Interpretation and reflection on the Measures for the Administration of Standards for Medicinal Products / 中国药房

In July 2023， the National Medical Products Administration issued the Measures for the Administration of Standards for Medicinal Products （hereinafter referred to as the Measures）. This article interprets the main content of the Measures， and analyzes its shortcomings as unclear definition of the drug standard code and the goals of drug standard information construction. It is recommended that the national drug regulatory department promptly apply to the standardization authority for the confirmation of the drug standard code “YB” letter， and the drug standard code and numbering rules would be included in the next round of amendments to the Measures. It is necessary to clarify the construction goals of the information system for drug standards at the same time， and build a national drug standard data-sharing platform based on the basic framework of user interface layer， computing processing layer， and data storage layer. Digital drug standards will be free， and access and download services for the public will be provided.

Epidemiological model for the construction of scenarios of the dissemination of COVID-19 in Codó-MA / Modelo epidemiológico para construção de cenários da disseminação da COVID-19 em Codó-MA / Modelo epidemiológico para la construcción de escenarios de la diseminación del COVID-19 en Codó-MA

Background and objectives: due to the increase in the number of cases of the new coronavirus in the city of Codó-MA, there was a need to carry out a study on the spread of COVID-19 in the municipality in order to have a better knowledge and understanding of the problem. A study was carried out on the spread of COVID-19 in the city of Codó-MA, comparing the quantitative data on the number of cases in 2020 and 2021 between May and July and using the epidemiological model Susceptible-Infectious-Isolated-Recovered (SIQR). Methods: we collected daily data from the epidemiological bulletins made available by the Municipal Health Department of Codó (SEMUS-Codó), we chose the SIQR compartmental model to carry out the simulations, we assumed hypotheses and estimated the parameters in order to design the scenarios. We simulated scenarios such as social distancing of healthy individuals and social isolation of infected individuals. Results: in early 2020, cases increased more frequently than in early 2021, and approximately 20% of those infected were in social isolation. According to projections, more than 80% of cases of COVID-19 were not accounted for in Codó. In 2021, there was greater underreporting than in 2020, approximately 82% and 85%, respectively. Conclusion: from the results, the authors conclude that the social isolation of those infected is a more efficient method to contain an epidemic than the total blockade of the population and that the high number of underreported cases is because most of these cases are asymptomatic.(AU)

Justificativa e objetivos: devido ao aumento do número de casos do novo coronavírus na cidade de Codó-MA, viu-se a necessidade para fazer um estudo sobre a propagação da COVID-19 no município para a ter melhor conhecimento e entendimento do problema. Foi realizado um estudo sobre a disseminação da COVID-19 na cidade de Codó-MA, sendo comparados os dados quantitativos dos números de casos nos anos de 2020 e 2021 entre os meses de maio e julho e utilizando o modelo epidemiológico Suscetíveis-Infecciosos-Isolados-Recuperados (SIQR). Métodos: coletamos os dados diários dos boletins epidemiológicos disponibilizados pela Secretaria Municipal de Saúde de Codó (SEMUS- Codó), escolhemos o modelo compartimental SIQR para a realização das simulações, supomos hipóteses e estimamos os parâmetros para podermos projetar os cenários. Simulamos cenários, tais como distanciamento social dos indivíduos sadios e isolamento social dos indivíduos infectados. Resultados: no início de 2020, os casos aumentaram com mais frequência do que no início de 2021, e aproximadamente 20% dos infectados estavam em isolamento social. De acordo com as projeções, mais de 80% dos casos de COVID-19 não foram contabilizados em Codó. Em 2021, houve maior subnotificação do que em 2020, aproximadamente 82% e 85%, respectivamente. Conclusão: a partir dos resultados, os autores concluem que o isolamento social dos infectados é um método mais eficiente para conter uma epidemia do que o bloqueio total da população e que o alto número de casos subnotificados são porque a maioria desses casos são assintomáticos.(AU)

Antecedentes y objetivos debido al incremento en el número de casos del nuevo coronavirus en la ciudad de Codó-MA, surgió la necesidad de realizar un estudio sobre la propagación del COVID-19 en el municipio con el fin de tener un mejor conocimiento y comprensión de el problema. Se realizó un estudio sobre la propagación del COVID-19 en la ciudad de Codó-MA, comparando datos cuantitativos del número de casos en 2020 y 2021 entre mayo y julio y utilizando el modelo epidemiológico Susceptible-Infeccioso-Aislado-Recuperado (SIQR). Métodos: recolectamos datos diarios de los boletines epidemiológicos que pone a disposición la Secretaría Municipal de Salud de Codó (SEMUS-Codó), elegimos el modelo compartimental SIQR para realizar las simulaciones, asumimos hipótesis y estimamos los parámetros para poder diseñar los escenarios. Simulamos escenarios como el distanciamiento social de personas sanas y el aislamiento social de personas infectadas. Resultados: a principios de 2020, los casos aumentaron con más frecuencia que a principios de 2021, y aproximadamente el 20% de los infectados se encontraban en aislamiento social. Según proyecciones, en Codó no se contabilizaron más del 80% de los casos de COVID-19. En 2021 hubo mayor subregistro que en 2020, aproximadamente 82% y 85%, respectivamente. Conclusión: de los resultados, los autores concluyen que el aislamiento social de los contagiados es un método más eficiente para contener una epidemia que el bloqueo total de la población y que el alto número de casos subregistrados se debe a que la mayoría de estos casos son asintomáticos.(AU)

Registros de enfermagem referentes à inserção de cateteres nasogástricos e nasoenterais: não conformidades e sub-registro / Nursing records regarding the insertion of nasogastric and nasoenteral catheters: nonconformities and sub-recording / Registros de enfermería respecto a la inserción de sondas nasogástricas y nasoenterales: no conformidades y subregistros

Objetivo: O registro dos dados referentes a Terapia Nutricional Enteral (TNE) é importante para assegurar o procedimento e comunicação sistemática da assistência. Com o estudo, objetivou-se analisar os registros de enfermagem referentes à inserção de cateteres nasogástricos (CNG) e nasoenterais (CNE) considerando o sub-registro e não conformidades encontradas em prontuários e durante observação dos pacientes. Métodos: estudo observacional, transversal com abordagem quantitativa, mediante a aplicação de instrumento para coleta de dados de pacientes internados em um Hospital Universitário no Pará entre agosto de 2019 a julho de 2020. Resultados: Foram identificadas 191 inserções de cateteres por enfermeiros, sendo 43 (22,52%) reinserções sub-registradas e 148 (77,48%) apresentaram não conformidades. Discussão: O sub-registro e as não conformidades interferem na qualidade da assistência de enfermagem, fragilizam as ações de segurança do paciente, além de apresentarem repercussões legais. Conclusão: Os dados apresentados neste artigo foram primordiais para a detecção de lacunas na assistência de enfermagem. (AU)

Objective: The recording of data referring to Enteral Nutrition Therapy (ENT) is important to ensure the procedure and systematic communication of care. The objective was to analyze the nursing records regarding the insertion of nasogastric (CNG) and nasoenteral (CNE) catheters, considering the under-recording and non-conformities found in medical records and during patient observation. Methods: observational, cross-sectional study with a quantitative approach, through the application of an instrument to collect data from patients admitted to a University Hospital in Pará between August 2019 and July 2020. Results: 191 insertions of catheters by nurses were identified, of which 43 (22.52%) underreported reinsertion and 148 (77.48%) presented non-conformities. Discussion: Under-registration and non-compliance interfere with the quality of nursing care, weaken patient safety actions, in addition to having legal repercussions. Conclusion: The data presented in this article were essential for the detection of gaps in nursing care. (AU)

Objetivo: El registro de los datos referentes a la Terapia de Nutrición Enteral (ENT) es importante para garantizar el procedimiento y la comunicación sistemática de los cuidados. El objetivo fue analizar los registros de enfermería con respecto a la inserción de catéteres nasogástricos (GNC) y nasoenterales (CNE), considerando el subregistro y las no conformidades encontradas en los registros médicos y durante la observación de los pacientes. Métodos: estudio observacional, transversal con abordaje cuantitativo, mediante la aplicación de un instrumento para recolectar datos de pacientes internados en un Hospital Universitario de Pará entre agosto de 2019 y julio de 2020. Resultados: fueron identificadas 191 inserciones de catéteres por enfermeros, de de los cuales 43 (22,52%) subreportaron reinserción y 148 (77,48%) presentaron no conformidades. Discusión: El subregistro y el incumplimiento interfieren en la calidad de la atención de enfermería, debilitan las acciones de seguridad del paciente, además de tener repercusiones legales. Conclusión: Los datos presentados en este artículo fueron esenciales para la detección de lagunas en el cuidado de enfermería. (AU)

Cobertura populacional de enfermeiros no Brasil: estimativas com base em diferentes fontes de dados / Population coverage of nurses in Brazil: estimates based on different data sources / Cobertura poblacional de enfermeros en Brasil: estimaciones basadas en diferentes fuentes de datos

Resumo Estima-se um déficit de seis milhões de enfermeiros em todo o mundo. Apesar da importância para os sistemas de saúde, estudos sociodemográficos são escassos devido à ausência de dados sistematizados específicos para enfermeiros. O objetivo deste estudo foi comparar a cobertura populacional de enfermeiros no Brasil com base em fontes oriundas do Instituto Brasileiro de Geografia e Estatística (IBGE), nos anos de 2010 e 2015, e do Conselho Federal de Enfermagem (Cofen), nos anos de 2013 e 2019. Em ambas as fontes, houve um aumento médio de 164 mil enfermeiros em todo o Brasil. A taxa de crescimento para o período das pesquisas do IBGE (15,7% ao ano) foi o triplo daquela registrada nos dados do Cofen (5,3% ao ano). A cobertura nos estados do Brasil permanece aquém da recomendação internacional (40 enfermeiros a cada 10 mil habitantes), com maiores déficits nos estados das regiões Norte e Nordeste. As comparações deste estudo reiteram a importância da disponibilidade de dados padronizados e sistematizados para a Enfermagem no Brasil. Indicadores de saúde acurados subsidiam políticas públicas para a redução de iniquidades em saúde, com destaque para a cobertura de enfermeiros, especialmente em regiões de elevadas vulnerabilidades socioeconômicas.

Abstract There is an estimated deficit of six million nurses worldwide. Despite its importance for health systems, sociodemographic studies are scarce due to the absence of systematized data specific to nurses. The objective of this study was to compare the population coverage of nurses in Brazil based on sources from the Brazilian Institute of Geography and Statistics (IBGE), in the years 2010 and 2015, and the Federal Nursing Council (Cofen), in the years 2013 and 2019. In both sources, there was an average increase of 164 thousand nurses throughout Brazil. The growth rate for the period of the IBGE surveys (15.7% per year) was triple that recorded in the Cofen data (5.3% per year). Coverage in the states of Brazil remains below the international recommendation (40 nurses per 10 thousand inhabitants), with greater deficits in the states of the North and Northeast regions. The comparisons in this study reiterate the importance of the availability of standardized and systematized data for Nursing in Brazil. Accurate health indicators subsidize public policies to reduce health inequities, with emphasis on the coverage of nurses, especially in regions with high socioeconomic vulnerabilities.

Resumen Hay un déficit estimado de seis millones de enfermeros en todo el mundo. A pesar de la importancia para los sistemas de salud, estudios sociodemográficos son escasos debido a la ausencia de datos sistematizados específicos para enfermeros. El objetivo de este estudio fue comparar la cobertura poblacional de enfermeros en Brasil a partir de fuentes del Instituto Brasileño de Geografía y Estadística (IBGE), en los años 2010 y 2015, y del Consejo Federal de Enfermería (Cofen), en los años 2013 y 2019. En ambas fuentes, hubo un aumento promedio de 164.000 enfermeros en todo Brasil. La tasa de crecimiento para el período de las encuestas del IBGE (15,7% anual) resultó el triple de la registrada en los datos del Cofen (5,3% anual). La cobertura en los estados de Brasil permanece por debajo de la recomendación internacional (40 enfermeros por 10.000 habitantes), con mayores déficits en los estados de las regiones Norte y Nordeste. Las comparaciones de este estudio reiteran la importancia de la disponibilidad de datos estandarizados y sistematizados para la Enfermería en Brasil. Indicadores precisos de salud apoyan las políticas públicas para reducir las desigualdades en salud, con énfasis en la cobertura de enfermeros, especialmente en regiones de alta vulnerabilidad socioeconómica.

Inclusão ou ilusão da identidade de gênero no país com o maior número de assassinatos de transgêneros: um ensaio crítico brasileiro / Inclusión o ilusión de la identidad de gênero en el país con el mayor número de asesinatos transgêneros: ensayo crítico brasileño / Inclusion or illusion of gender identity in the country with the highest transgender murders: a Brazilian critical essay

Resumo Objetivo refletir sobre as implicações e os riscos associados ao novo registro de identificação do Brasil para a população trans. Método trata-se de estudo reflexivo que explora o conceito de identidade social como um fenômeno complexo, fundamentado nos princípios da autodeterminação e da dignidade humana. São consideradas perspectivas feministas pós-humanistas e críticas, que desafiam o essencialismo biológico dos indivíduos, com foco especial na teoria de Judith Butler. Resultados o Brasil está atualmente implementando um registro nacional de identificação capaz de reconhecer a identidade de gênero das pessoas trans. Este estudo aborda as implicações do novo sistema nacional de identificação, incluindo possíveis retrocessos e avanços na luta pelos direitos das pessoas trans. Para proteger a identidade e a segurança dessas pessoas, este artigo defende a criação de um novo sistema de identificação emitido pelo governo que armazene informações pessoais em bancos de dados, exibindo apenas o nome social e o marcador de gênero no cartão. Considerações finais e implicações para a prática as altas taxas de violência contra pessoas trans no Brasil destacam a necessidade urgente do novo sistema. O reconhecimento precoce e o respeito pela identidade de gênero são fundamentais para promover o sucesso do novo sistema.

Resumen Objetivo reflexionar sobre las implicaciones y los riesgos asociados con el nuevo registro de identificación de Brasil para la población trans. Método este es un estudio reflexivo que explora el concepto de identidad social como un fenómeno complejo, fundamentado en los principios de autodeterminación y dignidad humana. Se consideran perspectivas feministas poshumanistas, que desafían el esencialismo biológico, con un enfoque particular en la teoría de Judith Butler. Resultados Brasil se encuentra implementando un registro nacional de identificación que puede reconocer la identidad de género entre personas trans. Este estudio aborda las implicaciones del nuevo sistema nacional de identificación, incluyendo posibles retrocesos y avances en la lucha por los derechos de las personas trans. Para proteger la identidad y la seguridad de estas personas, este artículo aboga por la creación de un nuevo sistema de identificación emitido por el gobierno que almacene información personal en bases de datos, mostrando solo el nombre social y el marcador de género en la tarjeta. Consideraciones finales e implicaciones para la práctica las altas tasas de violencia contra personas trans en Brasil enfatizan la necesidad urgente del nuevo sistema. El reconocimiento temprano y el respeto por la identidad de género son fundamentales para promover el éxito del nuevo sistema nacional de identificación.

Abstract Objective to reflect on the implications and risks associated with Brazil's new identification registry for the trans population. Method this is a reflective study that explores the concept of social identity as a complex phenomenon, grounded in the principles of self-determination and human dignity. To accomplish this, it draws upon feminist post-humanist and critical perspectives, challenging individuals' biological essentialism, with a particular focus on Judith Butler's theory. Results Brazil is currently implementing a national identification registry that can recognize trans individuals' gender identity. This manuscript addresses the implications of the new national identification system, including potential setbacks and advances in the struggle for trans rights. To safeguard people's identity and safety, this article advocates for a novel national government-issued identification system that stores personal information in central databases for linking purposes, displaying only the preferred name and gender marker on the identification card. Final considerations and implication for practice the high rates of anti-trans violence in Brazil emphasize the urgent need for the new system. Early recognition and respect for gender identity are integral to promoting the success of the new national identification system.

Avaliação dos dados de mortes por COVID-19 nas bases dos cartórios do RC-Arpen, SIVEP-Gripe e SIM no Brasil em 2020 / Evaluation of data on deaths due to COVID-19 from the databases of the Civil Registry (RC-Arpen), SIVEP-Gripe, and SIM in Brazil in 2020 / Evaluación de datos de muertes por COVID-19 en las bases de datos del Registro Civil-Arpen, SIVEP-Gripe y SIM en Brasil en 2020

Este estudo compara os registros de óbitos por COVID-19 em 2020 para todo o território nacional. Utilizamos três bases distintas: Registro Civil (RC-Arpen), Sistema de Informação sobre Mortalidade (SIM) e Sistema de Informação da Vigilância Epidemiológica da Gripe (SIVEP-Gripe). Há discordâncias entre os números de mortes por COVID-19 divulgados pelas diversas bases e essas diferenças variam em cada Unidade da Federação. A base do RC-Arpen é atualizada mais rapidamente que as outras duas bases do Departamento de Informática do Sistema Único de Saúde - DATASUS (SIM e SIVEP-Gripe), além de ser mais indicada para monitoramentos e pesquisas que abrangem períodos mais recentes. Apesar da atualização mais lenta, as bases do DATASUS apresentam números geograficamente similares e divulgam dados mais detalhados sobre as mortes. Esse detalhamento das informações torna as bases do DATASUS mais adequadas para pesquisas que demandam mais informações sobre o paciente e o tratamento.

This study compares the death records due to COVID-19 in 2020 for Brazilian territory. Three distinct databases were used: Civil Registry (RC-Arpen), Brazilian Mortality Information System (SIM), and Influenza Epidemiological Surveillance Information System (SIVEP-Gripe). We identified differences between the numbers of deaths due to COVID-19 in these databases, varying in each federative unit. The RC database is updated faster than the other two databases (SIM and SIVEP-Gripe) and it is most suited for monitoring and for studies covering recent periods. Despite the slower update, Brazilian Health Informatics Department (DATASUS) databases present geographically similar numbers and disclose more detailed data on deaths. This detailed information improves the DATASUS databases for studies that require more information about the patient and treatment.

Este estudio compara los registros de defunciones por COVID-19 en 2020 para todo el territorio brasileño. Se utilizaron tres bases diferentes: Registro Civil (RC-Arpen), Sistema de Información de Mortalidad (SIM) y Sistema de Información de Vigilancia Epidemiológica de la Gripe (SIVEP-Gripe). Existen discrepancias entre las cifras de muertes por COVID-19 comunicadas por las distintas bases de datos y estas diferencias varían en cada Unidad Federal. La base de datos RC se actualiza más rápidamente que las otras dos bases de datos del Departamento de Informática del Sistema Único de Salud - DATASUS (SIM y SIVEP-Gripe) y es más adecuada para el seguimiento y las encuestas que abarcan periodos más recientes. A pesar de que la actualización es más lenta, las bases de datos del DATASUS presentan cifras geográficamente similares y revelan datos más detallados sobre las muertes. Este detalle de la información hace que las bases de datos del DATASUS sean más adecuadas para investigaciones que requieren más información sobre el paciente y el tratamiento.

Non-rigid registration for medical images based on deformable convolution and multi-scale feature focusing modules / 生物医学工程学杂志

Non-rigid registration plays an important role in medical image analysis. U-Net has been proven to be a hot research topic in medical image analysis and is widely used in medical image registration. However, existing registration models based on U-Net and its variants lack sufficient learning ability when dealing with complex deformations, and do not fully utilize multi-scale contextual information, resulting insufficient registration accuracy. To address this issue, a non-rigid registration algorithm for X-ray images based on deformable convolution and multi-scale feature focusing module was proposed. First, it used residual deformable convolution to replace the standard convolution of the original U-Net to enhance the expression ability of registration network for image geometric deformations. Then, stride convolution was used to replace the pooling operation of the downsampling operation to alleviate feature loss caused by continuous pooling. In addition, a multi-scale feature focusing module was introduced to the bridging layer in the encoding and decoding structure to improve the network model's ability of integrating global contextual information. Theoretical analysis and experimental results both showed that the proposed registration algorithm could focus on multi-scale contextual information, handle medical images with complex deformations, and improve the registration accuracy. It is suitable for non-rigid registration of chest X-ray images.

Multiresolution discrete optimization registration method of ultrasound and magnetic resonance images based on key points / 生物医学工程学杂志

The registration of preoperative magnetic resonance (MR) images and intraoperative ultrasound (US) images is very important in the planning of brain tumor surgery and during surgery. Considering that the two-modality images have different intensity range and resolution, and the US images are degraded by lots of speckle noises, a self-similarity context (SSC) descriptor based on local neighborhood information was adopted to define the similarity measure. The ultrasound images were considered as the reference, the corners were extracted as the key points using three-dimensional differential operators, and the dense displacement sampling discrete optimization algorithm was adopted for registration. The whole registration process was divided into two stages including the affine registration and the elastic registration. In the affine registration stage, the image was decomposed using multi-resolution scheme, and in the elastic registration stage, the displacement vectors of key points were regularized using the minimum convolution and mean field reasoning strategies. The registration experiment was performed on the preoperative MR images and intraoperative US images of 22 patients. The overall error after affine registration was (1.57 ± 0.30) mm, and the average computation time of each pair of images was only 1.36 s; while the overall error after elastic registration was further reduced to (1.40 ± 0.28) mm, and the average registration time was 1.53 s. The experimental results show that the proposed method has prominent registration accuracy and high computational efficiency.

A comparative study based on the mandibular movement track and the movement parameters of the virtual articulator in simulating occlusal adjustment / 华西口腔医学杂志

OBJECTIVES@#This study aimed to compare the effects of virtual adjustment on occlusal interferences in mandibular posterior single crown and three-unit bridge restorations by using the mandibular movement track and the movement parameters of a virtual articulator.@*METHODS@#Twenty-two participants were recruited. Digital casts of the maxillary and mandibular arches were obtained using an intraoral scanner, and the jaw registration system was used to record the data of the mandibular movement track and the movement parameters of the articulator. Four kinds of restorations with 0.3 mm occlusal interferences were designed with dental design software. In particular, single crowns were designed for teeth 44 and 46, whereas three-unit bridges were designed for teeth 44-46 and 45-47, and the corresponding natural teeth were virtually extracted. Virtual adjustment of the restorations was performed using two dynamic occlusal recordings, namely, the mandibular movement track and the movement parameters of the virtual articulator. A reverse-engineering software was used to measure the root-mean-square of the three-dimensional deviation of the occlusal surfaces between natural teeth and the adjusted restorations. The differences between the two methods of virtual-occlusion adjustment were compared and analyzed.@*RESULTS@#For the same group of restorations, the three-dimensional deviation of the mandibular movement track group were lower than those of the virtual articulator group, and the differences were statistically significant (P<0.05). For the four groups of restorations adjusted by the same method, the three-dimensional deviation of the 46-tooth single crown was the largest and the smallest three-dimensional deviation was that of the 44-tooth single crown. Statistical differences existed between the 44-tooth single crown and the other groups (P<0.05).@*CONCLUSIONS@#For the occlusal design of posterior single crown and three-unit bridge, the mandibular movement track could be a more effective approach to virtual occlusal adjustment than the movement parameters of the virtual articulator.

Analysis of treatment outcomes of elderly pulmonary tuberculosis aged 65 and above in Chongqing from 2015 to 2020 / 中国热带医学

@#Abstract: Objective　To analyze the treatment outcomes of elderly patients with pulmonary tuberculosis in Chongqing, so as to provide reference for the prevention and control strategies of the epidemic of elderly pulmonary tuberculosis. Methods　The data of tuberculosis cases aged ≥65 years in Chongqing from 2015 to 2020 were collected from the National Health Insurance Information Project Disease Prevention and Control Information system. Descriptive statistical methods were used to analyze the data. Results The registration rates of elderly active pulmonary tuberculosis patients and etiological positive patients were 110.95/10-5and 32.25/10-5 in 2015 and 84.06/10-5 and 57.29/10-5 in 2020. The annual decline rate of active tuberculosis registration was 5.40%, and the annual increase rate of pathogenic-positive tuberculosis registration was 12.18%. The registration rates of active tuberculosis patients and etiological positive patients in the whole population were 70.75/10-5 and 17.63/10-5 in 2015 and 50.34/10-5 and 29.14/10-5 in 2020. The annual decline rate of active tuberculosis registration was 6.58%, and the annual increase rate of pathogenic-positive tuberculosis registration was 10.57%. From 2015 to 2020, a total of 25 931 cases of elderly pulmonary tuberculosis were registered, of which 21 374 (82.43%) cases were successfully treated and 4 010 (15.80%) cases had unfavorable outcomes. The proportion of cured and death patients showed an increasing trend year by year (χ2trend=313.853, 100.502, P<0.01). From 2015 to 2020, the average annual successful treatment rate of elderly pulmonary tuberculosis in the whole city was 82.43%, with the lowest rate in southeast Chongqing (74.23%), followed by urban areas (81.99%). The success rate of elderly pulmonary tuberculosis treatment in the whole city, west Chongqing, northeast Chongqing and southeast Chongqing showed a downward trend year by year (χ2trend=230.199, 35.278, 108.076, 112.130, all P<0.01), with annual decline rates of 2.77%, 2.26%, 3.0% and 4.12%, respectively. Among the registered elderly patients, female, 65-<75 years old, Han nationality, newly diagnosed, no complications, and negative for etiology (χ2=15.234, 255.910, 146.842, 179.998, 25.575, 131.170, P<0.01) had higher success treatment rates. Conclusions The prevalence of pulmonary tuberculosis in the elderly population in Chongqing City is declining, but the positive registration rate of etiology is increasing annually, and the success rate of treatment is decreasing. Therefore, it is necessary to strengthen the systematic management, publicity and education of elderly patients (especially those in southeast Chongqing, male, positive patients and severe patients) to effectively control the epidemic of tuberculosis in the elderly.

Long-term trend analysis of liver cancer survival rate in Qidong region, Jiangsu Province, 1972-2019 / 中华肝脏病杂志

Objective: To analyze the incidence and survival rate of liver cancer cases in the entire population in the Qidong region from 1972 to 2019, so as to provide a basis for prognosis evaluation, prevention, and treatment. Methods: The observed survival rate (OSR) and relative survival rate (RSR) of 34 805 cases of liver cancer in the entire Qidong region population from 1972 to 2019 were calculated using Hakulinen's method with SURV3.01 software. Hakulinen's likelihood ratio test was used for statistical analysis. Age-standardized relative survival (ARS) was calculated using the International Cancer Survival Standard. The Joinpoint regression analysis was performed with Joinpoint 4.7.0.0 software to calculate the average annual percentage change (AAPC) of the liver cancer survival rate. Results: 1-ASR increased from 13.80% in 1972-1977 to 50.20% in 2014-2019, while 5-ASR increased from 1.27% in 1972-1977 to 27.64% in 2014-2019. The upward trend of RSR over eight periods was statistically significant (χ (2) = 3045.29, P < 0.001). Among them, male 5-ASR was 0.90%, 1.80%, 2.33%, 4.92%, 5.43%, 7.05%, 10.78%, and 27.78%, and female 5-ASR was 2.33%, 1.51%, 3.35%, 3.92%, 3.84%, 7.18%, 11.45%, and 29.84%, respectively. There was a statistically significant difference in RSR between males and females (χ (2) = 45.68, P < 0.001). The 5-RSR for each age group of 25-34 years old, 35-44 years old, 45-54 years old, 55-64 years old, 65-74 years old, and 75 years old were 4.92%, 5.29%, 8.17%, 11.70%, 11.63%, and 9.60%, respectively. There were statistically significant differences in RSR among different age groups (χ (2) = 501.29, P < 0.001). The AAPC in Qidong region from 1972 to 2019 for 1-ARS, 3-ASR, and 5-ARS were 5.26% (t = 12.35, P < 0.001), 8.10% (t = 15.99, P < 0.001), and 8.96 % (t = 16.06, P < 0.001), respectively. The upward trend was statistically significant in all cases. The AAPC of 5-ARS was 9.82% in males (t = 14.14, P < 0.001), and 8.79% in females (t = 11.48, P < 0.001), and the upward trend was statistically significant in both. The AAPC of 25-34 years old, 35-44 years old, 45-54 years old, 55-64 years old, 65-74 years old, and 75 years old were 5.37% (t = 5.26, P = 0.002), 5.22% (t = 5.66, P = 0.001), 7.20% (t = 6.88, P < 0.001), 10.00% (t = 12.58, P < 0.001), 9.96% (t = 7.34, P < 0.001) and 8.83% (t = 3.51, P = 0.013), and the upward trend was statistically significant. Conclusion: The overall survival rate of registered cases of liver cancer in the Qidong region's entire population has greatly improved, but there is still much room for improvement. Hence, constant attention should be paid to the study on preventing and treating liver cancer.

Non-drug rehabilitation for gait abnormality of Parkinson's disease: a review based on ClinicalTrials.gov / 中国康复理论与实践

ObjectiveTo investigate the current trend of non-drug therapy for gait abnormality of Parkinson's disease. MethodsThe clinical trials about non-drug therapy for gait abnormality of Parkinson's disease were retrieved from the clinical trial registration platform ClinicalTrials.gov, from inception to October 25th, 2022. The records were screened by two researchers independently, and the registration time, registration count, sample sizes, interventions, primary outcome measurements and study design, etc., were summarized and analyzed, according to the PICOS principle. ResultsA total of 218 eligible records were included. The registration count increased in recently years. Almost all of the trials (93.6%) were with a relatively small sample size less than 100, mainly 21 to 30 cases. The major intervention approach was the neuromodulation technique, however, virtual reality and robot-assisted gait training were coming to use in recent years. The primary outcome measurements were the clinical scales, the questionnaires and the exercise examinations. Randomized parallel controlled trials were the most (111, 50.9%). ConclusionThe number of non-drug therapy for gait abnormality of Parkinson's disease increased year by year. The new technologies such as virtual reality and robot-assisted gait training may be used more in the future.

Analysis of the incentive effect of the patent linkage system on the application of generic drugs in China and suggestions for countermeasures / 中国药房

OBJECTIVE To optimize the system of patent linkage system and provide a reference for encouraging generic drugs to apply for listing. METHODS On the basis of literature research， combined with the author’s work experience， the situation of generic drug application and patent challenge were analyzed comparatively after the implementation of the patent linkage system in China. Based on the patent linkage system， the reasons for the insufficient incentive for the challenge of generic drug patents in China were analyzed； corresponding countermeasures and suggestions were proposed. RESULTS & CONCLUSIONS The patent linkage system in China was implemented in 2021， but due to the implementation of the system being still in its initial stage， the relevant documents for practical guidance are not yet complete， and the supporting incentive mechanism is not yet sound， resulting in a weak willingness of generic pharmaceutical enterprises to initiate patent challenges. It is suggested that China can further improve the patent linkage system by improving the patent information registration platform of generic drugs， developing professional drug patent agencies， and establishing the patent common challenges platform of the first generic drug， in order to incentivize Chinese generic drug enterprises to increase innovation motivation， challenge original research drug patents， and apply for listing， achieving the effect of suppressing drug prices and benefiting the people through full competition.

Development status of international transplantation pregnancy registration and its enlightenment for China / 中华器官移植杂志

With the continuous improvements of survival rate and quality-of-life for organ transplant recipients, the issue of pregnancy in organ transplant recipients is receiving greater attention from transplant specialists and obstetricians.Currently there are three major global registries related to transplant pregnancy, namely The United Kingdom Obstetric Surveillance System (UKOSS), The Australian and New Zealand Dialysis and Transplant Registry (ANZDATA) and The International Transplant Pregnancy Registry International (TPRI). Among them, TPRI is the most comprehensive and longest running system with a focus on the impact of pregnancy on transplant recipients and the impact of immunosuppressants on fertility and pregnancy outcomes.As the second largest organ transplant country in the world, China also has high expectations for pregnancy and fertility among transplant recipients.Therefore it is imperative to establish a pregnancy and childbirth registration office for organ transplantation in China, standardize the recording of relevant population data and conduct researches for formulating scientific guidance, providing reliable medical consultations and services for patients with pregnancy needs after organ transplantation in China.

Research progress and future prospect of hernia and abdominal wall surgery in China / 中华消化外科杂志

In recent years, due to the increasing population of ageing and obesity, the incidence rate of hernia is increasing year by year, which has become a social problem that needs to be focused. Although starting late, the hernia and abdominal wall surgery has developed rapidly in recent years in China, and many remarkable achievements have been made. The development of hernia and abdominal wall surgery is inseparable from the progress of medical technology, the continuous innovation of materials, the improvement of perioperative management concept and the improvement of registration and follow-up system. The authors investigate the relevant research at home and abroad in recent years, and summarize and prospect the materials science, the daytime surgery and the registration and follow-up system, in order to provide reference for the future development of hernia and abdominal wall surgery.

Analysis of Taijiquan-related clinical trial registration characteristics and reporting quality / 国际中医中药杂志

Objective:To analyze the registration characteristics and reporting quality of Taijiquan-related clinical trials.Methods:A database search of the China Clinical Trials Registry (ChiCTR) and ClinicalTrials.gov was performed by computer to collect basic information, study content, interventions, and other registration information of Taijiquan-related clinical trials from inception to June 30, 2022. The WHO TRDS was used to evaluate the registration quality of clinical trials.Results:Totally 381 Taijiquan-related clinical trials were incorporated, of which 241 (63.25%) were prospective registration and 140 (36.75%) were retrospective registration. The quantity of Taijiquan-related clinical trial registrations generally showed an increasing trend, reaching a peak in 2020 (14.70%). The number of clinical trials registered in Shanghai accounted for the most (9.97%). The largest contributor to the registered trials was Fujian University of Traditional Chinese Medicine (4.46%). 55.12% of registered studies were funded by hospitals and universities. The registered studies were most focused on cognitive impairment. 74.54% of the studies adopted randomized parallel controls, and the sample size was mainly between 20 and 200 (80.31%), and the age of the subjects was concentrated above 39 years (53.28%). The average report completion rate of WHO TRDS items was 86.90%.Conclusions:Presently, the development trend of clinical trials related to Taijiquan is relatively promising. However, imbalances exist in some aspects, for instance distribution of registration areas and institutions, funding allocation, and population of subjects. The description of some registration items is missing or not comprehensive, so corresponding measures are required to improve the quality of clinical trial design and to optimize registration details.

Study on African herbal medicine registration management measures and TCM registration strategy in Africa / 国际中医中药杂志

African herbal medicine is widely utilized with a long history. Most African countries have legalized herbal medicine and established a registration and listing mechanism. The present study firstly described the historical exchange and modern trade of TCM between China and Africa, and briefly described the herbal medicine registration management system of African countries from the regulations and guidelines of herbal medicine management and registration management institutions. Then it compared and analyzed the differences of registration systems in African countries from the following aspects: application materials, registration path, quality control and production, effectiveness evidence and food supplements, as well as summarizing the common points of African herbal medicine registration management. The registration strategy of TCM includes assessing the risk of registered investment, building a multilateral and diversified cooperation network between China and Africa, adhering to integrity and innovation, and promoting the international development of TCM, so as to form a standardized registration path of TCM in Africa and expand the TCM market in Africa.

Discussion of Application Status and Key Attentions on Registration for Ossicular Replacement Prosthesis / 中国医疗器械杂志

The ossicular replacement prosthesis should have good biocompatibility, stability, easy to install, and excellent sound transmission capacity. In this study, the characteristics of ideal materials for the ossicular replacement prosthesis were analyzed by searching the types of materials used in clinical practice and comparing the advantages and disadvantages of various materials and structures. At the same time, in combination with the current evaluation requirements and evaluation experience, the focus of the performance research project of ossicular replacement prosthesis in the process of registration is discussed to clarify the performance evaluation requirements of these products, so as to provide reference for the future work of manufacturers and regulators. The performance evaluation of ossicular replacement prosthesis focuses on its mechanical properties, fixation stability, sound transmission characteristics, biological characteristics, and magnetic resonance compatibility.

Analysis of Factors Affecting Effectiveness of Medical Device Registration Self-inspection from Perspective of Technical Evaluation / 中国医疗器械杂志

Type inspection is a necessary precondition of technical evaluation of medical device. The implementation of The Provisions for Administration of Self-Test for Medical Device Registration facilitates the registration pathway for applicants. How to improve the effectiveness of registration self-test has drawn attention from many stakeholders. In this study, we analyzed and discussed the factors affecting the validity of registration self-test from technical evaluation perspective, and proposed suggestions for improvement accordingly. The aim of this article is to boost the reliability and effectiveness of registration self-test and offer a reference for applicants to carry out registration self-test.

Analysis for Key Points of Registration Applications and Difficulties of Process Control of 3D Printed Customized Dentures / 中国医疗器械杂志

With the highlighted advantages of 3D printing technology in the field of dental prosthodontics, there is increasing in the numbers of registration applications for additive manufacturing customized dentures. However, there is still a lack of unified analysis in the core elements of process control, the key points of registration and the safety production quality control. Based on the current research status of the industry, the study is intended to clarify confusion and difficulties, deeply analyse the mechanism of the product defects, sort the core elements of process control, then try to establish a systematic evaluation system from product performance research, key process verification, production quality control and the description of registration files, so that it can provide help for practitioners to clarify research direction, establishing quality management system, improving the efficiency of registration and ensuring product quality.