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Foundation: Intensive pharmacovigilance is an effective tool to detect adverse reactions in relatively new drugs that have sanitary registration by a regulatory agency.Objective: to describe the adverse reactions of Heberprot-P® in patients with diabetic foot ulcer.Methods: descriptive, prospective, intensive pharmacovigilance study, carried out in the Dr. Gustavo Aldereguía Lima Hospital’s Angiology service, Cienfuegos, in 2022. This included 170 patients with diagnostic criteria for diabetic foot ulcer, treated with at least one dose of Heberprot-P®. In addition to sociodemographic variables, the type of adverse event, intensity, severity and causality were analyzed.Results: Patients with white skin color and over 60 years of age predominated. There were 210 adverse events, which were most frequently manifested by burning and pain at the injection site, tremor and chills, especially of mild intensity (61.4%) and with a probable causal relationship (76.6%).Conclusions: Despite being a safe drug, more pharmacovigilance studies related to Heberprot-P® should be carried out, since all marketed drugs require continuous monitoring.

Introduction: Epidermal growth factor precursor is immersed in the context to Platelets membrane. The regular procedure to obtain serum implies a barrier to biological understanding of the theoretical meaning of its values. Objective: To describe the effect to modified procedure to measure sample epidermal growth factors and the possible biological implications for this. Method: An in vitro experimental study was carried put, with blood samples from individuals with apparent health history, in adulthood. Serum epidermal growth factor precursor values were determined with the UMELISA-EGF kit recommended by the manufacturer; the experimental variation in sample collection was carried out according to SAMERSAC recommendations for platelet-rich plasma, with adjustments. Results: The average age was 45.89± 3.35 years, in a range of 27 to 62 years. The female sex predominates in a 1.8:1 ratio. Application of the experimental procedure showed significant and notable differences between the epidermal growth factor values (g=17.7; p=0.0001-23); no linear correlation was evident between the values (r= 0.1305; p= 0.6843). The "reserve" value was on average 1498.61 ±160.68 pg*mL-1, observing large effect differences, as well as a similar behavior to a transition value. The observed data suggest, a posteriori, consumption effect on the course of platelet lysis under standard conditions. Conclusions: Epidermal growth factor values are higher after platelet isolation; the existence of an intraplatelet reserve of epidermal growth factor is plausible. [ABSTRACT FROM AUTHOR]

Necrotizing soft tissue infections are characterized by extensive and progressive deterioration of surrounding tissues. This work continues the ozone therapy topic as a complementary and therapeutic technique in patients with this type of infections, as well as its approach in Primary Health Care. The case of a 73-year-old patient with a diagnosis of phlyctenular lymphangitis with a large area of necrosis in the right leg is presented. The area was debrided and systemic and topical antibiotics were administered until clinical stability was achieved. After the third week, it was necessary to repeat the debridement, with removal of slough and necrotic tissues. After the fourth week he was discharged, with follow-up and recommendations to the Basic Health Team, which included the combination of local ozone therapy and rectal insufflations. In week 26, elements of favorable evolution began to be observed: control of local signs of sepsis, granulation mainly at the edges and gradual disappearance of pain, among others. The described case confirms the therapeutic effectiveness of ozone therapy use as a complementary technique, specifically in the approach to necrotizing soft tissue infections.

One of the most common complications of diabetes mellitus is diabetic foot ulcer, as an important source of morbidity and mortality. The case of a 43-years-old patient with a diagnosis of type 2 diabetes mellitus, of seven years of evolution, referred from the Emergency Department of the Dr. Mario Muñoz Monroy University Polyclinic, Abreus, with the diagnosis of neuroinfectious diabetic foot complicated with an abscess is presented. Drainage of the abscess, modification of insulin treatment, and debridement of the lesion were performed. In addition, antibiotics and Heberprot-P® were indicated. In the absence of satisfactory evolution, new debridement was performed, with amputation of the third and fourth toes of the left foot; the initial treatment was resumed, this time combined with local and rectal ozone therapy. From week 18 on, the patient progressed favorably, with the presence of good granulation, gradual disappearance of pain and acceleration of the complete healing process of the lesion, in addition to achieving efficient metabolic control. The described case confirms the efficacy and safety of the Heberprot-P® combined use and ozone therapy.

One of the most common complications of diabetes mellitus is diabetic foot ulcer, as an important source of morbidity and mortality. The case of a 43-years-old patient with a diagnosis of type 2 diabetes mellitus, of seven years of evolution, referred from the Emergency Department of the Dr. Mario Muñoz Monroy University Polyclinic, Abreus, with the diagnosis of neuroinfectious diabetic foot complicated with an abscess is presented. Drainage of the abscess, modification of insulin treatment, and debridement of the lesion were performed. In addition, antibiotics and Heberprot-P® were indicated. In the absence of satisfactory evolution, new debridement was performed, with amputation of the third and fourth toes of the left foot; the initial treatment was resumed, this time combined with local and rectal ozone therapy. From week 18 on, the patient progressed favorably, with the presence of good granulation, gradual disappearance of pain and acceleration of the complete healing process of the lesion, in addition to achieving efficient metabolic control. The described case confirms the efficacy and safety of the Heberprot-P® combined use and ozone therapy. [ABSTRACT FROM AUTHOR]

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Introducción. La infiltración intralesional con factor de crecimiento epidérmico (EGF) ha emergido como alternativa terapéutica para la cicatrización de las úlceras de pie diabético (UPD). Los objetivos de esta investigación fueron: determinar el perfil molecular de los pacientes con UPD y caracterizar los efectos sistémicos del tratamiento intralesional con EGF en tales pacientes atendiendo a marcadores de balance redox, componentes de la vía de los productos avanzados de glicación (AGE), factores relacionados con la estabilidad de la matriz extracelular (MEC) y marcadores pro-inflamatorios. Métodos. Se caracterizaron 13 pacientes con UPD en comparación con diabéticos sin úlceras (compensados y no compensados) e individuos no diabéticos, atendiendo a marcadores de balance redox, componentes de la vía de los AGE y elementos relacionados con la estabilidad de la MEC. La respuesta sistémica de los pacientes con UPD al tratamiento intralesional con EGF se evaluó atendiendo a los mismos parámetros, además de otros marcadores pro-inflamatorios. Resultados. Los pacientes con UPD exhibieron un perfil bioquímico muy alterado, con elevado estrés oxidativo, bajas reservas antioxidantes, aumento de los productos de glicoxidación y de las metaloproteasas de la matriz (MMP), con respecto a los diabéticos sin úlceras y a los no diabéticos. La administración intralesional de EGF estuvo asociada a una recuperación significativa de los parámetros estudiados y a la atenuación sistémica de varios marcadores pro-inflamatorios. Conclusiones: Los resultados indican que la infiltración intralesional con EGF se traduce en efectos sistémicos antioxidantes, anti-inflamatorios, anti-degradativos y anti-AGE, que contribuyen a restaurar la homeostasia del paciente diabético.

Objective: To analyse the scientific studies of Human recombinant epithelial growth factor for the healing of diabetic wounds. Methods: A thorough review of the literature was performed in the following databases: PubMed, Scopus and LILACS. Results: 21 articles were selected, most studies were experimental (48%). Complete healing of Human recombinant epithelial growth factor-treated lesions has been reported by 17 articles (81%). Increased granulation tissue has been reported in nine publications (43%). Similarly, the reduction of the lesion area was described in two included articles (10%). Two publication describes the decrease in the number of amputations and oxidative stress and 62% of the articles addressed adverse events associated with the use of the product (13/21), of which the occurrence of tremors, local pain, chills, nausea, superficial infection, burning sensation and bruising were considered priority, considered adverse events light. Only one study showed chest pain as a serious adverse event. Conclusion: Although Human recombinant epithelial growth factor is indicated for topical use in the treatment of diabetic wounds and demonstrates good efficacy, more clinical studies should be developed. [ABSTRACT FROM AUTHOR]

Foundation: diabetes mellitus is a chronic disease. One of its frequent complications is the diabetic foot. For its treatment Heberprot-P is used.Objective: to describe the results of the application of Heberprot-P for the treatment of diabetic foot ulcer. Methods: prospective descriptive study conducted in the Diabetic Care Consultation, during the period from April 2009 to April 2016. The sample consisted of the 41 patients with diabetic foot ulcer older than 20 years, to whom the treatment with Heberprot-P. We analyzed: age, associated diseases, years of evolution of the disease, medication dose and healing. Results: female patients predominated (56.1%); the age group of 60-69 years (34.2%) and hypertension as an associated disease (48.8%); 43, 9% had an evolution of diabetes of 10-19 years; according to the Wagner classification, group III prevailed with 48.8% and II with 31.7%; 5 to 9 doses of Heberprot-P were applied in 43.5%. 78% achieved complete healing. Conclusions: in three quarters of patients with diabetic foot ulcer complete healing was achieved with the application of Heberprot-P therapy.

Fundamento: la diabetes mellitus es una enfermedad crónica. Una de sus complicaciones frecuentes es el pie diabético, para cuyo tratamiento se utiliza el Heberprot-P. Objetivo: describir los resultados de la aplicación de Heberprot-P para el tratamiento de la úlcera del pie diabético. Métodos: estudio descriptivo prospectivo realizado en la Consulta de Atención al Diabético, durante el periodo de abril 2009 a abril 2016. La muestra estuvo conformada por los 41 pacientes con úlcera de pie diabético mayores de 20 años, a los cuales se les ha aplicado el tratamiento con Heberprot-P. Se analizó: edad, enfermedades asociadas, años de evolución de la enfermedad, dosis del medicamento y cicatrización. Resultados: predominaron las pacientes femeninas (56,1 %); el grupo etario de 60-69 años (34,2 %) y la hipertensión arterial como enfermedad asociada (48,8 %); el 43, 9 % tenía una evolución de la diabetes de 10-19 años; según clasificación Wagner predominó el grupo III con un 48, 8 % y el II con un 31, 7 %; se aplicaron de 5 a 9 dosis de Heberprot-P en el 43,5 %. El 78 % logró una cicatrización completa. Conclusiones: en las tres cuartas partes de los pacientes con úlcera del pie diabético se logró la cicatrización completa con la aplicación de la terapéutica del Heberprot-P.

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Introducción. Un subgrupo de los carcinomas de mama sobreexpresa el receptor 2 del factor de crecimiento epidérmico (HER2). La determinación de esta sobreexpresión se realiza por inmunohistoquímica. La dificultad de diagnóstico surge cuando el resultado es ambiguo (2+), haciendo necesario realizar hibridación in situ (ISH) para determinar la amplificación del gen HER2/neu. Objetivo. Determinar si la amplificación del gen HER2/neu en los casos HER2 2+, se encuentra asociado a factores clinicopatologicos pronósticos. Diseño. Estudio descriptivo de corte transversal. Institución. Servicio de patología quirúrgica, Hospital Guillermo Almenara Irigoyen. Lima, Perú. Participantes. Casos de cáncer de mama HER2 2+. Metodología. Se estudiaron 117 casos de cáncer de mama HER2 2+ diagnosticados entre los años 2010 – 2015, a los que posteriormente se les realizó ISH. Todos los datos fueron analizados con el programa estadístico SPSS 22. Se utilizó el test de Chi cuadrado para analizar la asociación entre las variables. Principales medidas de resultados. Factores asociados a la amplificación del gen HER2/neu. Resultados. La amplificación del gen HER2/neu se observó en 41% del total de casos. En estos, se observó con mayor frecuencia un grado histológico III (66%), compromiso ganglionar presente (61%), tamaño tumoral ≥ 2 cm (86%) y Ki 67 ≥ 20% (83%). Se encontró una asociación estadísticamente significativa con una edad ≥ 50 años (X2 test, P=0,004) y el grado histológico III (X2 test, P=0.017). Conclusión. La amplificación del gen HER2/neu en casos ambiguos está asociado a una edad ≥ 50 años y grado histológico III.

Copyright of Boletín Latinoamericano y del Caribe de Plantas Medicinales y Aromáticas is the property of Universidad de Santiago de Chile and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Revista Habanera de Ciencias Médicas is the property of Universidad de Ciencias Medicas de La Habana and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Introducción: en los últimos años la biología de los meningiomas cerebrales ha comenzado a entenderse mejor. La inmunoterapia activa contra el factor de crecimiento epidérmico es un concepto emergente, en el que se propone manipular la respuesta inmune del individuo, para generar anticuerpos específicos contra el factor de crecimiento epidérmico, capaces de bloquear la unión ligando-receptor y por consiguiente la señalización a través de este último. El receptor del factor de crecimiento epidérmico está sobrexpresado en este tipo de tumor. Objetivo: estimar la sobrevida libre de progresión de la entidad clínica y su relación con algunas variables socio-demográficas y terapéuticas seleccionadas. Métodos: se realizó un estudio descriptivo, transversal, en 25 pacientes portadores de meningiomas, tratados con un anticuerpo monoclonal humanizado (AcM h-R3) (nimotuzumab), en el Hospital Provincial Docente Clínico Quirúrgico "Saturnino Lora" de Santiago de Cuba, en el período comprendido entre el 1 de diciembre del 2013 y el 30 de noviembre del 2015. Resultados: el conjunto de pacientes incluidos en el estudio (n= 25) se caracterizó por el predominio del sexo femenino (60 %), edad de 50 y más años (68 %), piel blanca (48 %) y escala de Karnofsky de 100 puntos (84 %). El tiempo medio libre de progresión fue de 17 ± 8,6 meses. Conclusiones: fueron identificadas las principales características de la supervivencia libre de progresión del meningiomas en pacientes vacunados con AcM h-R3 y el tiempo fue como promedio de alrededor de año y medio.

Objetivo: Analizar las asociaciones entre el nivel urinario de IL-6, EGF, MCP-1 y TGFβ1 y las características clínicas, bioquímicas y anatomopatológicas en enfermos con nefropatía IgA primaria y determinar su capacidad para realizar una estimación de la extensión de las lesiones de esclerosis glomerular e intersticial. Pacientes y métodos: Se estudió a 58 enfermos con nefropatía IgA. Se determinaron los niveles urinarios de IL-6, EGF, MCP-1 y TGFβ1 en el momento del diagnóstico. Tras realizar un análisis de la extensión de las lesiones renales mediante morfometría cuantitativa y mediante los criterios de Oxford, se analizó la capacidad de dichas moléculas para estimar la extensión de las lesiones glomerulares e intersticiales de fibrosis. Resultados: La IL-6, MCP-1 y TGF-β1 se asociaron a glomeruloesclerosis focal y a la extensión de la fibrosis intersticial, pero no a la presencia de proliferación mesangial, intracapilar o extracapilar. EGF presentó una asociación negativa con la fibrosis intersticial. Al categorizar a los enfermos según la clasificación de Oxford, los enfermos con scores T1 y T2 presentaron niveles significativamente superiores de IL-6, MCP-1 y TGFβ1, y niveles de EGF significativamente inferiores que los enfermos con T0. Tanto mediante regresión múltiple como mediante regresión logística, los niveles de MCP-1, IL-6 y EGF fueron predictores independientes de la superficie de fibrosis, tras ajustar por edad y FGe. Conclusión: La determinación de la concentración urinaria de IL-6, EGF y MCP-1 proporciona una información adicional que mejora de forma significativa la estimación de la superficie de fibrosis intersticial.

Foundation: diabetes mellitus is a chronic disease. One of its frequent complications is the diabetic foot. For its treatment Heberprot-P is used. Objective: to describe the results of the application of Heberprot-P for the treatment of diabetic foot ulcer. Methods: prospective descriptive study conducted in the Diabetic Care Consultation, during the period from April 2009 to April 2016. The sample consisted of the 41 patients with diabetic foot ulcer older than 20 years, to whom the treatment with Heberprot-P. We analyzed: age, associated diseases, years of evolution of the disease, medication dose and healing. Results: female patients predominated (56.1%); the age group of 60-69 years (34.2%) and hypertension as an associated disease (48.8%); 43, 9% had an evolution of diabetes of 10-19 years; according to the Wagner classification, group III prevailed with 48.8% and II with 31.7%; 5 to 9 doses of Heberprot-P were applied in 43.5%. 78% achieved complete healing. Conclusions: in three quarters of patients with diabetic foot ulcer complete healing was achieved with the application of Heberprot-P therapy. [ABSTRACT FROM AUTHOR]

Fundamento: existen muchos trabajos publicados sobre la efectividad del Heberprot P en la granulación y curación de las lesiones por úlcera de pie diabético de forma ambulatoria, pero muy pocos provienen de la Atención Primaria de Salud. Objetivo: evaluar la efectividad terapéutica del Herberprot P en pacientes con úlcera de pie diabético. Métodos: estudio descriptivo de serie de casos en 15 pacientes con pie diabético tratados con Herberprot P, en el Policlínico Docente Comunitario Área IV en el período comprendido de enero a diciembre 2012. Las variables analizadas fueron: edad, sexo, clasificación clínica de la enfermedad, clasificación de la lesión y evolución. Resultados: la úlcera de pie diabético fue más frecuente en el grupo de edad de 60 a 69 años y en el sexo femenino. La mayoría de los pacientes presentaron el diagnóstico de pie diabético neuroinfeccioso, y la lesión más frecuente fue la úlcera profunda, en 9 pacientes. Se observó la cura total en 11 pacientes, 6 de ellos en un periodo de 20-30 días. Conclusión: los resultados evidencian y sobre todo, ratifican, la efectividad del Heberprot P en la atención de los pacientes afectados por úlcera de pie diabético en la Atención Primaria de Salud.

Copyright of Nefrologia is the property of Revista Nefrologia and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Se presenta el caso de un paciente masculino de 59 años de edad, tratado por vías convencionales a causa de lesiones ulcerativas de miembros inferiores, de más de siete años de evolución, sin diagnóstico y tratamiento. La evolución ulterior permitió reconocer la aparición subsecuente de lepra multibacilar. La basiloscopía fue positiva, indicando el diagnóstico de las lesiones ulcerativas, que se trataron con el uso de factor de crecimiento epidérmico recombinante humano en su formulación Heberprot-P, permitiendo la granulación de las lesiones en toda su extensión en un plazo corto, de 16 días, sin que se presentaran eventos adversos graves. Su resultado final fue satisfactorio

Introduction: obesity, characterized by adiposity excess, is associated with endothelial dysfunction and possible inflammatory state with release of cytokines that determine endothelial function and can trigger chronic diseases. The dietary pattern are associated with the synthesis these cytokines. Fruits as the acai, which is rich in flavonoids, have a direct and beneficial effect on the control of this inflammatory process through the exercised antioxidant capacity.Objective: to evaluate the effect of acai pulp consumption on the inflammatory markers, anthropometric measurements, body composition, biochemical and dietary parameters in healthy women.Methods: forty women, were divided in 25 eutrophic and 15 with overweight. They intaked 200 g of acai pulp during 4 weeks. Anthropometric measurements, body composition, inflammatory markers, biochemical data, dietary intake and dietary antioxidants capacity were evaluated before and after the intervention.Results and Discussion: after the intervention, there was significant increase of EGF (p = 0.021) and PAI- 1(p = 0.011) in overweight women. Moreover, there was increase in body weight (p = 0.031), body mass index (p = 0.028), percentage of truncal fat (p = 0.003) and triceps skinfold thickness (p = 0.046) in eutrophic women. However, the skinfold thickness (p = 0.018) and total body fat (p = 0.016) decreased in overweight women. There was reduction of total protein (p = 0.049) due to the globulin reduction (p = 0.005), but the nutritional status was maintained in eutrophic group.Conclusion: the intake of 200g acai pulp, modulated the EGF and PAI-1 expression, possibly by modulation of acai on the parameters of body composition, dietary, clinical, biochemical and inflammatory, led to a redistribution and resizing of body fat of the trunk area, and presumably increased visceral fat. [ABSTRACT FROM AUTHOR]

Copyright of Biomédica: Revista del Instituto Nacional de Salud is the property of Instituto Nacional de Salud of Colombia and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Diabetes mellitus has become a significant health problem throughout the world, where it constitutes the underlying cause for 84% of lower limb amputations due to recalcitrant ulcers. The Center for Genetic Engineering and Biotechnology (CIGB) at Havana, Cuba has designed an integrated strategy for preclinical testing, pharmaceutical development, production, clinical trials and business negotiations of an injectable drug for treating diabetic foot ulcers, denominated Heberprot-P®. This product, which uses epidermal growth factor as active ingredient and avoids these amputations, is the only registered drug of its type and has already had considerable medical, social and economic impact in Cuba and other nations, placing national science and the Cuban health system at the forefront of the fight against this disorder. Phase III trials are planned for 2013, pending approval of the Advisory Scientific Council of the European Medicines Agency (EMA), for examining its efficacy and safety in this continent. Research teams at CIGB continue to develop new Heberprot-P® versions, based on advanced controlled release systems employing micro and nanospheres, in order to continuously improve the product and extend its existing intellectual property coverage beyond the year 2030. [ABSTRACT FROM AUTHOR]

Diabetes mellitus has become a significant health problem throughout the world, where it constitutes the underlying cause for 84% of lower limb amputations due to recalcitrant ulcers. The Center for Genetic Engineering and Biotechnology (CIGB) at Havana, Cuba has designed an integrated strategy for preclinical testing, pharmaceutical development, production, clinical trials and business negotiations of an injectable drug for treating diabetic foot ulcers, denominated Heberprot-P®. This product, which uses epidermal growth factor as active ingredient and avoids these amputations, is the only registered drug of its type and has already had considerable medical, social and economic impact in Cuba and other nations, placing national science and the Cuban health system at the forefront of the fight against this disorder. Phase III trials are planned for 2013, pending approval of the Advisory Scientific Council of the European Medicines Agency (EMA), for examining its efficacy and safety in this continent. Research teams at CIGB continue to develop new Heberprot-P® versions, based on advanced controlled release systems employing micro and nanospheres, in order to continuously improve the product and extend its existing intellectual property coverage beyond the year 2030. [ABSTRACT FROM AUTHOR]

The historical tag of the epidermal growth factor (EGF) as carcinogenesis promoter has not been uniformly reproduced, since, in some experiments, malignant cells are bound to growth inhibition and apoptosis. The present study intends to obtain additional data on the interaction of EGF with cancer cells by analyzing its effect in vitro on the growth of cultured A431 cells, and in vivo on nude mice xenotransplanted with this cell line; identifying, in addition, the gene expression patterns for a selected group of genes related to EGF and cancer pathways in the solid tumor. EGF-treated animals showed significantly smaller tumor volumes than controls, suggesting cellular growth inhibition mediated by this factor. Similar results were obtained regarding the proliferation of cultured A431 when treated with 2.2, 33 and 165 nM of EGF. These results may imply a common mechanism for the EGF-mediated growth inhibition of A431 cells in both biological conditions (in vivo and in vitro). The action of EGF at nanomolar concentrations may trigger a transient recovery of the tumor suppressor ability of tumor cells through the reduction of the biological action of mutated TP53, cell cycle arrest due to a decrease in Cdk4 expression levels and the initiation of caspase through the activation of CASP9. [ABSTRACT FROM AUTHOR]

The objective of this article is to present a review referred to general characteristics, such as structure and functionality of the growth factors, particularly those related to the Epidermal Growth Factor (EGF), as a responsible generator agent of cell differentiation at the mammary epithelial level. [ABSTRACT FROM AUTHOR]

Heberprot-P is a novel drug intended to solve an unmet medical need: to heal high-grade, poor-prognostic ulcers which affect lower limbs of diabetic patients. The human recombinant epidermal growth factor (hrEGF) is the active pharmaceutical ingredient of Heberprot-P. EGF is a highly evolutionarily conserved polypeptide playing a significant role on the intra and extra-uterine life in mammals. Based on the early findings of its epitheliotropic and mitogenic effects, it was prematurely intended as healing agent for problematic wounds. Our Center for Genetic Engineering and Biotechnology manufactures hrEGF since 1988. About 199, we unleashed an intense experimental research program on in vivo systems which somewhat mirrored a variety of human pathological conditions . Those studies accounted for the identification of novel pharmacological effects associated to the systemic or parenteral administration of EGF. Henceforth it enabled us to envision new therapeutic indications to treat processes requiring cytoprotective effects. We had demonstrated since 1995, that the local infiltration of EGF in the hindlimbs of rats , mitigated the degenerative process on peripheral nerves and soft-tissues undergoing the consecuenses of denervation. Further studies evidenced the ability of EGF to rescue tissues and organs from death by ischemia/reperfusion events, and also in models of multiorgan damage under acute preconditioning or therapeutic schedules. During that decade, we demonstrated the need to preserve EGF from the action of proteases released in full-thickness controlled wounds. All these aspects were pieces of knowledge supporting the hypothesis on the beneficial effect of the intralesional infiltration of EGF to rescue and perpetuate cells in diabetic ulcers ensuring an appropriate local bioavailability. [ABSTRACT FROM AUTHOR]

Heberprot-P is a novel drug intended to solve an unmet medical need: to heal high-grade, poor-prognostic ulcers which affect lower limbs of diabetic patients. The human recombinant epidermal growth factor (hrEGF) is the active pharmaceutical ingredient of Heberprot-P. EGF is a highly evolutionarily conserved polypeptide playing a significant role on the intra and extra-uterine life in mammals. Based on the early findings of its epitheliotropic and mitogenic effects, it was prematurely intended as healing agent for problematic wounds. Our Center for Genetic Engineering and Biotechnology manufactures hrEGF since 1988. About 199, we unleashed an intense experimental research program on in vivo systems which somewhat mirrored a variety of human pathological conditions . Those studies accounted for the identification of novel pharmacological effects associated to the systemic or parenteral administration of EGF. Henceforth it enabled us to envision new therapeutic indications to treat processes requiring cytoprotective effects. We had demonstrated since 1995, that the local infiltration of EGF in the hindlimbs of rats , mitigated the degenerative process on peripheral nerves and soft-tissues undergoing the consecuenses of denervation. Further studies evidenced the ability of EGF to rescue tissues and organs from death by ischemia/reperfusion events, and also in models of multiorgan damage under acute preconditioning or therapeutic schedules. During that decade, we demonstrated the need to preserve EGF from the action of proteases released in full-thickness controlled wounds. All these aspects were pieces of knowledge supporting the hypothesis on the beneficial effect of the intralesional infiltration of EGF to rescue and perpetuate cells in diabetic ulcers ensuring an appropriate local bioavailability. [ABSTRACT FROM AUTHOR]

Copyright of Revista Española de Cirugía Oral y Maxilofacial is the property of Sociedad Espanola de Cirugia Oral y Maxilofacial (SECOM) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

In order to obtain a procedure to quantify EGF by ELISA from semisolid formulations different buffers and organic solvents were used, having different polarities and miscibility with water. We studied it from oil-in-water (o/w) cream, water-in-oil (w/o), polyethylene glycol (PEG) ointment, and a jelly. Precision, accuracy and selectivity were determined and variation coefficients were less than 10% after different extraction method with a recovery of 95.54 -108.98%. According to results, it is possible to estimate the EGF concentration with high precision and reproducibility. No statistically significant differences were detected, when compared a placebo extraction solution with the ELISA standard solution demonstrating that placebo does not produce interferences in the quantification of the molecule. To determine the delivery of the active ingredient from different preparations we used a static diffusion cell system to evaluate the release and penetrability of the active ingredient throughout abdominal pig skin. Results showed that release and penetrability of EGF increased proportionally with the hydrosolubility of the vehicle. Therefore, the rate was obtained in jelly, PEG > o/w > w/o. Additionally, PEG ointment and o/w cream allowed the highest distribution of labeled 125I EGF in the epidermis and dermis and receptor medium. [ABSTRACT FROM AUTHOR]

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Se estableció como objetivo conocer si el factor de crecimiento epidérmico, por su función regeneradora y protectora, protegía al riñón del efecto tóxico de la kanamicina. Para esto se diseñó una investigación experimental, prospectiva con animales. Se dividieron en 3 grupos, a uno se le administró el antibiótico semejante al esquema en humanos, al segundo, el antibiótico más una monodosis profiláctica de factor, y un tercer grupo se tomó como control negativo; se les midió a los 3, al principio y al final del estudio, la función renal más un estudio histológico. Todas las variables cuantitativas fueron sometidas a análisis estadístico para buscar significación entre los grupos. Se comportaron de forma similar el control negativo y el que recibió el factor, no así el que tomó solo el antibiótico. El factor resultó un protector de la nefrona proximal.The objective was to determine if epidermal growth factor with its regenerating and protective function, was capable of protecting kidneys from toxic effect of kanamycin. To this end, a prospective experimental research study on animals was designed. They were divided into three groups, one was administered antibiotic in a way similar to humans; the second group was given the antibiotic plus a prophylactic one-dose of the factor, and the third group was the negative control. At the beginning and at the end of the study, renal function was assessed and a histological study was performed on the three groups. All the quantitative variables were statistically analyzed to find significance among the groups. It was observed that the negative control and the group receiving the factor had a similar behaviour, but the group under antibiotic treatment behaved differently. The factor was a protector of proximal nephrone.