Normative Data of Handgrip Strength in Macedonian Children and Adolescents According to Chronological and Biological Age / Datos Normativos de la Fuerza de Prensión Manual en Niños y Adolescentes Macedonios Según la Edad Cronológica y Biológica

SUMMARY: The handgrip strength is used as a means of individual's health prediction during life. It is used as an indicator of the nutrition status, bone fragility, presence of sarcopenia and it correlates with certain diseases and clinical complications. The research goal was to analyze the results of the hand dynamometry test, based on the chronological and biological age, and to offer normative and referent standards about children and adolescents from the Republic of North Macedonia. The study was conducted on a sample of 4031 respondents of both sexes at the age 6-14 years. In order to achieve the research goals, the measured characteristics were of the weight, height, sitting height and handgrip strength. The body mass index and biological maturity values (APHV) were obtained by using formulas. On the basis of the obtained results, it can be concluded that statistically significant differences in handgrip strength are established between the boys and girls of all age categories. Also, statistically significant differences between boys and girls are established in the hand dynamometry test of all APHV levels. In general, the use of the APHV allows a better categorization of the performance of the studied children and adolescents. With boys, the correlation between the chronological age and test was 68 %, and with girls - 77 %. The normative referent standards of the hand dynamometry test are presented in percentiles for both sexes. Thye hand dynamometry test's results during childhood and adolescence should be analyzed and interpret on the basis of biological age, and not on the chronological age. These tools can help specialists who work with children and adolescents in ethnic and epidemiological context.

La fuerza de prensión se utiliza como medio para predecir la salud del individuo durante la vida. Se utiliza como indicador del estado nutricional, fragilidad ósea, presencia de sarcopenia y se correlaciona con determinadas enfermedades y complicaciones clínicas. El objetivo de la investigación fue analizar los resultados de la prueba de dinamometría manual, con base en la edad cronológica y biológica, y ofrecer estándares normativos y referentes sobre niños y adolescentes de la República de Macedonia del Norte. El estudio se realizó en una muestra de 4031 encuestados de ambos sexos con edades comprendidas entre 6 y 14 años. Para lograr los objetivos de la investigación, las características medidas fueron el peso, la altura, la altura al sentarse y la fuerza de prensión. El índice de masa corporal y los valores de madurez biológica (APHV) se obtuvieron mediante fórmulas. Sobre la base de los resultados obtenidos, se puede concluir que se establecen diferencias estadísticamente significativas en la fuerza de prensión manual entre niños y niñas de todas las categorías de edad. Asimismo, se establecen diferencias estadísticamente significativas entre niños y niñas en la prueba de dinamometría manual de todos los niveles APHV. En general, el uso del APHV permite una mejor categorización del desempeño de los niños y adolescentes estudiados. En los niños, la correlación entre la edad cronológica y la prueba fue del 68 %, y en las niñas, del 77 %. Los estándares normativos referentes de la prueba de dinamometría manual se presentan en percentiles para ambos sexos. Los resultados de la prueba de dinamometría manual durante la infancia y la adolescencia deben analizarse e interpretarse en función de la edad biológica y no de la edad cronológica. Estas herramientas pueden ayudar a los especialistas que trabajan con niños y adolescentes en un contexto étnico y epidemiológico.

Evaluation of characteristics of periodontal probes

Aim: This study aimed to evaluate the millimeter distances and active tip diameters of different periodontal probes. Methods: Two types of periodontal probes were analyzed (North Carolina (15-UNC) and PCP-12). Two manufacturers were selected for each probe type. Digital images of the probes were obtained and the distances were measured using a software program. The diameter of the active tip was measured using a digital caliper. Both variables were measured by two trained and calibrated examiners. The data were analyzed using the Bland-Altman method and two-way ANOVA with Tukey's post-hoc test. Statistical significance was set at p<0.05. Results: A comparison of measurements between the 15UNC and PCP-12 probes showed a significant difference in all millimeter markings. The 15-UNC probe showed differences between the 3 and 12 mm markings. The PCP-12 probe only showed differences between the marks at the 12 mm mark. The 15-UNC probe had a similar active tip diameter between the two manufacturers. The PCP-12 probe showed a significant difference between the two manufacturers. Both types of probes had similar active tip diameters when compared by the two manufacturers. Conclusion: There was no standardization in relation to millimeter marks and tip diameters of the two types of periodontal probes produced by the two different manufacturers. The probe types exhibited little variability

O Sistema CEP/Conep e as pesquisas em ciências humanas e sociais: outras éticas, outras semânticas / The CEP/Conep System and research in human and social sciences: other ethics, other semantics / El Sistema CEP/Conep y las investigaciones en ciencias humanas y sociales: otras éticas, otras semánticas

Esta nota de conjuntura tem o objetivo de evidenciar algumas questões importantes sobre como se configura o Sistema CEP/Conep e as implicações dessa regulação no campo das ciências humanas e sociais. Primeiro, explicito o que consiste esse sistema para, em seguida, esboçar as controvérsias provenientes desse controle, que tem como aspecto central, ser regido pelo que a análise do Estado e sua organização burocrática chamam de lógica cartorial

This note aims to highlight some important questions about the configuration of the CEP/CONEP System and the implications of this regulation in the field of human and social sciences. First, I will explain what is this system, and then I will outline the controversies resulting from this control, which has as central aspect, to be governed by the so-called notarial logic, according to the analysis of the State and its bureaucratic organization

Esta nota de coyuntura tiene como objetivo poner en evidencia algunas cuestiones importantes sobre como es configurado el Sistema CEP/CONEP y las implicaciones de esta normativa para el campo de las ciencias humanas y sociales. Primero explicaré en que consiste ese sistema y, en seguida, esbozaré las controversias que surgen de ese control, que tiene como aspecto central ser regido por lo que el análisis del Estado y su organización burocrática denominan lógica notarial

Revisión del intervalo de referencia del recuento plaquetario: ¿son adecuados los valores que estamos utilizando? / Review of the platelet count reference range: are the values we are using appropriate?

Los intervalos de referencia (IR) dependen de la población y de las características metrológicas del procedimiento de medida utilizado. A pesar de las recomendaciones internacionales, son pocos los laboratorios que establecen sus propios IR para cada magnitud por la dificultad para conseguir voluntarios de referencia y el elevado costo económico asociado. La International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) acepta la adopción de IR bibliográficos o su cálculo por métodos indirectos dado su bajo costo y fácil obtención. Existen varias fuentes confiables de IR bibliográficos para el hemograma. No obstante, para el recuento plaquetario, es una práctica común de los laboratorios emplear el rango de valores de 150-450.109 /L independiente de la metodología utilizada y grupo etario. El objetivo de este trabajo fue revisar los IR bibliográficos disponibles para el recuento plaquetario y estimarlo empleando el método indirecto de Hoffmann a partir de nuestra población. Los métodos indirectos se basan en aplicar criterios de exclusión y cálculos matemáticos sobre los resultados de una base de datos de laboratorio. Nuestros IR para el recuento plaquetario se comparan con los bibliográficos, que han sido establecidos por técnicas de muestreo directo. Por este motivo y dado que no existen estudios poblacionales que lo avalen, sería apropiado reemplazar el rango de 150-450.109 / L. Estos límites podrían seguir empleándose como puntos de corte o niveles de decisión médica para definir, según la clínica y otros resultados de laboratorio, los pacientes que ameritan un seguimiento posterior (AU)

Reference ranges (RR) depend on the population and the metrological characteristics of the measurement procedure used. Despite international recommendations, few laboratories establish their own RRs for each magnitude because of the difficulty in obtaining reference volunteers and the associated high economic cost. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) accepts the use of literaturebased RRs or RRs calculated by indirect methods because of their low cost and easy collection. There are several reliable sources of literature-based RRs for the Cell Blood Count. However, for platelet count, it is common laboratory practice to use the range of 150-450,109 /L regardless of the methodology used and age group. The aim of this study was to review the available literature regarding RRs for platelet count and to establish it using the indirect Hoffmann method in our population. Indirect methods are based on applying exclusion criteria and mathematical calculations on the results of a laboratory database. Our RRs for platelet counts are compared with those in the literature, which have been established by direct sampling techniques. Therefore, and given that there are no population studies to support these findings, it would be appropriate to replace the 150-450,109 /L range. These limits may continue to be used as cut-off points or medical decision levels to define, according to clinical manifestations and other laboratory results, patients who warrant further follow-up (AU)

Consenso SOCHOG/SOCHUMB: utilizar en Chile la curva estándar OMS ultrasonográfica de crecimiento fetal / SOCHOG/SOCHUMB consensus: OMS fetal ultrasound curve is the standard curve for ultrasound growth assessment to use in Chile

La Sociedad Chilena de Obstetricia y Ginecología (SOCHOG) y la Sociedad Chilena de Ultrasonido en Medicina y Biología (SOCHUMB) convocaron a un comité de expertos en el tema de ultrasonido y crecimiento fetal con el fin de proponer utilizar la curva fetal que mejor se adapte a la población chilena. Luego de la discusión, al no contar con curvas chilenas de crecimiento fetal, se concluye proponer que la curva estándar de la Organización Mundial de la Salud (OMS) sería la indicada dada la calidad de su metodología y por ser multicéntrica.

The Chilean Society of Obstetrics and Gynecology (SOCHOG) and the Chilean Society of Ultrasound in Medicine and Biology (SOCHUMB) have convened a committee of experts on the subject of ultrasound and fetal growth in order to propose using the fetal curve that best adapts to the Chilean population. After the discussion, since there are no Chilean fetal growth curves, it is concluded that the World Health Organization (WHO) standard curve would be the one to use given the quality of its methodology and the fact that it is multicentric.

Formulación de galletas fortificadas por sustitución parcial de harina de moringa y suero lácteo / Formulation of fortified cookies by partial substitution of moringa flour and whey

El suero lácteo y la moringa poseen alto valor nutricional; sin embargo, su uso en la elaboración de productos alimenticios es una alternativa viable pero poco utilizada. Objetivo. Elaborar una galleta fortificada por sustitución parcial de harina de moringa (HM) y polvo de suero lácteo (PSL). Materiales y métodos. Durante septiembre-diciembre 2021, se desarrollaron cuatro formulaciones con sustitución parcial de harina de trigo por HM y PSL (F0=100:0:0; F1=90:5:5; F2=80:10:10; F3=70:15:15). La aceptación del producto se determinó mediante una evaluación sensorial considerando los atributos sabor, olor, color, textura y aceptación general. Se realizó el análisis químico proximal a la HM, al PSL, a la formulación de mayor aceptación y a F0. Se compararon los distintos parámetros químico proximales y de aceptación mediante una anova de una vía, seguido de una prueba de comparación de medias de Tukey (p<0,05). Resultados. Conforme se incrementa el porcentaje de sustitución de harina de trigo por HM y PSL se obtiene menor aceptación de las galletas, siendo F1 la más aceptada. F1 registró un contenido proteico de 6,90±0,04%, significativamente mayor al observado en F0. Conclusiones. La buena aceptabilidad de F1 indica que la sustitución parcial por HM y PSL no influyen en su aceptación; además, F1 mostró un enriquecimiento de proteinas, lípidos y cenizas, así como contenido adecuado de humedad y carbohidratos(AU)

Introduction. Whey and moringa have high nutritional value; however, their use in the production of food products is a viable but rarely used alternative. Objective. To make a biscuit fortified by partial substitution of moringa flour (MF) and whey powder (WP). Materials and methods. During September-December 2021, four formulations were developed with different degrees of partial substitution of wheat flour for MF and WP (F0=100:0:0; F1=90:5:5; F2=80:10:10; F3=70:15:15). The acceptance of the product was determined through a sensory evaluation considering the attributes taste, odor, color, texture and general acceptance. A proximal chemical analysis was performed on the MF, WP, the most widely accepted formulation and F0. Proximal chemical parameters and acceptance attributes were compared using a one-way anova, followed by a Tukey mean comparison test (p<0.05). Results. As the percentage of substitution of wheat flour by MF and WP increases less acceptance of the biscuits is obtained, with F1 as the most accepted formulation. F1 registered a protein content of 6.90±0.04%, significantly higher than that observed in F0. Conclusions: The good acceptability of F1 indicates that the partial substitution of wheat flour for MF and WP do not influence its acceptance; in addition, F1, showed an enrichment of protein, lipid and ash, as well as adequate moisture and carbohydrate content(AU)

Time Perspective and Decision-Making: A Study on Decisional Patterns in Argentinian Adults / Perspectiva temporal y toma de decisión: un estudio sobre patrones decisionales en adultos argentinos / Perspectiva temporal e tomada de decisão: um estudo sobre padrões decisórios em adultos argentinos

The first aim of this study was to adapt the mdmq to Argentinian Spanish and to collect evidence of its va-lidity and reliability; the second was to determine if time perspectives were adequate predictors of decision-making styles. A first sample of 536 participants served in the validation process; a second sample of 209 individuals who completed the mdmq and the Brief Zimbardo Time Perspective Inventory (ztpi) was used to conduct descriptive-correlational and regression analyses. Confirmatory factor analysis corroborated a fourfactor model with adequate internal consistency for each subscale. Regression analyses showed that future time perspective positively predicted the display of higher vigilant coping patterns ­adaptive and ratio-nal decision-making style­. Meanwhile, less future- time-oriented people were more likely to engage in defensive avoidance mechanisms to reach a decision. Past-negative and present-fatalistic time perspectives were positive predictors of non-vigilant decision-making style. It indicates that individuals with an aversive vision over their past experiences and present situation are more likely to engage in emotionally based and avoidant decision-making patterns. These findings support the reliability and construct-related validity of the mdmq for assessing decision-making styles among Argentinian individuals and set a step for con-ducting more in-depth research in the field of decision-making and time perspective.

El primer objetivo de este estudio fue adaptar el mdmq al español argentino y recolectar evidencia de su validez y confiabilidad; el segundo fue determinar si las perspectivas temporales eran predictores adecuados de los estilos de toma de decisiones. Una primera muestra de 536 participantes sirvió para el proceso de validación y una segunda muestra de 209 individuos completó el mdmq y el Brief Zimbardo Time Perspective Inventory (ztpi), para un análisis descriptivo-correlacional y de regresión. El análisis factorial confirmatorio corroboró un modelo de cuatro factores con adecuada consistencia interna para cada subescala. Los análisis de regresión mostraron que la perspectiva del tiempo futuro predijo positivamente la aparición de patrones de afrontamiento más vigilantes ­estilo de toma de decisiones adaptativo y racional­, mientras que las personas que estaban menos orientadas al tiempo futuro tenían más probabilidades de involucrarse en mecanismos de evitación defensiva para tomar una decisión. Las perspectivas temporales negativas del pasado y fatalistas del presente fueron predictores positivos del estilo de toma de decisiones no vigilante, lo que indicaría que las personas con una visión aversiva sobre sus experiencias pasadas y la situación presente, son más propensas a involucrarse en tipos de toma de decisiones basadas en emociones y evasivas. Estos hallazgos respaldan la confiabilidad y la validez relacionada con el constructo del mdmq para evaluar los estilos de toma de decisiones entre los argentinos y marcan un paso para realizar investigaciones más profundas en el campo de la toma de decisiones y la perspectiva temporal.

O primeiro objetivo deste estudo foi adaptar o mdmqpara o espanhol argentino e coletar evidências de sua validade e confiabilidade; a segunda foi determinar se as perspectivas de tempo eram preditores adequados dos estilos de tomada de decisão. Uma primeira amostra de 536 participantes foi usada para o processo de va-lidação e uma segunda amostra de 209 indivíduos completarou o mdmq e o Brief Zimbardo Time Perspec-tive Inventory (ztpi) e foi usada para realizar análises descritivas-correlacionais e de regressão. A análise fatorial confirmatória corroborou um modelo de quatro fatores com consistência interna adequada para cada subescala. As análises de regressão mostraram que a perspectiva do tempo futuro previu positivamente o surgimento de padrões de enfrentamento mais vigilantes ­estilos de tomada de decisão racionais e adaptativos­ enquanto as pessoas menos orientadas para o futuro eram mais propensas a se envolver em mecanismos de enfrentamento de evasão defensiva para tomar uma decisão. Perspectivas temporais negativas do passado e fatalistas do presente foram preditores positivos do estilo de tomada de decisão não vigilante, indicando que pessoas com uma visão aversiva de suas experiências passadas e da situação presente são mais propensas a se envolver em tipos de tomada de decisão baseadas em emoções e padrões evasivos. Essas descobertas apoiam a confiabilidade e a validade relacionada ao construto do mdmq para avaliar os estilos de tomada de decisão entre os argentinos e marcam um importante passo para realizar pesquisas mais profundas no campo da tomada de decisão e perspectiva de tempo.

Tradução, adaptação cultural e validação do Instrumento de Autoavaliação em Diabetes / Translation, cultural adaptation and validation of the diabetes self-report tool / Traducción, adaptación cultural y validación de la herramienta de autoevaluación de la diabetes

Objetivo: realizar tradução, adaptação cultural e validação do Instrumento de Autoavaliação em Diabetes para aplicação no contexto brasileiro. Métodos: estudo metodológico realizado com 132 profissionais, entre os anos de 2016 e 2018, em seis etapas: 1 - Tradução inicial; 2 - Síntese da tradução; 3 - Retrotradução (back translation); 4 - Avaliação pelo comitê de juízes; 5 - Adequação cultural (pré teste); e 6 - Reprodutibilidade. Houve participação de profissionais de equipes multiprofissionais envolvidas no tratamento do diabetes por meio da plataforma e-surv. Resultados: entre os participantes, predominaram o sexo feminino (73,5%), profissionais com especialização (pós-graduação Lato Sensu) (51,5%) e com experiência na assistência a pessoas com diabetes (84,4%). O Índice de Validade de Conteúdo (IVC) foi satisfatório (0,850). O instrumento apresentou boa consistência interna (Alfa de Cronbach = 0,878). A análise de confiabilidade do instrumento, realizada pelo cálculo do coeficiente de correlação intraclasse (CCI), indicou concordância adequada em todas as medidas, 0,878 (IC 95%: 0,864 - 0,891), com Kappa Ponderado médio de 0,714 e índices acima de 0,60 em 85% os itens, mostrando boa concordância teste e reteste. Conclusão: a versão traduzida e culturalmente adaptada do Instrumento d e Autoavaliação em Diabetes apresentou boa confiabilidade, aceitabilidade e estabilidade temporal satisfatórias conforme os parâmetros internacionais, podendo ser utilizada, pelos profissionais da saúde, para autoavaliação em diabetes.(AU)

Objective: to carry out translation, cultural adaptation, and validation of the Diabetes Self-Report Instrument for application in the Brazilian context. Methods: methodological study carried out with 132 professionals, between 2016 and 2018, in six steps: 1 - Initial translation; 2 - Synthesis of the translation; 3 - Back translation; 4 - Evaluation by the judging committee; 5 - Cultural adequacy (pre-test); and 6 - Reability. There was participation of professionals from multidisciplinary teams involved in the treatment of diabetes through the e-surv platform. Results: among the participants, there was a predominance of females (73.5%), professionals with specialization (Lato sensu postgraduate degree) (51.5%) and with experience in caring for people with diabetes (84.4%). The Content Validity Index (CVI) was satisfactory (0.850). The instrument showed good internal consistency (Cronbach's alpha=0.878). The instrument's reliability analysis, carried out by calculating the intraclass correlation coefficient (ICC), indicated adequate agreement in all measurements, 0.878 (95% CI: 0.864 - 0.891), with mean weighted Kappa of 0.714 and indices above 0. 60 out of 85% of the items, showing good test-retest agreement. Conclusion: the translated and culturally adapted version of the Diabetes Self-report Instrument showed good reliability, acceptability, and satisfactory temporal stability according to international parameters, and can be used by healthcare professionals for self-report of diabetes.(AU)

Objetivo: realizar la traducción, adaptación cultural y validación de la Herramienta de Autoevaluación de Diabetes para aplicación en el contexto brasileño. Métodos: estudio metodológico realizado con 132 profesionales, entre 2016 y 2018, en seis etapas: 1 ­ Traducción inicial; 2 ­ Síntesis de la traducción; 3 ­ Traducción inversa; 4 ­ Evaluación por el comité de jueces; 5 ­ Adecuación cultural (pre-test); y 6 ­ Reproducibilidad. Se contó con la participación de profesionales de equipos multidisciplinarios...(AU)

Manejo das enfermeiras sobre abordagem sindrômica na atenção primária à saúde / Nurses' management of the syndromic approach in primary health care / Gestión del enfoque sindrómico en atención primaria por parte de las enfermeras

Introdução: As Infecções Sexualmente Transmissíveis configuram um problema de saúde pública grave, tendo a consulta de enfermagem baseada na abordagem sindrômica como mecanismo de mitigação. Objetivos: analisar o manejo das enfermeiras sobre abordagem sindrômica na atenção primária à saúde, apreender os conhecimentos das enfermeiras sobre abordagem sindrômica na atenção primária à saúde, caracterizar as estratégias de manejo das enfermeiras sobre abordagem sindrômica na atenção primária à saúde e conhecer os fluxos de atendimento da rede assistencial em saúde na abordagem sindrômica. Metodologia: Estudo qualitativo, exploratório e descritivo, realizado com oito enfermeiras das Unidades de Saúde da Família de um município no interior da Bahia- Brasil. A coleta de dados foi realizada através da entrevista semiestruturada, presencial ou remota via Google Meet e a análise utilizada foi a técnica de conteúdo temática proposta por Bardin. Principais Resultados: O conhecimento das enfermeiras mostrou-se incipiente sobre o tema, porém, as profissionais que tiveram curso sobre o tema demonstraram construção teórica na abordagem sindrômica. Identificou-se que as estratégias de manejo estão baseadas em práticas assistenciais e educacionais da enfermagem e encaminhamento médico. Por fim, notou-se a utilização da referência para serviços especializados em algumas patologias específica, contudo, há falha na contrarreferência. Conclusão: Diante disso, aponta-se a necessidade de educação permanente, bem como é essencial a padronização dos fluxos e melhoria do sistema de contrarreferência dos serviços da abordagem sindrômica na Atenção Primária à Saúde.

Introduction: Sexually Transmitted Infections constitute a serious public health problem, with the nursing consultation based on the syndromic approach as a mitigation mechanism. Objectives: to analyze nurses management of the syndromic approach in primary health care, learn nurses knowledge of the syndromic approach in primary health care, characterize nurses management strategies regarding the syndromic approach in primary health care, and learn about the service flows of the health care network in the syndromic approach. Methodology: Qualitative, exploratory and descriptive study, carried out with eight nurses from the Family Health Units of a municipality in the interior of Bahia-Brazil. Data collection was carried out through semi- structured, face-to-face or remote interviews via Google Meet and the analysis used was the thematic content technique proposed by Bardin. Main Results: The nurses' knowledge was incipient on the subject, however, the professionals who had taken a course on the subject demonstrated theoretical construction in the syndromic approach. It was identified that the management strategies are based on care and educational nursing practices and medical referral. Finally, the use of referrals to services specialized in some specific pathologies was noted, however, there is a failure in the counter-referral. Conclusion: In view of this, the need for permanent education is pointed out, as well as the standardization of flows and improvement of the counter-referral system of services of the syndromic approach in Primary Health Care.

Introducción: Las Infecciones Sexualmente Transmisibles constituyen un grave problema de salud pública, teniendo la consulta de enfermería basada en el abordaje sindrómico como mecanismo de mitigación. Objetivos: analizar el manejo de las enfermeras sobre el abordaje sindrómico en la atención primaria en salud, aprehender los conocimientos de las enfermeras sobre el abordaje sindrómico en la atención primaria en salud, caracterizar las estrategias de manejo de las enfermeras sobre el abordaje sindrómico en la atención primaria en salud y conocer los flujos de atención de la red asistencial en salud sobre el abordaje sindrómico. Metodologia: Estudo qualitativo, exploratório e descritivo, realizado com oito enfermeiras das Unidades de Saúde da Família de um município no interior da Bahia-Brasil. La recogida de datos se realizó mediante entrevista semiestructurada, presencial o a distancia a través de Google Meet y el análisis utilizado fue la técnica de contenido temático propuesta por Bardin. Resultados principales: El conocimiento de las enfermeras sobre el tema parece incipiente, aunque los profesionales que han recibido formación sobre el tema han demostrado una construcción teórica en el abordaje sindrómico. Se identificó que las estrategias de manejo se basan en prácticas asistenciales y educativas de enfermería y encaminamiento médico. Por último, se observó que el uso de la referencia para servicios especializados en algunas patologías específicas, sin embargo, ha fallado en la contrarreferencia. Conclusão: Diante isso, aponta-se a necessidade de educação permanente, bem como é essencial a padronização dos fluxos e melhoria do sistema de contrarreferência dos serviços da abordagem sindrômica na Atenção Primária à Saúde.

Clinical comprehensive evaluation of Ruyi Zhenbao Pills in treatment of osteoarthritis / 中国中药杂志

This study evaluated the clinical effectiveness of Ruyi Zhenbao Pills in the treatment of osteoarthritis, aiming to clarify its clinical advantages and promote rational drug use and related policy transformation. Following the relevant standards in Guidelines for the Comprehensive Evaluation of Drugs in Clinical Practice and Technical Specifications for the Clinical Comprehensive Evaluation of Chinese Patent Medicine, comprehensive research and related data on Ruyi Zhenbao Pills in the treatment of osteoarthritis were collected in the dimensions of safety, effectiveness, economy, innovation, suitability, accessibility, and traditional Chinese medicine(TCM) cha-racteristics(referred to as the "6+1" dimensions). Through evidence-based medicine, questionnaire surveys, health technology assessment, pharmacoeconomic evaluation, and other methods, a multi-criteria decision analysis(MCDA) model and CSC v2.0 software were used to comprehensively evaluate the clinical value of Ruyi Zhenbao Pills. Spontaneous reporting system data on adverse reactions and literature data indicate that the adverse reactions of Ruyi Zhenbao Pills are mostly general adverse reactions, with no reports of se-rious adverse reactions. The known risks are small, and its safety is rated as class A. It has been shown to effectively relieve joint pain and restore joint function in the treatment of osteoarthritis. However, more high-quality, large-sample randomized controlled trials are needed to further validate its effectiveness, which is rated as class B. There is evidence supporting its economic viability, and its economic is rated as class B. It demonstrates good clinical innovation, innovative enterprise service system, and industrial innovation, and innovation is rated as class A. Medical professionals and patients have a favorable perception of the suitability of Ruyi Zhenbao Pills, and further improvement can be made in terms of convenience of administration and promotion to facilitate rational drug use by healthcare professionals and patients. Suitability is rated as class B. The drug has a favorable price level, availability, and affordability, and accessibility is rated as class A. Ruyi Zhenbao Pills are a classic Tibetan medicinal prescription with excellent TCM theoretical characteristics. However, further research is needed on its use in human studies. TCM characteristics are rated as class B. Based on the evaluation results of the "6+1" dimensions, the comprehensive clinical evaluation is rated as grade B. Ruyi Zhenbao Pills have good clinical value in the treatment of osteoarthritis, and it is recommended to undergo the necessary procedures for conditional transformation into a policy for the management of essential clinical drugs.

Selection and validation of reference genes for quantitative real-time PCR analysis in Paeonia veitchii / 中国中药杂志

Paeonia veitchii and P. lactiflora are both original plants of the famous Chinese medicinal drug Paeoniae Radix Rubra in the Chinese Pharmacopoeia. They have important medicinal value and great potential in the flower market. The selection of stable and reliable reference genes is a necessary prerequisite for molecular research on P. veitchii. In this study, two reference genes, Actin and GAPDH, were selected as candidate genes from the transcriptome data of P. veitchii. The expression levels of the two candidate genes in different tissues(phloem, xylem, stem, leaf, petiole, and ovary) and different growth stages(bud stage, flowering stage, and dormant stage) of P. veitchii were detected using real-time fluorescence quantitative technology(qRT-PCR). Then, the stability of the expression of the two reference genes was comprehensively analyzed using geNorm, NormFinder, BestKeeper, ΔCT, and RefFinder. The results showed that the expression patterns of Actin and GAPDH were stable in different tissues and growth stages of P. veitchii. Furthermore, the expression levels of eight genes(Pv-TPS01, Pv-TPS02, Pv-CYP01, Pv-CYP02, Pv-CYP03, Pv-BAHD01, Pv-UGT01, and Pv-UGT02) in different tissues were further detected based on the transcriptome data of P. veitchii. The results showed that when Actin and GAPDH were used as reference genes, the expression trends of the eight genes in different tissues of P. veitchii were consistent, validating the reliability of Actin and GAPDH as reference genes for P. veitchii. In conclusion, this study finds that Actin and GAPDH can be used as reference genes for studying gene expression levels in different tissues and growth stages of P. veitchii.

Varieties systematization and standards status analysis of fermented Chinese medicine / 中国中药杂志

Fermented Chinese medicine has long been used. Amid the advance for preservation of experience, the connotation of fermented Chinese medicine has been enriched and improved. However, fermented Chinese medicine prescriptions generally contain a lot of medicinals. The fermentation process is complicated and the conventional fermentation conditions fail to be strictly controlled. In addition, the judgment of the fermentation end point is highly subjective. As a result, quality of fermented Chinese medicine is of great difference among regions and unstable. At the moment, the quality standards of fermented Chinese medicine are generally outdated and different among regions, with simple quality control methods and lacking objective safe fermentation-specific evaluation indictors. It is difficult to comprehensively evaluate and control the quality of fermented medicine. These problems have aroused concern in the industry and also affected the clinical application of fermented Chinese medicine. This article summarized and analyzed the application, quality standards, and the modernization of fermentation technology and quality control methods of fermented Chinese medicine and proposed suggestions for improving the quality standards of the medicine, with a view to improving the overall quality of it.

Slicing specifications in general rule of processing in Chinese Pharmacopoeia from slicing development of Chinese materia medica processed product and thinking and suggestion on slicing techniques / 中国中药杂志

Slicing is critical in the processing of Chinese materia medica(CMM) processed product and the specification(thickness) is closely related to the quality of the decoction. On the basis of clarifying the concept and evolution of slicing of CMM processed product by reviewing the Chinese herbal classics of the past dynasties and general rules of local processing standards, this study discussed the development history of slicing specifications in general rules of Chinese Pharmacopoeia(2020 edition), analyzed the current situation and key problems, and proposed the thinking and suggestion on promoting the sound development of slicing of CMM processed product. Since 2000, the slicing thickness of CMM processed product in the general rules of local CMM processed product processing specifications newly revised and issued by 27 provinces, autonomous regions, and municipalities has been consistent with that in the general rules of the Chinese Pharmacopoeia(2020 edition). The standard that the thickness of extremely thin pieces is less than 0.5 mm is rarely retained, and the pieces in 0.5-1 mm thickness have not been found on the market, which is consistent with the provisions of the general rules of the Chinese Pharmacopoeia. This study can provide a historical and modern basis for the rationality of slicing of CMM processed product.

Technical points of human use experience of ethnic medicine / 中国中药杂志

Ethnic medicine has a rich history of application. Because of the large number of ethnic groups, wide geographical distribution, and unique medical systems in China, the research on the human use experience(HUE) of ethnic medicine should combine the characteristics of ethnic medicine, be based on practical experience, and respect folk practice and tradition. The clinical positioning of ethnic medicine should consider three factors, i.e., population region, dominant diseases, and clinical demand. We should consider the development of traditional preparations that meet the needs of ethnic regions and encourage the development of new drugs that can be popularized and used nationwide for the dominant diseases of ethnic medicines. Attention should be paid to the problems such as a large number of customary articles or substitutes of ethnic medicinal materials, the phenomena of foreign bodies with the same name and different names for the same substance, the different standards of medicinal materials, and the poor processing standards. The name, processing method, source, medicinal parts, and dosage of ethnic medicinal materials or decoction pieces should be determined, and resources should be carefully evaluated to ensure the safety of medicinal resources and ecology. The preparation of ethnic medicine is mostly in the form of pills, powder, ointment, etc., with simple processing technology. The problems of low-quality stan-dards of some preparations, different prescriptions with the same name, and inconsistent processing technology should be overcome, and the process route and main process parameters should be clarified to lay the foundation for the subsequent empirical research on HUE. In the collection and analysis of the HUE data of ethnic medicine, the core guiding ideology of "patient-centered" should be established, and the experience data of patients should be collected. The problems of weak links existing in the inheritance of ethnic medicine should be solved, and flexible and diverse methods should be adopted. Meanwhile, on the premise of complying with the requirements of the principles of medical ethics, we should respect the religion, culture, and customs of ethnic areas to obtain the key HUE information of ethnic medicine. On the basis of the patient preference information and differences in regional disease epidemiology, population characteristics, and medical practice, whether the HUE conclusions of ethnic medicine can be extrapolated to patients outside the region is evaluated from the aspects of clinical benefits, risk tolerance, risk acceptance, etc. The HUE research on ethnic medicine is carried out in a clear way to guide the research and development of new ethnic medicines.

Guideline for clinical comprehensive evaluation of Chinese patent medicine (2022 version) / 中国中药杂志

Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.

Inheritance, innovation and development of traditional Chinese medicine in new era call for scientific supervision / 中国中药杂志

Pharmaceutical products need to ensure the effectiveness, safety and quality controllability through scientific supervision, and as the broad masses of the people are full of new expectations for the supply of high-quality traditional Chinese medicine products, the reform and innovation of traditional Chinese medicine regulatory policies are also facing new opportunities and new challenges. National Medical Products Administration, National Administration of Traditional Chinese Medicine and other relevant departments have implemented the requirements of the Party Central Committee and the State Council, vigorously promoted the reform of the regulatory system in line with the characteristics of traditional Chinese medicine, introduced a series of innovative policies, and achieved phased results. Including the new registration classification standards in line with the characteristics of traditional Chinese medicine, encouraging the development of classical formulas and hospital preparations, encouraging the research and development of symptomatic Chinese medicines, and gra-dually improving the "three-combined " evidence system. However, in the face of the development problems of traditional Chinese medicine in the new era, it is still necessary to improve the scientific supervision system, further optimize the management measures for the registration of traditional Chinese medicines based on classical formulas, accelerate the improvement of the standard system for traditional Chinese medicine formula granules, and form management measures to encourage and support the secondary development of traditional Chinese medicines. In terms of scientific supervision of traditional Chinese medicine, it is necessary to follow the characteristics and development laws of traditional Chinese medicine itself, comprehensively consider the characteristics of epochal, scientific and systematic in regulatory policies, and serve the inheritance and innovative development of traditional Chinese medicine with scientific supervision.

Quality evaluation methods of Poria based on yield and content of alkali extracted polysaccharide / 中国中药杂志

To improve the quality control methods of Poria and develop and utilize its resources fully, alkaline extraction was used in this study to determine the yield and content of alkali-soluble polysaccharides of Poria. The alkali-soluble extracts of Poria were obtained according to the optimum extraction conditions on the basis of single-factor test, and 30 batches of samples were determined. The structure and chemical composition of the alkali-soluble extracts was characterized by high-performance gel permeation chromatography(HPGPC), Fourier transform infrared spectrometry(FT-IR), nuclear magnetic resonance(NMR) spectroscopy and high-performance liquid chromatography(HPLC) with 1-phenyl-3-methyl-5-pyrazolone(PMP-HPLC). The results showed that the content of the alkali-soluble extracts was in the range of 46.98%-73.86%. The main component was β-(1→3)-glucan, and its molecular mass was about 1.093×10~5. Further, the content of alkali-soluble polysaccharides of Poria was measured by UV-Vis spectrophotometry and HPLC coupled with the evaporative light scattering detector(HPLC-ELSD), and 30 batches of samples were measured. The results indicated that the content of alkali-soluble polysaccharides determined by UV-Vis spectrophotometry was in the range of 73.70%-92.57%, and the content of samples from Hubei province was slightly higher than that from Yunnan province, Anhui province and Hunan province. The content of alkali-soluble polysaccharides determined by HPLC-ELSD was in the range of 51.42%-76.69%, and the samples from Hunan province had slightly higher content than that from the other three provinces. The content determined by UV-Vis spectrophotometry was higher than that by HPLC-ELSD. However, the content determined by HPLC-ELSD was close to that of alkali-soluble extract, which could accurately characterize the content of alkali-soluble polysaccharides in Poria, and the method was simple and repeatable. Therefore, it is recommended that the quantitative analysis method for alkali-soluble extract and alkali-soluble polysaccharides by HPLC-ELSD be used in the quality standards of Poria in Chinese Pharmacopeia.

Screening of housekeeping genes in Gelsemium elegans and expression patterns of genes involved in its alkaloid biosynthesis / 生物工程学报

Gelsemium elegans is a traditional Chinese herb of medicinal importance, with indole terpene alkaloids as its main active components. To study the expression of the most suitable housekeeping reference genes in G. elegans, the root bark, stem segments, leaves and inflorescences of four different parts of G. elegans were used as materials in this study. The expression stability of 10 candidate housekeeping reference genes (18S, GAPDH, Actin, TUA, TUB, SAND, EF-1α, UBC, UBQ, and cdc25) was assessed through real-time fluorescence quantitative PCR, GeNorm, NormFinder, BestKeeper, ΔCT, and RefFinder. The results showed that EF-1α was stably expressed in all four parts of G. elegans and was the most suitable housekeeping gene. Based on the coexpression pattern of genome, full-length transcriptome and metabolome, the key candidate targets of 18 related genes (AS, AnPRT, PRAI, IGPS, TSA, TSB, TDC, GES, G8H, 8-HGO, IS, 7-DLS, 7-DLGT, 7-DLH, LAMT, SLS, STR, and SGD) involved in the Gelsemium alkaloid biosynthesis were obtained. The expression of 18 related enzyme genes were analyzed by qRT-PCR using the housekeeping gene EF-1α as a reference. The results showed that these genes' expression and gelsenicine content trends were correlated and were likely to be involved in the biosynthesis of the Gelsemium alkaloid, gelsenicine.