OBJECTIVE To investigate and analyze the current management of drug clinical trial institutions in Jiangxi Province and the situation of undertaking drug clinical trials after the implementation of the filing system. METHODS A survey was conducted on 38 new institutions （obtained qualifications during the implementation of the filing system） and old institutions （obtained qualifications during the implementation of the recognition system） that had completed drug clinical trial institution qualification filing for more than one year in Jiangxi Province. The survey focused on the basic information of the institutions， the number of registered principal investigator （PI）， institutional hardware and information construction， personnel allocation and training， and drug registration clinical trials undertaken by the institutions. RESULTS Of 38 institutions surveyed， there were 22 general hospitals and 16 specialized hospitals； there were 24 old institutions and 14 new institutions. Whether in general hospitals or specialized hospitals， the old institutions were better than the new institutions in the number of approved beds， the number of outpatients， the number of inpatients， the number of specialties， and the number of PI； both old and new institutions had separate offices； all new institutions were set up with GCP pharmacy. The adoption of clinical trial management system in new institutions is significantly less than in old institutions. In the general hospital， both the number of full-time managers and the number of quality controllers in old institutions were significantly more than in the new institutions， while the opposite was true at the level of specialized hospitals. In terms of centralized training on GCP， new institutions were all better than the old ones. Whether in general hospitals or specialized hospitals， the number of drug registration clinical trial projects undertaken by new institutions was significantly less than that of old ones. CONCLUSIONS The new institutions are worse than the old institutions in comprehensive strength and information construction of hospitals， and the number of clinical trials undertaken by new institutions is also less than old institutions.

Objective: To investigate the prevalence and influencing factors of menopausal syndrome among postmenopausal women in Pan'an County, Zhejiang Province, so as to provide the basis for guiding the health management of postmenopausal women. Methods: From May 2023 to April 2024, the postmenopausal women aged 40 to 69 years in Pan'an County were selected using the random cluster sampling method. Demographic information, lifestyle and prevalence of gynecological diseases were collected through questionnaire surveys. The prevalence of menopausal syndrome was assessed by modified Kupperman Score Scale. Factors affecting menopausal syndrome were analyzed by a multivariable logistic regression model. Results: A total of 816 postmenopausal women were surveyed, with an mean age of (57.63±2.92) years and a mean natural menopause age of (49.85±2.13) years. There were 574 cases with menopausal syndrome, with a prevalence of 70.34%. Flashes and sweating, insomnia and irritability were common symptoms, accounting for 62.87%, 47.43% and 41.18%, respectively. Multivariable logistic regression analysis showed that monthly personal income of ≤5 000 yuan (<3 000 yuan, OR=3.124, 95%CI: 1.829-5.335; 3 000-5 000 yuan, OR=2.399, 95%CI: 1.370-4.201) and having gynecological diseases (OR=1.970, 95%CI: 1.292-3.004) were associated with a higher risk of menopausal syndrome, while average (OR=0.141, 95%CI: 0.072-0.276) or sufficient sleep quality (OR=0.095, 95%CI: 0.049-0.185) were associated with a lower risk of menopausal syndrome. Conclusion The prevalence of menopausal syndrome among postmenopausal women in Pan'an County is relatively high, and is mainly influenced by personal economic status, sleep quality and the presence of gynecological diseases.

Objective: To evaluate the impact of comprehensive nursing based on the behavioral goal attainment model on the clinical intervention effect among elderly female patients with stress urinary incontinence (SUI), so as to provide a basis for optimizing the nursing strategies for patients with SUI and improving their quality of life. Methods: A total of 190 elderly female patients with SUI who were treated in the Department of Gynecology of the First Hospital of Jilin University from January 2023 to August 2024 were selected and randomly divided into the intervention group and the control group. The control group received routine nursing care, while the intervention group received comprehensive nursing based on the behavioral goal attainment model. The 1-hour pad test was used to assess urinary incontinence symptoms. The bio-electrical stimulation feedback instrument was employed to detect the electromyogram (EMG) values in the pre-resting stage and slow-muscle stage for evaluating pelvic floor function. The bladder function scale was utilized to evaluate bladder function. The Chinese version of urinary incontinence ego-efficacy rating scales and incontinence quality of life assessment scale (IQOL) were used to assess self-efficacy and quality of life. The data on intervention compliance and nursing satisfaction were collected by a questionnaire survey. The differences between the two groups before and after the intervention were compared using the analysis of variance for repeated-measures data to evaluate the intervention effect. Results: There were 95 cases in the control group and 95 cases in the intervention group, with median ages were 64.00 (interquartile range, 23.50) and 64.50 (interquartile range, 19.50) years, respectively. The proportion of patients with cesarean section as the last delivery method was 21.05% in the control group and 12.63% in the intervention group. The proportion of patients with moderate disease severity was 67.36% in the control group and 58.95% in the intervention group. There were no statistically significant differences in age, body mass index, number of pregnancies, number of deliveries, marital status, educational level, mode of last delivery and severity of the disease between the two groups of patients (all P>0.05). The analysis of variance of repeated-measures data showed that there were significant interactions between time and group for the urine leakage volume in the 1-hour pad test, the EMG values in the pre-resting stage, the EMG values in the slow-muscle stage, the scores of the bladder function, the self-efficacy scores, and the IQOL scores (all P<0.05). After 12 weeks of intervention, the EMG values in the slow-muscle stage, the scores of the bladder function, the self-efficacy scores, the IQOL scores in the intervention group were higher than those in the control group, while the urine leakage volume in the 1-hour pad test and the EMG values in the pre-resting stage in the intervention group were lower than those in the control group (all P<0.05). The good compliance rate of intervention and the satisfaction rate of nursing in the intervention group were higher than those in the control group (83.16% vs. 60.00%, 90.53% vs. 75.79%, both P<0.05). Conclusion Comprehensive nursing based on the behavioral goal attainment model can improve urinary incontinence symptoms, pelvic floor function, bladder function, self-efficacy, quality of life, and intervention compliance of elderly female patients with SUI.

Objective:To explore the efficacy of online pulmonary rehabilitation (PR) management among community-dwelling patients with stable chronic obstructive pulmonary disease (COPD).Methods:This study was a single-center randomized controlled trail with an unblinded design. A total of 130 patients with stable COPD who visited Zhuanqiao Community Health Service Center in Shanghai Minhang District from October 2020 to March 2022 were randomly divided into study group and control group with 65 cases in each group. Both groups received conventional treatment, while patients in study group attended online rehabilitation management, including face-to-face rehabilitation instruction and multiple online guidance. Pulmonary ventilation function including forced vital capacity (FVC), forced expiratory volume in the first second (FEV 1) and percentage of forced expiratory volume in the first second to forced expiratoty volume (FEV 1%pred), modified British Medical Research Council Dyspnea Scale (mMRC), chronic obstructive pulmonary disease assessment test (CAT), score of 6 minutes walking distance (6MWD) and DOSE (dyspnea, degree of airflow obstruction, smoking status, the number of exacerbation) index were measured at baseline and after 8 weeks of rehabilitation, and compared between two groups. Results:The baseline data of the two groups were comparable. After 8 weeks of management, FVC, FEV 1, FEV 1%pred, mMRC, CAT, 6MWD and DOSE index of both groups were improved compared with the baseline level(control group: t=-7.799, -7.581, -9.010, 3.565, 9.887, -16.677, 3.795; study group: t=-12.623, -13.914, -17.644, 7.404, 22.457, -26.826, 7.968; all P<0.05). The FEV 1%pred, CAT and 6MWD in the study group were better than those in the control group ( t=-2.939, 2.277,-2.130, all P<0.05); while there were no significant differences in FVC, FEV 1, mMRC and DOSE index between the two groups( t=-0.162, -1.280, 0.925, 1.939,all P>0.05). Conclusions:The online pulmonary rehabilitation management can better improve lung function, dyspnea symptoms and exercise tolerance of patients with stable COPD, which can be used for rehabilitation training and management of community-dwelling patients.

Objective:To evaluate the effects of cognitive behavior therapy(CBT)combined with attention training technique(ATT)on auditory hallucinations of schizophrenia.Methods:Sixty schizophrenia patients with au-ditory hallucinations were recruited according to the criteria of International Classification of Diseases,tenth Edition(ICD-10).They were randomly divided into the CBT group(30 cases,26 cases completed)and the CBT+ATT group(30 cases,25 cases completed).The CBT group received only 4 weeks of cognitive behavioral intervention for auditory hallucinations,and the CBT+ATT group received 6 weeks of attention training technology intervention based on cognitive behavioral intervention.At baseline and after 12 weeks,the Psychotic Symptom Rating Scales-Auditory Hallucinations(PSYRATS-AH)and Scale of Social function in Psychosis Inpatients(SSPI)were used to evaluate the auditory hallucinations symptoms and social functioning of the two groups,and the Attentional Control Scale(ACS)was used to evaluate patients'attentional control ability of the CBT+ATT group.Results:After 12 weeks,the differences(post intervention score-baseline score)of PSYRATS-AH total scores[(-6.8±2.2)vs.(-4.2±1.5)],auditory hallucinations'frequency,duration,number of distresses,control of voices were lower in the CBT+ATT group than in the CBT group(Ps＜0.05),and the differences of the SSPI total scores[(13.9± 2.9)vs.(11.6±4.2)]and scores of Factor I and Factor Ⅲ were higher in the CBT+ATT group than in the CBT group(Ps＜0.05).Conclusion:This study shows cognitive behavioral therapy combined with attention training technique could improve auditory hallucinations and social function more effectively in patients with schizophrenia.

Objective:To investigate the prevalence of norovirus and the correlation between norovirus infection and stool traits and clinical symptoms in children with acute gastroenteritis during 2021-2022.Method:A total of 2 195 anal swab samples were collected from cases of acute gastroenteritis in Beijing Children 's Hospital Affiliated to Capital Medical University from January 2021 to December 2022. PCR fluorescent probe assay was performed to detect norovirus，the clinical information and test results were performed by statistical analysis. Results:The detection rate of norovirus was 19.09%（419/2 195）in 2 195 children. The detection rates of male and female were 17.80%（244/1 371）and 21.24%（175/824），respectively，with statistically significant differences between genders（ χ2=3.945, P<0.05）. The positivity rate of noroviruses was higher in aged 1 month to 3 years［29.09%（64/220）~40.69%（94/231）］，especially in 1 year［40.69%（94/231）］. The norovirus detection rate ranged from 2.44%（2/82）to 35.84%（62/173）in different months，with a high detection rate between January and March，higher in the winter and spring［28.36%（150/529），21.07%（146/693）］，showing a clear seasonal distribution.Clinical symptoms of both vomiting and diarrhea were significantly more common among norovirus positive than negative children，the difference was statistically significant（ χ2=57.29, P<0.05）. Conclusion:In the high incidence season of winter and spring，for infants and young children aged 1 month to 3 years with diarrhea accompanied by vomiting symptoms，especially those aged 1 year，it is recommended to undergo norovirus related testing in time. Early treatment and isolation measures should be taken for diagnosed children to reduce cross infection and prevent outbreaks.

Objective To detect the serum levels of CC chemokine receptor 2(CCR2)and C-reactive pro-tein(CRP)in stroke patients,and analyze their relationship with the severity of stroke associated pneumonia and their clinical significance.Methods A total of 78 patients with stroke associated pneumonia who were di-agnosed and treated in the hospital from October 2022 to February 2023 were collected as the study group,ac-cording to the severity of pneumonia,the study group was divided into mild group(31 cases),moderate group(29 cases),and severe group(18 cases),78 stroke patients who did not develop pneumonia were included into control group.Pearson method was applied to analyze the correlation between serum CCR2 and CRP levels in stroke associated pneumonia patients.Multivariate Logistic regression was applied to analyze the factors influ-encing the occurrence of stroke associated pneumonia.Receiver operating characteristic(ROC)curve was ap-plied to analyze the diagnostic value of serum CCR2 and CRP for stroke associated pneumonia.Results The National Institute of Health stroke scale(NIHSS)score,serum CCR2,and CRP levels in the study group were obviously higher than those in the control group(P<0.05).The levels of serum CCR2 and CRP increased with the aggravation of pneumonia(P<0.05).The levels of serum CCR2 and CRP in the study group were positively correlated(r=0.799,P<0.05).NIHSS score,CCR2,and CRP levels were risk factors for stroke associated pneumonia in stroke patients(P<0.05).The area under the curve(AUC)for the diagnosis of stroke associated pneumonia using serum CCR2 and CRP alone was 0.873 and 0.888,respectively,and the AUC for the combined detection of the two was 0.936,the combined detection of the two was superior to the individual detection of serum CCR2 and CRP(Zcombination-CCR2=1.987,Zcombination-CRP=1.832,P=0.041,0.047).Conclusion Serum CCR2 and CRP are closely related to the severity of stroke associated pneumonia,and their combined detection has high diagnostic value for stroke associated pneumonia.

Objective : To investigate the changes of lipid biomarkers and lipid metabolic pathways related to liver injury in BTBR ob/ob mice with type 2 diabetes mellitus by biochemical and metabolomics methods． Methods : 16 BTBR wild-type (WT) mice (WT group) and 14 BTBR ob/ob obese mice (ob / ob group) at 7 weeks of age were selected and fed in SPF environment until 20 weeks of age．Liver injury was compared between the two groups : The activities of mitochondrial respiratory enzyme complex in liver tissue were detected by high-resolution respirators，and the lipid metabolomic analysis of liver tissue samples in the two groups of mice was performed by ultra-perform- ance liquid chromatography-quadrupole time-of-flight mass spectrometry，mainly detecting endogenous metabolites. Principal component analysis (PCA) ，orthogonal partial least squares discriminant analysis ( OPLS-DA) and other models were used to screen potential biomarkers，and the metabolic pathway analysis of the identified metabolites was performed by MetaboAnalyst 5. 0 . Results : Compared with the WT group，the ob / ob group had significantly increased body weight，fasting blood glucose ，serum levels of aspartate aminotransferase ( AST) ，alanine amin- otransferase (ALT) ，low-density lipoprotein (LDL-C) and cholesterol ( CHO) (P＜0. 01) ．Liver hematoxylin-eo- sin staining (HE) staining showed that the mice in ob / ob group had structural disorder of liver lobules，swelling of liver cells ，a large number of fat vacuoles in cells ，diffuse distribution and loose cytoplasm． Oil red O staining showed that there was a large amount of lipid deposition in the hepatocytes ofob/ob mice．The high resolution spi- rometer showed that the ob/ob mice had mitochondrial oxidative phosphorylation disorder and the activity of complex Ⅳ decreased．Lipid metabolomic analysis showed that the lipid metabolic profile of ob/ob mice changed，and the metabolic pathways involved mainly included glycerophospholipid metabolism，glycosylphosphatidylinositol ( GPI) anchor biosynthesis，triglyceride metabolism，linoleic acid metabolism，α-linolenic acid metabolism and arachidon- ic acid metabolism． Conclusion The liver injury of ob / ob group mice may be related to the disorder of lipid me- tabolism，in which the disorder of glycerophospholipid metabolism is the most critical metabolic pathway.

Objective:To construct a machine-learning model for predicting the progression of pancreatic cystic lesions (PCLs) based on clinical and CT features, and to evaluate its predictive performance in internal/external testing cohorts.Methods:Baseline clinical and radiological data of 200 PCLs in 177 patients undergoing abdominal thin slice enhanced CT examination at Peking Union Medical College Hospital from July 2014 to December 2022 were retrospectively collected. PCLs were divided into progressive and non-progressive groups according to whether the signs indicated for surgery by the guidelines of the European study group on PCLs were present during three-year follow-up. 200 PCLs were randomly divided into training (150 PCLs) and internal testing cohorts (50 PCLs) at the ratio of 1∶3. 15 PCLs in 14 patients at Jinling Affiliated Hospital of Medical School of Nanjing University from October 2011 to May 2020 were enrolled as external testing cohort. The clinical and CT radiological features were recorded. Multiple feature selection methods and machine-learning models were implemented and combined to identify the optimal machine-learning model based on the 10-fold cross-validation method. Receiver operating characteristics (ROC) curve was drawn and area under curve (AUC) was calculated. The model with the highest AUC was determined as the optimal model. The optimal model's predictive performance was evaluated on testing cohort by calculating AUC, sensitivity, specificity and accuracy. Permutation importance was used to assess the importance of optimal model features. Calibration curves of the optimal model were established to evaluate the model's clinical applicability by Hosmer-Lemeshow test.Results:In training and internal testing cohorts, the progressive and non-progressive groups were significantly different on history of pancreatitis, lesions size, main pancreatic duct diameter and dilation, thick cyst wall, presence of septation and thick septation (all P value <0.05) In internal testing cohort, the two groups were significantly different on gender, lesion calcification and pancreatic atrophy (all P value <0.05). In external testing cohort, the two groups were significantly different on lesions size and pancreatic duct dilation (both P<0.05). The support vector machine (SVM) model based on five features selected by F test (lesion size, thick cyst wall, history of pancreatitis, main pancreatic duct diameter and dilation) achieved the highest AUC of 0.899 during cross-validation. SVM model for predicting the progression of PCLs demonstrated an AUC of 0.909, sensitivity of 82.4%, specificity of 72.7%, and accuracy of 76.0% in the internal testing cohort, and 0.944, 100%, 77.8%, and 86.7% in the external testing cohort. Calibration curved showed that the predicted probability by the model was comparable to the real progression of PCLs. Hosmer-Lemeshow goodness-of-fit test affirmed the model's consistency with actual PCLs progression in testing cohorts. Conclusions:The SVM model based on clinical and CT features can help doctors predict the PCLs progression within three-year follow-up, thus achieving efficient patient management and rational allocation of medical resource.

Objective:To investigate the clinical value of Tyro3/Axl/Mertk (TAM) receptor tyrosine kinase and ligands in severity evaluation for acute pancreatitis (AP).Methods:The peripheral blood and clinical data of 27 patients with AP admitted in the Department of Gastroenterology of Shanghai General Hospital from February 2020 to July 2022 were prospectively selected. The patients were divided in to mild AP group (MAP, n=13), moderately severe AP (MSAP, n=10) and severe AP group (SAP, n=4) according to the 2012-revised Atlanta classification for AP. Another 10 healthy normal subjects were selected as the control group. The general information, biochemical indicators and blood cell analysis of the patients were recorded, and the levels of serum Gas6, protein S and soluble Axl (sAxl) were measured by ELISA. Linear regression equations were used to analyze the correlation of serum Gas6, protein S and sAxl levels with the white blood cell (WBC) counts, neutrophil percentages, lymphocyte percentages, and monocyte percentages of each group, and to assess the clinical value of Gas6, protein S and sAxl in predicting the severity of AP patients. Results:Compared with the control group, the serum Gas6 level [(31.3±13.0)ng/ml vs (21.2±2.6)ng/ml], protein S level [(24.4±11.3)μg/ml vs (17.7±3.4)μg/ml], and sAxl level [(9.0±4.4)ng/ml vs (6.6±1.3)ng/ml] were significantly higher in the AP group. The Gas6 level was significantly higher in the SAP group (54.1±13.7 ng/ml) than in the MAP group (31.0±9.4 ng/ml) and the MSAP group (25.2±8.9 ng/ml), and the differences were statistically significant (all P value <0.05). The Gas6 level was significantly positively correlated with the WBC count ( r=0.1733) and neutrophils percentage ( r=0.4424), and negatively correlated with lymphocyte percentage(r=-0.363), with statistically significant differences (all P value <0.05). The levels of protein S and sAXL were positively correlated WBC count and neutrophil percentage, and negatively correlated with monocyte percentage and lymphocyte percentage, but the differences were not statistically significant. Conclusions:The serum levels of Gas6 increase significantly with the severity grading of AP, which may serve as a relatively good predictor for the early severity assessment of AP.