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2.
Rev Colomb Psiquiatr (Engl Ed) ; 52(4): 287-296, 2023.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-38008670

RESUMO

OBJECTIVE: The aim is to evaluate the association between sleep quality and perinatal depression in pregnant women between the 12th week of gestation and the 36th week of gestation in a maternity and child centre in Lima. METHODS: Analytical cross-sectional study in pregnant women cared for in a primary care centre between August and December 2019. The data were collected through a self-administered survey. The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality. The evaluation of perinatal depression was performed with the Edinburgh Postnatal Depression Scale (EPDS). For the multivariate analysis, Poisson regression with robust variances was used to calculate the crude and adjusted prevalence ratios and their respective confidence intervals. RESULTS: The sample was composed of 200 participants. The median [IQR] age was 26 [22-32] years, and 111 (55.5%) pregnancies were unplanned. 52% presented a poor quality of sleep and the risk of perinatal depression was 31.5%. Poor quality of sleep was associated with a significantly higher frequency of perinatal depression (aPR = 4.8 for those with poor quality of sleep warranting medical attention, and aPR = 6.6 for those with poor quality of sleep warranting medical attention and treatment). CONCLUSIONS: There is a possible association between poor sleep quality and perinatal depression in pregnant women between weeks 12 and 36 of gestation. Operational research should be promoted to assess whether interventions to improve sleep quality could have a positive impact on reducing perinatal depression.


Assuntos
Gestantes , Transtornos do Sono-Vigília , Adulto , Feminino , Humanos , Gravidez , Adulto Jovem , Estudos Transversais , Depressão/epidemiologia , Peru/epidemiologia , Atenção Primária à Saúde , Qualidade do Sono , Transtornos do Sono-Vigília/epidemiologia
3.
Horiz. med. (Impresa) ; 23(3)jul. 2023.
Artigo em Espanhol | LILACS-Express | LILACS | ID: biblio-1514222

RESUMO

Objetivo: Evaluar la asociación entre la exposición a hostigamiento laboral y la presencia de síndrome de burnout en el personal sanitario de un hospital de referencia peruano. Materiales y métodos: Estudio transversal, analítico. Se incluyó a médicos internistas, cirujanos, enfermeras, residentes, internos de medicina y técnicos de enfermería de los departamentos de Medicina y Cirugía del Hospital Nacional Hipólito Unanue en Lima, Perú. Se usaron los cuestionarios Maslach Burnout Inventory-Human Services Survey (MBI-HSS) y Negative Acts Questionnaire-Revised (NAQ-R) para la detección de burnout y hostigamiento, respectivamente. Adicionalmente, se evaluó la asociación con la edad, género, ocupación, estado civil, lugar de trabajo, conformidad con salario, carga familiar, actividad física, hábitos nocivos, vacaciones, afiliación religiosa, número de trabajos, remuneración mensual, tiempo de trabajo, horas laborales por semana, número de pacientes atendidos por día, guardias semanales y horas de descanso. El análisis multivariado se realizó mediante el uso de un modelo de regresión logística múltiple, para lo cual se utilizó como variable respuesta la presencia o no de burnout. Resultados: Se incluyeron a 206 participantes. De ellos, 22 (10,7 %) presentaron burnout y 27 (14 %), hostigamiento moderado a elevado. En el análisis bivariado, la edad (OR 0,94; IC 95 % 0,89-0,99; p = 0,02), el estado civil casados y convivientes (OR 2,85; IC 95 % 1,01-8,06; p = 0,04) y el hostigamiento (OR 5,20; IC 95 % 1,92-14,09; p = 0,009) se asociaron a la presencia de burnout. En el análisis multivariado, el único predictor significativo de burnout fue el hostigamiento laboral. La presencia de un hostigamiento moderado a elevado se asoció a un OR de 4,00 (IC 95 % 1,4-11,3; p = 0,009) comparado con bajos niveles de hostigamiento. Conclusiones: Es importante identificar a trabajadores de la salud con hostigamiento laboral por su fuerte asociación con el síndrome de burnout. Se considera indispensable la realización de una investigación complementaria que permita entender y abordar la problemática del hostigamiento laboral y su influencia en el desarrollo de burnout, así como estudios que permitan evaluar intervenciones destinadas a prevenir tanto el hostigamiento laboral como el burnout.


Objective: To determine the association between workplace harassment and burnout syndrome among healthcare personnel of a Peruvian referral hospital. Materials and methods: An analytical cross-sectional study which included internists, surgeons, nurses, residents, interns and nursing technicians from the Medicine and Surgery departments of Hospital Nacional Hipólito Unanue in Lima, Peru. The Maslach Burnout Inventory-Human Services Survey (MBI-HSS) and the Negative Acts Questionnaire-Revised (NAQ-R) were used for the assessment of burnout and harassment, respectively. Additionally, the association with age, gender, occupation, marital status, workplace, salary satisfaction, family burden, physical activity, harmful habits, vacations, religious affiliation, number of jobs, monthly remuneration, job tenure, working hours per week, number of patients seen per day, weekly shifts and rest hours was evaluated. A multivariate analysis was conducted using a multiple logistic regression model and the presence or absence of burnout as an outcome variable. Results: The study consisted of 206 participants, out of whom 22 (10.7 %) suffered burnout and 27 (14 %) moderate to severe harassment. In the bivariate analysis, age (OR 0.94; 95 % CI 0.89-0.99; p = 0.02), marital status such as married and cohabiting (OR 2.85; 95 % CI 1.01-8.06; p = 0.04) and harassment (OR 5.20; 95 % CI 1.92-14.09; p = 0.009) were associated with burnout. In the multivariate analysis, the only significant predictor of burnout was workplace harassment. Moderate to severe harassment was associated with OR 4.00 (95 % CI 1.4-11.3; p = 0.009) compared to mild harassment. Conclusions: It is important to identify health workers suffering workplace harassment due to its strong association with burnout syndrome. It is essential to carry out further research to understand and address the problem of workplace harassment and its influence on the development of burnout, as well as studies to evaluate interventions aimed at preventing both workplace harassment and burnout.

4.
Microorganisms ; 11(6)2023 May 25.
Artigo em Inglês | MEDLINE | ID: mdl-37374887

RESUMO

The IGRA (Interferon Gamma Release Assays) test is currently the standard specific test for Mycobacterium tuberculosis infection status. However, a positive test cannot distinguish between active tuberculosis disease (ATBD) and latent tuberculosis infection (LTBI). Developing a test with this characteristic is needed. We conducted longitudinal studies to identify a combination of antigen peptides and cytokines to discriminate between ATBD and LTBI. We studied 54 patients with ATBD disease and 51 with LTBI infection. Cell culture supernatant from cells stimulated with overlapping Mycobacterium tuberculosis novel peptides and 40 cytokines/chemokines were analyzed using the Luminex technology. To summarize longitudinal measurements of analyte levels, we calculated the area under the curve (AUC). Our results indicate that in vitro cell stimulation with a novel combination of peptides (Rv0849-12, Rv2031c-14, Rv2031c-5, and Rv2693-06) and IL-1RA detection in culture supernatants can discriminate between LTBI and ATBD.

5.
BMJ Open ; 12(8): e056262, 2022 08 24.
Artigo em Inglês | MEDLINE | ID: mdl-36002215

RESUMO

INTRODUCTION: Research on public health interventions to improve hypertension care and control in low-income and middle-income countries remains scarce. This study aims to evaluate the effectiveness and assess the process and fidelity of implementation of a multi-component intervention to reduce the gaps in hypertension care and control at a population level in low-income communes of Medellin, Colombia. METHODS AND ANALYSIS: A multi-component intervention was designed based on international guidelines, cross-sectional population survey results and consultation with the community and institutional stakeholders. Three main intervention components integrate activities related to (1) health services redesign, (2) clinical staff training and (3) patient and community engagement. The effectiveness of the intervention will be evaluated in a controlled before-after quasi-experimental study, with two deprived communes of the city selected as intervention and control arms. We will conduct a baseline and an endline survey 2 years after the start of the intervention. The primary outcomes will be the gaps in hypertension diagnosis, treatment, follow-up and control. Effectiveness will be evaluated with the difference-in-difference measures. Generalised estimation equation models will be fitted considering the clustered nature of data and adjusting for potential confounding variables. The implementation process will be studied with mixed methods. Implementation fidelity will be documented to assess to which degree the intervention components were implemented as intended. ETHICS AND DISSEMINATION: The study protocol has been approved by the Ethics Research Committee of Metrosalud in Colombia (reference 1400/5.2), the Medical Ethics Committee of the Antwerp University Hospital (reference 18/40/424) and the Institutional Review Board of the Antwerp Institute of Tropical Medicine (reference 1294/19). We will share and discuss the study results with the community, institutional stakeholders and national health policymakers. We will publish them in national and international peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT05011838.


Assuntos
Hipertensão , Colômbia , Estudos Controlados Antes e Depois , Estudos Transversais , Humanos , Hipertensão/prevenção & controle , Pobreza , Saúde Pública
6.
Rev. cuba. med. gen. integr ; 38(2): e1827, abr.-jun. 2022. tab, graf
Artigo em Espanhol | LILACS, CUMED | ID: biblio-1408698

RESUMO

Introducción: El tinnitus es una condición de alta prevalencia que puede afectar la calidad de vida. Objetivos: Evaluar la calidad de vida y sus factores asociados en pacientes adultos con tinnitus. Métodos: Estudio analítico transversal. La población incluida fueron pacientes adultos con síntoma de tinnitus, atendidos en el servicio de otorrinolaringología en un hospital de referencia en Lima, Perú. El efecto del tinnitus sobre la calidad de vida fue medida mediante el cuestionario Tinnitus Handicap Inventory. Resultados: Se incluyeron 151 pacientes con tinnitus; 31,2 por ciento fueron varones y la media de edad fue 66 años, 17,2 por ciento y 23,1 por ciento de pacientes con tinnitus tuvieron antecedentes de trastornos depresivos y desórdenes de ansiedad, respectivamente; 85,4 por ciento y 62,2 por ciento de pacientes con tinnitus presentaron hipoacusia y cefalea, respectivamente. El Tinnitus Handicap Inventory tuvo una mediana de 26 (rango intercuartil: 8-50), un valor mínimo de 0 y un valor máximo de 100. De los pacientes, 101 (66,8 por ciento) tuvieron una discapacidad leve a moderada debido al tinnitus y 50 (33 por ciento) discapacidad moderada a severa. En el análisis multivariado se encontró que la ansiedad (OR = 2,59; IC 95 por ciento 1,14-5,9; p = 0,02), hipoacusia (OR = 12,9; IC 95 por ciento 1,65-102,1; p= 0,01) y cefalea (OR = 2,61; IC 95 por ciento 1,18-5,8; p = 0,01) se asociaron con discapacidad moderada a severa debido al tinnitus. Conclusiones: Los pacientes adultos con tinnitus frecuentemente tuvieron una afectación moderada a severa de su calidad de vida. Los factores asociados a discapacidad moderada a severa debido a tinnitus fueron la ansiedad, cefalea e hipoacusia(AU)


Introduction: Tinnitus is a highly prevalent condition that can affect the quality of life of patients. Objective: To assess the quality of life and its associated factors in adult patients with tinnitus. Methods: Cross-sectional and analytical study carried out with a population that included adult patients with tinnitus symptoms attended in the otorhinolaryngology service of a reference hospital in Lima, Peru. The effect of tinnitus on quality of life was measured using the Tinnitus Handicap Inventory. Results: The study included 151 patients with tinnitus: 31.2 percent were male and the mean age was 66 years, while 17.2 percent and 23.1 percent of patients with tinnitus had a history of depressive disorders and anxiety disorders, respectively. Of tinnitus patients, 85.4 percent and 62.2 percent had hearing loss and headache, respectively. The Tinnitus Handicap Inventory showed a median value of 26 (interquartile: 8-50), a minimum value of 0, and a maximum value of 100. Of the patients, 101 (66.8 percent) had mild to moderate disability due to tinnitus, while 50 (33 percent) had moderate to severe disability. In multivariate analysis, anxiety (OR=2.59; 95 percent CI: 1.14-5.9; P= 0.02), hearing loss (OR= 12.9; 95 percent CI: 1.65-102.1; P= 0.01) and headache (OR= 2.61; 95 percent CI 1.18-5.8; p= 0.01) were found to be associated with moderate to severe disability due to tinnitus. Conclusions: Adult patients with tinnitus frequently had moderate to severe impairment of their quality of life. Factors associated with moderate to severe disability due to tinnitus were anxiety, headache, and hearing loss(AU)


Assuntos
Humanos , Masculino , Feminino , Qualidade de Vida , Zumbido/diagnóstico , Inquéritos e Questionários , Estudos Transversais
7.
Rev. Fac. Med. (Bogotá) ; 70(2): e92602, Apr.-June 2022. tab, graf
Artigo em Inglês | LILACS-Express | LILACS | ID: biblio-1406797

RESUMO

Abstract Introduction: Multiple definitions of metabolic syndrome (MS) are used in Peru, and there is currently no consensus on which definition should be used in clinical practice. Objectives: To compare cardiovascular disease (CVD) risk estimators, obtained using the ACC/AHA ASCVD Risk Calculator, and to assess their level of agreement with different definitions of MS in patients treated in Lima, Peru. Materials and methods: Analytical cross-sectional study. Medical records, collected through consecutive sampling, of 233 patients treated between October and December 2019 at the Hospital Nacional Hipólito Unanue, Lima, Peru, were reviewed. CVR risk was calculated using the online ACC/AHA ASCVD Risk Calculator, and the MS definitions of the WHO, NCEP-ATP III, IDF, AHA/NHLBI, JIS and ALAD were considered to compare CVD risk according to each definition. Agreement between the different MS definitions was calculated using the kappa coefficient based on the six levels of strength of agreement described by Landis and Koch. Results: The median CVD risk in patients with MS according to the definitions of the WHO, NCEP-ATP III, IDF, AHA/NHLBI, ALAD and JIS was 9.6 (3.9-20.35), 7.9 (3.1-18.6), 7.3 (3- 16.5), 7.8 (3-17.6), 7.1 (2.9-16.5), and 7.1 (3.1-16.5), respectively. The prevalence of MS according to JIS, IDF, ALAD, AHA/NHLBI, NCEP-ATP III and WHO definitions was 81.97%, 80.26%, 74.68%, 67.81%, 65.67%, and 51.14%, respectively. Agreement between the JIS criteria and the IDF, ALAD, NCEP-ATP III, and AHA/NHLBI criteria was 0.944, 0.787, 0.592, and 0.567, respectively, but it was 0.286 between the JIS criteria and the WHO criteria. Conclusions: In Peru, there are differences between CVD risk estimates depending on the MS definition used and considered in the present study, which may have an impact on the intensity of the therapeutic and preventive interventions performed in these patients.


Resumen Introducción. En Perú se usan múltiples definiciones de síndrome metabólico (SM); sin embargo, actualmente no hay un consenso sobre cuál definición usar en la práctica clínica. Objetivos. Comparar las estimaciones de riesgo cardiovascular (RCV), obtenidas mediante la calculadora de RCV de la ACC/AHA, y evaluar su grado de concordancia con diferentes definiciones de SM en pacientes atendidos en Lima, Perú. Materiales y métodos. Estudio transversal analítico. Se revisaron las historias clínicas, obtenidas por muestreo consecutivo, de 233 pacientes atendidos entre octubre y diciembre de 2019 en el Hospital Nacional Hipólito Unanue, Lima, Perú. El RCV se calculó mediante la calculadora virtual de RCV de la ACC/AHA y se consideraron las definiciones de SM de la OMS, NCEP-ATP III, IDF, AHA/NHLBI, JIS y ALAD para comparar el RCV según cada definición. La concordancia entre las distintas definiciones de SM se calculó mediante el coeficiente kappa con base en los seis niveles de fuerza de concordancia de Landis y Koch. Resultados. Las medianas de RCV en pacientes con SM según las definiciones de la OMS, NCEP-ATP III, IDF, AHA/NHLBI, ALAD y JIS fueron 9.6 (3.9-20.35), 7.9 (3.1-18.6), 7.3 (3-16.5), 7.8 (3-17.6), 7.1 (2.9-16.5) y 7.1 (3.1-16.5), respectivamente. La prevalencia de SM según las definiciones JIS, IDF, ALAD, AHA/NHLBI, NCEP-ATP III y OMS fue 81.97%, 80.26%, 74.68%, 67.81%, 65.67% y 51.14%, respectivamente. La concordancia entre las definiciones JIS e IDF, ALAD, NCEP-ATP III y AHA/NHLBI fue 0.944, 0.787, 0.592 y 0.567, respectivamente, pero entre la JIS y la OMS fue 0.286. Conclusiones. Existen diferencias entre las estimaciones de RCV según las distintas definiciones de SM usadas en Perú y consideradas en el presente estudio, lo que puede tener repercusiones en la intensidad de las intervenciones terapéuticas y preventivas realizadas en estos pacientes.

8.
PLoS One ; 17(3): e0264789, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35235613

RESUMO

OBJECTIVES: To determine the risk factors for in-hospital mortality in patients with COVID-19 from a Peruvian national hospital. METHODS: Retrospective cohort study of medical records of patients with COVID-19 hospitalized at Hospital Nacional Hipólito Unanue (HNHU) during the months of April to August 2020. The dependent variable was in-hospital mortality. Independent variables included sociodemographic and clinical characteristics, physical examination findings, oxygen saturation (SaO2) at admission, treatment received during hospitalization and laboratory results at admission. A Cox regression model was used to evaluate the crude and adjusted hazard ratios for associated factors. RESULTS: We included 1418 patients. Median age was 58 years (IQR 47-68 years) and 944 (66.6%) were male. The median length of hospitalization was 7 (4-13) days, and the mortality rate was 46%. The most frequent comorbidities were type 2 diabetes mellitus, hypertension, and obesity. In the adjusted analysis, mortality was associated with age (HR 1.02; 95%CI 1.02-1.03), history of surgery (HR 1.89; 95%CI 1.31-2.74), lower oxygen saturation at admission (HR 4.08; CI95% 2.72-8.05 for SaO2<70% compared to SaO2>94%), the presence of poor general condition (HR 1.81; 95% CI 1.29-2.53), altered state of consciousness (HR 1.58; 95%CI 1.18-2.11) and leukocyte levels (HR 1.01; 95%CI 1.00-1. 02). Treatment with ivermectin (HR 1.44; 95%CI 1.18-1.76) and azithromycin (HR 1.25; 95%CI 1.03-1.52) were associated with higher mortality. Treatment with corticosteroids at low to moderate doses was associated with lower mortality (HR 0.56 95%CI 0. 37-0. 86) in comparison to no steroid use. CONCLUSION: A high mortality was found in our cohort. Low oxygen saturation at admission, age, and the presence of hematological and biochemical alterations were associated with higher mortality. The use of hydroxychloroquine, ivermectin or azithromycin was not useful and was probably associated with unfavorable outcomes. The use of corticosteroids at moderate doses was associated with lower mortality.


Assuntos
COVID-19/mortalidade , Mortalidade Hospitalar , Adulto , Idoso , COVID-19/epidemiologia , COVID-19/patologia , COVID-19/terapia , Estudos de Coortes , Comorbidade , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Peru/epidemiologia , Encaminhamento e Consulta/estatística & dados numéricos , Estudos Retrospectivos , Fatores de Risco , SARS-CoV-2/fisiologia
9.
Rev. chil. neuro-psiquiatr ; 60(1): 13-25, mar. 2022. tab, ilus
Artigo em Espanhol | LILACS | ID: biblio-1388415

RESUMO

INTRODUCCIÓN: Se ha postulado la relación entre la presencia de enfermedades cardiometabólicas con problemas de salud mental, en particular la depresión. OBJETIVOS: Determinar la asociación entre la presencia de enfermedades cardiometabólicas y la presencia de sintomatología depresiva evaluada mediante el cuestionario PHQ-9 en pacientes atendidos en consultorios externos de medicina interna del Hospital Nacional Hipólito Unanue. METODOLOGÍA: Estudio observacional, analítico, transversal. Se definió enfermedad cardiometabólica como la presencia de diabetes mellitus, hipertensión arterial, dislipidemia, y/u obesidad. Se utilizó el cuestionario PHQ-9 para evaluar la presencia de síntomas sugerentes de depresión. Se evaluó la asociación cruda y ajustada a posibles confusores. Para el análisis multivariado se utilizó un modelo de regresión de Poisson para hallar razones de prevalencia con sus respectivos intervalos de confianza al 95%. Se consideró un p<0,05 como estadísticamente significativo. Resultados: Se incluyeron 252 pacientes, de los que 205 (81,4%) presentaron enfermedades cardiometabólicas y 181 (71,9%) presentaron síntomas consistentes con algún grado de depresión. La presencia de enfermedades cardiometabólicas se asoció a síntomas depresivos tanto en el análisis crudo (RPc 1,43; IC 95% 1,08-1,89; p=0,012) como en el ajustado (RPa 1,31; IC 95% 1,00-1,71; p=0,048). Adicionalmente se encontró asociación entre el sexo femenino y sintomatología depresiva (RPa 1,35; IC 95% 1,11-1,63; p=0,002). CONCLUSIONES: La presencia de enfermedades cardiometabólicas se asoció con la presencia de síntomas depresivos en pacientes atendidos en la consulta externa de medicina interna. El abordaje de la salud mental debe ser parte integral del manejo multidisciplinario del paciente con enfermedad cardiometabólica.


INTRODUCTION: It has been postulated the relationship between presence of cardiometabolic diseases with mental health problems, particularly depression. Objectives: To determine the association between cardiometabolic diseases and presence of depressive symptoms, evaluated by PHQ-9 questionnaire, in patients attended at the outpatient clinic of internal medicine service at Hospital Nacional Hipolito Unanue. METHODS: Observational analytical cross-sectional study. Cardiometabolic disease was defined as the presence of diabetes mellitus, high blood pressure, dyslipidemia, and/or obesity. The PHQ-9 questionnaire was used to evaluate the presence of symptoms suggestive of depression. The association was evaluated crude and adjusted for possible confounders. For the multivariate analysis, a Poisson regression model was used to find prevalence ratios with their respective 95% confidence intervals. A p<0.05 was considered statistically significant. RESULTS: 252 patients were included, of which 205 (81,4%) presented cardiometabolic diseases and 181 (71,9%) presented symptoms consistent with some grade of depression. The presence of cardiometabolic diseases was associated with depressive symptoms both in the crude analysis (PRc 1.43; CI 95% 1.08-1.89; p=0.012) and in the adjusted one (PRa 1.31; CI 95% 1.00-1.71; p=0.048). Additionally, an association was found between female sex and depressive symptoms (PRa 1,35; CI 95% 1,11-1,63; p=0,002). CONCLUSIONS: The presence of cardiometabolic diseases was associated with the presence of depressive symptoms in patients seen at the outpatient clinic of internal medicine. The mental health approach should be an integral part of the multidisciplinary management for the patient with cardiometabolic disease.


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Doenças Cardiovasculares/psicologia , Doenças Cardiovasculares/epidemiologia , Síndrome Metabólica/psicologia , Síndrome Metabólica/epidemiologia , Depressão/epidemiologia , Peru , Estudos Transversais , Análise Multivariada , Inquéritos e Questionários , Diabetes Mellitus/psicologia , Diabetes Mellitus/epidemiologia , Dislipidemias/psicologia , Dislipidemias/epidemiologia , Hospitais , Hipertensão/psicologia , Hipertensão/epidemiologia , Obesidade/psicologia , Obesidade/epidemiologia
10.
Rev Soc Peru Med Interna ; 35(1): 32-36, 20220000.
Artigo em Espanhol | LILACS-Express | LILACS | ID: biblio-1361422

RESUMO

Se presenta el caso de un varón de 32 años de edad, con historia de dolor abdominal, anemia severa y confusión mental. Se le halló anemia ferropénica, hematomas perirrenales bilateral, microaneurismas de las arterias renales, trombosis venosa cerebral. Los estudios inmunológicos fueron positivos para anticuerpos antinucleares, anti Smith, anticoagulante lúpico, anti B2GP1 y anti cardiolipina, Se le trató con pulsos de metilprednisolona, con buena evolución clínica.

11.
Rev. Cuerpo Méd. Hosp. Nac. Almanzor Aguinaga Asenjo ; 14(Supl. 1): 88-89, oct. 21, 2021.
Artigo em Espanhol, Inglês | LILACS-Express | LILACS | ID: biblio-1354877

RESUMO

Señor editor: Para los pacientes con comorbilidades avanzadas preexistentes y que han desarrollado una neumonía moderada - severa por COVID-19, el manejo sintomático ha jugado un papel importante en el alivio del sufrimiento y la mejoría de su calidad de vida durante su hospitalización. La disnea y la ansiedad se han identificado como síntomas frecuentes en los pacientes con neumonía por COVID-19, e influyen en el patrón respiratorio, el trabajo respiratorio y la evolución clínica de la enfermedad.


Mr. Editor: For patients with pre-existing advanced comorbidities and who have developed moderate - severe COVID-19 pneumonia, symptomatic management has played an important role in alleviating their suffering and improving their quality of life during their hospitalization. Dyspnea and anxiety have been identified as frequent symptoms in patients with COVID-19 pneumonia, and influence the respiratory pattern, work of breathing and clinical course of the disease.

12.
Rev Peru Med Exp Salud Publica ; 38(2): 284-290, 2021.
Artigo em Espanhol, Inglês | MEDLINE | ID: mdl-34468577

RESUMO

The aim of this prospective cohort study was to determine the factors associated with mortality in elders admitted to an Internal Medicine Department of a public hospital in Lima. During 2019, 360 patients over 60 years of age were consecutively evaluated by applying the Comprehensive Geriatric Assessment tools and reviewing their medical records. During hospitalization, 45 (12.5%) died. There was a higher frequency of anemia (p = 0.043), hypoalbuminemia (p = 0.006), pressure ulcers (p = 0.003), high comorbidity (p < 0.001), functional dependence (p < 0.001) and malnutrition (p = 0.002) among deceased patients compared to non-deceased. In the multivariate model, the presence of delirium on admission was associated with a higher risk of hospital mortality (RR = 3.64; 95% CI: 1.51 - 8.76, p = 0.004). Additional studies are required in our country to assess the prognostic value of delirium and other geriatric syndromes on mortality and other adverse outcomes.


El presente estudio prospectivo de cohorte tuvo como objetivo determinar los factores asociados a la mortalidad de los adultos mayores admitidos en un servicio de Medicina Interna de un hospital público de Lima. Durante el 2019 se evaluaron consecutivamente 360 pacientes mayores de 60 años mediante la aplicación de las herramientas de la Valoración Geriátrica Integral y la revisión de sus historias clínicas. Del total, 45 (12,5%) fallecieron durante el internamiento. En el modelo multivariado, la presencia de delirio al ingreso se asoció con un mayor riesgo de mortalidad hospitalaria (RR = 3,64; IC95%: 1,51-8,76, p = 0,004). Hubo una mayor frecuencia de anemia (p = 0,043), hipoalbuminemia (p = 0,006), úlceras por presión (p = 0,003), comorbilidad alta (p < 0,001), dependencia funcional (p < 0,001) y malnutrición (p = 0,002) entre los pacientes fallecidos respecto a los no fallecidos. Se requieren estudios adicionales en nuestro país para evaluar el valor pronóstico del delirio, otros síndromes geriátricos sobre la mortalidad y otros desenlaces adversos.


Assuntos
Avaliação Geriátrica , Hospitalização , Idoso , Mortalidade Hospitalar , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco
13.
Mol Genet Genomic Med ; 9(10): e1764, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34510815

RESUMO

BACKGROUND: We determined the frequency of genetic polymorphisms in three anti-TB drug metabolic proteins previously reported: N-acetyltransferase 2 (NAT2), cytochrome P450 2E1 (CYP2E1), and arylacetamide deacetylase (AADAC) within a Peruvian population in a cohort of TB patients. METHODS: We genotyped SNPs rs1041983, rs1801280, rs1799929, rs1799930, rs1208, and rs1799931 for NAT2; rs3813867 and rs2031920 for CYP2E1; and rs1803155 for AADAC in 395 participants completed their antituberculosis treatment. RESULTS: Seventy-four percent of the participants are carriers of slow metabolizer genotypes: NAT2*5, NAT2*6, and NAT2*7, which increase the sensitivity of INH at low doses and increase the risk of drug-induced liver injuries. Sixty-four percent are homozygous for the wild-type CYP2E1*1A allele, which could increase the risk of hepatotoxicity. However, 16% had a NAT2 fast metabolizer phenotype which could increase the risk of acquiring resistance to INH, thereby increasing the risk of multidrug-resistant (MDR) or treatment failure. The frequency of rs1803155 (AADAC*2 allele) was higher (99.9%) in Peruvians than in European American, African American, Japanese, and Korean populations. CONCLUSIONS: This high prevalence of slow metabolizers for isoniazid in the Peruvian population should be further studied and considered to help individualize drug regimens, especially in countries with a great genetic diversity like Peru. These data will help the Peruvian National Tuberculosis Control Program develop new strategies for therapies.


Assuntos
Alelos , Arilamina N-Acetiltransferase/genética , Hidrolases de Éster Carboxílico/genética , Citocromo P-450 CYP2E1/genética , Frequência do Gene , Tuberculose/etiologia , Estudos de Associação Genética , Predisposição Genética para Doença , Genótipo , Humanos , Desequilíbrio de Ligação , Peru , Fenótipo , Polimorfismo de Nucleotídeo Único
14.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-34456055

RESUMO

OBJECTIVE: The aim is to evaluate the association between sleep quality and perinatal depression in pregnant women between the 12th week of gestation and the 36th week of gestation in a maternity and child centre in Lima. METHODS: Analytical cross-sectional study in pregnant women cared for in a primary care centre between August and December 2019. The data were collected through a self-administered survey. The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality. The evaluation of perinatal depression was performed with the Edinburgh Postnatal Depression Scale (EPDS). For the multivariate analysis, Poisson regression with robust variances was used to calculate the crude and adjusted prevalence ratios and their respective confidence intervals. RESULTS: The sample was composed of 200 participants. The median [IQR] age was 26 [22-32] years, and 111 (55.5%) pregnancies were unplanned. 52% presented a poor quality of sleep and the risk of perinatal depression was 31.5%. Poor quality of sleep was associated with a significantly higher frequency of perinatal depression (aPR=4.8 for those with poor quality of sleep warranting medical attention, and aPR=6.6 for those with poor quality of sleep warranting medical attention and treatment). CONCLUSIONS: There is a possible association between poor sleep quality and perinatal depression in pregnant women between weeks 12 and 36 of gestation. Operational research should be promoted to assess whether interventions to improve sleep quality could have a positive impact on reducing perinatal depression.

15.
Medwave ; 21(7): e8434, 2021 Aug 02.
Artigo em Espanhol, Inglês | MEDLINE | ID: mdl-34369917

RESUMO

INTRODUCTION: It is required to have validated instruments in health science students that identify unhealthy habits and assess the impact of educational interventions and programs aimed at promoting a healthy lifestyle. OBJECTIVE: To evaluate the validity and reliability of an instrument to measure medical students' lifestyles. METHODS: A lifestyle questionnaire was developed using the Delphi technique by a group of experts. The final questionnaire was applied to 332 students of the School of Medicine of the Ricardo Palma University in 2017. A preliminary examination was carried out to assess preconditions for construct validityincluding the correlation matrix, the Kaiser Meyer Olkin statistic, and the Bartlett sphericity test. Factor analysis was used for construct validity, and the possible resulting factors were extracted through the principal component analysis. Cronbach's alpha coefficient was calculated to assess the instrument reliability. RESULTS: In this study, 41.6% of participants were men with a mean age of 20 years (standard deviation = 3). The preconditions for the factor analysis were a Kaiser Meyer Olkin coefficient = 0.773 and a significant Bartlett sphericity test. For the 47 items of the final questionnaire, the factor analysis showed an explained variance of 56.7% with eigenvalues greater than one. Cronbach's alpha was 0.78. The final questionnaire could assume values between -23 to 151 points. Based on a cut point of 71 points, the prevalence of students with an unhealthy lifestyle was 73.6%. CONCLUSION: The developed instrument has acceptable validity and reliability to measure lifestyle in medical students. For external validation, studies in other university populations are suggested.


INTRODUCCIÓN: Se requiere contar con instrumentos validados en estudiantes de ciencias de la salud que permitan identificar hábitos no saludables, junto con evaluar el impacto de intervenciones y programas educativos destinados a promover un estilo de vida saludable. OBJETIVO: Evaluar la validez y fiabilidad de un instrumento para medir el estilo de vida en estudiantes de la carrera de medicina humana. MÉTODO: Se elaboró un cuestionario sobre estilos de vida desarrollado mediante la técnica Delphi entre un grupo de expertos. El cuestionario final resultante fue aplicado a una población de 332 estudiantes de la Facultad de Medicina Humana de una universidad peruana en el año 2017. Se realizó una exploración para evaluar las condiciones previas para ejecutar la validez de constructo, incluyendo la evaluación de la matriz de correlaciones, el estadístico Kaiser Meyer Olkin y la prueba de esfericidad de Bartlett. Para la validez de constructo se empleó el análisis factorial y se extrajeron los posibles factores resultantes por medio del análisis de componentes principales. Para demostrar la fiabilidad del instrumento se calculó el coeficiente α de Cronbach. RESULTADOS: El 41,6% de los participantes fueron varones. La edad media fue de 20 años (desviación estándar 3). Las condiciones previas al análisis factorial fueron un coeficiente Kaiser Meyer Olkin de 0,773 y una prueba de esfericidad de Bartlett significativa. El análisis factorial sobre los 47 ítems del cuestionario final obtuvo una varianza explicada de 56,7% con autovalores superiores a 1. El valor del α de Cronbach fue de 0,78. El cuestionario final puede tomar valores entre -23 hasta 151 puntos. Sobre la base de un punto de corte de 71 puntos, la prevalencia de estudiantes con un estilo de vida no saludable fue de 73,6%. CONCLUSIÓN: El instrumento desarrollado tiene validez y fiabilidad aceptable para medir el estilo de vida en estudiantes de medicina. Se sugiere la validación externa en otras poblaciones universitarias.


Assuntos
Estilo de Vida , Psicometria/instrumentação , Estudantes de Medicina/psicologia , Inquéritos e Questionários , Adulto , Humanos , Masculino , Reprodutibilidade dos Testes , Adulto Jovem
16.
Rev. colomb. cardiol ; 28(4): 378-382, jul.-ago. 2021. graf
Artigo em Espanhol | LILACS, COLNAL | ID: biblio-1351936

RESUMO

Resumen El túnel aorto-ventricular derecho es una anomalía congénita que consiste en un canal que conecta la aorta ascendente a la cavidad del ventrículo derecho. El diagnóstico se corrobora, en la mayoría de los casos, por ecocardiografía. El cierre quirúrgico se considera el tratamiento de elección y solo se han reportado dos casos previos en los que se ha logrado el cierre mediante intervencionismo. Se presenta el caso de una lactante con diagnóstico de túnel aorto-ventricular derecho, tratada por intervención percutánea con dispositivo de cierre percutáneo, que tuvo buena evolución clínica. La paciente, además, presentó un ductus permeable, el cual fue tratado en una segunda oportunidad por intervencionismo. La factibilidad de la técnica de cierre por procedimiento percutáneo y su baja tasa de complicaciones en comparación con el cierre por cirugía abierta pueden hacer de este el procedimiento de elección en la mayoría de los casos para esta infrecuente condición.


Abstract The aorto-right ventricular tunnel is a congenital anomaly that consists of a channel that connects the ascending aorta to the right ventricular cavity. The diagnosis is usually made by transthoracic echocardiography. Surgical closure is usually considered the treatment of choice and only two previous cases have been reported in which closure has been achieved by percutaneous intervention. We report a case of an infant with a diagnosis of aorto-right ventricular tunnel treated using a percutaneous device with good clinical evolution. The patient had also a patent ductus which was later treated by interventionism. The feasibility of the technique and its low rate of complications compared to the closure by open surgery can make it the procedure of choice in most cases for this rare condition.


Assuntos
Humanos , Túnel Aorticoventricular , Cardiopatias Congênitas
17.
Infect Drug Resist ; 14: 2795-2807, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34321896

RESUMO

PURPOSE: The purpose of this study is to evaluate the frequency of viral and bacterial respiratory pathogens detected by molecular methods in sputum samples of patients hospitalized for COVID-19 and to evaluate its impact on mortality and unfavorable outcomes (in-hospital death or mechanical ventilation). PATIENTS AND METHODS: The prospective cohort included patients with diagnosis of COVID-19 hospitalized at Hospital Nacional Hipólito Unanue. Sociodemographic and clinical data were collected from clinical records. Sputum samples were analyzed with the Biofire Filmarray Pneumonia plus® respiratory panel. Crude and adjusted associations with unfavorable outcomes were evaluated using logistic regression models. RESULTS: Ninety-three patients who were able to collect sputum samples were recruited between September 8 and December 28, 2020. The median age was 61.7 years (IQR 52.3-69-8) and 66 (71%) were male. The most frequent symptoms were dyspnea, cough, fever, and general malaise found in 80 (86%), 76 (82%), 45 (48%), and 34 (37%) patients, respectively. Fifty-three percent of patients had comorbidities. Seventy-six (82%) patients received antibiotics prior to admission and 29 (31%) developed unfavorable outcome. Coinfection was evidenced in 38 (40.86%) cases. The most frequently found bacteria were Staphylococcus aureus, Streptococcus agalactiae, Haemophilus influenzae and Klebsiella pneumoniae in 11 (11.83%), 10 (10.75%), 10 (10.75%), and 8 (8.6%) cases, respectively. Streptococcus pneumoniae was found in one case (1.08%). We neither identify atypical bacteria nor influenza virus. No association was found between the presence of viral or bacterial microorganisms and development of unfavorable outcomes (OR 1.63; 95% CI 0.45-5.82). CONCLUSION: A high frequency of respiratory pathogens was detected by molecular methods in patients with COVID-19 pneumonia but were not associated with unfavorable outcomes. No atypical agents or influenza virus were found. The high use antibiotics before admission is a concern. Our data suggest that the use of drug therapy against atypical bacteria and viruses would not be justified in patients hospitalized for COVID-19.

18.
Rev. gastroenterol. Perú ; 41(3): 169-175, jul.-sep. 2021. tab, graf
Artigo em Espanhol | LILACS-Express | LILACS | ID: biblio-1357342

RESUMO

RESUMEN Introducción : La canulación difícil en casos de colangiopancreatografía retrógrada endoscópica (CPRE) podría asociarse a diversos factores incluyendo el tipo de papila mayor, sin embargo, existen datos limitados con respecto a esta posible asociación. Objetivos : Determinar la asociación entre el tipo de papila y la canulación biliar difícil. Materiales y métodos : Se realizó un estudio retrospectivo transversal analítico en pacientes mayores de 18 años en quienes se realizó CPRE en papila virgen, de julio 2019 a abril 2021, en una institución privada. Se excluyeron las canulaciones frustras. La papila fue clasificada en base a la clasificación de Haraldsson. Se evaluó la asociación cruda y ajustada a posibles confusores entre el tipo de papila y canulación difícil. Se calcularon los riesgos relativo (RR) e intervalos de confianza al 95%. Resultados : Se incluyeron 188 pacientes. La edad media fue 55 años, el 66% de sexo femenino. La indicación más frecuente fue coledocolitiasis con 88,5%. El tipo de papila duodenal mayor más frecuente fue el tipo 1 (32%), seguido de tipo 3 (27%), tipo 2 (25%) y tipo 4 (16%). Las papilas tipo 2, 3, 4 presentaron una relación significativa con canulación difícil comparadas con la tipo 1 (p<0,001, p<0,001 y p=0,008 respectivamente). La indicación diferente a coledocolitiasis también mostró una relación significativa con canulación difícil (p<0,001). En el análisis ajustado, El RR para canulación difícil en comparación con la papila tipo 1 fue: de 2,51 (IC 95% 1,23-5,94) para la papila tipo 2, 3,72 (IC 95% 1,79-7,71) para la papila tipo 3 y 3,41 (IC 95% 1,54-7,71) para la tipo 4. La indicación distinta a la coledocolitiasis también se asoció a un mayor riesgo de canulación difícil con un RR de 2.36 (IC95% 1,57-3,56). El precorte tipo fistulotomía fue usado con mayor frecuencia en la papila tipo 3 (46%) mientras que el uso de canulótomo fue más frecuente en la papila tipo 4 (29,6%). Conclusiones : Los tipos de papila 2, 3 y 4, están asociados a mayor riesgo de canulación difícil. Ello debe ser considerado al momento de realizar la CPRE a fin de reducir el riesgo de complicaciones.


ABSTRACT Introduction : Difficult cannulation in cases of endoscopic retrograde cholangiopancreatography (ERCP) could be associated with several factors, including: type of major papilla, however, there are limited data regarding this possible association. Objectives : To determine the association between the type of papilla and difficult biliary cannulation. Materials and methods : A retrospective cross-sectional analytical study was conducted in patients over 18 years old who underwent ERCP on papilla naive, from July 2019 to April 2021, in a private institution. Unsuccessful cannulations were excluded. The papilla was classified based on Haraldsson classification. The crude association and adjusted for possible confounders between the type of papilla and difficult cannulation was evaluated. Relative risks (RR) and 95% confidence intervals were calculated. Results : 188 patients were included. The mean age was 55 years, 66% female. The most frequent indication was choledocholithiasis with 88.5%. The most frequent type of major duodenal papilla was type 1 (32%), followed by type 3 (27%), type 2 (25%) and type 4 (16%). Type 2, 3, 4 papillae showed a significant relationship with difficult cannulation compared to type 1 (p<0.001, p<0.001 and p=0.008 respectively). The indication other than choledocholithiasis also showed a significant relationship with difficult cannulation (p<0.001). In the adjusted analysis, the RR for difficult cannulation compared to type 1 papilla was: 2.51 (95% CI 1.23-5.94) for type 2 papilla, 3.72 (95% CI 1.79-7.71) for papilla type 3 and 3.41 (95% CI 1.54-7.71) for type 4. The indication other than choledocholithiasis was also associated with a higher risk of difficult cannulation with a RR of 2.36 (95% CI 1.57-3.56). The fistulotomy type precut was used more frequently in the type 3 papilla (46%), while the use of cannula was more frequent in the type 4 papilla (29.6%). Conclusions : Papilla types 2, 3 and 4 are associated with a higher risk of difficult cannulation. This should be considered when performing ERCP in order to reduce the risk of complications.

19.
Rev. Fac. Med. Hum ; 21(3): 610-622, Jul.-Sep. 2021.
Artigo em Inglês, Espanhol | LILACS-Express | LILACS | ID: biblio-1280817

RESUMO

Introducción: La coinfección entre otros microorganismos y el SARS-CoV-2, como virus, bacterias y hongos, es un factor importante en el manejo del COVID-19, el cual podría aumentar las dificultades en el diagnóstico, manejo, pronóstico, e incluso aumentar los síntomas y la mortalidad. Objetivos: El objetivo de la presente revisión es describir la evidencia científica publicada respecto a coinfección en pacientes con COVID-19. Métodos: Se llevó a cabo una búsqueda bibliográfica de estudios publicados en idioma español o inglés usando los buscadores de PubMed, The Cochrane Library y Google Scholar, se buscaron estudios publicados entre enero del 2020 hasta el 24 de enero del 2021. Resultados: Se incluyeron 25 artículos procedentes de diversos continentes (América, Asia y Europa). Todos los estudios contaron con pacientes con diagnóstico confirmado de COVID-19 sumado a alguna otra prueba que identifico alguna coinfección. Se identificaron estudios 18 estudios que mostraron coinfección bacteria, 17 estudios de coinfección viral y 5 estudios de coinfección fúngica. La prevalencia de coinfección mostro cifras extremadamente disimiles de acuerdo con la población estudiada y criterios diagnósticos. Conclusión: La presencia de coinfección parece ligarse a una mayor frecuencia de desenlaces desfavorables. Sin embargo, es importante desarrollar estudios latinoamericanos, dada la heterogeneidad en los estudios vista en los distintos países. Se deben desarrollar definiciones estandarizadas a fin de poder valorar el impacto de las coinfecciones en pacientes con diagnóstico de COVID-19.


Introduction: Co-infection between other microorganisms and SARS-CoV-2, such as viruses, bacteria and fungi, is an important factor in the management of COVID-19, which could increase the difficulties in diagnosis, management, prognosis, and even increase the mortality. Objectives: The objective of this review is to describe the published scientific evidence regarding coinfection in patients with COVID-19. Methods: A bibliographic search of studies published in Spanish or English was carried out using the PubMed, The Cochrane Library and Google Scholar search engines. Studies published between January 2020 and January 24, 2021 were assessed. Results: 25 articles from various continents (America, Asia and Europe) were included. All the studies had patients with a confirmed diagnosis of COVID-19 added to some other test that identified some co-infection. We identified 18 studies that showed bacterial coinfection, 17 studies of viral coinfection and 5 studies of fungal coinfection. The prevalence of coinfection showed extremely dissimilar figures according to the population studied and diagnostic criteria. Conclusions: The presence of coinfection seems to be linked to a higher frequency of unfavorable outcomes. However, it is important to develop Latin American studies, given the heterogeneity in the studies seen in different countries. Standardized definitions should be developed in order to be able to assess the impact of co-infections in patients with a diagnosis of COVID-19.

20.
Trials ; 22(1): 342, 2021 May 17.
Artigo em Inglês | MEDLINE | ID: mdl-34001174

RESUMO

OBJECTIVES: The general objective of this study is to test the hypothesis that administration of convalescent plasma from donors with previous diagnosis of severe COVID-19 pneumonia is safe and associated with a decrease in all-cause in-hospital mortality among hospitalized patients with COVID-19 at 30 days in comparison with standard treatment alone. The secondary objectives are as follows: (1) to assess the efficacy of convalescent plasma to reduce the length of hospitalization, (2) to assess the efficacy of convalescent plasma to reduce the length of ICU stay, and (3) to assess the efficacy of convalescent plasma on reducing the requirement of invasive mechanical ventilation or ICU stay. TRIAL DESIGN: PERUCONPLASMA is a IIb phase open label, randomized, superiority clinical trial with 1:1 allocation taking place in real life routine clinical practice at public hospitals in Lima, Peru. Participants will be randomized to receive convalescent plasma along with local standard treatment or local standard treatment alone. After allocation, all participants will be followed for a total of 30 days or until hospital discharge, whichever occurs first. PARTICIPANTS: The population for the study are patients with severe disease with a confirmed laboratory test for SARS-CoV-2 infection hospitalized in 3 tertiary-care hospitals in Lima, Peru. Subjects are eligible for the trial if they meet all of the following inclusion criteria: 1. Age 18 or older 2. Hospitalization due to COVID-19 with laboratory confirmation (either with serologic, molecular, or antigen test along with a compatible clinical presentation) 3. Severe or critical COVID-19 disease Severe illness was defined by 2 or more of the following: Respiratory rate of 22 or more Hypoxemia with oxygen saturation equal or less than 93% Abnormal blood gas analysis (PaO2 < 60 mmHg, PaCO2 > 50 mmHg, or Pa/FiO2 < 300) Critical disease was defined by either: Mechanical ventilation requirement less than 72 h. Shock. 4. Capacity to provide informed consent (patient or patient's direct relative) 5. Availability of convalescent plasma units compatible with ABO blood type of the subject. EXCLUSION CRITERIA: Subjects are not eligible for the trial if they meet any of the following criteria: 1. Contraindication for transfusion (e.g., prior anaphylaxis, congestive heart failure) 2. Hemodynamic instability (PA < 60 mmHg refractory to vasopressors) 3. Uncontrolled concomitant infections\ 4. Stupor or coma 5. Platelets < 50,000/µL or disseminated intravascular coagulation 6. Serum creatinine > 3.5 mg/dL or dialysis requirement 7. Total bilirubin > 6 mg/dL or jaundice of unknown etiology 8. Myocardial infarction or acute coronary syndrome 9. Active or recent (< 7 days) intracranial hemorrhage 10. Pregnancy Donors: The donors have to meet the following criteria: male between 30 and 60 years with a previous diagnosis of severe COVID-19-associated pneumonia within the last 3 months, with resolution of symptoms of at least 28 days. The rationale for including donors with severe disease is to maximize the probability of collecting convalescent plasma units with high titer of neutralizing antibodies, as the technology to measure this specific type of antibodies is not routinely available in Peru. Aliquots of plasma will be stored for future quantification of neutralizing antibodies. INTERVENTION AND COMPARATOR: Convalescent plasma from donors with previous severe COVID-19 is the investigational medical product. The experimental group will receive 1 to 2 units of 200 to 250 ml of convalescent plasma along with local standard treatment. The control group will receive local standard treatment alone. The participants randomized to plasma will have evaluations at 6 h and 24 h to specifically evaluate possible post transfusion events. All the participants will be evaluated at day 3, day 7, and day 30 after enrolment. MAIN OUTCOMES: Safety outcome: Incidence of serious adverse reactions related to convalescent plasma transfusion within 24 h after convalescent plasma administration. Efficacy outcomes: Mortality from any cause during hospitalization at 30 days post randomization. Length of hospitalization at 30 days post randomization or until hospital discharge. Duration of mechanical ventilation at 30 days post randomization or until hospital discharge. Length of hospitalization in an intensive care unit at 30 days post randomization or until hospital discharge. Exploratory: Oxygen requirement evolution at days 3 and 7. Score Sequential Organ Failure Assessment (SOFA) evolution at days 3 and 7. Dynamics of inflammatory marker (lymphocyte, C-reactive protein (CRP), D-dimer, lactate dehydrogenase (LDH)) evolution at days 3 and 7. Proportion of patients progressing to multi-organ failure at 30 days post randomization or until hospital discharge. Proportion of transfusion related adverse reactions at 30 days post randomization or until hospital discharge. RANDOMIZATION: Randomization will be carried out within the electronic case report form (eCRF) in 1:1 ratio (receive plasma/control) in a randomization process established by blocks of size 2, 4, and 6. Allocation to the treatment arm of an individual patient will not be available to the investigators before completion of the whole randomization process. Randomization blocks will be performed with "ralloc", Stata's randomization process v.16.0. Randomization through the eCRF will be available 24 h every day. BLINDING (MASKING): Both the participants and study staff will be aware of the allocated intervention. Blinded statistical analysis will be performed. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): The sample size was calculated using the Fleiss formula with continuity correction to detect a mortality reduction from 50 to 20% between the two treatment arms with a confidence level of 95% and a power of 80%. Based on this information, a total of 45 patients per arm would be needed. After adjustment for a drop-out rate of 10% after enrolment, a total of 50 patients per arm (100 patients in total) will be enrolled. TRIAL STATUS: Current protocol version: 5.0 dated January 04, 2021. Recruitment started on September 21, 2020, and is expected to finish by the end of March 2021. TRIAL REGISTRATION: Peruvian Register of Clinical Trials (REPEC) ID: PER-016-20, registered on June 27, 2020. Clinicaltrials.gov ID: NCT04497324 , registered on August 4, 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.


Assuntos
COVID-19 , Adolescente , Transfusão de Componentes Sanguíneos , COVID-19/terapia , Humanos , Imunização Passiva , Masculino , Peru , Plasma , Ensaios Clínicos Controlados Aleatórios como Assunto , SARS-CoV-2 , Resultado do Tratamento , Soroterapia para COVID-19
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