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1.
Br J Nutr ; 131(10): 1720-1729, 2024 May 28.
Artigo em Inglês | MEDLINE | ID: mdl-38275085

RESUMO

This study aimed to investigate the association between n-3 PUFA and lung function. First, a cross-sectional study was conducted based on the National Health and Nutrition Examination Survey (NHANES) 2007-2012 data. n-3 PUFA intake was obtained from 24-h dietary recalls. A multivariable linear regression model was used to assess the observational associations of n-3 PUFA intake with lung function. Subsequently, a two-sample Mendelian randomisation (MR) was performed to estimate the potential causal effect of n-3 PUFA on lung function. Genetic instrumental variables were extracted from published genome-wide association studies. Summary statistics about n-3 PUFA was from UK Biobank. Inverse variance weighted was the primary analysis approach. The observational study did not demonstrate a significant association between n-3 PUFA intake and most lung function measures; however, a notable exception was observed with significant findings in the highest quartile for forced vital capacity (FVC) and % predicted FVC. The MR results also showed no causal effect of circulating n-3 PUFA concentration on lung function (forced expiratory volume in one second (FEV1), ß = 0·01301, se = 0·01932, P = 0·5006; FVC, ß = -0·001894, se = 0·01704, P = 0·9115; FEV1:FVC, ß = 0·03118, se = 0·01743, P = 0·07359). These findings indicate the need for further investigation into the impact of higher n-3 PUFA consumption on lung health.


Assuntos
Ácidos Graxos Ômega-3 , Pulmão , Análise da Randomização Mendeliana , Inquéritos Nutricionais , Humanos , Ácidos Graxos Ômega-3/administração & dosagem , Ácidos Graxos Ômega-3/sangue , Pulmão/fisiologia , Masculino , Estudos Transversais , Feminino , Pessoa de Meia-Idade , Capacidade Vital , Adulto , Volume Expiratório Forçado , Dieta , Estudo de Associação Genômica Ampla , Idoso , Testes de Função Respiratória
2.
Sleep Breath ; 2024 Jul 17.
Artigo em Inglês | MEDLINE | ID: mdl-39017902

RESUMO

PURPOSE: Obstructive sleep apnoea hypoventilation syndrome (OSAHS) is a common sleep disorder that affects multiple body systems, which in turn is closely associated with cognitive dysfunction, diabetes mellitus, oncological cardiovascular diseases and metabolic disorders. In recent years, non-coding RNA (ncRNA) has emerged as a new opportunity for biomarker discovery. We therefore discuss the research progress and potential role of ncRNAs in obstructive sleep apnea hypoventilation syndrome. METHODS: This review systematically searched relevant academic literature from PubMed, Web of Science and other databases. During the retrieval process, a combination of keywords such as "OSAHS", "ncRNA", "lncRNA", "miRAN", "circRNA" was used for search. RESULTS: Circulating ncRNA has good area under the ROC curve, sensitivity and specificity in the diagnosis of OSAHS, and has the potential to become a diagnostic marker for OSAHS, while several circulating ncRNAs or circulating ncRNAs in combination with other tests such as the Obstructive Sleep Apnoea Screening Scale have a higher value of application as a test for OSAHS. Further analyses revealed that many circulating ncRNAs were significantly differentially expressed in the serum of OSAHS patients with different very severities, a potential marker for predicting the severity of OSAHS, and that the ncRNA content of patients' serum also had a significant effect during CPAP therapy, suggesting that it may have potential for therapeutic monitoring. Meanwhile, serum ncRNAs from patients have been shown to be effective in the diagnosis of OSAHS complications such as hypertension, Alzheimer's disease, acute myocardial infarction and atherosclerosis. The expression of up- or down-regulated ncRNAs can regulate different signalling pathways, which in turn affects various OSAHS complications such as pulmonary hypertension, diabetes mellitus, and cognitive dysfunction, and is expected to become a new direction for the treatment of these complications. CONCLUSIONS: The changes in ncRNA expression in OSAHS patients are expected to be a novel biomarker for the diagnosis and treatment of OSAHS, and can also be used as a potential biomarker for the combination of diabetes mellitus, cardiovascular disease, respiratory disease, and cognitive dysfunction in OSAHS. It is believed that the continuous progress of ncRNA-related research is expected to promote the early detection, diagnosis and treatment of OSAHS and its complications.

3.
BMC Pulm Med ; 24(1): 72, 2024 Feb 07.
Artigo em Inglês | MEDLINE | ID: mdl-38326796

RESUMO

BACKGROUND: While several traditional observational studies have suggested associations between gut microbiota and asthma, these studies are limited by factors such as participant selection bias, confounders, and reverse causality. Therefore, the causal relationship between gut microbiota and asthma remains uncertain. METHODS: We performed two-sample bi-directional Mendelian randomization (MR) analysis to investigate the potential causal relationships between gut microbiota and asthma as well as its phenotypes. We also conducted MR analysis to evaluate the causal effect of gut metabolites on asthma. Genetic variants for gut microbiota were obtained from the MiBioGen consortium, GWAS summary statistics for metabolites from the TwinsUK study and KORA study, and GWAS summary statistics for asthma from the FinnGen consortium. The causal associations between gut microbiota, gut metabolites and asthma were examined using inverse variance weighted, maximum likelihood, MR-Egger, weighted median, and weighted model and further validated by MR-Egger intercept test, Cochran's Q test, and "leave-one-out" sensitivity analysis. RESULTS: We identified nine gut microbes whose genetically predicted relative abundance causally impacted asthma risk. After FDR correction, significant causal relationships were observed for two of these microbes, namely the class Bacilli (OR = 0.84, 95%CI = 0.76-0.94, p = 1.98 × 10-3) and the order Lactobacillales (OR = 0.83, 95%CI = 0.74-0.94, p = 1.92 × 10-3). Additionally, in a reverse MR analysis, we observed a causal effect of genetically predicted asthma risk on the abundance of nine gut microbes, but these associations were no longer significant after FDR correction. No significant causal effect of gut metabolites was found on asthma. CONCLUSIONS: Our study provides insights into the development mechanism of microbiota-mediated asthma, as well as into the prevention and treatment of asthma through targeting specific gut microbiota.


Assuntos
Asma , Microbioma Gastrointestinal , Microbiota , Humanos , Microbioma Gastrointestinal/genética , Análise da Randomização Mendeliana , Asma/genética , Nonoxinol , Estudo de Associação Genômica Ampla
4.
Arch Microbiol ; 205(12): 373, 2023 Nov 07.
Artigo em Inglês | MEDLINE | ID: mdl-37934248

RESUMO

To investigate the biological characteristics of monoclonal antibodies (mAbs) against avian influenza virus (AIV) and the possible mechanism of AIV-related kidney injury. BALB/c mice were immunized with inactivated H5N1 AIV to prepare monoclonal antibody H5-32, and its subtype, titer and cross-reactivity with other influenza viruses were identified. The reactivity of monoclonal antibody with normal human tissue was analyzed by immunohistochemistry. Immunofluorescence and confocal laser scanning technique were used to detect the binding sites between mAb and human renal cortical cells, and Western blotting was used to detect the size of binding fragments. Immunohistochemical analysis confirmed that monoclonal antibody H5-32 cross-reacted with normal human kidney tissue. In human kidney, mAb H5-32 was localized in the cytoplasm of human renal tubular epithelial cells, and its binding fragment size was about 43 kDa. H5N1 AIV appears to bind to human renal tubular epithelial cells, which may be one of the mechanisms of kidney injury caused by AIV infection.


Assuntos
Virus da Influenza A Subtipo H5N1 , Influenza Aviária , Humanos , Animais , Camundongos , Anticorpos Monoclonais , Rim , Córtex Renal , Camundongos Endogâmicos BALB C
5.
Sensors (Basel) ; 23(17)2023 Sep 03.
Artigo em Inglês | MEDLINE | ID: mdl-37688082

RESUMO

Human pose estimation is the basis of many downstream tasks, such as motor intervention, behavior understanding, and human-computer interaction. The existing human pose estimation methods rely too much on the similarity of keypoints at the image feature level, which is vulnerable to three problems: object occlusion, keypoints ghost, and neighbor pose interference. We propose a dual-space-driven topology model for the human pose estimation task. Firstly, the model extracts relatively accurate keypoints features through a Transformer-based feature extraction method. Then, the correlation of keypoints in the physical space is introduced to alleviate the error localization problem caused by excessive dependence on the feature-level representation of the model. Finally, through the graph convolutional neural network, the spatial correlation of keypoints and the feature correlation are effectively fused to obtain more accurate human pose estimation results. The experimental results on real datasets also further verify the effectiveness of our proposed model.


Assuntos
Fontes de Energia Elétrica , Redes Neurais de Computação , Humanos
6.
Molecules ; 28(12)2023 Jun 07.
Artigo em Inglês | MEDLINE | ID: mdl-37375156

RESUMO

Photocatalytic conversion of carbon dioxide into chemical fuels offers a promising way to not only settle growing environmental problems but also provide a renewable energy source. In this study, through first-principles calculation, we found that the Se vacancy introduction can lead to the transition of physical-to-chemical CO2 adsorption on Janus WSSe nanotube. Se vacancies work at the adsorption site, which significantly improves the amount of transferred electrons at the interface, resulting in the enhanced electron orbital hybridization between adsorbents and substrates, and promising the high activity and selectivity for carbon dioxide reduction reaction (CO2RR). Under the condition of illumination, due to the adequate driving forces of photoexcited holes and electrons, oxygen generation reaction (OER) and CO2RR can occur spontaneously on the S and Se sides of the defective WSSe nanotube, respectively. The CO2 could be reduced into CH4, meanwhile, the O2 is produced by the water oxidation, which also provides the hydrogen and electron source for the CO2RR. Our finding reveals a candidate photocatalyst for obtaining efficient photocatalytic CO2 conversion.

7.
Neuroradiology ; 64(10): 2011-2019, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-35588325

RESUMO

PURPOSE: Cognitive impairment has been revealed in primary Sjögren's syndrome (pSS). However, the underlying white matter structural connectivity (SC) changes have not been studied. This study aimed to investigate the altered white matter brain network in patients with pSS using diffusion tensor imaging (DTI). METHODS: Forty-one pSS patients and sixty matched healthy controls (HCs) underwent neuropsychological tests and the subsequent MRI examinations. The clinical data were gathered from the medical record. The structural brain network was established using DTI, and a link-based comparison was performed between patients with pSS and HCs (false discovery rate correction, P < 0.05). Furthermore, the mean fractional anisotropy (FA) of the altered SCs was correlated with the neuropsychological tests and clinical data in patients with pSS (Bonferroni correction, P < 0.05). RESULTS: Compared with HCs, patients with pSS mainly exhibited decreased SC in the frontal and parietal lobes and some parts of the temporal and occipital lobes. In addition, increased SC was found between the right caudate nucleus and right median cingulate/paracingulate gyri. Specifically, the reduced SC between the left middle temporal gyrus and left middle occipital gyrus was negatively correlated with white matter high signal intensity (WMH). CONCLUSIONS: Patients with pSS showed diffusely decreased SC mainly in the frontoparietal network and exhibited a negative correlation between the reduced SC and WMH. SC represents a potential biomarker for preclinical brain impairment in patients with pSS.


Assuntos
Síndrome de Sjogren , Substância Branca , Encéfalo/diagnóstico por imagem , Imagem de Tensor de Difusão/métodos , Humanos , Imageamento por Ressonância Magnética , Síndrome de Sjogren/diagnóstico por imagem , Substância Branca/diagnóstico por imagem
8.
Acta Radiol ; 63(9): 1214-1222, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34282631

RESUMO

BACKGROUND: Sjögren's syndrome (SjS) associated with systemic lupus erythematosus (SjS-SLE) was considered a standalone but often-overlooked entity. PURPOSE: To assess altered spontaneous brain activity in SjS-SLE and SjS using amplitude of low-frequency fluctuation (ALFF). MATERIAL AND METHODS: Sixteen patients with SjS-SLE, 17 patients with SjS, and 17 matched controls underwent neuropsychological tests and subsequent resting-state functional magnetic resonance imaging (fMRI) examinations. The ALFF value was calculated based on blood oxygen level dependent (BOLD) fMRI. Statistical parametric mapping was utilized to analyze between-group differences and multiple comparison was corrected with Analysis of Functional NeuroImages 3dClustSim. Then, the ALFFs of brain regions with significant differences among the three groups were correlated to corresponding clinical and neuropsychological variables by Pearson correlation. RESULTS: ALFF differences in the bilateral precuneus/posterior cingulate cortex (PCC), right parahippocampal gyrus/caudate/insula, and left insula were found among the three groups. Both SjS-SLE and SjS displayed decreased ALFF in the right parahippocampal gyrus, right insula, and left insula than HC. Moreover, SjS-SLE showed wider decreased ALFF in the bilateral precuneus and right caudate, while the SjS group exhibited increased ALFF in the bilateral PCC. Additionally, patients with SjS-SLE exhibited lower ALFF values in the bilateral PCC and precuneus than SjS. Moreover, ALFF values in the right parahippocampal gyrus and PCC were negatively correlated to fatigue score and disease duration, respectively, in SjS-SLE. CONCLUSION: SjS-SLE and SjS exhibited common and different alteration of cerebral functional segregation revealed by AlFF analysis. This result appeared to indicate that SjS-SLE might be different from SjS with a neuroimaging standpoint.


Assuntos
Lúpus Eritematoso Sistêmico , Síndrome de Sjogren , Encéfalo/patologia , Mapeamento Encefálico , Humanos , Imageamento por Ressonância Magnética/métodos , Síndrome de Sjogren/diagnóstico por imagem
9.
Zhongguo Yi Liao Qi Xie Za Zhi ; 45(6): 594-598, 2021 Nov 30.
Artigo em Zh | MEDLINE | ID: mdl-34862768

RESUMO

Infertility has become one of the global problems, with the continuous improvement and penetration of human assisted reproductive technology, appliance products of medical devices for assisted reproductive technology, such as aspiration needles, micromanipulator and embryo transfer catheter, have been widely used. In order to ensure the safety and effectiveness of such products, it is necessary to establish an appropriate quality control system. This paper mainly discusses the quality control points of human assisted reproductive medical devices from the aspects of raw materials, product design, production process, key performance, packaging, preservation and transportation, so as to provide technical reference for the research and development, production and supervision of such products.


Assuntos
Técnicas de Reprodução Assistida , Estudos Transversais , Humanos , Controle de Qualidade
10.
Cell Biol Toxicol ; 36(4): 301-313, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-31884678

RESUMO

Particulate matter (PM) is an environmental pollutant closely associated with human airway inflammation. However, the molecular mechanisms of PM-related airway inflammation remains to be fully elucidated. It is known that COX-2/PGE2 play key roles in the pathogenesis of airway inflammation. Filaggrin is a transmembrane protein contributing to tight junction barrier function. As such, Filaggrin prevents leakage of transported solutes and is therefore necessary for the maintenance of epithelial integrity. The objective of the present study was to investigate the regulatory mechanisms of COX-2/PGE2 and Filaggrin upon PM exposure both in vivo and in vitro. C57BL/6 mice received intratracheal instillation of PM for two consecutive days. In parallel, human bronchial epithelial cells (HBECs) were exposed to PM for 24 h. PM exposure resulted in airway inflammation together with upregulation of COX-2/PGE2 and downregulation of Filaggrin in mouse lungs. Corresponding dysregulation of COX-2/PGE2 and Filaggrin was also observed in HBECs subjected to PM. PM exposure led to the phosphorylation of ERK, JNK, and PI3K signaling pathways in a time-dependent manner, while blockade of PI3K with the specific molecular inhibitor LY294002 partially reversed the dysregulation of COX-2/PGE2 and Filaggrin. Moreover, pretreatment of HBECs with NS398, a specific molecular inhibitor of COX-2, and AH6809, a downstream PGE2 receptor inhibitor, reversed the downregulation of Filaggrin upon PM exposure. Taken together, these data demonstrated that the PI3K signaling pathway upregulated COX-2 as well as PGE2 and acted as a pivotal mediator in the downregulation of Filaggrin.


Assuntos
Ciclo-Oxigenase 2/metabolismo , Células Epiteliais/metabolismo , Proteínas de Filamentos Intermediários/metabolismo , Material Particulado/metabolismo , Fosfatidilinositol 3-Quinases/metabolismo , Animais , Linhagem Celular , Epitélio/metabolismo , Proteínas Filagrinas , Humanos , Camundongos Endogâmicos C57BL
11.
Zhongguo Yi Liao Qi Xie Za Zhi ; 44(5): 439-442, 2020 Oct 08.
Artigo em Zh | MEDLINE | ID: mdl-33047570

RESUMO

Water is an important component in liquid medical device products for human assisted reproductive technology. Water traits, conductivity, microbial limits, total organic carbon, easy oxides, heavy metal content, bacterial endotoxin and other indicators have an important impact on sperm, egg and embryo development in vitro, so for such products, the quality of water control is extremely important. The production water for producing such products is generally prepared by MilliQ purification system. In this research, we used four different types of water to fabricate the IVF liquids. It included deionized reverse osmosis water, ultra purified water and ultra purified water without endotoxin or nucleic acid, and compared with tap water. The in vitro rat embryo test system was used to study the embryotoxicity of this four different culture liquid production waters. From the result, the group of the super purified water without endotoxin and nucleic acid has the best result of the embryo formation rate, the number of total cell number and the inner cell number. This study proved the importance of removing endotoxin and nucleic acid from the water used for the preparation of the liquid products for assisted reproduction, and provided the basis for the selection of water quality for the liquid products for assisted reproduction.


Assuntos
Desenvolvimento Embrionário , Contaminação de Equipamentos , Fertilização in vitro , Técnicas de Reprodução Assistida , Água , Animais , Fertilização in vitro/instrumentação , Humanos , Ratos , Pesquisa , Tecnologia
12.
Neuroradiology ; 61(6): 685-694, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30918990

RESUMO

PURPOSE: To investigate the diffusion kurtosis imaging (DKI) in early minimal hepatic encephalopathy (MHE) diagnosis and evaluate the correlations between changes in DKI metrics and cognitive performance. METHODS: We enrolled 116 cirrhosis patients, divided into non-HE (n = 61) and MHE (n = 55), and 46 normal controls (NCs). All patients underwent cognitive testing before magnetic resonance imaging. DKI metrics were calculated through whole-brain voxel-based analysis (VBA) and differences between the groups were assessed. Pearson correlation between the DKI metrics and cognitive performance was analysed. The receiver operating characteristic (ROC) curve was used to analyse the diagnostic efficiency of DKI metrics for MHE. RESULTS: MHE patients had significantly altered DKI metrics in a wide range of regions; lower fractional anisotropy (FA) and higher mean diffusivity (MD) are mainly located in the corpus callosum, left temporal white matter (WM), and right medial frontal WM. Furthermore, significantly altered kurtosis metrics included lower mean kurtosis (MK) in the corpus callosum and left thalamus, lower radial kurtosis (RK) in the corpus callosum, and lower axial kurtosis (AK) in the right anterior thalamic radiation. Alterations in axial diffusivity (AD), radial diffusivity (RD), and MD were closely correlated with cognitive scores. The ROC curves indicated AD in the forceps minor had the highest predictive performance for MHE in the cirrhosis patients (area under curve = 0.801, sensitivity = 77.05%, specificity = 74.55%). CONCLUSIONS: Altered DKI metrics indicate brain microstructure abnormalities in MHE patients, some of which may be used as neuroimaging markers for early MHE diagnosis.


Assuntos
Disfunção Cognitiva/diagnóstico por imagem , Imagem de Tensor de Difusão/métodos , Encefalopatia Hepática/diagnóstico por imagem , Substância Branca/diagnóstico por imagem , Anisotropia , Biomarcadores/sangue , Estudos de Casos e Controles , Disfunção Cognitiva/patologia , Feminino , Encefalopatia Hepática/patologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sensibilidade e Especificidade , Substância Branca/patologia
13.
Int J Phytoremediation ; 21(5): 479-486, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30560684

RESUMO

Large amounts of wastewater are generated from stone processing, which are toxic and cause serious environmental and health risks. To quantify the content of stone processing wastewater and estimate its effects on plant growth, we collected water samples from sewage outfall of four stone processing factories and nearby water bodies. The concentration of potential toxic metals were much higher in the wastewater than background controls. Wastewater inhibited plant primary root elongation, lateral root formation, and growth of aerial part. Seedlings treated with the effluents were unhealthy with deep purple leaves and usually died before flowering. Chlorophyll a/b contents and chloroplast number were reduced in those abnormal mesophyll cells. Transcriptional levels were decreased for chloroplast formation genes, but increased for those participated in chloroplast degradation and catabolism. Six out of nine tested senescence-associated genes were up-regulated. Furthermore, our results show that endogenous toxic metal levels indeed increased after wastewater treatment. Altogether, these results indicated that the potential toxic metals rich wastewater had significant inhibition on plant growth and led to senescence-associated program cell death, which could be helpful for the government and enterprises to understand the environmental risks and formulate reasonable wastewater emission standards for the stone processing industry.


Assuntos
Metais Pesados , Águas Residuárias , Biodegradação Ambiental , Clorofila A , Crescimento e Desenvolvimento
14.
Zhongguo Yi Liao Qi Xie Za Zhi ; 42(2): 119-121, 2018 Feb 08.
Artigo em Zh | MEDLINE | ID: mdl-29845813

RESUMO

This paper gives a brief introduction on the development of recognized consensus standards, the recognition working procedure and the overview of medical devices recognized consensus standards in USA, and analyzes the experience of the recognition management system in USA, aiming at providing a reference for the improvement of the medical device standard management system in China.


Assuntos
Consenso , Equipamentos e Provisões/normas , China , Aprovação de Equipamentos , Padrões de Referência , Estados Unidos , United States Food and Drug Administration
15.
Zhongguo Yi Liao Qi Xie Za Zhi ; 42(1): 49-52, 2018 Jan 30.
Artigo em Zh | MEDLINE | ID: mdl-29862747

RESUMO

Medical device standards provide effective technique foundation for supervision to ensure medical device safety for the people. With the optimization and upgrading of the medical device industry, the medical devices standard system including law and regulation system, organization management system, and technical management system has been advanced and developed. According to the requirements of the development of medical device industry and its standards, we put forward four working ideas, in order to improve the scientificity and applicability of medical device standards.


Assuntos
Segurança de Equipamentos , Equipamentos e Provisões/normas , Indústrias , Padrões de Referência
16.
Zhongguo Yi Liao Qi Xie Za Zhi ; 42(3): 202-205, 2018 May 30.
Artigo em Zh | MEDLINE | ID: mdl-29885129

RESUMO

By comparing new medical device regulations with existing directives in the European Union, the revising ideas of new EU medical device regulations, especially the changes of the classification management concepts, were analyzed to provide clues for the industry to interpret the new EU regulations, and references for the classification management innovation in our country.


Assuntos
Equipamentos e Provisões/classificação , União Europeia , Regulamentação Governamental , Indústrias
17.
Zhongguo Yi Liao Qi Xie Za Zhi ; 41(5): 362-364, 2017 Sep 30.
Artigo em Zh | MEDLINE | ID: mdl-29862726

RESUMO

OBJECTIVES: The present study was designed to analysis some misunderstanding on "medical devices classification rules" of CFDA, in order to correct understand and use the regulation. METHODS: The contents of "medical devices classification rules" by CFDA have been analysis and generalized. RESULTS: Through analyzing, we can conclude as followed:the priority principle of classification catalogue; the comprehensive judgment principle based on the classification decision table and special classification principles; medical devices' management class could be changed by CFDA according to risk analysis results. CONCLUSIONS: It is helpful to reach an agreement on the classification of a medical device among the regulatory authorities, production enterprises and other aspects, and establish a solid foundation for CFDA's regulatory science.


Assuntos
Equipamentos e Provisões/classificação , Regulamentação Governamental , Humanos
18.
Zhongguo Yi Liao Qi Xie Za Zhi ; 41(4): 283-285, 2017 Jul 30.
Artigo em Zh | MEDLINE | ID: mdl-29862790

RESUMO

The new version of Medical Device Classification Directory(revised Draft) has opened to the public comments. This paper briefly introduces the classification of medical device in China and the historical development of the directory, and focuses on the analysis of the main changes in the new version of the directory to help the supervision department, manufactures, and related organizations better understand and use the new directory.


Assuntos
Equipamentos e Provisões/classificação , China
19.
Zhongguo Yi Liao Qi Xie Za Zhi ; 41(5): 365-368, 2017 Sep 30.
Artigo em Zh | MEDLINE | ID: mdl-29862727

RESUMO

Based on analyzing the classification catalog of medical device for rehabilitation, combined with the example, this paper discusses the principle of judgment of the classification of medical device for rehabilitation, and the naming and technical standards related to classification, puts forward the suggestions of classification management, attributes definition, and the naming, in order to provide support for promoting the reform of medical device classification management, and improving the level of scientific supervision.


Assuntos
Equipamentos e Provisões/classificação , Reabilitação/instrumentação , Padrões de Referência
20.
Zhongguo Yi Liao Qi Xie Za Zhi ; 40(4): 271-4, 2016.
Artigo em Zh | MEDLINE | ID: mdl-29775523

RESUMO

In vitro diagnostic product(IVD) involved in disease prevention, diagnosis, treatment options, efficacy evaluation, etc., the quality level directly affects the accuracy of diagnosis. Based on the correct identification of the risk of IVD, a reasonable classifications of great significance to achieve scientific regulation, conservation of regulatory resources, promote the healthy development of the in vitro diagnostics industry. In this paper, opinions and suggestions on the reform and perfecting the regulatory classification of IVD in China is put forward through the analysis of the classification management system of IVD in Europe and the United States, combined with the status quo of China;s regulatory classification and existing problems.


Assuntos
Equipamentos e Provisões , Regulamentação Governamental , China , Europa (Continente) , Estados Unidos
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