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1.
Ciênc. Saúde Colet. (Impr.) ; 29(2): e19792022, 2024. tab
Article in Portuguese | LILACS-Express | LILACS | ID: biblio-1528365

ABSTRACT

Resumo Este estudo objetivou identificar padrões alimentares e avaliar a associação entre percepção da imagem corporal e esses padrões em escolares. Um estudo transversal foi conduzido em 385 escolares (ambos os sexos, 10-17 anos de idade) de 4 escolas públicas de Salvador, Brasil. Dois recordatórios alimentares de 24h não consecutivos foram aplicados e o padrão alimentar foi determinado por Análise Fatorial Exploratória, após ajuste dos dados dietéticos pelo Multiple Source Method. Para avaliar percepção da imagem corporal, nós usamos uma escala brasileira de silhuetas. Avaliamos as associações entre percepção da imagem corporal e padrões alimentares usando o modelo de regressão logística politômica ajustado para covariáveis. Três padrões alimentares foram obtidos: "padrão ocidental", "padrão saudável" e "comidas típicas/junk food". Após ajuste, adolescentes que desejavam uma silhueta menor (2,48 [IC95%: 1,04-6,11], 3,49 [IC95%: 1,35-9,05] e 2,87 [IC95%: 1,13-7,26]) tinham mais chances de aderir aos quintis de menor consumo do padrão ocidental, comparados àqueles satisfeitos com sua imagem corporal. Nenhuma associação foi identificada nos outros dois padrões alimentares. Adolescentes insatisfeitos com seus corpos tendem a aderir menos a padrões alimentares não saudáveis.


Abstract This study aimed to identify dietary patterns and to evaluate the association between body image perception and these patterns among schoolchildren. A cross-sectional study was conducted on 385 schoolchildren (both sexes, 10-17 years old) from four public schools in Salvador, Brazil. Two non-consecutive 24-hour dietary recalls were applied, and the dietary pattern was determined by Exploratory Factor Analysis after adjustment of dietary data using the Multiple Source Method. To evaluate body image perception, the Brazilian body shape silhouette was used. The associations between body image perception and dietary patterns using the polytomous logistic regression model adjusted for covariables was assessed. Three dietary patterns were obtained: "Western standard," unhealthy, "healthy pattern" and "typical dishes/ junk food." After adjustment, adolescents who wished for a slimmer silhouette (2.48 [95%CI: 1.04-6.11], 3.49 [95%CI: 1.35-9.05] and 2.87 [95%CI: 1.13-7.26]) were more likely to adhere to the quintiles with the lowest consumption of the Western standard, compared to those satisfied with their body image. No associations were identified in the other two dietary patterns. Adolescents dissatisfied with their bodies tend to adhere less to unhealthy dietary patterns.

2.
Journal of Environmental and Occupational Medicine ; (12): 83-88, 2024.
Article in Chinese | WPRIM | ID: wpr-1006461

ABSTRACT

Background At present, China's Public places health management regulations list 7 categories and 28 sub-categories of public places, but infant and young child swimming places are not in the list yet. Objective To understand the microbial pollution status in commercial infant and young child swimming places in Shijiazhuang City, compare with the microbial pollution in other five types of public places, and find the potential safety hazards in infant and young child swimming places. Methods A total of 3438 microbial samples were collected from the environment of infant and young child swimming places and 5 types of public places (hotels, barber stores, waiting rooms, shopping malls and supermarkets, and conventional swimming places) in Shijiazhuang City from 2021 to 2022. Sampling and monitoring were carried out according to the requirements of Examination methods for public places—Part 6: Technical specifications of health monitoring (GB/T 18204.6-2013). Chi-square test was used to compare hygiene qualification by microbial indicators, and Kruskal-Wallis H test was used to compare overall distributions of total bacterial counts on the surface of public articles. Results From 2021 to 2022, the highest qualified rate of microbial indicators on the surface of public articles was Staphylococcus aureus (100%) for all tested public places in Shijiazhuang City, followed by coliforms (99.44%), and that of total bacterial count was relative low (92.83%). The qualified rate of total bacterial count on the surface of public articles in the swimming places for infants and young children was 87.76%, and the qualified rates in hotels, barber stores, waiting rooms, shopping malls and supermarkets were all above 92%, and the difference among the 5 types of places was statistically significant (P<0.001). The highest value of total bacterial count on the surface of public articles in the swimming places for infants and young children was 80000 CFU·(25 cm2)−1 [100 CFU·(25 cm2)−1=4 CFU·cm−2]; that in 4 types of public places such as hotels (except mouthwash cups), barber stores, waiting rooms, and shopping malls or supermarkets was 2500 CFU·(25 cm2)−1. The difference of total bacteria count on the surface of public articles was statistically significant in comparing infant and young child swimming places with hotels (except mouthwash cups) or barber stores (H=5.432, H=2.997, both Ps<0.05); but the difference was not significant in comparing with waiting rooms and shopping malls or supermarkets (P>0.05). The qualified rates of total bacteria count and coliforms in pool water of infant and young child swimming places were 45.99% and 74.69% respectively, and the two indicators in pool water of conventional swimming places were 94.57% and 98.91% respectively; both showed significant differences between the two types of public places (χ2=162.532, χ2=71.910, both Ps<0.001). Conclusion Compared to conventional swimming places, hotels, barber stores, waiting rooms, and shopping malls or supermarkets, the infant and young child swimming places are not optimistic in hygiene condition; therefore, there is an urgent need to formulate national health standards for infants and young child swimming places, and include them in standard management to further improve their hygiene condition.

3.
Rev. cuba. inform. méd ; 15(2)dic. 2023.
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1536290

ABSTRACT

Introducción: Las aplicaciones informáticas en la práctica médica han permitido el desarrollo de novedosas formas de comunicación en la atención del Sistema de Salud. La estandarización representa un elemento necesario para la sostenibilidad y escalabilidad del software desarrollado. En sistemas para la salud existen diversas aplicaciones del estándar HL7. Objetivo: Realizar una Revisión Sistemática de la Literatura (RSL) sobre el estándar de interoperabilidad HL7. Materiales y métodos: Para la definición y ejecución del presente estudio se empleó la propuesta metodológica establecida por Petersen la cual plantea cinco pasos secuenciales: definición de las preguntas de investigación; definición de los criterios de búsqueda; definición de los criterios de selección de estudios primarios; determinación del esquema de clasificación; y extracción de datos y mapeo de estudios. Resultados: Se obtuvieron como resultado preliminar 428 569 entradas posibles. Aplicando el primer filtro de inclusión y exclusión sobre el título, resumen y palabras clave, quedaron 864 documentos, de los cuales solo 276 cumplieron con haber sido publicados en el período que se analiza (2017-2022). De ellos sólo 72 permitían acceso completo a la documentación y al ser analizados se descartan 51 por no ofrecer información acorde al tema de investigación. Resultaron un total de 21 artículos para un análisis a mayor profundidad. Conclusiones: A partir de la revisión sistemática se pudo constatar que en la optimización de los procesos comunicativos es preciso el uso de estándares que armonicen el intercambio de información y provean un lenguaje común para todos los agentes involucrados.


Introduction: Computer applications in medical practice have allowed the development of novel forms of communication in the Health Care System. Standardization represents a necessary element for the sustainability and scalability of the developed software. In health systems there are various applications of the HL7 standard. Objective: To perform a Systematic Review of Literature (RSL) on the HL7 interoperability standard. Methods: The methodological proposal established by Petersen, which proposes five sequential steps such as: definition of research questions, definition of search criteria, definition of the selection criteria of primary studies, determination of the classification scheme, and data extraction and mapping study, was used for the definition and implementation of this study. Results: A total of 428,569 possible entries were obtained as a preliminary result. Applying the first inclusion and exclusion filter on the title, abstract and keywords, 864 documents remained, of which only 276 complied with having been published in the period under analysis (2017-2022). Only 72 of them allowed full access to the documentation and when analyzed, 51 were excluded for not offering information according to the research topic. A total of 21 articles were selected for further analysis. Conclusions: Based on the systematic review, it was possible to verify that in the optimization of communication processes, standards must be used to harmonize the exchange of information and provide a common language for all the agents involved.

4.
Article | IMSEAR | ID: sea-220802

ABSTRACT

Experiment comprised of twenty six female type parents and seven restorer parents of pearl millet and their 182 hybrids was conducted at two locations viz., ICRISAT, Patancheru (Latitude 17.52° N; Longitude 78.26° E and Altitude 522 m) and research farm of Super seeds Pvt Ltd., Hisar (Latitude 29.15° N; Longitude 75.72° E and Altitude 215 m) during rainy 2018, for studying the extent of hybrid vigour in F1 for grain yield and its components. For days to 50% owering, top cross hybrid MBL-5 X MOPT-31 (-13.37**) showed highest signicant and positive heterosis over check 86M86. The top cross hybrid MBL-17 X MOPT-33 (45.21**) highest, signicant standard heterosis in positive direction over check 86M86 for panicle length (cm). The single cross hybrid MBL-3 X MIT-29 (14.12*) exhibited signicant and positive standard heterosis over 86M86 for panicle girth (cm). for productive tillers, single cross hybrid MBL-8 X MIT-28 (98.34**) showed highest signicant positive standard heterosis over check 86M86 and the single cross hybrid MBL-24 X MIT-28 (18.42) showed positive standard heterosis over check 86M86

5.
ARS med. (Santiago, En línea) ; 48(1): 15-22, 28 mar. 2023.
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1451903

ABSTRACT

Antecedentes: el envejecimiento de la población chilena y la transición epidemiológica que atraviesa el país, ha incrementado la necesidad de formar, entre otros especialistas, a médicos geriatras. Objetivo: estimar la brecha de geriatras en Chile de acuerdo con necesidades epidemiológicas de la población de 65 años y más. Método: se realizó una estimación de brecha de horas de geriatra para la red de salud, a partir de una consulta a 57 geriatras de laboralmente activos de un total de 156 geriatras registrados a enero del 2021. En dicha consulta se indagó sobre tiempo de duración de consulta y frecuencia de consultas ideales de acuerdo con la capacidad funcional de las personas mayores a nivel nacional y por región obtenida de la encuesta Casen 2017. Resultados: a febrero del 2022 existe un total de 162 geriatras en Chile, cifra que equivale a un geriatra por cada 15.806 personas de 65 años y más. De acuerdo con la estimación realizada, se requeriría en Chile, un total de 1.244.689 horas de geriatra anual, equivalentes a la existencia de 589 geriatras a nivel nacional. Conclusión: según los resultados del estudio, a nivel nacional se necesitarían de un total de 589 geriatras para cubrir las necesidades de atención de las personas mayores con algún nivel de dependencia. De acuerdo con estas cifras, al primer trimestre del 2022 el país presentaría una brecha de 427 geriatras. Ante lo elevada de esta brecha, se cree necesario avanzar en estrategias de formación general en geriatría y gerontología en los equipos de salud y socio-sanitarios.


Background:The ageing between the Chilean population and the epidemiological transition that the country is going through has increased the need to train, among other specialists, geriatric doctors.Objective: To estimate the gap between geriatricians in Chile according to the epidemiological needs of the population aged 65 years and over. Method:An estimate of the gap in geriatrician hours was made for the health network based on a consultation of 57 active geriatricians out of 156 registered as of January 2021. In this consultation, the duration and frequency of ideal consultations were inquired according to the functional capacity of the elderly at the national level and by region obtained from the Casen 2017 survey.Results: as of February 2022, there are 162 geriatricians in Chile, equivalent to one geriatrician for every 15,806 people aged 65 years and over. According to the estimate, a total of 1,244,689 hours of annual geriatrician would be required in Chile, equivalent to 589 geriatricians nationwide. Conclusion:According to the study's results, at the national level, a total of 589 geriatricians would be needed to cover the care needs of older people with some level of dependen-ce. According to these figures, in the first quarter of 2022, the country would present a gap of 427 geriatricians. Given the highness of this gap, it is believed necessary to advance general training strategies in geriatrics and gerontology in health and socio-health teams

6.
Article in Spanish | LILACS | ID: biblio-1433746

ABSTRACT

La prueba de latencia múltiple del sueño nos permite evaluar objetivamente las variaciones normales y patológicas en la somnolencia y el estado de alerta. Es una prueba que evalúa qué tan rápido una persona se duerme en condiciones estandarizadas que facilitan el sueño, y se repite a intervalos de 2 horas durante todo el día. Es el estándar para documentar el inicio del sueño REM (SOREMP), que es un síntoma de narcolepsia y en la somnolencia idiopática podría ser útil. Su uso está ampliamente descrito en adultos, pero la prueba no es tan común en niños. En esta revisión, se analizan los valores en adultos y niños, y su utilidad, a partir de la historia de la prueba.


The multiple sleep latency test allows us to objectively assess normal and pathological variations in sleepiness and alertness. It is a test that assesses how quickly a person falls asleep under standardized conditions that facilitate sleep and is repeated at 2-h intervals throughout the day. is the standard for documenting sleep onset REM (SOREMP), which is a symptom of Narcolepsy and idiopathic sleepiness could be useful. Its use is widely described in adults, but the test is not so common in children. In this review, we analyze the values in adults and children, and their usefulness, based on from the history of the test.


Subject(s)
Humans , Male , Female , Child , Adolescent , Sleep Latency/physiology , Sleepiness , Narcolepsy/physiopathology
7.
Article | IMSEAR | ID: sea-221340

ABSTRACT

Its start a decade ago, pharmacovigilance (PV) experienced tremendous development. There have been significant attempts in recent years to transform the current pharmacovigilance systems to meet future expectations. Adverse drug reactions (ADRs) are increasing in frequency, severity, and complexity as novel medication therapies are coming to market more quickly as a result of better laws and regulations. India is the second most popular nation in the world, with around 1 billion active and prospective consumers of pharmaceuticals. Despite being a member of the Uppsala Monitoring Centre, our nation has almost little commitment to the database. This problem is brought on by the inadequate ADR (adverse drug reaction) monitoring system and lack of knowledge among pharmacy associates and medical professionals. The primary objectives of the PV program are patient care, patient safety, and monitoring of negative medication reactions. There is a need for additional clinical preliminary exams and clinical assessments in India to accurately practice PV. A fully functional PV system is essential for the safe and responsible administration of medicines. This review gives a systematic review of pharmacovigilance in India from its origin to its current scenario and also discusses the various strategies and proposals to build, maintain and implement a robust pharmacovigilance system for India in coming years.

8.
Arq. neuropsiquiatr ; 81(1): 81-94, Jan. 2023. tab
Article in English | LILACS-Express | LILACS | ID: biblio-1429889

ABSTRACT

Abstract In the last few decades, there have been considerable improvements in the diagnosis and care of Duchenne muscular dystrophy (DMD), the most common childhood muscular dystrophy. International guidelines have been published and recently reviewed. A group of Brazilian experts has developed a standard of care based on a literature review with evidence-based graded recommendations in a two-part publication. Implementing best practice management has helped change the natural history of this chronic progressive disorder, in which the life expectancy for children of the male sex in the past used to be very limited. Since the previous publication, diagnosis, steroid treatment, rehabilitation, and systemic care have gained more significant insights with new original work in certain fields. Furthermore, the development of new drugs is ongoing, and some interventions have been approved for use in certain countries. Therefore, we have identified the need to review the previous care recommendations for Brazilian patients with DMD. Our objective was to create an evidence-based document that is an update on our previous consensus on those topics.


Resumo Nas últimas décadas, houve progressos significativos no diagnóstico e no tratamento da distrofia muscular de Duchenne (DMD), considerada a distrofia muscular mais comum na infância. Diretrizes internacionais foram publicadas e revisadas recentemente. Um grupo de especialistas brasileiros desenvolveu um padrão de atendimento baseado em revisão de literatura, com recomendações graduadas pautadas em evidências compiladas em uma publicação dividida em duas partes. A implementação de melhores práticas de manejo ajudou a modificar a história natural desta doença crônica, progressiva, que, no passado, oferecia uma expectativa de vida muito limitada para crianças do sexo masculino. Desde a publicação desse consenso anterior, o diagnóstico, o tratamento com esteroides, a reabilitação e os cuidados sistêmicos ganharam novas possibilidades a partir da divulgação dos resultados de trabalhos originais em algumas dessas áreas. Além disso, as pesquisas e o desenvolvimento de novos fármacos estão em andamento, e algumas intervenções já foram aprovadas para uso em determinados países. Nesse contexto, identificamos a necessidade de rever as recomendações anteriores sobre o manejo dos pacientes brasileiros com DMD. Nosso objetivo principal foi elaborar uma atualização baseada em evidências sobre esses tópicos do consenso.

9.
Chinese Journal of Radiological Medicine and Protection ; (12): 620-626, 2023.
Article in Chinese | WPRIM | ID: wpr-993134

ABSTRACT

Objective:To investigate the application of diagnostic criteria for common occupational radiation-induced diseases to radiation workers, in order to provide a basis for the revision, publicity and standardization of the standards.Methods:Radiation workers were selected from 1 city, 7 provinces and 1 corporation by using cluster random sampling method from January 2021 to May 2021. Awareness of the criteria and the effects of ionizing radiation, and the suggestions for diagnostic works were investigated and analyzed.Results:A total of 2 839 radiation workers were investigated. There were differences in the awareness of different diagnostic criteria, the inclusions in complex diagnostic criteria, the materials required for applying for diagnosis, and the ways of knowing the diagnostic criteria( χ2=416.06, 2 924.14, 83.45, 895.67, 815.94, P<0.001). The correct understanding rates of deterministic effects and stochastic effects were 80.63% and 43.64%, respectively. The acceptance rates in applicable materials were 96.79% for occupational exposure history, 94.72% for occupational health monitoring records and 93.55% for individual monitoring of occupational exposure, respectively. Pre-employment training rate was 80.20%, on-job training rate was 81.19%, and untrained rate was 3.77%. The suggestions to the diagnosis of occupational radiation-induced diseases are to strengthen training, pay attention to individual monitoring, occupational health examination, and strengthen health supervision and law enforcement. Conclusions:Radiation workers have a low awareness rate of certain diagnostic standards and a high awareness rate of diagnostic procedures. Publicity and training of health effects of ionizing radiation and diagnostic criteria of occupational radiation-induced diseases should be strengthened. Diagnostic procedure should be optimized.

10.
Chinese Journal of Radiological Medicine and Protection ; (12): 222-227, 2023.
Article in Chinese | WPRIM | ID: wpr-993077

ABSTRACT

There are differences and inconsistencies to some degree in the radioactive contamination control level of personnel′s body surface availiable in many national standards, thus puzzling the users. Therefore, it is proposed to compare the applicable scope, conditions and differences between relevant national standards, and combine with similar clinical nuclear medicine standards of radiological protection content to presevent recommendations on the contamination control level that should be correctly applied in an event of nuclear and radiological emergency. Based on the discussion of similar standards, the contaminated personnel with α of 0.04-10 Bq/cm 2 and β of 0.4-100 Bq/cm 2 are advised to be treated in the institutions with higher than secondary medical insititution. Both α econtamination control levels less than 0.04 Bq/cm 2 and β levels less than 0.4 Bq/cm 2 could be achivable, if fully decontaminated.

11.
Chinese Journal of Endemiology ; (12): 363-368, 2023.
Article in Chinese | WPRIM | ID: wpr-991637

ABSTRACT

Objective:To construct a follow-up evaluation index system for "Diagnosis of Brucellosis" (WS 269-2019), and provide a reference basis for the next revision and improvement of the standard.Methods:The evaluation index system for "Diagnosis of Brucellosis" (WS 269-2019) was preliminarily established by consulting relevant references and materials. The experts in the field of diagnosis, treatment, prevention and control of brucellosis were selected, and two rounds of expert consultation were carried out in the form of questionnaires using the Delphi method. The necessity and availability of evaluation indicators were scored, and suggestions for modifying and adding indicators were put forward. Based on this, a standard follow-up evaluation index system was established. At the same time, a judgment matrix was constructed combined with the Saaty scale, and the analytic hierarchy process was used to calculate the weight of each index in the system.Results:After 2 rounds of expert ( n = 10) consultation, a standard follow-up evaluation index system for "Diagnosis of Brucellosis" (WS 269-2019) was constructed with 3 first-level indexes, 8 second-level indexes and 21 third-level indexes. The positive coefficients of experts in 2 rounds of questionnaires were both 100%; the coefficient of authority of experts was 0.82; the Kendall's coefficients of concordance of first-level, second-level and third-level indexes were 0.722, 0.260, and 0.181, respectively, with P < 0.05. Among the first-level indexes, the weight of standard quality evaluation was the highest (0.364), and the weight of standard implementation status was the lowest (0.278); among the second-level indexes, the combined weight of social benefits was the highest (0.186), and the combined weight of advanced nature was the lowest (0.043); among the third-level indexes, the combined weight of timely diagnosis rate was the highest (0.096), and the combined weight of consistency with technical data was the lowest (0.009). Conclusions:The constructed follow-up evaluation index system for "Diagnosis of Brucellosis" (WS 269-2019) is scientific and reliable, which evaluated qualitatively and quantitatively, reduces the defects of a single evaluation, and provides a basis for subsequent revision and improvement of the standard.

12.
Chinese Journal of Medical Education Research ; (12): 91-94, 2023.
Article in Chinese | WPRIM | ID: wpr-991259

ABSTRACT

Objective:To study the teaching effect of the teaching method of case-based learning (CBL) combined with team-based learning (TBL) based on the standard patient (SP) in the clinical teaching of department of intensive care medicine.Methods:A total of 60 medical students clinically studying in the department of intensive care medicine were randomly divided into 2 groups, with 30 students in each group. The two groups received the clinical teaching through the lecture-based learning (LBL) teaching method and the CBL combined with TBL based on SP teaching method respectively. By evaluating the clinical synthesis ability of the students of two groups and the satisfaction survey of the two teaching methods, the teaching effect was evaluated. SPSS 19.0 statistical software was used to perform Chi-square test and t-test. Results:Compared with LBL teaching method, the students who accepted the CBL combined with TBL based on SP teaching method had significantly better clinical comprehensive ability ( P < 0.05), mainly in their clinical thinking ability [(4.18±0.55) vs. (3.66±0.47)], clinical skills [(4.03±0.61) vs. (3.59±0.52)] and communication ability with patients [(4.11±0.58) vs. (3.74±0.50)]. In addition, student satisfaction with teaching methods was also higher ( P <0.05), especially in the satisfaction of learning interest [(4.38 ± 0.72) vs. (3.65±0.56)], self-learning ability [(4.24±0.71) vs. (3.91±0.52)], clinical thinking ability [(4.09±0.66) vs. (3.22±0.54)], communication ability [(4.42±0.60) vs. (3.67±0.48)], and team cooperation spirit [(4.15±0.58) vs. (3.78±0.51)]. Conclusion:The teaching method of CBL combined with TBL based on SP is feasible and has good teaching effect in the clinical teaching of department of intensive care medicine.

13.
Journal of Pharmaceutical Analysis ; (6): 142-155, 2023.
Article in Chinese | WPRIM | ID: wpr-991131

ABSTRACT

Complex systems exist widely,including medicines from natural products,functional foods,and bio-logical samples.The biological activity of complex systems is often the result of the synergistic effect of multiple components.In the quality evaluation of complex samples,multicomponent quantitative analysis(MCQA)is usually needed.To overcome the difficulty in obtaining standard products,scholars have proposed achieving MCQA through the"single standard to determine multiple components(SSDMC)"approach.This method has been used in the determination of multicomponent content in natural source drugs and the analysis of impurities in chemical drugs and has been included in the Chinese Pharmacopoeia.Depending on a convenient(ultra)high-performance liquid chromatography method,how can the repeatability and robustness of the MCQA method be improved?How can the chromatography conditions be optimized to improve the number of quantitative components?How can computer software technology be introduced to improve the efficiency of multicomponent analysis(MCA)?These are the key problems that remain to be solved in practical MCQA.First,this review article summarizes the calculation methods of relative correction factors in the SSDMC approach in the past five years,as well as the method robustness and accuracy evaluation.Second,it also summarizes methods to improve peak capacity and quantitative accuracy in MCA,including column selection and two-dimensional chromatographic analysis technology.Finally,computer software technologies for predict-ing chromatographic conditions and analytical parameters are introduced,which provides an idea for intelligent method development in MCA.This paper aims to provide methodological ideas for the improvement of complex system analysis,especially MCQA.

14.
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery ; (12): 299-304, 2023.
Article in Chinese | WPRIM | ID: wpr-979480

ABSTRACT

@#The number of investigator initiated research (IIR) is increasing. But the recognition and management of IIR in China is still in its infancy, and there is a lack of specific and operable guidance for the implementation process. Based on our practical experiences, previous literature reports, and current policy regulations, the authors took prospective IIR as an example to summarize the implementation process of IIR into 14 steps, which are as the following: study initiation, ethical review, study registration, study filing, case report form design, database establishment, standard operating procedure making, investigator training, informed consent, data collection, data entry, data verification, data locking and data archiving.

15.
Chinese Journal of Schistosomiasis Control ; (6): 279-281, 2023.
Article in Chinese | WPRIM | ID: wpr-978516

ABSTRACT

Detection and identification standard of hookworm—Hookworm larvae coproculture techniques (WS/T 791—2021) is the first recommended technical standard for hookworm detection and species identification using the hookworm larvae coproculture technique in China. This standard was issued on November 23, 2021, and had been in effect since May 1, 2022. This article provides a detailed interpretation pertaining to the background, drafting process, main contents, and dos and don’ts for better understanding and application of this standard among professionals working in disease control and prevention institutions and medical institutions.

16.
Journal of Pharmaceutical Practice ; (6): 428-432, 2023.
Article in Chinese | WPRIM | ID: wpr-978482

ABSTRACT

Objective To establish the Good Agricultural Practice(GAP)for standard operation procedure of Shanghai Pheretima. Methods According to the comprehensive technical requirements of GAP standardized production of Chinese herbal medicine, the key technologies of standardized cultivation and processing were studied in Sangxin Town, Chongming District, Shanghai. Results The production area environment, variety characteristics, breeding technology, pest control, harvesting and processing, packaging, storage and transportation, quality monitoring and other technical links of Shanghai Pheretima were clearly defined and standardized. Conclusion This study provides practical basis for the standardization and modernization quality management of Shanghai Pheretima.

17.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 152-157, 2023.
Article in Chinese | WPRIM | ID: wpr-976550

ABSTRACT

High quality is the premise for the implementation of high quality and good price for decoction pieces, and grade is the most direct manifestation of high quality of decoction pieces. However, there is still a lack of scientific and reasonable methods for evaluating the grade of decoction pieces, and it is urgent to establish a widely recognized and unified standard for the grade of decoction pieces to ensure the quality of the decoction pieces and guarantee the safety and efficacy of clinical use. Based on this, this paper focused on analyzing the problems of the current grade evaluation methods, such as unclear distinction between quality standards and grade standards, unreasonable selection of grade evaluation indicators, and inaccurate application of mathematical statistical methods. Based on the analysis of the grade evaluation of decoction pieces, this paper proposed four criteria for establishing the grade evaluation method of decoction pieces, namely universality, comprehensiveness, reliability and convenience, in order to establish a more reasonable and unified grade standard for decoction pieces and promote the quality improvement of decoction pieces and the development of the industry.

18.
Chinese Journal of Biologicals ; (12): 429-2023.
Article in Chinese | WPRIM | ID: wpr-976173

ABSTRACT

@#ObjectiveTo develop a national standard for genomic titer determination of recombinant type 5 adeno-associated virus(rAAV5).MethodsThe rAAV5-GFP stock solution prepared by the three-plasmid system was identified and verified for the appearance,pH,sterility,genomic titer,purity and infection titer according to the relevant requirements of Chinese Pharmacopoeia(Volume Ⅲ,2020 edition),which was diluted and subpackaged to prepare candidate standards according to the results;The stability of candidate standards was investigated by thermal acceleration test;Three laboratories were organized to collaboratively calibrate the candidate standards using droplet digital PCR(ddPCR).ResultsAll the detection indexes of the candidate standard and the stock solution met the relevant requirements;The genomic titer showed no significant decrease at 25,4,-20,-40,-80 ℃ for 1,3,4,6 months;Through collaborative calibration by three laboratories,the candidate standard was assigned a value of 2. 56 × 10(12)copies/mL,and the 95% confidence interval was 2. 48 ×10(12)copies/mL,and the 95% confidence interval was 2. 48 ×10(12)copies/mL ~ 2. 64 × 10(12)copies/mL ~ 2. 64 × 10(12)copies/mL.ConclusionThe developed national standard for the determination of rAAV5 genomic titer had good stability and might be used for the quality evaluation of rAAV5 related products.

19.
Chinese Journal of Biologicals ; (12): 419-2023.
Article in Chinese | WPRIM | ID: wpr-976171

ABSTRACT

@#ObjectiveTo establish the national reference panel for coxsackievirus A16(CA16)nucleic acid detection kit and related quality standard.MethodsThe CA16 positive and negative samples were collected and screened,and then were filled and lyophilized to establish the national reference panel for CA16 nucleic acid detection kit. According to the cooperative calibration results of various reagent manufacturers,the quality standard of reference panel was determined.Meanwhile,the homogeneity and stability of the national reference panel were well studied.ResultsThe national reference panel of CA16 nucleic acid detection kit consisted of 9 positive samples,8 negative samples,1 limit-detecting sample and1 precision sample. The quality standard was as follows:the coincidence rate of positive samples was no less than 8/9;The coincidence rate of negative samples was 8/8;The minimum detection limit required that the dilution of limit-detecting sample was no less than 1∶103;The precision required that the coefficient of variation(CV)of Ct value of 10 precision samples diluted 100 times was no higher than 5% and the results were all positive. The homogeneity of the reference panel met the requirement,and the stability was not affected by the storage at room temperature(25 ℃)for 24 hours and repeated freezing and thawing three times.ConclusionThe first national reference panel of CA16 nucleic acid detection kit and the related quality standard have been established,which provided a reference for the quality control and evaluation of the related reagents.

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Chinese Journal of Experimental Traditional Medical Formulae ; (24): 122-129, 2023.
Article in Chinese | WPRIM | ID: wpr-973753

ABSTRACT

ObjectiveTo establish the quality standard for Fraxini Cortex(Fraxinus chinensis) dispensing granules based on standard decoction, and to provide a basis for the quality control of this dispensing granules. MethodHigh performance liquid chromatography(HPLC) specific chromatograms of 15 batches of Fraxini Cortex(F. chinensis) standard decoctions and 3 batches of Fraxini Cortex(F. chinensis) dispensing granules were established with the mobile phase of 0.1% phosphoric acid aqueous solution(A)-acetonitrile(B) for gradient elution(0-10 min, 12%-15%B; 10-30 min, 15%-32%B) and the detection wavelength of 220 nm. And similarity evaluation, cluster analysis and principal component analysis(PCA) were also carried out. HPLC quantitative analysis of multi-components by single marker(QAMS) was established to determine the contents of the main components in the standard decoctions and dispensing granules. The contents of the corresponding components in Fraxini Cortex(F. chinensis) decoction pieces were also detected, and the transfer rates from decoction pieces to standard decoctions and dispensing granules were calculated. ResultThe similarities between specific chromatograms of 15 batches of Fraxini Cortex(F. chinensis) standard decoctions and 3 batches of Fraxini Cortex(F. chinensis) dispensing granules were all>0.9, and 7 common peaks were identified. The results of cluster analysis and PCA showed that there was some differences in the composition of different batches of standard decoctions, but did not show aggregation of origin. As the standard decoctions, the extract rate was 6.18%-11.62%, the contents of esculin, syringin, fraxin, esculetin, fraxetin, calceolarioside B were 44.92-103.51, 1.36-11.87, 33.26-90.73, 4.63-29.75, 2.40-16.86, 2.49-17.35 mg·g-1, and the transfer rates from decoction pieces to standard decoction were 25.21%-42.54%, 52.57%-88.84%, 43.43%-79.45%, 49.15%-88.27%, 49.22%-72.69%, 27.66%-47.67%, respectively. The extract rates of Fraxini Cortex(F. chinensis) dispensing granules were 10.4%-10.7%, the transfer rates of the above six components from decoction pieces to dispensing granules were 42.76%-43.17%, 80.01%-80.90%, 59.59%-59.88%, 51.35%-52.67%, 60.50%-60.93%, 37.98%-38.37%, respectively, which were generally consistent with the transfer rates from decoction pieces to standard decoctions. ConclusionThe established quality control standard of Fraxini Cortex(F. chinensis) dispensing granules based on standard decoctions is reasonable and reliable, which can provide reference for the quality control and process research of this dispensing granules.

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