GENERIC DRUG REGISTRATION AND COUNTRY-SPECIFIC REQUIREMENTS IN SAUDI ARABIA, QATAR, BAHRAIN, AND OMAN

Objective: This research aims to examine the regulatory framework and prerequisites for generic drug registration in the Middle East and North Africa (MENA) region, with a specific focus on the countries that make up the Gulf Cooperation Council (GCC). This will enable a deeper understanding of the procedures, records, schedules, and discrepancies related to registration.Methods: The study makes use of an extensive examination of the rules, regulations, and practices about the registration of generic drugs in the MENA. Official government sites, regulatory agencies, and respectable trade journals for the pharmaceutical sector were used as sources of information. The main procedures for registering generic drugs were explained and inspected, encompassing the submission of documents, dossier preparation, bioavailability/bioequivalence tests, and application filing.Results: There are substantial growth prospects for generics. Research highlights the sequential registration process for generic drugs, submitting documents electronically using the Common Technical Document (eCTD) method. For registration to be successful, specific records and data such as bioavailability/bioequivalence research data must be provided.Conclusion: The effective registration of generic medications in the MENA region, especially in the GCC nations, depends on understanding and abiding by nation-specific regulatory standards. The research offers a tactical guide that outlines the essential procedures, paperwork needs, and regional variances in the generic medicine registration process. The goal is to offer affordable healthcare solutions by navigating the regulatory landscape meticulously and streamlining the approval and market entry process for generic pharmaceuticals in the MENA region.

Review on the registration of herbal drugs in north America and Europe / 国际中医中药杂志

International registration of herbal drugs is a necessary prerequisite for the internationalization of Chinese materia medica. North America and European Union occupy an important position in the world herbal drugs market, and their drug administration and quality supervision requirements are relatively complete and progressiveness. By summarizing the definition of herbal drugs in North America and European Union, combing and interpreting the relevant laws, regulations and policy documents, this article constructed the registration path of herbal drugs, and discussed the current status of market registration of herbal drugs in North America and European Union based on the examples of successful marketing of herbal drugs under current application and approval in overseas markets. This article believed that in the future, an internationally matched TCM quality standard evidence system should be built, clinical trials of TCM products in line with international standards should be carried out, standards that are the same or higher than international mainstream GMP should be developed, the registration path of TCM compounds should be explored, and professionals to establish an international registration application team should be recruited to provide theoretical and practical support for China's overseas registration of Chinese TCM products, promote TCM products to enter the world mainstream market, and achieve high-quality development of TCM internationalization.

Design and implementation of registration system based on Elasticsearch / 中国医学装备

Objective:To design and implement a registration system based on Elasticsearch,so as to solve the problems of the conventional registration system included single method of appointment and registration,and one-sidedness information of search registration platform,and to meet the growing needs of patients for diversified and intelligent medical registration and treatment.Methods:The browser/server(B/S)architecture was used to implement the design of registration system.The front-end used the neuron organic object description language(NOODL)language to render the interface,and implemented interaction between function methods and interface data through Typescript.The Elasticsearch search engine implemented high efficient search functions.The back-end processed the requirements of data through the(edge-based cloud object storage)ECOS system,and stored business data in the MySQL database.The system included a three-layer architecture with application layer,service layer and storage layer,which can realize a series of functions such as login and registration,search for appointments,link appointments,scan code for appointments,and setting appointment information by doctors.Results:The registration system based on Elasticsearch can realize multiple methods of appointment registration such as online search appointment,exclusive link appointment of hospital,appointment by scanning code,etc.,which was suitable to multiple platforms such as Web and mobile device.It has been applied in many overseas medical institutions.As of June 2023,the system possessed 219 doctors,and had serviced for 19,903 patients,and had completed 62,737 appointments,which saved a lot of time for patients to seek medical treatment,and improved operation efficiency of hospital.Conclusion:The registration system based on Elasticsearch can meet the diversified and intelligent needs of patients for medical treatment,which can provide comprehensive,accurate and intelligent services of appointment and treatment for patients,and can effectively improve the efficiency of appointment and treatment.

Analysis on the Registration of Clinical Trials of Headache Treated by TCM / 中国中医药信息杂志

Objective To analyze the registered clinical trials of headache treated by TCM;To discuss the current research status;To provide reference for the optimization of subsequent clinical trial research plans.Methods All clinical trials of headache treated by TCM were retrieved from the ChiCTR and the ClinicalTrials.The retrieval time was from the database establishment to May 22,2023.The general characteristics,study types,intervention measures and outcome indicators of the trials were analyzed respectively.Results A total of 104 registered studies were included,with the number of registered studies increasing since 2004 and reaching a peak in 2020,involving 25 provincial administrative regions or countries and 69 clinical trial institutions;the funding sources were mainly scientific research funds of universities,national finance and local finance.The research type was mainly intervention research;the designing scheme was mainly randomized parallel control study;the high frequency random method was simple random method;45 registered studies used blind methods.Exploratory studies/pre-trials were the most commonly used in the phases of clinical researches.Most of the registered studies were single-center clinical trials with a total sample size of 9 648 patients.The main interventions were acupuncture and oral Chinese medicines.The high frequency outcome indicators included life quality of score,headache attack frequency,headache attack days and headache severity,etc.There were some problems in outcome indicators,such as non-standard,lack of TCM characteristic advantages,and insufficient patient participation.Conclusion The number of registered studies of headache treated by TCM has increased by year,but there are some problems in design elements,such as random method,blind method,number of research centers,sample size and the setting of outcome indicator.

Clinical prediction models of radiation-induced rectal injury after brachytherapy combined with external beam radiation therapy for cervical cancer / 中华放射医学与防护杂志

Objective:To explore the dosimetric differences of different dose accumulation method for brachytherapy combined with external beam radiation therapy (EBRT) of cervical cancer and establish clinical prediction models for radiation-induced late rectal injury (RLRI) after radiotherapy.Methods:A retrospective analysis was conducted for the clinical data of patients who received radical concurrent chemoradiotherapy (CCRT) for cervical cancer in the Department of Oncology of the Affiliated Hospital of North Sichuan Medical College from January 1, 2020 to November 30, 2021. EBRT combined with brachytherapy was employed for the patients, and dose assessment was performed in two means: the direct accumulation using equivalent dose in 2-Gy fractions (EQD2) and deformable image registration (DIR)-based dose accumulation of 3D planning images. The toxicity criteria of the Radiation Therapy Oncology Group were adopted as the RLRI grading criteria. The prediction models of RLRI using both dose assessment method were constructed. The areas under the receiver operating characteristic (ROC) curves were calculated to assess the predictive accuracy of the different dose assessment method.Results:In the case of brachytherapy, the D95% and D90% EQD2 doses to high-risk clinical target volumes (HR-CTVs) were 2.18 and 2.92 Gy higher respectively and the D2 cm 3, D1 cm 3, and D0.1 cm 3 EQD2 doses to the rectal were 1.74, 2.28, and 2.26 Gy higher, respectively compared to DIR-based dose accumulation ( t = 3.82, 5.21, 4.58, 5.17, 2.05, P < 0.05). For EBRT combined with brachytherapy, the D2 cm 3, D1 cm 3, and D0.1 cm 3 EQD2 doses to the rectal were 6.22, 7.61, 9.56 Gy higher than DIR-based doses, respectively, and the dosimetric differences were statistically significant ( t = 9.40, 10.59, 7.87, P < 0.001). The joint prediction model yielded an area under the ROC curve of 0.788. The sensitivity and specificity of the optimal cut-off value were 0.850 and 0.660, respectively. Furthermore, the Hosmer-Lemeshow goodness-of-fit tests indicated high goodness-of-fit ( P > 0.05). The prediction model for DIR-based dose accumulation of traditional predictors yielded areas under the ROC curves for D2 cm 3 and D1 cm 3 to the rectal of 0.784 and 0.763, respectively. The sensitivities of the optimal cut-off values were 0.850 and 0.750, respectively, and the specificities were 0.679 and 0.717, respectively. Conclusions:There are dosimetric differences between the direct dose accumulation using EQD2 and DIR-based dose accumulation of 3D planning images for brachytherapy combined with EBRT. Both the joint prediction model and the DIR-based dose accumulation of D2 cm 3 and D1 cm 3 to the rectal are effective in predicting RLRI. Given the complex calculation of the joint prediction model, it is recommended that RLRI should be predicted through DIR-based dose accumulation of D2 cm 3 and D1 cm 3 to the rectal clinically.

Application of Jacobian determinant of reverse deformation field to evaluation of deformation registration algorithm / 中华放射医学与防护杂志

Objective:To effectively quantify and evaluate the quality of different deformation registration algorithms, in order to enhance the possibility of implementing deformation registration in clinical practice.Methods:The Jacobian determinant mean (JDM) is proposed based on the Jacobian determinant (JD) of displacement vector field (DVF), and the Jacobian determinant error (DJDE) is introduced by incorporating the JD of the inverse DVF. The optical flow method (OF-DIR) and fast demons method with elastic regularization (FD-DIR) were tested on nasopharyngeal and lung cancer datasets. Finally, JDM and DJDE with the Jacobian determinant negative percentage (JDNP), inverse consistency error (ICE) and normalized mean square error (NMSE) were used to evaluate the registration algorithms and compare the differences evaluation indicators in different tumor images and different algorithms, and the receiver operating curve (ROC) was analyzed in evaluation.Results:In lung cancer, OF-DIR outperformed FD-DIR in terms of JDM, NMSE, DJDE and ICE, and the difference was statistically significant( z = -2.24, -4.84, t = 4.01, 6.54, P<0.05). In nasopharyngeal carcinoma, DJDE, ICE and NMSE of OF-DIR were superior to FD-DIR, and the difference was statistically significant ( t = 4.46, -7.49, z = -2.22, P<0.05), but there was no significant difference in JDM ( P>0.05). In lung cancer and nasopharyngeal carcinoma, JDNP of OF-DIR was worse than that of FD-DIR, and the difference was statistically significant ( z = -4.29, -4.02, P<0.01). In addition, DJDE is more specific and sensitive on ROC curve (AUC=0.77), and has different performance result for tumor images at different sites. Conclusions:The JDM and DJDE evaluation metrics proposed are effective for deformation registration algorithms. OF-DIR is suitable for both lung cancer and nasopharyngeal carcinoma, while the influence of organ motion on the registration effect should be considered when using FD-DIR.

Discussion and analysis of laboratory developed tests management model with the goal of product registration / 中华检验医学杂志

Currently, the management of domestic laboratory developed test (LDT) is still in the exploration stage, and new plans and ideas need to be investigated that are suitable for our national development. By analyzing encountered issues, combining the actual needs of the government, healthcare reform, and patients, this article proposes that "promoting healthy development of LDT projects and focusing on the organic combination of patients′ interest protection and innovation support" is an important direction for LDT management, around which the new idea for LDT project management is proposed, that is, LDT management model targeting product registration. The core of this management model is to target product registration and to ensure low service fees for patients and continuous real-time data monitoring. Benefit and risk analysis demonstrate that this management model can to a larger extent balance the realistic demands of patients, medical institutions, in vitro diagnostics companies, and government management departments, which benefits promoting the perfection and development of LDT projects in our country.

Application of mixed reality technology in the diagnosis and treatment of oral and maxillofacial tumors / 口腔疾病防治

@#Oral and maxillofacial tumors are common oral and maxillofacial surgery-related diseases. Digital surgical technology, represented by virtual surgical design and surgical navigation, is the main auxiliary means of the surgical diagnosis and treatment of oral and maxillofacial tumors. However, the existing digital technology still has some problems and room for improvement in terms of 3D visualization imaging and intraoperative hand-eye coordination. At present, the application of 3D visualization technology represented by mixed-reality technology has been rapidly developing in the medical field. It assists in realizing the real-time stereoscopic presentation of medical images by superimposing 3D virtual images onto the real surgical environment. Mixed-reality technology has been gradually applied to the diagnosis and treatment of oral and maxillofacial tumors. Preoperatively, mixed-reality technology can be used to construct a 3D model of the tumor and its surrounding vital structures based on imaging data, at which point the medical team can personalize the preoperative assessment and design the surgical plan in the mixed-reality environment. Intraoperatively, the combination of mixed-reality technology and surgical navigation technology can be used to display the 3D virtual model in real time in the actual environment of the operation area, overcoming the hand-eye coordination problem associated with using navigation technology alone and further improving the accuracy and safety of oral and maxillofacial tumor surgery. The combination of mixed-reality technology and internet medical technology can provide a high-quality teaching platform to promote the development of regional oral and maxillofacial surgery practices. The limitations of mixed-reality technology include image occlusion, lack of accuracy when used alone, and long alignment times. In this review, the application of mixed-reality technology to the diagnosis and treatment of oral and maxillofacial tumors will be summarized and assessed by combining information from domestic and international literature reports with the practical clinical experience of the author group.

Characteristics analysis of clinical trial registration for endodontic diseases based on the ClinicalTrials.gov and ChiCTR databases / 口腔疾病防治

Objective@#To summarize the clinical registration data of endodontic diseases registered in ClinicalTrials.gov in the United States and Chinese Clinical Trial Registry (ChiCTR), and analyze the registration characteristics at home and abroad@*Methods@#We searched the clinical studies related to endodontic disease registered in the two databases from January 1, 2000, to August 20, 2023. We extracted and analyzed the information from clinical studies related to endodontic diseases. The extracted content included information on the registration region, registration year, trial title, research direction, sample size, trial progress, study type, trial design, blinding method, clinical trial phase, and participating institutions.@*Results@#The two databases contained a total of 536 191 registered items, of which 634 were endodontic diseases. Clinical trials in the registry of endodontic diseases involved 43 countries, of which the top three were Egypt (188 items), China (130 items), and the America (46 items). In addition, the number of registrations of clinical trials on endodontic diseases has significantly increased since 2015. The research directions were mainly pulposis (434 items), caries (106 items), and periapical diseases (77 items), which mostly involved etiology, drug intervention, surgical intervention, new technology, and new materials. Moreover, there were 430 clinical trials (67.82%) with a sample size < 100 and 185 (29.18%) with a sample size of 100-999. The progress status at the time of registration showed the largest number of completed trials, accounting for 286 items (45.11%), followed by unknown (125 items), recruiting (110 items), and not yet recruiting (81 items). The main research types were intervention studies (546 items, 86.12%), and the main design model was randomized parallel controlled trials (473 items, 74.61%). Additionally, 423 items (66.72%) were marked using the blind method, mainly double-blind trials (195 items), followed by other/unmarked (123 items, 19.40%) and open study (88 items, 13.88%). Furthermore, the largest number of items in the study phase were marked other/unlabeled (388 items), followed by phaseⅡ study (69 items) and preliminary study (62 items). Additionally, 611 items (96.37%) were clinical trials with a number of participating institutions < 3, and 23 items (3.63%) had a number of participating institutions ≥ 3@*Conclusion@#The number of clinical trials registered for endodontic diseases is generally on the rise, but it is still relatively small. The quality of the study design needs to be enhanced, and the registration information in the study phase needs to be improved. Moreover, the number of multicenter trials is small. In the future, we should fully mobilize the talent advantages of well-known stomatology majors in China, take the lead in conducting high-quality, multi-center clinical research, and realize the transformation of results.

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.

Application of electronic rotation registration manual for residency training based on hospital information system docking: Practice and exploration / 中华医学教育探索杂志

The contents recorded in the rotation registration manual is not only the quantitative indicators for evaluating the quality of residency training, but also the important basis for training assessment and issuance of training certificates. In order to solve the problems of data authenticity, information delay, and repeated entry in the rotation registration manual for residency training, Shanghai East Hospital, Tongji University, launched a project to dock the electronic rotation registration manual with the hospital information system. Through the establishment of the project team, the development of working mechanisms, and the implementation of the project, data analysis was used for process reformation and system optimization, so as to continuously improve management efficiency and medical safety while solving problems and form a set of implementation system with reference significance in practice.

Multidimensional analysis of endometriosis clinical trials based on the ClinicalTrials.gov database / 中国临床药理学与治疗学

AIM:To perform a multidimensional analysis of the clinical study characteristics of endo-metriosis based on the ClinicalTrials.gov,providing comprehensive and objective information for re-searchers,clinicians,and clinical pharmacists.METHODS:A thorough investigation was conduct-ed on clinical trials related to endometriosis,regis-tered on the ClinicalTrials.gov from its inception to October 20,2023.Relevant trial data were extract-ed and statistically analyzed using bibliometrics and comparative research methods.RESULTS:A to-tal of 667 endometriosis clinical studies were regis-tered globally,showing an annual increase.The United States(127 trials),France(70 trials),and Ita-ly(57 trials)had the highest number of registered trials.Interventional studies were predominant(416 trials,62.4%),followed by observational stud-ies(251 trials,37.6%).Within interventional stud-ies,drug therapy was the primary intervention(223 trials,53.6%).Despite endometriosis being a female condition,male subjects were also consid-ered,with 6 trials specifically requiring male partici-pants and 37 trials not restricting gender.Compa-nies/corporations were the main funding sources,while public and governmental organizations pro-vided relatively less funding.CONCLUSION:Clinical trial research on endometriosis is in a phase of growth,with drug therapy being the main treat-ment approach.However,there is a relative lack of investment and attention from public funds and governmental organizations.

Effects of pay for performance in primary care in an under-registration scenario / Efeitos da remuneração por desempenho na atenção primária em um cenário de sub-registro

ABSTRACT OBJECTIVE To propose a method for detecting and analyzing under-registration and highlight its potential financial effect in view of the implementation of the Previne Brasil Program. METHODS An ecological study was carried out to analyze cytopathological exams in programmatic area 3.1 in the municipality of Rio de Janeiro. The data was collected from the Departamento de Informática do Sistema Único de Saúde (DATASUS - Department of Informatics of the Unified Health System) database, including information on reports from outsourced cytopathology laboratories and those available in the Sistema de Informação em Saúde para a Atenção Básica (SISAB - Health Information System for Primary Care) and the Sistema de Informação do Câncer do Colo do Útero (SISCOLO - Cervical Cancer Information System) of DATASUS/Ministry of Health. RESULTS The estimated under-registrations per health unit totaled 108,511 exams in the last two years in the programmatic area 3.1 area, which corresponds to an estimated total of R$ 435,129.00 that would have been foregone if the Previne Brasil Program had been in place during the period studied. CONCLUSION The article's main contribution lies in the presentation of empirical evidence of the potential effects of under-registration on Primary Health Care financing. In addition, there are two other significant findings - firstly, it highlights weaknesses in the process of recording health information inherent to vulnerable regions; secondly, it indicates a vicious circle potentially fueled by sudden changes in Primary Health Care funding conditions, in addition to potential consequences for other levels of care.

RESUMO OBJETIVO Propor um método de detecção e análise do sub-registro e evidenciar o seu potencial efeito financeiro em face da implementação do Programa Previne Brasil. MÉTODOS Foi realizado um estudo ecológico de análise dos exames citopatológicos na área programática 3.1 do município do Rio de Janeiro. Os dados foram coletados do barramento do Datasus, incluindo as informações relativas aos relatórios dos laboratórios terceirizados dos exames citopatológicos e aquelas disponíveis no Sistema de Informação em Saúde para a Atenção Básica (Sisab) e Sistema de Informação do Câncer do Colo do Útero (Siscolo) do Datasus/Ministério da Saúde. RESULTADOS Os sub-registros estimados por unidade de saúde totalizaram 108.511 exames nos últimos dois anos na área programática 3.1, o que corresponde a um total estimado de R$ 435.129,00 que teriam sido deixados de receber, caso o Programa Previne Brasil já estivesse efetivado no período estudado. CONCLUSÃO A principal contribuição do artigo está na apresentação de evidência empírica dos potenciais efeitos do sub-registro para o financiamento da atenção primária à saúde. Além disso, há dois outros achados significativos - primeiro, evidencia fragilidades no processo de registro das informações de saúde inerentes a regiões vulneráveis; segundo, indica um círculo vicioso potencialmente alimentado pela alteração brusca dos condicionantes do financiamento da atenção primária à saúde, além de potenciais consequências para os demais níveis de atenção.

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)

Textual research on ancient and modern literature and analysis on research hot spots of classical prescription Shenling baizhu powder / 中国药房

OBJECTIVE To provide reference for the clinical application and further research and development of Shenling baizhu powder. METHODS Using the methods of textual research and bibliometrics， the key information such as the composition， dose， processing and usage of Shenling baizhu powder in ancient and modern literature were systematically summarized and sorted out， and the number of publications， keywords， and other contents of modern literature were visually analyzed. RESULTS & CONCLUSIONS Shenling baizhu powder was first collected in Taiping Huimin Hejiju Fang （abbreviated “Jufang”）， the composition of core drugs and most widely used dose ratio in previous generations were the same as those in Jufang， basically focusing on powder making and being taken after mixed with liquid； the dosage was concentrated on 2-3 qian； the function and application of it had been expanded to a certain extent compared with Jufang； its clinical application had gradually extended from internal medicine to surgery， gynecology， pediatrics， ophthalmology， dermatology， etc.， covering all aspects of the disease caused by spleen deficiency in general； the composition mechanism revolved around “strengthening the spleen， replenishing qi and removing dampness”； the recommended prescription drugs were all selected from the corresponding varieties in the pharmacopoeia. Modern research mainly focuses on clinical practice， with traditional Chinese medicine or traditional Chinese and Western medicine combined with this formula as the main modified treatment for various intestinal diseases， diarrhea diseases， and lung diseases. The efficacy and application are the frontier hot spots today， and the mechanism of action has begun to be explored. The usage in the literature and the inclusion in the pharmacopoeia are inconsistent， and further research is needed.

Implementation of points-based household registration policy for voluntary blood donors in Nanjing / 中国输血杂志

【Objective】 To analyze the implementation effect of points-based household registration policy for blood donors in Nanjing, so as to provide reference for other provinces and cities to develop incentive policies for blood donation. 【Methods】 The basic demographic profile, registration situation and deferral reasons of blood donors who applied for points-based household registration from 2017 to 2021 were analyzed by Excel. 【Results】 1) A total of 388 blood donors applied for points-based household registration for blood donation from 2017 to 2021, accounting for 0.042% of the total blood donors in Nanjing (388/923 160), and 357 applications were approved, accounting for 0.039% (357/923 160). 2) The proportion of male applicants was higher than that of female applicants (55.15% vs 44.85%). Applicants aged 26~35 accounted for the largest, followed by applicants aged 36~45, and applicants aged 18~25 accounted for the least. The proportion of applicants in Jiangsu province(23.27%) was higher than that of applicants from other provinces. The top three occupations were employees, workers and jobless. In terms of education level, applicants with junior high school education or below accounted for the largest, followed by high school and secondary school (35.05% vs 29.38% vs 23.20%). The proportion of first-time blood donors was the highest (33.24%). Among the repeated blood donors, blood donors who donated blood 2~3 times were with the highest share (23.93%). Nineteen donors(4.90%) got more than 100 points. 3) A total of 31 blood donors were deferred from 2017 to 2021, accounting for 7.90% of the total applicants. Among them, 23 applicants donated in other cities than Nanjing, 5 applicants failed to provide valid blood donation certificates, and 3 applicants submitted irrelevant material. 【Conclusion】 The implementation of points-based household registration policy for voluntary blood donors in Nanjing helped blood donors who could not reach other points due to low education level and income to become registered permanent residence in Nanjing

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.

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.

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.