Quality of life in children with cerebral palsy

Background: Cerebral palsy (CP) is the most common motor disability in childhood. Quality of life (QOL) has emerged as an important concept in childhood, especially for children with disabilities. CP has an impact on a child’s capacity to do activities of daily living thus affecting QOL of patients and their families. Aims and Objectives: The objective of present study was to assess the QOL in children with CP. Materials and Methods: In this study, 29 children with CP in the age group of 4–12 years were evaluated for QOL was assessed using CPQOL-Child Primary Caregiver Questionnaire (4–12 years). The questionnaire was completed by one of the parents or their caregiver. Scores for each domain of QOL were converted to a scale ranging from 0 to 100 and analyzed. Results: The scores as reported by the parents were low for each of the domains with maximum effect seen in functioning domain and least in pain domain. Girls had better QOL than boys. The QOL scores were negatively related to the severity of CP which was assessed by gross motor function classification system suggesting that severity of disability had negative impact on QOL. Conclusion: QOL of children with CP was found to be poor and was influenced by age, sex and motor functioning

Maxillary Molar Root Canal Morphology Using Cone-Beam Computed Tomography: An Epidemiological Study from Shandong Province, China / Morfología del Conducto Radicular del Molar Maxilar Mediante Tomografía Computarizada de Haz Cónico: Un Estudio Epidemiológico de la Provincia de Shandong, China

SUMMARY: The objective of this study was to evaluate the maxillary molar root canal morphology in individuals from the Shandong province, China, using cone-beam computed tomography (CBCT) and classify it based on Ahmed et al. (2017) classification system to obtain a reference for clinical diagnosis and treatment. From December 2020 to June 2021, we screened CBCT data of 1,619 patients at the Jinan Stomatological Hospital who had been indicated for CBCT because of various oral abnormalities. The root and root canal morphologies of all teeth were statistically analyzed, and the root canal morphology was classified based on Ahmed et al. (2017) classification system. In the maxillary molars, three roots were the most common, accounting for 99.24 % and 74.61 % of all maxillary first and second molars, respectively. Two roots were the second most common, accounting for 0.66 % and 17.29 % of all maxillary first and second molars, respectively. Root morphology variation, e.g., fusion or furcation defect, was present in 22 (0.76 %) maxillary first molars and 765 (25.39 %) maxillary second molars, with the most common being mesiobuccal and distobuccal root fusion. Detection rates of a second mesiobuccal canal (MB2) in the maxillary first and second molars were 48.5 % and 26.5 %, respectively. Among age groups, the frequency of MB2 was the highest in the 15-24-year-old group and lowest in the 55-64-year-old group. Bilateral MB2 root canals were present in 64.8 % and 48.4 % of the maxillary first and second molars, respectively. Men and women accounted for 60.6 % and 67.8 % of the maxillary first molars, respectively, and 51.7 % and 45.6 % of the maxillary second molars, respectively. According to Ahmed et al. (2017) classification of root canal morphology, 18 and 22 root canal configurations were found in 1,453 right maxillary first molars and 1,444 left maxillary first molars, respectively. The right maxillary first molars showed three two-rooted, 14 three-rooted, and one four-rooted type. The left maxillary first molars showed two one-rooted, six two-rooted, and 14 three-rooted types. According to Ahmed et al. (2017) classification of root canal morphology, 43 and 45 root canal configurations were found in 1,507 right maxillary second molars and 1,506 left maxillary second molars, respectively. The right maxillary second molars showed 17 one-rooted, 16 two- rooted, eight three-rooted, and two four-rooted types. The left maxillary second molars showed 19 one-rooted, 13 two-rooted, 12 three- rooted, and one four-rooted type. This study showed that the maxillary molar root canal morphology is diverse in the Shandong province. Ahmed et al. (2017) classification system provides a clear description of the root canal morphology. CBCT can be used to study complex root and root canal morphologies.

El objetivo de este estudio fue evaluar la morfología del conducto radicular del molar superior en individuos de la provincia de Shandong, China, utilizando tomografía computarizada de haz cónico (CBCT) y clasificarla con base en el sistema de clasificación de Ahmed et al. (2017) para obtener una referencia para diagnóstico clínico y tratamiento. Desde diciembre de 2020 hasta junio de 2021, analizamos los datos de CBCT de 1619 pacientes en el Hospital Estomatológico de Jinan a quienes se les indicó CBCT debido a diversas anomalías orales. Las morfologías de la raíz y del conducto radicular de todos los dientes se analizaron estadísticamente, y la morfología del conducto radicular se clasificó según el sistema de clasificación de Ahmed et al. (2017). En los molares superiores, tres raíces fueron las más comunes, representando el 99,24 % y el 74,61 % de todos los primeros y segundos molares superiores, respectivamente. Dos raíces fueron las segundas más comunes, representando el 0,66 % y el 17,29 % de todos los primeros y segundos molares superiores, respectivamente. La variación de la morfología de la raíz, por ejemplo, fusión o defecto de furcación, estuvo presente en 22 (0,76 %) primeros molares superiores y 765 (25,39 %) segundos molares superiores, siendo la fusión radicular mesiovestibular y distovestibular la más común. Las tasas de detección de un segundo canal mesiovestibular (MB2) en los primeros y segundos molares superiores fueron del 48,5 % y 26,5 %, respectivamente. Entre los grupos de edad, la frecuencia de MB2 fue más alta en el grupo de 15 a 24 años y más baja en el grupo de 55 a 64 años. Los conductos radiculares MB2 bilaterales estaban presentes en el 64,8 % y el 48,4 % de los primeros y segundos molares superiores, respectivamente. En los hombres y en las mujeres representaron el 60,6 % y el 67,8 % de los primeros molares superiores, respectivamente, y el 51,7 % y el 45,6 % de los segundos molares superiores, respec- tivamente. Según la clasificación de la morfología del conducto radicular de Ahmed et al. (2017) se encontraron configuraciones de conducto radicular 18 y 22 en 1453 primeros molares superiores derechos y 1444 primeros molares superiores izquierdos, respectivamente. Los primeros molares superiores derechos mostraron tres tipos de dos raíces, 14 de tres raíces y uno de cuatro raíces. Los primeros molares superiores izquierdos mostraron dos tipos de una raíz, seis de dos raíces y 14 de tres raíces. Según la clasificación de la morfología del conducto radicular de Ahmed et al. (2017) se encontraron configuraciones de conducto radicular 43 y 45 en 1507 segundos molares superiores derechos y 1506 segundos molares superiores izquierdos, respectivamente. Los segundos molares superiores derechos mostraron 17 tipos de una raíz, 16 de dos raíces, ocho de tres raíces y dos de cuatro raíces. Los segundos molares superiores izquierdos mostraron 19 de una raíz, 13 de dos raíces, 12 de tres raíces y uno de cuatro raíces. Este estudio mostró que la morfología del conducto radicular del molar superior es diversa en la provincia de Shandong. El sistema de clasificación de Ahmed y colaboradores proporciona una descripción clara de la morfología del conducto radicular. CBCT se puede utilizar para estudiar morfologías complejas de raíces y conductos radiculares.

Construction of a knowledge base for hierarchical prevention care of neonatal hypoglycemia based on risk prediction model / 中国实用护理杂志

Objective:To build the standardized knowledge base for hierarchical prevention care of neonatal hypoglycemia based on the risk prediction model of neonatal hypoglycemia, and to provide a decision-making basis for risk management to achieve predicitive neonatal hypoglycemia.Methods:Based on the best evidence summarized in strategies for the prevention and management of neonatal hypoglycemia published in 2020, evidence on the prevention and management of neonatal hypoglycemia was searched from BMJ Best Practice, UpToDate, Registered Nurses Association of Ontario, CNKI and other domestic and foreign databases and professional association websites. The retrieval period was from September 1, 2019 to August 31, 2022. The quality of newly included literature was evaluated, new evidence was extracted, and the best evidence in the prevention and management strategy of neonatal hypoglycemia published in 2020 was summarized and combined to form the first draft of the knowledge base. Experts in the field of neonatal nursing were invited to revise and discuss each item of the knowledge base, and the final draft of the knowledge base was formed. The final draft of the knowledge base was coded using the 2.5 version of the Clinical care classification system as the standardized language.Results:The risk prediction model of neonatal hypoglycemia was used as a grading tool, the final draft of the knowledge included 1 nursing diagnosis, 6 modules and 18 specific preventive nursing measures.Conclusions:The knowledge base for hierarchical prevention care of neonatal hypoglycemia based on risk prediction model can realize the prospective hierarchical nursing of neonatal hypoglycemia, which is scientific and practical, and is the basis to assist nurses to make clinical decisions.

A clinical cross-sectional study of resting energy expenditure in children with cerebral palsy / 中华实用儿科临床杂志

Objective:To investigate the characteristics of resting energy expenditure (REE) in children with cerebral palsy (CP) graded with different levels of Gross Motor Function Classification System (GMFCS), and to evaluate the accuracy and association of commonly used REE prediction formulas in children with CP.Methods:It was a retrospective study involving 36 children with CP aged 24-144 months who visited the Third Affiliated Hospital of Zhengzhou University between September 2021 and August 2022.REE was measured by the indirect calorimetry.Based on the GMFCS, children with CP were divided into grade Ⅰ-Ⅱ group (20 cases), grade Ⅲ group (6 cases) and grade Ⅳ-Ⅴ group(10 cases). During the same period, 11 age-matched healthy children were included in control group.The measured REE (MREE) between children with CP and healthy controls was compared.Predicted REE (PREE) calculated by the Harris-Benedict, WHO, Schofield-W, Schofield-WH and Oxford prediction formulas were compared with MREE in children for their consistency and correlation.Independent samples were analyzed using t-test or Mann- Whitney U test, and categorical data were analyzed using Chi- square test.Using paired t-test and Pearson linear correlation analysis to analyze the correlation between MREE and PREE.The accuracy of PREE values calculated by different formulas was assessed using the root mean square error. Results:The MREE in control group and children with CP were (952.18±270.56) kcal/d and (801.81±201.89) kcal/d, respectively.There was no significant difference in the MREE between grade Ⅰ-Ⅱ group versus control group[(868.30±194.81) kcal/d vs.(952.18±270.56) kcal/d, P>0.05], and grade Ⅲ group versus control group [(813.17±192.48) kcal/d vs.(952.18±270.56) kcal/d, P>0.05]. The MREE was significantly lower in grade Ⅳ-Ⅴ group than that of control group [666.00(513.50, 775.50) kcal/d vs.(952.18±270.56) kcal/d, P=0.011]. There were no significant difference between MREE and PREEs calculated by Harris-Benedict, WHO, Schofield-W, Schofield-WH, and Oxford (all P>0.05). The correct classification fraction calculated by the 5 formulas were 33.3%, 47.2%, 41.7%, 47.2%, and 41.7%, respectively.The r values of the consistency of PREE calculated by the 5 formulas were 0.585, 0.700, 0.703, 0.712, and 0.701, respectively.The Blande-Altman Limits of Agreement were (-297.77, 359.22), (-245.60, 326.94), (-250.62, 316.05), (-242.22, 177.36) and (-241.28, 325.81), respectively.The clinically acceptable range was -80.18 to 80.18 kcal/d.The root mean square error were 168.09 kcal/d, 149.64 kcal/d, 146.24 kcal/d, 144.23 kcal/d and 148.77 kcal/d, respectively. Conclusions:The MREE values decreased significantly in children with CP classified as CMFCS grade Ⅳ and Ⅴ.When REE cannot be regularly monitored by indirect calorimetry to develop nutritional support programs, children with CP may be prioritized to estimate REE using the prediction formula of Schofield-WH.

Applicability of Modified Pediatric Nutritional Risk Screening Tool in children with cerebral palsy / 中华实用儿科临床杂志

Objective:To explore the scheme of assigning rational scores to the Modified Pediatric Nutritional Risk Screening Tool for children with cerebral palsy(CP) at different Gross Motor Function Classification System(GMFCS) levels.Methods:The clinical data of 360 children with CP hospitalized in the Department of Children′s Rehabilitation, the Third Affiliated Hospital of Zhengzhou University from January to October 2019 were analyzed retrospectively.All the CP children at different GMFCS levels who met the inclusion criteria were subject to nutrition screening and assessment by using the Modified Pediatric Nutritional Risk Screening Tool and the Subjective Global Nutritional Assessment(SGNA) scale.The distribution of malnutrition rates assessed by the SGNA scale among the children at different GMFCS levels was examined.Data between groups were compared by the χ2 test.Children at different GMFCS levels were divided into different subgroups according to the statistical difference.Then, 0 or 1 score was assigned to the Modified Pediatric Nutritional Risk Screening Tool in different subgroups, and different combinations were formed.The nutritional risk screening results of different combinations were evaluated by using the SGNA scale assessment results as a reference. Results:In children with CP, the risk detection rate and incidence rate of malnutrition were 58.1%(209/360) and 36.9%(133/360), respectively.There was no significant difference in the incidence rate of malnutrition between GMFCS Ⅱ and GMFCS Ⅲ, as well as between GMFCS Ⅳ and GMFCS Ⅴ(all P>0.05). Therefore, children with CP were divided into 3 subgroups, namely, group Ⅰ, group Ⅱ to Ⅲ, and group Ⅳ to Ⅴ.Different CP disease scores were given to the Modified Pediatric Nutritional Risk Screening Tool in 3 subgroups, forming 3 different protocols[protocol 1 (0, 0, 1 point); protocol 2(0, 1, 1 point); current protocol (1, 1, 1 point)]. Taking the SGNA scale assessment results as a reference, the sensitivity of protocol 1, protocol 2 and current protocol were 85.7%, 92.5%, and 93.2% respectively.The specificity protocol 1, protocol 2 and current protocol were 81.1%, 78.0%, and 62.6%, respectively.And the Youden indexes of above three protocols were 0.668, 0.705, and 0.558, respectively.The Youden index of protocol 2 was relatively high. Conclusions:The Modified Pediatric Nutritional Risk Screening Tool can effectively identify the risk of malnutrition in children with CP.The scheme of assigning 0 points to children with GMFCS grade Ⅰ and 1 point to children with GMFCS grade Ⅱ to Ⅴ is more reasonable.

Manufacturing classification system for oral solid dosage forms of traditional Chinese medicines (Ⅱ): classification of tablets disintegration behavior / 中国中药杂志

In this paper, 50 batches of representative traditional Chinese medicine tablets were selected and the disintegration time was examined with the method in Chinese Pharmacopoeia. The disintegration time and disintegration phenomenon were recorded, and the dissolution behaviors of water-soluble and ultraviolet-absorbent components during the disintegration process of tablets were characterized by self-control method. The results revealed that coating type and raw material type influenced the disintegration time of tablets. It was found that only 4% of traditional Chinese medicine tablets had obvious fragmentation during the disintegration process, while 96% of traditional Chinese medicine tablets showed gradual dissolution or dispersion. Furthermore, according to the disintegration speed, disintegration phenomenon, and whether the cumulative dissolution of measured components was > 90% at complete disintegration, a disintegration behavior classification system(DBCS) was created for the regular-release traditional Chinese medicine tablets. As a result, the disintegration behaviors of 50 batches of traditional Chinese medicine tablets were classified into four categories, i.e. ⅠA_2, ⅠB_1, ⅡB_1, and ⅡB_2. traditional Chinese medicine tablets(Class I) with disintegration time ≤ 30 min were defined to be rapid in disintegration, which can be the objective of optimization or improvement of Chinese herbal extract(semi extract) tablets. Different drug release models were used to fit the dissolution curve of traditional Chinese medicine tablets with gradual dissolution or dispersion phenomenon(i.e. Type B tablets). The results showed that the dissolution curves of water-soluble components in the disintegration process conformed to the zero order kinetics and the Ritger-Peppas model. It could be inferred that the disintegration mechanisms of type B tablets were a combination of dissolution controlled and swelling controlled mechanisms. This study contributes to understanding the disintegration behavior of traditional Chinese medicine tablets, and provides a reference for the design and improvement of disintegration performance of traditional Chinese medicine tablets.

Manufacturing classification system for oral solid dosage forms of traditional Chinese medicines(Ⅰ): classification of processing routes / 中国中药杂志

Oral solid dosage(OSD) occupies a key position in the market of Chinese patent medicines and new traditional Chinese medicines. Processing route is the foundation for the research and development of traditional Chinese medicine OSDs. On the basis of prescriptions and preparation methods of 1 308 traditional Chinese medicine OSDs recorded in the Chinese Pharmacopoeia, we summarized the patterns of processing routes of both modern dosage forms(tablets, granules, and capsules) and traditional dosage forms(pills and powder) and constructed a manufacturing classification system(MCS) based on the processing routes. Based on the MCS, statistical analyses were conducted respectively on medicinal materials, pharmaceutical excipients, extraction solvents in the pretreatment process, crushed medicinal materials, methods of concentration and purification, and methods of drying and granulation, aiming to uncover the process features. The results showed that each dosage form can be prepared via different routes with different processing methods of decoction pieces and raw materials for dosage preparation. The raw materials for dosage form preparation of traditional Chinese medicine OSDs included total extract, semi-extract, and total crushed powder, which accounted for different proportions. The raw materials for traditional dosage forms are mainly decoction pieces powder. Semi-extracts are the main raw materials for tablets and capsules, which account for 64.8% and 56.3%, respectively. Total extracts are the main raw materials for granules, with a proportion of 77.8%. Compared with tablets and capsules, traditional Chinese medicine granules with dissolubility requirements had a larger proportion of water extraction process, a higher proportion of refining process(34.7%), and a lower proportion of crushed medicinal mate-rials in semi-extract granules. There are four ways to add volatile oil to the modern dosage forms of traditional Chinese medicine. In addition, some new technologies and processes have been used in concentration, filtration, and granulation processes of traditional Chinese medicine OSDs, and the application of pharmaceutical excipients is diversified. The results of this study are expected to provide reference for the processing route design and upgrading of OSDs for new traditional Chinese medicines.

Relationship between the gross motor function classification system and hip and lumbar spine development in children with spastic cerebral palsy / 中国骨伤

OBJECTIVE@#To investigate the relationship among the gross motor function classification system (GMFCS)and the development of hip joint and lumbar spine in children with spastic cerebral palsy.@*METHODS@#The clinical data of 125 children with spastic cerebral palsy admitted from January 2018 to July 2021 were retrospectively analyzed. There were 85 males and 40 females, aged from 4 to 12 years old with an average of (8.4±2.9) years. According to GMFCS, the patients were divided into gradeⅠ, Ⅱ, Ⅲ and Ⅳ groups. There were 27 cases in gradeⅠgroup, 40 cases in gradeⅡgroup, 35 cases in grade Ⅲ group and 23 cases in grade Ⅳ group. The migration percentage(MP), central edge angle(CE), neck-shaft angle(NSA), acetabular index(AI) were measured by the radiograph of pelvis, abnormal parameters were selected to evaluate the relationship between different GMFCS grades and hip joint development. Lumbar sagittal Cobb angle, lumbar sacral angle, lumbar lordosis index and apical distance were measured by lateral lumbar radiographs to evaluate the relationship between different GMFCS grades and lumbar spine development.@*RESULTS@#①Among the 125 spastic cerebral palsy children, there were 119 cases of pelvic radiographs that met the measurement standards. In the four groups with gradeⅠ, Ⅱ, Ⅲ, Ⅳ, MP was (22.72±3.88), (26.53±4.36), (33.84±4.99), and (49.54±7.87)%, CE was(30.10±6.99) °, ( 22.92±4.19) °, ( 17.91±5.50) °, and (-0.70±17.33)°, AI was (16.41±2.77) °, (20.46±4.63) °, (23.76±5.10) °, and ( 29.15±7.35)°, respectively, there were significant differences between the two comparisons (P<0.05). And the higher GMFCS grade, the greater MP and AI, and the smaller CE.The NSA was(142.74±10.03) °, (148.66±9.09) °, (151.66±10.52) °, and (153.70±8.05)° in four groups with gradeⅠ, Ⅱ, Ⅲ, Ⅳ, respectively. The differences between the two comparisons of the GMFCS gradeⅠgroup and the other three groups were statistically significant (P<0.05). NSA of GMFCSⅠgroup was significantly lower than that of the others, there was no significant difference among other groups(P>0.05). ② Among the 125 spastic cerebral palsy children, there were 88 cases of lumbar spine radiographs that met the measurement standards. ③The lumbar sagittal Cobb angle was(32.62±11.10) °, (29.86±9.90) °, (31.70±11.84) °, and (39.69±6.80)° in the four groups with gradeⅠ, Ⅱ, Ⅲ, Ⅳ, respectively;GMFSS of grade Ⅳ group was significantly higher than that of other three groups, there was significant difference between the two comparisons (P<0.05);there were no significant differences between other groups (P>0.05). In the four groups with gradeⅠ, Ⅱ, Ⅲ, Ⅳ, the lumbosacral angle was (31.02±9.91) °, ( 26.57±9.41) °, (28.08±8.56) °, and ( 27.31±11.50)°, the lumbar lordosis index was (4.14±12.89), (8.83±13.53), (13.00±11.78), and (10.76±9.97) mm, the arch apex distance was (9.50±6.80), (6.68±3.20), (7.16±4.94), and (6.62±4.13) mm, respectively, there were no significant differences between the two comparisons(P>0.05).@*CONCLUSION@#①In children with GMFCS gradeⅠ-Ⅳ, the higher the GMFCS grade, the worse the hip develops. ② Children with GMFCS grade Ⅲ-Ⅳ may be at greater risk for lumbar kyphosis.

Intelligent co-design of material, process, and equipment for manufacturing high-quality traditional Chinese medicine preparations / 中国中药杂志

In the context of Pharma 4.0, the design tools that support the pharmaceutical Quality by Design(QbD) are iterating fast toward intelligent or smart design. The conventional development methods for traditional Chinese medicine(TCM) preparations have the limitations such as over dependence on experience, low dimensions for the designed experiment parameters, poor compatibility between the process and equipment, and high trial-and-error cost during process scale-up. Therefore, this paper innovatively proposed the intelligent co-design involving material, process, and equipment for manufacturing high-quality TCM preparations, and introduced the design philosophy, targets, tools, and applications with TCM oral solid dosage(OSD) as an example. In terms of design philosophy, the pharmaceutical design tetrahedron composed of critical material attributes, critical process parameters, critical equipment attributes, and critical quality attributes was developed. The design targets were put forward based on the product performance classification system. The design tools involve a design platform that contains several modules, such a as the iTCM material database, the processing route classification system, the system modeling and simulation, and reliability-based optimization. The roles of different modules in obtaining essential and universal design knowledge of the key common manufacturing units were introduced. At last, the applications of the co-design methodology involving material, process, and equipment in the high shear wet granulation process development and the improvement of the dissolving or dispersion capability of TCM formula granules are illustrated. The research on advanced pharmaceutical design theory and methodology will help enhance the efficiency and reliability of drug development, improve the product quality, and promote the innovation of high-end TCM products across the industry.

Analysis of Cesarean Section Rates and its Indications Using Robson's Classification at a Tertiary Care Hospital, Manipur

Context: The World Health Organization proposed the Robson’s classification system as a global standard for assessing and comparing cesarean section (CS) rates within health-care facilities over time and between facilities. Aims: This study aims to assess the frequency and indications of CS and to identify the groups within the obstetric population contributing to CS using Robson’s classification. Settings and Design: A retrospective chart review was conducted in a Tertiary Care Teaching Hospital in Imphal, Manipur. Methods: All women who delivered between January and December 2019 were classified using the Robson’s Ten Group Classification System. The overall CS rate and the CS rate in each Robson’s group were calculated. The indications for CS were also recorded. Statistical Analysis Used: Descriptive statistics, such as frequency, percentage, mean, and standard deviation, was used. Results: A total of 10,282 births were reported. The overall CS rate was 35.2%. Group 3 (multiparous women without previous CS in spontaneous labor) (27.6%) and Group 1 (nulliparous women in spontaneous labor) (23.7%) contributed to most of the obstetric populations. The majority of CS belonged to the women in Group 5 (multiparous women with previous lower segment CS) (11%), followed by Group 2 (nulliparous women with labor induced or prelabor CS) (8.6%) and Group 4 (multiparous women without previous CS were induced or taken for prelabor CS) (5.5%). Conclusions: The study revealed that Groups 5, 2, and 4 contributed to the high CS rate. Efforts to reduce the overall CS rate should be directed at increasing vaginal births after CS, performing effective pelvic examinations, and encouraging obstetricians to perform versions when indicated.

Estudo da permeabilidade de fármacos por meio do modelo de saco intestinal de ratos / Study of drug permeability through the rat gut sac model

Os parâmetros de permeabilidade e solubilidade são fundamentais à absorção oral de fármacos e a partir dessas características, foi criado o Sistema de Classificação Biofarmacêutica, através do qual os fármacos são divididos em quatro classes. Atualmente, para a determinação da solubilidade de um fármaco, existem diversos métodos padronizados por agências regulatórias, no entanto, para a determinação da permeabilidade, os ensaios são passíveis de diversas variações em sua execução, diminuindo a confiabilidade dos resultados obtidos e impossibilitando a comparação dos mesmos quando realizados com técnicas diferentes umas das outras. O objetivo do presente trabalho é avaliar as variáveis experimentais do modelo do saco intestinal que podem influenciar nos resultados de permeabilidade aparente de fármacos e na viabilidade do tecido. O presente estudo foi aprovado pelo Comitê de Ética no Uso de Animais da FCF-USP (109.2018-P574). Foram utilizados 33 Rattus norvegicus da linhagem Wistar, machos, jovens adultos, com peso entre 200 g e 300 g. Para realização do procedimento, cada animal permaneceu em jejum por cerca de quatro horas e após adequada anestesia a porção do jejuno do intestino delgado foi retirada e dividida em seis segmentos de aproximadamente 8,5cm cada. Foram realizados experimentos com e sem inversão do saco intestinal, submetidos a diferentes tempos de banho de gelo após sua ressecção, na presença ou ausência de inibidor da glicoproteína-P (verapamil). Os fármacos naproxeno e famotidina foram empregados como marcadores de alta e baixa permeabilidade, respectivamente. A losartana foi utilizada como substrato da glicoproteína P. Cada um dos sacos intestinais foi colocado em um tubo de ensaio contendo tampão Krebs, a 37°C, saturado com gás carbogênio. Para avaliação da integridade e viabilidade dos segmentos intestinais, observou-se a presença de movimentos peristálticos e coletaram-se amostras do meio de incubação nos tempos 0, 30, 45, 60, 90 e 120 minutos para quantificação dos fármacos e de glicose, uma vez que esta é ativamente transportada para a serosa do intestino delgado. Determinou-se a permeabilidade aparente de cada fármaco e as concentrações de glicose nas diferentes condições experimentais, realizou-se planejamento fatorial multinível e os resultados foram analisados por análise variância (ANOVA), seguida de pós-teste de Tukey. Observou-se que as variáveis experimentais interferiram de forma significativa na viabilidade tecidual e na permeabilidade aparente dos fármacos. Não foram observadas diferenças significativas da permeabilidade de fármacos nos diferentes segmentos do jejuno. A glicose mostrou-se um bom marcador de viabilidade tecidual e foi constatado que a presença ou ausência de movimentos peristálticos não está relacionada diretamente com a viabilidade do tecido. Uma vez que foram constatadas tantas interferências nos resultados, é imprescindível que os procedimentos experimentais sejam padronizados, para que os resultados apresentem menor variabilidade e possam ser comparados entre si

The permeability and solubility parameters are fundamental to the oral absorption of drugs and from these characteristics, the Biopharmaceutical Classification System was created, through which drugs are divided into four classes. Currently, for the determination of the solubility of a drug, there are several methods standardized by regulatory agencies, however, for the determination of permeability, the tests are subject to several variations in their execution, reducing the reliability of the results obtained and making it impossible to compare the results obtained. same when performed with different techniques. The aim of this study is to evaluate if different experimental conditions can influence the results of apparent drug permeability and tissue viability on gut sac model. The present study was approved by the Ethics Committee for the Use of Animals of FCF-USP (109.2018-P574). Thirty-three male, young adult Rattus norvegicus were used, weighing between 200 g and 300 g. To perform the procedure, each animal fasted for about four hours and after adequate anesthesia, the portion of the jejunum of the small intestine was removed and divided into six segments of approximately 8.5 cm each. Experiments were performed with and without inversion of the gut sac, submitted to different times of ice bath after its resection, in the presence or absence of a P-glycoprotein inhibitor (verapamil). The drugs naproxen and famotidine were used as markers of high and low permeability, respectively. Losartan was used as a substrate for P-glycoprotein. Each of the gut sacs was placed in a test tube containing Krebs buffer, at 37°C, saturated with carbogen gas. To evaluate the integrity and viability of the intestinal segments, the presence of peristaltic movements was observed and samples of the incubation medium were collected at 0, 30, 45, 60, 90 and 120 minutes for quantification of drugs and glucose, as it is actively transported to the serosa of the small intestine. The apparent permeability of each drug and the glucose concentrations were determined under different experimental conditions, multilevel factorial design was performed and the results were analyzed by analysis of variance (ANOVA), followed by Tukey's post-test. It was observed that the experimental variables significantly interfered in the tissue viability and in the apparent permeability of the drugs. No significant differences in drug permeability were observed in the different segments of the jejunum. Glucose proved to be a good marker of tissue viability and it was found that the presence or absence of peristaltic movements is not directly related to tissue viability. Since so many interferences were found in the results, it is essential that the experimental procedures be standardized, so that the results show less variability and can be compared between different authors

Comparator product issues for biowaiver implementation: the case of Fluconazole

The aim of this work was to assess if the commercially available Fluconazole drug products (Reference, Generic and Similar) would meet the biowaiver criteria from Food and Drug Administration (FDA) and Brazilian Agency for Health Surveillance (ANVISA) agencies. All formulations were evaluated considering the dissolution profile carried out in Simulated Gastric Fluid (SGF) pH 1.2, Acetate Buffer (AB) pH 4.5 and Simulated Intestinal Fluid (SIF) pH 6.8. The results demonstrated that all formulations fulfilled the 85% of drug dissolved at 30 min criterion in SGF pH 1.2. However, in AB pH 4.5 and SIF pH 6.8, some formulations, including the comparator, did not achieve this dissolution percentage. The discrepant dissolution profiles also failed the ƒ2 similarity factor analysis, since none of the formulations showed values between 50 and 100 in the three dissolution media. Comparative dissolution profiles were not similar, considering that the main issues concerning the dissolution were evidenced for the comparator product. Hence, a revision in the regulatory norms in order to establish criteria to switch the comparator could result in an increased application of drugs based on biowaiver criteria

Requisitos de bioisenção com base no Sistema de Classificação Biofarmacêutica no Brasil e no mundo / Biowaiver requirements based on the Biopharmaceutical Classification System in Brazil and worldwide

O acesso a medicamentos pode ser facilitado por programas globais de desenvolvimento farmacêutico, mas há necessidade de que as agencias regulatórias e as indústrias farmoquímicas e farmacêuticas interajam e haja um consenso quanto as exigências para o registro de medicamentos. Este artigo examinou a legislação especifica sobre bi isenção com base no Sistema de Classificação Biofarmacêutica, comparando os cenários do Brasil e do mundo. A partir dessa análise, identificou os entraves a aplicação dos critérios internacionais na realidade regulatória nacional, identificando algumas fragilidades da legislação, como no caso de pro-fármacos. Analisaram-se os critérios de cinco organismos regulatórios (Agência Europeia de Medicamentos, Food and Drug Administration, Health Canada, Conselho Internacional para Harmonização de Requisitos Técnicos para Medicamentos de Uso Humano e Organização Mundial da Saúde) frente aos requisitos da Agência Nacional de Vigilância Sanitária, pontuando as diferenças e o que já se encontra pacificado no tocante a classe do Sistema de Classificação Biofarmacêutica aceita, a comparabilidade entre formulação teste e de referência, solubilidade, permeabilidade intestinal e perfil de dissolução in vitro. Concluiu--se que a Agência Nacional de Vigilância Sanitária deve internalizar os preceitos e critérios da bioisenção com base no Sistema de Classificação Biofarmacêutica por meio de um novo marco regulatório. Além disso, para que esse marco regulatório seja bem-sucedido e produza resultados palpáveis, em especial na área de saúde publica e vigilância sanitária, a agência brasileira deve estar aberta ao diálogo com o setor regulado e as inovações e orientações da academia, sem desviar o foco de sua missão institucional.

Access to medicines can be facilitated by global pharmaceutical development programs, but there is a need for regulatory agencies and the pharmochemical and pharmaceutical industries to interact and to have a consensus on the requirements for drug registration. This article examined the specific legislation concerning to biowaiver based on the Biopharmaceutical Classification System, comparing the scenario in Brazil and worldwide. Based on this analysis, it identified the obstacles to the application of international criteria in the national regulatory reality, identifying some weaknesses of the legislation, as in the case of prodrugs. The criteria of five regulatory bodies (European Medicines Agency, Food and Drug Administration, Health Canada, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use and World Health Organization) were analyzed in relation to the requirements of the Brazilian Health Regulatory Agency (Anvisa), pointing out the differences and what has already been settled regarding the accepted class of the Biopharmaceutical Classification System, the comparability between test and reference formulations, solubility, intestinal permeability and in vitro dissolution profile. It was concluded that Anvisa should internalize the percepts and criteria of the biowaiver based on Biopharmaceutical Classification System, through a new regulatory framework. Moreover, for this regulatory framework to be successful and produce tangible results, especially in the area of public health and health surveillance, Anvisa must be open to dialogue with the regulated sector and to innovations and guidance from academia, without losing focus of its institutional mission.

Evolução do consumo de nutrientes e de alimentos segundo a classificação NOVA em frequentadores de serviço de promoção da saúde da atenção primária / Evolution of nutrient and food consumption according to the NOVA classification among users of health promotion service in primary health care

INTRODUÇÃO: Consumir alimentos in natura, minimamente processados e preparações culinárias (PC), em detrimento aos ultraprocessados (AUP), pode melhorar o perfil nutricional da dieta e reduzir o risco de desenvolvimento de doenças crônicas não transmissíveis (DCNT). OBJETIVO: Avaliar a evolução do consumo de nutrientes e de alimentos, segundo a classificação NOVA, após intervenção coletiva de incentivo ao consumo de frutas e hortaliças (FH) em usuários do Programa Academia da Saúde (PAS) de Belo Horizonte, Minas Gerais. MÉTODOS: Foram desenvolvidos três artigos com dados oriundos de ensaio comunitário controlado e randomizado (ECCR), conduzido entre 2013 ­ 2015, com amostra representativa das unidades do PAS de Belo Horizonte, sendo 9 unidades pertencentes ao Grupo Controle (GC) e 9 ao Grupo Intervenção (GI). Indivíduos alocados no GC participaram das atividades rotineiras do serviço de saúde (prática regular de exercícios físicos três vezes/semana) e aqueles do GI adicionalmente receberam, durante sete meses, intervenção de incentivo ao consumo de FH, pautada no Modelo Transteórico e na pedagogia dialógica e problematizadora de Paulo Freire. Artigo 1: Estudo transversal realizado com dados da linha de base do ECCR que objetivou analisar o consumo de AUP segundo fatores sociodemográficos, e sua associação com o perfil nutricional da dieta. O perfil nutricional da dieta foi analisado segundo os quintis de contribuição percentual de energia oriunda de AUP mediante análises de associação e de Regressão Linear referente ao consumo de energia total, densidade energética, carboidratos, fibras, proteínas, gorduras totais e subgrupos de gorduras: saturada, monoinsaturada, poli-insaturada, trans, ômega 3 e ômega 6, vitaminas A, B3, B6, B12, Folato e C; e os minerais cálcio, ferro, fósforo, magnésio, potássio e sódio. Além disso, avaliou-se o percentual de inadequação do consumo de nutrientes recomendados para prevenção de DCNT e do consumo de vitaminas por Regressão de Poisson. Artigo 2: ECCR que objetivou verificar a efetividade de intervenção coletiva de incentivo ao consumo de FH sobre o consumo de alimentos, segundo a classificação NOVA, em frequentadores de serviço de promoção da saúde da Atenção Primária em Saúde (APS) brasileira. Os desfechos analisados foram consumo de PC, de alimentos processados (AP) e de AUP por meio de análises de associação e de comparação entre GC e GI, e Equações de Estimações Generalizadas (GEE). Artigo 3: ECCR que objetivou verificar a efetividade de intervenção coletiva de incentivo ao consumo de FH sobre a adequação do consumo de nutrientes, especialmente aqueles voltados para prevenção de DCNT, em frequentadores de serviço de promoção da saúde da APS brasileira. Também foram utilizadas análises de associação e GEE entre os grupos GI e GC. Os nutrientes analisados foram: energia total, carboidratos, fibras, proteínas, gorduras totais e subgrupos de gorduras: saturada, monoinsaturada, poli-insaturada, trans, ômega 3 e ômega 6, vitaminas A, B1, B2, B3, B6, B12, Folato, C, D, E; e os minerais cálcio, ferro, fósforo, magnésio, manganês, potássio, selênio, sódio e zinco. RESULTADOS - Artigo 1: O consumo de AUP contribuiu com 27,7% da energia total da dieta. O seu maior consumo associou a maiores valores de ingestão de energia, densidade de energia, gorduras totais e sódio; e menores de proteínas, gorduras monoinsaturadas, ômega 3 e algumas vitaminas e minerais. A prevalência de inadequação de nutrientes para prevenção de DCNT variou entre 30% e 100% entre o menor e maior quintil de consumo de AUP. Artigo 2: Após 12 meses de acompanhamento, observou-se entre os indivíduos do GI e do GC, aumento no consumo de PC e redução de AUP; além de aumento no consumo de AP entre os indivíduos do GC. Foi observado que a intervenção nutricional contribuiu para redução do consumo de AP para indivíduos alocados no primeiro quartil (RR: 0.861; CI: 0.749; 0.988) e aumento para aqueles alocados no segundo quartil de consumo de AP (RR: 1.145; CI: 1.041; 1.259). Também foi observada relação entre participação na intervenção nutricional e aumento do consumo de AUP para indivíduos alocados no terceiro quartil de consumo de AUP (RR: 1,062; CI: 1,005; 1,122). Artigo 3: Participantes dos grupos GC e GI, após 12 meses, apresentaram redução no consumo de energia, ômega 6 e sódio; e aumento de carboidratos, fibras, vitaminas A, B1, B2, B3, B6, B12, C, D e E, folato, cálcio, magnésio, potássio, selênio, manganês, zinco e ferro. Indivíduos do GC relataram ainda aumento do consumo de fósforo; e aqueles do GI, redução do consumo de gorduras totais, saturadas e poli-insaturadas; e aumento de monoinsaturadas. Em ambos os grupos, observou-se aumento na prevalência de adequação de nutrientes para prevenção de DCNT, exceto para gorduras trans. A participação na intervenção nutricional mostrou relação inversa com o consumo de energia (RR: 0,979; CI: 0,960; 0,999) e proteínas (RR: 0,978; CI: 0,959; 0,997) da dieta, mas não aumentou a chance de adequação dos demais nutrientes, incluindo aqueles voltados para prevenção de DCNT. CONCLUSÃO: Os resultados apontaram para a importância do PAS, um serviço de promoção da saúde do Sistema Único de Saúde, para a promoção da alimentação adequada e saudável, e prevenção das DCNT. A condução de intervenção coletiva de incentivo ao consumo de FH apresentou poucos resultados adicionais, evidenciando a necessidade de se realizar abordagens específicas relativas à classificação NOVA de alimentos visando alcançar melhores resultados.

INTRODUCTION: Consuming fresh, minimally processed foods and culinary preparations (CP), in detriment to ultra-processed foods (UPF), can improve the nutritional profile of the diet and reduce the risk of developing chronic non-communicable diseases (NCD). OBJECTIVE: Evaluating the evolution of nutrient and food consumption, according to the NOVA classification, after conducting a collective intervention to encourage the consumption of fruits and vegetables (FV) among users of the Health Academy Program (Programa Academia da Saúde - PAS) in Belo Horizonte, Minas Gerais. METHODS: Three articles were developed with data from a randomized controlled community trial (ECCR), conducted between 2013 and 2015, with a representative sample of the PAS units in Belo Horizonte, with 9 units belonging to the Control Group (CG) and 9 to the Intervention Group (IG). Individuals allocated to the CG participated in the routine activities of the health service (regular practice of physical exercise three times/week) and those in the IG additionally received, for seven months, an intervention to encourage the consumption of FV, based on the Transtheoretical Model and on the dialogical and problematizing pedagogy of Paulo Freire. Article 1: Cross-sectional study carried out with baseline data from the ECCR, which aimed to analyze the consumption of UPF according to sociodemographic factors, and its association with the nutritional profile of the diet. The nutritional profile of the diet was analyzed according to the quintiles of percentage contribution of energy from UPF through association and Linear Regression analyzes regarding total energy consumption, energy density, carbohydrates, fiber, proteins, total fat and fat subgroups: saturated, monounsaturated, polyunsaturated, trans, omega 3 and omega 6, vitamins A, B3, B6, B12, folate and C; and the minerals calcium, iron, phosphorus, magnesium, potassium and sodium. In addition, the percentage of inadequate consumption of nutrients recommended for the NCD prevention and the consumption of vitamins were evaluated by Poisson Regression. Article 2: ECCR which aimed to verify the effectiveness of collective intervention to encourage the consumption of FV on food consumption, according to the NOVA classification, among users of health promotion services in the Brazilian Primary Health Care (PHC). The outcomes analyzed were consumption of CP, processed foods (PF) and UPF through association and comparison analysis between CG and IG, and Generalized Estimating Equation (GEE) analysis. Article 3: ECCR which aimed to verify the effectiveness of a collective intervention to encourage the consumption of FV on the adequacy of nutrient intake for NCD prevention in health promotion service users of the Brazilian PHC. Association, comparison and GEE analyzes were also used between the GI and CG groups. The analyzed nutrients were total energy, carbohydrates, fiber, protein, total fat and fat subgroups: saturated, monounsaturated, polyunsaturated, trans, omega 3 and omega 6, vitamins A, B1, B2, B3, B6, B12, folate, C, D and E; and the minerals calcium, iron, phosphorus, magnesium, manganese, potassium, selenium, sodium and zinc. RESULTS - Article 1: The consumption of UPF contributed with 27.7% of the total energy of the diet. Its higher consumption was associated with higher values of energy intake, energy density, total fat and sodium; and smaller proteins, monounsaturated fats, omega 3 and some vitamins and minerals. The prevalence of inadequacy of nutrients for the NCD prevention ranged between 30% and 100% between the lowest and highest quintile of consumption of UPF. Article 2: After 12 months of follow-up, there was an increase in CP consumption and a reduction in UPF among individuals in the IG and CG; in addition to an increase in PF consumption among individuals in the CG. It was observed that the nutritional intervention contributed to a reduction in AP consumption for individuals allocated to the first quartile (RR: 0.861; CI: 0.749; 0.988) and an increase for those allocated to the second quartile of AP consumption (RR: 1,145; CI: 1,041; 1,259). A relationship was also observed between participation in the nutritional intervention and increased consumption of UPF for individuals in the third quartile of AUP consumption (RR: 1.062; CI: 1.005; 1.122). Article 3: Participants in the CG and IG groups, after 12 months, showed a reduction in the consumption of energy, omega 6 and sodium; and increased carbohydrates, fiber, vitamins A, B1, B2, B3, B6, B12, C, D and E, folate, calcium, magnesium, potassium, selenium, manganese, zinc and iron. Individuals from the CG showed an increase in phosphorus consumption; and those of the IG, reduction in the consumption of total, saturated and polyunsaturated fats; and increased monounsaturated. In both groups, there was an increase in the prevalence of nutrient adequacy for the NCD prevention, except for trans fats. Participation in nutritional intervention showed an inverse relationship with dietary energy (RR: 0,979; CI:0,960; 0,999) and protein intake (RR: 0,978; CI: 0,959; 0,997), but did not increase the chance of adequacy of nutrient intake for NCD prevention. CONCLUSION: The results pointed to the importance of the PAS, a health promotion service of the Unified Health System, for the promotion of adequate and healthy food, and NCD prevention. The conduction of collective intervention to encourage the consumption of FV showed few additional results, highlighting the need to carry out specific approaches related to the NOVA classification of foods in order to achieve better results.

Correlação entre o tempo de aceleração plantar, o índice tornozelo braquial e os escores SVS-WIfI em pacientes com isquemia crônica ameaçadora do membro / Plantar acceleration time correlates with WIfI stages in both non-diabetic and diabetic patients with chronic limb threatening ischemia

RESUMO Introdução: A avaliação hemodinâmica dos membros pelo índice tornozelo-braquial (ITB) em pacientes diabéticos com isquemia crônica ameaçadora dos membros pode estar falsamente elevada devido à calcinose da camada média das artérias. Alternativas como medidas de pressão do dedo do pé, pressão transcutânea de oxigênio (TCPO2) ou pletismografia não estão disponíveis na maioria das unidades vasculares no mundo. Uma nova abordagem diagnóstica por meio da análise espectral do fluxo ao Doppler na artéria plantar lateral do pé mostrou correlação com o grau de isquemia do membro e os estágios de risco de amputação do sistema de classificação (SVS-WIfI). Objetivo: Determinar a acurácia do Tempo de Aceleração Plantar (TAP) em relação ao Índice Tornozelo-Braquial (ITB) e os estágios de risco de amputação do sistema de classificação SVS-WIfI em pacientes com isquemia crônica ameaçadora do membro (Chronic Limb Threatening Ischemia-CLTI). Métodos: Estudo transversal realizado na Unidade de Cirurgia Vascular do Hospital Universitário Risoleta Tolentino Neves, Brasil, entre junho de 2019 e março de 2020, incluindo pacientes maiores de 18 anos, portadores de CLTI. Os dados coletados nos prontuários foram: dados demográficos, comorbidades, ITB e mensuração do TAP. Os indivíduos foram categorizados em três graus com base no ITB (ITB <0,8; ITB <0,6; ITB <0,4) e dois graus com base no risco de amputação (1-muito baixo e baixo; 2- moderado e alto), de acordo com a Classificação SVS-WIfI. A correlação do ITB e do risco de amputação com o TAP foi feita por meio da correlação de Spearman. Sensibilidade, especificidade, valor preditivo positivo, valor preditivo negativo e acurácia também foram calculados através das curvas ROC (Receiver Operator CharacCurves) Resultados: Cento e oitenta e quatro pacientes consecutivos (265 membros inferiores) foram encaminhados para exame de ultrassonografia vascular com Doppler do membro inferior. 141 pacientes (74 diabéticos e 67 não diabéticos), 198 membros inferiores (104 diabéticos e 94 não diabéticos) atenderam aos critérios e foram incluídos para análise. O TAP correlacionou-se significativamente com o ITB e o risco de amputação (P <0,001) em ambos os grupos. A acurácia do TAP para detectar ITB<0,8 foi de até 91% no grupo diabético e 85% no grupo não diabético. Da mesma forma, para o diagnóstico de ITB<0,6 em pacientes diabéticos, observamos uma acurácia de 79% e em não diabéticos essa acurácia foi de 85%. Para detectar um ITB inferior a 0,4, a acurácia atingiu 88% em pacientes diabéticos e 87% em não diabéticos. No grupo diabético e não diabético, a acurácia do PAT para detectar SVS de risco moderado e alto de amputação atingiu 77%. O TAP se correlacionou com precisão com o ITB e os escores SVS-WifI. Conclusões: O tempo de aceleração plantar demonstrou alta correlação com o ITB e os estágios de classificação de isquemia e risco de amputação do sistema de classificação SVS-WIfI com alta sensibilidade, especificidade e acurácia em pacientes com isquemia crônica com risco de membro.

ABSTRACT Introduction: Limb hemodynamic evaluation through ankle-brachial index (ABI) in diabetic patients with chronic limb threatening ischemia may be falsely elevated due to the calcinosis of the arteries media layer. Alternatives as toe pressure measurements, transcutaneous oxygen pressure (TCPO2) or plethysmography are not readily available in most of the vascular units in the world. A new diagnostic approach through Spectral Doppler analysis of the flow in the lateral plantar artery of the foot has shown correlation with the grade of the limb ischemia and amputation risk stages of the Wound, Ischemia, and foot Infection (WIfI) classification system and ABI. Objective: to determine the accuracy of Plantar Acceleration Time (TAP) compared to the Ankle-Brachial Index (ABI) and the amputation risk stages of the SVS-WIfI classification system in patients with chronic limb threatening ischemia (CLTI). Methods: a cross-sectional study at the Vascular Surgery Unit at the university Hospital Risoleta Tolentino Neves, in Brazil, between June 2019 and March 2020, included patients >18 years, with CLTI. Data collected from medical records were demographics, comorbidities, ABI and measurement of TAP. Individuals were categorized in three degrees based on their ABI (ABI < 0,8; ABI < 06; ABI <0,4) and two degrees based on their amputation risk (1-very low and low; 2- moderate and high), according to SVS-WIfI classification. The correlation of ABI and amputation risk with TAP was made through Spearman's correlation. Sensitivity, specificity, positive predictive value, negative predictive value and accuracy were also calculated using receiver operator characteristic (ROC) curves Results: A hundred eighty-four consecutive patients (265 lower limbs) were referred to the vascular imaging unit for an arterial lower limb vascular ultrasound examination. 141 patients (74 diabetic and 67 non-diabetic), 198 lower limbs (104 diabetic and 94 non-diabetic) met the criteria and were included for analysis. Plantar Acceleration Time correlated significantly with ABI and amputation risk (P < 0.001) in both groups. The accuracy of PAT to detect ABI<0.8 was up to 91% in diabetic group and 85% in non-diabetic group. Likewise, for diagnosing ABI <0.6 in diabetic patients, we observed an accuracy of 79% and in non-diabetics this accuracy was 85%. To detect an ABI lower than 0.4, the accuracy reached 88% in diabetic patients and 87% in non-diabetics. In the diabetic and non-diabetic group, the accuracy of PAT to detect moderate and high amputation risk WIfI SVS reached 77%. PAT accurately correlates with ABI and WIfI-SVS scores. Conclusions: Measurement of the Plantar Acceleration Time demonstrates high correlation with ABI and the Ischemia grading and amputation risk stages of the SVS-WIfI classification system with high sensitivity, specificity and accuracy in patients with chronic limb threatening ischemia.

An update on oral drug delivery

Orally administered drug entities have to survive the harsh gastrointestinal environment, penetrate the enteric epithelia and circumvent hepatic metabolism before reaching the systemic circulation. Whereas the gastrointestinal stability can be well maintained by taking proper measures, hepatic metabolism presents as a formidable barrier to drugs suffering from first-pass metabolism. The pharmaceutical academia and industries are seeking alternative pathways for drug transport to circumvent problems associated with the portal pathway. Intestinal lymphatic transport is emerging as a promising pathway to this end. In this review, we intend to provide an updated overview on the rationale, strategies, factors and applications involved in intestinal lymphatic transport. There are mainly two pathways for peroral lymphatic transport-the chylomicron and the microfold cell pathways. The underlying mechanisms are being unraveled gradually and nowadays witness increasing research input and applications.

Biopharmaceutical classification and transport mechanism of 4 alkaloids in Mongolian herbal medicine Sophorae Flavescentis Radix / 中国中药杂志

In this study, we studied the solubility and permeability of matrine, oxymatrine, sophoridine, and oxysophocarpine, four alkaloids in the Mongolian herbal medicine Sophorae Flavescentis Radix, and evaluated the absorption mechanism with the Caco-2 cell model, so as to provide a basis for the new drug development and efficacy evaluation of Sophorae Flavescentis Radix. The results showed that all the four alkaloids had high solubility and high permeability and can be well absorbed, belonging to the class-I drugs of Biopharmaceutical Classification System(BCS). The absorption(AP→BL) and excretion(BL→AP) of matrine and oxymatrine were not affected by the concentration while the absorption depended on P-gp protein. The absorption(AP→BL) and excretion(BL→AP) of sophoridine and oxysophocarpine were positively related to the concentration and time, and the absorption process was independent from P-gp protein. The results provide scientific reference and an experimental basis for the development of Mongolian medical prescriptions containing Sophorae Flavescentis Radix.

Classification of caesarean section based on Robson ten group classification system in our hospital

Background: Recent data indicate that one in five women undergo caesarean section (CS). In the last decade, there has been a dramatic increase in the caesarean section rate worldwide, which now exceeds 30% in some regions. Thus, the increasing rate of caesarean section became a matter of international public health concern. Our study aimed to classify the CS-based on Robson ten group classification system (RTGCS) criteria which will subsequently enable us to standardise the indication of CS and establish protocols to reduce the number of CS in our set up.Method: A retrospective study was conducted in ESI Hospital, New Delhi wherein Robson TGCS was used to classify CS for 15 months (January 2019 to April 2020).Results: Overall CS rate in our hospital over the specified period was 34.5%. All women with one or more previous cesareans (group V) had the maximum number of cesareans, 37%, followed by nulliparous, single, cephalic, term pregnancy (induced) i.e group II, 22.1% and nulliparous women more than 37 weeks in spontaneous labour (group I), 9.5%.Conclusions: RTGCS is easy to comprehend and reproduce. All deliveries and cesareans should be universally categorized by the Robsons TGCS. An attempt should be made to evaluate the group contributing most to the CS rate and interventions should be made accordingly.

Assessment of TerraClass and MapBiomas data on legend and map agreement for the Brazilian Amazon biome

Reliable environmental monitoring and evaluation require high-quality maps of land use and land cover. For the Amazon biome, the TerraClass and MapBiomas projects apply different methodologies to create these maps. We evaluated the agreement between land cover and land use maps generated by TerraClass and MapBiomas (Collections 2 and 3) for the Brazilian Amazon biome, from 2004 to 2014. Specifically, we: (1) described both project legends based on the LCCS (Land Cover Classification System); (2) analyzed the differences between their classes; and (3) compared the mapping differences among the Brazilian states that are totally or partially covered by the Amazon biome. We compared the classifications with a per-pixel approach and performed an evaluation based on agreement matrices. The overall agreement between the projects was 87.4% (TerraClass x MapBiomas 2) and 92.0% (TerraClass x MapBiomas 3). We analyzed methodological differences to explain the disagreements in class identification. We conclude that using these maps together without a properly adapted legend is not recommended for the analysis of land use and land cover change. Depending on the application, one mapping system may be more suitable than the other. (AU)

Materiales didácticos para enseñar a resumir y clasificar en Bibliotecología / Educational materials to teach to summarize and classify in Library Science

RESUMEN Artículo científico que busca identificar la percepción de estudiantes de bibliotecología con respecto a la utilidad de la aplicación de materiales didácticos en la elaboración de resúmenes y clasificación documental. Se evidencia la falta de generación de material didáctico para la enseñanza práctica de la bibliotecología. Para lograr el objetivo, se realiza una investigación descriptiva con enfoque cuantitativo, en la que se aplicó un cuestionario a 24 estudiantes de la Escuela de Bibliotecología y Ciencias de la Información de la Universidad de Costa Rica, en los cursos de Indización y Clasificación, durante el año 2018. Los resultados evidencian que los materiales didácticos elaborados sí fueron percibidos como útiles por el estudiantado, la estructura para resúmenes le facilitó su elaboración al 70,8% del estudiantado; no obstante éstos recomiendan que se brinde una estructura más flexible que permita adaptarla a diferentes tipos de documentos y de resumen. Además, la aplicación del Código Junior en Colores le facilitó la comprensión del proceso de clasificación documental al 91,7%. Por su parte, la aplicación de la estructura de tablas le facilitó la realización del proceso de clasificación documental al 87,5% del estudiantado. Se recomienda utilizar los materiales didácticos para resumir y clasificar sólo al inicio del proceso, mientras se adquieren las bases prácticas.

ABSTRACT Article that seeks to identify the perception of library science students, regarding the usefulness of the application of teaching materials in the elaboration of summaries and classification documentaries. The lack of generation of teaching material for the practical teaching of library science is evident. To achieve the goal, a descriptive investigation with quantitative approach is carried out, in which a questionnaire was applied to 24 students of the School of Library and Information Sciences of the University of Costa Rica, enrolled in the Indexing and Classification courses during the year 2018. The results show that the teaching materials were perceived as useful by the students, the structure for abstracts facilitated its preparation to 70,8% of the students; however, they recommend that a more flexible structure be provided to adapt it to different types of documents and summaries. In addition, the application of the "Junior Color Code" provided 91,7% of students with an understanding of the document classification process. The application of the table structure facilitated the application of the document classification process to 87,5% of the students. It is recommended to use the teaching resources to summarize and classify only at the beginning of the process, while the practical bases are acquired.