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1.
Rev. bras. med. esporte ; 29(spe1): e2022_0180, 2023. tab
Article in English | LILACS | ID: biblio-1394849

ABSTRACT

ABSTRACT Introduction A tennis match may last up to four hours with long intervals between moves of medium to high exercise intensity for 10 minutes and aerobic characteristic that requires specific sources of energy. Inappropriate diets can negatively impact sports performance and delay the recovery phase. Fortified wheat germ protein powder has the supplementation characteristics required in aerobic activities, although there are no practical studies on its impacts on the work performance of female tennis athletes. Objective Explore the influence of two weeks of training in a warm environment combined with nutritional intervention on the performance of female tennis players. Methods It was observed by testing the immunological indices of elite female tennis players while training their changes and their effects on nutritional intervention. Results The increase in serum CK activity was closely related to the amount of exercise. Many studies have shown that serum CK activity increased significantly after strenuous exercise, and the serum CK value of subjects in the test group was significantly lower than that of the control group, showing better adaptability to exercise. Compared with before the nutritional intervention, the athletes' weight decreased slightly, and the body fat percentage decreased significantly after the nutritional intervention. Compared with before nutritional intervention, sugar and salt supplements in athletes were significantly increased (P<0.05). Sweating rate, hydration rate, and hydration/sudden rate were also significantly increased (P<0.05). Conclusion Strengthening wheat germ protein supplementation may improve the nutritional albumin level in female tennis players, manifested in blood levels and immune function performance. Level of evidence II; Therapeutic studies - investigation of treatment outcomes.


RESUMO Introdução Partidas de tênis podem durar até quatro horas com intervalos longos entre jogadas de intensidade de exercício média a alta por 10 minutos, características aeróbicas que requerem fontes específicas de energia. Dietas inapropriadas podem impactar negativamente o desempenho esportivo e retardar o período de recuperação. O pó de proteína de germe de trigo fortificado apresenta as características de suplementação requeridas nas atividades aeróbicas, embora não haja estudos práticos sobre seus impactos no desempenho profissional de atletas do tênis feminino. Objetivo Explorar a influência no treinamento de duas semanas em ambiente quente combinado com a intervenção nutricional sobre o desempenho das atletas tenistas. Métodos Ao testar os índices imunológicos das tenistas de elite durante o treinamento, observamos suas mudanças e seus efeitos na intervenção nutricional. Resultados O aumento da atividade de CK sérico esteve intimamente relacionado à quantidade de exercício. Muitos estudos mostraram que a atividade do soro CK aumentou significativamente após o exercício extenuante, e o valor sérico CK dos sujeitos no grupo de teste foi significativamente menor do que o do grupo controle, mostrando melhor adaptabilidade ao exercício. Em comparação com antes da intervenção nutricional, o peso dos atletas diminuiu ligeiramente e o percentual de gordura corporal diminuiu significativamente após a intervenção nutricional. Em comparação com antes da intervenção nutricional, os suplementos de açúcar e sal em atletas foram significativamente incrementados (P<0,05). A taxa de sudorese, a taxa de hidratação e a taxa de hidratação/sudorese também aumentaram significativamente (P<0,05). Conclusão Fortalecer a suplementação com proteína de germe de trigo pode melhorar o nível nutricional de albumina nas tenistas, manifestadamente nos níveis sanguíneos e desempenho da função imunológica. Nível de evidência II; Estudos terapêuticos - investigação dos resultados do tratamento.


RESUMEN Introducción Los partidos de tenis pueden durar hasta cuatro horas con largos intervalos entre jugadas de intensidad de ejercicio media a alta durante 10 minutos, características aeróbicas que requieren fuentes de energía específicas. Las dietas inadecuadas pueden afectar negativamente al rendimiento deportivo y retrasar el periodo de recuperación. La proteína de germen de trigo en polvo enriquecida presenta las características de suplementación requeridas en las actividades aeróbicas, aunque no existen estudios prácticos sobre sus impactos en el rendimiento profesional de las atletas de tenis. Objetivo Explorar la influencia de dos semanas de entrenamiento en un ambiente cálido combinado con una intervención nutricional en el rendimiento de las atletas de tenis. Métodos Mediante el análisis de los índices inmunológicos de las tenistas de élite durante el entrenamiento, observamos sus cambios y sus efectos en la intervención nutricional. Resultados El aumento de la actividad de la CK en suero estaba estrechamente relacionado con la cantidad de ejercicio. Muchos estudios han demostrado que la actividad de la CK en suero aumenta significativamente después de un ejercicio extenuante, y el valor de la CK en suero de los sujetos del grupo de prueba fue significativamente menor que el del grupo de control, lo que demuestra una mejor adaptabilidad al ejercicio. En comparación con antes de la intervención nutricional, el peso de los atletas disminuyó ligeramente y el porcentaje de grasa corporal se redujo significativamente después de la intervención nutricional. En comparación con antes de la intervención nutricional, los suplementos de azúcar y sal en las atletas aumentaron significativamente (P<0,05). La tasa de sudoración, la tasa de hidratación y la tasa de hidratación/sudoración también aumentaron significativamente (P<0,05). Conclusión El refuerzo de la suplementación con proteínas de germen de trigo puede mejorar el nivel nutricional de albúmina en las jugadoras de tenis, manifestándose en los niveles sanguíneos y en el rendimiento de la función inmunitaria. Nivel de evidencia II; Estudios terapéuticos - investigación de los resultados del tratamiento.


Subject(s)
Humans , Female , Adolescent , Young Adult , Tennis , Climate , Dietary Supplements , Athletic Performance , Athletes
2.
Ciênc. Saúde Colet. (Impr.) ; 27(8): 3103-3116, ago. 2022. tab, graf
Article in Portuguese | LILACS-Express | LILACS | ID: biblio-1384459

ABSTRACT

Resumo O desenvolvimento de novos medicamentos depende de etapas científicas que culminam nos ensaios clínicos em seres humanos. A farmácia de ensaios clínicos (FEC) é o local destinado ao recebimento, preparação, armazenamento e dispensação do produto investigacional (PI). Para tanto, deve possuir infraestrutura e procedimentos que garantam a segurança do participante e a qualidade da pesquisa. Este trabalho teve por objetivo sistematizar diretrizes para FEC no Brasil. Foi realizada uma revisão de escopo e as diretrizes foram organizadas utilizando o método de Ishikawa ("método 6Ms"). No total foram selecionadas 51 publicações, sendo 39 diretrizes e normas e 12 artigos científicos para cada "M"; 25 descreveram o ciclo de assistência farmacêutica (procedimentos para assegurar a segurança dos participantes, desde a requisição do produto até a destinação final), 14 indicadores de qualidade, 12 de recursos humanos, 11 de infraestrutura e recursos materiais e 5 descreveram PIs. para organização, funcionamento e avaliação de FEC no Brasil e corroboram a necessidade da presença do profissional farmacêutico no ciclo da assistência farmacêutica no contexto dos ensaios clínicos, contribuindo ainda na preparação para monitorias, auditorias e inspeções de agências regulatórias.


Abstract The development of new drugs depends on several scientific steps, which culminate in clinical trials. The clinical trials pharmacy (CTP) is the place for receiving, preparing, storing and dispensing the investigational product or study drug. Therefore, it must have infrastructure and procedures that guarantee participant safety and quality of research data. This study aimed to systematize guidelines for CTP in Brazil. We conducted a scope review and organized the results using the Ishikawa Method (6Ms). In total, 51 publications were selected for each "M", 39 laws, regulations or guidelines and 12 scientific articles: 25 publications for pharmaceutical services (pharmacy procedures to ensure participant safety from investigational product ordering to final disposition), 14 for Quality Indicators, 12 for Human Resources, 11 for Infrastructure, 11 for Material Resources and 5 for Investigational Product. Our results synthesize information for the organization, operation and evaluation of CTP in Brazil, emphasizes the inclusion of the pharmacist within the clinical trials context, and contributes to preparation for monitoring, auditing, and inspections conducted by regulatory agencies.

3.
Rev. bioét. (Impr.) ; 30(2): 325-336, abr.-jun. 2022. tab
Article in Portuguese | LILACS | ID: biblio-1387742

ABSTRACT

Resumo Este artigo busca investigar conflitos de interesses envolvendo a apresentação de ensaios clínicos em congressos brasileiros de cinco especialidades médicas, ocorridos entre 2004 e 2018. Foram estudados 407 resumos em 22 anais. Após aplicar critérios de seleção, obteve-se um corpus de 77 ensaios. Detectou-se maior frequência de conflitos de interesses envolvendo ensaios com drogas para as quais não havia genéricos/similares ( p =0,000), sendo que em 48% daqueles em conflito de interesses não houve declaração. Os resultados favoráveis à droga-teste ocorreram em 90,9% do total de ensaios, mas em 48,6% deles não foi reportado valor de p . As categorias terapêuticas mais testadas foram imunossupressores e imunomoduladores, antidiabéticos e antineoplásicos, que, juntas, representaram 68,9% do total de drogas envolvidas. Os resultados apontam conflitos de interesses ocultos, supervalorização de resultados positivos de drogas-testes, nem sempre com evidências suficientes, e concentração de produção em drogas de alto custo.


Abstract This article seeks to investigate conflicts of interest involving the presentation of clinical trials in Brazilian congresses of five medical specialties between 2004 and 2018. A total of 407 abstracts in 22 annals were studied. After applying selection criteria, we reached a corpus of 77 essays. A higher frequency of conflicts of interest was found involving essays with drugs for which no generic/similar option was available (p=0.000), and 48% of those with a conflict of interest declared nothing. Favorable results to the test drug occurred in 90.9% of the total of essays, but 48.6% of them lacked the p-value. The most tested therapeutic categories were immunosuppressors and immunomodulators, antidiabetic, and antineoplastic, which, together, amounted to 68.9% of the total of the involved drugs. The results pointed to hidden conflicts of interest, overvaluing of positive results of test drugs, not always with sufficient evidence, and focus of production on high-cost drugs.


Resumen Este artículo analiza los conflictos de intereses en ensayos clínicos presentados en congresos brasileños de cinco especialidades médicas, realizados entre 2004 y 2018. Se analizaron 407 resúmenes de 22 anales. Tras aplicados los criterios de selección se obtuvo un corpus de 77 ensayos. Hubo una mayor frecuencia de conflictos de intereses en ensayos con medicamentos para los que no había medicaciones genéricas/similares ( p =0,000), y el 48% con conflictos no hubo su declaración. Los resultados favorables para droga prueba están en el 90,9% del total de ensayos, pero el 48,6% de ellos no informó el valor de p . Las categorías terapéuticas más probadas fueron inmunosupresores e inmunomoduladores, antidiabéticos y antineoplásicos, que juntas compusieron el 68,9% del total de fármacos. Los resultados apuntan a conflictos de intereses ocultos, sobreestimación de los resultados positivos de las drogas prueba, no siempre con evidencia suficiente, y concentración de la producción en medicamentos de alto costo.


Subject(s)
Conflict of Interest , Clinical Conference , Ethics, Research , Drug Industry
4.
Säo Paulo med. j ; 140(3): 430-438, May-June 2022. tab, graf
Article in English | LILACS | ID: biblio-1377394

ABSTRACT

ABSTRACT BACKGROUND: Use of inhaled corticosteroids for managing acute asthma exacerbations has been tested since the 1990s. OBJECTIVE: To compare high doses of inhaled ciclesonide with systemic hydrocortisone for managing acute asthma exacerbations in the emergency department. DESIGN AND SETTING: Double-blind, randomized clinical trial in the public healthcare system of the city of São Paulo. METHODS: Fifty-eight patients with moderate or severe asthma with peak flow < 50% of predicted were randomized into two groups. Over the course of four hours, one group received 1440 mcg of inhaled ciclesonide plus hydrocortisone-identical placebo (ciclesonide + placebo), while the other received 500 mg of intravenous hydrocortisone plus ciclesonide-identical placebo (hydrocortisone + placebo). Both groups received short-acting bronchodilators (fenoterol hydrobromide and ipratropium bromide). The research protocol included spirometry, clinical evaluation, vital signs and electrocardiogram monitoring. Data were obtained at 30 (baseline), 60, 90, 120, 180, and 240 minutes. We compared data from baseline to hour 4, between and within groups. RESULTS: Overall, 31 patients received ciclesonide + placebo and 27 received hydrocortisone + placebo. Inhaled ciclesonide was as effective as intravenous hydrocortisone for improving clinical parameters (Borg-scored dyspnea, P = 0.95; sternocleidomastoid muscle use, P = 0.55; wheezing, P = 0.55; respiratory effort, P = 0.95); and spirometric parameters (forced vital capacity, P = 0.50; forced expiratory volume in the first second, P = 0.83; peak expiratory flow, P = 0.51). CONCLUSIONS: Inhaled ciclesonide was not inferior to systemic hydrocortisone for managing acute asthma exacerbations, and it improved both clinical and spirometric parameters. TRIAL REGISTRATION: RBR-6XWC26 - Registro Brasileiro de Ensaios Clínicos (http://www.ensaiosclinicos.gov.br/rg/RBR-6xwc26/).


Subject(s)
Asthma/drug therapy , Hydrocortisone/therapeutic use , Hydrocortisone/pharmacology , Pregnenediones , Brazil , Forced Expiratory Volume , Double-Blind Method , Emergency Service, Hospital
5.
Braz. j. otorhinolaryngol. (Impr.) ; 88(3): 345-350, May-June 2022. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1384166

ABSTRACT

Abstract Introduction Tympanoplasty techniques with different types of graft have been used to close tympanic perforations since the 19th century. Tragal cartilage and temporalis fascia are the most frequently used types of graft. They lead to similar functional and morphological results in most cases. Although little published evidence is present, nasal mucosa has also been shown to be a good alternative graft. Objective Surgical and audiological outcomes at the six-month follow-up in type I tympanoplasty using nasal mucosa and temporalis fascia grafts were analyzed. Methods A total of 40 candidates for type I tympanoplasty were randomly selected and divided into the nasal mucosa and temporalis fascia graft groups with 20 in each group. The assessed parameters included surgical success; the rate of complete closure of tympanic perforation and hearing results; the difference between post- and pre-operative mean quadritonal airway-bone gap, six months after surgery. Results Complete closure of the tympanic perforation was achieved in 17 of 20 patients in both groups. The mean quadritonal airway-bone gap closures were11.9 and 11.1 dB for the nasal mucosa and temporalis fascia groups, respectively. There was no statistically significant difference between the groups. Conclusion The nasal mucosa graft can be considered similar to the temporal fascia when considering the surgical success rate of graft acceptance and ultimate audiological gain.


Resumo Introdução Técnicas de timpanoplastia com diferentes tipos de enxerto têm sido usadas para fechar perfurações timpânicas desde o século XIX. A cartilagem tragal e a fáscia temporal são os tipos de enxerto mais usados, com resultados funcionais e morfológicos semelhantes na maioria dos casos. Embora ainda com poucas evidências publicadas, a mucosa nasal tem se mostrado uma boa opção de enxerto. Objetivo Comparar os resultados cirúrgicos e audiológicos da timpanoplastia tipo I com enxerto de mucosa nasal e de fáscia temporal em seis meses de seguimento. Método Foram selecionados aleatoriamente 40 pacientes candidatos a timpanoplastia tipo I divididos nos grupos enxerto de mucosa nasal e de fáscia temporal com 20 em cada grupo. Os parâmetros avaliados incluíram sucesso cirúrgico, ou seja, a taxa de fechamento completo da perfuração timpânica, e resultados audiológicos; diferença entre o gap quadritonal médio do gap aéreo-ósseo pré e pós-operatório após seis meses da cirurgia. Resultados O fechamento completo da perfuração timpânica foi alcançado em 17 de 20 pacientes no grupo mucosa nasal, como também no grupo fáscia temporal. O ganho quadritonal médio do gap aéreo-ósseo foi de 11,9 dB no grupo mucosa nasal e 11,1 dB no grupo fáscia temporal, respectivamente. Não houve diferença estatisticamente significante entre os grupos. Conclusão O enxerto de mucosa nasal pode ser considerado semelhante ao da fáscia temporal quando se considera o sucesso cirúrgico de pega do enxerto e o ganho audiológico.

6.
BrJP ; 5(1): 39-46, Jan.-Mar. 2022. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1364400

ABSTRACT

ABSTRACT BACKGROUND AND OBJECTIVES: The use of socio-educational booklets is recommended for assisting in the control of chronic pain. However, the efficacy and safety of these light technologies have not yet been tested enough for widespread application, based on the model of scientific evidence. This study aimed to assess the effect of a health education program in individuals suffering from CP using the EducaDor booklet. METHODS: Randomized clinical trial conducted with chronic pain patients from Unidades Básicas de Saúde (UBS - Primary Health Care Units) in Salvador, Bahia, Brazil. Assessments were performed using the Brief Pain Inventory (BPI), Visual Analog Scale of Pain (VAS-P) and World Health Organization Quality of Life instrument-Bref (WHOQoL-bref ), before and after the intervention, for intra and intergroup analyses: Test Group (Booklet) and Control Group (Conventional Care). The contents of the EducaDor booklet were presented didactically in six meetings with an interval of one week between them. RESULTS: The sample was composed of 10 individuals in each group (n = 20). In the Control Group, there was an increase in pain intensity (p=0.034), while the Test Group showed a reduction in pain intensity (p=0.015) and a lower level of interference in the physical, psychological, social relationships and environmental quality of life domains (p<0.05). In the intergroup comparisons, an improvement was observed in the domain of social relationships in the Test Group (p=0.015). CONCLUSION: EducaDor booklet has been shown to be effective and safe for the education of patients suffering from CP by reducing pain intensity and improving patients' quality of life.


RESUMO JUSTIFICATIVA E OBJETIVOS: Recomenda-se a utilização de cartilhas socioeducativas para auxiliar no controle da dor crônica (DC). No entanto, a eficácia e a segurança dessas tecnologias leves foram pouco testadas para ampla aplicação, com base no modelo de evidências científicas. Este estudo teve como objetivo avaliar o efeito de um programa de educação em saúde em indivíduos com DC por meio da cartilha EducaDor. MÉTODOS: Ensaio clínico randomizado realizado com indivíduos que apresentam DC em Unidades Básicas de Saúde (UBS) de Salvador, Bahia, Brasil. Os participantes foram submetidos à aplicação do Inventário Breve de Dor (BPI), Escala Analógica Visual (EAV) e do instrumento de Qualidade de Vida da Organização Mundial da Saúde - Bref (WHOQoL-bref ), antes e após a intervenção, para análises intra e intergrupos: Grupo Teste (booklet) e Grupo Controle (cuidado convencional). O conteúdo da cartilha EducaDor foi apresentado didaticamente em seis encontros com intervalo de uma semana entre eles. RESULTADOS: A amostra foi composta por 10 pessoas em cada grupo (n = 20). No Grupo Controle, houve aumento da intensidade da dor (p=0,034), enquanto o Grupo Teste apresentou redução da intensidade de dor (p=0,015) e menor nível de interferência nos domínios de qualidade de vida físico, psicológico, social e ambiental (p<0,05). Nas comparações intergrupos, observou-se melhora no domínio relações sociais no Grupo Teste (p=0,015). CONCLUSÃO: A cartilha EducaDor mostrou-se eficaz e segura para a educação de pacientes com DC, por reduzir a intensidade da dor e melhorar a qualidade de vida dos pacientes.

7.
Rev. bras. ortop ; 57(1): 150-158, Jan.-Feb. 2022. tab, graf
Article in English | LILACS | ID: biblio-1365739

ABSTRACT

Abstract Objective To compare the techniques for the osteosynthesis of intertrochanteric fractures with dynamic hip screws (DHSs) through the Hardinge and minimally-invasive access routes of the hip, evaluating the operative time, the degree of pain in the immediate postoperative period, the hematimetric loss, and the functional aspects of active mobility. Methods A randomized, double-blinded clinical trial in which 66 patients with intertrochanteric fractures were submitted to osteosynthesis by DHS. The patients were divided into a test group, submitted to the minimally-invasive access, and a control group, in whom the surgery was performed through the Hardinge route. Results Patients submitted to the minimally-invasive treatment presented a lower degree of postoperative pain compared to the group treated by the Hardinge lateral route (p< 0.001), as well as lower hematimetric loss (p< 0.001), shorter operative time (p< 0.001), and improvement in immediate postoperative active mobility tests (p <0.05). Conclusion The study demonstrated the clinical superiority of the minimally-invasive access route parameters analyzed in relation to the Hardinge access for the fixation of intertrochanteric fractures when DHS is the choice osteosynthesis method. Level of evidence I.


Resumo Objetivo Comparar as técnicas de osteossíntese de fraturas intertrocantéricas com o parafuso dinâmico de quadril (dynamic hip screw, DHS, em inglês) pelas vias de acesso de Hardinge e minimamente invasiva do quadril, avaliando o tempo cirúrgico, o grau de dor no pós-operatório imediato, a perda hematimétrica, e os aspectos funcionais de mobilidade ativa. Métodos Estudo clínico randomizado e duplo-cego, em que 66 pacientes com fratura intertrocantérica foram submetidos a osteossíntese com DHS. Os pacientes foram divididos em um grupo teste, submetidos ao acesso minimamente invasivo, e um controle, em que a cirurgia foi realizada pela via de Hardinge. Resultados Os pacientes submetidos ao tratamento pela via minimamente invasiva apresentaram um grau de dor pós-operatória inferior em comparação ao grupo tratado pela via lateral de Hardinge (p< 0,001), assim como menor perda hematimétrica (p< 0,001), menor tempo operatório (p< 0,001), e melhora nos testes de mobilidade ativa pós-operatória imediata (p< 0,05). Conclusão O estudo demonstrou a superioridade clínica nos parâmetros analisados da via de acesso minimamente invasiva em relação ao acesso de Hardinge para a fixação de fraturas intertrocantéricas, quando o DHS for a opção de osteossíntese escolhida. Nível de evidência I.


Subject(s)
Humans , Male , Female , Aged , Aged, 80 and over , Pain, Postoperative , Postoperative Period , Control Groups , Clinical Trial , Minimally Invasive Surgical Procedures , Fracture Fixation, Internal , Hip Fractures
8.
Rev. bras. enferm ; 75(5): e20210818, 2022. tab, graf
Article in English | LILACS-Express | LILACS, BDENF | ID: biblio-1387762

ABSTRACT

ABSTRACT Objective: to assess the effectiveness of a cognitive-behavioral program to control lower urinary tract symptoms after radical prostatectomy. Methods: a randomized clinical trial study, with 41 participants randomized into intervention (n=20) and control (n=21), for three months. The intervention group received the cognitive-behavioral program, while the control group received routine guidance from the service. Outcome variables were urinary incontinence intensity and lower urinary tract symptoms, assessed by the Pad-Test and Urinary Incontinence Scale of Radical Prostatectomy and King's Health Questionnaire. Results: at the end of the study, the intervention group had a lower urinary incontinence intensity (p≤0.001), and there were less chances of presenting changes in urinary frequency (p≤0.001), urinary urgency (p≤0.001), nocturia (p=0.005), stress urinary incontinence (p≤0.001) and urge incontinence (p≤0.045). Conclusion: the cognitive-behavioral program was effective in reducing lower urinary tract symptoms after radical prostatectomy. Brazilian Clinical Trial Registry: RBR-3sstqg.


RESUMEN Objetivo: evaluar la efectividad de un programa cognitivo-conductual para controlar los síntomas del tracto urinario inferior después de la prostatectomía radical. Métodos: estudio de ensayo clínico aleatorizado, con 41 participantes aleatorizados en intervención (n=20) y control (n=21), durante tres meses. El grupo de intervención recibió el programa cognitivo-conductual, mientras que el grupo control recibió orientación rutinaria del servicio. Las variables de resultado fueron la intensidad de la incontinencia urinaria y los síntomas del tracto urinario inferior, evaluados mediante Pad-Test y Urinary Incontinence Scale of Radical Prostatectomy y King's Health Questionnaire. Resultados: al final del estudio, el grupo intervención presentó menor intensidad de incontinencia urinaria (p≤0,001), y hubo menos posibilidades de presentar cambios en la frecuencia urinaria (p≤0,001), urgencia urinaria (p≤0,001), nicturia (p=0,005), incontinencia urinaria de esfuerzo (p≤0,001) e incontinencia de urgencia (p≤0,045). Conclusión: el programa cognitivo-conductual fue eficaz para reducir los síntomas del tracto urinario inferior después de la prostatectomía radical. Registro Brasileño de Ensayos Clínicos: RBR-3sstqg.


RESUMO Objetivo: avaliar a efetividade de um programa cognitivo-comportamental para controle de sintomas do trato urinário inferior pós-prostatectomia radical. Método: estudo de ensaio clínico randomizado, com 41 participantes aleatorizados em intervenção (n=20) e controle (n=21), durante três meses. O grupo intervenção recebeu o programa cognitivo-comportamental, enquanto o grupo controle recebeu orientações de rotina do serviço. As variáveis desfechos foram intensidade da incontinência urinária e sintomas do trato urinário inferior, avaliados pelo Pad-Test e Urinary Incontinence Scale of Radical Prostatectomy e King's Health Questionnaire. Resultados: ao final do estudo, o grupo intervenção apresentou menor intensidade da incontinência urinária (p≤0,001), e houve menos chances de apresentar alterações da frequência urinária (p≤0,001), urgência miccional (p≤0,001), noctúria (p=0,005), incontinência urinária de esforço (p≤0,001) e urge-incontinência (p≤0,045). Conclusão: o programa cognitivo-comportamental foi efetivo para a redução de sintomas do trato urinário inferior após a prostatectomia radical. Registro Brasileiro de Ensaios Clínicos: RBR-3sstqg.

9.
Rev. bras. enferm ; 75(5): e20210355, 2022. tab, graf
Article in English | LILACS-Express | LILACS, BDENF | ID: biblio-1387774

ABSTRACT

ABSTRACT Objectives: to evaluate the effectiveness of carbohydrate popsicles, carbohydrate solution, and usual care (fasting) on the intensity and discomfort of preoperative thirst. Methods: a randomized clinical trial with 60 preoperative patients aged between 18 and 60 years, randomized into three groups: control (fasting), carbohydrate solution (100 ml), and carbohydrate popsicle (100 ml). The outcomes were thirst intensity and discomfort. Results: there was a difference between groups for final thirst intensity (p = 0.01) and final thirst discomfort (p = 0.001). The effect size for both the Solution Group and the Popsicle Group was robust: 0.99 and 1.14, respectively. Conclusions: the groups that received the carbohydrate fasting abbreviation showed a reduction in thirst discomfort compared to the control group. The carbohydrate popsicle proved more effective in reducing the intensity of thirst. NCT: 3.209.283


RESUMEN Objetivos: evaluar efectividad del polo de carbohidrato, solución de carbohidrato y cuidado usual (ayuno) sobre la intensidad e incomodidad de sed en el preoperatorio. Métodos: ensayo clínico randomizado, con 60 pacientes en el preoperatorio, edad entre 18 y 60 años, randomizados en tres grupos: control (ayuno); solución de carbohidrato (100 ml); polo de carbohidrato (100 ml). Los desfechos fueron la intensidad e incomodidad de sed. Resultados: hubo diferencia entre los grupos cuanto a la intensidad final de sed (p = 0,01) e incomodidad final de sed (p = 0,001). El tamaño del efecto tanto para el Grupo Solución cuanto para el Grupo Polo fue fuerte: 0,99 y 1,14, respectivamente. Conclusiones: los grupos que recibieron la abreviación del ayuno con carbohidrato presentaron reducción en la incomodidad de sed cuando comparados al grupo-control. El polo de carbohidrato se mostró más efectivo en la reducción de la intensidad de la sed. NCT: 3.209.283


RESUMO Objetivos: avaliar a efetividade do picolé de carboidrato, solução de carboidrato e cuidado usual (jejum) sobre a intensidade e desconforto da sede no pré-operatório. Métodos: ensaio clínico randomizado, com 60 pacientes no pré-operatório, idade entre 18 e 60 anos, aleatorizados em três grupos: controle (jejum); solução de carboidrato (100 ml); picolé de carboidrato (100 ml). Os desfechos foram a intensidade e o desconforto da sede. Resultados: houve diferença entre os grupos quanto à intensidade final da sede (p = 0,01) e ao desconforto final da sede (p = 0,001). O tamanho do efeito tanto para o Grupo Solução quanto para o Grupo Picolé foi forte: 0,99 e 1,14, respectivamente. Conclusões: os grupos que receberam a abreviação do jejum com carboidrato apresentaram redução no desconforto da sede quando comparados ao grupo-controle. O picolé de carboidrato mostrou-se mais efetivo na redução da intensidade da sede. NCT: 3.209.283

10.
Rev. gaúch. enferm ; 43: e20210127, 2022. tab, graf
Article in English | LILACS-Express | LILACS, BDENF | ID: biblio-1389113

ABSTRACT

ABSTRACT Objective To evaluate the clinical, obstetric, maternal and perinatal effects of the use of flower essences in labor, against factors that enhance it. Method Clinical trial, randomized, controlled, in 164 parturients divided into two groups, flower essences and placebo, respectively, evaluated before and after the intervention. Carried out in a vaginal delivery center, in the city of São Paulo, from May to October 2018. Data were analyzed using descriptive statistics, Student's t test, bilateral hypothesis, negative and positive observed critical t, Pearson's chi-square, exact test. Fisher. Results It was observed in the Experimental Group, moderate increase in systolic blood pressure (p=0.046), frequency (p=0.055) and intensity of contractions (p=0.031), as well as a reduction in time to birth (194 minutes), higher number of vaginal deliveries (p=0.038) and better pattern of fetal vitality. Conclusion There was evidence of a positive action of the Floral Essence on the potentiating factors of labor, being effective in maternal clinical and obstetrical repercussions, as well as perinatal ones.


RESUMEN Objetivo Evaluar los efectos clínicos, obstétricos, maternos y perinatales del uso de esencias florales en el parto, frente a factores que lo potencian. Método Ensayo clínico, aleatorizado, controlado, en 164 parturientas divididas en dos grupos, esencias florales y placebo, respectivamente, evaluadas antes y después de la intervención. Realizado en un centro de parto vaginal, en la ciudad de São Paulo, de mayo a octubre de 2018. Los datos fueron analizados mediante estadística descriptiva, prueba t de Student, hipótesis bilateral, t crítica observada negativa y positiva, chi-cuadrado de Pearson, prueba exacta. Pescador. Resultados Se observó en el Grupo Experimental, aumento moderado de la presión arterial sistólica (p = 0,046), frecuencia (p = 0,055) e intensidad de las contracciones (p = 0,031), así como una reducción del tiempo hasta el nacimiento (194 minutos), mayor número de partos vaginales (p = 0,038) y mejor patrón de vitalidad fetal. Conclusión Se evidenció una acción positiva de la Esencia Floral sobre los factores potenciadores del parto, siendo efectiva en las repercusiones clínicas y obstétricas maternas, así como perinatales.


RESUMO Objetivo Avaliar os efeitos clínicos, obstétricos maternos e perinatais com o uso de essências florais no trabalho de parto, frente a fatores que o potencializam. Método Ensaio clínico, randomizado, controlado, em 164 parturientes divididas em dois grupos, essências florais e placebo, respectivamente, avaliadas pré e pós intervenção. Realizado em centro de parto normal, na cidade de São Paulo, de maio a outubro de 2018. Os dados foram analisados por estatística descritiva, teste t de Student hipótese bilateral, t crítico observado negativo e positivo, Qui-quadrado de Pearson, Exato de Fisher. Resultados Observou-se no Grupo Experimental, moderada elevação da pressão arterial sistólica (p=0,046) da frequência (p=0,055) e intensidade das contrações (p=0,031), assim como, redução do tempo ao nascimento (194 minutos), maior número de partos vaginais (p=0,038) e melhor padrão de vitalidade fetal. Conclusão Evidenciou-se ação positiva da Essência Floral perante os fatores potencializadores do trabalho de parto, sendo efetiva nas repercussões clínicas e obstétricas maternas, bem como perinatais.

11.
Psico (Porto Alegre) ; 53(1): 36259, 2022.
Article in Portuguese | LILACS | ID: biblio-1368243

ABSTRACT

O método experimental (ME) envolve um conjunto de procedimentos que podem ser utilizados por várias ciências para responder questões de pesquisa, refutar ou corroborar hipóteses. No presente trabalho, conduzimos uma revisão sistemática de artigos de revisão publicados em português que tiveram como foco explicar o ME. Utilizamos as bases de dados SciELO e Google Acadêmico, sem restringir a data de publicação dos artigos. Incluímos 64 artigos após a aplicação dos critérios de elegibilidade. Por meio da análise de conteúdo, sintetizamos informações desses artigos que favorecem a condução de estudos experimentais e a avaliação crítica de seus métodos. Adicionalmente, apontamos lacunas como a carência de artigos sobre estatística aplicada ao ME e uso de técnicas qualitativas.


The experimental method (EM) involves a set of procedures that can be used by different sciences to answer research questions, refute or corroborate hypotheses. In the present work, we conducted a systematic review of review articles published in Portuguese that focused on explaining the EM. We use the SciELO and Google Scholar databases, without restricting the articles publication date. We included 64 articles after applying the eligibility criteria. Using content analysis, we synthesized information from these articles that favor the conduction of experimental studies and the critical evaluation of their methods. Additionally, we point out gaps such as the lack of papers on statistics applied to the EM and the use of qualitative techniques.


El método experimental (ME) implica un conjunto de procedimientos que pueden ser utilizados por diferentes ciencias para responder preguntas de investigación, refutar o corroborar hipótesis. En el presente trabajo, realizamos una revisión sistemática de artículos de revisión publicados en portugués que se centraron en explicar el ME. Utilizamos las bases de datos SciELO y Google Académico, sin restringir la fecha de publicación de los artículos. Incluimos 64 artículos después de aplicar los criterios de elegibilidad. Mediante el análisis de contenido, sintetizamos información de estos artículos que favorecen la realización de estudios experimentales y la evaluación crítica de sus métodos. Además, señalamos lagunas, como la carencia de artículos sobre estadísticas aplicadas a él ME y el uso de técnicas cualitativas.


Subject(s)
Science , Research , Clinical Trial
12.
Article in Chinese | WPRIM | ID: wpr-927403

ABSTRACT

The paper introduces the placebo acupuncture simulation devices commonly used in clinical trial of acupuncture therapy. These devices are composed of Streitberger, Park, Takakura, Foam and Phantom acupuncture. Because acupuncture therapy is a kind of complex intervention, there are the controversies in methodology for the acupuncture placebo control of clinical trial. Placebo acupuncture may be an effective control, with a certain of specific therapeutic effect. The blinding effect of placebo acupuncture is highly questioned, specially, the sensation of deqi is hardly imitated during acupuncture. On these grounds, in this research, the suggestions has been proposed on the selection and the setting of placebo control in clinical trial of acupuncture therapy.


Subject(s)
Acupuncture , Acupuncture Therapy/methods , Sensation
13.
Article in Chinese | WPRIM | ID: wpr-927382

ABSTRACT

The paper introduced the experiences of quality management in the implementation of multi-center acupuncture clinical trials and the keys in training acupuncture operators. The process management was explained in view of the division of labor for researchers, protocol learning and the communication among sub-centers. Besides, specificity links of acupuncture research were summarized, i.e. meaning implementation brief of acupuncture operation training, control for quantity of stimulus in acupuncture and doctor-patient communication. It is anticipated to provide a valuable reference for the quality control and improvement of multi-center acupuncture clinical trial in future.


Subject(s)
Acupuncture Therapy , Clinical Trials as Topic , Humans , Multicenter Studies as Topic , Quality Control
14.
Journal of Clinical Hepatology ; (12): 1398-1401, 2022.
Article in Chinese | WPRIM | ID: wpr-924721

ABSTRACT

Nonalcoholic steatohepatitis (NASH) can cause end-stage liver diseases such as liver cirrhosis and liver cancer, and therefore, it is urgent to treat NASH, reverse hepatic steatosis, and delay the onset of end-stage liver diseases. NASH has a complex pathogenesis and there are currently no effective drugs for treatment. At present, new drugs still have huge market potential and are the research hotspots of various pharmaceutical companies in China and globally. This article mainly reviews and summarizes the clinical research status, drug types, mechanism of action, and future market prospects of the new drugs for NASH in existing phase Ⅲ studies.

15.
Journal of Clinical Hepatology ; (12): 1387-1392, 2022.
Article in Chinese | WPRIM | ID: wpr-924719

ABSTRACT

At present, antiviral therapy for chronic hepatitis B (CHB) has a low clinical cure rate and hardly remove cccDNA. With the progress of medical science, more and more new drugs are in the stage of research and development. This article focuses on the research and development of representative drugs with relatively detailed clinical trial data. Rapid progress has been made in the new drugs such as small-interfering RNA and core protein allosteric modulators in recent years. The results of clinical trials show that it still takes some time for new drugs to enter clinical use, and multi-drug combination therapy may become the trend of treatment in the future.

16.
Article in Japanese | WPRIM | ID: wpr-924394

ABSTRACT

A crossover study was conducted to evaluate suppressive effect of a commercially available green juice (Katuna-Aojiru;Egao Co., Ltd.) containing mulberry leaf powder as the main ingredient on postprandial hyperglycemia. The blood glucose and iAUC (0-120min) values after loading cooked white rice were significantly lower with the consumption of Katuna-Aojiru than with the consumption of water. Katuna-Aojiru is effective in controlling postprandial blood glucose.

17.
Article in Chinese | WPRIM | ID: wpr-923447

ABSTRACT

@#Heart failure affects quality of life and life expectancy of tens of millions of individuals. There are no available economic and effective treatments for end-stage heart failure. Hydrogels are novel tissue engineering materials, which have the potential to ameliorate myocardium remodeling, increase cardiac output, improve quality of life and prolong life span by implantation into myocardium. The preclinical experiments and clinical trials have greatly explored the function of hydrogels in heart failure. In this review, we summarized the approaches of implantation, mechanism and clinical outcomes of the hydrogels.

18.
Journal of Clinical Hepatology ; (12): 798-804, 2022.
Article in Chinese | WPRIM | ID: wpr-923281

ABSTRACT

Objective To describe the characteristics and registration status of clinical trials of new drugs for nonalcoholic steatohepatitis (NASH), and to provide a reference for the design and implementation of clinical trials of new drugs for NASH. Methods The U.S. Clinical Trials Database, China Clinical Trial Registry, and Center for Drug Evaluation, National Medical Products Administration, were searched for clinical trials of new drug registration and interventional studies with NASH as the indication published up to August 6, 2021, using NASH in English and Chinese characters as the keywords, and liver cirrhosis was excluded. Two researchers independently searched and screened the articles to extract relevant information. Results A total of 196 clinical trials of new drug registration or interventional studies for NASH were included, among which there were 174 trials registered abroad and 22 trials registered in China, and the number of registrations tended to increase year by year. The numbers of phase Ⅰ, phase Ⅰ/Ⅱ(including Ⅰb/Ⅱa), phase Ⅱ, phase Ⅱ/Ⅲ, and phase Ⅲ clinical trials were 45(23.0%), 8(4.1%), 112(57.1%), 4(2.0%), and 19(9.7%), respectively. The main drug types included farnesoid X receptors, fibroblast growth factors, peroxisome proliferator-activated receptor agonists, and glucagon-like peptide-1, with numbers of 16(8.16%), 14(7.14%), 11(5.61%), and 13(6.63%), respectively. The clinical trials of innovative drugs for NASH initiated by the sponsors in European and American regions accounted for the highest proportion, and there was a gradual increase in the number of clinical trials of innovative drugs in China in recent years, with a similar distribution of single-center and multicenter clinical trials. As for the trials with NASH patients as subjects, the numbers of trials with pathology, imaging, and clinical diagnosis as the main inclusion criteria were 125, 66, and 42, respectively. Phase Ⅰ clinical trials used safety, tolerability, and pharmacokinetic parameters as the main assessment indices, while phase Ⅱ and phase Ⅲ clinical trials often used safety and efficacy as the main assessment indices. The number of clinical trials for the registration of innovative drugs for NASH was relatively low but kept increasing in China, and there were fewer clinical trials of innovative traditional Chinese medicine drugs compared with innovative chemical drugs. Conclusion There is a significant increase in the registration of international clinical trials of innovative drugs for NASH, and most of these trials are in the early phases, with large differences in inclusion criteria and assessment indices, a lack of unified evaluation indices, and relatively few trials with new designs. There are fewer clinical trials of innovative drugs for NASH in China than in European and American countries, and the number of such trials is gradually increasing in China.

19.
Acta Pharmaceutica Sinica ; (12): 287-295, 2022.
Article in Chinese | WPRIM | ID: wpr-922905

ABSTRACT

Diabetic retinopathy (DR), one of the common complications of diabetes, is the main cause of blindness. Due to the limitations of the existing clinical treatment methods, it is urgent to develop new targets or/and new therapeutic drugs. This review summarizes the clinical trials of anti-DR drugs in recent years, and we note that gene therapy is a potential direction for DR treatment development. Due to the characteristics of ocular structure, including small size, a relatively independent organ, immune privilege and the opportunity for local administration, gene therapy could well be advantageous in the treatment of DR. Furthermore, the long-term therapeutic effects of gene therapy also improve compliance by DR patients. All these indicate that gene therapy is likely a future direction for development of DR therapies.

20.
Braz. oral res. (Online) ; 36: e066, 2022. tab, graf
Article in English | LILACS-Express | LILACS, BBO | ID: biblio-1374751

ABSTRACT

Abstract: The purpose of this review was to systematically evaluate all the existing literature on the efficacy of treatments used to relieve the signs and symptoms associated with teething. A systematic search up to February 2021, without restrictions on language or date of publication, was carried out in MEDLINE/PubMed, SCOPUS, Web of Science, The Cochrane Library, EMBASE, LILACS, BBO, OpenGrey, Google Scholar, Portal de Periódicos da CAPES, clinicaltrials.gov, and the references of the included studies. Clinical studies that evaluated the effect of any intervention to alleviate the signs and symptoms associated with teething in babies and children were included. The risk of bias was assessed using the ROB-2 and ROBINS-I tools. The characteristics and results of the individual studies were extracted and synthesized narratively. The GRADE approach was followed to rate the certainty of the evidence. Three randomized and two non-randomized clinical trials were included. The outcomes of these five articles were classified as high or serious risk of bias. Three studies using homeopathy reported improvement in appetite disorders, gum discomfort, and excess salivation. One study showed a new gel with hyaluronic acid was more effective than an anesthetic gel in improving signs and symptoms such as pain, gingival redness, and poor sleep quality. Another study applied non-pharmacological treatments, which were more effective, especially against excess salivation. Although the present systematic review suggests some therapies could have a favorable effect on signs and symptoms related to teething, definitive conclusions on their efficacy cannot be drawn because of the very low certainty of the evidence. The existing literature on the subject is scarce and heterogeneous and has methodological flaws; therefore, further high-quality investigations are necessary.

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