RESUMO
Background: The pandemic of COVID-19 raised the urgent need for safe and efficacious vaccines against SARS-CoV-2. We evaluated the efficacy and safety of a new SARS-CoV-2 virus receptor-binding domain (RBD) vaccine. Methods: A phase 3, multicentre, randomised, double-blind, placebo-controlled trial was carried out at 18 clinical sites in three provinces of the south-eastern region of Cuba. Subjects (healthy or those with controlled chronic diseases) aged between 19 and 80 years, who gave written informed consent were eligible. Subjects were randomly assigned (1:1, in blocks) to two groups: placebo, and 50 µg RBD vaccine (Abdala). The product was administered intramuscularly, 0.5 mL in the deltoid region, in a three-dose immunization schedule at 0-14-28 days. The organoleptic characteristics and presentations of the vaccine and placebo were identical. All participants (subjects, clinical researchers, statisticians, laboratory technicians, and monitors) remained blinded during the study period. The main endpoint was to evaluate the efficacy of the Abdala vaccine in the prevention of symptomatic COVID-19. The trial is registered with the Cuban Public Registry of Clinical Trials, RPCEC00000359. Findings: Between March 22 to April 03, 2021, 48,290 subjects were included (24,144 and 24,146 in the placebo and Abdala groups, respectively) in the context of predominant D614G variant circulation. The evaluation of the main efficacy outcomes occurred during May-June 2021, starting at May 3rd, in the context of high circulation of mutant viruses, predominantly VOC Beta. The incidence of adverse reactions for individuals in the placebo and Abdala vaccine groups were 1227/24,144 (5.1%) and 1621/24,146 (6.7%), respectively. Adverse reactions were mostly mild, and from the injection site, which resolved in the first 24-48 h. No severe adverse events with demonstrated cause-effect relationship attributable to the vaccine were reported. Symptomatic COVID-19 disease was confirmed in 142 participants in the placebo group (78.44 incidence per 1000 person-years, 95% confidence interval [CI], 66.07-92.46) and in 11 participants in Abdala vaccine group (6.05 incidence per 1000 person years; 95% CI 3.02-10.82). The Abdala vaccine efficacy against symptomatic COVID-19 was 92.28% (95% CI 85.74-95.82). Moderate/serious forms of COVID-19 occurred in 30 participants (28 in the placebo group and only 2 in the Abdala vaccine group) for a vaccine efficacy of 92.88% (95% CI 70.12-98.31). There were five critical patients (of which four died), all in the placebo group. Interpretation: The Abdala vaccine was safe, well tolerated, and highly effective, fulfilling the WHO target product profile for COVID-19 vaccines. Those results, along with its immunization schedule and the advantage of easy storage and handling conditions at 2-8 °C, make this vaccine an option for the use in immunization strategies as a key tool for the control of the pandemic. Funding: Centre for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba.
RESUMO
Se realizó un estudio descriptivo y transversal de 113 pacientes con insuficiencia cardíaca egresados del Servicio de Medicina Interna del Hospital Clinicoquirúrgico Docente Dr Joaquín Castillo Duany, de Santiago de Cuba, desde enero de 2013 hasta igual mes de 2014, a fin de caracterizarles según variables clínicas y epidemiológicas. Entre los resultados principales predominaron el sexo femenino, los pacientes mayores de 70 años (38,5 por ciento), la insuficiencia cardíaca como el diagnóstico más frecuente, así como los afectados con más de 10 años de evolución de la enfermedad con asociación heredofamiliar (53,1 por ciento); asimismo, se comprobó el uso inadecuado del tratamiento farmacológico, con una tasa de letalidad elevada(AU)
A descriptive and cross-sectional study of 113 patients with heart failure was carried out. They were discharged from the Internal Medicine Service of Dr Joaquín Castillo Duany Teaching Clinical Surgical Hospital in Santiago de Cuba, from January, 2013 to the same month in 2014, in order to characterize them according to clinical and epidemiological variables. Among the main results there was a prevailence of the female sex, patients over 70 years (38.5 percent), heart failure as the most frequent diagnosis, as well as those affected with more than 10 years of the disease clinical course with inherited family association (53.1 percent); also, the inadequate use of the pharmacological treatment was demonstrated, with a high letality rate(AU)
Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Idoso , Atenção Secundária à Saúde , Prescrições de Medicamentos , Isquemia Miocárdica , Hipertensão , Epidemiologia Descritiva , Estudos TransversaisRESUMO
Se realizó un estudio descriptivo y transversal de 113 pacientes con insuficiencia cardíaca egresados del Servicio de Medicina Interna del Hospital Clinicoquirúrgico Docente Dr Joaquín Castillo Duany, de Santiago de Cuba, desde enero de 2013 hasta igual mes de 2014, a fin de caracterizarles según variables clínicas y epidemiológicas. Entre los resultados principales predominaron el sexo femenino, los pacientes mayores de 70 años (38,5 por ciento), la insuficiencia cardíaca como el diagnóstico más frecuente, así como los afectados con más de 10 años de evolución de la enfermedad con asociación heredofamiliar (53,1 por ciento); asi mismo, se comprobó el uso inadecuado del tratamiento farmacológico, con una tasa de letalidad elevada
A descriptive and cross-sectional study of 113 patients with heart failure was carried out. They were discharged from the Internal Medicine Service of Dr Joaquín Castillo Duany Teaching Clinical Surgical Hospital in Santiago de Cuba, from January, 2013 to the same month in 2014, in order to characterize them according to clinical and epidemiological variables. Among the main results there was a prevailence of the female sex, patients over 70 years (38.5 percent), heart failure as the most frequent diagnosis, as well as those affected with more than 10 years of the disease clinical course with inherited family association (53.1 percent); also, the inadequate use of the pharmacological treatment was demonstrated, with a high letality rate
Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Prescrições de Medicamentos , Atenção Secundária à Saúde , Isquemia Miocárdica , Insuficiência Cardíaca , Epidemiologia Descritiva , Estudos Transversais , HipertensãoRESUMO
Se presenta el caso clínico de un anciano de 83 años de edad, ingresado en el Hospital Clinicoquirúrgico Docente Dr Joaquín Castillo Duany de Santiago de Cuba por presentar enfermedad cerebrovascular, además de fibrilación auricular, de manera que se sospechó una fuente embolígena cardiovascular. En el ecocardiograma realizado se observó una imagen de tipo T en la aurícula derecha que no explicaba el cuadro clínico del paciente, pero llamó la atención que esta desapareció después del tratamiento, lo cual motivó a la descripción del siguiente caso clínico para ser publicado(AU)
The case of a 83-year-old man is reported, who was admitted to Dr Joaquín Castillo Duany Teaching Clinical Surgical Hospital in Santiago de Cuba due to cerebrovascular disease and atrial fibrillation, so that an embolic cardiovascular source was suspected. The echocardiogram showed a T-type image in the right atrium that did not explain the patient's clinical pattern, but it was noticed that it disappeared after treatment, which led to the description of this case for publication(AU)
Assuntos
Humanos , Masculino , Idoso , Transtornos Cerebrovasculares , Fibrilação Atrial , Ecocardiografia , Átrios do CoraçãoRESUMO
Se presenta el caso clínico de un anciano de 83 años de edad, ingresado en el Hospital Clinicoquirúrgico Docente "Dr. Joaquín Castillo Duany" de Santiago de Cuba por presentar enfermedad cerebrovascular, además de fibrilación auricular, de manera que se sospechó una fuente embolígena cardiovascular. En el ecocardiograma realizado se observó una imagen de tipo T en la aurícula derecha que no explicaba el cuadro clínico del paciente, pero llamó la atención que esta desapareció después del tratamiento, lo cual motivó a la descripción del siguiente caso clínico para ser publicado.
The case of a 83-year-old man is reported, who was admitted to "Dr. Joaquín Castillo Duany" Teaching Clinical Surgical Hospital in Santiago de Cuba due to cerebrovascular disease and atrial fibrillation, so that an embolic cardiovascular source was suspected. The echocardiogram showed a T-type image in the right atrium that did not explain the patient's clinical pattern, but it was noticed that it disappeared after treatment, which led to the description of this case for publication.
RESUMO
Se expone el caso clínico de un paciente de 40 años de edad, con aparente buena salud, atendido en el Hospital Clinicoquirúrgico Docente Dr Joaquín Castillo Duany de Santiago de Cuba por presentar, desde hacía varios meses, dolor abdominal en epigastrio, no irradiado, asociado a molestia en la región anterior del tórax, dificultad para respirar, hinchazón en las piernas, decaimiento, somnolencia y dolores articulares, así como andar lento y disminución de la memoria, entre otros síntomas. Los resultados de los exámenes complementarios confirmaron que se trataba de un derrame pericárdico de causa hipotiroidea. Se indicó tratamiento sustitutivo con hormonas tiroideas (levotiroxina sódica). Evolucionó favorablemente y egresó de la institución hospitalaria, pero fue reevaluado a los 3 meses, observándose una mejoría significativa
The case of an apparently healthy 40 year-old patient is reported, who was attended in Dr Joaquín Castillo Duany Clinical Surgical Hospital of Santiago de Cuba to present with epigastric abdominal pain for several months, no irradiated and associated with discomfort in anterior chest, breathing difficulty, swelling of the legs, weakness, drowsiness and joint pains, as well as slow gait, impaired memory, and other symptoms. The results of additional tests confirmed a pericardial effusion of hypothyroid cause. A replacement therapy was administered with thyroid hormones (sodium levothyroxine). He made good progress and was discharged from the hospital, but he was reevaluated at 3 months and a significant improvement was observed
Assuntos
Humanos , Masculino , Adulto , Derrame Pericárdico/etiologia , Hipotireoidismo/complicações , Hipotireoidismo/tratamento farmacológico , Tiroxina/uso terapêuticoRESUMO
Se expone el caso clínico de un paciente de 40 años de edad, con aparente buena salud, atendido en el Hospital Clinicoquirúrgico Docente Dr Joaquín Castillo Duany de Santiago de Cuba por presentar, desde hacía varios meses, dolor abdominal en epigastrio, no irradiado, asociado a molestia en la región anterior del tórax, dificultad para respirar, hinchazón en las piernas, decaimiento, somnolencia y dolores articulares, así como andar lento y disminución de la memoria, entre otros síntomas. Los resultados de los exámenes complementarios confirmaron que se trataba de un derrame pericárdico de causa hipotiroidea. Se indicó tratamiento sustitutivo con hormonas tiroideas (levotiroxina sódica). Evolucionó favorablemente y egresó de la institución hospitalaria, pero fue reevaluado a los 3 meses, observándose una mejoría significativa(AU)
The case of an apparently healthy 40 year-old patient is reported, who was attended in Dr Joaquín Castillo Duany Clinical Surgical Hospital of Santiago de Cuba to present with epigastric abdominal pain for several months, no irradiated and associated with discomfort in anterior chest, breathing difficulty, swelling of the legs, weakness, drowsiness and joint pains, as well as slow gait, impaired memory, and other symptoms. The results of additional tests confirmed a pericardial effusion of hypothyroid cause. A replacement therapy was administered with thyroid hormones (sodium levothyroxine). He made good progress and was discharged from the hospital, but he was reevaluated at 3 months and a significant improvement was observed(AU)
Assuntos
Humanos , Masculino , Adulto , Derrame Pericárdico/etiologia , Hipotireoidismo/complicações , Hipotireoidismo/tratamento farmacológico , Tiroxina/uso terapêuticoRESUMO
Se presenta el caso clínico de un hombre de 55 años de edad, en quien se diagnosticó en vida una polimiositis como manifestación paraneoplásica; sin embargo, como no mejoró con el tratamiento esteroideo, se complicó y falleció. El resultado de la necropsia confirmó la presencia de una neoplasia gástrica(AU)
The clinical case of a man aged 55 undergoing polymiositis diagnosis as a paraneoplastic manifestation when he was alive is presented. Nonetheless, his health condition got worse and he died even after receiving the steroid therapy. The necropsy result confirmed the presence of gastric neoplasm(AU)
Assuntos
Humanos , Masculino , Adulto , Polimiosite , Neoplasias Gástricas , Esteroides/uso terapêuticoRESUMO
Se presenta el caso clínico de un hombre de 55 años de edad, en quien se diagnosticó en vida una polimiositis como manifestación paraneoplásica; sin embargo, como no mejoró con el tratamiento esteroideo, se complicó y falleció. El resultado de la necropsia confirmó la presencia de una neoplasia gástrica.
The clinical case of a man aged 55 undergoing polymiositis diagnosis as a paraneoplastic manifestation when he was alive is presented. Nonetheless, his health condition got worse and he died even after receiving the steroid therapy. The necropsy result confirmed the presence of gastric neoplasm.
Assuntos
Humanos , Masculino , Adulto , Esteroides/uso terapêutico , Polimiosite , Neoplasias GástricasRESUMO
Se realizó un estudio descriptivo y transversal de 57 pacientes con cáncer de colon en el Hospital Clinicoquirúrgico Docente Dr. Joaquín Castillo Duanyde Santiago de Cuba durante el trienio 2000 - 2003, a fin de identificar las características de la enfermedad según variables seleccionadas. La mayor parte de los integrantes de la casuística eran blancos y mayores de 55 años, pero sin diferencias en cuanto a la distribución por sexo. El colon izquierdo resultó ser el más afectado (54,4 por ciento) y entre las afecciones más comúnmente asociadas figuraron la colitis ulcerativa idiopática y la diverticulosis del colon. El adenocarcinoma bien diferenciado fue el tipo histológico más frecuente (61,4 por ciento). La mayoría de los pacientes fueron diagnosticados en los estadios de Dukes B, C y D, por lo cual se recomienda determinar los factores que influyen sobre el diagnóstico tardío (AU)