Developing a breast cancer screening decision aid in Spanish for average-risk women: a mixed methods study / Estudios originales Publicado el 14 de marzo de 2024 | http://doi.org/10.5867/medwave.2024.02.2726 Developing a breast cancer screening decision aid in Spanish for average-risk women: a mixed methods study Desarrollo de una herramienta en español para ayudar en la toma de decisiones del cribado de cáncer de mama para mujeres de riesgo promedio: un estudio de métodos mixtos

Introduction We aimed to develop a decision aid to support shared-decision making between physicians and women with average breast cancer risk when deciding whether to participate in breast cancer screening. Methods We included women at average risk of breast cancer and physicians involved in supporting the decision of breast cancer screening from an Academic Hospital in Buenos Aires, Argentina. We followed the International Patient Decision Aid Standards to develop our decision aid. Guided by a steering group and a multidisciplinary consultancy group including a patient advocate, we reviewed the evidence about breast cancer screening and previous decision aids, explored the patients' information needs on this topic from the patients' and physicians' perspective using semi-structured interviews, and we alpha-tested the prototype to determine its usability, comprehensibility and applicability. Results We developed the first prototype of a web-based decision aid to use during the clinical encounter with women aged 40 to 69 with average breast cancer risk. After a meeting with our consultancy group, we developed a second prototype that underwent alpha-testing. Physicians and patients agreed that the tool was clear, useful and applicable during a clinical encounter. We refined our final prototype according to their feedback. Conclusion We developed the first decision aid in our region and language on this topic, developed with end-users' input and informed by the best available evidence. We expect this decision aid to help women and physicians make shared decisions during the clinical encounter when talking about breast cancer screening.

Concordancia inter- e intraobservador del puntaje PI-RADS 2.1 del Colegio Americano de Radiología / Intraobserver and interobserver agreement of the American College of Radiology PI-RADS 2.1 score

Resumen Antecedentes: La resonancia magnética (RM) de próstata es uno de los métodos diagnósticos para la identificación del carcinoma de próstata. La escala PI-RADS (Prostate Imaging and Reporting Data System) es el sistema usado para la interpretación de estas imágenes. Es importante, para su reproducibilidad, la estandarización y la evaluación de dicha escala. Objetivo: Determinar la concordancia inter- e intraobservador de la versión 2.1 del PI-RADS. Material y métodos: Estudio observacional retrospectivo, evaluando 129 RM de pacientes con sospecha de cáncer de próstata por tres radiólogos con diferentes años de experiencia y en dos momentos del tiempo, usando el puntaje PI-RADS 2.1. Se evaluó la concordancia intra- e interobservador. Resultados: La concordancia interobservador fue sustancial (kappa > 0,6) en todos los observadores, siendo la categoría 5 la de mayor acuerdo interobservador. Se observó una alta reproducibilidad intraobservardor, con la mayor kappa siendo de 0,856. Cuando se realizó el análisis según años de experiencia de los radiólogos, la concordancia interobservador fue significativa en todos los casos. Conclusiones: El sistema de clasificación PI-RADS 2.1 es reproducible para las diferentes categorías y aumenta la concordancia cuando se trata de lesiones con mayor probabilidad de cáncer clínicamente significativo.

Abstract Background: Magnetic Resonance Imaging (MRI) of the prostate is a key diagnostic tool for identifying prostate carcinoma. The Prostate Imaging-Reporting and Data System (PI-RADS) scale is the standard system for interpreting these images. Standardizing and evaluating this scale is crucial for ensuring consistent and reproducible results. Objective: This study aims to assess both the interobserver and intraobserver agreement of the PI-RADS version 2.1. Material and methods: In this retrospective observational study, 129 prostate MRI scans from patients with suspected prostate cancer were evaluated. Three radiologists, each with different levels of experience, analyzed these scans at two separate times using the PI-RADS 2.1 scoring system. Both intraobserver and interobserver agreements were measured. Results: The study found substantial interobserver agreement (kappa > 0.6) across all categories, with category 5 showing the highest level of agreement. Intraobserver reproducibility was also high, with the highest kappa value reaching 0.856. Further analysis based on the radiologists’ years of experience revealed significant interobserver agreement in all instances. Conclusions: The PI-RADS 2.1 classification system demonstrates high reproducibility across different categories, particularly for lesions more likely to be clinically significant cancers. This underscores its reliability in varied diagnostic scenarios.

Lung cancer screening in Brazil: recommendations from the Brazilian Society of Thoracic Surgery, Brazilian Thoracic Association, and Brazilian College of Radiology and Diagnostic Imaging / Recomendações da Sociedade Brasileira de Cirurgia Torácica, Sociedade Brasileira de Pneumologia e Tisiologia e Colégio Brasileiro de Radiologia e Diagnóstico por Imagem para o rastreamento do câncer de pulmão no Brasil

ABSTRACT Although lung cancer (LC) is one of the most common and lethal tumors, only 15% of patients are diagnosed at an early stage. Smoking is still responsible for more than 85% of cases. Lung cancer screening (LCS) with low-dose CT (LDCT) reduces LC-related mortality by 20%, and that reduction reaches 38% when LCS by LDCT is combined with smoking cessation. In the last decade, a number of countries have adopted population-based LCS as a public health recommendation. Albeit still incipient, discussion on this topic in Brazil is becoming increasingly broad and necessary. With the aim of increasing knowledge and stimulating debate on LCS, the Brazilian Society of Thoracic Surgery, the Brazilian Thoracic Association, and the Brazilian College of Radiology and Diagnostic Imaging convened a panel of experts to prepare recommendations for LCS in Brazil. The recommendations presented here were based on a narrative review of the literature, with an emphasis on large population-based studies, systematic reviews, and the recommendations of international guidelines, and were developed after extensive discussion by the panel of experts. The following topics were reviewed: reasons for screening; general considerations about smoking; epidemiology of LC; eligibility criteria; incidental findings; granulomatous lesions; probabilistic models; minimum requirements for LDCT; volumetric acquisition; risks of screening; minimum structure and role of the multidisciplinary team; practice according to the Lung CT Screening Reporting and Data System; costs versus benefits of screening; and future perspectives for LCS.

RESUMO O câncer de pulmão (CP) é uma das neoplasias mais comuns e letais no Brasil, e apenas 15% dos pacientes são diagnosticados nos estágios iniciais. O tabagismo persiste como o responsável por mais de 85% de todos os casos. O rastreamento do CP (RCP) por meio da TC de baixa dosagem de radiação (TCBD) reduz a mortalidade do CP em 20%, e, quando combinado com a cessação do tabagismo, essa redução chega a 38%. Na última década, diversos países adotaram o RCP como recomendação de saúde populacional. No Brasil, embora ainda incipiente, a discussão sobre o tema é cada vez mais ampla e necessária. Com o intuito de aumentar o conhecimento e estimular o debate sobre o RCP, a Sociedade Brasileira de Cirurgia Torácica, a Sociedade Brasileira de Pneumologia e Tisiologia e o Colégio Brasileiro de Radiologia e Diagnóstico por Imagem constituíram um painel de especialistas para elaborar as recomendações para o RCP. As recomendações aqui apresentadas foram baseadas em revisão narrativa da literatura, com ênfase em grandes estudos populacionais, em revisões sistemáticas e em recomendações de diretrizes internacionais, sendo construídas após ampla discussão pelo grupo de especialistas. Os temas revisados foram os seguintes: porque rastrear, considerações gerais sobre tabagismo, epidemiologia do CP, critérios de elegibilidade, achados incidentais, lesões granulomatosas, modelos probabilísticos, requisitos mínimos da TCBD, aquisições volumétricas, riscos do rastreamento, estrutura mínima e papel da equipe multidisciplinar, conduta segundo o Lung CT Screening Reporting and Data System (Lung-RADS), custos vs. benefícios e perspectivas do rastreamento.

Availability of resources for paediatric hearing care in a South African province

Background: Unavailability of healthcare resources can lead to poor patient outcomes. The latter is true for infants with hearing loss and require early hearing detection and intervention (EHDI). Aim: To determine the availability and distribution of resources for EHDI in state hospitals in the Eastern Cape (EC) province, South Africa. Setting: Sixteen state hospitals (nine district, four regional and three tertiary hospitals). Methods: Descriptive cross-sectional survey completed between July 2022 and October 2022. Results: Thirteen hospitals had audiologists (n = 4) or speech therapists and audiologists (n = 9). Specific to equipment, 10 hospitals had a screening otoacoustic emissions or automated auditory brainstem response, 8 hospitals had diagnostic middle ear analysers and only 3 hospitals had diagnostic auditory brainstem response and/or auditory steady state response. Twelve hospitals did not have visual response audiometry (VRA) and 94% had no hearing aid verification systems. Budget allocations were uneven, with only 10 hospitals, i.e., 4 districts, all regional and 2 tertiary hospitals being allocated varying amounts. Subsequently, only 50% provided newborn hearing screening, 56% provided diagnostic evaluations and 14 hospitals fitted hearing aids. Conclusion: Results revealed a limited and uneven distribution of resources, which negatively impacted the provision of EHDI. Even distribution of healthcare resources and further research aimed at strengthening hearing health services is recommended as these could potentially improve equitable access to EHDI and the overall quality of healthcare provided. Contribution: This study highlights the need for even distribution of resources and strengthening of health systems, especially in the dawn of the National Health Insurance.

Development and verification of whole column imaging detection-capillary isoelectric focusing method for determination of isoelectric point of pertactin / 中国生物制品学杂志

@#Objective To develop and verify a whole column imaging detection-capillary isoelectric focusing(WCID-CIEF)method for the determination of isoelectric point(pI)of pertactin(PRN).Methods The WCID-CIEF method for the determination of PRN antigen was developed by optimizing the parameters such as the focusing time and final concentration of samples in the WCID-CIEF process,and verified for the specificity,accuracy,repeatability,intermediate precision,durability and inter-batch consistency.Results The optimal focusing time of WCID-CIEF for the determination of PRN antigen pI was 1 min at 1 500 V and 3 min at 3 000 V. The optimal final concentration of PRN antigen was 300 μg/mL. The PRN antigen pI was about 6. 035,and the blank matrix showed no interference peak in the position of each peak of antigen. The method had good specificity,accuracy,repeatability,intermediate precision,durability and consistency among batches.Conclusion The developed WCID-CIEF method is suitable for the pI detection and charge heterogeneity analysis of PRN antigen,which can provide basis for the characterization of PRN antigen and reference for the quality control in the process of development and production of related vaccines.

Caracterización de adultos mayores con cáncer colorrectal en la comunidad

Fundamento: el cáncer colorrectal es la neoplasia más frecuente del sistema digestivo en los adultos mayores. En Cuba es un problema de salud de primer orden por su elevada incidencia y mortalidad, constituye la tercera causa de muerte en la población general. Objetivo: caracterizar a los adultos mayores con cáncer colorrectal en el Policlínico Sur Rudesindo García del Rijo de la provincia Sancti Spíritus. Métodos: se realizó una investigación de tipo descriptiva en el Policlínico Sur Rudesindo García del Rijo del municipio y provincia Sancti Spíritus, de enero a marzo del 2019. Se trabajó con una muestra intencional de 127 adultos mayores, pertenecientes a consultorios urbanos. Las variables analizadas fueron: edad, sexo, nivel de escolaridad, estadio del cáncer colorrectal al diagnóstico, estado de salud, comorbilidades, capacidad y percepción del autocuidado y supervivencia. Para el estadio al diagnóstico se utilizó la clasificación anatomoclínica, la comorbilidad, se midió mediante el índice de Charlson y el Test de Capacidad y Percepción de Autocuidado del Adulto Mayor. La información se procesó mediante el análisis porcentual. Los resultados alcanzados se interpretaron los números con sus porcientos. Resultados: en la caracterización de la muestra predominaron las féminas, el grupo de edad entre 70 y 79 años y el nivel de escolaridad de secundaria básica. El estadio II con un mal estado de salud y la inadecuada percepción de autocuidado fue mayoritario. La comorbilidad fue moderada con una supervivencia entre 40 a 60 meses. Conclusiones: predominaron las mujeres entre los 70 y los 79 años y como nivel de escolaridad, la secundaria básica; además prevaleció el estadio II y la inadecuada percepción de autocuidado.

Foundation: colorectal cancer is the most common neoplasm of the digestive system in older adults. In Cuba it is a major health problem due to its high incidence and mortality; it is the third cause of death in the general population. Objective: to characterize older adults with colorectal cancer at the Rudesindo García del Rijo Sur Polyclinic in the Sancti Spíritus province. Methods a descriptive research was carried out at the Sur Rudesindo García del Rijo Polyclinic in the municipality and province of Sancti Spíritus, from January to March 2019. We worked with an intentional sample of 127 older adults, belonging to urban clinics. The variables analyzed were: age, sex, educational level, stage of colorectal cancer at diagnosis, health status, comorbidities, capacity and perception of self-care and survival. For the stage at diagnosis, the anatomoclinical classification was used, comorbidity was measured using the Charlson index and the Self-Care Capacity and Perception Test for the Elderly. The information was processed through percentage analysis. The results achieved were interpreted as numbers with their percentages. Results: in the characterization of the sample, females, the age group between 70 and 79 years and the level of lower secondary education predominated. Stage II with a poor state of health and inadequate perception of self-care was the majority. Comorbidity was moderate with survival between 40 to 60 months. Conclusions: women between 70 and 79 years of age and lower secondary education level predominated, stage II and inadequate perception of self-care also prevailed.

Detección molecular de patógenos en deposiciones en niños consultantes por diarrea aguda en Servicios de Urgencia

Introducción: La diarrea aguda continúa siendo una de las principales causas de morbilidad en niños; sin embargo, el diagnóstico etiológico presenta limitaciones dada la baja sensibilidad de los métodos tradicionales. Objetivo: Describir los microorganismos identificados en niños que acudieron al Servicio de Urgencia (SU) de un hospital universitario en Santiago, Chile, por diarrea aguda y a los que se le solicitó panel molecular gastrointestinal. Métodos: Se revisaron fichas clínicas y resultados de panel gastrointestinal realizados entre junio de 2017 y marzo de 2020. Resultados: Se incluyeron 198 pacientes, edad promedio de 54,5 meses y 60,6% (120/198) de sexo masculino. La positividad del panel fue de 78,8% (156/198) con 35,3% (55/156) de las muestras polimicrobianas. Se identificaron 229 microorganismos, de los cuales 72,9% (167/229) corresponden a bacterias, 25,8% (59/229) a virus y 1,3% (3/229) a parásitos. Destacaron Campylobacter spp. y Escherichia coli enteropatógena (ECEP) como las bacterias más frecuentemente identificadas. Los pacientes con detección de Campylobacter spp. presentaron con mayor frecuencia fiebre (p = 0,00). ECEP se aisló principalmente (82,5%) en muestras polimicrobianas. Discusión: Los resultados enfatizan el potencial que poseen los estudios moleculares para mejorar el diagnóstico etiológico de la diarrea, pero a la vez llevan a cuestionar el rol patogénico de algunos microorganismos identificados.

Background: Acute diarrhea continues to be one of the main causes of morbidity in children, however the etiologica diagnosis presents limitations given the low sensitivity of traditional methods. Aim: To describe the microorganisms identified in children who attended the emergency department (ED) in Santiago, Chile, due to acute diarrhea and to whom a gastrointestinal panel was requested as part of their study. Material and Methods: Clinical records and results of the gastrointestinal panel carried out between June 2017 and March 2020 were reviewed. Results: 198 patients were included, the average age was 54.5 months and 60.6% (120/198) were males. Positivity was 78.8% (156/198) with 35.3% (55/156) of the samples being polymicrobial. 229 microorganisms were identified, of which 72.9% (167/229) corresponded to bacteria, 25.8% (59/229) to viruses, and 1.3% (3/229) to parasites. Campylobacter spp. and enteropathogenic Escherichia coli (EPEC) were the most frequently identified bacteria. Patients with detection of Campylobacter spp. presented a higher frequency of fever (p = 0.00). EPEC was isolated in 82.5% of the cases in polymicrobial samples. Discussion: The results emphasize the potential of molecular studies to improve the etiological diagnosis of diarrhea and at the same time lead to question the pathogenic role of some microorganisms.

Molecular detection of SARS-CoV-2 in Argentina: Evaluation of alternative diagnostic tools for the decentralization of the diagnosis

Abstract The rocketing number of COVID-19 cases highlighted the critical role that diagnostic tests play in medical and public health decision-making to contain and mitigate the SARS-CoV-2 pandemic. This study reports the evaluation and implementation of different tests for the molecular detection of SARS-CoV-2 in the central region of Argentina. We evaluated 3 real time RT-PCR kits (GeneFinder COVID-19 Plus RealAmp Kit, DisCoVery SARS-CoV-2 RT-PCR Detection Kit and WGene SARS-CoV-2 RT Detection), 2 nucleic acid extraction methods [MagaBio plus Virus DNA/RNA Purification Kit II (BioFlux), 35-min vs. 9-min, a pre-analytical reagent (FlashPrep®) and 2 isothermal amplification tests (Neokit Plus and ELA CHEMSTRIP®). The order according to the best performance of the 3 real-time RT-PCR kits evaluated was: DisCoVery > GeneFinderTM> WGene. The 2 RNA extraction methods showed similar good results: MagaBio plus Virus RNA Purification Kit II (BioFlux) 9-min was selected due to its faster performance. FlashPrep® reagent showed excellent results to perform direct RNA detection. Isothermal amplification assays showed acceptable sensitivity and specificity values (>80%), except in samples with Ct> 30. Our data show optimal real time RT-PCR kits and alternative molecular methods for SARS-CoV-2 diagnostic. These alternative assays proved to be aceptable.

Resumen La explosión de casos de COVID-19 resaltó el papel fundamental que desempeñan las pruebas de diagnóstico en la toma de decisiones médicas y de salud pública para contener y mitigar la pandemia de SARS-CoV-2. Este estudio reporta la evaluación y la implementación de diferentes test para la detección molecular de SARS-CoV-2 en la región central de Argentina. Evaluamos tres kits de RT-PCR en tiempo real (GeneFinder COVID-19 Plus RealAmp Kit, DisCoVery SARS-CoV-2 RT-PCR Detection Kit y WGene SARS-CoV-2 RT Detection), dos métodos de extracción de ácidos nucleicos (MagaBio plus Virus DNA/RNA Purification Kit II [BioFlux, 35-min vs. 9-min), un reactivo pre-analítico (FlashPrep®) y dos test de amplificación isotérmica (Neokit Plus and ELA CHEMSTRIP®). El orden de rendimiento de los tres kits de RT-PCR en tiempo real evaluados fue el siguiente: DisCoVery GeneFinder™ WGene. Los dos métodos de extracción de RNA mostraron buenos y similares resultados; se seleccionó MagaBio plus Virus RNA Purification Kit II (BioFlux) 9-min debido a su rápido tiempo de procesamiento. El reactivo FlashPrep® mostró excelentes resultados para realizar detección directa de RNA. Los ensayos de amplificación isotérmica mostraron valores de sensibilidad y de especificidad aceptables (80%), excepto en muestras con Ct 30. Nuestros resultados muestran kits de RT-PCR en tiempo real óptimos, como así también métodos moleculares alternativos para el diagnóstico de SARS-CoV-2 que resultan aceptables para su uso en contextos adversos, de descentralización y en diferentes escenarios epidemiológicos, para la detección rápida y precisa del SARS-CoV-2.

Current Insights on Neoplasms and Adequate Dental Care for Patients with Oral Cancer / Actualización sobre Neoplasmas y su Correcta Atención Odontológica en Pacientes con Cancer Oral

The present study aimed to review the literature on the main complications of antineoplastic therapies and the degree of knowledge of dental surgeons about these complications. A bibliographic search was conducted in the main health databases PUBMED (www.pubmed.gov) and Scholar Google (www.scholar.google.com.br), in which studies published from 1987 to 2023 were collected. Laboratory studies, case reports, systematic and literature reviews, which were developed in living individuals, about the main neoplastic genes and their relationship with the cells of individuals affected by neoplasms in the head and neck region, and studies on the care with this group of patients, were included. Therefore, articles that did not deal with neoplasm and the main complications of antineoplastic therapies were excluded. Neoplasm is a clonal disorder, caused by mutations, resulting from changes in the genetic structure of cells. Each healthy cell has instructions on how to grow and divi de. In the presence of any error in these instructions (mutation), it can result in a diseased cell that, when proliferating, may cause a tumor. Countless knowledge has been accumulated over the years on the main characteristics of neoplasms, whether they are cancer cell biology, carcinogenesis mechanism, neoplasms of the maxillofacial system and sequels of antineoplastic treatments. In this context, methods have been developed that offer a better quality of life for patients diagnosed with this pathology, as well as preventive vaccine models that may, in the not too distant future, contribute to this goal to be successfully achieved.

El presente estudio tuvo como objetivo revisar la literatura sobre las principales complicaciones de las terapias antineoplásicas y el grado de conocimiento de los odontólogos sobre este abordaje. Se realizó una búsqueda bibliográfica en las principales bases de datos de salud PUBMED (www.pubmed.gov) y Scholar Google (www.scholar.google.com.br), en la que se recopilaron estudios publicados entre 1987 y 2023. Fueron incluidos estudios de laboratorio, relatos de casos, revisiones de la literatura y revisiones sistemáticas, desarrolladas en individuos vivos, que incluyeran los principales genes neoplásicos y su relación con las células de individuos afectados por neoplasias en la cabeza y el cuello. También, se tuvieron en cuenta estudios relacionados con la atención a este grupo de pacientes. La neoplasia es un trastorno clonal, causado por mutaciones, como resultado de cambios en la estructura genética de las células. Cada célula sana tiene instrucciones sobre cómo crecer y dividirse. En presencia de cualquier error en estas instrucciones (mutación), puede provocar una célula alterada que, al proliferar, puede causar un tumor. Se han acumulado innumerables conocimientos a lo largo de los años sobre las principales características de las neoplasias, ya sea sobre biología de células cancerosas, el mecanismo de la carcinogénesis, la neoplasias del sistema maxilofacial y las diferentes secuelas de tratamientos antineoplásicos. En este contexto, se han desarrollado métodos que ofrecen una mejor calidad de vida para los pacientes diagnosticados con esta patología, así como modelos de vacunas preventivas que, en un futuro no muy lejano, pueden contribuir a alcanzar este objetivo con éxito.

Accuracy of an artificial intelligence-based mobile application for detecting cataracts: Results from a field study

Purpose: To assess the accuracy of e?Paarvai, an artificial intelligence?based smartphone application (app) that detects and grades cataracts using images taken with a smartphone by comparing with slit lamp?based diagnoses by trained ophthalmologists. Methods: In this prospective diagnostic study conducted between January and April 2022 at a large tertiary?care eye hospital in South India, two screeners were trained to use the app. Patients aged >40 years and with a best?corrected visual acuity <20/40 were recruited for the study. The app is intended to determine whether the eye has immature cataract, mature cataract, posterior chamber intra?ocular lens, or no cataract. The diagnosis of the app was compared with that of trained ophthalmologists based on slit?lamp examinations, the gold standard, and a receiver operating characteristic (ROC) curve was estimated. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were computed. Results: The two screeners used the app to screen 2,619 eyes of 1,407 patients. In detecting cataracts, the app showed high sensitivity (96%) but low specificity (25%), an overall accuracy of 88%, a PPV of 92.3%, and an NPV of 57.8%. In terms of cataract grading, the accuracy of the app was high in detecting immature cataracts (1,875 eyes, 94.2%), but its accuracy was poor in detecting mature cataracts (73 eyes, 22%), posterior chamber intra?ocular lenses (55 eyes, 29.3%), and clear lenses (2 eyes, 2%). We found that the area under the curve in predicting ophthalmologists’ cataract diagnosis could potentially be improved beyond the app’s diagnosis based on using images only by incorporating information about patient sex and age (P < 0.0001) and best?corrected visual acuity (P < 0.0001). Conclusions: Although there is room for improvement, e?Paarvai app is a promising approach for diagnosing cataracts in difficult?to?reach populations. Integrating this with existing outreach programs can enhance the case detection rate.

Detección de novedad y codificación predictiva en el sistema auditivo: Impacto clínico en disfunciones auditivas y vestibulares. Revisión de la literatura

Una propiedad fundamental de los sistemas sensoriales es su capacidad para detectar estímulos novedosos en el entorno. El sistema nervioso posee neuronas que disminuyen su respuesta a los estímulos sonoros que se repiten a lo largo del tiempo y otras neuronas que aumentan su frecuencia de disparo ante estímulos novedosos, siendo la diferencia entre ambas respuestas conocida como adaptación-específica a estímulos. En las últimas décadas, se ha propuesto que el cerebro establece, continuamente, predicciones de los estímulos novedosos y del entorno basándose en sus experiencias previas y en modelos de representación internos, teoría denominada codificación predictiva. En esta revisión, abordaremos algunos conceptos de la adaptación-específica a estímulos y codificación predictiva, centrándonos principalmente en el sistema auditivo. Por último, propondremos una explicación teórica basada en el marco de la codificación predictiva para algunas disfunciones neuropsiquiátricas, auditivas y vestibulares.

A fundamental property of sensory systems is their ability to detect novel stimuli in the environment. The nervous system possesses neurons that decrease their response to sound stimuli that are repeated over time and other neurons that increase their firing rate to novel stimuli, the difference between the two responses being known as stimulus-specific adaptation. In recent decades, it has been proposed that the brain continuously makes predictions of novel stimuli and the environment based on its previous experiences and internal representational models, a theory called predictive coding. In this review, we will address some concepts of stimulus-specific adaptation and predictive coding, focusing mainly on the auditory system. Finally, we will propose a theoretical explanation based on the predictive coding framework for some neuropsychiatric, auditory, and vestibular dysfunctions.

Desarrollo de la habilidad en el diagnóstico precoz del cáncer bucal durante las prácticas preprofesionales de Estomatología / Development of the competence in oral cancer early diagnosis during pre-professional training in Dentistry i: en

Introducción: La creciente aparición del cáncer bucal en etapas avanzadas revela la necesidad de egresar profesionales preparados que contribuyan a su prevención y diagnóstico precoz. Objetivo: Evaluar un sistema de tareas docentes para el desarrollo de la habilidad en el diagnóstico precoz del cáncer bucal. Métodos: Se realizó un preexperimento en 32 estudiantes y 10 profesores vinculados al proceso de enseñanza-aprendizaje de la asignatura Atención Integral a la Población de la carrera de Estomatología en la Universidad de Ciencias Médicas de Guantánamo, en el curso escolar 2022-2023. A tal efecto, se determinó la variable el desarrollo de la habilidad para el diagnóstico precoz del cáncer bucal, con sus dimensiones e indicadores, y se comprobó la significación de un sistema de tareas docentes para este fin a través de la prueba de Wilcoxon. Resultados: De acuerdo con los rangos de Wilcoxon, el sistema de tareas docentes resultó confiable para contribuir al desarrollo de la habilidad objeto de estudio (p<0,05). Los estudiantes consideraron que dicho sistema constituye la vía idónea para su preparación en el tema; de igual forma, todos los profesores coincidieron en cuanto a su pertinencia, factibilidad, efectividad, utilidad práctica y relevancia. Conclusiones: El sistema de tareas docentes aplicado durante la práctica preprofesional de los estudiantes de estomatología demostró ser factible para el desarrollo de la habilidad en el diagnóstico precoz del cáncer bucal.

Introduction: The increasing appearance of advanced oral cancer reveals the need of graduating professionals, prepared to contribute to its prevention and early diagnosis. Objective: To evaluate a system of teaching tasks for the development of competence in oral cancer early diagnosis. Methods: A pre-experiment was carried out with 32 students and 10 professors, who were involved in the teaching-learning process of the subject Comprehensive Dental Care for the Population of Dentistry degree in the University of Medical Sciences from Guantánamo, in the 2022-2023 academic year. For this purpose, the development of competence in oral cancer early diagnosis was determined as the variable, with its dimensions and indicators, and the significance of a system of teaching tasks for this objective was verified through the Wilcoxon test. Results: According to the Wilcoxon ranks, the teaching task system was reliable in contributing to the development of the competence under study (p<0.05). The students considered that this system is the ideal way for their training on the subject; in the same way, all teachers agreed regarding the relevance, feasibility, effectiveness, and practical utility of the teaching task system. Conclusions: The teaching task system applied during pre-professional practice of dentistry students proved to be feasible for the development of competence in oral cancer early diagnosis.

A New Brazilian Device for Cervical Cancer Screening: Acceptability and Accuracy of Self-sampling / Um Novo Dispositivo Brasileiro para Diagnóstico de Câncer Cervical: Aceitabilidade e Precisão da Autoamostragem

Abstract Objective To evaluate the accuracy and patient acceptability toward self-sampling using a new device - SelfCervix® - for detecting HPV-DNA. Methods A total of 73 women aged 25-65 who underwent regular cervical cancer screening from March to October 2016 were included. Women performed self-sampling followed by a physician-sampling, and the samples were analyzed for HPV-DNA. After that, patients were surveyed about their acceptability of self-sampling. Results HPV-DNA detection rate of self-sampling presented high accuracy and was similar to physician-collection. Sixty-four (87.7%) patients answered the acceptability survey. Most patients (89%) considered the self-sampling comfortable, and 82.5% preferred self-sampling to physician-sampling. The reasons cited were time-saving and convenience. Fifty-one (79.7%) reported that they would recommend self-sampling. Conclusion Self-sampling using the new Brazilian device SelfCervix® is not inferior in HPV-DNA detection rate compared with physician-collection, and patients are supportive of the method. Therefore, it might be an option to reach under-screened populations in Brazil.

Resumo Objetivo Avaliar a acurácia e aceitabilidade da auto-coleta utilizando um novo coletor - SelfCervix® - para a detecção de DNA de HPV. Métodos Foram incluídas no estudo 73 mulheres com idade entre 25-65 anos que realizaram seu rastreamento regular do câncer de colo do útero entre Março e Outubro de 2016. Estas mulheres realizaram a auto-coleta, seguida de coleta profissional e as amostras foram analisadas paraa presença de DNA de HPV. Após, elas responderam um questionário sobre a experiência da auto-coleta. Resultados As taxas de detecção de DNA de HPV por auto-coleta foram altas e similares as da coleta profissional. Sessenta e quatro (87,7%) pacientes responderam o questionário de experiência. A maioria (89%) considerou a auto-coleta confortável, e 82,5% preferiram o método comparado a coleta profissional. As razões citadas foram economia de tempo e conveniência. Cinquenta e uma (79,7%) mulheres confirmaram que recomendariam a auto-coleta. Conclusão Auto-coleta utilizando o novo coletor desenvolvido no Brasil não é inferior na detecção de DNA de HPV quando comparada a coleta profissional, e apresenta uma boa aceitabilidade pelas mulheres. Desta maneira, pode ser uma opção para alcançar populações que não realizam o rastreamento padrão.

Computer-aided diagnosis system versus conventional reading system in low-dose (< 2 mSv) computed tomography: comparative study for patients at risk of lung cancer

ABSTRACT BACKGROUND: Computer-aided diagnosis in low-dose (≤ 3 mSv) computed tomography (CT) is a potential screening tool for lung nodules, with quality interpretation and less inter-observer variability among readers. Therefore, we aimed to determine the screening potential of CT using a radiation dose that does not exceed 2 mSv. OBJECTIVE: We aimed to compare the diagnostic parameters of low-dose (< 2 mSv) CT interpretation results using a computer-aided diagnosis system for lung cancer screening with those of a conventional reading system used by radiologists. DESIGN AND SETTING: We conducted a comparative study of chest CT images for lung cancer screening at three private institutions. METHODS: A database of low-dose (< 2 mSv) chest CT images of patients at risk of lung cancer was viewed with the conventional reading system (301 patients and 226 nodules) or computer-aided diagnosis system without any subsequent radiologist review (944 patients and 1,048 nodules). RESULTS: The numbers of detected and solid nodules per patient (both P < 0.0001) were higher using the computer-aided diagnosis system than those using the conventional reading system. The nodule size was reported as the maximum size in any plane in the computer-aided diagnosis system. Higher numbers of patients (102 [11%] versus 20 [7%], P = 0.0345) and nodules (154 [15%] versus 17 [8%], P = 0.0035) were diagnosed with cancer using the computer-aided diagnosis system. CONCLUSIONS: The computer-aided diagnosis system facilitates the diagnosis of cancerous nodules, especially solid nodules, in low-dose (< 2 mSv) CT among patients at risk for lung cancer.

Clinical and microbiological assessment in a subpopulation of young Argentine patients with severe periodontitis / Periodontitis severa en jóvenes argentinos. Evaluación clínica y microbiológica en jóvenes argentinos con periodontitis severa

ABSTRACT Aggressive periodontitis (AP) is the most serious entity of periodontal disease (stage III/IV, grade C periodontitis according to the latest classification, 2017). Aim: to enhance knowledge of periodontal microbiota in AP in native Argentine patients and describe the effect of a combined pharmacological-mechanicalperiodontal treatment on clinical and microbiological parameters. Materials andMethod: The study analyzed 42 periodontal sites in 11 patients diagnosed with AP. Clinical periodontal parameters were recorded at baseline, 45, 90 and 180 days. Microbiological samples were taken before treatment and at 180 days. PCR was used to determine presence of the periodontopathic bacteria Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Tannerella forsythia (Tf), Treponema denticola (Td), Prevotella intermedia (Pi) and Fusobacterium nucleatum (Fn). Patients underwent periodontal therapy including antibiotics (Amoxicillin 500mg + Metronidazole 250mg; 8hs/7 days), and were reevaluated at 45, 90 and 180 days. Results: Mean age was 28.4 ± 7.9 years. The initial PCR detected the following frequencies: Aa 14.3%, Pi 61.9%, Pg 71.4%, Tf 81.0%, Fn 95.2% and Td 97.6%. Baseline microbiological samples revealed significantly higher prevalence of Pg over Aa (p=0.012). Clinical parameters improved significantly after treatment (73.8% PS<5 mm; PS, NIC, SS p<0.001). At 180 days, a significant decrease in microbiological detection rates was observed (Fn, Td, Tf, Pi, Aa p<0.05). Aa was no longer detectable while Pg did not decrease significantly (p=0.052). Fn was the only study species detected in 100% (n=11:42) of residual pockets (PS>5 mm) (p=0.053). Conclusion: In the initial samples, there was significant prevalence of Pg over Aa. Significant clinical improvement was achieved after the mechanical-pharmacological treatment, with undetectable levels ofAa, while Fn persisted in residual pockets, and Pg was present at most of the treated sites.

RESUMEN La periodontitis agresiva (PA) es la entidad más grave de la enfermedad periodontal (clasificación 2017: periodontitis estadio III/IV, grado C). Objetivo: mejorar el conocimiento sobre la microbiota periodontal de la PA en sujetos nativos argentinos y describir el efecto de un tratamiento mecánico-farmacológico periodontal sobre los parámetros clínicos y microbiológicos. Materiales y Método: se estudiaron 42 sitios periodontales correspondientes a 11 pacientes con PA. Los parámetros clínicos se registraron a 0, 45, 90 y 180 días. Las tomas microbiológicas se realizaron antes de iniciar el tratamiento y a los 180 días. La determinación de especies periodontopáticas (Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Tannerella forsythia (Tf, Treponema denticola (Td), Prevotella intermedia (Pi) y Fusobacterium nucleatum (Fn)) se realizó por PCR. Los pacientes iniciaron terapia básica periodontal junto con antibioticoterapia (Amoxicilina 500 mg + Metronidazol 250 mg; 8 hs/7 días) y fueron evaluados a los 45, 90 y 180 días. Resultados: la edad media fue 28,4 ± 7,9 años. Las detecciones iniciales fueron: Aa 14,3%, Pi 61,9%, Pg 71,4%, Tf 81,0%, Fn 95,2% y Td 97,6%. En las muestras iniciales la prevalencia de Pg sobre Aa fue significativamente superior (p=0,012). Los pacientes tuvieron una respuesta clínica favorable al tratamiento (73,8% PS<5 mm; PS, NIC, SS p<0,001). A 180 días, se observó una disminución estadísticamente significativa en la detección microbiana (Fn, Td, Tf, Pi, Aa p<0,05). En igual plazo, Aa no fue detectado, mientras que Pg mostró una disminución no significativa (p=0,052). Fn fue el único detectado en el 100% (n=11:42) de las bolsas periodontales residuales (PS>5 mm) (p=0,053). Conclusión: Las muestras iniciales evidenciaron prevalencia significativa de Pg sobre Aa. El tratamiento logró una significativa mejora clínica con niveles indetectables de Aa. La persistencia de Fn en las bolsas residuales y de Pg en la mayoría de los sitios tratados, caracterizaron la muestra poblacional estudiada.

Infarto agudo do miocárdio: Tempo é músculo / Acute myocardial infarction: Time is muscle

Objetivo: descrever a impotância de uma detecção precoce do Infarto Agudo do Miocárdio (IAM) por meio da equipe multidisciplinar de saúde e expor se o tempo interfere ou não na piora da lesão miocárdica. Método:Trata-se de uma revisão integrativa da literatura com artigos de 2015 e 2020. As bases utilizadas foram LILACS, MEDLINE, SCIELO, BDEFN e Google Acadêmico. Resulatdos: O tempo porta-balão <90 minutos é eficiente no manejo do paciente com IAM, pois quanto mais rápido atendimento melhor o prognóstico, mas ainda existem muitas dificuldades na realização desse manejo, pois muitos sintomas não são detectados precocemente, a busca pelo atendimento é demorada e as instituições não seguem os protocolos corretamente. Conclusão: Diante deste cenário a telemedicina surge como um aliado no prevenção, diagnóstico e tratamento e principalmente o menor tempo para o atendimento, pois trará mais saúde para o miocárdio e consequentemente para o paciente.(AU)

Objetivo: describir la importancia de la detección precoz del Infarto Agudo de Miocardio (IAM) a través del equipo multidisciplinario de salud y exponer si el tiempo interfiere o no en el empeoramiento de la lesión miocárdica. Método: Se trata de una revisión integrativa de la literatura con artículos de 2015 y 2020. Las bases de datos utilizadas fueron LILACS, MEDLINE, SCIELO, BDEFN y Google Scholar. Resultados: El tiempo puerta-balón < 90 minutos es eficiente en el manejo de los pacientes con IAM, pues cuanto más rápido el tratamiento, mejor el pronóstico, pero aún existen muchas dificultades para realizar este manejo, ya que muchos síntomas no se resuelven. detectada a tiempo, la búsqueda de atención lleva mucho tiempo y las instituciones no siguen correctamente los protocolos. Conclusión: Ante este escenario, la telemedicina surge como un aliado en la prevención, diagnóstico y tratamiento y sobre todo en el menor tiempo de atención, ya que traerá más salud al miocardio y consecuentemente al paciente.(AU)

Objective: to describe the importance of an early detection of Acute Myocardial Infarction (AMI) through the multidisciplinary health team and expose whether or not time interferes in the worsening of the myocardial injury. Method: This is an integrative literature review with articles from 2015 and 2020. The databases used were LILACS, MEDLINE, SCIELO, BDEFN and Google Scholar. Results: The door- to-balloon time <90 minutes is efficient in the management of patients with AMI, because the faster the treatment, the better the prognosis, but there are still many difficulties in carrying out this management, since many symptoms are not detected early, the search for care it is time consuming and institutions do not follow protocols correctly. Conclusion: Given this scenario, telemedicine emerges as an ally in prevention, diagnosis and treatment and especially the shortest time for care, as it will bring more health to the myocardium and consequently to the patient.(AU)

Analysis of Aflatoxin Levels in Broiler Chicken Feed from Selected Farms in Nairobi City County, Kenya

Aflatoxin levels in animal feed should be observed from the farm to the table to ensure the safety of the feed to animals and humans. The contamination of cereals and other agricultural supplies used in animal feed production could happen in the farm in the pre-harvest phase or in the post-harvest phase. The study sought to determine Aflatoxin levels in broiler feed from selected farms in Nairobi City County. A total of 42 feed samples were collected. Samples were analyzed using the LCMS/MS technique. Results from the study show that Aflatoxin levels in broiler starter were; B1(17.26±3.07 ppb), B2 (2.44±0.84 ppb), G1 (8.87±2.41 ppb), G2 (0.9±0.44 ppb) and Total AF (29.47±6.13 ppb). Aflatoxin levels in broiler finisher were B1 (17.17±3.09 ppb), B2 (2.68±1.18 ppb), G1 (9.25±2.7 ppb), G2 (1±0.45 ppb) and Total AF (30.1±6.88 ppb). Results from analysis of feed samples showed that AFB1 levels in both broiler starter and broiler finisher were above the KEBS limit but were below the EAC, EU and WHO/FAO limit. Total Aflatoxin levels were above the KEBS limit but below the EAC limit. There is need to enhance the capacity of feed surveillance and monitoring in the country through various laboratory analysis techniques among various agencies in the feed value chain to ensure feed safety.

Accuracy of visual inspection, cytology and colposcopy in the diagnosis of high-grade cervical intraepithelial neoplasia / Acurácia da inspeção visual, citologia e colposcopia no diagnóstico da neoplasia intraepitelial cervical de alto grau

Cervical cancer is still one of the leading causes of cancer and mortality in women, especially in low- and middle-income countries. Normally, the prevention of its occurrence is done through efficient screening and treatment programs for high-grade epithelial lesions, which are pre-malignant lesions. Cheaper diagnostic techniques ensure greater access to women, which can prevent a large number of cancer cases worldwide. Objective: The aim of the study was to evaluate the accuracy of visual inspection either with acetic acid or with Lugol's iodine, cervical cytology and colposcopy in the diagnosis of cervical intraepithelial neoplasia 2 and 3. Methods: This is a study of diagnostic accuracy. We evaluated 115 women with high-grade squamous intraepithelial lesion confirmed by biopsy, 54 with cervical intraepithelial neoplasia 2 and 61 with cervical intraepithelial neoplasia 3, from January 2016 to December 2018 at the Lower Genital Tract Pathology and Colposcopy Service of the Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil. A comparative analysis of the visual inspection, Pap smear and colposcopy diagnostic methods was performed. Results: The average age was 33.1 years (standard deviation=9.83) for cervical intraepithelial neoplasia 2 cases and 35.2 years (standard deviation=7.97) for cervical intraepithelial neoplasia 3. In the cervical intraepithelial neoplasia 2 group, visual inspection tests were positive for high-grade squamous intraepithelial lesion in 98.1% of the cases with acetic acid and 94.4% with Lugol's iodine. Colposcopy identified a probable high-grade squamous intraepithelial lesion in 94.4% of the cases, while cytology only in 42.6%. In the cervical intraepithelial neoplasia 3 group, the visual inspection tests were positive for high-grade squamous intraepithelial lesion in 91.8% of the cases with acetic acid and 95.1% with Lugol's iodine. Colposcopy identified a probable high-grade squamous intraepithelial lesion in 93.5% of the cases, while cytology in 65.6%. Conclusion: Visual inspection with acetic acid and Lugol's iodine, and colposcopy test were more accurate for the diagnosis of cervical intraepithelial neoplasia 2 and 3 than through cytopathology. (AU)

Introdução: O câncer do colo de útero ainda é uma das principais causas de câncer e mortalidade em mulheres, especialmente em países de baixa e média renda. Normalmente, a prevenção de sua ocorrência é feita por meio de programas eficientes de triagem e tratamento de lesões epiteliais de alto grau, que são as lesões pré-malignas. Técnicas diagnósticas mais baratas garantem maior acesso às mulheres, podendo evitar um grande número de casos de câncer no mundo inteiro. Objetivo: O objetivo deste estudo foi avaliar a acurácia da inspeção visual (com ácido acético e com solução de lugol), da citologia cervical e da colposcopia no diagnóstico de neoplasias intraepiteliais cervicais 2/3. Métodos: Trata-se de um estudo de acurácia diagnóstica. Foram avaliadas 115 mulheres com lesão intraepitelial escamosa de alto grau confirmada por biópsia, 54 com neoplasias intraepiteliais cervicais 2 e 61 com neoplasias intraepiteliais cervicais 3, no período de janeiro de 2016 a dezembro de 2018 no Serviço de Patologia e Colposcopia do Trato Genital Inferior do Hospital de Clínicas de Porto Alegre, em Porto Alegre, Brasil. Foi realizada análise comparativa dos métodos de diagnóstico Inspeção visual com ácido acético, Inspeção visual com Solução de Lugol, colpocitologia oncótica e colposcopia. Resultados: A média de idade foi de 33,11 anos (DP 9,83) para os casos de neoplasias intraepiteliais cervicais 2 e de 35,28 anos (DP 7,97) para neoplasias intraepiteliais cervicais 3. No grupo de neoplasias intraepiteliais cervicais 2, os testes de inspeção visual foram positivos para tratamento de lesões epiteliais de alto grau em 98,1% dos casos com Inspeção visual com ácido acético e em 94,4% daqueles com Inspeção visual com Solução de Lugol. A colposcopia identificou provável tratamento de lesões epiteliais de alto grau em 94,4% dos casos, enquanto a citologia apenas 42,6%. No grupo neoplasias intraepiteliais cervicais 3, os testes de inspeção visual foram positivos para tratamento de lesões epiteliais de alto grau em 91,8% dos casos com Inspeção visual com ácido acético e em 95,1% daqueles com Inspeção visual com Solução de Lugol. A colposcopia identificou provável tratamento de lesões epiteliais de alto grau em 93,5% dos casos, enquanto a citologia em 65,6%. Conclusão: A inspeção visual (com ácido acético e com Solução de Lugol) e a colposcopia foram mais precisas para o diagnóstico de neoplasias intraepiteliais cervicais 2/3 do que a citopatologia. (AU)

Current understanding of an Emerging Coronavirus using in silico approach: Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) / Compreensão atual de um coronavírus emergente usando abordagem in silico: síndrome respiratória aguda grave - coronavírus-2 (SARS-CoV-2)

Abstract Novel coronavirus (nCoV) namely "SARS-CoV-2" is being found responsible for current PANDEMIC commenced from Wuhan (China) since December 2019 and has been described with epidemiological linkage to China in about 221 countries and territories until now. In this study we have characterized the genetic lineage of SARS-CoV-2 and report the recombination within the genus and subgenus of coronaviruses. Phylogenetic relationship of thirty nine coronaviruses belonging to its four genera and five subgenera was analyzed by using the Neighbor-joining method using MEGA 6.0. Phylogenetic trees of full length genome, various proteins (spike, envelope, membrane and nucleocapsid) nucleotide sequences were constructed separately. Putative recombination was probed via RDP4. Our analysis describes that the "SARS-CoV-2" although shows great similarity to Bat-SARS-CoVs sequences through whole genome (giving sequence similarity 89%), exhibits conflicting grouping with the Bat-SARS-like coronavirus sequences (MG772933 and MG772934). Furthermore, seven recombination events were observed in SARS-CoV-2 (NC_045512) by RDP4. But not a single recombination event fulfills the high level of certainty. Recombination mostly housed in spike protein genes than rest of the genome indicating breakpoint cluster arises beyond the 95% and 99% breakpoint density intervals. Genetic similarity levels observed among "SARS-CoV-2" and Bat-SARS-CoVs advocated that the latter did not exhibit the specific variant that cause outbreak in humans, proposing a suggestion that "SARS-CoV-2" has originated possibly from bats. These genomic features and their probable association with virus characteristics along with virulence in humans require further consideration.

Resumo O novo coronavírus (nCoV), nomeadamente "SARS-CoV-2", foi considerado responsável pela pandemia atual iniciada em Wuhan (China) desde dezembro de 2019 e foi descrito com ligação epidemiológica à China em cerca de 221 países e territórios até agora. Neste estudo, caracterizamos a linhagem genética do SARS-CoV-2 e relatamos a recombinação dentro do gênero e subgênero dos coronavírus. A relação filogenética de 39 coronavírus pertencentes a seus quatro gêneros e cinco subgêneros foi analisada usando o método de Neighbour-joining usando MEGA 6.0. Árvores filogenéticas do genoma de comprimento total, várias proteínas (espícula, envelope, membrana e nucleocapsídeo), sequências de nucleotídeos foram construídas separadamente. A recombinação putativa foi testada via RDP4. Nossa análise descreve que o "SARS-CoV-2", embora mostre grande semelhança com as sequências de Bat-SARS-CoVs em todo o genoma (dando semelhança de sequência de 89%), exibe agrupamento conflitante com as sequências de coronavírus do tipo Bat-SARS (MG772933 e MG772934) Além disso, sete eventos de recombinação foram observados em SARS-CoV-2 (NC045512) por RDP4. Mas nem um único evento de recombinação preenche o alto nível de certeza. A recombinação está alojada mais em genes de proteína de pico, principalmente, do que no resto do genoma, indicando que o cluster de ponto de interrupção surge além dos intervalos de densidade de ponto de interrupção de 95% e 99%. Os níveis de similaridade genética observados entre "SARS-CoV-2" e Bat-SARS-CoVs defendem que o último não exibe a variante específica que causa surto em humanos, sugerindo que "SARS-CoV-2" tenha se originado possivelmente de morcegos. Essas características genômicas e sua provável associação com as características do vírus, juntamente com a virulência em humanos, requerem uma consideração mais aprofundada.

Discussion on Microbial Quality Control Strategy in Whole Process of Chinese Materia Medica Production Guided by Concept of QbD / 中国实验方剂学杂志

Safety is the core of the quality of Chinese materia medica products， and microbial pollution caused by medicinal materials， decoction pieces， intermediate products and others can bring certain impact on the quality and safety of Chinese materia medica products. The reasons for this are not only the problems of medicinal materials themselves， but also the exogenous pollution introduced in the production process. How to effectively use microbial detection technology and establish an appropriate microbial quality control strategy in the whole process of Chinese materia medica production is of great significance to improve the quality of Chinese materia medica products. Therefore， the authors put forward a microbial quality control strategy in the whole process of Chinese materia medica production based on the guidance of quality by design （QbD） concept， emphasizing the scientific linkage between the internal and external microbial quality control systems to jointly ensure the quality of products in all aspects. Among them， the internal microbial quality control system includes the control of the whole chain of Chinese materia medica-decoction pieces-intermediate products-excipitents-packaging materials-final products， which should be carried out by stages and characteristics， while the external microbial quality control system includes the control of personnel-equipment and facilities-pharmaceutical water-environment， emphasizing the principle of quality risk management and the development of monitoring programs， aiming to closely integrate microbial quality risk management with the production process of Chinese materia medica products， and to classify and develop microbial control strategies in order to minimize the impact of contaminating microorganisms and effectively guarantee the quality of Chinese materia medica products.