The rapid development of artificial intelligence (AI), especially generative AI (GenAI), has already brought, and will continue to bring, revolutionary changes to our daily production and life, as well as create new opportunities and challenges for diagnostic and therapeutic practices in the medical field. Haihe Hospital of Tianjin University collaborates with the National Supercomputer Center in Tianjin, Tianjin University, and other institutions to carry out research in areas such as smart healthcare, smart services, and smart management. We have conducted research and development of a full-process disease diagnosis and treatment assistance system based on GenAI in the field of smart healthcare. The development of this project is of great significance. The first goal is to upgrade and transform the hospital's information center, organically integrate it with existing information systems, and provide the necessary computing power storage support for intelligent services within the hospital. We have implemented the localized deployment of three models: Tianhe "Tianyuan", WiNGPT, and DeepSeek. The second is to create a digital avatar of the chief physician/chief physician's voice and image by integrating multimodal intelligent interaction technology. With generative intelligence as the core, this solution provides patients with a visual medical interaction solution. The third is to achieve deep adaptation between generative intelligence and the entire process of patient medical treatment. In this project, we have developed assistant tools such as intelligent inquiry, intelligent diagnosis and recognition, intelligent treatment plan generation, and intelligent assisted medical record generation to improve the safety, quality, and efficiency of the diagnosis and treatment process. This study introduces the content of a full-process disease diagnosis and treatment assistance system, aiming to provide references and insights for the digital transformation of the healthcare industry.
Artificial Intelligence ; Humans ; Delivery of Health Care ; Generative Artificial Intelligence

OBJECTIVE To provide a reference for the definition of the legal attributes of the provincial Chinese herbal pieces processing norms and the improvement of legal expression for the drug standards in Drug Administration Law. METHODS Based on the legal evolution of local drug standards in China， the composition of national drug standards for Chinese herbal pieces and the composition of current provincial Chinese herbal pieces processing norms were analyzed； at the same time， based on the method of legal interpretation， the legal connotation of the provincial Chinese herbal medicine processing norms in Drug Administration Law was investigated. RESULTS & CONCLUSIONS In the practice of drug supervision， the provincial Chinese herbal pieces processing norms are essentially local drug standards. The newly revised Drug Administration Law defines the drug standards specifically， but does not stipulate the legal attribute of drug standards for the provincial Chinese herbal pieces processing norms， and there are certain legislative technical defects. It is suggested that when amending the Drug Administration Law， the legal attributes of the drug standards of the provincial Chinese herbal medicine processing norms should be clarified.

OBJECTIVE To explore the therapeutic effect and safety of tolvaptan in the treatment of heart failure with preserved ejection fraction （HFpEF） complicated with hyponatremia. METHODS Overall 106 patients with HFpEF complicated with hyponatremia were collected from the Department of Cardiology in the First Affiliated Hospital of Nanyang Medical College from January 1， 2020 to June 1， 2023. According to the random number table， the patients were divided into conventional treatment group （n＝53） and tolvaptan group （n＝53）. The conventional treatment group was given conventional treatment. Tolvaptan group additionally received Tolvaptan tablets 15 mg on the basis of conventional treatment group， increasing to 30 mg after 24 h， and then adjusting the dosage according to the levels of serum sodium； the maximum dose should not exceed 60 mg/d， and the medication should be stopped when the serum sodium level was≥150 mmol/L. Both groups of patients were treated for 6 months. The levels and changes of cardiac function indexes [left ventricular ejection fraction （LVEF）， left ventricular end systolic diameter （LVESD）， left ventricular end diastolic diameter （LVEDD）， N-terminal pro-brain natriuretic peptide （NT-proBNP）]， 24 h urine output， serum sodium， blood creatinine and urea nitrogen were compared between 2 groups before and after treatment. The occurrence of adverse drug reaction （ADR） was recorded. RESULTS Before treatment， there was no statistically significant difference in those indexes between 2 groups （P＞0.05）. After treatment， the levels of LVEF， 24 h urine output and serum sodium in 2 groups were significantly higher than before treatment， and the tolvaptan group was significantly higher than the conventional treatment group； the levels of LVESD， LVEDD and NT-proBNP were significantly lower than before treatment， and the tolvaptan group was significantly lower than the conventional treatment group （P＜0.05 or P＜0.01）. The changes in cardiac function indexes， 24 h urine output and serum sodium levels in the atorvastatin group were more significant than the conventional treatment group （P＜0.05）. There was no statistically significant difference in the levels and changes of blood creatinine and urea nitrogen before and after treatment， as well as the incidence of nausea and vomiting， dizziness， hypernatremia and frequent urination between 2 groups （P＞0.05）. CONCLUSIONS Tolvaptan can improve cardiac function and increase the blood sodium levels in patients with HFpEF complicated with hyponatremia， without affecting their renal function or increasing the risk of ADR.

Objectives:The present study evaluated the impact of ablation pain during pulmonary vein isolation(PVI)on catheter-tissue contact at different regions. Methods:Forty consecutive patients with atrial fibrillation(AF)referred to Central China Fuwai Hospital for catheter radiofrequency ablation from February to May 2023 were enrolled.The pulmonary veins on each side were divided into 8 regions.The catheter-tissue contact force(CF)and the number of ablation contact stability(>50%catheter attach time CF≥10 g)of each ablation lesion were analyzed.Pain scores during the ablation were assessed using the Faces Pain Scale-Revised and the maximum score was taken for each ablation region.Based on the pain scores,in each region,20 cases with higher pain scores were categorized into the pain group and 20 cases with lower pain scores were categorized into the normal group.The CF characteristics of each region and the relationship with ablation induced pain were analyzed. Results:A total of 3 832 lesions were recorded in 40 patients with AF,with a mean CF of(12.2±7.8)g.Among them,the CF in the pain group was significantly lower than that in the normal group([11.1±5.1]g vs.[13.4±4.8]g,P<0.05).The top region of the right pulmonary vein was the region with the largest CF(16.5±5.8)g,and the upper part of the left anterior wall(at the ridge between the left atrial appendage)was the region with the smallest CF(7.5±3.7)g.At the bottom of right pulmonary vein,right lower posterior wall,left pulmonary vein,and left posterior wall,as well as the middle region of left posterior wall,and upper region of left posterior wall,the CF was significantly smaller in the pain group than that in the normal group(all P<0.05).Of the 3 832 lesions,2 193(57.2%)were stable lesions,and the proportion of stable lesions in the pain group was significantly lower than that in the normal group(55.2%vs.59.5%,P<0.05).In the right pulmonary vein bottom,right lower posterior wall,left lower anterior wall,left pulmonary vein bottom,and left lower posterior wall,the proportion of stable lesions was significantly lower in the pain group than in the normal group(all P<0.05).In addition,the ratio of stable lesions in left pulmonary vein regions was lower than in the right(54.2%vs.60.5%,P<0.05).In the upper part of the left anterior wall(at the ridge between the left atrial appendage),only 88(39.3%)of the 224 lesions in 40 patients were stable lesions. Conclusions:Pain during ablation significantly affects the stability of the catheter to tissue.Monitoring real-time CF during PVI may have important implications for improving ablation efficacy,especially in regions with more intense pain.

Objective:To explore and think about the project management model of investigator-initiated trial (IIT), and the project management of industry sponsored trial (IST), we should standardize the management process of clinical research projects initiated by researchers, improve the management system of clinical research in medical institutions, improve the quality management level of clinical research, and protect the rights and interests of research participants.Methods:By taking the clinical research management of a medical and health institution in Hainan province as an example, one of the first pilot areas for the standardized management of clinical research by the National Health Commission, the difficulties in the management of clinical research initiated by researchers were sorted out, to analyze and standardize the management of clinical research project initiated by researchers.Results:Discussion Project management was the primary link and basic guarantee of standardized management of clinical research, and scientific and feasible project management was a powerful hand to carry out deep and high-quality IIT.Conclusions:It can be manifested in a Hainan provincial public medical institution that a feasible project management was the basement in carrying out the profound and high quality IIT. It is advicable to make full use of policy advantages and clinical resources to produce high-quality research results as well as build a high-level research hospital.

OBJECTIVE To sort out and analyze the expression and provisions of drug standards in the text of the newly revised Drug Administration Law ，and to explore the connotation and legal positioning of drug registration standards so as to provide reference for the rational application and interpretation of relevant provisions of drug standards in Drug Administration Law . METHODS Through the review of the evolution of drug standard management in China ，the legal provisions of drug standard in the Drug Administration Law were analyzed. Comparative study and literature research methods were used to analyze the legal expression and connotation of drug standards. RESULTS & CONCLUSIONS There were different expressions about “national drug standards ”“drug standards ”and“quality standards ”in the current provisions of the newly revised Drug Administration Law ； the legal position of the provincial-level standard for the preparation of Chinese herbal pieces was not clear ，and there may be insufficient legal regulation in the enforcement of drug administration. It is necessary to make an administrative interpretation for the content of relevant drug standards and provisions ，and further clarify the legal attributes of drug standards in the processing of provincial Chinese herbal pieces in order to promote the standardized management of Chinese herbal pieces.

For the ideal preclinical animal model of hepatitis B virus (HBV), its hepatocytes should allow HBV entry and cccDNA generation and have both innate and adaptive immune systems. However, HBV only naturally infects humans and chimpanzees due to highly restricted species specificity, and no effective model has been established so far to truly reflect the immune mechanism and pathogenesis of HBV infection. This article reviews five commonly used mouse models, i.e., HBV transgenic model, HBV plasmid DNA hydrodynamic injection model, AAV-HBV transfection model, cccDNA surrogate model, and human-mouse chimeric liver model, and looks forward to the new models that will appear in the future, such as hNTCP transgenic cynomolgus monkey, rhesus monkey, or pig models, so as to provide a reference for researchers to select these models, accelerate the process of drug screening, validate new therapies, and better solve the problems of HBV biological pathogenesis.

OBJECTIVE: To observe the sub-acute toxicity of 1-bromopropane(1-BP) oral exposure for 28 days in SD rats. METHODS: Specific pathogen free adult female SD rats were randomly assigned to the control and exposed group, 8 rats in each group. The 1-BP was suspended in corn oil and administered by gavages in a dose of 800 mg/kg body weight to rats in the exposed group, once a day, 5 days per week for 4 weeks. The rats in the control group were given equal volume of corn oil. After the last exposure, blood and urine of rats were collected for 1-BP level detection and hematological examination. Brain, heart, lung, liver, kidney and spleen of rats were collected for gross pathological examination and histopathological examination. RESULTS: The rats of exposed group showed unstable standing, weakness of hind limbs, limping and lying down from the 3 rd week of exposure. From the 1 st to 4 th week of exposure, mean body weight of rats in the exposed group were significantly lower than those of the control group(P<0.05). In the exposed group, the level of 1-BP in urine was higher than that in blood(P<0.05), and that there was positive correlation between them(Spearman correlation coefficient=0.954, P<0.01). In the control group, 1-BP was not detected. The absolute weights of brain and lung tissue in the exposure group decreased(P<0.05), meanwhile the organ coefficients of heart, liver, spleen and kidney were significantly increased compared with the control group(P<0.05). The number of red blood cells, hemoglobin concentration, hematocrit, the mean hemoglobin concentration, the total serum cholesterol and triglycerides were decreased(P<0.05). No pathological change related to 1-BP exposure was observed in the main organs of the rats in the exposed group. CONCLUSION: The sub-acute oral toxicity of 1-BP is mainly neurotoxicity and hematotoxicity. The 1-BP level in urine may reflect its exposure.

Objective To investigate the prevalence of restless legs syndrome (RLS) in peritoneal dialysis patients and analyze the related risk factors.Methods This study was a cross-sectional study.The patients receiving maintenance peritoneal dialysis from January 2017 to December 2017 in the Peritoneal Dialysis Center of the Second Hospital Affiliated to Soochow University were selected as the study subjects.RLS was screened for peritoneal dialysis patients by epidemiological field investigation based on the RLS diagnostic criteria of the International Restless Leg Syndrome Research Group in 2014.Clinical data and laboratory examinations of selected patients were collected and the differences of clinical indicators between RLS and non-RLS patients were compared.The risk factors related to RLS were analyzed by logistic regression.Results Seventy-six cases of RLS were screened out from 396 PD patients.The prevalence of RLS was 19.2％.Compared with non-RLS group,RLS group patients had longer dialysis age,less 24 hours urine volume,and elevated blood intact Parathormone (iPTH) and alkaline phosphatase (AKP) (all P ＜ 0.05).There was no significant difference in primary disease ratio,sex,age,body mass index,blood pressure,hemoglobin,creatinine,urea nitrogen,uric acid,ferritin,serum iron,transferrin saturation,blood calcium,blood phosphorus,total cholesterol,triglyceride,low density lipoprotein,high density lipoprotein,eGFR,Kt/V,Ccr between RLS and non-RLS group patients (all P ＞ 0.05).Multivariate logistic regression analysis showed that long dialysis age (OR=1.010,95％CI 1.001-1.018,P=0.022) and high blood AKP (OR=1.005,95％CI 1.001-1.010,P=0.021) were independent risk factors for RLS in peritoneal dialysis patients (both P ＜ 0.05).Conclusions The prevalence of RLS is high in peritoneal dialysis patients.Long dialysis age and high blood AKP are independent risk factors for RLS.

BACKGROUND: Traditional toxicological studies focus on individual compounds. However, this single-compound approach neglects the fact that the mixture exposed to human may act additively or synergistically to induce greater toxicity than the single compounds exposure due to their similarities in the mode of action and targets. Mixture effects can occur even when all mixture components are present at levels that individually do not produce observable effects. So the individual chemical effect thresholds do not necessarily protect against combination effects, an understanding of the rules governing the interactive effects in mixtures is needed. The aim of the study was to test and analyze the individual and combined estrogenic effects of a mixture of three endocrine disrupting chemicals (EDCs), bisphenol A (BPA), nonylphenol (NP) and diethylstilbestrol (DES) in immature rats with mathematical models. METHOD: In the present study, the data of individual estrogenic effects of BPA, NP and DES were obtained in uterotrophic bioassay respectively, the reference points for BPA, NP and DES were derived from the dose-response ralationship by using the traditional no observed adverse effect (NOAEL) or lowest observed adverse effect level (LOAEL) methods, and the benchmark dose (BMD) method. Then LOAEL values and the benchmark dose lower confidence limit (BMDL) of single EDCs as the dose design basis for the study of the combined action pattern. Mixed prediction models, the 3 × 2 factorial design model and the concentration addition (CA) model, were employed to analyze the combined estrogenic effect of the three EDCs. RESULTS: From the dose-response relationship of estrogenic effects of BPA, NP and DES in the model of the prepuberty rats, the BMDL(NOAEL) of the estrogenic effects of BPA, NP and DES were 90(120) mg/kg body weight, 6 mg/kg body weight and 0.10(0.25) μg/kg body weight, and the LOAEL of the the estrogenic effects of three EDCs were 240 mg/kg body weight, 15 mg/kg body weight and 0.50 μg/kg body weight, respectively. At BMDL doses based on the CA concept and the factorial analysis, the mode of combined effects of the three EDCs were dose addition. Mixtures in LOAEL doses, NP and DES combined effects on rat uterine/body weight ratio indicates antagonistic based on the CA concept but additive based on the factorial analysis. Combined effects of other mixtures are all additive by using the two models. CONCLUSION Our results showed that CA model provide more accurate results than the factorial analysis, the mode of combined effects of the three EDCs were dose addition, except mixtures in LOAEL doses, NP and DES combined effects indicates antagonistic effects based on the CA model but additive based on the factorial analysis. In particular, BPA and NP produced combination effects that are larger than the effect of each mixture component applied separately at BMDL doses, which show that additivity is important in the assessment of chemicals with estrogenic effects. The use of BMDL as point of departure in risk assessment may lead to underestimation of risk, and a more balanced approach should be considered in risk assessment.
Animals ; Benzhydryl Compounds ; toxicity ; Diethylstilbestrol ; toxicity ; Dose-Response Relationship, Drug ; Drug Interactions ; Endocrine Disruptors ; toxicity ; Estrogens ; toxicity ; Models, Theoretical ; Phenols ; toxicity ; Rats ; Rats, Sprague-Dawley ; Risk Assessment