Objective: To investigate the basic situation of pre-analytical quality management in blood station laboratories in North China, and to provide baseline data for promoting the homogenization and standardization of these pre-analytical processes in each blood station laboratory. Methods: A cross-sectional status survey was designed based on the quality management regulations of blood stations, ISO15189 standards and relevant quality management requirements. This survey covering various aspects including laboratory general situation, sample collection and temporary storage, transportation, reception, and quality continuous improvement situations. Data analysis was performed on the survey results of each laboratory. Results: All the 38 blood station laboratories in North China had established a pre-analytical quality management system framework and implemented basic pre-analytical quality control activities; however, there were differences in implementation. 1) Among the 12 basic quality items, 3 items were monitored by all the investigated laboratories (100%), 6 items were monitored by the vast majority of laboratories (about 90%), and 3 items were monitored by a portion of laboratories (about 60%). There were no significant differences in the monitoring index among the three regions and among different types of laboratories (P>0.05). 2) Among the total of 26 items in the three key processes before testing (sample collection and storage, transportation, reception and processing), 12 items were monitored by all laboratories (100%), 11 items were monitored by the vast majority of laboratories (about 90%), and 3 items were monitored by a portion of laboratories (about 75%). There were no significant differences in monitoring index among different regions and types of laboratories (P>0.05). Conclusion: This survey provides a reference and basis for the gap analysis of the pre-analytical process quality management in 38 blood station laboratories across North China. It facilitates laboratories in identifying pre-analytical quality problems, resolving problems, preventing errors, and ensuring that the quality of blood samples before testing meets the established requirements. It lays a foundation for the homogenization of pre-analytical quality management in regional blood stations.

Objective: To determine the frequency and main reasons of unqualified samples by analyzing the quality of pre-analytical samples in blood stations in North China, thereby providing a reference and basis for gap analysis in the implementation of pre-analytical process quality management for participating laboratories and ensuring that only high-standard and high-quality blood samples proceed to testing. Methods: Data on the quality of pre-analytical samples from blood station laboratories in North China was collected via questionnaire. Statistical analysis were performed on: 1) the basic information of samples quality monitoring in the laboratories; 2) the distribution of the overall pre-analytical unqualified rate of samples and the pre-analytical unqualified rate of samples in each laboratory; 3) the distribution of reasons for sample disqualification. Results: 1) The overall pre-analytical unqualified rate of samples in blood station laboratories in North China was 4.55, with a total sigma level of 5.39σ. The 25th, 50th and 75th percentiles (P25, P50, P75) for the total unqualified rate were 0.00, 1.10 and 5.96, respectively. The corresponding percentiles for the Sigma level were 5.34σ, 5.71σ, and 6.00σ, respectively. The pre-analytical unqualified rate of serological and nucleic acid samples (4.89 vs 4.22) showed a significant difference (χ =9.575, P<0.05). 2) The average unqualified rate of samples in region A, B and C was 1.71, 9.50 and 12.64 (χ =1 590.721, P<0.05), and the sigma level was 5.66σ, 5.21σ and 5.16σ, respectively. 3) The main reasons for unqualified serological samples were chylous blood (72.65%), hemolysis (17.39%), abnormal hematocrit (5.80%), and insufficient volume (3.50%). The main reasons for the unqualified nucleic acid samples were chylous blood (78.26%), hemolysis (8.84%), failure to centrifuge as required (5.01%), abnormal hematocrit (4.66%), and insufficient volume (1.92%). Conclusion: In North China, the quality indicators for the pre-analytical processes in blood station laboratories are generally well-managed. Laboratories in region A outperformed the national average in pre-analytical specimen quality control. However, participating laboratories exhibit gaps in implementing pre-analytical quality management. Through effective analysis of pre-analytical process quality metrics and inter-laboratory comparisons, laboratories can identify discrepancies and address shortcomings. By establishing clear quality objectives, they can achieve continuous improvement and ensure the validity of test results.

Objective: To investigate the assessment criteria and subsequent handling practices of hemolytic and lipemic blood samples before testing in blood screening laboratories in North China, and to provide data to support the standardization of their management in blood station laboratories. Methods: Data on the preanalytical management of hemolytic and lipemic samples from 38 laboratories were collected. The details of management on the criteria and verificatioon for assessment, the assessment methods, and subsequent handling procedures of hemolytic and lipemic samples in blood station laboratories were analyzed. Results: 1) All 38 blood station laboratories monitored serological and nucleic acid samples for hemolysis and lipemia in pre-analytical phase. 2) The criteria and methods for assessing hemolytic and lipemic samples varied among the laboratories of the 38 blood stations. 15 laboratories (39.47%) followed manufacturer's instructions, 9 laboratories (23.68%) formulated their own criteria, and 14 laboratories (36.84%) referred to the criteria of other laboratories. 16 laboratories (42.11%) verified the criteria for assessing hemolytic and lipemic samples, with significant variations in verification rate across laboratories from different regions (P<0.05). For the assessment methods, visual inspection was used by 28 laboratories (73.68%) for hemolytic samples and by 27 laboratories (71.05%) for lipemic samples; the colorimetric card method was used by 10 laboratories (26.32%) for assessing both hemolytic and lipemic samples; the instrumental method was used by 1 laboratory (2.63%) for assessing lipemic samples.3) The handling procedures for hemolytic and lipemic samples varied significantly and followed a gradient distribution pattern among 38 laboratories (including accepting samples for testing, accepting samples for concession testing, re-collecting samples, and rejecting samples and halting testing). With increasing severity of hemolysis and lipemia, more laboratories halted testing, and relatively fewer laboratories accepted samples for normal testing. 5 laboratories (13.16%) applied different handling procedures on serological and nucleic acid samples. Conclusion: This survey provides a reference and basis for analyzing gaps in the management of hemolytic and lipemic samples during the preanalyical phase in blood station laboratories in North China. It enables laboratories to identify the problems and deficiencies in the management of hemolytic and lipemic samples, to ensure preanalytical samples quality meets the established requirements, and to lay a foundation for promoting the homogenization and standardization of the regional sample quality management mode.

Purpose/Significance To explore the research progress of health recommender system(HRS),so as to provide refer-ences for medical personnel to build HRS to help intelligent health care.Method/Process The application of common recommendation technology and HRS in the field of health care is summarized by literature research,and the research status and development direction of HRS is discussed.Result/Conclusion HRS has been applied in health service recommendation,diet recommendation,health behavior promotion,disease prognosis characteristics and health risk prediction,chronic disease management,mental health promotion and medi-cation recommendation,and the related research is conducive to the development of intelligent health care.

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.

Background::Pulmonary embolism (PE) is a severe and acute cardiovascular syndrome with high mortality among patients with autoimmune inflammatory rheumatic diseases (AIIRDs). Accurate prediction and timely intervention play a pivotal role in enhancing survival rates. However, there is a notable scarcity of practical early prediction and risk assessment systems of PE in patients with AIIRD.Methods::In the training cohort, 60 AIIRD with PE cases and 180 age-, gender-, and disease-matched AIIRD non-PE cases were identified from 7254 AIIRD cases in Tongji Hospital from 2014 to 2022. Univariable logistic regression (LR) and least absolute shrinkage and selection operator (LASSO) were used to select the clinical features for further training with machine learning (ML) methods, including random forest (RF), support vector machines (SVM), neural network (NN), logistic regression (LR), gradient boosted decision tree (GBDT), classification and regression trees (CART), and C5.0 models. The performances of these models were subsequently validated using a multicenter validation cohort.Results::In the training cohort, 24 and 13 clinical features were selected by univariable LR and LASSO strategies, respectively. The five ML models (RF, SVM, NN, LR, and GBDT) showed promising performances, with an area under the receiver operating characteristic (ROC) curve (AUC) of 0.962-1.000 in the training cohort and 0.969-0.999 in the validation cohort. CART and C5.0 models achieved AUCs of 0.850 and 0.932, respectively, in the training cohort. Using D-dimer as a pre-screening index, the refined C5.0 model achieved an AUC exceeding 0.948 in the training cohort and an AUC above 0.925 in the validation cohort. These results markedly outperformed the use of D-dimer levels alone.Conclusion::ML-based models are proven to be precise for predicting the onset of PE in patients with AIIRD exhibiting clinical suspicion of PE.Trial Registration::Chictr.org.cn: ChiCTR2200059599.

Objective:To explore the relation of depressive and anxiety symptoms to defense mechanism in transgender population.Methods:Totally 451 transgender patients in the sexual and psychological outpatient depart-ment of a hospital were selected.They were assessed with the self-Rating Depression Scale(SDS),Self-Rating Anxiety Scale(SAS)and Defense Mechanism Scale(DSQ).The SDS standard score of ≥53 was classified as having depressive symptoms,and the SAS standard score of ≥50 was classified as having anxiety symptoms.Re-sults:The detection rates of depression and anxiety were 46.8％and 28.8％respectively.Multiple linear regression analysis showed that SDS scores were positively correlated with DSQ scores of projection,conceit,complaint,with-drawal,somatization,control,isolation and identity(β=0.08-0.22),while SDS scores were negatively correlated with DSQ scores of sublimation,depression,omnipotence with incompetence and denial(0=-0.09--0.19).The SAS scores were positively correlated with the DSQ scores of projection,latent manifestation,somatization,control,isolation,identity,and consumption tendency(0=0.09-0.26),while the SAS scores were negatively cor-related with the DSQ scores of sublimation,depression,omnipotence accompanied by incompetence,and denial(β=-0.09--0.15).Conclusion:The proportion of depression and anxiety symptoms detected in the transgender group is higher,which may be related to the use of some defenses.

OBJECTIVE To investigate the association between the functional GLCCI1 gene rs37973 polymorphism and inhaled corticosteroids （ICSs） response in patients with asthma-chronic obstructive pulmonary disease overlap （ACO）. METHODS Totally 173 newly diagnosed ACO patients were recruited from Shanghai Pudong New Area People’s Hospital during April 1st， 2019 to December 31st， 2020. All patients were treated with Salmeterol fluticasone inhalation powder， twice a day， for 24 weeks. The genotype of rs37973 locus was determined， and lung function indicators [forced expiratory volume in one second （FEV1）， FEV1/forced vital capacity （FVC）， the percentage of FEV1 to expected value （FEV1%pred）]， and lung function improvement （ΔFEV1 and ΔFEV1%pred） were all detected. RESULTS Totally 111 patients completed the whole 24-week follow-up and lung function detection. Among them， there were 42 cases of AA genotype， 52 cases of AG genotype， and 17 cases of GG genotype. After 12， 24 weeks of treatment， lung function indexes of patients were significantly better than baseline lung function indexes before treatment （P＜0.05）. After 24 weeks of treatment， ACO patients with AA and AG genotypes showed significantly better lung function improvement than GG genotype， and ΔFEV1%pred of AA genotype was significantly better than AG genotype （P＜ 0.05）. After 12， 24 weeks of treatment， the improvement of lung function in patients with a smoking history ≤20 pack year was significantly better than those with a smoking history ＞20 pack year， and among patients with a smoking history ≤20 pack year， only AA genotype had significantly better FEV1%pred than AG genotype （P＜0.05）. After 12 weeks of treatment， among patients with a smoking history ＞20 pack year， the improvement of lung function in AA genotype and AG genotype was significantly better than GG genotype， and the FEV1%pred in AA genotype was significantly better than AG genotype （P＜0.05）. After 24 weeks of treatment， the improvement of lung function of AA genotype and AG genotype was significantly better than GG genotype （P＜0.05）. CONCLUSIONS GG genotype of GLCCI1 gene rs37973 locus is associated with the poor treatment response to ICSs in patients with ACO， especially in patients with smoking history ＞20 pack year.

Objective: To investigate the prevalence of depression and anxiety among transgender populations and the correlation with defense mechanism, so as to provide the evidence for improving mental health among transgender populations. Methods: Transgender populations that visited Psychosexual Outpatient Department of Beijing Huilongguan Hospital for the first time from December 2020 to December 2021 were enrolled. Participants' demographics, depression, anxiety and type of defense mechanisms were collected using self-designed questionnaires, Self-rating Depression Scale, Self-rating Anxiety Scale and Defense Style Questionnaire (DSQ). Factors affecting depression and anxiety were identified using a multivariable logistic regression model. Results: Totally 126 transgender individuals were enrolled, including 95 men (75.40%) with a mean age of (21.53±4.55) years and 31 women (24.60%) with a mean age of (23.58±5.55) years. The prevalence of depression was 46.83% among participants, including 44.07% of participants with mild depression, 30.51% with moderate depression and 25.42% with severe depression, and the prevalence of anxiety was 26.19% among participants, including 60.61% of participants with mild anxiety, 21.21% with moderate anxiety and 18.18% with severe anxiety. The detection of depression was 54.74% among men and 22.58% among women (P<0.05), and the detection of both depression (62.79% vs. 38.55%, P<0.05) and anxiety (41.86% vs. 18.07%, P<0.05) was significantly higher among transgender populations with self-injury or suicide behaviors than among those without. Multivariable logistic regression analysis showed that immature defense mechanisms increased the risk of depression (OR=1.034, 95%CI: 1.018-1.051) and anxiety (OR=1.031, 95%CI: 1.014-1.049) among transgender populations, while mature defense mechanisms reduced the risk of depression (OR=0.887, 95%CI: 0.832-0.946) and anxiety (OR=0.878, 95%CI: 0.821-0.938) among transgender populations. Conclusions The prevalence of depression and anxiety was 46.83% and 26.19% among transgender populations included in this study. Mature defense mechanisms are beneficial to reduce the risk of depression and anxiety among transgender populations. Key words： transgender population depression anxiety defense mechanism

OB JECTIVE To study the protective effects of saponins from Gleditsia sinensis on ischemic stroke with phlegm and blood stasis （ISPBS）model rats ，and to explore its mechanism. METHODS Totally 119 rats were randomly divided into normal group （normal saline ），sham operation group （normal saline ），model group （normal saline ），nimodipine group （positive control group ，5 mg/kg），G. sinensis saponin low-dose ，medium-dose and high-dose groups （3.21，6.42 and 12.84 mg/kg），with 17 rats in each group. Except for normal group ，other groups were all given high-fat diet+suture-occluded method to induce ISPBS model. The neurological function score ，water content of brain tissue ，pathological morphology of brain tissue ，the changes of hemorheology indexes （whole blood viscosity ， erythrocyte aggregation index ， Casson-viscosity）， four items of blood lipid [triacylglycerol （TG），total cholesterol （TC），low-density lipoprotein cholesterol （LDL-C），high-density lipoprotein cholesterol（HDL-C）] and inflammatory factors in serum and oxidative stress indexes [malondialdehyde （MDA），nitric oxide （NO），superoxide dismutase （SOD）] in brain tissue were determined or observed in rats. The protein expressions of B lymphocytoma 2（Bcl-2），Bcl-2 associated X protein （Bax）and caspase- 3 in cerebral tissue were also detected. RESULTS Compared with normal group ，the score of nerve function ，5 kinds of serum indexes （TC，TG，LDL-C，TNF-α，IL-1β）， hemorheology indexes ，the contents of MDA and NO and protein expressions of Bax and caspase- 3 in cerebral tissue were all increased significantly in model group （P＜0.01）. The levels of HDL-C and IL- 10 in serum ，SOD activity and protein expression of Bcl- 2 in cerebral tissue were decreased significantly （P＜0.01），and obvious lesions such as nuclear pyknosis and cell membrane fragmentation occurred in brain tissue. Compared with model group ，above indexes of administration groups were improved to different extents ，among which there was statistical significance in above indexes of G. sinensis saponin high-dose group （P＜ 0.01）. CONCLUSIONS Saponin from G. sinensis has a good protective effect on ISPBS model rats. Its mechanism may beassociated with reducing oxidative damage ， reducing the production of pro-inflammatory mediators and resisting neuronal apoptosis.