Abstract Objective To analyze the effectiveness, safety, outcomes, and associated factors of tuberculosis preventive treatment (TPT) in children and adolescents in Paraná, southern Brazil. Method This was an observational cohort study with a retrospective collection of secondary data from the TPT information systems of the state of Paraná from 2009 to 2016, and tuberculosis in Brazil from 2009 to 2018. Results In total, 1,397 people were included. In 95.4% of the individuals, the indication for TPT was a history of patient-index contact with pulmonary tuberculosis. Isoniazid was used in 99.9% of the cases with TPT, and 87.7% completed the treatment. The TPT protection was 98.7%. Among the 18 people who had TB, 14 (77.8%) became ill after the second year of treatment, and four (22.2%) in the first two years (p < 0.001). Adverse events were reported in 3.3% of cases, most of them were gastrointestinal and medication was discontinued in only 2 (0.1%) patients. No risk factors associated with the illness were observed. Conclusions The authors observed a low rate of illness in pragmatics routine conditions in TPT for children and adolescents, especially within the first two years after the end of treatment, with good tolerability and a good percentage of adherence to the treatment. TPT should be encouraged to achieve the goals of the End TB Strategy of the World Health Organization as an essential strategy to reduce the incidence rate of the disease, but studies with new schemes must continue to be carried out in real-life scenarios.

RESUMO O objetivo do estudo foi realizar a tradução, a adaptação cultural e a validação psicométrica do instrumento Parental Health Literacy Activities Test (PHLAT), que avalia o letramento em saúde para cuidadores/familiares que buscam atendimento às suas crianças menores de 1 ano na unidade de atenção primária. Estudo metodológico, quantitativo, de validação e adaptação transcultural de instrumento, seguindo as etapas de tradução, retrotradução, análise por comitê de juízes, aplicação de testes estatísticos para avaliação das propriedades psicométricas, obtendo-se sua versão para o português do Brasil. O pré-teste foi realizado com 31 familiares, e o teste/reteste, com 93, em unidades de atenção primária do município do Oeste do Paraná, em 2018 e 2019. Análise estatística inferencial foi aplicada para verificar a validade e a confiabilidade do instrumento. Na validade de conteúdo com comitê de juízes, obteve-se taxa de concordância de 100%. Os dados na fase de pré-teste apresentaram coeficiente Alfa de Cronbach de 0,73; e na etapa do teste/reteste, obteve-se 0,69. A avaliação da confiabilidade pelo coeficiente de correlação intraclasse foi de 0,865, considerada substancial. O instrumento foi tido como adequado quanto a sua adaptação cultural e validado para o português do Brasil, confiável para a aplicação entre cuidadores/familiares.

ABSTRACT The purpose of the study was to perform the translation, cultural adaptation and psychometric validation of the instrument Parental Health Literacy Activities Test (PHLAT), which assesses health literacy for caregivers/family members seeking care for their children under one year old in the primary care unit. Methodological, quantitative, validation and cross-cultural instrument adaptation study, following the steps of translation, back-translation, judges committee analysis, application of statistical tests to evaluate psychometric properties, obtaining its version for Brazilian Portuguese. The pre-test was performed with 31 family members and test/retest with 93, in primary care units in the municipality of Western Paraná, in 2018 and 2019. Inferential statistical analysis was applied to verify the validity and reliability of the instrument. On the content validity of the judges committee, a 100% agreement rate was obtained. The data in the pretest phase presented Cronbach’s alpha coefficient of 0.73, and the test/retest of 0.69. The reliability assessment by the intraclass correlation coefficient was 0.865, considered substantial. The instrument was considered adequate for its cultural adaptation and validated for Brazilian Portuguese, reliable for application between caregivers/family members.

RESUMO O objetivo do estudo foi realizar a tradução, a adaptação cultural e a validação psicométrica do instrumento Parental Health Literacy Activities Test (PHLAT), que avalia o letramento em saúde para cuidadores/familiares que buscam atendimento às suas crianças menores de 1 ano na unidade de atenção primária. Estudo metodológico, quantitativo, de validação e adaptação transcultural de instrumento, seguindo as etapas de tradução, retrotradução, análise por comitê de juízes, aplicação de testes estatísticos para avaliação das propriedades psicométricas, obtendo-se sua versão para o português do Brasil. O pré-teste foi realizado com 31 familiares, e o teste/reteste, com 93, em unidades de atenção primária do município do Oeste do Paraná, em 2018 e 2019. Análise estatística inferencial foi aplicada para verificar a validade e a confiabilidade do instrumento. Na validade de conteúdo com comitê de juízes, obteve-se taxa de concordância de 100%. Os dados na fase de pré-teste apresentaram coeficiente Alfa de Cronbach de 0,73; e na etapa do teste/reteste, obteve-se 0,69. A avaliação da confiabilidade pelo coeficiente de correlação intraclasse foi de 0,865, considerada substancial. O instrumento foi tido como adequado quanto a sua adaptação cultural e validado para o português do Brasil, confiável para a aplicação entre cuidadores/familiares.

ABSTRACT The purpose of the study was to perform the translation, cultural adaptation and psychometric validation of the instrument Parental Health Literacy Activities Test (PHLAT), which assesses health literacy for caregivers/family members seeking care for their children under one year old in the primary care unit. Methodological, quantitative, validation and cross-cultural instrument adaptation study, following the steps of translation, back-translation, judges committee analysis, application of statistical tests to evaluate psychometric properties, obtaining its version for Brazilian Portuguese. The pre-test was performed with 31 family members and test/retest with 93, in primary care units in the municipality of Western Paraná, in 2018 and 2019. Inferential statistical analysis was applied to verify the validity and reliability of the instrument. On the content validity of the judges committee, a 100% agreement rate was obtained. The data in the pretest phase presented Cronbach’s alpha coefficient of 0.73, and the test/retest of 0.69. The reliability assessment by the intraclass correlation coefficient was 0.865, considered substantial. The instrument was considered adequate for its cultural adaptation and validated for Brazilian Portuguese, reliable for application between caregivers/family members.

Secnidazol é um agente antimicrobiano utilizado principalmente no tratamento da amebíase. Para este estudo de bioequivalência de secnidazol em voluntários saudáveis, foram incluídos vinte e oito voluntárias mulheres no estudo randomizado cruzado. Cada voluntária recebeu uma única dose oral de secnidazol do produto teste e referência para comparação, com um intervalo de wash-out de duas semanas. As concentrações plasmáticas de secnidazol foram determinados por CLAE, as amostras foram extraídas com terc-butil-metil-éter: dicloromethano (60:40, v/v). O secnidazol e seu padrão interno metronidazol foram separados em uma coluna (C18 ) com fase móvel água ultra-pura:acetonitrila (85:15, v/v) e monitorado em 310 nm. As razões entre as médias geométricas de Cmáx, ASC0-t e ASC0-∞, encontraram-se dentro do estabelecido pela ANVISA, demonstrando que as formulações são bioequivalentes quanto à taxa e extensão de absorção

Secnidazole is an antimicrobial agent used primarily in the treatment of amoebiasis. For this bioequivalence study of secnidazole, twenty-eight healthy female volunteers were enrolled in a randomized crossover study. Each volunteer was given a single oral dose of secnidazole test preparation and then the reference preparation, or vice versa, with a wash out interval of two weeks. The plasma concentrations of secnidazole were determined by HPLC, and the samples were extracted with tert-butyl-methyl-ether: dicloromethane (60:40, v/v). Secnidazole and its parent compound metronidazole were separated on a C18 column with water:acetonitrile (85:15, v/v) as the mobile phase, and monitored at 310 nm. The ratio of mean Cmax, AUC0-t and AUC0-∞ values for the test and reference products were within the predetermined range established by ANVISA, demonstrating that the two formulations are bioequivalent in rate and extent of absorption.