Adesão à quimioterapia antineoplásica oral, apoio social e bem- estar de pacientes com câncer cerebral: estudo correlacional / Adhesión a la quimioterapia antineoplásica oral, apoyo social y bienestar de pacientes con cáncer cerebral: estudio correlacional / Adherence to oral antineoplastic chemotherapy, social support and well-being of patients with brain cancer: a correlational study

Objetivos: identificar as percepções sobre o bem-estar, apoio social, intensidade dos sintomas e o seu impacto nas atividades diárias de pacientes com cânceres cerebrais e correlacionar os achados com os níveis de adesão aos quimioterápicos antineoplásicos orais. Método: estudo correlacional e transversal, realizado num ambulatório hospitalar universitário de São Paulo, Brasil, entre 2019 e 2020. Utilizou-se instrumento para caracterização da amostra e escalas específicas. Resultados: 26 participantes, mediana de 36,5 anos, 61,5% sexo masculino, 53,9% diagnosticados com glioblastoma; 73,1% apresentaram adesão, rede de apoio social e índice alto de bem-estar. O escore médio de intensidade dos sintomas foi de baixo para médio, com pior pontuação para preocupação no pior estado. A maior adesão relacionou-se ao apoio afetivo, apoio informação, interação social e apoio emocional. Conclusão: a maioria declarou níveis positivos de bem-estar, suporte social e poucos sintomas. A percepção de apoio social e bem-estar influenciaram positivamente na adesão medicamentosa.

Objetivos: identificar las percepciones sobre el bienestar, apoyo social, intensidad de los síntomas y su impacto en las actividades diarias de pacientes con cánceres cerebrales y correlacionar los resultados con los niveles de adhesión a los quimioterápicos antineoplásicos orales. Método: estudio correlacional y transversal, realizado en un ambulatorio hospitalario universitario de São Paulo, Brasil, entre 2019 y 2020. Se utilizó un instrumento para la caracterización de la muestra y escalas específicas. Resultados: 26 participantes, mediana de 36,5 años, 61,5% sexo masculino, 53,9% diagnosticados con glioblastoma; 73,1% presentaron adhesión, red de apoyo social y índice alto de bienestar. El puntaje promedio de intensidad de los síntomas fue de bajo a medio, con peor puntuación para preocupación en el peor estado. La mayor adhesión se relacionó al apoyo afectivo, apoyo información, interacción social y apoyo emocional. Conclusión: la mayoría declaró niveles positivos de bienestar, apoyo social y pocos síntomas. La percepción de apoyo social y bienestar influyó positivamente en la adhesión medicamentosa.

Objectives: to identify perceptions about well-being, social support, intensity of symptoms and their impact on the daily activities of patients with brain cancers and correlate the findings with levels of adherence to oral antineoplastic chemotherapy. Method: correlational and cross-sectional study, conducted in a university hospital outpatient clinic in São Paulo, Brazil, between 2019 and 2020. An instrument was used to characterize the sample, in addition to specific scales. Results: 26 participants, median 36.5 years, 61.5% male, 53.9% diagnosed with glioblastoma; 73.1% showed adherence, social support network and high well-being index. The mean symptom intensity score was low to medium, with a worse score for worry in the worst state. Greater adherence was related to affective support, information support, social interaction and emotional support. Conclusion: most reported positive levels of well-being, social support and few symptoms. The perception of social support and well-being positively influenced drug adherence.

Uso de anticoagulantes orales directos en pacientes con fibrilación auricular post implante de TAVI: resultados de una encuesta internacional

Background: Transcatheter Aortic Valve Implantation (TAVI) is beneficial in patients with symptomatic severe Aortic Stenosis (AS). There is no consensus about the best anticoagulation strategy for patients with a recent TAVI and with atrial fibrillation (AF). Direct oral anticoagulants (DOACs) are effective to prevent embolic events with a significant lower incidence of bleeding. There is scarce evidence about the use of these drugs in patients undergoing TAVI. Aim: To assess the management of anticoagulation at the moment of discharge of patients with AF and TAVI. Material and Methods: A four question survey was sent to cardiologists involved in TAVI programs in different international centers. Results: The survey was answered by 72 interventional cardiologists. Even with the lack of randomized evidence, in most of the scenarios DOACs are prescribed at discharge in patients with indication for anticoagulation. Also, in patients with high bleeding risk, most cardiologists would perform a left atrial appendage closure. In patients with concomitant coronary artery disease, if a stent was recently implanted, prescription of the combination of a DOAC and one antiplatelet drug was the most common answer. In patients with a former coronary angioplasty, DOAC or Warfarin was the therapy of choice. Conclusions: In the absence of randomized data, interventional cardiologists prescribe DOACs at discharge to patients with AF and TAVI, without following current guidelines in most cases.

Oral Antineoplastics: Treatment Adherence and Medication Beliefs / Antineoplásicos Orais: Adesão ao Tratamento e Crenças sobre os Medicamentos / Agentes Antineoplásicos Orales: Adherencia al Tratamiento y Creencias sobre los Medicamentos

Introduction: Adherence to oral antineoplastics (OA) is an important indicator of therapeutic response related to personal, social, and structural factors. Objective: To determine rates of adherence to OA, investigating possible risk factors for nonadherence and to assess patient beliefs about medication, identifying opportunities for pharmaceutical intervention. Method: An analytical study was conducted with cancer patients using OA in 2015. Adherence to Refills and Medication Scale (ARMS) and Beliefs about Medicines Questionnaire (BMQ) were applied to assess adherence and beliefs about medication and treatment. Mann-Whitney, Chi-square, and Fisher's Exact tests were used for data analysis. Results: A total of 222 patients were interviewed, with a 92.8% adherence rate according to ARMS and 84.7% according to BMQ, in which the necessity-beliefs exceeded the concerns with the treatment and use of OA. Family income, treatment interruption, number and causes of interruptions, depression, and medication possession ratio were the risk factors identified. Comparison of BMQ domains showed that, in the adherent group, patient beliefs in the necessity of the medication exceeded their concerns about it. Conclusion: Understanding the patient's beliefs is a decisive factor in comprehending the risks related to nonadherence as well as in defining strategies to deal with it.

Introdução: A adesão aos antineoplásicos orais (AO) é um importante indicador de resposta terapêutica relacionada a fatores pessoais, sociais e estruturais. Objetivo: Determinar as taxas de adesão aos AO, investigando possíveis fatores de risco para a não adesão, e avaliar as crenças dos pacientes sobre medicamentos, identificando oportunidades de intervenção farmacêutica. Método: Estudo analítico realizado com pacientes com câncer em uso de AO em 2015. Escala de Adesão e Recarga dos Medicamentos (ARMS) e Questionário de Crenças sobre Medicamentos (BMQ) foram aplicados para avaliar a adesão e crenças sobre medicamentos e tratamento. Os testes de Mann-Whitney, qui-quadrado e exato de Fisher foram usados para análise de dados. Resultados: Foram entrevistados 222 pacientes, com taxa de adesão de 92,8%, segundo o ARMS e 84,7%, segundo o BMQ, no qual as crenças de necessidade excederam as preocupações com o tratamento e o uso de AO. Renda familiar, interrupção do tratamento, número e causas das interrupções, depressão e razão de posse de medicamentos foram os fatores de risco identificados. A comparação dos domínios do BMQ demostrou que, no grupo aderente, as crenças dos pacientes sobre a necessidade do medicamento excederam suas preocupações quanto a isso. Conclusão: Considerar as crenças do paciente é um fator decisivo para compreender os riscos relacionados à não adesão, bem como para definir estratégias para lidar com ela.

Introducción: La adherencia a antineoplásicos orales (AO) es un indicador importante de la respuesta terapéutica relacionada con factores personales, sociales y estructurales. Objetivo: Determinar tasas de adherencia a AO, investigar posibles factores de riesgo de incumplimiento y evaluar creencias de los pacientes sobre la medicación, identificando oportunidades para intervención farmacéutica. Método: Estudio analítico con pacientes con cáncer que usaban AO en 2015. Se aplicó Adherencia a la Recogida y Administración de la Medicación (ARMS) y Cuestionario de Creencias sobre Medicación (BMQ) para evaluar el cumplimiento y las creencias sobre medicación y tratamiento. Las pruebas de Mann-Whitney, Chi-cuadrado y Exacto de Fisher se utilizaron para análisis de datos. Resultados: Se entrevistó un total de 222 pacientes, con una tasa de adherencia de 92,8% según ARMS y 84,7% según BMQ, en la cual las creencias de necesidad excedieron preocupaciones con el tratamiento y uso de AO. Ingreso familiar, interrupción del tratamiento, número y causas de interrupciones, depresión y proporción de posesión de medicamentos fueron los factores de riesgo identificados. La comparación de los dominios de BMQ mostró que, en el grupo adherente, las creencias sobre necesidad de la medicación excedieron preocupaciones. Conclusión: La consideración de las creencias del paciente es un factor decisivo para comprender los riesgos relacionados con la no adherencia, así como para definir estrategias para afrontarla.

Práticas educativas junto às famílias de crianças e adolescentes em quimioterapia antineoplásica oral: revisão integrativa / Prácticas educativas con familias de niños y adolescentes en quimioterapia antineoplástica oral: revisión integrativa / Educative practices with families of children and teenagers under oral antineoplastic chemotherapy: an integrative review

Objetivo: Analisar, nas produções científicas, as práticas educativas empregadas para orientação dos familiares e cuidadores de crianças e adolescentes com câncer quanto ao tratamento quimioterápico antineoplásicos orais. Método: Revisão integrativa da literatura disponível nas bases de dados LILACS via BVS, SCIELO, CINAHL, PUBMED e EMBASE, realizada no mês de setembro de 2020. Foram incluídos artigos originais que abordassem a temática. Excluíram-se aqueles que focavam práticas educativas direcionadas a profissionais, pacientes adultos e outros tipos de quimioterapia. Resultados: A amostra foi constituída de cinco artigos internacionais. As evidências foram agrupadas de acordo com o tipo de prática educativa: consulta clínica, orientações em grupo com dinâmicas, programa de manutenção domiciliar e produção de materiais educativos impressos. Considerações Finais: A educação em saúde é essencial no preparo de familiares de crianças e adolescentes em quimioterapia antineoplásica oral e a equipe de enfermagem deve desenvolver treinamentos e orientações que promovam um cuidado integral, seguro e resolutivo(AU)

Objective: This study aims to analyze the educative practices applied to the orientation of families and caregivers of children and teenagers with cancer under oral antineoplastic chemotherapy treatment. Method: In this study an integrative review of the available literature was performed through the utilization of databases such as LILACS by BVS, SCIELO, CINAHL, PUBMAD and EMBASE on September of 2020. Original articles that approached this subject were selected. Articles that focused on educative practices directed to professionals, adult patients and other types of chemotherapy were excluded. Results: A sample of five international articles was taken. The evidences were grouped according to the type of educative practice: clinical appointment, group orientations with dynamics, homecare program and production of printed educative material. Final considerations: Health education is essential in the preparation of families of children and teenagers that have cancer and are under oral antineoplastic chemotherapy treatment. The nursing team should develop training sessions and orientation that promote comprehensive, safe and resolving care.(AU)

Objetivo: Analizar, en las producciones científicas, las prácticas educativas empleadas en la orientación de las familias y de los cuidadores de niños y adolescentes con respecto al tratamiento con quimioterapia antineoplásica oral. Método: Revisión integradora de la literatura disponible en las bases de datos LILACS vía BVS, SCIELO, CINAHL, PUBMED y EMBASE logadas en el mes de septiembre de 2020. Fueran inclusos artículos originales que abordaron el tema. Se excluyeron los que eran centrados en prácticas educativas dirigidas a profesionales, pacientes adultos y otros tipos de quimioterapia. Resultados: La muestra se constituyó de cinco artículos internacionales. Las evidencias fueran agrupadas de acordo con el tipo de práctica educativa: citas clínicas, orientaciones grupales con dinámica, programa de atención domiciliaria y producción de materiales educativos impresos. Consideraciones finales: La educación en salud es esencial en el preparo de las familias de niños y adolescentes en tratamiento con quimioterapia antineoplásica oral y el equipo de enfermería debe desarrollar capacitaciones y pautas que promuevan una atención integral, segura y resolutiva(AU)

Prevención del stroke en fibrilación auricular. Hallazgos del registro GLORIA-AF / Stroke Prevention In Atrial Fibrillation. Findings From The Gloria-Af Registry

RESUMEN Introducción: El GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) es un registro internacional, prospectivo, en tres fases, para determinar la seguridad y eficacia del dabigatrán en pacientes con fibrilación auricular no valvular recientemente diagnosticada, en riesgo de stroke. La fase II empezó cuando el dabigatrán, el primer anticoagulante oral no antagonista de la vitamina K (NOAC) estuvo disponible. Objetivos: Describir los datos clínicos basales de la fase II en la población general y el seguimiento a 2 años de aquellos que recibieron dabigatrán. Material y Métodos: Se reclutaron un total de 15 644 pacientes, de los cuales 15 308 fueron elegibles y 4873 recibieron dabigatrán. Se analizaron las características de la fibrilación auricular, los hallazgos en el seguimiento y las enfermedades concomitantes. Los datos fueron analizados usando estadísticas descriptivas. Resultados: Del total de pacientes elegibles, el 45,5% eran mujeres, con una edad promedio de 71 (rango intercuartilo: 64-78) años. Los pacientes eran de Europa (47,9%), América del Norte (22,2%), Asia (20,1%), América Latina (6,0%) y Medio Oriente/ África (3,9%). La mayoría se encontraba en alto riesgo de stroke (CHA2DS2-VASc score >2; 86,1%); un 13,9% tuvieron riesgo moderado (CHA2DS2-VASc score >1). El 80,3% recibieron anticoagulantes orales; de ellos, el 47,9% recibieron NOAC y el 32,4%, antagonistas de la vitamina K (VKA); 12,0% recibieron agentes antiagregantes plaquetarios y el 7,6% no recibieron tratamiento antitrombótico. A 2 años de seguimiento, el 70,5% permanecieron en dabigatrán. Conclusiones: Los datos de la fase II del registro GLORIA-AF demostraron que, en FA no valvular, los NOAC han sido ampliamente adoptados en la práctica clínica y fueron más frecuentemente prescriptos que los VKA. No obstante, una gran proporción de pacientes en todo el mundo permanecieron sin tratamiento.

ABSTRACT Background: GLORIA-AF is a prospective, global, 3-phase registry program to determine the safety and effectiveness of dabigatran in patients with newly diagnosed non-valvular atrial fibrillation at risk of stroke. Phase II began when dabigatran, the first non-vitamin K antagonist oral anticoagulant (NOAC), became available. Objectives: To describe phase II baseline clinical data in the general population and 2-year follow-up of those patients treated with dabigatran. Methods: A total of 15,644 patients were enrolled, 15,308 of whom were eligible and 4,873 received dabigatran. Atrial fibrillation disease characteristics, follow-up findings and concomitant diseases were collected. Data were analyzed using descriptive statistics. Results: Of the total eligible patients, 45.5% were female; median age was 71.0 (interquartile range: 64, 78) years. Patients were from Europe (47.9%), North America (22.2%), Asia (20.1%), Latin America (6.0%), and the Middle East/Africa (3.9%). Most had high stroke risk (CHA2DS2-VASc score ≥2; 86.1%); 13.9% had moderate risk (CHA2DS2-VASc =1). Overall, 80.3% received oral anticoagulants, of whom 47.9% received NOACs and 32.4% vitamin K antagonists (VKA); 12.0% received anti-platelet agents; and 7.6% received no antithrombotic treatment. At 2-year follow-up, 70.5% remained on dabigatran. Conclusions: Data from GLORIA-AF phase II showed that in non-valvular AF, NOACs have been highly adopted in clinical practice, becoming more frequently prescribed than VKAs. Worldwide, however, a large proportion of patients remain undertreated.

Efficacy and safety of beta carotones in treatment of oral leukoplakia: systematic review and meta-analysis / Eficacia y seguridad de las betacarotonas en el tratamiento de la leucoplasia oral: revisión sistemática y metanálisis

Objectives: A systematic review was conducted to evaluate effectiveness and safety of beta carotenes for the treatment of oral leukoplakia regarding clinical resolution and prevention of malignant transformation. Material and Methods: The systematic search was conducted in three electronic databases and the study's selection was performed according to pre-set eligibility criteria. Four studies evaluating the efficacy of beta carotenes in oral leukoplakia compared to placebo were included in the review; three of which were assigned for quantitative analysis. Data were extracted, tabulated, quality assessed and statistically analyzed. Results: The meta-analysis revealed that when comparing clinical resolution the beta carotene group favored was favored compared to placebo, with statistically significant difference. However, a meta-analysis comparing beta carotene and placebo groups regarding malignant transformation as a primary outcome failed to show any significant benefit. Furthermore, results showed evidence of beta carotene safety. Conclusion: the overall quality of evidence about efficacy of beta carotene in oral leukoplakia treatment was not high. However, given the obvious safety of this agent, data suggests it could have a promising effect in clinical improvement of oral leukoplakia lesions. However, no evidence supporting its benefits in reducing risk of malignant transformation in these lesions was found. Therefore, further long term, well designed randomized clinical trials are highly recommended.

Objetivos: Se realizó una revisión sistemática para evaluar la efectividad y la seguridad de los betacarotenos para el tratamiento de la leucoplasia oral en relación con la resolución clínica y la prevención de la transformación maligna. Material y Métodos: la búsqueda sistemática se realizó en tres bases de datos electrónicas y la selección del estudio se realizó de acuerdo con los criterios de elegibilidad preestablecidos. En la revisión se incluyeron cuatro estudios que evaluaban la eficacia de los betacarotenos en la leucoplasia oral en comparación con el placebo; tres de los cuales fueron asignados para el análisis cuantitativo. Los datos fueron extraídos, tabulados, su calidad evaluada y analizados estadísticamente. Resultados: El metanálisis reveló que al comparar la resolución clínica, el grupo de betacaroteno fue favorecido en comparación con el placebo, con una diferencia estadísticamente significativa. Sin embargo, un metaanálisis que comparó los grupos de betacaroteno y placebo con respecto a la transformación maligna como resultado primario no mostró ningún beneficio significativo. Además, los resultados mostraron evidencia de seguridad de betacaroteno. Conclusión: La calidad general de la evidencia sobre la eficacia del betacaroteno en el tratamiento de la leucoplasia oral no es alta. Sin embargo, dada la obvia seguridad de este agente, los datos sugieren que podría tener un efecto prometedor en la mejora clínica de las lesiones de leucoplasia oral. Sin embargo, no se encontraron pruebas que respalden sus beneficios en la reducción del riesgo de transformación maligna en estas lesiones. Por lo tanto, se recomiendan ensayos clínicos aleatorios bien diseñados a largo plazo.

Determination of Mirabegron in rat plasma by UPLC-MS/MS after oral and intravenous administration

SUMMARY Mirabegron is a kind of β3 adrenergic receptor agonist which is an effective drug for the treatment of overactive bladder. In this research, a UPLC-MS/MS method is developed and validated for the study of mirabegron pharmacokinetic in rats. A protein precipitation method is applied for sample preparation with acetonitrile. m/z 397.3→379.6, m/z 326.4→121.0 for mirabegron, tolterodine (IS), respectively in the positive ion mode was performed for quantitation. The method is reliable and reproducible in our study (intra-day precision≤11.06%, inter-day precision≤11.43%) with concentration curves linear from 5 to 2500 ng/mL(R2>0.999). Stability studies demonstrated that mirabegron was stable under a variety of storage conditions. This method was successfully applied for determining mirabegron in rats after oral and intravenous administration.

RESUMO Mirabegron é um tipo de agonista do receptor adrenérgico beta 3 que demonstra eficácia no tratamento de bexiga hiperativa. Nesta pesquisa, o método UPLC-MS/MS é desenvolvido e validado para o estudo da farmacocinética mirabegron em ratos. Um método de precipitação de proteínas é aplicado para a preparação de amostras com acetonitrilo. 397.3 → 379.6 M / Z, M / Z 326.4 → 121.0 para mirabegron, tolterodina (IS), respectivamente, para o íon positivo foi realizado para quantificação. O método é fiável e reprodutível em nosso estudo (precisão intradia ≤ 11,06%; precisão entredia ≤ 11.43%), com curvas de concentração linear de 5 a 2 ng/ml (R2 > 0,999). Estudos de estabilidade demonstraram que mirabegron permanece estável sob uma variedade de condições de armazenamento. Este método foi aplicado com sucesso para a determinação de mirabegron em ratos após administração oral e intravenosa.

Potential drug-food interactions in patients hospitalized in the Cardiology Unit / Potenciais interações fármaco-alimento em pacientes internados no Setor de Cardiologia

ABSTRACT Objective To analyze potential Drug-Food Interactions identified in prescriptions of patients admitted to the Cardiology Unit of a university hospital. Methods This is a descriptive, cross-sectional quantitative study carried out in the Cardiology Unit of a university hospital in the city of Rio de Janeiro, Brazil. Data collection took place in archived medical records of hospitalized patients between August and September, 2016. Results In each prescription, there were on average 7.5 drugs mentioned (Standard Deviation of 2.1). Most were tablets (93%) and antihypertensive drugs (40%). Two hundred and fifty two potential Drug-Food Interactions were identified. Acetylsalicylic acid and omeprazole were the most potentially interactive drugs. Conclusion Drug-Food Interactions occur with commonly used drugs, for example omeprazole and acetylsalicylic acid. However, health teams do not know or identify a substantial part of interactions. This factor leads to an exposure to risks related to changes in drug response and patient safety.

RESUMO Objetivo Analisar as potenciais interações fármaco-alimento identificadas a partir das prescrições medicamentosas de pacientes internados no Serviço de Cardiologia de um Hospital Universitário. Métodos Trata-se de um estudo quantitativo, descritivo e transversal, realizado em uma unidade de internação cardiológica de um Hospital Universitário localizado no município do Rio de Janeiro. A coleta de dados ocorreu em prontuários arquivados de pacientes internados entre agosto e setembro de 2016. Resultados Em cada prescrição haviam em média 7,5 medicamentos, desvio padrão de 2,1, sendo a maioria comprimidos (93%) e da classe dos anti-hipertensivos (40%). Identificou-se 252 potenciais interações fármaco-alimento, sendo o ácido acetilsalicílico e omeprazol os medicamentos de maior potencialidade de interação. Conclusão As interações fármaco-alimento ocorrem com medicamentos comumente utilizados, a exemplo do omeprazol e ácido acetilsalicílico. No entanto, parte substancial das interações não são conhecidas ou identificadas pela equipe de saúde, colaborando para exposições aos riscos de alterações na resposta medicamentosa e na segurança do paciente.

Clinical study on treatment of radiation proctitis with Bupi-Qingchang recipe combined with Chinese herbal enema / 国际中医中药杂志

Objective To evaluate the efficacy of Bupi-Qingchang recipe combined with traditional Chinese medicine enema on the patients with radiation proctitis.Methods Eighty patients with radioactive proctitis who met the inclusion criteria were randomly divided into two groups,40 in each group.The control group was treated with western medicine combined with enema,and the observation group was treated with oral spleen and clearing spleen combined with traditional Chinese medicine enema.Symptoms were scored before and after treatment from abnormal sensation of bowel movement,blood in stool,stool traits and frequency,abdominal pain;TNF-α,IL-8,IL-6,IL-10 levels were detected by ELISA.The intestinal mucosal healing and recurrence were observed by microscopy.Results After treatment,the serum TNF-α (1.18 ± 0.61 ng/ml vs.1.78 ± 0.66 ng/ml,t=4.860),IL-6 (2.52 ± 0.75 ng/ml vs.3.02 ± 0.81 ng/ml,t=3.297),IL-8 (2.51 ± 0.68 ng/ml vs.3.01 ± 0.82 ng/ml,t=3.417),IL-10 (0.56 ± 0.25 ng/ml vs.0.89 ± 0.29 ng/ml,t=6.275) in the observation group were significantly lower than those in the control group (P＜0.01).The total scores of abdominal pain,blood in the stool,stool characteristics and frequency,abnormal feeling of defecation and symptoms were significantly lower in the observation group than in the control group (t values were 8.108,2.085,4.965,7.865,9.586,P＜0.01 or P＜0.05).The total effective rate was 92.5％ (37/40) in the observation group and 67.5％ (27/40) in the control group.The difference between the two groups was statistically significant (x2=7.813,P＜0.01).The intestinal mucosa of the observation group was treated.The healing rate was significantly better than that of the control group (x2=15.535,P＜0.01),and the recurrence rate was significantly lower than that of the control group (x2=10.912,P＜0.01).Conclusions The Bupi-Qingchang recipe combined with traditional Chinese medicine enema can improve the clinical symptoms of patients with radiation proctitis,reduce inflammation,reduce recurrence and improve curative effect.

Comparison of the efficacy of oral versus intravascular magnesium in the prevention of hypomagnesemia and arrhythmia after cabg

Abstract Objective: Cardiac arrhythmias are a common challenge following open-heart surgeries. Hypomagnesemia is believed to be correlated with this condition. Prophylactic intravenous magnesium supplementation has been practiced for a long time in patients undergoing CABG. This study was designed in an attempt to compare the efficacy of oral versus intravenous routes in the prevention of hypomagnesemia and arrhythmia. Methods: In this interventional clinical study, 82 patients were randomly assigned to 2 groups. All patients were evaluated for baseline serum magnesium level and arrhythmias. One group received 1,600 mg of oral magnesium hydroxide through nasogastric (NG) tube prior to surgery, while the other group received 2 g of magnesium sulfate during the induction of anesthesia. The serum magnesium level was monitored for 48 hours after the operation. The difference in preoperative hypomagnesemia was non-significant (Sig: 0.576). Results: During the operation, the serum magnesium level peaked around 4 mg/dL, and no hypomagnesemia was detected in any patient. Although the curve of oral group declined parallel and below that of intravenous (IV) group, no significant differences were detected during postoperative monitoring. In addition, a prevalence of arrhythmia of 13.9% and 6.5% was noticed in IV and oral groups, respectively (OR: 0.428). Conclusion: Providing 1,600 mg of oral magnesium supplement to patients is as effective as 2,000 mg of magnesium sulfate IV in preventing hypomagnesemia and arrhythmia after CABG. Thus, the authors introduce this treatment regimen as a promising and cost-effective method.

Use of active metabolites of vitamin D orally for the treatment of psoriasis

SUMMARY Objective: The objective of this study was to analyse the existing bibliographic production on clinical trials related to the use of vitamin D for oral treatment of psoriasis. Method: A literature review of clinical trials related to the use of vitamin D for oral treatment of psoriasis, published in the LILACS, Scielo, Medline, PubMed and Cochrane Library from 1986 to 2013. The search included the following terms: "Psoriasis and oral Vitamin D"; "psoríase e vitamina D oral". Results: After analysing the titles and summaries, 10 articles met the eligibility criteria. Discussion: According to the literature, most tests were made in moderate psoriasis with doses ranging from 0.25 to 2μg, demonstrating improvement with this treatment modality. Some studies suggest the use of high doses, but the biggest concern is hypercalciuria as a side effect. Conclusion: The use of active metabolites of vitamin D orally for the treatment of psoriasis showed efficacy and safety.

RESUMO OBJETIVO: O objetivo deste estudo foi analisar a produção bibliográfica existente sobre os ensaios clínicos relacionados ao uso da vitamina D para tratamento por via oral da psoríase. MÉTODOS: Revisão de literatura de ensaios clínicos relacionados ao uso de vitamina D para tratamento por via oral da psoríase publicados no Lilacs, SciELO, MedLine, PubMed e Biblioteca Cochrane no período de 1986 a 2013. A pesquisa incluiu os seguintes termos: "Psoriasis and oral Vitamin D"; "psoríase e vitamina D oral". RESULTADOS: Depois de analisar os títulos e resumos, dez artigos preencheram os critérios de elegibilidade. DISCUSSÃO: Segundo a literatura, a maioria dos ensaios foi realizada na psoríase moderada, com dose que varia de 0,25 a 2 μg, demonstrando melhora com esta modalidade terapêutica. Alguns estudos sugerem o uso de doses elevadas, porém a maior preocupação é a hipercalciúria como efeito colateral. CONCLUSÃO: O uso de metabólitos ativos de vitamina D por via oral para o tratamento da psoríase demonstrou eficácia e segurança com relação aos efeitos colaterais.

Comparison of PET/CT performance after oral administration and intravenous injection of 18F-NaF / 中华核医学与分子影像杂志

Objective@#To investigate the possibility and diagnostic efficiency of 18F-NaF PET/CT bone scan after oral administration (PO) by comparing with that of intravenous injection (IV).@*Methods@#Fifty patients (19 males, 31 females; average age: (52.8±11.7) years) with cancer who underwent PET/CT scans after oral and intravenous administration of 18F-NaF respectively with an interval of 2-7 d from June 2015 to September 2016 were prospectively enrolled. Single-phase 18F-NaF PET/CT was performed 60 min after IV, and dual-phase 18F-NaF PET/CT was performed 60 and 120 min after PO. All PET/CT images were reviewed, lesions were counted, and maximum standardized uptake value (SUVmax) and target/non-target (T/NT) ratios were calculated and compared. Paired t test was used.@*Results@#Forty-one patients (15 males, 26 females; average age: (53.5±10.4) years) who finished all PET/CT scans were enrolled. The images at 120 min after PO was visually similar to the images at 60 min after IV. Three modalities detected the same cases and lesions (35 positive cases: 25 malignant, 8 benign, 2 cases with indefinite diagnosis; 302 lesions: 172 malignant, 108 benign, 22 ambiguous lesions). The SUVmax-PO60 min and SUVmax-PO120 min were lower than the SUVmax-IV60 min in the same lesion (18.22±12.64, 26.60±19.49 vs 28.07±16.34; t values: -12.36 and -3.59, both P<0.05). A total of 194 lesions were included for T/NT ratio analysis. T/NTIV60 min, T/NTPO60 min and T/NTPO120 min were 2.76±1.30, 2.87±1.50, 2.98±1.42, respectively, and T/NTPO120 min was higher than T/NTIV60 min (t=3.18, P<0.05).@*Conclusion@#18F-NaF PET/CT images after PO, especially at 120 min post-PO, has similar diagnostic power of lesion-detection and SUVmax-measurement with IV.

Efficacy observation of high dose oral methylprednisolone in the treatment of infantile spasms / 中国医师杂志

Objective To investigate the clinical efficacy and safety of oral high-dose methylprednisolone in the treatment of infantile spasms (IS).Methods The clinical data of 38 children with infantile spasms were analyzed retrospectively who treated with oral administration of high-dose methylprednisone in Department of Neurology,Wuhan Children's Hospital,Tongji Medical College,Huazhong University of Science and Technology from January 2016 to April 2017.Results (1) Twenty patients (52.6％) of all the 38 patients were seizure-free after 2 weeks of treatment,and 16 cases (42.1％) were seizure-free at the end of treatment.(2) All the 38 cases were typical or atypical hyperarrhythmia.After treatment of 2 weeks,25 cases (65.8％) of hyperarrhythmia disappeared;at the end of the treatment,30 cases (78.9％) of hyperarrhythmia disappeared.(3) Adverse effects mainly were weight gain,Cushing signs,increased appetite,irritability,drowsiness,co-infection,electrolyte disturbance.(4) Follow-up of 3 to 12 months,the recurrence rate was low and the development quotient had improved.Conclusions Oral high dose methylprednisolone in the treatment of IS is effective,safe and has a low recurrence rate.It can be recommended in clinicalal application.

Panorama dos aspectos regulatórios que norteiam a partição de comprimidos / Overview of regulatory aspects guiding tablet scoring

RESUMO A partição de comprimidos é uma prática controversa no meio da saúde. Mesmo assim, é amplamente difundida, principalmente em tratamentos envolvendo crianças e idosos, para ajustar doses, facilitar a ingestão do medicamento ou baratear o custo do tratamento medicamentoso. Os riscos dessa prática estão relacionados principalmente à imprecisão na dosagem das frações e a problemas de estabilidade no medicamento partido. O objetivo deste trabalho foi traçar um panorama das bases sanitárias que norteiam esse tema no mundo. Constatamos que as agências regulatórias de saúde dos países que integram o Mercosul, além de outros países sul-americanos, não possuem normas publicadas que tratem de partição de comprimidos. Entre as agências sanitárias pesquisadas, a Food and Drug Administration (FDA), nos Estados Unidos, é a única a apresentar normas que abrangem desde instruções para orientar o fracionamento até a regulação do processo de fabricação. O conceito de sulco funcional implementado pela FDA estabelece algumas garantias quanto à capacidade do comprimido de ser fracionado. Pode-se concluir que ainda faltam bases técnicas e científicas para direcionar as normas sanitárias acerca desse tema, tornando a decisão sobre a partição de comprimidos, em determinadas situações, aleatória e de alto risco para a saúde pública. A necessidade de regulação mais pormenorizada é vital para garantir a segurança dos usuários de medicamentos.

ABSTRACT Tablet scoring is a controversial but common practice used to adjust doses, facilitate drug intake, or lower the cost of drug treatment, especially in children and the elderly. The risks of tablet scoring are mainly related to inaccuracies in the resulting dose and stability problems. The aim of this article is to provide an overview of worldwide guidelines regarding tablet scoring. We found that regulatory health agencies in Mercosur countries as well as other South American countries do not have published standards addressing tablet splitting. Among the surveyed health agencies, the Food and Drug Administration (FDA) in the United States is the only one to present standards, ranging from splitting instructions to regulation of the manufacturing process. The concept of functional scoring implemented by the FDA has introduced some level of guarantee as to the ability of tablets to be split. In conclusion, technical and scientific bases are still insufficient to guide health rules on this subject, making the decision on scoring, in certain situations, random and highly risky to public health. The need for more detailed regulation is vital to ensure the safety of tablet medications.

Dose issue of novel oral anticoagulants to prevent stroke in patients with atrial fibrillation / 国际脑血管病杂志

Oral anticoagulants are important for preventing stroke in patients with atrial fibrillation.Compared with the traditional oral anticoagulant warfarin,the novel oral anticoagulants (NOACs) have the characteristics of high efficiency,safety,and no need to monitor coagulation function.However,current clinical reports have showed that the dose is usually low when NOACs were used for preventing stroke in patients with atrial fibrillation.Its main reason may be associated with the risk avoidance and the difference in doctor and patient preferences.The analysis from the aspects of safety and effectiveness,the risk of ischemic stroke or systemic embolism is lower when the dose of NOACs is relatively high,and the risk of hemorrhage is lower when the dose of NOACs is relatively lower.Given the differences between the incidences of different events,the disability rate and the mortality rate,the patient with atrial fibrillation are more suitable for using high-dose drug.When choosing a specific dose,taking into account the specificity,the appropriate dose,intensity,and dosing regimen should be given according to the guideline recommendations,appropriate reference to renal function and patient preferences,and individual differences in order to obtain the best clinical efficacy..

Clinical observation on the treatment of low-dose oral theophylline in patents with COPD / 中国医师杂志

Objective To investigate the effects of low-dose,sustained release oral theophylline on the chronic obstructive pulmonary disease (COPD) patient.Methods Fifty-six patients with stable COPD were randomly divided into two group:theophylline group (n =35) that was treated with slow-release theophylline(100 mg,twice daily),and control group (n =21) that was given with placebo.A series of parameters including lung function,quality of life scores,body mass index,airflow obstruction,dyspnea,and exercise capacity index (BODE) score,exercise tolerance,exacerbations,satisfaction with treatments and adverse effects were tested before and 12 weeks after the treatments.Results Forty two patients completed the study,25 cases in the slow-release theophylline group,and 17 cases in the placebo group.The differences of two groups before the treatment were not prominent except the age (P ＞ 0.05).After treated with slow-release theophylline,the forced expiratory volume in one second (FEV1),forced vital capacity (FVC) and the symptom score were slightly increased,but there were no statistically significant differences (P ＞0.05).After theophylline therapy,the quality of life score,including activity ability score,disease activity score and total score,and BODE index score were significantly decreased(P ＜0.05),but 6 minutes walk test (6 MWT) differences were no significant (P ＞0.05).The differences in pulmonary function test,the quality of life score,BODE index score and 6 minutes walk test were no significant between before and after the treatment with the placebo (P ＞ 0.05).Compared to the cases who treated with the placebo group,the patients in slow-release theophylline group reduced the frequencies of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) (3/25 vs 7/17,x2 =4.748,P ＜0.05),and increased the efficacy satisfaction (Z =-2.579,P ＜ 0.05).Slightly adverse reaction was observed in 3 cases in slow-release theophylline group,but it could relieve by oneself,and not affect the common treatment.There was no adverse reaction in the placebo group.Conclusions Low dose,sustained release oral theophylline was efficient in improvement of the quality of life scores and BODE index score.

Do pediatric medicines induce topographic changes in dental enamel?

Abstract The purpose of the present study was to evaluate the effect of common pediatric liquid medicines on surface roughness and tooth structure loss and to evaluate the pH values of these medicines at room and cold temperatures in vitro. Eighty-four bovine enamel blocks were divided into seven groups (n = 12): G1-Alivium®, G2-Novalgina®, G3-Betamox®, G4-Clavulin®, G5-Claritin®, G6-Polaramine® and G7-Milli-Q water (negative control). The pH was determined and the samples were immersed in each treatment 3x/day for 5 min. 3D non-contact profilometry was used to determine surface roughness (linear Ra, volumetric Sa) and the Gap formed between treated and control areas in each block. Scanning electron microscopy (SEM) and energy dispersive spectrometry (EDS) were also performed. The majority of liquid medicines had pH ≤ 5.50. G1, G4, and G5 showed alterations in Ra when compared with G7 (p < 0.05). According to Sa and Gap results, only G5 was different from G7 (p < 0.05). Alteration in surface was more evident in G5 SEM images. EDS revealed high concentrations of carbon, oxygen, phosphorus, and calcium in all tested groups. Despite the low pH values of all evaluated medicines, only Alivium®, Clavulin®, and Claritin® increased linear surface roughness, and only Claritin® demonstrated the in vitro capacity to produce significant tooth structure loss.

The research progress of Chinese medicine treatment of psoriasis vulgaris / 国际中医中药杂志

Based on the literature related to psoriasis in recent years,this paper first summarizes the modem practitioners' insights into the etiology and pathogenesis of psoriasis and then summarizes the therapeutic methods which can be divided into two parts:TCM internal medicine and TCM external treatment.On such basis,the pathogenesis of the disease,various treatments and the corresponding clinical efficacy are generalized.

Cost-minimization analysis of oral and intravenous administration of linezolid in a public hospital in southern Brazil / Análise de custo-minimização entre as vias de administração oral e endovenosa de linezolida em um hospital público da região sul do Brasil

Due to the paucity of cost-minimization studies about linezolid, the aim of this study was to estimate the cost differential between intravenous and oral administration. A retrospective cohort study and costminimization analysis was conducted between August 2009 and August 2013 in a public hospital in southern Brazil. Inpatient records were evaluated for 152 patients who received linezolid intravenously or orally. Over two-thirds of the patients (103, 67.8%) received the antibiotic by the intravenous route only (IV group), and the remainder received the antibiotic both routes sequentially (mixed group). In the IV group, 33 patients (31.7%) were eligible to receive the antibiotic orally. The total cost per patient (mean) after changing from intravenous to oral administration was significantly lower than the real cost paid per patient (mean) (p<0.001). The cost savings associated with switching to oral linezolid administration would be US$14,328.32 over four years. Pharmacoeconomic analyses of linezolid therapy can inform hospitals' decisions about the rational use of therapeutics and economic resources.

Devido à escassez de estudos de custo-minimização a cerca da linezolida, o objetivo deste estudo foi estimar a diferença de custo entre a administração intravenosa e oral desse antibiótico. Um estudo de coorte retrospectiva e uma análise de custo-minimização foram realizados entre agosto de 2009 e agosto de 2013, em um hospital público do sul do Brasil. Foram avaliados os prontuários médicos de 152 pacientes que receberam linezolida por via intravenosa e / ou oralmente. Mais de dois terços dos pacientes (103, 67.8%) receberam o medicamento exclusivamente por via intravenosa (grupo IV), e o restante (grupo misto) recebeu o antibacteriano por via intravenosa e por via oral sequencialmente. No grupo IV, 33 pacientes (31.7%) eram elegíveis para receber o antibiótico por via oral. O custo médio total por paciente após a troca hipotética da via de administração intravenosa para oral foi significativamente mais baixo do que o custo médio real pago por cada tratamento com linezolida (p <0.001). A economia de custos associados com a mudança para a administração oral de linezolida seria de US $ 14,328.32 ao longo de quatro anos. A análise farmacoeconômica da terapia com linezolida pode orientar as decisões dos hospitais quanto ao uso racional de terapêuticas e de recursos econômicos.

Polypeptide drugs for oral administration with nanoparticles as carriers:current situation, existing problems and developmental prospects / 中国组织工程研究

BACKGROUND:The new formulation and preparation technology of new drugs have become a hot spot for improving the utilization of polypeptides. In particular, the development of nanotechnology in recent years has promoted the clinical application of polypeptide drugs. OBJECTIVE:To review the current research of nanoparticles as carriers of polypeptide drugs for oral administration. METHODS:A computer-based search of CNKI database and SCI database was performed for relevant articles published from 1996 to 2014 by using the keywords of“protein, peptide drugs, nanoparticles, oral administration”in Chinese and English, respectively. RESULTS AND CONCLUSION:The encapsulation efficiency, release rate of drug delivery, stability of nanoparticles in the gastrointestinal tract and penetrability of the intestinal mucosa are determined by many factors, such as the kind, size, surface charge and modification of nanoparticles. The nanoparticles can increase the stability of protein drugs and improve the bioavailability of drugs. The targeting property of the nanoparticles can decrease the adverse reactions of some drugs. The release effect of the nanoparticles can decrease the dosage of drugs and increase the drug circulating time. However, there are stil many problems to be solved in nanotechnology:the activities of some protein drugs are lost in the preparation process;theencapsulation efficiency and drug loading need to be improved;protein burst release cannot be solved completely;the mass production of nanoparticles is stil difficult.