ABSTRACT
BACKGROUND AND AIMS: Submucosal injection agents are widely used solutions in gastric polyp resection techniques. Currently, many different solutions are used in clinical practice, but most are not authorised for this use or are not biopharmaceutical characterised. The objective of this multidisciplinary work is to test the efficacy of a novel thermosensitive hydrogel designed specifically for this indication. METHODS: A mixture design of various components (Pluronic®, hyaluronic acid and sodium alginate) was carried out to select the combination with optimal properties for this use. Three final thermosensitive hydrogels were selected on which biopharmaceutical characterisation was performed and stability and biocompatibility were analysed. Efficacy in maintaining elevation was tested ex vivo on pig mucosa and in vivo in pigs RESULTS: The mixture design allowed selection of the ideal combinations of agents for the characteristics sought. The thermosensitive hydrogels studied showed high values of hardness and viscosity at 37 °C, maintaining good syringeability. One of them demonstrated superiority in maintaining polyp elevation in the ex vivo assay and non-inferiority in the in vivo assay. CONCLUSION: The thermosensitive hydrogel specifically designed for this use is promising both for its biopharmaceutical characteristics and for its demonstrated efficacy. This study lays the foundation for evaluating the hydrogel in humans.
Subject(s)
Biological Products , Hydrogels , Humans , Animals , Swine , Temperature , Poloxamer , Mucous MembraneABSTRACT
Antecedentes: la hepatitis aguda por virus de la hepatitis E (VHE) en Europa era tradicionalmente una infección adquirida por personas que viajaban a zonas endémicas, fundamentalmente Asia y África. Actualmente, cada vez es mayor el número de casos autóctonos esporádicos diagnosticados en Occidente. Objetivo: analizar los casos diagnosticados de hepatitis aguda por virus hepatitis E (VHE) en nuestro medio, identificando las características clínicas-epidemiológicas. Material y método: se recogieron los casos diagnosticados de hepatitis aguda por VHE (IgM anti-VHE positiva y/o ARN-VHE presente en suero) desde enero de 2008 a diciembre 2014. Se analizaron diversas variables clínicas y epidemiológicas y la evolución posterior. Resultados: se encontraron 23 casos, todos ellos naturales de España. Catorce sujetos (60,87%) presentaban ictericia en el momento del diagnóstico y marcada citolisis (aspartato aminotransferasa [AST] 1.106,91 U/l y alanina aminotransferasa [ALT] 1.407,04 U/l). Veintidós casos fueron considerados autóctonos y uno había realizado un viaje a China tres meses antes. El tiempo medio de resolución fue de 11,2 semanas. En total, diez pacientes (43,5%) mostraban algún marcador de autoinmunidad positivo. Dos sujetos estaban diagnosticados de enfermedad hepática crónica previa y fueron catalogados como 'acute-on-chronic liver failure' (ACLF); uno de ellos finalizó en exitus y el otro, en trasplante hepático. Conclusión: la hepatitis aguda por VHE en nuestro medio es una entidad autóctona, probablemente infradiagnosticada, que se manifiesta con ictericia y citolisis. La presencia de marcadores de autoinmunidad positivos supone un epifenómeno que en ocasiones dificulta su diagnóstico (AU)
Background: In Europe, acute hepatitis caused by the hepatitis E virus (HEV) traditionally was an infection found in people who had travelled to endemic zones, mainly Asia and Africa. However, a growing number of sporadic autochthonous cases are now being diagnosed in the Western world. Objective: To analyze the cases of acute HEV hepatitis diagnosed in our setting, with the identification of the clinical-epidemiological characteristics. Material and methods: We included the cases of acute HEV hepatitis diagnosed (positive anti-HEV IgM and/or HEV RNA present in serum) between January 2008 and December 2014. Different clinical, epidemiological and evolutive parameters were analyzed. Results: A total of 23 patients were identified, all originating from Spain. Fourteen cases (60.87%) presented jaundice and marked cytolysis at the time of diagnosis (aspartate aminotransferase [AST] 1,106.91 U/l and alanine aminotransferase [ALT] 1,407.04 U/l). Twenty-two cases were regarded as autochthonous, and one patient had travelled to China three months before. The mean time to resolution was 11.2 weeks. Some autoimmune markers were positive in 43.5% of the patients. Two subjects were diagnosed with previous chronic liver disease and were classified as 'acute-on-chronic liver failure' (ACLF), one died and the other underwent liver transplantation. Conclusion: Acute HEV hepatitis in our setting is an autochthonous condition that is probably underdiagnosed, manifesting with jaundice and cytolysis. Autoimmune marker positivity is an epiphenomenon, which in some cases complicates the diagnosis (AU)
Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Hepatitis E/diagnosis , Hepatitis E/epidemiology , Jaundice/complications , Autoimmunity/physiology , Hepatitis A/diagnosis , Hepatitis, Autoimmune/diagnosis , Retrospective Studies , Immunoglobulin M/analysis , Immunoglobulin G/analysis , Enzyme-Linked Immunosorbent Assay/methods , Liver Failure/complications , Diagnosis, DifferentialABSTRACT
BACKGROUND: In Europe, acute hepatitis caused by the hepatitis E virus (HEV) traditionally was an infection found in people who had travelled to endemic zones, mainly Asia and Africa. However, a growing number of sporadic autochthonous cases are now being diagnosed in the Western world. OBJECTIVE: To analyze the cases of acute HEV hepatitis diagnosed in our setting, with the identification of the clinical-epidemiological characteristics. MATERIAL AND METHODS: We included the cases of acute HEV hepatitis diagnosed (positive anti-HEV IgM and/or HEV RNA present in serum) between January 2008 and December 2014. Different clinical, epidemiological and evolutive parameters were analyzed. RESULTS: A total of 23 patients were identified, all originating from Spain. Fourteen cases (60.87%) presented jaundice and marked cytolysis at the time of diagnosis (aspartate aminotransferase [AST] 1,106.91 U/l and alanine aminotransferase [ALT] 1,407.04 U/l). Twenty-two cases were regarded as autochthonous, and one patient had travelled to China three months before. The mean time to resolution was 11.2 weeks. Some autoimmune markers were positive in 43.5% of the patients. Two subjects were diagnosed with previous chronic liver disease and were classified as "acute-on-chronic liver failure" (ACLF), one died and the other underwent liver transplantation. CONCLUSION: Acute HEV hepatitis in our setting is an autochthonous condition that is probably underdiagnosed, manifesting with jaundice and cytolysis. Autoimmune marker positivity is an epiphenomenon, which in some cases complicates the diagnosis.
