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1.
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.

2.
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
3.
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.

4.
J. vasc. bras ; 21: e20210101, 2022. tab
Article in Portuguese | LILACS-Express | LILACS | ID: biblio-1360564

ABSTRACT

Resumo Contexto A gravidez é caracterizada por mudanças fisiológicas que podem contribuir para o desenvolvimento de varizes, insuficiência venosa e edema das pernas. Objetivos Avaliar o efeito das meias de compressão em edema de membros inferiores e a percepção sobre o uso por gestantes. Métodos Trata-se de um ensaio clínico randomizado, controlado, prospectivo, paralelo e cego realizado com 60 mulheres grávidas distribuídas aleatoriamente em dois grupos: grupo intervenção (n = 30), que usou meias de compressão, e grupo controle (n = 30). Foram realizadas medições padronizadas de tornozelo e panturrilha, empregando-se fita métrica, em todos os 120 membros inferiores. No final do estudo, foi aplicado também um questionário para verificação das dificuldades e vantagens percebidas com relação ao uso das meias de compressão. Resultados As gestantes do grupo intervenção apresentaram aumento significativamente menor (p < 0,05) nos diâmetros de panturrilha e tornozelo em relação ao grupo controle. As diferenças médias, no início e no final da gestação, nos diâmetros de panturrilha direita, panturrilha esquerda, tornozelo direito e tornozelo esquerdo foram de, respectivamente, 0,30 cm, 0,30 cm, 0,15 cm e 0,15 cm no grupo intervenção e 1,95 cm, 1,95 cm, 1,73 cm e 1,87 cm no grupo controle. A maioria das gestantes não teve dificuldade para utilizar as meias de compressão, e todas relataram que sentiram diferença nos sintomas das pernas e que usariam as meias novamente. Conclusões As meias de compressão foram eficazes na prevenção de edema em membros inferiores de gestantes, as quais apresentaram percepção positiva quanto à sua utilização.


Abstract Background Pregnancy is characterized by physiological changes that can contribute to development of varicose veins, venous insufficiency, and leg edema. Objectives To evaluate the effect of compression stocking on lower limb edema in pregnant women and their perceptions of wearing them. Methods This was a randomized, controlled, prospective, parallel, blinded clinical trial conducted with 60 pregnant women randomly distributed into two groups: an intervention group (n = 30) wearing compression stockings and a control group (n = 30). Standardized ankle and calf measurements were taken of all 120 lower limbs using a tape measure. At the end of the study, a questionnaire was administered to identify perceived difficulties and advantages related to wearing compression stockings. Results Pregnant women in the intervention group had a significantly smaller increase (p < 0.05) in calf and ankle diameters compared to those in the control group. The mean differences from the beginning to the end of gestation in the diameters of the right calf, left calf, right ankle, and left ankle respectively were 0.30 cm, 0.30 cm, 0.15, cm and 0.15 cm in the intervention group and 1.95 cm, 1.95 cm, 1.73 cm, and 1.87 cm in the control group. Most of the pregnant women had no difficulty wearing the compression stockings and all reported that they felt a difference in leg symptoms and would wear stockings again. Conclusions Compression stockings were effective for preventing lower limb edema in pregnant women, who had a positive perception of wearing them.

5.
Texto & contexto enferm ; 31: e20210018, 2022. tab, graf
Article in English | LILACS, BDENF | ID: biblio-1361172

ABSTRACT

ABSTRACT Objective: to evaluate knowledge, attitude and practice about Gestational Hypertensive Syndrome among pregnant women, after an educational intervention. Method: a controlled, randomized and longitudinal clinical trial, related to the Knowledge, Attitude and Practice survey on Gestational Hypertensive Syndrome complications, carried out with 120 pregnant women at a public maternity hospital in Fortaleza-CE, Brazil. Data collection was performed at three moments and the pregnant women were separated into two groups with 60 participants each. For quantitative comparisons, the Student's t test or the Mann-Whitney's test were applied. To study qualitative associations, the Chi-square or Fisher's exact tests were employed. Results: adequate assessment of knowledge, attitude and practice was identified in the intervention group, on the seventh and thirtieth days after the intervention (p<0.05), with an increased chance of adequate knowledge on the seventh (Odds Ratio=6.63 - Confidence Interval: 3.5-12.55) and on the thirtieth (Odds Ratio=6.25 - Confidence Interval: 3.13-12.50) days. In this group, the attitude was adequate on the seventh (Odds Ratio=6.11 - Confidence Interval: 3.28-11.39) and on the thirtieth (Odds Ratio=6.44 - Confidence Interval: 3.49-11.89) days. The practice was also adequate on the seventh (Odds Ratio=3.73 - Confidence Interval: 2.21-6.28) and on the thirtieth (Odds Ratio=4.91 - Confidence Interval: 2.90-8.32) days. Conclusion: the pregnant women who participated in the educational intervention presented more adequacy in relation to knowledge, attitude and practice, when compared to those in the control group. Brazilian Registry of Clinical Trials (Registro Brasileiro de Ensaios Clínicos, REBEC) RBR-8wyp8j


RESUMEN Objetivo: evaluar el conocimiento, la actitud y la práctica sobre el Síndrome Hipertensivo Gestacional entre mujeres embarazadas, después de una intervención educativa. Método: ensayo clínico controlado, aleatorizado y longitudinal, relacionado con la encuesta de Conocimiento, Actitud y Práctica sobre complicaciones del Síndrome Hipertensivo Gestacional, realizado con 120 mujeres embarazadas en una maternidad pública de Fortaleza-CE, Brasil. La recolección de datos tuvo lugar en tres momentos y se separó a las mujeres embarazadas en dos grupos de 60 participantes cada uno. Para las comparaciones cuantitativas, se aplicó la prueba t de Student o la de Mann-Whitney. Para estudiar las asociaciones cualitativas, se empleó la prueba de Chi-cuadrado o la prueba exacta de Fisher. Resultados: se identificó una evaluación adecuada del conocimiento, la actitud y la práctica en el grupo intervención, a los siete y treinta días posteriores a las intervenciones (p<0,05), con un incremento en la probabilidad de conocimiento adecuado al día siete (Odds Ratio=6,63 - Intervalo de Confianza: 3,5-12,55) y al día treinta (Odds Ratio=6,25 - Intervalo de Confianza: 3,13 - 12,50). En este grupo, la actitud fue adecuada al día siete (Odds Ratio=6,11 - Intervalo de Confianza: 3,28 -11,39) y al día treinta (Odds Ratio=6,44 - Intervalo de Confianza: 3,49-11,89). La práctica también resultó adecuada al día siete (Odds Ratio=3,73 - Intervalo de Confianza: 2,21-6,28) y al día treinta (Odds Ratio=4,91 - Intervalo de Confianza: 2,90-8,32). Conclusión: las mujeres embarazadas que participaron en la intervención educativa presentaron más adecuación en relación con el conocimiento, la actitud y la práctica, en comparación las participantes del grupo control. Registro Brasileño de Ensayos Clínicos (REBEC) RBR-8wyp8j


RESUMO Objetivo: avaliar conhecimento, atitude e prática sobre Síndrome Hipertensiva Gestacional entre gestantes, após intervenção educativa. Método: ensaio clínico controlado, randomizado e longitudinal, relacionado ao inquérito Conhecimento, Atitude e Prática sobre complicações da Síndrome Hipertensiva Gestacional, realizado em maternidade pública de Fortaleza-CE, Brasil, com 120 gestantes. A coleta de dados foi realizada em três momentos e as gestantes separadas em dois grupos com 60 participantes cada. Para comparações quantitativas, aplicou-se o teste t de Student ou Mann-Whitney. Para estudar associações qualitativas, empregou-se o teste Qui-quadrado ou exato de Fisher. Resultados: identificou-se avaliação adequada do conhecimento, da atitude e prática no grupo intervenção, no sétimo e trigésimo dia pós-intervenção (p<0,05), com aumento de chance para o conhecimento adequado no sétimo (Odds Ratio=6,63 - Intervalo de Confiança: 3,5-12,55) e no trigésimo dia (Odds Ratio=6,25 - Intervalo de Confiança: 3,13 - 12,50). Neste grupo, a atitude foi adequada no sétimo (Odds Ratio= 6,11 - Intervalo de Confiança: 3,28-11,39) e no trigésimo dia (Odds Ratio=6,44 - Intervalo de Confiança: 3,49-11,89). Prática também adequada no sétimo (Odds Ratio=3,73 - Intervalo de Confiança: 2,21-6,28) e trigésimo dia (Odds Ratio=4,91 - Intervalo de Confiança: 2,90-8,32). Conclusão: as gestantes que participaram da intervenção educativa apresentaram mais adequabilidade em relação ao conhecimento, à atitude e prática, quando comparadas às participantes do grupo controle. Registro Brasileiro de Ensaios Clínicos (REBEC) RBR-8wyp8j


Subject(s)
Humans , Female , Pregnancy , Health Knowledge, Attitudes, Practice , Health Education , Clinical Trial , Educational Technology , Knowledge , Pregnant Women , Hypertension, Pregnancy-Induced , Controlled Clinical Trial
6.
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
7.
Estima (Online) ; 19(1): e0621, jan.-dez. 2021. tab, ilus
Article in English, Portuguese | LILACS, BDENF | ID: biblio-1255201

ABSTRACT

Objetivo:avaliar taxa de cicatrização em úlceras do pé diabético tratadas com biomembrana de proteínas do látex de Calotropis procera (BioMem CpLP) quando comparada ao hidrocoloide em pó. Método: ensaio clínico randomizado controlado, registrado pelo Registro Brasileiro de Ensaio Clínico (REBEC), conforme protocolo RBR-98f3j9, realizado junto a oito pessoas com pé diabético, em ambulatório de pé diabético, de março a julho de 2019. No grupo experimental (n=04), realizou-se a aplicação de biomembrana; no grupo controle (n=04), utilizou-se o pó de hidrocoloide. A taxa de cicatrização foi avaliada com 30 e 60 dias após início do tratamento. Resultados: não se constataram diferenças estatísticas entre taxas de cicatrização do grupo controle e do grupo experimental na análise temporal dos 30 dias iniciais (p=0,726) e nos 60 dias subsequentes ao início do tratamento (p=0,562). Conclusão: a BioMem CpLP apresentou taxas de cicatrização semelhantes ao produto convencional, configurando-se como alternativa eficaz e de baixo custo para o tratamento de pés diabéticos.


Objective:to evaluate the rate of healing in diabetic foot ulcers treated with a biomembrane of latex proteins from Calotropis procera (BioMem CpLP) when compared to powdered hydrocolloid. Method: randomized controlled clinical trial, registered by the Brazilian Clinical Trial Registry (REBEC), according to protocol RBR-98f3j9, carried out with eight people with diabetic foot, in a diabetic foot clinic, from March to July 2019. In the experimental group (n = 04), biomembrane was applied; in the control group (n = 04), hydrocolloid powder was used. The healing rate was assessed at 30 and 60 days after starting treatment. Results: no statistical differences were found between the healing rates of the control group and the experimental group in the temporal analysis of the initial 30 days (p = 0.726) and in the 60 days following the start of treatment (p = 0.562). Conclusion: BioMem CpLP presented healing rates similar to the conventional product, being an effective and low cost alternative for the treatment of diabetic feet.


Subject(s)
Wound Healing , Nursing , Randomized Controlled Trial , Diabetic Foot
8.
Int. braz. j. urol ; 47(6): 1150-1159, Nov.-Dec. 2021. tab, graf
Article in English | LILACS | ID: biblio-1340025

ABSTRACT

ABSTRACT Purpose: To evaluate the efficacy of intravaginal electrical stimulation (IVES) added to bladder training (BT) on incontinence-related quality of life (QoL) and clinical parameters in women with idiopathic overactive bladder (OAB). Materials and Methods: Sixty-two women with idiopathic OAB were randomized into two groups using the random numbers generator as follows: Group 1 received BT alone (n:31), and Group 2 received BT+IVES (n:31). IVES was performed for twenty minutes three days a week over a course of eight weeks for a total of 24 sessions. Patients were evaluated in terms of incontinence severity (24-hour pad test), pelvic floor muscles strength (perineometer), 3-day voiding diary (frequency of voiding, nocturia, incontinence episodes and number of pads), symptom severity (OAB-V8), incontinence-related QoL (IIQ-7), treatment success (positive response rate), cure/improvement rate and treatment satisfaction (Likert scale). Results: A statistically significant improvement was found in all parameters for all groups at the end of the treatment compared to the baseline values except pelvic floor muscles strength in Group 1 (p <0.05). At the end of treatment, incontinence severity, frequency of voiding, nocturia, incontinence episodes, number of pads, symptom severity, and QoL were significantly improved in Group 2 compared to Group 1 (p <0.05). Treatment satisfaction, cure/improvement, and positive response rates were significantly higher in group 2 compared to Group 1 (p <0.05). Conclusion: We conclude that BT+IVES were more effective than BT alone on both incontinence-related QoL and clinical parameters in women with idiopathic OAB.


Subject(s)
Humans , Female , Urinary Bladder, Overactive/therapy , Quality of Life , Prospective Studies , Surveys and Questionnaires , Pelvic Floor , Electric Stimulation
9.
Rev. peru. med. exp. salud publica ; 38(4): 634-642, oct.-dic. 2021. tab, graf
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1365939

ABSTRACT

RESUMEN El desarrollo y producción de vacunas seguras y eficaces contra la enfermedad por coronavirus 2019 (COVID-19) ofrece la esperanza para el control de la pandemia actual. Los eventos adversos posteriores a la inmunización son respuestas indeseadas o acontecimientos involuntarios que siguen a la vacunación, y que deben ser cuidadosamente vigilados, ya que todas las vacunas, incluyendo las desarrolladas contra el SARS-CoV-2, requieren cumplir con los criterios de seguridad para su administración en humanos. Se recopiló la información de la base de datos de PubMed/Medline durante los meses de agosto de 2020 a noviembre de 2021. La mayoría de los eventos adversos identificados en los ensayos clínicos fueron leves o moderados; sin embargo, se identificaron eventos trombóticos asociados a algunas vacunas basadas en vectores virales contra la COVID-19 en estudios de seguimiento, aunque se requiere la conclusión de los distintos estudios en curso y vigilancia poscomercialización para determinar todos los posibles eventos adversos y de especial interés.


ABSTRACT The development and production of safe and effective vaccines against coronavirus disease 2019 (COVID-19) provides hope for controlling the current pandemic. Adverse events following immunization are unwanted responses or unintended events that must be carefully monitored, as all vaccines, including those developed against SARS-CoV-2, are required to meet safety criteria for administration in humans. Information was collected from the PubMed/Medline database during the months of August 2020 to November 2021. Most adverse events reported in clinical trials were mild or moderate; however, thrombotic events associated with some viral vector-based vaccines against COVID-19 were identified in follow-up studies, although completion of the various ongoing studies and post-marketing surveillance is required to determine all potential adverse events, as well as those of special interest.

10.
Horiz. meÌüd. ; 21(4): e1276, oct.-dic. 2021. tab, graf
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1356249

ABSTRACT

RESUMEN La capacidad de propagación y letalidad del SARS-CoV-2 en todo el mundo motiva la urgente necesidad de desarrollar una estrategia terapéutica apropiada para controlar los casos de COVID-19. El desarrollo de nuevos fármacos frente a este nuevo virus es apremiante debido a su rápida diseminación. Se han propuesto alternativas paralelas empleando fármacos ya disponibles para fines similares. Esta revisión describe el potencial antiviral de la ivermectina, así como sus mecanismos de acción frente a algunos virus, y discute su probable aplicación contra el SARS-CoV-2.


ABSTRACT The global spread and lethality of SARS-CoV-2 prompt the urgent need to develop an appropriate therapeutic strategy to control COVID-19 cases. The development of new drugs to fight this novel virus is urgent due to its rapid spread. Parallel alternatives have been proposed by using drugs already available for similar purposes. This review article describes the antiviral potential of ivermectin as well as its mechanisms of action against some viruses, and discusses its probable use to fight SARS-CoV-2.

11.
Fisioter. Pesqui. (Online) ; 28(4): 483-490, out.-dez. 2021. graf
Article in Portuguese | LILACS-Express | LILACS | ID: biblio-1364868

ABSTRACT

RESUMO O objetivo deste estudo foi propor um protocolo de ensaio clínico randomizado para avaliar o efeito da reabilitação robótica sobre a funcionalidade de pacientes com acidente vascular cerebral (AVC) subagudo. Trata-se de um protocolo de um ensaio clínico randomizado que será desenvolvido no hospital e centro de reabilitação do Pavilhão Pereira Filho da Irmandade da Santa Casa de Misericórdia de Porto Alegre (ISCMPA). Quarenta pacientes com AVC, de ambos os sexos, com idades entre 18 e 85 anos e que apresentem hemiparesia ou fraqueza muscular (Medical Research Council - MRC <48 pontos) serão divididos aleatoriamente em grupo controle ou grupo de intervenção. O grupo de intervenção será aquele que realizará reabilitação robótica utilizando equipamento Erigo®, além da fisioterapia convencional, e o grupo controle receberá fisioterapia convencional por meio de exercícios com movimentos semelhantes aos realizados no robô. As intervenções ocorrerão todos os dias na fase hospitalar e, após a alta, três vezes por semana, totalizando aproximadamente 18 sessões. A funcionalidade será considerada o desfecho primário do estudo e será avaliada por meio da escala de Fugl-Meyer. Consideramos como desfechos secundários a força muscular (MRC e teste de repetição máxima), espasticidade (escala de Ashworth modificada), arquitetura do músculo quadríceps e ecogenicidade (ultrassom), mobilidade (teste timed up and go), grau de incapacidade e dependência (escala de Rankin e de medida de independência funcional), qualidade de vida (questionário EQ-5D), repercussões cardiorrespiratórias (monitoramento de sinais vitais), tempo de internação (em dias) e mortalidade (número de óbitos). Os grupos serão avaliados antes das intervenções, após a décima sessão e ao final de seis semanas de tratamento ou 18 sessões.


ABSTRACT The aim of this study was to propose a randomized clinical trial protocol to evaluate the effect of robotic rehabilitation on the functionality of patients with subacute stroke. This is a protocol of a randomized clinical trial that will be developed at hospital and rehabilitation center of Pavilhão Pereira Filho of ISCMPA. We will recruit 40 patients with stroke, all genders, aged between 18 and 85 years and showing hemiparesis or muscle weakness (Medical Research Council- MRC<48 points), who will be randomized to a control group or intervention group. The intervention group-besides conventional physical therapy-will perform robotic rehabilitation using Erigo® equipment. The control group, in its turn, will receive conventional physical therapy executing exercises with similar movements to those performed on the robot. Interventions will occur every day during hospital phase and three times/week after discharge, totaling approximately 18 sessions. Functioning will be considered the primary outcome of the study and will be assessed using the Fugl-Meyer scale. As secondary outcomes, we considered: muscle strength (MRC and maximum repetition test); spasticity (modified Ashworth scale); quadriceps muscle architecture and echogenicity (ultrasound); mobility (timed up go test); degree of disability and dependence (Rankin scale and Functional Independence Measure); quality of life (EQ-5D questionnaire); cardiorespiratory repercussions (monitoring vital signs); length of hospital stay (in days); and mortality (number of deaths). The groups will be evaluated before the interventions, after the 10th session, and at the end of six weeks of treatment or 18 sessions.


RESUMEN El objetivo de este estudio fue proponer un protocolo de ensayo clínico aleatorizado para evaluar el efecto de la rehabilitación robótica en la funcionalidad de pacientes con accidente cerebrovascular subagudo. Se trata de un protocolo de ensayo clínico aleatorizado que será desarrollado en el hospital y centro de rehabilitación del Pavilhão Pereira Filho da Irmandade de la Santa Casa de Misericórdia de Porto Alegre (ISCMPA). Se asignarán aleatoriamente a cuarenta pacientes con ACV, de ambos sexos, con edades entre 18 y 85 años, que presenten hemiparesia o debilidad muscular (Medical Research Council - MRC <48 puntos) a un grupo de control o grupo de intervención. El grupo de intervención realizará rehabilitación robótica utilizando la herramienta Erigo® y fisioterapia convencional, mientras que el grupo de control recibirá fisioterapia convencional mediante ejercicios con movimientos similares a los realizados en el robot. Las intervenciones se realizarán todos los días durante la fase hospitalaria y, tras el alta, tres veces por semana, totalizando aproximadamente 18 sesiones. La funcionalidad se considerará el resultado primario del estudio y se evaluará mediante la escala de Fugl-Meyer. Se consideraron como resultados secundarios la fuerza muscular (MRC y test de máxima repetición), la espasticidad (escala de Ashworth modificada), la arquitectura del músculo cuádriceps y ecogenicidad (ultrasonido), la movilidad (test timed up and go), el grado de discapacidad y dependencia (escala de Rankin y medida de independencia funcional), la calidad de vida (cuestionario EQ-5D), la repercusión cardiorrespiratoria (seguimiento de constantes vitales), la estancia hospitalaria (en días) y la mortalidad (número de defunciones). Los grupos serán evaluados antes de las intervenciones, después de la décima sesión y al final de las seis semanas de tratamiento, es decir, 18 sesiones.

12.
Cuad. Hosp. Clín ; 62(1): 111-118, jun. 2021. ilus
Article in Spanish | LILACS | ID: biblio-1284364

ABSTRACT

La importancia de la investigación científica referida a la definición de la anemia por deficiencia de hierro en altitud, se relaciona con los hallazgos de los estudios realizados y que permiten avanzar al conocimiento científico, en poblaciones vulnerables, siendo que están dirigidos a mejorar la salud pública e influir en políticas de salud. Se presenta el análisis y reflexión de una innovadora modalidad para nuestro medio de altitud, basada en la suplementación con hierro y folatos para definir anemia en la población estudiada, situación que difiere de investigaciones previas sobre el tema en nuestro contexto de altitud. Estos estudios han tenido un escrutinio intenso de parte de los revisores que han valorado las publicaciones sobre anemia ferropénica a gran altitud. La claridad de los diseños de ensayos clínicos formales y controlados aleatorizados, pertinentes en tiempo y necesarios por su importancia fueron realizados, en regiones de altitud de Bolivia. La falta de reconocimiento por terceros de este nivel de evidencia logrado, equivaldría a sustituirlos por estudios de ensayos no formales y no controlados, es decir seguir aplicando diseños de tipo observacional, con contrastación teórica y lógica que solo incrementan el estado de incertidumbre sobre el tema en Bolivia. El sumario presentado de la historia sobre la anemia ferropénica en regiones de altitud en Bolivia nos permite reflexiones importantes, a saber: 1. Es importante resaltar, como claro ejemplo, que la observación simple puede llevar a la incertidumbre y lo costoso de sus consecuencias futuras por la persistencia de la anemia ferropénica en poblaciones de altitud, más aún si se mantiene el posible manejo de prueba y error en resultados difundidos. 2. Se demuestra la necesidad de los controles en la investigación científica, y finalmente 3. Los ensayos clínicos controlados aleatorizados son la mejor fuente de evidencia confiable.


The importance of scientific research related to the definition of iron deficiency anemia at altitude is related to the findings of the studies carried out and that allow advancing scientific knowledge, in vulnerable populations, being that they are aimed at improving public health and influence health policies. The analysis and reflection of an innovative modality for our altitude environment is presented, based on supplementation with iron and folates to define anemia in the studied population, a situation that differs from previous research on the subject in our altitude context. These studies have received intense scrutiny from reviewers who have evaluated the publications on high altitude iron deficiency anemia. The clarity of the designs of formal and randomized controlled clinical trials, pertinent in time and necessary due to their importance, were carried out in highland regions of Bolivia. The lack of recognition by third parties of this level of evidence achieved, would be equivalent to replacing them with studies of non-formal and uncontrolled trials, that is, to continue applying observational designs, with theoretical and logical contrast that only increase the state of uncertainty on the subject in Bolivia. The summary presented of the history of iron deficiency anemia in high-altitude regions of Bolivia allows us important reflections, namely: 1. It is important to highlight, as a clear example, that simple observation can lead to uncertainty and the cost of its future consequences due to the persistence of iron deficiency anemia in high altitude populations, even more so if the possible trial and error management is maintained in disseminated results. 2. The need for controls in scientific research is demonstrated, and finally 3. Randomized controlled clinical trials are the best source of reliable evidence.


Subject(s)
Iron Deficiency , Anemia, Iron-Deficiency , Altitude , Anemia
13.
Rev. bras. ginecol. obstet ; 43(4): 297-303, Apr. 2021. tab, graf
Article in English | LILACS | ID: biblio-1280048

ABSTRACT

Abstract Objective To evaluate the number of patients with early-stage breast cancer who could benefit from the omission of axillary surgery following the application of the Alliance for Clinical Trials in Oncology (ACOSOG) Z0011 trial criteria. Methods A retrospective cohort study conducted in the Hospital da Mulher da Universidade Estadual de Campinas. The study population included 384 women diagnosed with early-stage invasive breast cancer, clinically negative axilla, treated with breast-conserving surgery and sentinel lymph node biopsy, radiation therapy, chemotherapy and/or endocrine therapy, from January 2005 to December 2010. The ACOSOG Z0011 trial criteria were applied to this population and a statistical analysis was performed to make a comparison between populations. Results A total of 384 patients underwent breast-conserving surgery and sentinel lymph node biopsy. Of the total number of patients, 86 women underwent axillary lymph node dissection for metastatic sentinel lymph nodes (SNLs). One patient underwent axillary node dissection due to a suspicious SLN intraoperatively, thus, she was excluded fromthe study. Among these patients, 82/86 (95.3%) had one to two involved sentinel lymph nodes andmet the criteria for the ACOSOG Z0011 trial with the omission of axillary lymph node dissection. Among the 82 eligible women, there were only 13 cases (15.9%) of lymphovascular invasion and 62 cases (75.6%) of tumors measuring up to 2 cm in diameter (T1). Conclusion The ACOSOG Z0011 trial criteria can be applied to a select group of SLNpositive patients, reducing the costs and morbidities of breast cancer surgery.


Resumo Objetivo Avaliar o número de pacientes com câncer de mama em estágio inicial que se beneficiariam da omissão da linfadenectomia axilar segundo o protocolo Z0011 da Alliance for Clinical Trials in Oncology (ACOSOG). Métodos Estudo de coorte retrospectiva conduzido no Hospital da Mulher da Universidade Estadual de Campinas. Foram incluídas mulheres diagnosticadas com carcinoma invasivo de mama em estágio inicial, com axila clinicamente negativa, tratadas com cirurgia conservadora e biópsia do linfonodo sentinela, radioterapia, quimioterapia e/ou hormonioterapia, de janeiro de 2005 a dezembro de 2010. Os critérios do estudo da ACOSOG Z0011 foram aplicados a essas mulheres e foi realizada uma análise estatística que comparou ambas as populações dos estudos. Resultados Foram estudadas 384 mulheres submetidas a cirurgia conservadora de mama e biópsia do linfonodo sentinela. Entre elas, 86 mulheres foram submetidas a linfadenectomia axilar por metástase presente no linfonodo sentinela. Uma paciente foi submetida a linfadenectomia axilar por ter um linfonodo palpável suspeito no intraoperatório, não incluída no estudo. Entre essas 86 pacientes, 82 (95,3%) tiveram de 1 a 2 linfonodos sentinela comprometidos e seriam elegíveis para omissão da linfadenectomia axilar pelos critérios do ACOSOG Z0011. Entre as 82 pacientes elegíveis, apenas 13 (15,9%) delas apresentaram tumores com invasão angiolinfática, e 62 (75,6%) dos tumores mediram até 2 cm (T1). Conclusão Os critérios do estudo ACOZOG Z0011 podem ser aplicados a um seleto grupo de pacientes com linfonodo sentinela positivo reduzindo os custos e a morbidade cirúrgica do tratamento do câncer de mama.


Subject(s)
Humans , Female , Breast Neoplasms/surgery , Breast Neoplasms/pathology , Mastectomy, Segmental , Lymph Node Excision , Axilla/pathology , Randomized Controlled Trials as Topic , Retrospective Studies , Chemotherapy, Adjuvant , Radiotherapy, Adjuvant , Sentinel Lymph Node Biopsy , Lymph Nodes/pathology , Lymphatic Metastasis , Middle Aged , Neoplasm Staging
14.
Rev. Asoc. Odontol. Argent ; 109(1): 3-8, ene.-abr. 2021. ilus, tab, graf
Article in Spanish | LILACS | ID: biblio-1255177

ABSTRACT

Objetivo: Comparar clínicamente el comportamiento, el tiempo operatorio requerido, el costo y la dificultad de diferentes técnicas de restauración en piezas primarias, empleando ionómero vítreo fotoactivado (IVF) polvo/líquido, con y sin uso de acondicionamiento dentinario, y en cápsulas, con acondicionamiento. Materiales y métodos: El diseño de este estudio fue experimental y comparativo. Se realizaron, en 18 pacientes de 7±2 años, 33 restauraciones con IVF de una o más piezas primarias vitales con lesiones amelodentinarias en 1 o 2 superficies. Según su día de concurrencia a la Cátedra de Odontología Integral Niños, se empleó: A) IVF polvo/líquido, con acondicionamiento (3M™ VitremerTM); B) IVF polvo/líquido, sin acondicionamiento (3M™ VitremerTM); y C) IVF en cápsulas, con acondicionamiento (Riva Light Cure). Las restauraciones fueron evaluadas clínicamente al inicio y a los 12 meses según los siguientes criterios: pérdida total, pérdida total con caries, requerimiento de reemplazo por pérdida parcial, requerimiento de reemplazo por caries, aceptable con deterioro, en condiciones. El grado de dificultad se analizó utilizando una planilla diseñada para tal fin. El tiempo operatorio requerido se midió sin considerar el tiempo de inserción. Resultados: El tiempo operatorio requerido fue de 2 minutos, 15 segundos en A; 1 minuto, 25 segundos en B; y 1 minuto, 10 segundos en C, sin considerar el tiempo de inserción. El costo fue 61,11% mayor para C. La dificultad fue de 3,2±0,6 para A y B, y de 1,5±0,7 para C (ANOVA; P<0,001). El comportamiento clínico no registró diferencias significativas entre los grupos (Fisher; P=0,339). Conclusión: Los ionómeros de restauración fotoactivados encapsulados utilizados en este estudio presentaron menor dificultad de manipulación, mayor costo y similar comportamiento clínico a un año que las presentaciones polvo-líquido, con o sin uso de acondicionamiento previo en piezas primarias (AU)


Aim: To assess the clinical performance, operative time required, cost and technical difficulties of different restorative techniques in primary teeth, using light cured glass ionomers (LCG), powder/liquid, with and without dentin conditioning and light cured glass ionomer in capsules with conditioning. Materials and methods: The design of this study was experimental and comparative. 33 restorations with LCG were performed in 18 patients, 7 ± 2-years-old, in one or more vital primary teeth with carious lesions involving one or more tooth surfaces. Patients were assigned to one of the three groups according to the day of the week in which they attended to the Pediatric Department of the Dental School: A) LCG powder/liquid, with conditioning (3M™ VitremerTM); B) LCG powder/liquid without conditioning (3M™ VitremerTM); and C) LCG in capsules with conditioning (Riva Light Cure). The restorations were clinically evaluated at baseline and after 12 months according to the following criteria: complete loss of the restoration, complete loss with caries, need of replacement because of partial loss, need of replacement because of caries, good condition with some wear and good condition. Technical difficulties were analyzed using a data sheet designed for that purpose. The operative time required was evaluated without considering the insertion time. Results: Time operative time required was 2 minutes 15 seconds in A, 1 minute 25 seconds in B and 1 minute 10 seconds in C. Cost was 61.11% higher for C. Difficulty was 3.2±0.6 for A and B and 1.5±0.7 for C (ANOVA; P<0.001). No significant differences were observed among the three groups in relation to the clinical performance (Fisher; P=0.339). Conclusions: In these 12 months, study in primary teeth, the light cured glass ionomers used dispensed in capsules showed to be the easiest to handle, had higher cost and similar clinical performance than the powder liquid presentations with and without dentin conditioner (AU)


Subject(s)
Humans , Male , Female , Child, Preschool , Child , Tooth, Deciduous , Dentin-Bonding Agents , Dental Care for Children/methods , Dental Restoration, Permanent/methods , Glass Ionomer Cements/therapeutic use , Argentina , Schools, Dental , Statistical Analysis , Prospective Studies , Analysis of Variance , Clinical Trial , Costs and Cost Analysis , Light-Curing of Dental Adhesives , Time-to-Treatment
15.
Humanidad. med ; 21(1): 274-290, ene.-abr. 2021.
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1250056

ABSTRACT

RESUMEN El presente artículo es el resultado de un estudio dirigido a demostrar la contribución del Registro Público Cubano de Ensayos Clínicos (RPCEC) en la transparencia de las publicaciones de investigaciones en seres humanos. Se realizó una revisión bibliográfica de diferentes fuentes de información científica en la biblioteca electrónica SciELO y otros sitios web con el objetivo de caracterizar el RPCEC desde una perspectiva de los estudios sociales de la Ciencia y la Tecnología. Se precisaron consideraciones sobre las temáticas en el momento de realizar la investigación. Se constató que el RPCEC es una tecnología informática que favorece la limpieza de los datos y su generalización, lo cual contribuye a eliminar el sesgo de publicación. Además, desde el punto de vista de la bioética promueve el desarrollo científico y la búsqueda efectiva en la sociedad contemporánea.


ABSTRACT This article is the result of a study aimed at demonstrating the contribution of the Cuban Public Registry of Clinical Trials (RPCEC) in the transparency of research publications on human beings. A bibliographic review of different sources of scientific information was carried out in the SciELO electronic library and other websites in order to characterize the RPCEC from a perspective of the social studies of Science and Technology. Considerations on the issues were required at the time of conducting the research. It was found that RPCEC is a computer technology that favors data cleaning and generalization, which helps to eliminate publication bias. Furthermore, from the point of view of bioethics, it promotes scientific development and effective research in contemporary society.

16.
Rev. bras. ativ. fís. saúde ; 26: 1-9, mar. 2021.
Article in English | LILACS | ID: biblio-1344341

ABSTRACT

Prevention and treatment of overweight among children have been a global challenge. A better un-derstanding of different interventions to improve overweight children's health is needed. This paper describes the methodological approach of Sport and Health for Overweight children (SHOW ) study, which investigated the effects of a multicomponent intervention on health markers of over-weight children. The SHOW study is a non-randomized clinical trial performed during 16 weeks enrolling 72 overweight children aged eight to 12 years in an intervention (IG = 35) and control group (CG = 37). It is a multicomponent intervention program including generalized sport initia-tion, health education, and weekly communication between parents and researchers. Besides char-acterizing the participants', several health outcomes were analyzed in the SHOW study. Primary outcomes were accelerometer based physical activity and anthropometric indicators of overweight and obesity. Secondary outcomes were made up of cardiometabolic, fitness, behavioral, and psycho-logical health indicators. We hypothesize that the SHOW study improves health outcomes and can be replicated in other settings as well as implemented by public policies


A prevenção e o tratamento do excesso de peso em crianças tem sido um desafio global. O melhor entendimento sobre diferentes propostas de intervenções que objetivem a melhoria do perfil de saúde de crianças com excesso de peso é necessário. O objetivo deste artigo foi descrever os procedimentos metodológicos do estudo Sport and Health for Overweight children (SHOW ) que teve como objetivo investigar os efeitos de uma intervenção multicomponente sobre marcadores de saúde de crianças com sobrepeso. O estudo SHOW é um ensaio clínico não randomizado realizado durante 16 sema-nas envolvendo 72 crianças com sobrepeso de oito a 12 anos de idade alocadas em grupo intervenção (GI = 35) e controle (GC = 37). Trata-se de um programa de intervenção multicomponente compos-to por iniciação esportiva generalizada, educação em saúde e comunicação semanal entre pais e pes-quisadores. Além da caracterização dos participantes vários desfechos em saúde foram analisados . Os desfechos primários foram atividade física medida por acelerometria e indicadores antropométricos de sobrepeso e obesidade. Os desfechos secundários foram compostos por indicadores cardiometa-bólicos, de aptidão física, comportamentais e psicológicos. Nossa hipótese é que a proposta de inter-venção do SHOW melhorará os desfechos em saúde podendo ser replicada em outros ambientes e implementada por políticas públicas


Subject(s)
Exercise , Child , Health Education , Clinical Trial , Obesity
17.
Rev. cuba. med. mil ; 50(1): e529, 2021. tab
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1289500

ABSTRACT

RESUMEN Introducción: En 1967 se estableció, por primera vez, un comité de monitoreo de datos, en un estudio de mortalidad cardiovascular; desde entonces su uso se ha incrementado debido a su valor para garantizar la seguridad de los sujetos participantes en ensayos clínicos y la validez e integridad de los datos. Se realizó una exploración documental de los últimos 20 años, sobre aspectos relacionados con los requisitos de creación y funcionamiento de los comités de monitoreo de datos a nivel mundial, con los objetivos de mostrar el desarrollo alcanzado en el establecimiento de los comités de monitoreo de datos e identificar sus características fundamentales. Desarrollo: Existe un incremento en la producción documental sobre los comités de monitoreo de datos, liderado por angloparlantes de países desarrollados, con franco aumento de publicaciones sobre el tema en el último quinquenio, superior en 50 % a los 15 años anteriores. Este fenómeno lo provoca el auge de la industria farmacéutica y biotecnológica, los altos costos de investigación y desarrollo de medicamentos, la necesidad de introducir nuevos fármacos y el incremento de las exigencias regulatorias. Se describen las características estructurales, requisitos clínicos y metodológicos para el establecimiento de los comités. Conclusiones: Existe alto desarrollo de los comités de monitoreo de datos en los ensayos clínicos, con tendencia al incremento de su uso en los últimos años. Los comités de monitoreo de datos se caracterizan por requerimientos clínicos y metodológicos para su establecimiento.


ABSTRACT Introduction: For the first time, in 1967, a data monitoring committee was established in a study of cardiovascular mortality. Since then its use has increased, due to its value to guarantee the safety of subjects participating in clinical trials, the validity and integrity of the data. A documentary exploration of the last 20 years was carried out, on aspects related to the requirements for the creation and operation of data monitoring committees worldwide, with the aim of showing the development achieved in the establishment of data monitoring committees and identify its fundamental characteristics. Development: There is an increase in documentary production on data monitoring committees, led by English speakers from developed countries, with a clear increase in publications on the subject, in the last five-year period, 50% higher than in the previous 15 years. This phenomenon is caused by the rise of the pharmaceutical and biotechnology industry, the high costs of drug research and development, the need to introduce new drugs and the increase in regulatory requirements. The structural characteristics, clinical and methodological requirements for the establishment of the committees are described. Conclusions: There is a high development of data monitoring committees in clinical trials, with a tendency to increase their use in recent years. Data monitoring committees are characterized by clinical and methodological requirements for their establishment.

18.
Article in Chinese | WPRIM | ID: wpr-910159

ABSTRACT

Objective:To investigate effects of metformin and rosiglitazone in non-obese polycystic ovary syndrome (PCOS) women with insulin resistance.Methods:Totally 200 non-obese PCOS women with insulin resistance in West China Second Hospital of Sichuan University were enrolled into this study from Sep. 2013 to Jun. 2016, and were randomly divided into two treatment groups: metformin group (1 500 mg/d) and rosiglitazone group (4 mg/d). The treatment lasted for 6 months. Their clinical and biochemical parameters were collected and compared.Results:In both groups, menstrual cycles [metformin group (37±4) days, rosiglitazone group (35±4) days] were shorter after treatment for 6 months (both P<0.01). After treatment for 6 months, body mass index [metformin group (21.6±1.6) kg/m 2, rosiglitazone group (21.7±1.7) kg/m 2] decreased in both groups (both P<0.01); decreased LH/FSH ratio (metformin group 1.67±0.80, rosiglitazone group 1.70±0.83) was also observed (both P<0.05). After treatment for 6 months, fasting insulin level [metformin group (13.5±5.1) mU/L, rosiglitazone group (12.7±5.6) mU/L] and homeostasis model assessment-insulin resistance index (metformin group 3.0±1.2, rosiglitazone group 2.8±1.2) were decreased in both groups (all P<0.01). Conclusions:For non-obese PCOS insulin resistance patients, screening of anthropometric and metabolic parameters is necessary. For PCOS with insulin resistance, lifestyle plus insulin sensitizers such as metformin could improve their clinical symptoms, correct the biochemical and metabolic dysfunction.

19.
Article in Chinese | WPRIM | ID: wpr-909803

ABSTRACT

Objective:To get comprehensive understanding of the registration characteristics of global clinical trials of coronavirus disease 2019(COVID-19) based on the ClinicalTrials. gov and the Chinese Clinical Trial Registry (ChiCTR).Methods:The clinical trials of COVID-19 in the ClinicalTrials.gov and ChiCTR were retrieved. The search start time was unlimited, with deadlines of 14 December, 2020 and 19 March, 2021, respectively. The registration numbers, registration submitted time, country/region distribution, recruitment status, study types, number of recruits, research phases, and other aspects were analyzed by using bibliometric methods.Results:As of March 19, 2021, there were 775 clinical trials in ChiCTR. As of December 14, 2020, there were 4 137 clinical trials in the ClinicalTrials.gov, and 3 157(76.31%) of the clinical trials recruited subjects who were aged≥18 years old. There were 2 347 intervention trials and 1 759 observational trials. The intervention measures mainly included drugs, biologics and medical devices. The numbers of recruits were 110(48, 308) cases for interventional studies, and 300(100, 1 000) cases for observational trials. The interventional research phases were mainly phaseⅡ (570 items) and phase Ⅲ (358 items). Totally, 50.33%(2 082/4 137) of the clinical trials were under recruitment, 13.10%(542/4 137) had been completed. Among the interventional studies, 729(31.06%) were multi-center studies, with the center numbers of 5(2, 15).Conclusions:At present, there are a large number of clinical trials with various intervention measures in the world. However, the number of recruits is unreasonable, and multi-center study with multi-agency cooperation is insufficient.

20.
Article in Chinese | WPRIM | ID: wpr-909156

ABSTRACT

Objective:To investigate the clinical efficacy of alprostadil injection in the treatment of acute cerebral infarction.Methods:A total of 300 patients with acute cerebral infarction who received treatment in The First People's Hospital of Jiashan, China between August 2016 and August 2018 were included in this study. They were randomly divided into a control group and an observation group ( n = 150/group). Based on conventional treatment, patients in the control group received Xueshuantong power injection treatment and those in the observation group received alprostadil injection treatment. All patients were treated for 14 days. Clinical efficacy was compared between the control and observation groups. Results:In the observation group, infarct volume, plaque area, lumen area, intima-media thickness of the common carotid artery, Crouse score, recanalization rate, Barthel Index, National Institutes of Health Stroke Scale (NIHSS) score, hematocrit and plasma viscosity in the observation group were (3.16 ± 1.19) cm 3, (0.21 ± 0.05) mm 2, (0.30 ± 0.06) mm 2, (1.05 ± 0.23) mm, (2.18 ± 0.61) points, 98.67% (148/150), (96.38 ± 1.75) points, (6.31 ± 1.08) points, (41.03 ± 4.28)%, (1.12 ± 0.03) mPa/s, respectively, which were superior to those in the control group [ (2.25 ± 1.37) cm 3, (0.68 ± 0.46) mm 2, (0.89 ± 0.54) mm 2, (1.76 ± 0.85) mm, (3.29 ± 0.78) points, 72.00% (108/150), (85.22 ± 1.56) points, (10.18 ± 1.43) points, (50.76 ± 5.31)%, (1.54 ± 0.34) mPa/s, t = 1.869, 1.231, 1.452, 1.326, 2.285, χ2 = 12.528, t = 11.428, 4.28, 17.473, 15.071, all P < 0.05]. Conclusion:Based on conventional treatment, alprostadil injection exhibits good clinical efficacy in the treatment of acute cerebral infarction.

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