Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 44
Filtrar
1.
PLoS One ; 18(9): e0288006, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37751460

RESUMO

Despite that more than one hundred vaccines against SARS-CoV-2 have been developed and that some of them were evaluated in clinical trials, the latest results revealed that these vaccines still face great challenges. Among the components of the virus, the N-protein constitutes an attractive target for a subunit vaccine because it is the most abundant, highly conserved and immunogenic protein. In the present work, a chimeric protein (N-CD protein) was constructed by the fusion of the N-protein to the extracellular domain of human CD154 as the molecular adjuvant. HEK-293 cells were transduced with lentiviral vector bearing the N-CD gene and polyclonal cell populations were obtained. The N-CD protein was purified from cell culture supernatant and further characterized by several techniques. Immunogenicity studies in mice and non-human primates showed the N-CD protein induced high IgG titers in both models after two doses. Moreover, overall health monitoring of non-human primates demonstrated that animals were healthy during 228 days after first immunization. Data obtained support further investigation in order to develop this chimeric protein as vaccine candidate against COVID-19 and other coronavirus diseases.


Assuntos
COVID-19 , Vacinas , Humanos , Animais , Camundongos , SARS-CoV-2/genética , COVID-19/prevenção & controle , Células HEK293 , Vacinas contra COVID-19 , Nucleocapsídeo , Ligante de CD40/genética , Proteínas Recombinantes de Fusão/genética
3.
CorSalud ; 13(3)sept. 2021.
Artigo em Espanhol | LILACS-Express | LILACS | ID: biblio-1404446

RESUMO

RESUMEN La mayoría de las toracotomías que con más frecuencia son utilizadas en la práctica quirúrgica actual fueron creadas en los quirófanos del siglo XX. En la búsqueda de diferentes opciones terapéuticas para lidiar con afecciones cancerígenas e infecciosas, de órganos torácicos y mediastinales, los padres de la cirugía torácica moderna crearon abordajes que han vencido la prueba del tiempo y se continúan practicando, a pesar del enorme desarrollo de la cirugía torácica de accesos mínimos o video-asistida. Sin embargo, muchos cirujanos desconocen los acontecimientos que rodearon el nacimiento de las principales toracotomías clásicas y, por otra parte, en no pocas ocasiones la historia ha reconocido como padres de algunas técnicas a quienes realmente no merecen ese crédito. En esta tercera parte de nuestra revisión se continúa exponiendo la historia, no del todo conocida, de las incisiones torácicas.


ABSTRACT Most of thoracotomies that are most frequently used in today's surgical practice were created in the operating rooms of the 20th century. In the search for different therapeutic options to treat cancerous and infectious conditions of the thoracic and mediastinal organs, the fathers of modern thoracic surgery created approaches that have stood the test of time and continue to be practiced, despite the enormous development of minimal access or video-assisted thoracic surgery. However, many surgeons are unaware of the events surrounding the birth of the main classical thoracotomies and, on the other hand, on more than a few occasions history has recognized as the fathers of some techniques those who do not really deserve that credit. In this third part of our review we continue to unravel the history of thoracic incisions, not all of which is well known.

4.
Vet Microbiol ; 260: 109153, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34271304

RESUMO

E2-CD154 subunit vaccine candidate is safe and protects swine from Classical Swine Fever (CSF). However, its safety and immunogenicity in pregnant sows, and the capacity of maternal derived neutralizing antibodies (MDNA) to protect the offspring is yet to be demonstrated. The aim of this study was to evaluate the safety and immunogenicity of E2-CD154 in pregnant sows, and the capacity of MDNA to protect the offspring. Seventeen pregnant sows were vaccinated twice with E2-CD154 in either the first or the second third of pregnancy. Pregnancy and litter parameters were compared with a control group of non-vaccinated sows. Neutralizing antibodies (NAb) were monitored. The time course of MDNA was assessed in a group of six piglets born to an E2-CD154 immunized sow, and the animals were challenged with CSFV at day 63 after birth. No local or systemic adverse effects were found. Neither abortions, nor congenital malformations, nor stillbirths were observed. All sows develop high NAb titers after the first immunization. Piglets born to an E2-CD154 vaccinated sow still showed MDNA titers of 1:100 at day 63 after birth. Five animals were negative for virus isolation after challenge, and showed neither signs of CSF, nor macroscopic lesions in the organs. The other piglet was positive for CSFV isolation, and macroscopic lesions were observed in the spleen, although no clinical signs of CSF other than fever were detected. E2-CD154 vaccine candidate was safe and immunogenic in pregnant sows, and the passive immunity transmitted to the offspring was still protective by day 63 after birth.


Assuntos
Vírus da Febre Suína Clássica/imunologia , Peste Suína Clássica/prevenção & controle , Imunização/veterinária , Imunogenicidade da Vacina/imunologia , Vacinas Virais/imunologia , Animais , Anticorpos Neutralizantes/imunologia , Peste Suína Clássica/virologia , Feminino , Gravidez , Suínos , Vacinas de Subunidades Antigênicas/imunologia
5.
CorSalud ; 13(2)jun. 2021.
Artigo em Espanhol | LILACS-Express | LILACS | ID: biblio-1404424

RESUMO

RESUMEN Durante el siglo XIX se constataron más avances en la cirugía torácica que los experimentados en las más de 40 centurias transcurridas desde la escritura del papiro de Edwin Smith. En un período de poco menos de cien años el hombre abordó la cavidad pericárdica no solo para evacuar derrames, sino para suturar satisfactoriamente heridas en el músculo cardíaco. Además, se realizaron las primeras toracotomías con la específica intención de resecar segmentos pulmonares y se abrió por primera vez el esternón en toda su longitud, un abordaje que con el paso del tiempo se convertiría en la más usada de todas las incisiones torácicas. La mayoría de los cirujanos torácicos conoce poco acerca del verdadero origen de muchos de estos procedimientos quirúrgicos que se emplean en los salones de operaciones del siglo XXI. Esta segunda parte de nuestra revisión tiene la intención de seguir develando la desconocida historia de las incisiones torácicas.


ABSTRACT The 19th century saw more advances in thoracic surgery than in the more than 40 centuries since the writing of the Edwin Smith papyrus. In a period of less than a century, man approached the pericardial cavity not only to drain effusions, but to successfully suture wounds in the cardiac muscle. Moreover, the first thoracotomies were performed for the specific purpose of resecting lung segments and the sternum was completely opened for the first time, an incision that would eventually become the most widely used of all thoracotomies. Most thoracic surgeons know little about the true story behind many thoracotomies performed in the operating rooms of the 21st century. This second part of our review further unveils the unknown history of thoracic incisions.

6.
Medisur ; 19(3): 356-362, 2021. graf
Artigo em Espanhol | LILACS-Express | LILACS | ID: biblio-1287318

RESUMO

RESUMEN La toracotomía axilar vertical es un procedimiento quirúrgico que permite realizar múltiples técnicas para el diagnóstico y tratamiento de enfermedades del tórax, área que implica consideraciones anestésicas especiales. El presente estudio pretende exponer determinantes para el manejo anestésico de pacientes intervenidos quirúrgicamente por toracotomías axilares. Se realizó una revisión bibliográfica, mediante la búsqueda en bases de datos (Medline/Pubmed e Hinari), incluyendo los términos: toracotomía axilar vertical, manejo anestésico y cirugía torácica. Las determinantes identificadas dentro del manejo anestésico durante la toracotomía axilar vertical fueron la evaluación preoperatoria, monitorización, manejo de la vía aérea, estrategia de ventilación, tratamiento anestésico y la analgesia postoperatoria inmediata. Se determinó, de acuerdo con la necesidad y condiciones del equipo, establecer como prioritaria la defensa del momento óptimo de relajación muscular. El control hemodinámico del paciente, el aislamiento pulmonar, la relajación muscular para el abordaje quirúrgico, la ventilación pulmonar y la analgesia perioperatoria, siguen siendo hoy día la piedra angular del manejo anestésico en la toracotomía axilar vertical.


ABSTRACT Vertical axillary thoracotomy is a surgical procedure that allows multiple techniques to be performed for the diagnosis and treatment of chest diseases, an area that involves special anesthetic considerations. The present study aims to expose determinants for the anesthetic management of patients operated on for axillary thoracotomies. A bibliographic review was carried out by searching databases (Medline / Pubmed and Hinari), including the terms: vertical axillary thoracotomy, anesthetic management and thoracic surgery. The determinants identified within anesthetic management during vertical axillary thoracotomy were preoperative evaluation, monitoring, airway management, ventilation strategy, anesthetic treatment, and immediate postoperative analgesia. According to the needs and conditions of the team, it was determined to establish as a priority the defense of the optimal moment of muscle relaxation. Hemodynamic control of the patient, pulmonary isolation, muscle relaxation for the surgical approach, pulmonary ventilation, and perioperative analgesia continue to be the cornerstone of anesthetic management in vertical axillary thoracotomy today.

7.
Medicentro (Villa Clara) ; 25(2): 355-362, graf
Artigo em Espanhol | LILACS | ID: biblio-1279429

RESUMO

RESUMEN El secuestro pulmonar es una de las malformaciones pulmonares más comunes en el adulto joven. Este puede ser originado a partir de un brote pulmonar accesorio que migra junto al desarrollo del esófago, o puede ocurrir por infecciones pulmonares repetitivas; sus manifestaciones clínicas son muy variables y su detección es un hallazgo radiológico. Se presentó un paciente joven con ingresos múltiples por neumonía en el Hospital Universitario Dr. Celestino Hernández Robau. En la radiografía de tórax se apreció una imagen no homogénea en la base pulmonar derecha, que no mejoró a pesar de múltiples tratamientos antimicrobianos de amplio espectro. En una tomografía axial computarizada se observó un grueso vaso que partía de la aorta abdominal hasta la base pulmonar derecha. Se realizó reconstrucción de imágenes y con el diagnóstico de secuestro pulmonar se intervino quirúrgicamente. El paciente tuvo una evolución satisfactoria.


ABSTRACT Pulmonary sequestration is one of the most common lung malformations in young adults. This can be originated from an accessory lung bud that migrates along the development of the esophagus, or it can occur by repetitive pulmonary infections; its clinical manifestations are highly variable and its detection is a radiological finding. We present a young patient with multiple admissions for pneumonia at "Dr. Celestino Hernández Robau" University Hospital. Chest X-ray showed a non-homogeneous image in the right lung base, which did not improve despite several broad-spectrum antimicrobial treatments. A thick vessel that started from the abdominal aorta to the right pulmonary base was observed through a computerized axial tomography. Image reconstruction was performed and with the diagnosis of pulmonary sequestration, surgery was performed. The patient had a satisfactory evolution.


Assuntos
Sequestro Broncopulmonar
8.
CorSalud ; 13(1): 59-67, 2021. graf
Artigo em Espanhol | LILACS | ID: biblio-1345921

RESUMO

RESUMEN A lo largo de la historia de la cirugía numerosas inexactitudes han rodeado el capítulo relacionado con el surgimiento de las incisiones torácicas. Siempre será muy difícil precisar la fecha exacta y el nombre de quienes realmente realizaron las primeras toracotomías; obviamente debe asumirse como tales a quienes publicaron o informaron las descripciones originales, pero la historia no siempre ha sido correctamente contada. En unos casos solo se conocen apellidos; en otros, la incongruencia de los lapsos de tiempo se opone a toda lógica. Se ha realizado una profunda investigación histórica que ha permitido confeccionar un breve recuento del surgimiento de las toracotomías más importantes y descubrir algunos hallazgos desconocidos para la mayoría de los cirujanos torácicos. Esta es la primera parte de un breve relato de hechos conocidos, pero especialmente, de la historia desconocida del origen de las incisiones torácicas que han vencido la prueba del tiempo.


ABSTRACT Throughout the history of surgery many inaccuracies have surrounded the chapter related to the emergence of thoracic incisions. It will always be very difficult to determine the exact date and names of those who actually performed the first thoracotomies; obviously those who published or reported the first descriptions should be assumed as such, but the history has not always been well told. In some cases, only surnames are known; in some others, the inconsistency of time lapses opposes all logic. A thorough historical research has been carried out, which has made it possible to compile a brief account about the emergence of the most important thoracotomies, as well as to reveal some findings that are unknown to most thoracic surgeons. This is the first part of a brief account about the known facts, but also, it is especially about the unknown history of the thoracic incisions' origin, which has overcome the test of time.


Assuntos
Pericárdio , Derrame Pleural , Toracotomia , Abscesso , História da Medicina , Pulmão
9.
Fish Shellfish Immunol ; 110: 44-54, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33348037

RESUMO

Nile tilapia (Oreochromis niloticus) is a freshwater fish, which is extensively cultivated worldwide and constitutes one of the model species for the study of fish immunology. Monoclonal antibodies are very advantageous molecular tools for studying teleost immune system. Specifically, monoclonal antibodies that react with immunoglobulins are used successfully in the study of the humoral immune response of several fish species. In the present study, we produced and characterized a monoclonal antibody against tilapia IgM heavy chain using a peptide-based strategy. The peptide sequence was selected from the surface-exposed region between CH3-CH4 domains. The specificity of the polyclonal serum and the hybridoma culture supernatant obtained by immunization with the peptide conjugated to keyhole limpet hemocyanin were evaluated by western blotting, both showing reactivity against tilapia serum IgM. The purified mAb was able to recognize secreted IgM by western blotting and ELISA and membrane IgM by flow cytometry. We also demonstrated that the antibody doesn't cross-react with a recombinant IgT fragment. This tool allowed us to study for the first time the stimulation of mucosal immunity after Pituitary Adenylate Cyclase Activating Polypeptide administration. Overall, the results demonstrated the utility of this mAb to characterize humoral immune response in O. niloticus.


Assuntos
Anticorpos Monoclonais/imunologia , Ciclídeos/imunologia , Proteínas de Peixes/imunologia , Imunidade Humoral , Cadeias Pesadas de Imunoglobulinas/imunologia , Imunoglobulina M/imunologia , Sequência de Aminoácidos , Animais , Alinhamento de Sequência
10.
Clean Technol Environ Policy ; 22(9): 1843-1854, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32904530

RESUMO

ABSTRACT: The enormous inroads made by renewable energy in recent years have been the key to the development of new technologies designed to obtain energy from a range of resources. Hydrokinetic microturbines used to harness kinetic energy from rivers, tidal and marine currents epitomize such developments. As the reservoir is dispensed with, the water footprint normally associated with conventional hydroelectric generation is minimized. The new prototypes being developed require laboratories with water tunnel infrastructures where they can be accurately reproduced under controlled conditions. However, the construction of a water tunnel demands considerable investment, which prevents many research groups from completing their prototype design work. This paper charts the design of a low-cost hydrodynamic water tunnel at the University of Oviedo, indicating the mechanical and electronic elements as well as the software developments that make up the facility. This construction is a part of a research strategy focused on making the study of new hydrokinetic microturbines designs economically feasible. Moreover, it includes a description of a special software application used to perform the characterization of a hydrokinetic microturbine model in the water tunnel and a demonstration of the scope of the facility in the experimental study of a unit with a Darrieus rotor.

11.
Edumecentro ; 12(3): 67-81, jul.-set. 2020. graf
Artigo em Espanhol | LILACS | ID: biblio-1124703

RESUMO

RESUMEN Fundamento: la cirugía torácica es indispensable en la formación del cirujano general, específicamente las vías de abordajes al tórax. Del análisis de elementos contradictorios y teniendo como fundamentos la práctica y la revisión continua de la literatura, fue necesario realizar innovaciones sucesivas a las toracotomías axilares verticales, las cuales después de realizadas demandaron un instrumento para su socialización. Objetivo: diseñar un folleto didáctico para la socialización de los resultados de la investigación "Modificaciones a la toracotomía axilar vertical". Métodos: se realizó un estudio de innovación tecnológica, empleando el método general del conocimiento dialéctico-materialista en la confección de un folleto didáctico que contiene los resultados de una investigación cuasiexperimental en pacientes operados, en el período comprendido entre septiembre de 2012 a diciembre de 2016, por afecciones en la cavidad torácica (no cardiovasculares), en el Hospital Clínico Quirúrgico "Arnaldo Milián Castro" de Santa Clara, Villa Clara. Resultados: el folleto didáctico incluye la explicación metodológica de las modificaciones a la técnica quirúrgica e imágenes que las ilustran; tiene 35 páginas cuyo contenido está desglosado en ocho acápites que incluyen fundamentos teóricos, desarrollo de la técnica, novedad, ventajas, desventajas y resultados de su aplicación. Se encuentra disponible en la biblioteca del mencionado hospital para la preparación de los profesionales que se entrenan con este fin. Conclusiones: el folleto didáctico constituye un valioso material de apoyo a la docencia y una herramienta eficaz para elevar el desempeño profesional en la identificación y solución de problemas en la práctica médica relacionados con la toracotomía axilar vertical.


ABSTRACT Background: thoracic surgery is essential for the general surgeon training, specifically the approaches to reviewing the chest. Taking as reference the analysis of contradictory elements and having as basis practice and the continuous review of literature, it was necessary to make subsequent innovations to the vertical axillary thoracotomies, which after being performed required an instrument for their socialization. Objective: to design a didactic leaflet to socialize the research results "Modifications to vertical axillary thoracotomy". Methods: a technological innovation study was conducted, using the general method of dialectical-materialistic knowledge for designing a didactic leaflet containing the results of a quasi-experimental research in patients who underwent surgery, from September 2012 to December 2016, due to conditions in the thoracic cavity (non-cardiovascular conditions), at the "Arnaldo Milián Castro" Clinical Surgical Hospital in Santa Clara, Villa Clara. Results: the didactic leafklet includes the methodological details of the modifications to the surgical technique and images that illustrate them; the leaflet is 35 pages long with the content that is organized into eight chapters that include theoretical underpinnings, development of the technique, novelty, advantages, disadvantages and results of its application. It is available at the library of the above mentioned hospital, for the professional development of specialists in this field. Conclusions: the didactic leaflet is a valuable learner-teacher support material and an effective tool for the professional development of specialists in recognizing and solving problems in clinical practice related to vertical axillary thoracotomy.


Assuntos
Cirurgia Torácica , Manual de Referência , Educação Médica , Ferida Cirúrgica
13.
In. Caballero López, Armando; Domínguez Perera, Mario Antonio; Pardo Núñez, Armando Bárbaro; Abdo Cuza, Anselmo Antonio. Terapia intensiva. Tomo 10. Urgencias traumáticas. Tercera edición. La Habana, Editorial Ciencias Médicas, 3 ed; 2020. , ilus, tab.
Monografia em Espanhol | CUMED | ID: cum-76534
14.
CorSalud ; 11(3): 219-224, jul.-set. 2019. graf
Artigo em Espanhol | LILACS | ID: biblio-1089740

RESUMO

RESUMEN Las toracotomías axilares están entre las más descritas y modificadas en la historia de la cirugía. A pesar del sostenido desarrollo de la cirugía torácica video-asistida, es ineludible el protagonismo de las toracotomías clásicas en la práctica quirúrgica actual, en especial cuando no están disponibles las opciones mínimamente invasivas. La toracotomía axilar vertical posterior extendida, surgió hace casi 30 años a partir de la introducción de innovadoras modificaciones a incisiones torácicas axilares previamente descritas. Una extensa revisión bibliográfica permite afirmar que nunca antes ha sido informada una toracotomía axilar que contenga al unísono todas las características distintivas que la que ahora se presenta. Se discuten sus principales ventajas en relación con la disminución del tiempo operatorio y de las complicaciones durante y después de la cirugía.


ABSTRACT Axillary thoracotomies are among the most described and modified in the history of surgery. Despite the sustained development of video-assisted thoracic surgery, the role of classic thoracotomies in current surgical practice is unavoidable, especially when minimally invasive options are not available. Extended posterior vertical axillary thoracotomy emerged almost 30 years ago from the introduction of innovative modifications to axillary thoracic incisions previously described. An extensive literature review makes it possible to affirm that an axillary thoracotomy, which contains all the distinctive features that the one presented herein, has never been reported before. Its main advantages are discussed in relation to the decrease in the operating time and complications during and after surgery.


Assuntos
Toracotomia , Pneumonectomia , Cirurgia Torácica , Abscesso , Pulmão
15.
CorSalud ; 11(1): 66-69, ene.-mar. 2019. graf
Artigo em Espanhol | LILACS | ID: biblio-1089711

RESUMO

RESUMEN Los tumores de células germinales no son tan frecuentes, dentro de ellos se encuentra el teratoma como el más usual en ubicación mediastinal, es más habitual en hombres jóvenes cuando es maligno (teratocarcinoma), con una relación por género de 13,5:1, y una edad promedio de 26 años. Se describe la evolución de un hombre de 19 años de edad con un tumor mediastinal, con metástasis pulmonares e infiltración intracardíaca, resecado satisfactoriamente, cuyos síntomas más frecuentes fueron: disnea, dolor retroesternal, fiebre, tos, pérdida de peso y síndrome de vena cava superior. El diagnóstico se realizó por radiografía de tórax y tomografía axial computarizada. Se logró realizar la excéresis total del tumor y las metástasis, así como la tumoración intracardíaca, con reparación de la válvula tricúspide. El paciente ha tenido una evolución satisfactoria durante el primer año de seguimiento.


ABSTRACT Germ cell tumors are not so frequent; among them, teratomas are most common in the mediastinal location. Teratomas in young men are usually malignant (teratocarcinoma), with a gender ratio of 13.5:1, and an average age of 26 years. We describe the evolution of a 19-year-old man with a mediastinal tumor, with pulmonary metastases and intracardiac infiltration, successfully removed; whose most frequent symptoms were: dyspnea, retrosternal pain, fever, cough, weight loss and superior vena cava syndrome. The diagnosis was made by chest x-ray and computed tomography. Total removal of the tumor and metastases was achieved, as well as the intracardiac tumor, with tricuspid valve repair. The patient had a satisfactory outcome during the first follow-up year.


Assuntos
Neoplasias do Mediastino , Neoplasias de Tecido Gonadal , Neoplasias Embrionárias de Células Germinativas , Células Germinativas
16.
Biologicals ; 52: 67-71, 2018 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-29311002

RESUMO

The development of subunit vaccines against classical swine fever is a desirable goal, because it allows discrimination between vaccinated and infected animals. In this study, humoral and cellular immune response elicited in inbred BALB/c mice by immunization with a recombinant classical swine fever virus (CSFV) E2 protein fused to porcine CD154 antigen (E2CD154) was assessed. This model was used as a predictor of immune response in swine. Mice were immunized with E2CD154 emulsified in Montanide ISA50V2 or dissolved in saline on days 1 and 21. Another group received E2His antigen, without CD154, in the same adjuvant. Montanide ISA50V2 or saline served as negative controls for each experimental group. Animals immunized with 12.5 and 2.5 µg/dose of E2CD154 developed the highest titers (>1:2000) of CSFV neutralizing antibodies. Moreover, CSFV specific splenocyte gamma-interferon production, measured after seven and twenty-eight days of immunization, was significantly higher in mice immunized with 12.5 µg of E2CD154. As a conclusion, E2CD154 emulsified in Montanide ISA50 V2 was able to induce a potent humoral and an early cellular immune response in inbred BALB/c mice. Therefore, this immunogen might be an appropriate candidate to elicit immune response in swine, control CSF disease and to eliminate CSFV in swine.


Assuntos
Ligante de CD40/imunologia , Imunidade Celular , Imunidade Humoral , Imunogenicidade da Vacina , Proteínas Recombinantes de Fusão/imunologia , Proteínas Virais/imunologia , Vacinas Virais/imunologia , Animais , Anticorpos Neutralizantes/imunologia , Anticorpos Antivirais/imunologia , Ligante de CD40/genética , Vírus da Febre Suína Clássica , Feminino , Camundongos , Camundongos Endogâmicos BALB C , Proteínas Recombinantes de Fusão/genética , Suínos , Proteínas Virais/genética , Vacinas Virais/genética
17.
Biologicals ; 51: 12-17, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29246787

RESUMO

A sandwich enzyme-linked immunosorbent assay for quantifying a recombinant human Epidermal Growth Factor (rhEGF) protein used in a vacunal preparation is described. The protein was detected with high specificity in a short incubation time at elevated temperature, the assay showing a linear range between 0.0625 and 1 ng/mL. According to the regression analysis for the dilutional linearity data, r2 = 0.9998, slope = 1.07 and intercept = 0.05 were obtained. The intra- and inter-assay coefficient of variation, ranged from 0.79 to 2.87% and 4.87-9.69% respectively demonstrating high reproducibility and precision. The ANOVA test used in the specificity/interference study revealed parallelism among curves (p > 0.1), which indicated lack of interference in the working range. Recovery obtained in accuracy test for three concentration levels varied between 89 and 111%; evidencing a reliable analytical assay to characterize the quality of the recombinant protein in the manufacturing process at large scale, and other biological matrixes as: urine and serum.


Assuntos
Ensaio de Imunoadsorção Enzimática/métodos , Fator de Crescimento Epidérmico/análise , Proteínas Recombinantes/análise , Fator de Crescimento Epidérmico/sangue , Fator de Crescimento Epidérmico/urina , Humanos , Proteínas Recombinantes/sangue , Proteínas Recombinantes/urina , Valores de Referência , Reprodutibilidade dos Testes
18.
PDA J Pharm Sci Technol ; 71(6): 454-461, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28733332

RESUMO

Water for injection is used in multiple applications in the biopharmaceutical industry. Regarding this, several methods have been use to generate water with this high quality. Within them, the thermocompression distillation method has been widely employed. However, reports on the maintenance of the qualification and validation status of thermocompression systems used for water for injection generation are non-existent in the scientific literature. Therefore, this paper sought to give results of continuous process verification of a system used for water for injection generation over 2 years analyzing the level of conductivity, nitrate, total organic carbon, endotoxins, and microbiology in 1284 water samples. The main findings were that conductivity and nitrate values were always below the specification limit defined according to the United States Pharmacopeia and European Pharmacopoeia, respectively. The highest total organic carbon value measured was 156 ppb. Regarding the microbiology results, the maximum endotoxin content detected was 0.063 EU/mL and 2 cfu/100 mL. In conclusion, this study demonstrated that the analyzed water for injection system operated under a validated status for 2 years, and it was supported by an appropriate monitoring program according to current process validation guidelines.LAY ABSTRACT: There are multiple methods used to produce water for injection in the biopharmaceutical industry. The thermocompression distillation method has been one of the most used methods for the production of this high-quality water. Nevertheless, to verify maintenance of the validated state of these systems it is necessary to carry out continued process verification of different parameters such as conductivity, total organic carbon, limulus amebocyte lysate, and microbiology according to the mandatory requirements of the United States Pharmacopeia and the European Pharmacopoeia. Therefore, this article presents an example of the application of thermocompression technology to generate water for injection and evidence of continuous monitoring to allow demonstration of the efficiency and reliability of these systems used in the biotechnological industry.


Assuntos
Química Farmacêutica/métodos , Química Farmacêutica/normas , Destilação/métodos , Qualidade da Água/normas , Água/análise , Água/normas , Força Compressiva , Contaminação de Medicamentos/prevenção & controle , Injeções , Reprodutibilidade dos Testes , Microbiologia da Água/normas
19.
Medicentro electrón ; 20(4)oct.-dic. 2016.
Artigo em Espanhol | CUMED | ID: cum-66571

RESUMO

El consentimiento informado es un procedimiento que brinda oportunidad a los pacientes de disponer de información y participar en la toma de decisiones médicas. El conocimiento informado constituye actualmente un elemento esencial de la relación médico-paciente. En este artículo se presenta una propuesta de modelo para el consentimiento informado en pacientes que requieren tratamiento quirúrgico(AU)


Assuntos
Consentimento Livre e Esclarecido , Temas Bioéticos
20.
MEDICC Rev ; 16(1): 37-42, 2014 01.
Artigo em Inglês | MEDLINE | ID: mdl-24487674

RESUMO

INTRODUCTION: Alcohol withdrawal syndrome is an important problem for management of alcoholism. It is known that alcohol alters the function of neurotransmitters such as serotonin, but our review found no studies associating serotonin concentration changes with patient clinical status during detoxification. The authors hypothesized that total platelet serotonin concentration should significantly increase during alcohol detoxification. OBJECTIVE: Assess possible association between total (endogenous and captured) platelet serotonin concentration and clinical status of patients with alcohol withdrawal syndrome, at beginning and end of detoxification with clomethiazole. METHODS: Thirty-one alcohol-dependent patients, diagnosed with alcohol withdrawal syndrome according to DSM-IV and classified in three clinical groups (18-20, 21-22 and 23-26 points) per the Clinical Institute Withdrawal Assessment for Alcohol Scale, were included in a prospective case series from May 2009 through May 2011 at the Hermanos Ameijeiras Clinical-Surgical Teaching Hospital in Cuba. Patients were predominantly male (87%), ranging in age from 22 to 57 years; 40% were white, 40% mestizo and 20% black. All had been hospitalized for detoxification in the hospital's psychiatry service. Blood samples taken were mixed with 1% EDTA and centrifuged for isolating platelets. Serotonin concentrations (endogenous and captured) were measured within 2 hours of blood collection and mean values at treatment days 1 and 12 compared by t test (p <0.05). RESULTS: Total serotonin concentration mean values (µg of serotonin per mg of total platelet protein) were statistically different between days 1 and 12 of treatment (1.329±0.916 µg/mg vs. 2.573±1.224 µg/mg; p <0.001). There was a direct association between total serotonin concentration and patient clinical classification both initially and at day 12. At day 1, the 29 patients in the group with 18-20 points had mean serotonin of 1.358±0.0.94 µg/mg; one patient with 21 points had serotonin of 1.25 µg/mg; and one patient with 24 points had serotonin of 0.740 µg/mg. At day 12, 26 patients had 0-1 points, with mean serotonin 2.688±1.244 µg/mg; and 5 patients had 2-8 points, with mean serotonin 1.244±0.596 µg/mg. No patient had >8 points at day 12. CONCLUSIONS: Serotonin is a potential biomarker for initial clinical classification and outcome monitoring and could be useful to psychiatrists working with patients in this area of medical practice and research. Further studies including more patients and variables are necessary to support these preliminary results.


Assuntos
Alcoolismo/terapia , Plaquetas/metabolismo , Etanol/farmacocinética , Serotonina/sangue , Síndrome de Abstinência a Substâncias/sangue , Adolescente , Adulto , Biomarcadores , Cuba , Feminino , Nível de Saúde , Humanos , Inativação Metabólica , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Adulto Jovem
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...