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1.
Rev. bras. med. esporte ; 28(6): 785-788, Nov.-Dec. 2022. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1376733

ABSTRACT

ABSTRACT Introduction Sedentary people are more likely to be affected by obesity and cardiovascular diseases than regularly practicing physical activity. Therefore, it is essential to investigate the effects of physical exercise on the health of sedentary people. Objective Study the physical exercise effects on physical activity and autonomy in sedentary people. Methods Structural equations and mathematical statistics were used to analyze sedentary people's autonomy during physical exercise and the repercussions of the activity on the practitioners' physique. Results Sedentary people increased confidence and self-esteem after participating in physical exercise. Their physical functions could be effectively improved after practicing physical exercises. Conclusion Effective and realistic suggestions for improving exercise awareness were presented, considering the particular conditions of sedentary people. Physical exercise also helps sedentary people to develop exercise confidence by improving their overall self-efficacy level. Evidence Level II; Therapeutic Studies - Investigating the results.


RESUMO Introdução Pessoas sedentárias estão mais propensas a sofrer de obesidade e doenças cardiovasculares quando comparadas às pessoas que praticam atividades físicas regularmente. Por isso, é de grande importância estudar os efeitos do exercício físico sobre a saúde das pessoas sedentárias. Objetivo Estudar os efeitos do exercício físico sobre a atividade física e a autonomia das pessoas sedentárias. Métodos Equações estruturais e estatísticas matemáticas foram utilizadas para analisar a autonomia das pessoas sedentárias durante o exercício físico e as repercussões da atividade no físico dos praticantes. Resultados As pessoas sedentárias tiveram um aumento de confiança e autoestima após participarem de exercícios físicos. Suas funções físicas podem ser efetivamente melhoradas após a prática de exercícios físicos. Conclusão Foram apresentadas sugestões efetivas e realistas para melhorar a consciência do exercício físico, considerando as condições particulares das pessoas sedentárias. O exercício físico também ajuda as pessoas sedentárias a desenvolverem a confiança no exercício, melhorando o nível de autoeficácia geral. Nível de evidência II; Estudos Terapêuticos - Investigação de Resultados.


RESUMEN Introducción Las personas sedentarias tienen más probabilidades de padecer obesidad y enfermedades cardiovasculares en comparación con las personas que practican regularmente actividad física. Por ello, es de gran importancia estudiar los efectos del ejercicio físico en la salud de las personas sedentarias. Objetivo Estudiar los efectos del ejercicio físico sobre la actividad física y la autonomía de las personas sedentarias. Métodos Se utilizaron ecuaciones estructurales y estadísticas matemáticas para analizar la autonomía de las personas sedentarias durante el ejercicio físico y las repercusiones de la actividad en el físico de los practicantes. Resultados Las personas sedentarias tuvieron un aumento de la confianza y la autoestima después de participar en el ejercicio físico. Sus funciones físicas podrían mejorar eficazmente tras la práctica de ejercicios físicos. Conclusión Se presentaron sugerencias eficaces y realistas para mejorar la concienciación sobre el ejercicio físico, teniendo en cuenta las condiciones particulares de las personas sedentarias. El ejercicio físico también ayuda a las personas sedentarias a desarrollar la confianza en el ejercicio al mejorar su nivel de autoeficacia general. Nivel de evidencia II; Estudios terapéuticos - Investigación de resultados.

2.
Invest. educ. enferm ; 40(2): 47-60, 15 de junio 2022. tab, ilus
Article in English | LILACS, BDENF, COLNAL | ID: biblio-1378689

ABSTRACT

Abstract Objective. This study investigated the effect of Extended Theory of Planned Behavior (ETPB) extended theory of planned behavior in comparison with the Theory Of Planned Behavior (TPB) in explaining the intention of Exclusive Breastfeeding Intention (EBF) in Pregnant nulliparous women of Kerman (Iran). Methods. In this descriptive study, 249 pregnant women in Kerman participated via simple random sampling. The research instruments included Questionnaire related to the structures of the theory of planned behavior, breastfeeding self-efficacy and social support questionnaire for breastfeeding. Results. The results of the correlation test showed a significant relationship between all constructs of the theory of extended planned behavior and the intention of EBF. The highest correlation belonged to the construct of subjective norms (r=0.49). Path regression coefficients in the second model showed that the Self-Efficacy mediator variable is fully capable of meaningful mediation between Social Support and Intention (p<0.001; B=0.383). The conceptual diagram of Structural equation modeling showed a higher explained variance or R2 index for the intention variable for the developed model compared to that of the first model, i.e. (the first model: R2=0.37, the second model: R2=0.46). The goodness-of-fit index had a better status for the developed model. Conclusion. Extended TPB with social support and breastfeeding self-efficacy constructs can be appropriate model for predicting the intention and behavior of EBF.


Resumen Objetivo. Este estudio investigó el efecto de la Teoría Extendida del Comportamiento Planificado (TECP) en comparación con la Teoría del Comportamiento Planificado (TCP) para explicar la intención de la Lactancia Materna Exclusiva (LME) en mujeres nulíparas embarazadas de Kerman. Métodos. En este estudio descriptivo participaron 249 mujeres embarazadas de la ciudad de Kerman (Iran), seleccionadas por muestreo aleatorio simple. Los instrumentos de investigación incluían un cuestionario relacionado con las estructuras de la teoría de la conducta planificada, un cuestionario de autoeficacia para la lactancia materna y un cuestionario de apoyo social para la lactancia materna. Resultados. La prueba de correlación mostró una relación significativa entre todos los constructos de la TECP y la intención de LME. La correlación más alta correspondió al constructo de normas subjetivas (r=0.49). Los coeficientes de la regresión en el segundo modelo mostraron que la variable Autoeficacia mediaba significativamente entre las variables Apoyo Social e Intención (p<0.001; B=0.383). El diagrama conceptual del Structural equation modeling mostró una mayor varianza explicada o índice R2 para la variable de intención para el modelo desarrollado en comparación con el del primer modelo, es decir, (el primer modelo: R2=037, el segundo modelo: R2=0.46). El índice de bondad de ajuste fue mejor para el modelo desarrollado. Conclusión. La TECP con los constructos de apoyo social y autoeficacia para la lactancia materna puede ser un modelo apropiado para predecir la intención y el comportamiento de la LME.


Resumo Objetivo. Este estudo investigou o efeito da Teoria Estendida do Comportamento Planejado (TECP) comparada à Teoria do Comportamento Planejado (TCP) na explicação da intenção da Lactância Materna Exclusiva (LME) em gestantes nulíparas de Kerman. Métodos. Neste estudo descritivo, participaram 249 gestantes da cidade de Kerman (Irã), selecionadas por amostragem aleatória simples. Os instrumentos de pesquisa incluíram um questionário relacionado às estruturas da teoria do comportamento planejado, um questionário de autoeficácia para amamentar e um questionário de apoio social à amamentação. Resultados. O teste de correlação mostrou uma relação significativa entre todos os construtos do TCP e a intenção de LME. A maior correlação correspondeu ao construto das normas subjetivas (r=0.49). Os coeficientes de regressão no segundo modelo mostraram que a variável Autoeficácia mediou significativamente entre as variáveis Apoio Social e Intenção (p <0.001; B=0.383). O diagrama conceitual da Estrutura equação a modelagem apresentou maior variância explicada ou índice R2 para a variável intenção para o modelo desenvolvido em relação ao primeiro modelo, ou seja, (o primeiro modelo: R2=0.37, o segundo modelo: R2=0.46). O índice de bondade de ajuste foi melhor para o modelo desenvolvido. Conclusão. A TECP com os construtos de apoio social e autoeficácia em amamentar pode ser um modelo adequado para predizer a intenção e o comportamento do LME.


Subject(s)
Humans , Female , Breast Feeding , Health Behavior , Self Efficacy , Pregnant Women
3.
Invest. educ. enferm ; 40(1): 183-200, 01/03/2022. ilus, tab
Article in English | LILACS, BDENF, COLNAL | ID: biblio-1371183

ABSTRACT

Objective. This study aimed to compare home visits and telephone follow-up effectiveness on patients' self-efficacy undergoing Coronary Artery Bypass Graft Surgery -CABG- and caregivers' burden. Methods. In this randomized clinical trial, 114 patients undergoing CABG were assigned to the three groups of home visits, telephone follow-up, and control based on the stratified block randomization. The self-management program of the home visit group included four face-to-face 60-minute training sessions once a week, and for the telephone follow-up group, four 30-minute telephone counseling sessions twice each week for a month. The control group received routine care. Data were collected using the cardiac rehabilitation self-efficacy questionnaire and the caregiver burden scale before and after the intervention. Results. Before the study, there were no statistically significant differences between the three groups in terms of the means of self-efficacy and caregiver burden scores. However, there was a statistically significant difference between the home visit and control groups (p<0.001) and between the telephone follow-up and control groups (p<0.001) after the intervention, with increased self-efficacy and reduced caregiver burden reported. In contrast, there was no significant difference between the home visit and telephone follow-up groups regarding self-efficacy and caregiver burden scores. Conclusion. Both methods of self-management education have similar effectiveness in increasing self-efficacy and reducing the caregiver burden after discharge for patients who have undergone CABG.


Objetivo. Comparar la eficacia de las visitas domiciliarias y del seguimiento telefónico sobre la autoeficacia de los pacientes sometidos a cirugía de derivación arterial coronaria con injerto (CABG en inglés) y la carga de sus cuidadores. Métodos. En este ensayo clínico aleatorio, 114 pacientes sometidos a CABG se asignaron a uno de los tres grupos de investigación: visitas domiciliarias, seguimiento telefónico y control sobre la base de la aleatorización en bloque estratificada. El programa de educación en autoeficacia en el grupo de visitas domiciliarias incluía cuatro sesiones presenciales de formación de 60 minutos una vez a la semana, y para el grupo de seguimiento telefónico, cuatro sesiones de asesoramiento telefónico de 30 minutos dos veces por semana por un mes. El grupo de control recibió atención rutinaria. Los datos se recogieron mediante el cuestionario de autoeficacia de la rehabilitación cardíaca y la escala de carga del cuidador antes y después de la intervención. Resultados. Antes del estudio, no hubo diferencias entre los tres grupos en cuanto a las medias de las puntuaciones de las escalas de autoeficacia y carga del cuidador. Sin embargo, se encontró una diferencia estadísticamente significativa entre los grupos de visitas domiciliarias y de control (p<0.001) y entre los grupos de seguimiento telefónico y de control (p<0.001) después de la intervención, con un aumento de la autoeficacia y una reducción de la carga del cuidador. Es de anotar que no hubo diferencias significativas entre los grupos de visita domiciliaria y de seguimiento telefónico en cuanto a las puntuaciones de autoeficacia y de carga del cuidador. Conclusión. Ambos métodos de educación en este estudio tuvieron una efectividad similar en el aumento de la autoeficacia y la reducción de la carga de los cuidadores tras el alta de los pacientes sometidos a CABG.


Objetivo. Comparar a eficácia das visitas domiciliares e do seguimento telefónico sobre a autoeficácia dos pacientes submetidos a cirurgia de derivação arterial coronária com enxerto (CABG em inglês) e a carga dos seus cuidadores. Métodos. Neste ensaio clínico aleatório, 114 pacientes submetidos a CABG foram designados a um dos três grupos de investigação: visitas domiciliares, seguimento telefónico e controle sobre a base aleatorizada em blocos estratificada. O programa de educação em autoeficácia no grupo de visitas domiciliares incluía quatro sessões de formação presenciais de 60 minutos uma vez por semana, e para o grupo de seguimento telefónico, quatro sessões de assessoramento telefónico de 30 minutos duas vezes por semana durante um mês. O grupo de controle recebeu atenção rotineira. Os dados se recolheram mediante o questionário de autoeficácia da reabilitação cardíaca e a escala de carga do cuidador antes e depois da intervenção. Resultados. Antes do estudo, não houve diferenças entre os três grupos enquanto às médias das pontuações das escalas de autoeficácia e carga do cuidador. Porém, se encontrou uma diferença estatisticamente significativa entre os grupos de visitas domiciliares e de controle (p<0.001) e entre os grupos de seguimento telefónico e de controle (p<0.001) depois da intervenção, com um aumento da autoeficácia e uma redução da carga do cuidador. É importante anotar que não houve diferenças significativas entre os grupos de visita domiciliar e de seguimento telefónico enquanto às pontuações de autoeficácia e de carga do cuidador. Conclusão. Ambos os métodos de educação neste estudo tiveram uma efetividade similar no aumento da autoeficácia e a redução da carga dos cuidadores após a alta dos pacientes submetidos a CABG.


Subject(s)
Coronary Artery Bypass , Caregivers , Self Efficacy , Telenursing , Self-Management , House Calls
4.
Psico USF ; 27(1): 87-97, jan.-mar. 2022. tab
Article in English | LILACS, INDEXPSI | ID: biblio-1376044

ABSTRACT

The study evaluated the effects of a Social and Educational Skills Program on the repertoire of social skills, educational social skills, and self-efficacy beliefs in teachers. Participants included 45 teachers who taught at the final grades of elementary school, in public schools in the state of Rio de Janeiro. Participants were allocated by convenience into 2 groups: intervention (n=22) and control (n=23). The program consisted of 10 meetings, with pre-test and post-test measures. The teachers responded to the following instruments: Social Skills Inventory, Educational Social Skills Inventory-teacher, Teacher Self-Efficacy Scale, and Socioeconomic Questionnaire. Results indicated that the intervention promoted the repertoire of social and educational skills of teachers and increased teaching self-efficacy beliefs. It was concluded that the intervention showed some indicators of efficacy, signaling the interpersonal development of the educators. Future research should include accompanying measures and experimental design (AU).


O estudo avaliou os efeitos de um Programa de Habilidades Sociais e Educativas no repertório de habilidades sociais, habilidades sociais educativas e nas crenças de autoeficácia docente. Participaram do estudo 45 professores que lecionavam nos anos finais do Ensino Fundamental, em escolas públicas no Estado do Rio de Janeiro. Os participantes foram alocados por conveniência em dois grupos: intervenção (n = 22); controle (n = 23). O programa foi composto por 10 encontros, com medidas de pré-teste e pós-teste. Os professores responderam aos instrumentos: Inventário de Habilidades Sociais, Inventário de Habilidades Sociais Educativas-professor, Escala de Autoeficácia Docente e Questionário Socioeconômico. Os resultados indicaram que a intervenção promoveu o repertório de habilidades sociais e educativas dos professores e aumentou as crenças de autoeficácia docente. Conclui-se que a intervenção evidenciou alguns indicadores de efetividade, sinalizando o desenvolvimento interpessoal dos educadores. Futuras pesquisas deverão incluir medidas de seguimento e delineamento experimental (AU).


El estudio evaluó los efectos de un programa de habilidades sociales y educativas sobre el repertorio de habilidades sociales educativas y las creencias de autoeficacia de los profesores. El estudio incluyó a 45 profesores que enseñaban en los últimos años de la Educación Primaria en escuelas públicas del Estado de Río de Janeiro. Los participantes fueron asignados por conveniencia en dos grupos: intervención (n=22); control (n=23). El programa se compuso por 10 reuniones, con medidas pre test y post test. Los docentes respondieron a los instrumentos: Inventario de Habilidades Sociales; Inventario de Habilidades Sociales Educativas-docente; Escala de Autoeficacia Docente; Cuestionario Socioeconómico. Los resultados indicaron que la intervención promovió el repertorio de habilidades sociales y educativas de los docentes y aumentó las creencias de autoeficacia docente. Se concluye que la intervención evidenció algunos indicadores de efectividad, señalando el desarrollo interpersonal de los educadores. Futuras investigaciones deben incluir medidas de seguimiento y diseño experimental (AU).


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Self Efficacy , Education, Primary and Secondary , Social Skills , School Teachers/psychology , Surveys and Questionnaires
5.
Rev. eletrônica enferm ; 24: 1-8, 18 jan. 2022.
Article in English, Portuguese | LILACS, BDENF | ID: biblio-1353280

ABSTRACT

Objetivo: identificar e analisar a presença dos fatores terapêuticos nos atendimentos em sala de espera em um Centro de Atenção Psicossocial Álcool e Drogas, na perspectiva dos coordenadores e membros do grupo. Método: pesquisa de abordagem qualitativa do tipo convergente assistencial realizada com 14 pessoas. A coleta de dados ocorreu por meio de entrevistas individuais, instrumento tipo check-list com base no Q-sort de fatores terapêuticos de Yalom e observação participante. Os dados foram submetidos à análise temática e organizados com o software ATLAS.ti. Resultados: no decorrer dos encontros, tanto na perspectiva das coordenadoras e dos integrantes do grupo, foram identificados os mesmos fatores terapêuticos: instilação de esperança, universalidade, compartilhamento de informações, aprendizagem interpessoal, coesão grupal, fatores existenciais, altruísmo, desenvolvimento de técnicas de socialização e comportamento imitativo. Conclusão: reconhece-se o valor dos atendimentos em sala de espera, contribuindo significativamente no trajeto terapêutico de seus participantes.


Objective: to identify and analyze the presence of therapeutic factors in care in the waiting room at a Psychosocial Care Center for Alcohol and Drugs, from the perspective of coordinators and group members. Method: a qualitative approach research of the convergent care type carried out with 14 people. Data collection took place through individual interviews, a checklist-type instrument based on Yalom's Q-sort of therapeutic factors and participant observation. Data were subjected to thematic analysis and organized with the ATLAS.ti software. Results: During the meetings, both from the perspective of the coordinators and the group members, the same therapeutic factors were identified: instillation of hope, universality, information sharing, interpersonal learning, group cohesion, existential factors, altruism, development of socialization techniques and imitative behavior. Conclusion: the value of care in the waiting room is recognized, significantly contributing to the therapeutic path of its participants.


Subject(s)
Community Mental Health Services , Evaluation of the Efficacy-Effectiveness of Interventions , Substance-Related Disorders/rehabilitation
6.
Rev. eletrônica enferm ; 24: 1-9, 18 jan. 2022.
Article in English, Portuguese | LILACS, BDENF | ID: biblio-1370426

ABSTRACT

Objetivo: realizar a adaptação transcultural do instrumento General Self Efficacy Scale-12 para o português do Brasil. Método: trata-se de um estudo metodológico, de adaptação transcultural de um instrumento de autoeficácia, que seguiu as etapas de tradução, síntese, retrotradução, avaliação semântica, validação de conteúdo e pré-teste. Resultados: a tradução e a retrotradução não apresentaram alterações em relação à versão original. Foram alcançadas a validação de conteúdo e a semântica e obteve-se um coeficiente de validade de conteúdo superior a 0,80. Conclusão: depois de desenvolver as etapas metodológicas, a escala foi devidamente adaptada à cultura brasileira e apresenta equivalência conceitual, semântica, cultural e operacional em relação à versão original. Portanto, esse instrumento tem potencial para ser utilizado na mensuração da autoeficácia.


Objective: to perform the cross-cultural adaptation of the General Self Efficacy Scale-12 into Brazilian Portuguese. Method: this is a methodological study of cross-cultural adaptation of a self-efficacy instrument in which the steps of translation, synthesis, back-translation, semantic evaluation, content validation and pre-test were followed. Results: the translation and back-translation showed no changes in relation to the original version. Content and semantic validation were achieved and a content validity coefficient greater than 0.80 was obtained. Conclusion: after developing the methodological steps, the scale was duly adapted to the Brazilian culture and presents conceptual, semantic, cultural and operational equivalence in relation to the original version. Therefore, this instrument has potential to be used for measuring self-efficacy.


Subject(s)
Disabled Persons , Validation Study , Self Efficacy
7.
J. bras. pneumol ; 48(2): e20210384, 2022. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1375730

ABSTRACT

ABSTRACT Objective: Multidrug-resistant tuberculosis (MDR-TB) is a life-threatening infectious disease. Treatment requires multiple antimicrobial agents used for extended periods of time. The present study sought to evaluate the treatment success rate of bedaquiline-based regimens in MDR-TB patients. Methods: This was a systematic review and meta-analysis of studies published up to March 15, 2021. The pooled treatment success rates and 95% CIs were assessed with the fixed-effect model or the random-effects model. Values of p < 0.05 were considered significant for publication bias. Results: A total of 2,679 articles were retrieved by database searching. Of those, 29 met the inclusion criteria. Of those, 25 were observational studies (including a total of 3,536 patients) and 4 were experimental studies (including a total of 440 patients). The pooled treatment success rate was 74.7% (95% CI, 69.8-79.0) in the observational studies and 86.1% (95% CI, 76.8-92.1; p = 0.00; I2 = 75%) in the experimental studies. There was no evidence of publication bias (p > 0.05). Conclusions: In patients with MDR-TB receiving bedaquiline, culture conversion and treatment success rates are high even in cases of extensive resistance.


RESUMO Objetivo: A tuberculose multirresistente (MDR-TB, do inglês multidrug-resistant tuberculosis) é uma doença infecciosa potencialmente fatal. O tratamento exige múltiplos agentes antimicrobianos usados durante longos períodos. O presente estudo buscou avaliar a taxa de sucesso de esquemas terapêuticos com bedaquilina em pacientes com MDR-TB. Métodos: Trata-se de uma revisão sistemática e meta-análise de estudos publicados até 15 de março de 2021. As taxas combinadas de sucesso do tratamento e os IC95% foram avaliados por meio do modelo de efeito fixo ou do modelo de efeitos aleatórios. Valores de p < 0,05 foram considerados significativos para viés de publicação. Resultados: Por meio de buscas eletrônicas em bancos de dados, foram recuperados 2.679 artigos. Destes, 29 preencheram os critérios de inclusão. Destes, 25 eram estudos observacionais (com um total de 3.536 pacientes) e 4 eram estudos experimentais (com um total de 440 pacientes). A taxa combinada de sucesso do tratamento foi de 74,7% (IC95%: 69,8-79,0) nos estudos observacionais e de 86,1% (IC95%: 76,8-92,1; p = 0,00; I2 = 75%) nos estudos experimentais. Não foram encontradas evidências de viés de publicação (p > 0,05). Conclusões: Em pacientes com MDR-TB tratados com bedaquilina, as taxas de conversão da cultura e sucesso do tratamento são altas mesmo em casos de resistência extensa.

8.
China Pharmacy ; (12): 230-235, 2022.
Article in Chinese | WPRIM | ID: wpr-913116

ABSTRACT

OBJECTIVE To compare the anticoagulant effectiveness and safety of new oral anticoagulants (NOACs)and warfarin after heart valve replacement ,and to provide evidence-based reference for clinical drug use. METHODS Retrieved from PubMed,Cochrane Library ,Embase,Web of Science ,CNKI,Wanfang database and VIP ,clinical studies about the use of NOACs versus warfarin after heart valve replacement were collected during the inception to July 2021. After literature screening and data extrac tion,the quality of included randomized controlled trials (RCTs)were evaluat ed by bias risk assessment tool recommended by Cochrane system evaluator manual 5.2.0. After the quality of the included cohort studies was evaluated by Newcastle-Ottawa scale (NOS),RevMan 5.3 software was used for meta-analysis and sensitivity analysis. RESULTS A E-mail:carolmeng_0813@163.com total of 9 studies involving 4 962 patients were included ,of which 7 were RCTs and 2 were cohort studie s. Results of meta-analysis showed that after biological valve replacement/repair ,the incidence of stroke and systemic embolism (SSE)[OR=0.71,95%CI(0.52,0.97),P=0.03],major bleeding [OR =0.40,95%CI (0.30,0.54),P<0.000 01] and intracranial hemorrhage [OR =0.20,95%CI(0.04,0.95),P=0.04] in trial group were significantly lower than warfarin group ;there was no significant difference in all-cause mortality between 2 groups [OR =1.25,95%CI(0.88, 1.79),P=0.22]. After mechanical valve replacement/repair ,there were no significant difference in the incidence of SSE [OR =1.52, 95%CI(0.04,60.29),P=0.82] or all-cause mortality [OR =0.26,95%CI(0.04,1.84),P=0.18] between 2 groups. The results of subgroup analysis according to the follow-up time showed that after biological valve replacement/repair ,the incidence of SSE in trial group was significantly lower than that in control group when the follow-up time was ≤3 months [OR =0.20,95%CI(0.06, 0.74),P=0.03];but there was no significant difference in the incidence of major bleeding between 2 groups [OR =0.67,95%CI (0.19,2.38),P=0.53];when the follow-up time was longer than 3 months,there was no statistical significance in the incidence of SSE between 2 groups [OR =0.74,95%CI(0.54,1.02),P=0.07],while the incidence of major bleeding in trial group was significantly lower than control group [OR =0.39,95%CI(0.29,0.52),P<0.001]. Subgroup analysis by study type showed that after biological valve replacement/repair ,the incidence of SSE in the RCT in trial group was significantly lower than that in control group [OR =0.51,95%CI(0.29,0.92),P=0.03],but there was no significant difference in the incidence of major bleeding between 2 groups[OR=0.58,95%CI(0.33,1.03),P=0.06]. In cohort study ,there was no significant difference in the incidence of SSE between 2 groups [OR =1.03,95%CI(0.40,2.66),P=0.95],while the incidence of major bleeding in trial group was significantly lower than control group [OR =0.20,95%CI(0.06,0.74),P<0.001]. Sensitivity analysis results showed that the results of the above-mentioned meta-analysis were relatively robust. CONCLUSIONS For the patients underwent biological valve replacement/repair,the effectiveness and safety of NOACs are better than or similar to those of warfarin ;for the patients underwent mechanical valve replacement/repair ,there is no significant difference in the effectiveness and safety between NOACs and warfarin.

9.
China Pharmacy ; (12): 209-216, 2022.
Article in Chinese | WPRIM | ID: wpr-913113

ABSTRACT

OBJECT IVE To evaluate the efficacy ,safety and cost-effectiveness of Qili qiangxin capsule in the treatment of chronic heart failure ,and provide reference for drug selection and evaluation in relevant institutions. METHODS Meta-analysis was performed to investigate clinical efficacy and safety of Qili qiangxin capsule combined with routine treatment (combined treatment group)versus routine treatment (routine treatment group )in the treatment of chronic heart failure. From the perspective of Chinese health care system ,a decision tree model was constructed. The time horizon of the model was 1 year. The effective rate obtained by meta-analysis was taken as the effect parameter ,and the total cost was calculated by drug cost and hospitalization cost ,to evaluate the cost-effectiveness of combined treatment versus routine treatment in the treatment of chronic heart failure. Subgroup analysis was carried out according to the course of treatment and literature quality ,and one-way sensitivity analysis and probability sensitivity analysis were adopted to check the robustness of basic analysis results. RESULTS Total of 72 literatures involving 9 575 patients were included in meta-analysis. Results of meta-analysis showed that effective rate ,left ventricular ejection fraction , N-terminal fragment of the prohomone brain-type natriuretic peptide and 6 minute walking distance in combined treatment group were all better than those of routine treatment group , while its safety was similar to routine therapy. The results of cost-effectiveness analysis showed that the cost of combined therapy was 1 867 yuan higher than that of routine therapy ,patients could get 0.016 QALYs more ,and the incremental cost-effectiveness ratio (ICER)was 117 861 yuan/QALY. If only high-quality literature were included for meta-analysis and the effectiveness parameters were obtained ,the ICERs of the combined therapy versus routine therapy were 102 162 yuan/QALY(based on all high-quality literature )and 72 354 yuan/QALY(based on high-quality literature with treatment course of 24 weeks). The results of the probability sensitivity analysis showed that taking twice China ’s per capita gross domestic product in 2020 as the willingness to pay threshold ,the probability of cost-effectiveness for Qili qiangxin capsule combined with routine therapy was 67.1% . CONCLUSIONS Compared with routine therapy ,Qili qiangxin capsule combined with routine therapy has better clinical efficacy ,equivalent safety and cost-effective.

10.
Article in Chamorro | WPRIM | ID: wpr-904812

ABSTRACT

Objective@#To investigate the clinical efficacy of Nd: YAG laser combined with 3% acyclovir cream in the treatment of herpes labialis. @* Methods @# A total of 72 patients with herpes labialis were enrolled. According to the random number table method, the patients were divided into an observation group and a control group with 36 patients in the observation group and 36 patients in the control group. The Nd: YAG laser combined with 3% acyclovir cream was administered to the observation group, while 3% acyclovir cream was administered to the control group. The total effective rate, scab, scab removal, analgesic time, and quality of life were compared between the two groups.@*Results@# 7 days after treatment, the total effective rate of clinical treatment in the control group was 27 patients (75%), and that in the observation group was 34 patients (94.4%); the contrast difference was statistically significant (P < 0.05). Compared with those in the control group, the crusting, prolapse and analgesic time of the observation group were shorter, and the differences were statistically significant (P < 0.05). Compared with the control group, the observation group had higher quality of life scores, and there was a statistical significance (P < 0.05). @*Conclusion @#For patients with herpes labialis, using Nd: YAG laser combined with 3% acyclovir cream treatment can significantly improve the quality of life of patients and accelerate the speed of patient rehabilitation.

11.
Acta Pharmaceutica Sinica B ; (6): 2417-2428, 2022.
Article in English | WPRIM | ID: wpr-929405

ABSTRACT

Glycosite-specific antibody‒drug conjugatess (gsADCs), harnessing Asn297 N-glycan of IgG Fc as the conjugation site for drug payloads, usually require multi-step glycoengineering with two or more enzymes, which limits the substrate diversification and complicates the preparation process. Herein, we report a series of novel disaccharide-based substrates, which reprogram the IgG glycoengineering to one-step synthesis of gsADCs, catalyzed by an endo-N-acetylglucosaminidase (ENGase) of Endo-S2. IgG glycoengineering via ENGases usually has two steps: deglycosylation by wild-type (WT) ENGases and transglycosylation by mutated ENGases. But in the current method, we have found that disaccharide LacNAc oxazoline can be efficiently assembled onto IgG by WT Endo-S2 without hydrolysis of the product, which enables the one-step glycoengineering directly from native antibodies. Further studies on substrate specificity revealed that this approach has excellent tolerance on various modification of 6-Gal motif of LacNAc. Within 1 h, one-step synthesis of gsADC was achieved using the LacNAc-toxin substrates including structures free of bioorthogonal groups. These gsADCs demonstrated good homogeneity, buffer stability, in vitro and in vivo anti-tumor activity. This work presents a novel strategy using LacNAc-based substrates to reprogram the multi-step IgG glycoengineering to a one-step manner for highly efficient synthesis of gsADCs.

12.
Acta Pharmaceutica Sinica B ; (6): 2462-2478, 2022.
Article in English | WPRIM | ID: wpr-929391

ABSTRACT

Drug optimization, which improves drug potency/specificity by structure‒activity relationship (SAR) and drug-like properties, is rigorously performed to select drug candidates for clinical trials. However, the current drug optimization may overlook the structure‒tissue exposure/selectivity-relationship (STR) in disease-targeted tissues vs. normal tissues, which may mislead the drug candidate selection and impact the balance of clinical efficacy/toxicity. In this study, we investigated the STR in correlation with observed clinical efficacy/toxicity using seven selective estrogen receptor modulators (SERMs) that have similar structures, same molecular target, and similar/different pharmacokinetics. The results showed that drug's plasma exposure was not correlated with drug's exposures in the target tissues (tumor, fat pad, bone, uterus), while tissue exposure/selectivity of SERMs was correlated with clinical efficacy/safety. Slight structure modifications of four SERMs did not change drug's plasma exposure but altered drug's tissue exposure/selectivity. Seven SERMs with high protein binding showed higher accumulation in tumors compared to surrounding normal tissues, which is likely due to tumor EPR effect of protein-bound drugs. These suggest that STR alters drug's tissue exposure/selectivity in disease-targeted tissues vs. normal tissues impacting clinical efficacy/toxicity. Drug optimization needs to balance the SAR and STR in selecting drug candidate for clinical trial to improve success of clinical drug development.

13.
Acta Pharmaceutica Sinica B ; (6): 2533-2549, 2022.
Article in English | WPRIM | ID: wpr-929380

ABSTRACT

Induction of immunogenic cell death promotes antitumor immunity against cancer. However, majority of clinically-approved drugs are unable to elicit sufficient ICD. Here, our study revealed that mitochondria-targeted delivery of doxorubicin (DOX) massively amplified ICD via substantial generation of reactive oxygen species (ROS) after mitochondrial damage. The underlying mechanism behind increased ICD was further demonstrated to be ascribed to two pathways: (1) ROS elevated endoplasmic reticulum (ER) stress, leading to surface exposure of calreticulin; (2) ROS promoted release of various mitochondria-associated damage molecules including mitochondrial transcription factor A. Nevertheless, adaptive upregulation of PD-L1 was found after such ICD-inducing treatment. To overcome such immunosuppressive feedback, we developed a tumor stimuli-responsive nano vehicle to simultaneously exert mitochondrial targeted ICD induction and PD-L1 blockade. The nano vehicle was self-assembled from ICD-inducing copolymer and PD-L1 blocking copolymer, and possessed long-circulating property which contributed to better tumor accumulation and mitochondrial targeting. As a result, the nano vehicle remarkably activated antitumor immune responses and exhibited robust antitumor efficacy in both immunogenic and non-immunogenic tumor mouse models.

14.
Frontiers of Medicine ; (4): 39-55, 2022.
Article in English | WPRIM | ID: wpr-929196

ABSTRACT

Vaccination is the most effective and feasible way to contain the Coronavirus disease 2019 (COVID-19) pandemic. The rapid development of effective COVID-19 vaccines is an extraordinary achievement. This study reviewed the efficacy/effectiveness, immunogenicity, and safety profile of the 12 most progressed COVID-19 vaccines and discussed the challenges and prospects of the vaccine-based approaches in a global crisis. Overall, most of the current vaccines have shown safety and efficacy/effectiveness during actual clinical trials or in the real-world studies, indicating a development of pandemic control. However, many challenges are faced by pandemic control in terms of maximizing the effect of vaccines, such as rapid vaccine coverage, strategies to address variants with immune escape capability, and surveillance of vaccine safety in the medium- and long-terms.


Subject(s)
COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Humans , Pandemics/prevention & control , SARS-CoV-2 , Vaccination
15.
Article in English | WPRIM | ID: wpr-929022

ABSTRACT

OBJECTIVES@#Hepatitis B virus related acute-on-chronic liver failure (HBV-ACLF) is the most common type of liver failure in China, with a high mortality. Early rapid reduction of HBV-DNA load can improve the survival rate of HBV-ACLF patients. At present, the commonly used drugs are nucleoside (acid) analogues, such as entecavir (ETV), tenofovir, and so on. The newly listed tenofovir alafenamide fumarate (TAF) has attracted great attention of clinicians because of its stronger antiviral effect, higher transaminase normalization rate, better bone and kidney safety, and zero drug resistance. However, there are few clinical research data on the efficacy and safety of TAF in the treatment of Chinese HBV-ACLF patients, and there is a lack of pharmacoeconomic evaluation. This study aims to compare the efficacy, safety, and cost-effectiveness between TAF and ETV in patients with HBV-ACLF.@*METHODS@#The data were collected from 196 HBV-ACLF patients (80 patients in the TAF group and 116 patients in the ETV group) who were hospitalized in Xiangya Hospital, Central South University from May 2020 to March 2021. Biochemistry and virology were detected before and after treatment (at baseline, Week 2, 4, and 12). Clinical features, disease prognosis, and cost-effectiveness were compared between the 2 groups. According to the baseline, HBV-ACLF patients were divided into 4 stages including pre-liver failure stage, early stage, medium stage, and end stage. And the liver transplantation rate and mortality was also compared. Pharmacoeconomic evaluation was taken using cost-effectiveness analysis and cost minimization analysis..@*RESULTS@#After 4 weeks of treatment, there were no significant differences in the efficacy (liver function, viral load) between the 2 groups (all P>0.05). The TAF group showed lower creatinine [(80.35±18.77) μmol/L vs (105.59±82.32) μmol/L, P<0.05] and higher estimated glomerular filtration rate (eGFR) levels [(95.65±23.21) mL/(min·1.73 m2) vs (82.68±26.32) mL/(min·1.73 m2), P<0.05] than the ETV group. After 12 weeks of treatment, the analysis of overall the liver transplantation rate and mortality between the 2 groups showed similar conclusion. However, the TAF group had a lower the liver transplantation rate and mortality than the ETV group in patients with pre-liver failure (0vs13.89%, P<0.05). No evident distinction was found in the liver transplantation rate and mortality during the early, medium, or end stages of liver failure (13.04% vs 17.65%, 37.50% vs 37.04%, and 54.55% vs 68.42%, respectively). Ratio of cost to effectiveness in the ETV group was higher than that in the TAF group.@*CONCLUSIONS@#TAF is not more efficient than ETV group in improving liver function and reducing viral load for HBV-ACLF patients and they also show similar safety. However, TAF has a greater advantage over ETV not only in preserving renal function, but also in reducing the liver transplantation rate and mortality in patients with pre-liver failure. TAF can provide economic benefit to patients with HBV-ACLF.


Subject(s)
Acute-On-Chronic Liver Failure/drug therapy , Alanine/therapeutic use , Antiviral Agents/therapeutic use , Guanine/analogs & derivatives , Hepatitis B virus/genetics , Hepatitis B, Chronic/drug therapy , Humans , Tenofovir/analogs & derivatives , Treatment Outcome
16.
Article in English | WPRIM | ID: wpr-929019

ABSTRACT

OBJECTIVES@#Genetic mutation is one of the important causes for tumor genesis and development, but genetic mutation in nasopharyngeal carcinoma (NPC) has rarely been reported. This study explored the role of phosphatidylinositol 3 kinase-protein kinase B (PI3K-Akt), mammalian target of rapamycin (mTOR), and adenosine 5'-monophosphate (AMP)-activated protein kinase (AMPK) signaling pathway in the efficacy and prognosis in patients with NPC.@*METHODS@#A total of 31 patients with advanced NPC, who came from the Affiliated Cancer Hospital of Xiangya School of Medicine of Central South University/Hunan Provincial Cancer Hospital, were enrolled. All of the exons of 288 genes, introns of 38 genes and promoters or fusion breakpoint regions from the nasopharyngeal biopsy tissues before treatment were detected by the gene sequencing platform Illumina NextSeq CN500. The coding regions of 728 genes were carried out a high-depth sequencing of target region capture, and the 4 variant types of tumor genes (including point mutations, insertion deletions of small fragments, copy number variations, and currently known fusion genes) were detected. All of 31 patients received platinum-based induction chemotherapy combined with concurrent chemoradiotherapy and were followed up for a long time.@*RESULTS@#The 3-year regional failure-free survival (RFFS) and disease-free survival (DFS) in patients with PI3K-Akt pathway mutation were significantly lower than those in unmutated patients (χ2=6.647, P<0.05). The 3-year RFFS and DFS in patients with mTOR pathway mutations were significantly lower than those in unmutated patients, and there was significant difference (χ2=5.570, P<0.05). The rate of complete response (CR) in patients with unmutated AMPK pathway was significantly higher than that in patients with mutation at 3 months after treatment (P<0.05), and the 3-year RFFS and DFS in patients with AMPK pathway mutation were significantly lower than those in unmutated patients (χ2=4.553, P<0.05). PI3K-Akt/mTOR/AMPK signaling pathway mutations and pre-treatment EB virus DNA copy numbers were independent prognostic factors for 3-year RFFS and DFS in patients with NPC (both P<0.05).@*CONCLUSIONS@#The NPC patients with PI3K-Akt/mTOR/AMPK signaling pathway mutation have poor prognosis, and the detection of PI3K-Akt, mTOR, AMPK driver genes and signaling pathways by next-generation sequencing is expected to provide new idea for basic research and targeted therapy of NPC.


Subject(s)
AMP-Activated Protein Kinases/metabolism , DNA Copy Number Variations , Humans , Mutation , Nasopharyngeal Carcinoma/genetics , Nasopharyngeal Neoplasms/metabolism , Phosphatidylinositol 3-Kinases/metabolism , Prognosis , Proto-Oncogene Proteins c-akt/metabolism , Signal Transduction , Sirolimus , TOR Serine-Threonine Kinases/metabolism
17.
Article in English | WPRIM | ID: wpr-928957

ABSTRACT

OBJECTIVE@#To assess the efficacy and safety of mulberry twig alkaloids (Sangzhi alkaloids, SZ-A) for treatment of type 2 diabetes in a randomized, double-blind, placebo-controlled multicenter clinical trial.@*METHODS@#A total of 200 patients were randomized to receive SZ-A (n=100) or placebo (n=100) for 16 weeks. The data analysis system for electronic data capture clinical trial central randomization system was used for randomization and dispensing of drugs. The primary outcome was the change in glycosylated hemoglobin (HbA1c) level. The secondary outcome included the proportions of cases with HbA1c <7.0% and HbA1c <6.5%, fasting blood glucose (FBG), postprandial blood glucose (PBG), area under curve for the PBG (AUC0-2h), body weight, and body mass index (BMI). Adverse events (AEs), severe adverse events (SAEs), treatment-related adverse events (TAEs), gastrointestinal disorders (GDs), blood pressure, routine blood tests, and liver and kidney function were monitored.@*RESULTS@#Compared with baseline, the change of HbA1c at week 16 was -0.80% (95% CI: -0.98% to -0.62%) and -0.09% (95% CI: -0.27% to 0.09%) in SZ-A group and placebo group, respectively. The proportion of patients with HbA1c <7% and <6.5% was higher in the SZ-A group than in the placebo group (46.8% vs. 21.6% and 29.9% vs. 10.8%). The observed values and changes in FBG, 1 h-PBG, 2 h-PBG, and AUC0-2h differed significantly between groups (P<0.001), but differences were not significant in body weight and BMI (P>0.05). The incidence rates of AEs, TAEs, and GDs differed significantly between groups (P=0.010, P=0.005, and P=0.006, respectively), whereas the incidence rates of SAEs showed no significant differences between groups (P=1.000).@*CONCLUSION@#SZ-A are effective and safe for treatment of type 2 diabetes. The protocol was registered in http://www.chictr.org.cn/showproj.aspx?proj=60117 (ChiCTR2000038550).


Subject(s)
Alkaloids , Blood Glucose , Diabetes Mellitus, Type 2/drug therapy , Double-Blind Method , Glycated Hemoglobin A , Humans , Hypoglycemic Agents/therapeutic use , Morus , Tablets/therapeutic use , Treatment Outcome
18.
Article in Chinese | WPRIM | ID: wpr-928781

ABSTRACT

BACKGROUND@#Primary lung squamous carcinoma that produces alpha-fetoprotein (AFP) is rare and only four related cases have been reported so far. The specific reasons for elevated serum level of AFP and effective treatment regimens for AFP-producing lung squamous carcinoma are not clear. This paper reports the diagnosis and treatment of AFP-producing lung squamous carcinoma so as to provide some references for similar cases in clinical practice.@*METHODS@#The diagnosis and treatment of an AFP-producing lung squamous carcinoma patient admitted to the Shandong Cancer Hospital on October 23, 2020 was retrospectively analyzed, and literatures were reviewed.@*RESULTS@#A 52-year-old male patient was diagnosed as T4N3M0 stage, IIIc right upper lobe lung squamous cell carcinoma with mediastinal lymph node metastasis and multiple metastases in the lung. The main tumor marker was abnormally increased serum AFP. After the rapid progression of two lines chemotherapy, the patient was given anlotinib combined with carrizumab as third-line treatment. The efficacy evaluation reached to partial response (PR) and stable disease (SD) after 2 and 4 cycles of treatment, respectively. The treatment regimen was replaced with albumin paclitaxel plus carrizumab due to gastrointestinal bleeding after the fifth cycle. The patient's condition was under continuous control.@*CONCLUSIONS@#The AFP-producing lung squamous carcinoma patient had a good response to anlotinib and immunotherapy in the case report, which may provide some guidances for the clinical practice and the research on AFP-producing lung squamous carcinoma.


Subject(s)
Carcinoma, Non-Small-Cell Lung , Carcinoma, Squamous Cell/drug therapy , Humans , Lung , Lung Neoplasms/drug therapy , Male , Middle Aged , Retrospective Studies , alpha-Fetoproteins
19.
Article in Chinese | WPRIM | ID: wpr-928750

ABSTRACT

OBJECTIVE@#To investigate the difference of therapeutic effects on children with thalassemia at different age after hematopoietic stem cell transplantation.@*METHODS@#The clinical data of children with thalassemia treated in our hospital were retrospectively analyzed. The children were divided into 2-5 years old group and 6-12 years old group. The success rate of implantation, transplant-related mortality, GVHD incidence, and other transplant-related complications, as well as thalassemia-free survival (TFS) were compared between the two groups.@*RESULTS@#The incidence of GVHD, hemorrhagic cystitis and severe oral mucositis after transplantation in the 2-5 years old group were significantly lower than those in the 6-12 years old group, while there was no statistically significant difference in the TFS between the two groups.@*CONCLUSION@#Children in the low age (2-5 years old) group show fewer complications and higher quality of life after transplantation, therefore, stem cell transplantation at 2-5 years old is more conducive to rehabilitation of the children with thalassemia.


Subject(s)
Child , Child, Preschool , Graft vs Host Disease/complications , Hematopoietic Stem Cell Transplantation , Humans , Quality of Life , Retrospective Studies , Thalassemia/therapy , beta-Thalassemia/therapy
20.
Article in Chinese | WPRIM | ID: wpr-928698

ABSTRACT

OBJECTIVE@#To evaluate the clinical effect of haploid allogeneic hematopoietic stem cell transplantation(haplo-HSCT) in the treatment of severe aplastic anemia (SAA), and to explore the efficacy different between post-transplant cyclophosphamide (PT/Cy) and standard-dose ATG.@*METHODS@#The clinical data of 38 patients with SAA in our hospital from January 2012 to December 2019 were collected and retrospectively analyzed. The efficacy was evaluated. The patients with haplo-HSCT were divided into low-dose ATG combined with PT/Cy group and standard-dose ATG group, and the blood cell hematopoietic reconstruction time, GVHD incidence, mortality and survival time of the patients in the two groups was compared.@*RESULTS@#Among the 32 patients, hematopoietic reconstitution were detected in 9375%(30/32) recipients. The median time of neutrophil and platelet engraftment was 15(10-22) days and 13(7-30) days, respectively. The incidence of GVHD was 21.89%, the incidence of infection was 93.75%, and the 2-year overall survival rate was 84.38%. The hematopoietic reconstitution time, incidence of GVHD, mortality rate and survival time were no statistical differences between the patients in the two groups(all P>0.05).@*CONCLUSION@#Haplo-HSCT is an effective method for the treatment of SAA,low-dose ATG combined with PT/Cy can lighten the economic burden on patients, it would be a feasible treatment plan for SAA with light side effect.


Subject(s)
Anemia, Aplastic/therapy , Cyclophosphamide , Graft vs Host Disease , Haploidy , Hematopoietic Stem Cell Transplantation , Humans , Retrospective Studies , Transplantation Conditioning
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