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3.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-31706974

RESUMO

OBJETIVE: The aim of this study was to examine the quality of life, anxiety and affectivity in children and adolescents with type 1 diabetes (T1D) and in their parents after participating in a diabetes summer camp. METHOD: A total of 20 children and adolescents with T1D, aged 8-14, and their parents participated. The study design was quasi-experimental longitudinal with an intra-subject factor with two measurements (pre/post), and an inter-group factor (child/parent). RESULTS: After attending camp, a significantly increased quality of life, demonstrated by the emotional well-being and self-esteem scores, was found in the children but not in the parents. Less negative affectivity and an improvement in positive affectivity was seen in the parents, but not in the children. Differences in anxiety were found in both the children and the parents. CONCLUSIONS: This research presents empirical evidence of the benefits of participation in a diabetes camp in both children and their parents.

4.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-31734177

RESUMO

INTRODUCTION: Protocol for prescribing hormone replacement therapy in isolated growth hormone (GH) deficiency includes magnetic resonance imaging of the brain. There is controversy on the frequency of structural pituitary abnormalities and on the importance of abnormal MRI findings on prognosis and response to GH replacement. METHODS: A descriptive, retrospective study of children of both sexes aged 0-14 years, who had undergone brain MRI, diagnosed with isolated GH deficiency at a tertiary hospital in the past 14 years, aimed at reporting the frequency of abnormal MRI findings in isolated GH deficiency, and to establish whether differences exist in height diagnosis and evolution according to MRI findings. MRI findings were also compared with the findings reported in healthy children in order to establish incidence. RESULTS: 96 patients were studied, of whom 74/96 (77%) reached adult age. Abnormal MRI findings were seen in 11.5% of them (8/11 of pituitary origin). No brain or pituitary tumor was seen in any case. Patients with abnormal images had a mean age at treatment start of 8 years, a target height of -0.8SD, and a final height of 1.04SD, while patients with normal MRI findings had an age at treatment start of 10 years old, a target height of -1.44SD, and a final height of -1.75SD, with statistically significant differences. CONCLUSIONS: Patients with abnormal MRI findings show a more favorable response to GH replacement therapy.

5.
Endocrinol. diabetes nutr. (Ed. impr.) ; 66(9): 540-549, nov. 2019. tab, graf
Artigo em Inglês | IBECS | ID: ibc-184376

RESUMO

Introduction: Few studies assessing the relationship between oxidative stress and glycemic variability in children with type 1 diabetes mellitus (T1DM) are available, and most of them reported no significant results. Objective: To assess the relationship between glucose control, glycemic variability, and oxidative stress as measured by urinary excretion of 8-iso-prostanglandin F2-alpha (8-iso-PGF2alfa) in children with T1DM. Materials and methods: A cross-sectional study including 25 children with T1DM. Participants were evaluated during five days in two different situations: 1st phase during a summer camp, and 2nd phase in their everyday life at home. The following data were collected in each study phase:. Six capillary blood glucose measurements per day. Mean blood glucose (MBG) levels and glucose variability parameters, including standard deviation, coefficient of variation, and mean amplitude of glycemic excursions (MAGE), were calculated. - Capillary HbA1c level. - 24-h urine sample to measure 8-iso-PGF2alfa. Results: There were no statistically significant differences in urinary 8-iso-PGF2alfa levels (142 ± 37 vs. 172 ± 61 pg/mg creatinine) and glucose control and glycemic variability parameters between both phases. In the 2nd phase, statistically significant correlations were found between urinary 8-iso-PGF2alfa and HbA1c levels (r = 0.53), MBG (r = 0.72), standard deviation (r = 0.49), and MAGE (r = 0.42). No significant correlations between glucose control, glycemic variability and urinary 8-iso-PGF2alfa excretion were found in the 1st phase. Conclusions: A significant correlation was found between glycemic variability and HbA1c level and urinary 8-iso-PGF2α excretion in a group of children with T1DM during their daily lives. Additional studies are needed to confirm this finding and to explore its long-term impact on health


Introducción: En niños con diabetes tipo 1 (DM1) hay pocos estudios que evalúen la relación entre estrés oxidativo y variabilidad glucémica, y la mayoría de ellos no encuentran resultados significativos. Objetivo: Evaluar la relación entre control metabólico, variabilidad glucémica y estrés oxidativo medido por la excreción urinaria de 8-iso-prostaglandina F2 alfa (8-iso-PGF2alfa) en niños con DM1. Material y método: Estudio transversal que incluyó 25 niños con DM1. Los participantes fueron evaluados durante 5 días en 2 situaciones diferentes: 1.a fase durante un campamento de verano y 2.a fase durante su actividad habitual en domicilio. En cada fase se recogieron:- Seis determinaciones de glucemia capilar diarias. Se calcularon glucemia media y parámetros de variabilidad glucémica: desviación estándar, coeficiente de variación y «mean amplitude of glycemic excursions» (MAGE). - HbA1c capilar. - Muestra de orina de 24h para la determinación de 8-iso-PGF2alfa. Resultados: No se encontraron diferencias estadísticamente significativas en excreción urinaria de 8-iso-PGF2alfa (142 ± 37 vs. 172 ± 61 pg/mg creatinina) y parámetros de control y variabilidad glucémicos entre las fases. En la 2.a fase se observaron correlaciones estadísticamente significativas entre 8-iso-PGF2alfa urinario con HbA1c (r = 0,53), glucemia media (r = 0,72), desviación estándar (r = 0,49) y MAGE (r = 0,42). En la 1.a fase del estudio no se han detectado correlaciones significativas. Conclusiones: Se ha encontrado una correlación significativa entre parámetros de variabilidad glucémica y HbA1c con la excreción urinaria de 8-iso-PGF2alfa en un grupo de niños con DM1 evaluados durante su vida diaria. Son necesarios más estudios para confirmar estos resultados y evaluar el impacto a largo plazo sobre la salud


Assuntos
Humanos , Criança , Diabetes Mellitus Tipo 1/complicações , Estresse Oxidativo , Índice Glicêmico , Metabolismo Basal , Dinoprosta/análogos & derivados , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/diagnóstico , Estudos Transversais , Diabetes Mellitus Tipo 1/urina , Dinoprosta/sangue
6.
Endocrinol. diabetes nutr. (Ed. impr.) ; 66(9): 550-554, nov. 2019. tab
Artigo em Espanhol | IBECS | ID: ibc-184377

RESUMO

Introducción: La hipertirotropinemia aislada se describe como un a elevación de la hormona estimulante del tiroides (TSH) con niveles normales de hormonas tiroideas y autoinmunidad negativa en pacientes asintomáticos y sin hallazgos en la exploración. Dado el aumento no justificado del análisis de la función tiroidea en niños asintomáticos, el objetivo principal es analizar la evolución de estos pacientes. Como objetivo secundario se realiza un análisis de costes asociado. Material y métodos: Estudio longitudinal observacional retrospectivo de los pacientes derivados a endocrinología de un hospital de tercer nivel por hipertirotropinemia aislada (TSH 5-20 mUI/l). Se recogieron variables clínicas, analíticas, número de visitas hasta el alta, necesidad de tratamiento, tiempo de seguimiento, así como variables económicas. Resultados: Se obtuvo una muestra de 155 pacientes, con edad media de 7,8 años ± 3,6 DE. La derivación a endocrinología representó el 4% de las consultas de primera visita. La cifra media de TSH inicial fue de 7,8 mU/l (5,03-15,8 mU/l). Los niveles de TSH se normalizaron tras la primera repetición durante el mes posterior, en el 60% de los casos. En un intervalo máximo de 3años fueron dados de alta el 83,6%, con un seguimiento medio de 8,14 ± 6,8 meses y 2,4 visitas/paciente. Se obtuvo un coste medio de 251,27 €/paciente (rango 143,49-444,21 €). Conclusión: Es fundamental no generar alarma familiar ante una hipertirotropinemia, dado que se trata de una situación bioquímica que, en la mayoría de los casos, se normaliza. Este hecho, junto con el coste medio derivado de la asistencia especializada, pone de manifiesto que el primer paso debería ser la repetición de la misma en atención primaria


Introduction: Subclinical hypothyroidism is defined as elevation of thyroid-stimulating hormone (TSH) levels, with normal thyroid hormone levels and negative autoimmunity, in asymptomatic patients with no findings on examination. Because of the unwarranted increase in thyroid function tests in asymptomatic children, the main objective of this review was to analyze the course of these patients. Analysis of associated costs was a secondary objective. Material and methods: A longitudinal, observational, retrospective study of patients referred to the endocrinology department of a tertiary hospital for high TSH levels (TSH 5-20 mIU/L). Clinical and laboratory variables, number of visits until discharge, need for treatment, monitoring time, and economic variables were collected. Results: The study sample consisted of 155 patients with a mean age of 7.8 years ± 3.6SD. Referrals to endocrinology accounted for 4% of first office visits. Baseline mean TSH level was 7.8 mU/L (5.03-15.8 mU/L). TSH levels normalized after the first repeated measurement during the subsequent month in 60% of cases. A total of 83.6% of patients were discharged within a maximum of 3years, with a mean follow-up of 8.14 ± 6.8 months and 2.4 visits/patient. Average cost per patient was € 251.27 (range € 143.49-444.21). Conclusion: It is essential not to alarm the family when subclinical hypothyroidism is detected, because this is a biochemical situation which normalizes in most cases. This fact, together with the mean cost of specialized care, suggests that the first step should be repeated TSH measurements in primary care


Assuntos
Humanos , Masculino , Feminino , Pré-Escolar , Criança , Evolução Clínica , Hipotireoidismo/economia , Atenção Primária à Saúde/economia , Tireotropina/sangue , Estudos Longitudinais , Estudos Retrospectivos , Autoimunidade , Custos e Análise de Custo
8.
Endocrinol. diabetes nutr. (Ed. impr.) ; 66(8): 480-486, oct. 2019. tab
Artigo em Espanhol | IBECS | ID: ibc-184141

RESUMO

Introducción: La diabetes mellitus tipo 1 es la segunda enfermedad crónica y el trastorno endocrino-metabólico más frecuente en la infancia. El objetivo de este estudio es realizar una estimación del coste directo de la diabetes mellitus tipo 1 en Andalucía, en pacientes pediátricos. Metodología: Se trata de un estudio descriptivo, observacional multicéntrico realizado durante 6 meses consecutivos de 2017-2018, partiendo de una muestra de 220 pacientes, procedentes de 6 centros hospitalarios de Andalucía. Se recogieron variables demográficas, variables relacionadas con el control metabólico, uso de sistemas de monitorización continua de glucosa, hemoglobina glucosilada media, episodios de hipoglucemias graves o cetoacidosis, comorbilidades y complicaciones existentes, así como los costes directos sanitarios; englobando los costes de medicación, materiales, determinaciones analíticas, pruebas complementarias y los relacionados con la asistencia sanitaria tanto hospitalaria como extrahospitalaria. Resultados: Se obtuvo una muestra de 178 pacientes. La edad media al diagnóstico fue de 6 años y los años de evolución de la enfermedad de 4,69 (0,29 DE) años. La hemoglobina glucosilada media fue de 7,06%, encontrándose el 25% por encima de 7,5%. El coste medio anual estimado por paciente fue de 4.720,4 €. El derivado de las insulinas (2.212,9 €) y el material para la administración de la misma y monitorización de la glucemia (1.518 €) supusieron el mayor porcentaje del gasto (79,1%). No se detecta asociación entre el control metabólico, comorbilidades y el coste de la enfermedad. Conclusión: Este estudio demuestra un coste directo asociado a la DM en edad pediátrica en Andalucía de aproximadamente 4.700 € por paciente


Introduction: Type 1 Diabetes Mellitus (T1DM) is the second leading chronic disease and the most common endocrine-metabolic disorder in childhood. The study objective was to estimate the direct cost of T1DM in pediatric patients in Andalusia. Methodology: A descriptive, observational, multicenter study was conducted during six consecutive months of 2017-2018 on a sample of 220 patients from 6 hospitals in Andalusia. Variables collected included demographic characteristics, metabolic control parameters, glucose levels, use of continuous monitoring systems, mean HbA1c levels, episodes of severe hypoglycemia and ketoacidosis, comorbidities and complications, as well as direct healthcare costs, including costs of drugs, materials, laboratory tests, and supplemental tests, as well as those derived from both inpatient and outpatient care. Results: The study sample consisted of 178 patients. Mean age at diagnosis was 6 years, and mean disease duration was 4.69 (0.29 SD) years. Mean HbA1c level was 7.06%, and 25% of patients had values higher than 7.5%. The estimated annual cost per patient was € 4,720.4. Cost derived from use of insulins (€ 2,212.9) and materials for insulin administration and blood glucose monitoring (€ 1,518) accounted for greatest proportion of cost (79.1%). No association was found between metabolic control, comorbidities, or complications and cost of disease. Conclusion: This study has shown a direct cost associated to T1DM in Andalusian children of approximately € 4,700 per patient


Assuntos
Pré-Escolar , Criança , Adolescente , Humanos , Masculino , Feminino , Diabetes Mellitus Tipo 1/economia , Custos Diretos de Serviços , Espanha , Hemoglobina A Glicada/administração & dosagem , Hemoglobina A Glicada/economia , Estudos Prospectivos , Inquéritos e Questionários
11.
Endocrinol Diabetes Nutr ; 66(8): 480-486, 2019 Oct.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-31122889

RESUMO

INTRODUCTION: Type 1 Diabetes Mellitus (T1DM) is the second leading chronic disease and the most common endocrine-metabolic disorder in childhood. The study objective was to estimate the direct cost of T1DM in pediatric patients in Andalusia. METHODOLOGY: A descriptive, observational, multicenter study was conducted during six consecutive months of 2017-2018 on a sample of 220 patients from 6 hospitals in Andalusia. Variables collected included demographic characteristics, metabolic control parameters, glucose levels, use of continuous monitoring systems, mean HbA1c levels, episodes of severe hypoglycemia and ketoacidosis, comorbidities and complications, as well as direct healthcare costs, including costs of drugs, materials, laboratory tests, and supplemental tests, as well as those derived from both inpatient and outpatient care. RESULTS: The study sample consisted of 178 patients. Mean age at diagnosis was 6 years, and mean disease duration was 4.69 (0.29 SD) years. Mean HbA1c level was 7.06%, and 25% of patients had values higher than 7.5%. The estimated annual cost per patient was € 4,720.4. Cost derived from use of insulins (€ 2,212.9) and materials for insulin administration and blood glucose monitoring (€ 1,518) accounted for greatest proportion of cost (79.1%). No association was found between metabolic control, comorbidities, or complications and cost of disease. CONCLUSION: This study has shown a direct cost associated to T1DM in Andalusian children of approximately € 4,700 per patient.

12.
An. pediatr. (2003. Ed. impr.) ; 90(5): 285-292, mayo 2019. tab, graf
Artigo em Espanhol | IBECS-Express | ID: ibc-ET2-3884

RESUMO

Introducción: El crecimiento en pacientes con déficit aislado de hormona del crecimiento (GH) es heterogéneo a pesar del tratamiento, debido a la baja especificidad de las pruebas diagnósticas, por lo que es necesario definir las variables de eficacia. Objetivos: Evaluar la eficacia de la terapia de reemplazo hormonal en niños con déficit aislado de GH. Métodos: Estudio observacional-ambispectivo de pacientes tratados en nuestro servicio en los últimos 14 años por déficit aislado de GH, definido como GH inferior a 7,4 mg/dl en 2 pruebas de estímulo, en pacientes con talla < -2DE y velocidad de crecimiento disminuida. Resultados: Se estudiaron 97 pacientes. El 69% eran varones. Con el tratamiento hubo una ganancia de talla de 1,17DE. El 79,31% alcanzaron la talla diana. El 71,13% fueron reevaluados en la edad adulta, de los cuales el 39,4% mantuvo el déficit. La talla diana, el pronóstico de talla adulta y la ganancia puberal total se correlacionaron positivamente con la talla adulta, mientras que la relación edad ósea/edad cronológica y factor de crecimiento insulínico tipo 1 inicial mostraron una correlación negativa. Ninguno tuvo efectos secundarios. Conclusiones: La mayoría de los pacientes alcanzaron la talla diana, aunque no todos mostraron permanencia del déficit en edad adulta. La talla diana, el pronóstico de talla adulta y las variables de pubertad están directamente relacionados con la talla adulta; mientras que la edad ósea/edad cronológica y factor de crecimiento insulínico tipo 1 están inversamente relacionadas, pudiendo utilizarse estas como variables de eficacia. No se han observado efectos adversos en la muestra con las dosis utilizadas


Introduction: Growth in patients with isolated growth hormone (GH) deficiency is heterogeneous despite treatment due to the low specificity of diagnostic tests, making it necessary to define efficacy variables. Aims: To evaluate efficacy of hormone replacement therapy in children with isolated GH deficiency. Methods: Observational-ambispective study of patients treated in our department in the last 14 years for isolated GH deficiency. This was defined as a GH level less than 7.4 mg/dl in response to 2 stimulation tests in patients with height < 2SD and a decreased growth rate. Results: The study included a total 97 patients, of whom 69% were boys. The large majority (89.58%) achieved final height. None of them had side effects. The median dose of GH used was 0.028 mg/kg/day (0.03-0.025). There was a gain of 1.17 SD in final height. Around three-quarters (71.13%) of the patients were reassessed in adulthood, of whom 39.4% maintained the deficiency, and 79.31% achieved target range height. Target height, estimated height, and the total pubertal gain were positively correlated with final height, while the bone age/chronological age ratio and the initial insulin-like growth factor-1 showed a negative correlation. Conclusions: A majority of patients reached target size, although only a few of them maintained the deficiency in adulthood. Target size, estimated adult height, and pubertal variables are directly related to adult height, while bone age/chronological age and insulin-like growth factor-1 were inversely related, and these can be used as efficacy variables. No adverse effects were observed in the sample with the doses used for the treatment

13.
Curr Med Res Opin ; : 1-7, 2019 Apr 09.
Artigo em Inglês | MEDLINE | ID: mdl-30964364

RESUMO

OBJECTIVES: This study assessed the health-related quality of life (HRQOL) of pediatric patients with type 1 diabetes mellitus (T1DM) and their caregivers. METHODS: CHRYSTAL was an observational cross-sectional study conducted in Spain in 2014 on 275 patients under 18 years old diagnosed with T1DM. Patient/caregiver pairs were stratified by patients' HbA1c level (≥7.5% versus <7.5%) and by presence or absence of T1DM complications and/or comorbidities. EQ-5D and PedsQL questionnaires were administered to patients and caregivers. RESULTS: On the EQ-5D, according to caregivers' perception, 17.7% of children experienced moderate pain or discomfort, 9.7% suffered problems performing usual activities, and 13.2% demonstrated moderate anxiety or depression. Mean EQ-5D index score was 0.95 and mean visual analog scale (VAS) score was 86.1. By HbA1c level (≥7.5% versus <7.5%), mean index scores were 0.94 and 0.95, and mean VAS scores were 82.8 and 89.2, respectively. Mean index scores were 0.91 for children with complications and/or comorbidities and 0.96 for children without. Mean VAS scores were 83.7 and 87.2, respectively. HRQOL per the PedsQL tool ranged from 68.1 (ages 2-4) to 73.1 (ages 13-18). EQ-5D index and VAS scores were significantly correlated (rho = 0.29-0.43) with several age groups of the PedsQL. EQ-5D scales showed significant moderate correlation between EQ-5D-Y and EQ-5D-3L proxy VAS score (rho = 0.45; p < .001). CONCLUSIONS: Patients with few complications and controlled HbA1c reported a relatively high HRQOL. The results suggest that parent-proxy EQ-5D ratings are valid for use as part of an overall health outcomes assessment in clinical studies of T1DM in pediatric patients.

14.
Endocrinol Diabetes Nutr ; 66(9): 550-554, 2019 Nov.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-31023597

RESUMO

INTRODUCTION: Subclinical hypothyroidism is defined as elevation of thyroid-stimulating hormone (TSH) levels, with normal thyroid hormone levels and negative autoimmunity, in asymptomatic patients with no findings on examination. Because of the unwarranted increase in thyroid function tests in asymptomatic children, the main objective of this review was to analyze the course of these patients. Analysis of associated costs was a secondary objective. MATERIAL AND METHODS: A longitudinal, observational, retrospective study of patients referred to the endocrinology department of a tertiary hospital for high TSH levels (TSH 5-20mIU/L). Clinical and laboratory variables, number of visits until discharge, need for treatment, monitoring time, and economic variables were collected. RESULTS: The study sample consisted of 155 patients with a mean age of 7.8years ±3.6SD. Referrals to endocrinology accounted for 4% of first office visits. Baseline mean TSH level was 7.8mU/L (5.03-15.8mU/L). TSH levels normalized after the first repeated measurement during the subsequent month in 60% of cases. A total of 83.6% of patients were discharged within a maximum of 3years, with a mean follow-up of 8.14 ±6.8months and 2.4visits/patient. Average cost per patient was €251.27 (range €143.49-444.21). CONCLUSION: It is essential not to alarm the family when subclinical hypothyroidism is detected, because this is a biochemical situation which normalizes in most cases. This fact, together with the mean cost of specialized care, suggests that the first step should be repeated TSH measurements in primary care.

15.
Endocrinol Diabetes Nutr ; 66(9): 540-549, 2019 Nov.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-30853269

RESUMO

INTRODUCTION: Few studies assessing the relationship between oxidative stress and glycemic variability in children with type 1 diabetes mellitus (T1DM) are available, and most of them reported no significant results. OBJECTIVE: To assess the relationship between glucose control, glycemic variability, and oxidative stress as measured by urinary excretion of 8-iso-prostanglandin F2-alpha (8-iso-PGF2α) in children with T1DM. MATERIALS AND METHODS: A cross-sectional study including 25 children with T1DM. Participants were evaluated during five days in two different situations: 1st phase during a summer camp, and 2nd phase in their everyday life at home. The following data were collected in each study phase:. - Six capillary blood glucose measurements per day. Mean blood glucose (MBG) levels and glucose variability parameters, including standard deviation, coefficient of variation, and mean amplitude of glycemic excursions (MAGE), were calculated. - Capillary HbA1c level. - 24-h urine sample to measure 8-iso-PGF2α. RESULTS: There were no statistically significant differences in urinary 8-iso-PGF2α levels (142±37 vs. 172±61pg/mg creatinine) and glucose control and glycemic variability parameters between both phases. In the 2nd phase, statistically significant correlations were found between urinary 8-iso-PGF2α and HbA1c levels (r=0.53), MBG (r=0.72), standard deviation (r=0.49), and MAGE (r=0.42). No significant correlations between glucose control, glycemic variability and urinary 8-iso-PGF2α excretion were found in the 1st phase. CONCLUSIONS: A significant correlation was found between glycemic variability and HbA1c level and urinary 8-iso-PGF2α excretion in a group of children with T1DM during their daily lives. Additional studies are needed to confirm this finding and to explore its long-term impact on health.

18.
An Pediatr (Barc) ; 90(5): 285-292, 2019 May.
Artigo em Espanhol | MEDLINE | ID: mdl-29960877

RESUMO

INTRODUCTION: Growth in patients with isolated growth hormone (GH) deficiency is heterogeneous despite treatment due to the low specificity of diagnostic tests, making it necessary to define efficacy variables. AIMS: To evaluate efficacy of hormone replacement therapy in children with isolated GH deficiency. METHODS: Observational-ambispective study of patients treated in our department in the last 14 years for isolated GH deficiency. This was defined as a GH level less than 7.4mg/dl in response to 2 stimulation tests in patients with height<2SD and a decreased growth rate. RESULTS: The study included a total 97 patients, of whom 69% were boys. The large majority (89.58%) achieved final height. None of them had side effects. The median dose of GH used was 0.028mg/kg/day (0.03-0.025). There was a gain of 1.17 SD in final height. Around three-quarters (71.13%) of the patients were reassessed in adulthood, of whom 39.4% maintained the deficiency, and 79.31% achieved target range height. Target height, estimated height, and the total pubertal gain were positively correlated with final height, while the bone age/chronological age ratio and the initial insulin-like growth factor-1 showed a negative correlation. CONCLUSIONS: A majority of patients reached target size, although only a few of them maintained the deficiency in adulthood. Target size, estimated adult height, and pubertal variables are directly related to adult height, while bone age/chronological age and insulin-like growth factor-1 were inversely related, and these can be used as efficacy variables. No adverse effects were observed in the sample with the doses used for the treatment.


Assuntos
Nanismo Hipofisário/tratamento farmacológico , Terapia de Reposição Hormonal/métodos , Hormônio do Crescimento Humano/administração & dosagem , Fator de Crescimento Insulin-Like I/metabolismo , Adolescente , Fatores Etários , Estatura/efeitos dos fármacos , Criança , Pré-Escolar , Relação Dose-Resposta a Droga , Feminino , Hormônio do Crescimento Humano/efeitos adversos , Humanos , Masculino , Estudos Prospectivos , Estudos Retrospectivos
19.
An. pediatr. (2003. Ed. impr.) ; 89(2): 111-116, ago. 2018. tab
Artigo em Espanhol | IBECS | ID: ibc-177018

RESUMO

Introducción: La representación de nuestro país en los estudios epidemiológicos europeos en diabetes es exigua, tan solo un centro en el estudio Hvidoere y otro en el SWEET. No existen estudios publicados en España que combinen datos epidemiológicos y recursos asistenciales. El objetivo de este estudio es conocer los datos epidemiológicos, los recursos asistenciales y el uso de nuevas tecnologías en los hospitales andaluces que atienden a niños con diabetes mellitus tipo 1 (DM1) menores de 14 años. Material y métodos: Un cuestionario electrónico de 18 preguntas fue enviado a los endocrinólogos pediátricos que atendían a niños con DM1 en todos los hospitales andaluces. Resultados: La media de la ratio de endocrinólogo pediátrico por 100 pacientes fue 3,12 (DE: 2,58). La media de la ratio de enfermero educador en diabetes por 100 pacientes y centro fue de 2,50 (DE: 3,94). Solo uno de los 29 centros disponía de psicólogo, 9/29 disponían de hospital de día y 11/29 disponían de atención telefónica durante 24 h. La media de días de consulta a la semana destinados exclusivamente a pacientes con DM1 fue de 1,56 días (DE: 1,21). Un 5% de los pacientes fueron tratados con infusor continuo de insulina, con un aumento significativo en los centros que tenían más de 150 pacientes. Conclusiones: Este estudio ofrece por primera vez datos actuales de la situación epidemiológica en Andalucía en relación con los datos asistenciales; comparándolos con las recomendaciones de estándares europeos, destaca una baja ratio de endocrinólogos y educadores en diabetes, ausencia de psicólogo y baja penetrancia de tecnología


Introduction: The representation of Spain in European epidemiological studies on diabetes is limited, with only one centre in the Hvidoere study and another in the SWEET study. No Spanish studies have been published that combine epidemiological data and care resources. The aim of this study was to determine the epidemiological data, care resources, and use of new technologies in all Andalusian hospitals that care for children with Diabetes Mellitus type 1 (DM1) under 14 years. Material and methods: An electronic questionnaire of 18 questions was sent to all paediatric endocrinologists who treated children with diabetes in Andalusian hospitals. Results: There was a mean of 3.12 (SD: 2.58) paediatric endocrinologist for every 100 patients, with a mean diabetes nurse educator ratio of 2.50 (SD: 3.94) per 100 patients and centre. Only 1 of the 29 centres had a psychologist, 9/29 had a day hospital, and 11/29 had a 24-hour telephone line. The mean of days of consultations exclusively for patients with DM1 was 1.56 days (SD: 1.21) per week. Continuous insulin infusion was used to treat 5% of patients, with a significant increase in centres with more than 150 patients. Conclusions: This study offers, for the first time, current data on the epidemiological situation related to health care data, comparing them with the recommendations of European standards, highlighting a low ratio of endocrinologists and educators in diabetes, absence of psychologists and low technology penetrance


Assuntos
Humanos , Lactente , Pré-Escolar , Criança , Adolescente , Diabetes Mellitus Tipo 1/epidemiologia , Diabetes Mellitus Tipo 1/terapia , Espanha/epidemiologia , Pesquisas sobre Serviços de Saúde , Mão de Obra em Saúde , Análise de Variância
20.
An. pediatr. (2003. Ed. impr.) ; 88(4): 209-215, abr. 2018. graf
Artigo em Espanhol | IBECS | ID: ibc-172991

RESUMO

Introducción: La hormona de crecimiento humana recombinante biosimilar (rhGH) fue el primer medicamento autorizado por la Agencia Europea del Medicamento (EMA), en el año 2006, por la vía de registro biosimilar. Se aprobó su uso para el tratamiento del déficit de hormona de crecimiento, trastorno de crecimiento asociado al síndrome de Turner, trastorno de crecimiento asociado a insuficiencia renal crónica, síndrome de Prader-Willi, trastorno de crecimiento en niños/adolescentes nacidos pequeños para su edad gestacional y como terapia de sustitución en adultos con deficiencia pronunciada de hormona de crecimiento. Materiales y métodos: Esta revisión se centra en las evidencias científicas publicadas en los últimos 10 años, incluyendo los ensayos clínicos utilizados para conseguir la aprobación por parte de la EMA y los estudios más relevantes que evalúan el medicamento en la práctica clínica habitual. Resultados: La equivalencia entre este biosimilar de rhGH y su producto de referencia ha sido demostrada en los ensayos clínicos publicados por Romer et al. y López-Siguero et al. Asimismo, los estudios del fármaco realizados en condiciones de práctica clínica habitual confirman su eficacia y seguridad a largo plazo, así como la ausencia de impacto clínico al cambiar el producto original por el biosimilar. Conclusión: Desde su aprobación, el número de pacientes que reciben esta medicación ha experimentado un continuo crecimiento. Los datos preliminares del estudio postautorización PATRO indican que la eficacia y seguridad del fármaco se correlaciona con la obtenida en los ensayos clínicos. No obstante, aún queda pendiente evaluar los resultados definitivos del estudio que aportarán información adicional sobre la eficacia y seguridad del fármaco a largo plazo


Introduction: Recombinant human growth hormone (rhGH) is the first biosimilar drug approved by the European Medicines Agency in 2006, using the biosimilar registration process. It was authorised for the treatment of growth hormone deficiency, and growth disorders associated with Turner's syndrome, chronic renal failure, Prader-Willi syndrome, and growth disorders in children/adolescents born small for gestational age, and replacement therapy in adults with pronounced growth hormone deficiency. Materials and methods: This review is focused on the scientific evidence published about this drug in the last ten years, including the clinical trials on which the approval of the regulatory authority is based, and the most relevant studies evaluating the clinical impact of the drug in clinical practice. Results: The equivalence between biosimilar and original product has been confirmed in the clinical trials published by Romer et al. and López-Siguero et al. Furthermore, studies carried out in real-life conditions confirm its long-term efficacy and safety, as well as the absence of clinical impact by switching treatment from the original to the biosimilar product. Conclusion: The number of patients receiving this medication has continuously increased since its approval. Its equivalence with the original product has been verified. Preliminary data from the post-authorisation PATRO study confirm the efficacy and safety of the biosimilar product in comparison with data from clinical trials. However, final results must be evaluated at the end of the study, which will provide additional information about the long-term efficacy and safety of the biosimilar drug


Assuntos
Humanos , Hormônio do Crescimento/deficiência , Hormônio do Crescimento/uso terapêutico , Medicamentos Biossimilares/administração & dosagem , Resultado do Tratamento , Medicina Baseada em Evidências/estatística & dados numéricos
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