OBJECTIVE:To provide a way to evaluate test capability for biological sample analysis laboratory,so as to im-prove this test quality. METHODS:By analyzing the use of measurement uncertainty in China and detailing the steps of biological sample analysis laboratory measurement uncertainty,the effects of measurement uncertainty on biological sample analysis laborato-ry are illustrated from two aspects of inner and outer quality control. RESULTS & CONCLUSIONS:National laboratories mainly examine the source of uncertainty through establishing mathematical model,and then uncertainty is evaluated. Uncertainty evalua-tion is a continuous process. Uncertainty assessment and assurance is the overall situation in a biological sample analysis laboratory quality control. Thus,biological sample analysis laboratory can find a method of self-testing capabilities by uncertainty evaluation, find the maximum uncertainty and eliminate or reduce it gradually,ultimately improve laboratory testing quality.

Health promoting lifestyle can help patients with chronic diseases to prevent diseases, maintain their health, and reduce or eliminate dangerous behaviors by changing the incorrect lifestyle of chronic diseases. This article reviews the overview, measuring tool, status quo, influencing factors, and interventions of health promotion lifestyle for patients with chronic diseases, and puts forward the corresponding prospects.

Objective:To investigate the effects of cyclic tensile stress on the function and degeneration of nucleus pulposus cells.Methods:The human primary nucleus pulposus cells were isolated and cultured. The cyclic tensile stress (100 000 μ?, 10% tensile strain, 0.1 Hz, 8 640 cycles) was loaded on the cells for 24 h. The proliferation of the cells was examined by MTT method. The cell cycle and apoptosis were detected through flow cytometry. Gene expression profile chip was used to detect the differentially expressed genes between the tensile stress group and control group. The function of these gene was analyzed by bioinformatics. The expression of inflammatory related factors, TGF-β, matrix degrading enzymes and extracellular matrix molecules were examined by qRT-PCR.Results:The cyclic tensile stress significantly promoted proliferation and cell cycle of nucleus pulposus cells. The cell percentage of S phase ( t=5.336, P<0.05) and G2/M phase ( t=7.288, P<0.01) was significantly different between the tensile stress group and control group. The cyclic tensile stress inhibited apoptosis of nucleus pulposus cells (8.56%±0.48% vs 10.63%±0.32%, t=4.474, P<0.05). A total of 866 differentially expressed genes were detected. Gene ontology analysis showed the roles of these genes in cells including focal adhesion, extractable matrix, membrane raft, condensed chrome kinetochore, cytoskeleton, etc. The cyclic tensile stress significantly affected the mRNA expression of inflammatory related factors, TGF-β genes, matrix proteinase and extracellular matrix molecules. Compared with the control group, the mRNA expression of inflammatory related factors IL15 ( t=5.379, P<0.05), IGF1 ( t=5.454, P<0.05) and IGFBP7 ( t=13.57, P<0.01) were significantly decreased in the tensile stress group; The mRNA expression of TGF-β genes TGFB1 ( t=6.931, P<0.05), TGFB2 ( t= 15.56, P<0.01) and TGFB3 ( t=7.744, P<0.05) were significantly increased in the tensile stress group; The mRNA expression of matrix proteinase ADAMTS3 ( t=5.241, P<0.05) and MMP19 ( t=24.72, P<0.01) were significantly decreased, and TIMP3 ( t=8.472, P<0.01) increased in the tensile stress group; The mRNA expression of extracellular matrix molecules COL2A1 ( t=5.871, P<0.05), FLRT2 ( t=5.216, P<0.05) and FN1 ( t=4.289, P<0.05) were significantly increased. Conclusion:The cyclic tensile stress promoted cell cycle and proliferation and inhibited apoptosis of nucleus pulposus cells. The cyclic tensile stress may affect the function and degeneration of nucleus pulposus cells by regulating the expression of inflammatory related factors, TGF-β, matrix degradation enzymes and ECM molecules.

Objective To establish a high-throughput evaluation model for anaphylactic reactions; To screen and identify potential anaphylactogens from TCM monomeric compounds.MethodsCell model of stably expressed MrgX2 was established. Recombinate plasmid pmCherry-C1-MrgX2 was transfected to HEK293 to establish cell line for screening model. MrgX2 agonist and antagonist were used to identify the validation and stability of the cell line. A small library consisting of 180 compounds was profiled by using a cell-based calcium mobilization assay to find novel compounds targeting the MrgX2 receptor. EC50 test, IC50 test, specificity validation and cytotoxicity evaluation were carried out to detect the function of the positive agonist.ResultsThe EC50 of C48/80 to MrgX2 model was 2.7 μg/mL and the IC50 of 2-APB (evoked by 10 μg/mL C48/80) was 46.29 μmol/L. The first generation cell model of MrgX2 was similar to the 20th generation, and the Z factor of MrgX2 cell model was 0.78. In the primary screening for agonist, isoliensinine was identified as a novel agonist targeting receptor MrgX2 with an EC50 of 4.5 μmol/L and IC50 of39.47 μmol/L. Moreover, isoliensinine was validated to activate MrgX2 receptor specifically without cytotoxicity. Conclusion A high-throughput evaluation method for anaphylactic reactions can be established in vitro through calcium mobilization assay. A potential anaphylactogen isoliensinine is identified and validated.

Objective:To understand the current status of humanistic care ability of undergraduate intern nursing students and patient safety perception and to explore the correlation between them, so as to provide a new basis for nursing managers to formulate intervention strategies to improve patient safety perception of undergraduate nursing students.Methods:Using the convenient sampling method, a total of 120 senior nursing students who were intern in a Class Ⅲ Grade A hospital in Dalian were selected as the research objects.The general data questionnaire, Human Care Ability Scalefor Nursing College Students and Chinese version of Health Professional Education in Patient Safety Survey (H-PEPSS) were used to investigate the patients. A total of 120 questionnaires were sent out and 111 were effectively returned, with an effective recovery rate of 92.5%.Results:The total score of Human Care Ability Scale for Nursing College Students of 111 undergraduate nursing students was (67.25±9.14) and the total score of H-PEPSs was (70.69±9.71) . The results of multiple linear regression analysis showed that instilling faith and hope, promoting emotional communication and helping to relieve difficulties were the influencing factors of patient safety perception of undergraduate nursing students ( P< 0.05) . Conclusions:The humanistic care ability of undergraduate nursing students is positively correlated with patient safety perception.Universities and teaching hospitals should pay more attention to the cultivation of humanistic care ability of undergraduate nursing students in order to achieve the purpose of improving their patient safety perception.

In this study, virtual reality technology is applied to the teaching of ART due to its characteristic of real-time interaction, and a virtual operation platform of intracytoplasmic sperm injection (ICSI) is developed in the scene of ART, which can be used for the practice and training of ICSI during teaching. By this virtual system we can overcome some kinds of teaching limitations brought by scarce experimental materials and expensive equipment, and it is suitable for multi-center and multi-region popularization and application for other ART laboratories.

OBJECTIVE: To explore the clinical features and genetic basis for a Chinese pedigree diagnosed with congenital glycosylation disease (CGD). METHODS: Clinical manifestations of two brothers were analyzed. Whole exome sequencing was carried out for the sib pair. Suspected variants were verified by Sanger sequencing. RESULTS: Both the proband and her younger brother were found to carry compound heterozygous variants of the PMM2 gene, which included a known pathogenic mutation of c.395T>C (p.I132T) and a previously unreported c.448-1(delAG) in the 5' end of exon 6 of the gene. CONCLUSION The compound heterozygous variants of the PMM2 gene probably underlay the CGD in the sib pair.
Asians/genetics* ; China ; Female ; Glycosylation ; Humans ; Male ; Mutation ; Pedigree ; Whole Exome Sequencing

Objective:To explore the research hotspots and effective promotion paths of post market surveillance and supervise of medical consumables with non-active medical devices.Methods:Data mining methods were used to collect related journal literatures and documents from the websites of China regulatory institutions and the China National Knowledge Infrastructure(CNKI),order sub item data of medical device adverse event reports,extract the MeSH element words of literatures and documents,perform bibliometric analysis and visual display.Results:The number of medical devices adverse event reports in China has been increasing year by year,reaching 694 866 in 2022,in the four statistical years from 2019 to 2022,the number of reports on non-active medical devices and IVD reagents also showed a parallel increasing trend,accounting for about 65.00% of the total number of adverse event reports on medical devices in the year.The bibliometric analysis of journal literature shows that research in this field has received varying degrees of participation from regulatory institutions,universities,medical institutions,and enterprises.Regulatory institutions have contributed 46 articles,accounting for 56.79% of the total number of articles,followed by 28 articles from universities.The co-occurrence analysis shows that hot topic is focused in 5 clusters:quality management,risk management,international experiences discussion and adverse event surveillance and re-evaluation and real-world research.China regulatory institutions attach great importance to post market surveillance and supervise,and have issued more than 20 relevant documents since 2006,focusing on specific topics and gradually deepening around safety and effectiveness.Conclusion:The post market surveillance and supervise of medical devices,especially medical consumables based on non-active medical devices,need to be promoted synchronously in three dimensions:regulatory institutions,medical institutions,and enterprises.Universities,research institutes,and industry organizations should work in coordinating to strengthen the collection,identification,and active surveillance of risk signals based on adverse event surveillance,safety evaluation based on risk management,and conducting real-world research,research and develop risk control and corrective and preventive measures.

Objective:To investigate the effect of CHI3L1 on the biological function of chondrocytes and its role in lumbar facet joint degeneration.Methods:The human lumbar facet joint articular cartilage were collected, and the relative mRNA expression of CHI3L1 gene detected by quantitative fluorescence PCR. Then explored the correlation between joint degeneration and gender, age and relative mRNA expression of CHI3L1. Human chondrocytes were cultured in vitro. The effects of CHI3L1 on chondrocyte proliferation, cycling, and apoptosis, as well as expression of related inflammatory factors, were investigated. The mechanism by which CHI3L1 regulates the degeneration of articular cartilage was investigated using the signal transduction pathway protein chip.Results:There was a positive correlation between the grade of degeneration in lumbar facet joint and the relative expression of CHI3L1 gene mRNA ( r=0.76, P<0.001). There was no correlation with the patient's gender ( r=-0.12, P=0.500). A positive correlation between the age of patients and the relative expression of CHI3L1 gene mRNA was found ( r=0.47, P=0.005). Compared with the non-degenerative group, the expression of CHI3L1 gene mRNA significantly increased in the degenerative group, and the expression of CHI3L1 gradually increased with the aggravation in the grade of degeneration ( F=18.90, P<0.001). Compared with the non-degenerative group, the chondrocytes in the CHI3L1 group had significantly lower proliferation at 48 h (OD 490/fold=7.132), 72 h (OD 490/fold=4.803), 96 h (OD 490/fold=2.431) and 120 h (OD 490/fold=0.009). The ratio of chondrocytes in G1 phase, S phase and G2/M phase were 85.03%±3.05%, 12.78%±2.29% and 0.90%±0.76% in the CHI3L1 group, and 73.93%±2.73%, 22.81%±1.93% and 0.99%±0.87% in control group, respectively. There were significant differences in the percentage of chondrocytes in G1 phase ( t=4.70, P<0.001) and S phase ( t=5.80, P<0.001) between the two groups. The percentages of apoptosis in chondrocyte in CHI3L1 group and control group were 8.64%±0.76% and 5.68%±1.13%, which has a statistically difference ( t=4.47, P<0.001). The expression of IL-6 in chondrocytes of CHI3L1 group was 49.60±0.01 pg/ml, which was higher than that of 47.88±0.01 pg/ml in the control group ( t=132.70, P<0.001). The expression of TNF-α was 95.93±0.02 pg/ml, which was higher than 90.69±0.02 pg/ml in the control group ( t=376.10, P<0.001). There was significant difference in expression of IL-6 in chondrocytes between the CHI3L1 group and the control group ( t=132.72, P<0.001). The expression of TNF-α ( t=376.10, P<0.001) was statistically difference. Protein chip detected 53 proteins with significant differences in expression and 43 proteins with significant differences in protein phosphorylation levels. Bioinformatics analysis was used to identify 16 signaling pathways in which the above different proteins might be involved, including ErbB, PI3K, Akt, Ras, JAK, STAT3, MAPK pathway. In the MAPK pathway, the expression of MAPK1 and RAF1 proteins was higher in the chondrocytes of the CHI3L1 group than in the control group (1.094±0.00 vs. 0.814±0.00, 0.988±0.00 vs. 0.786±0.00; t=103.16, P<0.001; t=54.32, P<0.001). Compared with the control group, the expression of MAPK1 and RAF1 proteins was significantly increased in the chondrocytes of the CHI3L1 group. Conclusion:The expression of CHI3L1 is corrected to articular cartilage degeneration. CHI3L1 is able to inhibit the proliferation of articular chondrocytes, which regulated the cycling of chondrocytes from G1 phase to S phase, promote the apoptosis of chondrocytes, and promote the expression of IL-6 and TNF-α in chondrocytes. Regulation of chondrocytes biological function through the MAPK pathway, which is a potential biomarker for the clinical diagnosis and treatment of lumbar joint degeneration.

OBJECTIVE To evaluate the cost-effectiveness of durvalumab for consolidation therapy after chemoradiotherapy for unresectable stage Ⅲ non-small cell lung cancer from the perspective of the Chinese health care system. METHODS A Markov model was developed by using updated four-year survival data from the PACIFIC trial in May 2021 and relevant literature. The cost-effectiveness of durvalumab for consolidation therapy after chemoradiotherapy for unresectable stage Ⅲ non-small cell lung cancer was evaluated by using quality-adjusted life years （QALYs）as health output index with 20-year simulation time frame and a 2-week cycling period. The costs and health output were discounted using discount rate of 5％；one-way sensitivity analysis and probabilistic sensitivity analysis were used to examine the robustness of the model simulation results. RESULTS The results of the base analysis showed that compared with placebo group ，durvalumab resulted in 0.73 QALYs at an incremental cost of 1 076 062.86 yuan and an incremental cost-utility ratio （ICER）of 1 467 546.54 yuan/QALY，which was much higher than 3-fold per capita gross domestic products （GDP）in 2020（217 713 yuan）as willingness-to-pay （WTP）threshold. The results of one-way sensitivity analysis showed that the price of durvalumab and discount rate had a great impact on ICER. Probabilistic sensitivity analysis showed no cost-effective advantage for durvalumab when the WTP threshold was three times of GDP per capita in 2020 （217 713 yuan）. CONCLUSIONS From the perspective of Chinese health care system ，there is no cost-effective advantage to the use of durvalumab for consolidation therapy after chemoradiotherapy for unresectable stage Ⅲ non-small cell lung cancer when the WTP threshold was three times of GDP per capita in 2020.