Clinical trials represent a pivotal stage in the development of pharmaceutical drugs. Nevertheless， given the unique characteristics of traditional Chinese medicine （TCM） and the diagnostic and treatment principle of syndrome differentiation and treatment in TCM， the clinical evaluation techniques and methods that can comprehensively reflect the characteristics of TCM and are tailored to its specificities are still in need of refinement and innovation. This paper systematically summarizes the key techniques and methods for designing and evaluating the clinical research on the treatment of the spleen and stomach diseases with TCM from three aspects including clinical research design， evaluation， and platform construction， compares domestic and international research landscapes， and proposes for future directions. It is suggested that a multidimensional evaluation system integrating modern medicine and TCM theory should be established， and further innovation is needed in TCM research design and methodologies， leveraging intelligent devices and technologies powered by next-generation information technology to transform clinical data into high-quality TCM evidence. Moreover， standardized and shared platforms for TCM clinical data should be accelerated， so as to provide references for the design， implementation， and evaluation of future clinical research on the treatment of the spleen and stomach diseases with TCM.

BACKGROUND:Traditional Chinese medicine has rich experience and unique advantages in the empirical treatment of phlegm-heat and Fu-organs excess syndrome of ischemic stroke.In order to further explore the therapeutic targets and mechanisms of traditional Chinese medicine for this disease,it is crucial to establish a stable and reliable animal model of phlegm-heat and Fu-organs excess syndrome combined with empirical symptoms of ischemic stroke. OBJECTIVE:To explore the establishment method and evaluation system of the rat model of ischemic stroke with phlegm-heat and Fu-organ excess syndrome. METHODS:Sixty male Sprague-Dawley rats were randomly divided into four groups:blank control group(n=12),ischemic stroke group(n=18),disease+syndrome group(n=18),phlegm-heat and Fu-organ excess syndrome group(n=12),all of which were given high-fat diet for 25 days.On the 26th day,the rats in the blank control group and ischemic stroke group were intragastrically given normal saline and high fat diet,while those in the other two groups were intragastrically given autologous feces suspension and high fat diet for 3 continuous days.After gavage,ischemic stroke models were established using the suture method in the ischemic stroke group and disease+syndrome group.The changes in diet,water intake,body mass,body temperature,fecal traits,nasal secretions,sputum in the throat,and tongue image were recorded.Neurological deficits,tongue image,blood lipid levels,morphological changes of brain tissue and carotid artery,and the serum levels of motilin and somatostatin were detected. RESULTS AND CONCLUSION:Compared with the control group,the rats in the disease+syndrome group had shortness of breath,listlessness,irritability,bradykinesia,a large number of secretions around the nose,audible and heavy sputum in the throat,decreased diet and water intake,increased body mass,body temperature,and slingual vein score,decreased fecal pellet count,Bristol score and fecal moisture content,increased serum total cholesterol,triglyceride,low-density lipoprotein and somatostatin levels,decreased motilin level,increased neurological deficit score,significant pathological changes of the carotid artery,and significant morphological changes of the brain tissue.The ischemic stroke group only showed pathological changes of ischemic brain tissue,without the characteristics of phlegm-heat and Fu-organ excess syndrome.The phlegm-heat and Fu-organ excess syndrome group could present with the typical characteristics of traditional Chinese medicine syndromes,without the pathological changes of brain tissue with ischemic stroke.To conclude,the compound modeling method of high-fat induction combined with suture method and autologous feces gavage can establish an animal model of ischemic stroke with phlegm-heat and Fu-organ excess syndrome.

BackgroundThe functional changes of the default mode network （DMN） are closely related to the onset of major depressive disorders. However， the relationship between the DMN subsystem （core subsystem， dorsomedial prefrontal cortex subsystem， medial temporal lobe subsystem） and symptoms of first-episode major depressive disorder remains unclear. ObjectiveTo investigate abnormal functional connectivity between DMN subsystems and the whole brain in first-episode major depressive disorder patients during the resting-state， and to analyse the correlations between these functional connectivity patterns and clinical symptoms， so as to reveal the potential neural mechanisms from the perspective of DMN subsystem. MethodsFrom September 2020 to September 2023， a total of 64 first-episode outpatients and inpatients meeting the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders， fourth edition （DSM-IV） were enrolled at the Inner Mongolia Autonomous Region Mental Health Center as the study group. During the same period， 54 healthy volunteers matched for age， gender， and years of education were recruited from the community as the control group. Both groups were assessed using the Hamilton Depression Scale-24 item （HAMD-24）. Resting-state functional magnetic resonance images （rs-fMRI） of the two groups were acquired using a Siemens 3.0 T scanner， and differences in functional connectivity between DMN subsystems （core subsystem， dorsomedial prefrontal cortex subsystem， medial temporal lobe subsystem） and the whole brain were compared. The functional connectivity values of brain regions with statistically significant differences between the two groups were extracted. Spearman's rank correlation coefficient analysis was used to investigate the correlation between these functional connectivity values and HAMD-24 scores of the study group. ResultsUltimately， 46 patients and 43 controls completed the study. Compared with the control group， the study group exhibited significantly stronger functional connectivity in the following pathways： between the right superior parietal lobule （core subsystem） and right cerebellar lobule VIII （t=3.954， P<0.05， GRF-corrected）， between the right lateral temporal cortex （dorsomedial prefrontal cortex subsystem） and right cerebellar lobule VIII， right and left hippocampi， right medial， and paracingulate gyrus （t=4.595， 4.208， 5.200， 4.038， P<0.05， GRF-corrected）， and between the temporoparietal junction （dorsomedial prefrontal cortex subsystem） and left lingual gyrus and right cerebellar lobule VIII （t=3.557， 4.274， P<0.05， GRF-corrected）. Conversely， weaker functional connectivity was observed between the right inferior frontal gyrus and left gyrus rectus （t=-3.824， P<0.05， GRF-corrected）. Furthermore， within the study group， the functional connectivity values between the right lateral temporal cortex and right hippocampus， as well as between the temporoparietal junction and right cerebellar lobule VIII， were both negatively correlated with the HAMD-24 cognitive impairment factor score （r=-0.306， -0.318， P<0.05）. ConclusionIncreased functional connectivity between the DMN （specifically its core and dorsomedial prefrontal cortex subsystems） and cerebellum， partial limbic system， and lingual gyrus may be associated with the neuropathology of first-episode major depressive disorder. Furthermore， alterations in functional connectivity between the dorsomedial prefrontal cortex subsystem and both the cerebellum and hippocampus in these patients may be related to cognitive function. ［Funded by 2019 Annual Inner Mongolia Autonomous Region Natural Science Foundation Project （number， 2019MS03038）； 2023 Annual Inner Mongolia Autonomous Region Natural Science Foundation Project （number， 2023MS08028）］

Objective:To predict the occurrence of chronic radiation enteritis (CRE) in cervical cancer patients by developing a prediction model based on the combination of radiomic features derived from magnetic resonance imaging (MRI) scans and clinical parameters, in order to provide a reference for clinicians to determine the prognosis of these patients and offer them individualized diagnosis and treatment.Methods:A retrospective analysis was conducted on 111 cervical cancer patients who received radical radiotherapy at the First Affiliated Hospital of Anhui Medical University. Radiological features were extracted from the T1-weighted MRI images of local lesions of cervical cancer obtained before the radiotherapy. Features were selected using the least absolute shrinkage and selection operator (LASSO) to obtain the radiomics score. The radiomics scores and clinical parameters were assessed using univariate and multivariate logistic regression analyses, followed by the establishment of nomograms. The ability of radiomics to achieve CRE prediction was assessed using the area under the curve (AUC) and the calibration and decision curves.Results:Multivariate logistic regression analysis result revealed that the independent risk factors for identifying CRE in patients included radiomics score ( HR: 17.457, 95% CI: 5.540-55.009, P<0.001), tumor volume ( HR: 3.617, 95% CI: 1.293-10.115, P=0.014), and pelvic lymph node metastasis ( HR: 3.559, 95% CI: 1.013-12.501, P=0.048). The model combining radiomics and clinical data demonstrated high performance, with its AUCs of the training and validation groups (0.888 and 0.870, respectively) higher than those of the radiomics model (0.842 and 0.804, respectively) and the clinical data model (0.721 and 0.704, respectively). The analyses of calibration and decision curves confirmed the application value of clinical radiomic nomograms. Conclusions:The model combining radiomics and clinical data allows for accurate CRE prediction. Therefore, radiomic features have the potential to serve as a promising imaging biomarker for CRE.

Objective:To explore the feasibility of the new auxiliary analysis software in chromosomal aberration analysis of radiation workers during occupational health examinations.Methods:Health examination data of 2 469 radiation workers in Henan province were collected. Manual analysis of chromosomal aberrations in peripheral blood lymphocytes was conducted using the new auxiliary software and the Ikaros software. Then, the chromosomal aberrations detected using both software tools were compared.Results:The new auxiliary software yielded a lower chromosomal aberration rate among radiation workers compared with the Ikaros software [(0.314 ± 0.014)% vs. (0.391 ± 0.022)%, χ2 = 9.24, P = 0.002]. Notably, the new auxiliary software yielded a significantly lower rate of acentric fragments (ace) [(0.136 ± 0.009)% vs. (0.209 ± 0.020)%, χ2= 17.76, P < 0.001]. However, no statistically significant differences were observed between the result of the two software tools in the rates of dicentrics plus rings (dic + r) and translocations ( P > 0.05). According to the GBZ/T 248-2014 standard, the differences in abnormality rates of chromosomal aberrations between the two groups had no statistically significance ( P > 0.05), with both groups showing an abnormality rate of 0 for ace. Furthermore, the new auxiliary software could double the detection efficiency. Among pre-service radiation workers of various occupations, the differences in the chromosomal aberrations detected using the two software tools exhibited statistical significance ( χ2 = 10.26, P = 0.001). In contrast, the differences in the chromosomal aberrations among in-service and post-service radiation workers had no statistically different significance ( P>0.05). The Poisson regression analysis result demonstrated that the rate of chromosomal aberrations excluding ace was affected by age ( z = 2.73, P = 0.006), while gender, analysis method, service status, and occupation had no impact. Conclusions:The two software tools yielded largely consistent result in detecting chromosomal aberrations induced by exposure to ionizing radiation. Notably, the new auxiliary software can significantly improve detection efficiency, indicating the feasibility of applying it to chromosomal aberration analysis among radiation workers.

Objective:To propose a deep learning（DL）-based ultrasound imaging auxiliary tool for automatic segmentation and recognition of the brachial plexus（BP），and to enhance the accuracy and safety of clinical procedures.Methods:It was a multicenter study that collected 773 healthy subjects from Peking University Third Hospital and its branch campuses，the Third Medical Center of the Chinese PLA General Hospital，and Shanghai Eighth People's Hospital between August 2024 and February 2025. Brachial plexus（BP）images in the interscalene groove were captured used high-frequency ultrasound by senior sonographers，a dataset comprising 1 289 standardized images were constructed and the improved model（CHA-TransUNet）was trained. The test set was input into 6 different models（CHA-TransUNet，R50-Unet，TransUnet，SegFormer，SwinUnet，MISSFormer）for segmentation. Segmentation accuracy was evaluated using metrics including the Dice similarity coefficient（DSC），95% Hausdorff distance（HD95）and mean intersection over union（mIoU），and was compared with the segmentation results of 3 ultrasound physicians with varying experience levels（junior physicians and senior physicians）to validate the model's segmentation efficacy.Results:The CHA-TransUNet model established based on a dataset of 1 289 standardized images achieved segmentation results for the BP with a DSC of 90.15%，mIoU of 91.02%，and HD95 of 8.08. Its accuracy was higher than other mainstream models（DSC：90.15% vs. 87.60%，87.77%，81.35%，84.78%，84.55%），significantly better than junior physicians（DSC：90.15% vs. 68.73%， Z=-127.76， P<0.001），and approached the level of senior physician（DSC：90.15% vs. 86.15%， Z=-31.33， P=0.549）. The model demonstrated superior boundary recognition in complex anatomical structures（e.g.，C6/C7 nerve roots）compared to ultrasound physicians（junior and senior）（HD95：8.08 vs. 26.34，17.44，56.80）. Conclusions:This study proposes an analysis model for BP ultrasound images，CHA-TransUNet. This model achieves segmentation and recognition of the BP with relatively complex pathways and structures. The model exhibits high accuracy and stability，outperforming current mainstream network models and junior physicians while approaching the performance level of senior physicians. It assists junior physicians or trainees in more accurately identifying and localizing the BP.

Aim To study the correlation between es-trogen metabolism function of intestinal flora and liver fibrosis disease phenotype and differential intestinal bacteria by fecal microbiota transplantation(FMT).Methods C57BL/6J male mice were divided into normal group(Control-M),liver fibrosis Model group(Model),FMT-1 group(normal mice fecal microbiota transplantation from liver fibrosis mice),and FMT-2 group(liver fibrosis mice fecal microbiota transplanta-tion from female mice).The model group was induced by high fat and high glucose combined with low dose of CCl4 for 16 weeks.In the FMT group,the bacteria were destroyed by mixed antibacterial solution and then the corresponding fecal microbiota solution was given.The model group was established in the FMT-2 group and the model group at the same time.Liver function(ALT,AST)was detected by biochemical methods;liver inflammation(IL-1α,IL-6)was detected by ELISA;liver pathology was detected by HE and Mas-son methods;the expressions of α-SMA,collagen Ⅰ,estrogen receptor ERα,ERβ and GPER were detected by Western blot;estrogen metabolic enzymes β-glucu-ronidase and β-glucosidase in intestinal flora were de-tected by double antibody sandwich assay;gut microbi-ota was detected by 16S rDNA method;the correlation between estrogen metabolic enzymes,estrogen receptors and disease phenotypes and disease-related differential bacteria was analyzed by Pearson correlation analysis.Results Liver function,inflammation and fibrosis in-dices were significantly higher in the model group than those in the control-M group and significantly lower in the FMT-2 group than in the model group;estrogen metabolic enzymes of the intestinal flora significantly increased in the model group compared to the control-M group and significantly decreased in the FMT-2 group compared to the model group;the model group showed a significant increase in ERβ and GPER and a significant decrease in ERα compared to the control-M group,while the FMT-2 group showed a significant de-crease in ERβ and GPER and a significant increase in ERα compared to the model group;the FMT-2 group increased the enterobacterial abundance and diversity reduced by modelling;estrogen metabolic enzymes,es-trogen receptor ERβ and GPER were all positively cor-related with the disease phenotype,while the opposite was true for ERα;estrogen metabolic enzymes were positively correlated with Allobaculum,Ruminococcus and Alistipes,and negatively correlated with Akkerman-sia,Lactobacillus and Prevotella.Conclusions Fecal microbiota transplantation in female mice can alleviate liver fibrosis in male mice,which is related to the im-provement of estrogen metabolism of intestinal flora.

OBJECTIVE To observe the dynamic change trends of vancomycin resistance rates of Enterococcus fae-calis and Enterococcus faecium in medical institutions of Shanghai and nationwide based on the data from China Antimicrobial Resistance Surveillance System(CARSS)between 2014 and 2023 so as to provide bases for optimi-zing the prevention and control strategies for drug-resistant organisms.METHODS The data regarding to the van-comycin resistance rates of E.faecalis and E.faecium in Shanghai and nationwide were extracted from CARSS.The annual percentage change(APC),average annual percentage change(AAPC)and its 95％confi-dence interval(CI)were calculated by Joinpoint regression model(version 5.4.0).The differences in the changing trends and its statistical significance were analyzed.RESULTS The drug resistance rate of E.faecalis showed a re-markable and continuous decline in Shanghai(AAPC=-85.301％,P＜0.001),the isolation rate of the spe-cies maintained zero after 2019.The drug resistance rate nationwide showed a moderate decreasing amplitude(AAPC=-16.237％,P＜0.001),and there was no significant difference in the changing trend after 2019(P=0.628).The drug resistance rate of E.faecium showed a continuous decline trend in Shanghai(AAPC=-27.838％,P＜0.001),while the drug resistance rate nationwide firstly declined and then rose:with the decline from 2014 to 2020(APC=-18.476％,P＜0.001),the quick rebound from 2020 to 2023(APC=43.976％,P=0.005),and there was no significant difference in the overall change(AAPC=-1.459％,P=0.638).The decreasing amplitudes of drug resistance rates of the two species of Enterococcus were greater in Shanghai than nationwide(all P＜0.001),and the rebounds of drug resistance rates did not emerge nationwide.CONCLUSIONS Shanghai has achieved remarkable effect on control of drug resistance of Enterococcus through the management of antibiotics and infection control measures.The drug resistance rate of E.faecium re-bounds nationwide in recent years,indicating that the prevention and control should be strengthened in grass-roots medical institutions.It is suggested that Shanghai experience should be promoted,and the impact of transmis-sion mechanisms of drug resistance genes and COVID-19 epidemic on the use of antibiotics should be focused on.

Paraplegia caused by spinal cord injury is a serious neurological complication, for which surgery is currently the main treatment method. Due to different surgical approaches, patients are usually expected to maintain a passive prone position for a long time or switch between the supine and prone positions. Affected by multiple factors such as neurogenic sensory disorders, pathological changes in muscle tone and operative duration, the risk of intraoperative acquired pressure injury (IAPI) is significantly increased. Current clinical prevention strategies for IAPI in these patients predominantly focus on localized pressure relief during positioning, lacking systematic, standardized comprehensive prevention protocols or evidence-based guidelines. To address it, Department of Nursing, Orthopedics Branch, China International Exchange and Promotive Association for Medical and Health Care, Spinal Trauma Professional Committee, Orthopedics Branch, Chinese Medical Doctor Association, Nursing Group of Spine and Spinal Cord Professional Committee of Chinese Association of Rehabilitation Medicine organized experts in relevant fields to formulate Guideline for the prevention of intraoperative acquired pressure injury in paraplegic patients with spinal cord injury ( version 2025), based on evidence-based medical evidence and latest research results and clinical practice at home and abroad. Eleven recommendations were put forward from the aspects of preoperative risk assessment, intraoperative prevention strategies, postoperative handover and monitoring, and supportive mechanisms for IAPI prevention, aiming to standardize the prevention measures and management strategies of IAPI in paraplegic patients with spinal cord injury and accelerate the recovery of patients and improve the therapeutic effect.

Objective:To analyze the genetic characteristics of coxsackievirus A16 (CVA16) related to hand, foot and mouth disease (HFMD) in Jiaxing from 2021 to 2023, and understand the biological and molecular evolutionary characteristics of CVA16 in this city.Methods:Real-time fluorescent quantitative PCR was used to detect enterovirus and its types in collected HFMD case samples. At the same time, virus isolation and cultivation were performed on positive samples using RD cells. Then high-throughput sequencing of the whole genome was performed on 23 strains of CVA16 identified from the isolated samples. Finally we obtained its whole genome sequence. DNAStar, MEGA 6.0, Simplot 3.5.1 and other bioinformatics software were used to compare and analyze the sequences, construct the phylogenetic tree of VP1 region, and realize the genotype composition. And these software were also used to analyze the homology of the whole genome nucleotide sequence and the encoded amino acids, while know well the amino acid mutation sites and gene recombination in the main regions.Results:The results showed that among the 1 836 HFMD specimens tested from 2021 to 2023, 1 432 (78.00%, 1 432/1 836) were positive for enterovirus general genes, of which 263 were positive for CVA16, accounting for 18.37% (263/1 432) of the confirmed positive cases. Twenty-three CVA16 strains were sequenced and all of them were B1 subtype, of which 6 strains belong to B1b and 17 strains belong to B1a, with B1a being dominant. B1a strains in Jiaxing showed genetic relatedness to strains isolated in Beijing, Yunnan, Guangzhou, Jiangsu and other places in 2018 to 2023, as well as strains from Vietnam, Thailand, and Australia from 2015 to 2017. B1b strains exhibited consistent amino acid mutations of L23M in the VP1 region and V217I in the VP2 region, while B1a strains exhibited amino acid mutations of S14N/D, T164K, and V251I in the VP1 region and R41H in the VP3 region. Compared with the prototype strain, the 23 strains of CVA16 in Jiaxing accumulated the largest number of amino acid mutations in the coding region, with 28 and 50 mutations in the VP1 and 3D regions, respectively. The recombination patterns of B1a and B1b strains were slightly different, with B1a type showing recombination with CVA8 in the 5′-UTR region instead of CVA4, B1a was similar to enterovirus A71 in most of P2 and P3 regions, and recombined with CVA5 in the 3D region of P3.Conclusions:The prevalent strain of CVA16 in Jiaxing may share a common trend of co-circulation and evolution with those in other provinces. The recombination mainly occurs in the 5′-UTR region and non-structural protein coding regions of P2 and P3. Continuous molecular surveillance of CVA16 is in need, and whole-genome sequencing can help understand the genetic variation, evolution, and recombination of strains.This information will provide a more robust basis for the monitoring and early warning, vaccine development, and prevention and control efforts against HFMD.