , Histoplasmosis , Infecciones Oportunistas Relacionadas con el SIDARESUMEN
Os autores revisam a literatura sobre a candidíase oroesofagiana em pacientes portadores do vírus da imunodeficiência adquirida. Apresentam aspectos da fisiopatogenia, quadro clínico, diagnóstico e, em especial, do manejo terapêutico