Preparation of the first national reference standard for determination of HEK293 cell DNA content / 中国生物制品学杂志

@#Objective To prepare a national reference standard for the quantification of HEK293 cell DNA content,so as to provide a support for the determination of residual DNA in HEK293 cells in the industry.Methods HEK293 cell DNA prepared using Genomic-tip 500/G and genomic DNA purification reagents was used as source materials,and the purity and content were assessed using ultraviolet spectrophotometry and agarose gel electrophoresis.After dilution to approximately 100 ng/μL,the DNA was aliquoted at 160 μL/tube.Five different laboratories were organized for collaborative calibration by using ultraviolet spectrophotometry, and the stability and applicability were evaluated.Results The HEK293 cell DNA national reference standard exhibited A_(260)/A_(280) ratios between 1.8 and 2.0 and displayed a single band on electrophoresis,meeting the specified criteria.Collaborative calibration across five laboratories yielded 78 valid data points with an average content of 104.8 ng/μL,a relative standard deviation(RSD) of 4.2%.The 95% confidence interval for the mean was 103.8—105.8 ng/μL,and the 95% reference range for single measurements was 96.0—113.6 ng/μL.The average confidence limit rate was 1.0%,and the recommended storage condition was-80 ℃.Applicability studies were conducted using two different models of fluorescence quantitative PCR instruments.The reference standard exhibited good applicability within the range of 0.3—3 000 pg/reaction,with amplification efficiencies of 101% and 95%,and R~2 values of 0.999 2 and 0.999 5 for the standard curves,respectively.Conclusion This batch of HEK293 cell DNA national reference standard meets all required specifications and can be utilized as a national reference standard for fluorescence quantitative PCR detection,with a certified content of 104.8 ng/μL,assigned batch number 270039-202301.

Astigmatism inclusivity of regional refractive intraocular lens / 国际眼科杂志(Guoji Yanke Zazhi)

AIM: To investigate the effect of residual astigmatism on visual quality after phacoemulsification combined with regional refractive intraocular lens(IOL)implantation in patients with age-related cataract, and to evaluate the astigmatism inclusivity of regional refractive IOL.METHODS: Retrospective cohort study. The clinical data of 62 cases(73 eyes)of age-related cataract patients who underwent phacoemulsification combined with regional refractive IOL(Lentis Comfort LS-313 MF15)implantation from July 2020 to March 2022 at the ophthalmology department of our hospital were collected. They were grouped according to residual astigmatism at 6 mo postoperatively, taking 35 cases(40 eyes)with residual astigmatism of 0.75 D to 1.50 D as the experimental group, and 27 cases(33 eyes)with residual astigmatism ≤0.75 D as the control group. Visual acuity, defocus curves, objective visual acuity [wavefront aberrations, Strehl ratio(SR), modulation transfer functions(MTF)], subjective visual acuity(national eye institute visual function questionnaire-25), patients' satisfaction, and spectacle independence were compared between the two groups at 6 mo postoperatively.RESULTS:There was a difference in the preoperative astigmatism and the number of postoperative 6 mo residual astigmatism between the two groups(P<0.01). At 6 mo postoperatively, there was no difference in uncorrected distance, intermediate, and near visual acuity, objective visual quality, subjective visual quality, satisfaction, and spectacle independence between the two groups(P>0.05). The defocus curves showed that there was no difference in visual acuity between the two groups at all points in the +2.00 to -4.00 D defocus range of the additional spherical equivalent(P>0.05).CONCLUSION:Lentis Comfort LS-313 MF15 IOL was able to accommodate regular astigmatism of 1.50 D.

Research progress on dental materials for preventing root caries / 口腔疾病防治

@#The high incidence and untreated rate of root caries, a common and frequently occurring oral disease with challenging treatment in elderly individuals, is the main cause of tooth loss among elderly people, as rapid development results in pulpitis and periapical periodontitis or residual crown and root, which has been regarded as one of the common chronic oral diseases seriously affecting the quality of life of elderly people. Thus, early intervention and prevention are important. Traditional dental materials for preventing root caries have been widely used in clinical practice; however, they have the disadvantages of tooth coloring, remineralization and low sterilization efficiency. A series of new dental materials for preventing root caries have gradually become a research hotspot recently, which have the advantages of promoting the mineralization of deep dental tissue, prolonging the action time and enhancing adhesion. Future caries prevention materials should be designed according to the characteristics of root surface caries and the application population and should be developed toward simplicity, high efficiency and low toxicity. This review describes current research regarding anti-caries prevention material application, serving as a theoretical underpinning for the research of root caries prevention materials, which is important for both promotion in the effective prevention of root caries and improvement in the status of oral health and the quality of life among old people.

Impacto de la optimización del tratamiento hipolipemiante en el riesgo cardiovascular residual / Impact of Optimizing Lipid-Lowering Therapy on Residual Cardiovascular Risk

RESUMEN Introducción: el modelo SMART-REACH predice el riesgo de eventos cardiovasculares recurrentes. Objetivos: los objetivos de este estudio fueron: a) evaluar el riesgo residual en una población en prevención secundaria y niveles de colesterol asociado a lipoproteínas de baja densidad (C-LDL) fuera de meta; b) mediante un modelo de simulación, determinar el impacto de optimizar las terapias hipolipemiantes en términos de reducción del riesgo residual. Material y métodos: estudio transversal, descriptivo y multicéntrico. Se incluyeron consecutivamente pacientes con antecedentes cardiovasculares y un C-LDL mayor o igual que 55 mg/dL. El riesgo de eventos recurrentes (infarto agudo de miocardio, accidente cerebrovascular o muerte vascular) a 10 años y a lo largo de la vida se estimó utilizando el modelo SMART-REACH. Mediante una simulación, se optimizó el tratamiento hipolipemiante de cada paciente (utilizando estatinas, ezetimibe o inhibidores de proproteína convertasa subtilisina kexina tipo 9 [iPCSK9]), se estimó el descenso del C-LDL, se verificó el alcance del objetivo lipídico y se calculó la reducción del riesgo cardiovascular y el número necesario a tratar (NNT) correspondiente. Resultados: se incluyeron 187 pacientes (edad media 67,9 ± 9,3 años, 72,7% hombres). Los riesgos residuales calculados a 10 años y a lo largo de la vida fueron 37,1 ± 14,7% y 60,3 ± 10,7%, respectivamente. Globalmente, se pudo optimizar una sola estrategia farmacológica con estatinas, ezetimibe o un iPCSK9 en el 38,5%, el 11,5% y el 5,5% de la población, respectivamente. La optimización basada en dos tratamientos se realizó en el 27,5% (estatinas + ezetimibe), el 7,7% (estatinas + iPCSK9) y el 1,1% (ezetimibe + iPCSK9) de los casos. En 15 pacientes se optimizó el tratamiento considerando los tres fármacos. El 53,9% y el 62,9% de las acciones para optimizar el tratamiento mostraron un NNT menor que 30 para evitar un evento a 10 años o a lo largo de la vida, respectivamente. Conclusión: en este estudio, los pacientes con antecedentes cardiovasculares que no alcanzan la meta de C-LDL mostraron un riesgo residual considerable. La simulación mostró un importante margen para optimizar el tratamiento, con un impacto notable en el riesgo residual.

ABSTRACT Background: The SMART-REACH model predicts the risk or recurrent cardiovascular events. Objectives: The objectives of this study were: a) to evaluate the residual cardiovascular risk in a secondary prevention population with LDL-C levels above the recommended goal, using a simulation model; and b) to determine the impact of optimizing lipid-lowering therapies in terms of residual cardiovascular risk reduction. Methods: We conducted a cross-sectional, descriptive and multicenter study. Patient with a history of cardiovascular disease and a LDL-C ≥55 mg/dL were consecutively included. The 10-year and lifetime risk of recurrent events (myocardial infarction, stroke, or vascular death) were estimated using the SMART-REACH model. By means of a simulation, lipid-lowering treatment was optimized for each patient [using statins, ezetimibe and/or PCSK9 (PCSK9) inhibitors], with estimation of LDL-C reduction, checking if lipid-lowering goal was achieved and calculating the reduction in cardiovascular risk and the corresponding number needed to treat (NNT). Results: The cohort was made up of 187 patients; mean age was 67.9 ± 9.3 years and 72.7% were men. The calculated 10-year and lifetime residual risks were 37.1 ± 14.7% and 60.3 ± 10.7%, respectively. Overall, treatment was optimized with a single pharmacological strategy with statins, ezetimibe or PCSK9 inhibitor in 38.5%, 11.5% and 5.5% of the population, respectively. Optimization based on two treatments was performed in 27.5% (statins + ezetimibe), 7.7% (statins + PCSK9 inhibitor) and 1.1% (ezetimibe + PCSK9 inhibitor) of the cases. In 15 patients, treatment was optimized when the three drugs (statins + ezetimibe + PCSK9 inhibitor) were considered. Overall, 53.9% and 62.9% of the actions implemented to optimize treatment showed a 10-year or lifetime NNT < 30 to prevent an event, respectively. Conclusion: In this study, patients with a history of cardiovascular disease who do not reach LDL-C goal showed significant residual cardiovascular risk. The simulation model showed a significant margin for optimizing treatment, with a marked reduction in residual cardiovascular risk.

Silage quality and bacterial diversity of silages inoculated with Listeria monocytogenes and Lacticaseibacillus paracasei_6714

Introduction: King grass (Cenchrus purpureus (Schumach.) Morrone, syn. Pennisetum purpuphoides) and pineapple peel (Ananas comosus) silages are food alternatives for livestock in conditions of feed shortage. Objective: To describe the dynamics of the microbiota present in king grass and pineapple silage during the fermentation process using next generation sequencing (NGS) and to evaluate the protective effect of Lacticaseibacillus paracasei_6714 as a silage inoculum against Listeria monocytogenes. Methods: We used an unrestricted randomized design to characterize the microbiota present in silages made from king grass harvested 70 days after regrowth and pineapple peel. We inoculated mixtures of grass and peel with L. paracasei_6714 or L. monocytogenes, or both, with a non-inoculated treatment as control. The nutritional and fermentative profile was evaluated after 30 days. After 15 and 30 days of fermentation, we used 16S rRNA analysis to determine the dynamics and diversity of the microbiota in the inoculated and control silages. Result: Dry matter content and digestibility did not differ significantly; however, there were differences in crude protein, pH and organic acids. We obtained 4432 amplicon sequence variants of Proteobacteria, Firmicutes, Bacterioidetes, Actinobacteria, Verrucomicrobia, Planctomycetes and Patescibacteria. The relative abundance of each phylum varied depending on the material and fermentation period. Phylum similarity was over 70 % (but not greater than 50 % with Bray-Curtis at the species level). Conclusion: These bacterial communities seem to have an important role during silage fermentation. Proper management of silage processing can reduce or eliminate pathogenic bacteria.

Introducción: Los ensilajes del pasto king grass (Cenchrus purpureus (Schumach.) Morrone, syn. Pennisetum purpuphoides) y cáscaras de piña (Ananas comosus) son alternativas de alimento para ganado en condiciones de escasez alimentaria. Objetivo: Describir las dinámicas de la microbiota presente en los ensilajes de king grass y piña durante el proceso de fermentación usando secuenciación de próxima generación (NGS) y evaluar el efecto de protección de Lacticaseibacillus paracasei_6714 como inoculante de ensilaje ante Listeria monocytogenes. Métodos: Usamos un diseño aleatorio no restringido para caracterizar la microbiota presente en ensilajes de king Grass cosechados 70 días después de rebrote y de cáscaras de piña. Inoculamos mezclas de pasto y cáscara con L. paracasei_6714 o L. monocytogenes, o ambos, con un tratamiento control sin inocular. El perfil nutricional y de fermentación fue evaluado luego de 30 días. Después de 15 y 30 días de fermentación, usamos un análisis de para determinar la dinámicas y diversidad de la microbiota en los ensilajes inoculados y control. Resultados: Los contenidos de materia seca y digestibilidad, no difirieron significativamente; sin embargo, hubo diferencias en proteína cruda, pH y ácidos orgánicos. Obtuvimos 4 432 secuencias variantes de amplicon de Proteobacteria, Firmicutes, Bacterioidetes, Actinobacteria, Verrucomicrobia, Planctomycetes y de Patescibacteria. La abundancia relativa de cada filo vario dependiendo del material y periodo de fermentación. Similitudes de filo fueron mayores al 70 % (pero no mayor que 50 % con Bray-Curtis a nivel de especie). Conclusión: Estas comunidades bacterianas parecen cumplir un papel importante durante la fermentación del ensilaje. Un manejo apropiado del proceso de ensilaje puede reducir o eliminar baterías patogénicas.

Comparative study of small incision refractive lenticule extraction with 5 mm versus 6.5 mm optic zone for myopia

Purpose: To compare residual stromal thickness (RST) in eyes undergoing small incision refractive lenticule extraction (SMILE) using a lenticular diameter of 6.5 mm versus those with a diameter of 5 mm. Methods: In this retrospective comparative case series, consecutive patients who underwent SMILE between 2016 and 2021 with at least 6 months of follow?up were included. Preoperative best?corrected distance visual acuity (BCDVA), refractive error, contrast sensitivity, central corneal thickness, keratometry, higher order aberrations, and scotopic pupil size were recorded using a Placido disk topography with Sheimpflug tomography?based system. Patients underwent SMILE with a lenticular diameter of 6.5 mm until 2018 (n = 372 eyes). Thereafter, the lenticular diameter was reduced to 5 mm (n = 318). The RST, postoperative refraction, aberrations, subjective glare, and halos were compared across groups at 1 and 6 months. Results: The mean age of participants was 26.8 ± 5.8 years with a mean preoperative spherical equivalent of ?4.48 D ± 2.16 D (range: ?0.75 to ?12.25 D) and mean scotopic pupil of 3.7 ± 0.75 mm. Eyes in the 5 mm group had 30.6 m (95% confidence interval [CI] = 28 to 33 m, P < 0.001) greater RST compared to the 6.5 mm group after adjusting for spherical equivalent and preoperative pachymetry. There were no differences in vision, contrast sensitivity, aberrations (wavefront error of 0.19 ± 0.2 vs. 0.25 ± 0.2, P = 0.19) or glare between the two groups. Conclusion: SMILE performed with a lenticular diameter of 5 mm leads to greater RST across the myopic range, but without inducing significant higher?order aberrations.

Enfermedad mínima residual en leucemia mieloide aguda no promielocítica: Resultados preliminares de un estudio colaborativo internacional / Minimal residual disease in non-myelocytic acute myeloid leukemia: preliminary results of an international collaborative study

A pesar de los avances en los protocolos de tratamiento y en las medidas de soporte en pacientes con Leucemia Mieloide Aguda (LMA), 27% presentan recaídas de la enfermedad. Esto se debe, entre otras causas, a la persistencia de pequeñas cantidades de células malignas (blastos) resistentes a la terapia. Estas pequeñas cantidades de blastos remanentes se denominan Enfermedad Mínima Residual (EMR). La determinación de EMR requiere de técnicas no solo muy sensibles, sino también específicas, y permite evaluar la respuesta individual a la terapia. La introducción de la EMR como parámetro de respuesta y estratificación está bien definida en Leucemia Linfoblástica Aguda (LLA). Por el contrario, aunque existen publicaciones sobre el impacto pronóstico de la EMR en LMA, aún no se encuentra incluida en forma sistemática en los protocolos nacionales actuales, entre otros motivos, por lo laborioso de la determinación y por la necesidad de validación de la misma. Debe tenerse en cuenta que el inmunofenotipo de los blastos mieloides suele ser más heterogéneo que el de los blastos en LLA, presentando, en muchos casos, subpoblaciones diferentes entre sí, lo cual dificulta su detección certera y no hay consenso definido en cuanto a la metodología más eficaz. En este trabajo describimos una nueva estrategia de marcación y análisis estandarizada en un estudio multicéntrico internacional para LMA y la utilidad de la EMR como parámetro de respuesta y de estratificación. Asimismo, detallamos los resultados preliminares de nuestra cohorte de pacientes (AU)

Despite the improvement in treatment and supportive care of patients with Acute Myeloid Leukemia (AML), 27% of them relapse. This is due to the persistence of small amounts of malignant cells (blasts) resistant to therapy, among other causes. These small amounts of blasts are called Minimal Residual Disease (MRD). The determination of MRD requires not only techniques with high sensitivity but also with high specificity, and allows to evaluate the individual response to treatment. The introduction of MRD as a response parameter is well established in Acute Lymphoblastic Leukemia (ALL), and it is used in current stratification protocols. On the other hand, even though there are some reports regarding the prognostic impact of MRD in AML, it is still not included in the current national protocols due to the lack of validation of the determination, among other causes. This is due to the fact that the immunophenotype of myeloid blasts is more heterogeneous than in ALL, presenting different subpopulations, which difficults their accurate detection. Thus, there is still no consensus regarding the most effective approach. In this article, we describe a new staining and analysis strategy standardized by an international multicentric study, and the utility of EMR as a response and stratification parameter. Additionally, we show the preliminary results of our patient cohort. (AU)

Analysis of drying kinetic of brewer ́s spent grains: effect of the temperature on the physical properties and the content of bioactive compounds / Análisis de la cinética de secado del bagazo residual de malta: efecto de la temperatura sobre las propiedades físicas y el contenido de compuestos bioactivos

Background: Brewer ́s spent grain (BSG) is a biomass by-product generated in large volumes during industrial beer production. BSG has become a growing environmental problem, as most breweries discard it inappropriately, negatively impacting the environment. Alternatives for the exploitation of this by-product have consisted of elaborating food supplements for farm animals, obtaining biofuels, developing adsorbents, and obtaining substances for the food industry. However, the high moisture content in BSG (approximately 70%), poses a significant challenge in exploring various reuse alternatives. Therefore, the implementation of a pre-drying process becomes essential. Objective: This study aimed to analyze the BSG drying kinetics at different temperatures and the effect of the drying temperature on the physical properties and the content of bioactive compounds. Methods: BSG samples were dried at different temperatures (50, 60, 70, 80, 90, and 105°C) and analyzed for their moisture ratio, water activity, total polyphenol content (TPC), and DPPH (1,1-diphenyl-2-picrylhydrazil) radical scavenging activity. Also, four kinetics models were fitted to the drying data. Results:It was determined that the effective diffusivity was between 5.23x10

Antecedentes: El Bagazo residual de malta (BSG por sus siglas en inglés) es un subproducto biomásico generado en grandes volúmenes durante la producción industrial de cerveza. El BSG se ha convertido en un creciente problema para el medio ambiente, debido a que la mayoría de las cervecerías descartan inapropiadamente este residuo generando un impacto negativo al ambiente. Las alternativas para el aprovechamiento de este subproducto han consistido especialmente en la elaboración de suplementos alimenticios para animales de granja, obtención de biocombustibles, desarrollo de adsorbentes y obtención de productos para la industria alimentaria. Sin embargo, el alto contenido de humedad (~70%) del BSG representa un reto para el desarrollo de diferentes alternativas de reutilización, por lo que se hace necesario un proceso de secado previo. Objetivos: En este estudio se analizó la cinética de secado del BSG a diferentes temperaturas y el efecto de la temperatura de secado sobre sus propiedades físicas y contenido de compuestos bioactivos. Métodos: Las muestras de BSG fueron secadas a diferentes temperaturas (50, 60, 70, 80, 90 y 105°C) y analizadas en términos de razón de humedad, actividad acuosa, contenido de polifenoles totales (TPC) y actividad secuestradora del radical DPPH. Además, se ajustaron 4 modelos cinéticos a los datos de secado. Resultados: Se determinó que la difusividad efectiva del BSG varió entre 5.23x10

Novel custom designed toric piggyback intraocular lens for the correction of residual postoperative astigmatism

We report the outcomes of a custom-designed toric piggyback intraocular lens in a patient with high postoperative residual astigmatism. A 60-year-old male patient underwent customized toric piggyback IOL for postoperative residual astigmatism of 13 D, with follow-up examinations for IOL stability and refractive outcomes. The refractive error stabilized at two months and remained stable at one year, with a correction of nearly 9 D of astigmatism. The IOP remained within normal limits, and there were no postoperative complications. The IOL remained stable in the horizontal position. To our knowledge, this is the first case report of correction of unusually high astigmatism by a novel smart toric design of piggyback IOL.

Diagnóstico por imagen de abscesos hepáticos y pulmonares por estreptococos del grupo viridans. Presentación de caso / Imaging diagnosis of liver and lung abscesses due to viridans streptococci. Case presentation

Resumen El Streptococcus viridans es conocido más comúnmente como agente infeccioso en las endocarditis, sin embargo, poco se conoce sobre su potencial infeccioso en otros órganos o sistemas, donde ha demostrado una elevada mortalidad. El reconocimiento del Streptococcus viridans como agente productor de abscesos en otras localizaciones como a nivel hepático o pulmonar, permitirá un diagnóstico oportuno mediante los distintos métodos de imagen, reduciendo las graves consecuencias para el paciente y los tiempos de hospitalización. Se presenta el caso de un paciente del sexo masculino de 33 años de edad sin antecedentes crónico degenerativos, que inició con sintomatología 7 meses previos a su ingreso, con fiebre intermitente, fatiga, astenia, anorexia y pérdida de peso. A la exploración física presentó dolor a la palpación media y profunda en hipocondrio derecho, en el panel de laboratorios presentó llamativa neutrofilia, en la tomografía de tórax y abdomen se mostró lesión cavernomatosa en pulmón y quistes complicados hepáticos, a los cuales se les realizó drenaje percutáneo guiado por ultrasonido, con envío de muestras a cultivo con resultado positivo para Streptococcus viridans, lo que permitió brindar el tratamiento dirigido al paciente, y que remitiera la enfermedad.

Abstract Streptococcus viridans is more commonly known as an infectious agent in endocarditis, however, little is known about its infectious potential in other organs or systems, where it has shown high mortality. The recognition of Streptococcus viridans as an abscess-producing agent in other locations, such as the liver or lungs, will allow timely diagnosis using different imaging methods, reducing serious consequences for the patient and hospitalization times. We present the case of a 33-year-old male patient with no chronic degenerative history, who started symptoms 7 months prior to admission, with intermittent fever, fatigue, asthenia, anorexia and weight loss, on physical examination he presented pain at the medium and deep palpation in the right hypochondrium, in the laboratory panel I present striking neutrophilia, in the tomography of the thorax and abdomen a cavernous lesion in the lung and complicated hepatic cysts are shown, to which percutaneous drainage guided by ultrasound is performed, with sending of cultured samples with a positive result for Streptococcus viridans. Thus, allowing treatment to be provided to the patient, thereby achieving remission of the disease.

Understanding the Relationship between Vaccine Supply Dead Space and Wasted COVID-19 Vaccine Doses

ABSTRACT Introduction: By July 2023, Brazil had administered approximately 540 million COVID-19 vaccine doses. This study aimed to quantify wasted doses resulting from dead space in vaccine supplies. Methods: The vaccine supply was initially weighed, filled with distilled water, and expelled to simulate administration. Weighing it again after the application determined the dead space volume. Descriptive analyses calculated the waste rate/wasted dose count. Results: The estimated total number of wasted vaccine doses using supplies with the lowest dead space was 62,097,338. Conclusions: Syringe dead space is a crucial factor in dose wastage, directly influencing the number of wasted doses.

Indicaciones para el uso de pertuzumab en cáncer de mama HER2 positivono metastásico en los escenarios neoadyuvante y adyuvante. Revisión de la evidencia y abordaje terapéutico en el Instituto Nacional de Cancerología - Colombia / Indications for the use of pertuzumab in non-metastatic HER2-positive breast cancer in the neoadjuvant and adjuvant. Review of the literature and therapeutic approach at the Instituto Nacional de Cancerología - Colombia

La adición de la terapia dirigida a la quimioterapia citotóxica en pacientes con cáncer de mama ha mejorado significativamente los desenlaces oncológicos en las pacientes con tumores HER2 positivo. El uso de pertuzumab durante el manejo neoadyuvante incrementa significativamente la respuesta patológica completa y en la actualidad permite emplear regímenes libres de antraciclinas con una eficacia similar y menores efectos cardiovasculares (en especial sobre la fracción de eyección). El beneficio en supervivencia libre de enfermedad invasiva, de adicionar pertuzumab en el escenario adyuvante en las pacientes sin tratamiento anti HER2 previo, está limitado a aquellas con ganglios positivos. La implementación de esquemas con bloqueo dual anti HER2, durante el tratamiento inicial del cáncer de mama HER2 positivo, mejora significativamente el pronóstico oncológico en este grupo de pacientes.

The addition of targeted therapy to cytotoxic chemotherapy in patients with breast cancer has significantly improved oncologic outcomes in patients with HER2-positive tumors. The use of pertuzumab during neoadjuvant management significantly increases the complete pathological response and currently allows the use of anthracycline-free regimens with similar efficacy and fewer cardiovascular effects (especially on ejection fraction). The benefit of pertuzumab in disease-free survival in the adjuvant setting for patients without prior anti-HER2 treatment is limited to those with positive nodes. The implementation of schemes with dual anti-HER2 blockade during the initial treatment of HER2-positive breast cancer significantly improves the oncological outcomes in this group of patients.

An Algorithm for Measuring Vertical Ground Reaction Force Based on Insole Sensors / 医用生物力学

Objective A practical and highly accurate algorithm for dynamic monitoring of plantar pressure was proposed, the magnitude of vertical ground reaction force (vGRF) during walking was measured by a capacitive insole sensor, and reliability of the prediction accuracy was verified. Methods Four healthy male subjects were require to wear capacitive insole sensors, and their fast walking and slow walking data were collected by Kistler three-dimensional (3D) force platform. The data collected by the capacitive insole sensors were pixelated, and then the processed data were fed into a residual neural network, ResNet18, to obtain high-precision vGRF. Results Compared with analysis of the data collected from Kister force platform, the normalized root mean square error (NRMSE) for fast walking and slow walking were 8.40% and 6.54%, respectively, and the Pearman correlation coefficient was larger than 0.96. Conclusions This study provides a novel algorithm for dynamic measurement of GRF in mobile scenarios, which can be used for estimation of complete GRF outside the laboratory without being constrained by the number and location of force plates. Potential application areas include gait analysis and efficient capture of pathological gaits.

MinerVa: A high performance bioinformatic algorithm for the detection of minimal residual disease in solid tumors / 生物医学工程学杂志

How to improve the performance of circulating tumor DNA (ctDNA) signal acquisition and the accuracy to authenticate ultra low-frequency mutation are major challenges of minimal residual disease (MRD) detection in solid tumors. In this study, we developed a new MRD bioinformatics algorithm, namely multi-variant joint confidence analysis (MinerVa), and tested this algorithm both in contrived ctDNA standards and plasma DNA samples of patients with early non-small cell lung cancer (NSCLC). Our results showed that the specificity of multi-variant tracking of MinerVa algorithm ranged from 99.62% to 99.70%, and when tracking 30 variants, variant signals could be detected as low as 6.3 × 10 -5 variant abundance. Furthermore, in a cohort of 27 NSCLC patients, the specificity of ctDNA-MRD for recurrence monitoring was 100%, and the sensitivity was 78.6%. These findings indicate that the MinerVa algorithm can efficiently capture ctDNA signals in blood samples and exhibit high accuracy in MRD detection.

Automatic sleep staging algorithm for stochastic depth residual networks based on transfer learning / 生物医学工程学杂志

The existing automatic sleep staging algorithms have the problems of too many model parameters and long training time, which in turn results in poor sleep staging efficiency. Using a single channel electroencephalogram (EEG) signal, this paper proposed an automatic sleep staging algorithm for stochastic depth residual networks based on transfer learning (TL-SDResNet). Firstly, a total of 30 single-channel (Fpz-Cz) EEG signals from 16 individuals were selected, and after preserving the effective sleep segments, the raw EEG signals were pre-processed using Butterworth filter and continuous wavelet transform to obtain two-dimensional images containing its time-frequency joint features as the input data for the staging model. Then, a ResNet50 pre-trained model trained on a publicly available dataset, the sleep database extension stored in European data format (Sleep-EDFx) was constructed, using a stochastic depth strategy and modifying the output layer to optimize the model structure. Finally, transfer learning was applied to the human sleep process throughout the night. The algorithm in this paper achieved a model staging accuracy of 87.95% after conducting several experiments. Experiments show that TL-SDResNet50 can accomplish fast training of a small amount of EEG data, and the overall effect is better than other staging algorithms and classical algorithms in recent years, which has certain practical value.

Mid-term outcomes of tricuspid valve detachment versus non-detachment for ventricular septal defect closure / 中国胸心血管外科临床杂志

@#Objective 聽 聽To evaluate the mid-term outcomes between tricuspid valve detachment (TVD) and non-detachment (NTVD) for ventricular septal defect (VSD). Methods 聽 聽 The patients who underwent perimembranous VSD repair in the Department of Cardiovascular Surgery, West China Hospital from 2015 to 2020 were included. According to the surgical method, the patients were divided into a TVD group and a NTVD group. The clinical data of the two groups were compared. Results 聽 聽 Totally 538 patients were included in the study. There were 240 patients in the TVD group, including 121 males and 119 females, with an average age of 3.85卤8.42 years and an average weight of 14.12卤12.97 kg. There were 298 patients in the NTVD group, including 149 males and 149 females, with an average age of 4.42卤9.36 years and an average weight of 14.87卤12.51 kg. There was no statistical difference in the age, weight, sex, preoperative New York Heart Association (NYHA) classification or tricuspid regurgitation (TR) degree between the two groups (P>0.05). Median follow-up was 30 (23, 40) months in the TVD group, and 29 (23, 41) months in the NTVD group (P=0.600). After operation, one patient in each group developed third-degree atrioventricular block and recovered to sinus rhythm before discharge (P=0.848). No pacemaker was needed. There was no statistical difference in the length of stay (P=0.054), mortality (P=1.000), in-hospital reoperation (P=0.199), or follow-up reoperation (P=0.505). More than 98% of patients in both groups had postoperative TR less than moderate (P=0.926). At the last follow-up, only 7 (2.9%) patients in the TVD group were detected trivial residual shunting, and 14 (4.7%) in the NTVD group (P=0.289). No one needed to have reoperation because of residual VSD. The TVD group showed less TR during the follow-up (P=0.019). Conclusion     TVD is an alternative technique which can be safely used in the closure of VSD, especially in technologically mature medical center. Appropriate tricuspid valve detachment for those hard-to-expose VSDs does not result in poorer tricuspid valve function or higher risk of atrioventricular block, and might reduce the incidence of residual shunting.

Totally endoscopic transmitral septal myectomy for the treatment of recurrent left ventricular outflow tract obstruction after alcohol septal ablation / 中国胸心血管外科临床杂志

@#Objective    To investigate the surgical strategies and clinical efficacy of transmitral septal myectomy in the treatment of recurrent left ventricular outflow tract obstruction (LVOTO) after alcohol septal ablation. Methods    The clinical data of patients with recurrent LVOTO after alcohol septal ablation from July 2020 to July 2021 in the Department of Cardiac Surgery, Guangdong Provincial People's Hospital were retrospectively analyzed. Patients were preoperatively evaluated by echocardiography, cardiac magnetic resonance imaging, cardiac computed tomography, 3D modeling and printing technology. A personalized surgical strategy was preoperatively developed according to multimodality imaging assessment, while visual exploration was performed on the digital model and simulated surgical resection was performed on the printed model. Results     Two female patients were enrolled, aged 62 years and 64 years, respectively. Totally endoscopic transmitral extended myectomy was successfully performed on both patients with aortic cross-clamping time of 96 min and 85 min, respectively. LVOTO was relieved immediately (subaortic peak pressure gradient decreased from 100 mm Hg to 4 mm Hg and from 84 mm Hg to 6 mm Hg, respectively) and the mitral regurgitation significantly improved after the procedure. No patient had complete atrioventricular block or required permanent pacemaker implantation. The patients were discharged uneventfully without postoperative complications. Conclusion    Personalized totally endoscopic transmitral extended myectomy combined with multimodality imaging assessment and 3D modeling and printing has an acceptable clinical effect in patients with recurrent LVOTO after alcohol septal ablation. The procedure can precisely resect the hypertrophic septal myocardium while avoiding serious complications such as septal perforation or complete atrioventricular block.

Development and verification of chemical chromogenic method for determination of residual cetyltrimethyl ammonium bromide content in ACYW135 meningococcal polysaccharide stock solution / 中国生物制品学杂志

@#Objective To develop and verify a chemical choromogenic method for the determination of residual cetyltrimethylammonium bromide(CTAB)content in ACYW135 meningococcal polysaccharide stock solution. Methods A chemical chromogenic method was developed for the determination of residual CTAB content by using titan yellow as chromogenic reagent,and verified for the linear range,intermediate precision and accuracy. ACYW135 meningococcal polysaccharide stock solution were determined for residual CTAB content by the developed method. Results The CTAB reference at concentrations of 4. 0～10. 0 μg/mL showed good linear relationship to A_(500),with a R~2 value of more than 0. 990. The recovery rates of CTAB standard at concentrations of 5. 0,7. 0,and 9. 0 μg/mL were all within 95% ～ 110% in six repeated tests,with the CV values of determination results of less than 10%. All the residual CTAB contents in four batches of meningococcal polysaccharide stock solutions were less than 8. 0 μg/mL. Conclusion The chemical chromogenic method showed good linearity,intermediate precision and accuracy,which might be used for the determination of residual CTAB content in ACYW135 meningococcal polysaccharide stock solution.

Development and verification of qPCR method for detection of residual host DNA in human rabies vaccine(Vero cells) / 中国生物制品学杂志

@#Objective To develop and verify a qPCR method for the qualitative and quantitative analysis of residual host DNA in human rabies vaccine(Vero cells) stock solution.Methods The qPCR standard curve was established by using the Vero cell DNA quantitative national standard,and the residual host DNA was extracted using magnetic beads.The specificity,repeatability,intermediate precision,accuracy and durability of the method were verified,and the linear range and limit of quantification were determined.The residual DNA of three batches of human rabies vaccine(Vero cells) stock solution was quantitatively analyzed and the fragment size was qualitatively analyzed by using this method.Results The correlation coefficients(R~2) of Vero cell DNA quantitative national standard amplification standard curve were all more than 0.99 by qPCR,and the quantitative range was 0.3 pg/mL～30 ng/mL.The method showed good specificity and repeatability.In the verification of intermediate precision,accuracy and durability,the relative standard deviations(RSD)of detection results of the samples were all less than 10%.The residual DNA content of Vero cells in three batches of stock solution was 0.20～0.77 ng/dose,which met the relevant standard of Chinese Pharmacopoeia(Volume Ⅲ,2020edition).The residual DNA fragments greater than 154 bp accounted for 52%～63%.Conclusion The developed qPCR method for the detection of residual DNA in human rabies vaccine(Vero cells) stock solution had good specificity,repeatability,intermediate precision and durability,and qualitatively and quantitatively analyzed the residual DNA rapidly and accurately,which was of great significance for improving the detection and control of residual DNA content in the production process and final product of human rabies vaccine(Vero cells).

Artificial intelligence recognition of bone marrow cells can be applied to diagnosis of minimal residual disease in acute leukemia / 中华检验医学杂志

Objective:To explore the diagnostic value and problems of artificial intelligence (AI) bone marrow cell recognition technology in the detection of minimal residual disease (MRD) of leukemia.Methods:A total of 65 cases with minimal residual disease of leukemia confirmed by flow cytometry from the Hematology Medical Center of Xinqiao Hospital affiliated to the Army Medical University (AMMU) from November 1 to December 31, 2020 were collected. The bone marrow Wright′s staining smears were obtained, and all bone marrow smears were scanned and classified automatically without artificial intervention by the analysis system based on Artificial Intelligence platform (morphogo). AI-MRD was defined to positive when the proportion of primary cells was more than 3%. According to the number of AI automatic recognition cells, the cases were divided into 18 cases of less than 500 (L500), 35 cases of 500 to 1900 (between 500 and 1900, B1900), and 12 cases of more than 1900 (M1900), no overlap or omission between groups. Kappa consistency test was performed on the results of artificial intelligence test and the results of flow cytometry for minimal residual disease of leukemia (MFC-MRD) in each group. The receiver operating characteristic curve (ROC) of the artificial intelligence test results of each group of patients was drawn based on the MFC-MRD results, and the sensitivity, specificity and accuracy of the area under the curve (AUC) value and AI results were calculated.Results:After grouping according to the number of cells automatically recognized by AI, the detection results of L500 group were MFC-MRD+/AI-MRD+7 cases, MFC-MRD+/AI-MFC-2 cases, MFC-MRD-/AI-MRD+6 cases, MFC-MRD-/AI-MRD-3 cases; In B1900 group, MFC-MRD+/AI-MRD+13 cases, MFC-MRD+/AI-MFC-6 cases, MFC-MRD-/AI-MRD+6 cases, MFC-MRD-/AI-MRD-10 cases; The results of M1900 group were MFC-MRD+/AI-MRD+5 cases, MFC-MRD+/AI-MFC-0 cases, MFC-MRD-/AI-MRD+1 case, MFC-MRD-/AI-MRD-6 cases. Taking MFC-MRD as the determination standard, the sensitivity of AI-MRD detection in L500 group, B1900 group and M1900 group was 53.8%, 68.4% and 83.3%, the specificity was 60%, 62.5% and 100%, the accuracy was 55.6%, 65.7% and 91.7%, and the AUC value were 0.568 P=0.654, 0.678 P=0.069,1.000 P=0.000. Conclusions:This study preliminarily explored the diagnostic value and problems of AI bone marrow cell recognition in the detection of minimal residual disease of leukemia. It was confirmed that when 3% of the proportion of blasts in AI cell classification is set>3% as the positive threshold of AI-MRD, the consistency between AI and MFC-MRD detection increases with the increase of the number of cells recognized by AI.