ObjectiveTo observe the clinical effectiveness and safety of Dingchan Granule （定颤颗粒） for paroxysmal atrial fibrillation with syndrome of qi stagnation and blood stasis. MethodsUsing a randomised， double-blind， placebo controlled study method， 90 patients with paroxysmal atrial fibrillation with qi stagnation and blood stasis syndrome were divided into 45 cases each in the treatment group and the control group. Both groups were given conventional western medicine treatment， and the treatment group was additionally treated with Dingchan Granule， while the control group was treated with Dingchan Granule placebo， both of which were taken orally for 8 g each time twice a day. Both groups were treated for 8 weeks. We compared the clinical effectiveness， the improvement of traditional Chinese medicine （TCM） symptoms and the recovery rate of atrial fibrillation between the two groups. We compared the number and duration of atrial fibrillation episodes， TCM symptoms score， atrial fibrillation symptom classification， 24-hour average ventricular rate， Pittsburgh Sleep Quality Index （PSQI）， anxiety index， depression index before and after treatment， and evaluated the safety of the two groups. ResultsThe total clinical effectiveness rate in the treatment group was 82.22% （37/45）， which was better than 60.00% （27/45） in the control group （P＜0.05）. The total effective rate of TCM syndrome effectiveness in the treatment group was 88.89% （40/45）， which was better than 66.67% （30/45） in the control group （P＜0.05）； and the rate of atrial fibrillation regression in the treatment group was 26.67% （12/45）， better than 6.67% （3/45） in the control group （P＜0.05）. The number and duration of atrial fibrillation episodes in both groups were significantly decreased （P＜0.01）， and the number and duration of atrial fibrillation episodes in the treatment group were lower than those in the control group （P＜0.01）. The TCM syndrome scores of both groups after treatment were significantly lower than before treatment （P＜0.01）， and the scores of the treatment group was lower than those of the control group （P＜0.05）. The severity of atrial fibrillation symptoms and the grading of atrial fibrillation symptoms in both groups after treatment were improved （P＜0.01）， and the degree of symptom improvement in the treatment group was better than that in the control group （P＜0.01）. The 24-hour average ventricular rate of both groups after treatment was significantly lower （P＜0.01）. The PSQI， anxiety index and depression index of the treatment group were all lower than before treatment （P＜0.01）， while the PSQI and anxiety index of the control group were both lower than before treatment （P＜0.01 or P＜0.05）， the PSQI， anxiety index and depression index of the treatment group being lower than those of the control group （P＜0.05 or P＜0.01）. No adverse events occurred in both groups， and no abnormalities were observed in blood， urine， stool routine， liver and kidney function， and coagulation function indexes. ConclusionDingchan Granule for paroxysmal atrial fibrillation with qi stagnation and blood stasis syndrome can alleviate clinical symptom， improve TCM symptom scores， increase atrial fibrillation recovery rate， stabilise the average ventricular rate， and significantly improve the quality of sleep， alleviate the anxiety and depression， with a good safety profile.

With the deepening application of artificial intelligence (AI) technology in the field of medical devices, pre-trained models have increasingly become a crucial engine driving innovation in intelligent healthcare due to their efficiency, generalization capability, and transfer learning performance. However, potential risks associated with pre-trained models—such as issues related to source diversity and quality controllability —pose new challenges to the safety and effectiveness of AI-based medical devices. Against this background, the National Medical Products Administration (NMPA) released the sectoral standard YY/T 1833.5-2024 Artificial Intelligence Medical Devices—Quality Requirements and Evaluation-Part 5: Pre-trained Models in September 2024. This standard provides essential technical guidance and a regulatory framework for standardizing the application of pre-trained models in medical devices, marking a milestone in ensuring the safety and efficacy of AI-powered medical products. This article offers an in-depth interpretation and analysis of the standard's background, orientation, and key technical consideration. It elucidates specific requirements regarding documentation for pre-trained models, definitions of critical quality attributes, and conformity assessment pathways. Furthermore, the practical and far-reaching implications of the standard are discussed, including its role in enhancing quality assurance throughout the entire lifecycle of AI-based medical devices and guiding technological innovation and healthy development within the industry. Additionally, by dissecting the standard, this article aims to support the industry in conducting prudent evaluations during model selection phases, thereby reducing the application of low-quality and high-risk models.

AIM: To evaluate the efficacy of 0.05% cyclosporine eye drops in promoting ocular surface recovery following pterygium excision combined with autologous corneal limbal stem cell transplantation.METHODS:This study is a prospective randomized controlled trial, selecting 104 cases(104 eyes)of primary pterygium with monocular onset admitted to Baoding First Central Hospital from September 2023 to September 2024 as the initial sample. The patients were divided into an experimental group and a control group using a random number table method, with 52 eyes in each group. Both groups underwent pterygium excision and autologous corneal limbal stem cell transplantation performed by the same surgeon. The control group received tobramycin dexamethasone eye drops combined with 0.3% sodium hyaluronate eye drops, while the experimental group was additionally treated with 0.05% cyclosporine eye drops. The corneal epithelial repair status, ocular surface function [corneal fluorescein staining(FL)score, Schirmer I test(SIt), break-up time of tear film(BUT)] at preoperative and postoperative time points(1 and 3 mo), and dry eye symptoms [ocular surface disease index(OSDI), standard patient evaluation of eye dryness(SPEED)scores]. Additionally, the recurrence rate and postoperative complications were recorded.RESULTS: During the follow-up period, there was 1 case of loss to follow-up in both the experimental group and the control group, with lost to follow-up rate of 1.9%. Finally, 51 cases in each group completed all followed-up. No statistically significant difference was observed in preoperative general characteristics of patients between the two groups(P>0.05), and there was no statistically significant difference in corneal epithelial repair time or suture removal time(all P>0.05). At 1 mo postoperatively, the SIt and BUT decreased in both groups compared to preoperative levels, with the experimental group showing higher values than the control group(all P<0.05). FL scores increased compared to preoperative levels but were lower in the experimental group(all P<0.05). By 3 mo, the SIt, BUT and FL score of the control group were not statistically different from preoperative levels(all P>0.05), whereas the experimental group showed increased SIt and BUT, which were higher than the control group, and reduced FL scores, and decreased FL scores, which was lower than the control group(all P<0.05). At 3 mo postoperatively, both groups showed increased SIt and BUT compared to 1-month values, with the experimental group outperforming the control group(all P<0.05). FL scores decreased in both groups compared to 1-month values, with the experimental group maintaining lower scores(P<0.05). At 1 mo postoperatively, OSDI and SPEED scores were higher than preoperative levels, with the experimental group higher than the control group(all P<0.05); at 3 mo postoperatively, the scores returned to preoperative level(all P>0.05), and the OSDI and SPEED scores of the control group increased and higher than those of the experiment group(all P<0.05); at 3 mo postoperatively, the OSDI and SPEED scores decreased when compared with 1-month preoperative level, and the experiment group was lower than the control group(all P<0.05). There was no difference in the total incidence of postoperative complications between the two groups(P>0.05). According to the statistics of 6 mo follow-up after operation, there was no recurrence in the experimental group, and the recurrence rate was 11.8% in the control group(P<0.05).CONCLUSION: Adjunctive use of 0.05% cyclosporine eye drops after pterygium excision with limbal stem cell transplantation enhances ocular surface recovery, reduces dry eye symptoms, and lowers recurrence rates without compromising corneal epithelial healing or safety.

Objective To explore the clinical efficacy of prone position ventilation(PPV)in improving hypoxemia in patients with severe brain damage.Methods A retrospective research method was conducted,140 patients with severe brain damage who were admitted to the department of critical care medicine of the First Affiliated Hospital,Zhejiang University School of Medicine from August 2020 to August 2021 were selected as subject objected.According to the inclusion and exclusion criteria,20 patients with oxygenation index≤200 mmHg(1 mmHg≈0.133 kPa)who were treated with PPV were statistically analyzed.The patients'blood gas analysis related indicators[including arterial partial pressure of oxygen(PaO2),fractional of inspired oxygen(FiO2),oxygenation index,arterial oxygen saturation(SaO2),arterial partial pressure of carbon dioxide(PaCO2),pH value],ventilator-related parameters[including peak inspiratory pressure(PIP),positive end-expiratory pressure(PEEP),tidal volume(VT),lung dynamic compliance(Cdyn),etc.],and mean arterial pressure(MAP),heart rate(HR)were compared before PPV,12 hours after PPV,and 12 hours after reverting to supine position.At the same time,the related complications of patients during PPV were recorded.Results There were 15 males and 5 females,the mean age of the patients was(46.10±17.22)years old,the average PPV time was(22.20±5.94)hours.Compared with before PPV,patients showed significant increases in PaO2,oxygenation index,SaO2,VT,and Cdyn at 12 hours after PPV and 12 hours after recovery from supine position[PaO2(mmHg):98.35±21.85,98.45±17.90 vs.72.15±10.14,oxygenation index(mmHg):198.82±40.51,202.27±46.39 vs.133.20±33.95,SaO2:0.97±0.02,0.97±0.01 vs.0.94±0.03,VT(mL):558.42±111.23,580.29±119.44 vs.484.82±123.77,Cdyn(mL/cmH2O):26.11±5.42,27.90±5.80 vs.24.15±6.13,all P<0.05];Compared with 12 hours after PPV,the Cdyn of the patient still showed a significant increase after 12 hours of recovery from supine position(P<0.05).There were no statistical differences in the FiO2,PaCO2,pH value,PIP,PEEP,HR,and MAP of patients at various time points before and after PPV(all P>0.05).Five patients developed redness and swelling at the skin compression site mainly on the face after PPV,which gradually improved after returning to a supine position.During this period,there was no occurrence of catheter detachment,malignant arrhythmia,or significant hemodynamic instability.Conclusion PPV has a certain clinical effect on improving hypoxemia in patients with severe brain damage.

Objective To investigate the clinical application value of pediatric electronic bronchoscopy on the diagnosis of respiratory disease in the pediatric intensive care unit(PICU)by morphological diagnosis.Methods The clinical data of 124 patients with PICU respiratory critically ill patients who underwent bedside electronic bronchoscopy from July 2017 to December 2022 in Lanzhou University Second Hospital were retrospectively analyzed.Pathogen examination of 96 cases of bronchoalveolar lavage fluid(BALF),bronchoscopy guided nasal endotracheal intubation in 3 cases was conducted.The accuracy of diagnosis of lung lesions was compared between electronic bronchoscopy and chest CT,and the morphological changes of lung lesions under electronic bronchoscopy were observed.Results The accuracy of electronic bronchoscopy in the diagnosis of tracheoesophageal fistula,tracheoesophageal rupture and bronchial foreign body is significantly higher than that of chest CT(tracheoesophageal fistula:4 cases vs.0 case,tracheoesophageal rupture:4 cases vs.0 case,bronchial foreign body:4 cases vs.6 cases,all P<0.05),and there was no significant difference in the accuracy of diagnosis of lung contusion and bronchiectasis between electronic bronchoscopy and chest CT.Typical cases confirmed under endoscopic:4 cases(3.23%)had tracheoesophageal fistula.Bronchial rupture 4 cases(3.23%).Endobronchial tuberculosis was diagnosed in 1 case(0.81%)with bronchial neoplasms and white caseous material attached to the mucosa.Positive bacteria were detected in 23 cases(23.96%).Guided nasotracheal intubation was performed in 3 children with jaw or cervical fracture.Endotracheal catheterization under mechanical ventilation was performed in 13 cases.There were no serious complications and death during and after the operation.Conclusion Pediatric bendable bronchoscopy with PICU is safe and reliable.It can improve the diagnosis rate of respiratory diseases in PICU,and has high clinical application value.

Objective:To obtain the normal reference range of hemodynamic ultrasound parameters after pediatric liver transplantation through big data query and statistical analysis, and compare their changes with age.Methods:The clinical liver transplantation ultrasound imaging database software V1.0 independently developed by Tianjin First Central Hospital was used to query the ultrasound hemodynamic parameters of 0-14 years old pediatric patients after parental liver transplantation from December 2012 to December 2022, including portal vein diameter (PVD) on the 1st day, 7th day, 1st month, 6th month, 1st year, 5th year, and 10th year after surgery. The changes in ultrasound blood flow parameters such as portal vein velocity (PVV), hepatic artery peak velocity (S), hepatic artery end diastolic velocity (D), and left hepatic vein velocity (LHVV) with postoperative time in different age groups were analyzed, the differences between age groups were compared, and statistical analysis was perform to obtain the 95% reference value range for each parameter.Results:A total of 731 pediatric patients aged 0-14 years who underwent parental liver transplantation were included in this study, with a total of 5 283 monitoring results. The ultrasound hemodynamic parameters PVV, hepatic artery S, D, and LHVV were highest at 7th day after surgery, and gradually showed a sustained and slightly decreasing trend with the prolongation of postoperative time. At the same time, there was no statistically significant difference in PVV, hepatic artery S, D, and LHVV among different age groups (all P>0.05). Conclusions:This study obtains the trend of ultrasound hemodynamic parameters after pediatric liver transplantation with prolonged follow-up time, and compared them among different age groups.After pediatric liver transplantation, there is no significant change in liver hemodynamic parameters with increasing age. Obtaining reference value ranges for various parameters in different age groups is of great clinical significance for early detection and diagnosis of postoperative vascular complications. Pediatric liver transplantation is more complex than adult liver transplantation, and in clinical monitoring, more attention should be paid to the dynamic changes of transplanted liver blood flow, combining with individual patient status, to provide imaging support for clinical diagnosis.

Objective To study the levels of serum Periostin and interleukin(I1-)-18 in preterm infants with bronchopulmonary dysplasia(BPD),and to analyze their correlation with the severity of the disease and their predictive value for BPD.Methods A total of 62 preterm infants with BPD diagnosed and treated in the hospital from January 2019 to January 2022 were retrospectively selected as the BPD group,and 80 preterm in-fants without BPD during the same period were selected as the non-BPD group.According to the severity of BPD,the infants with BPD were divided into mild subgroup(22 cases),moderate subgroup(24 cases)and se-vere subgroup(16 cases).The serum levels of Periostin and IL-18 were detected by enzyme-linked immu-nosorbent assay.Pearson correlation analysis was used to analyze the correlation between the clinical parameters.Multivariate Logistic regression was used to analyze the influencing factors of BPD,and receiver operating characteristic(ROC)curve was used to analyze the predictive value of each indicator for BPD.Results Compared with the non-BPD group,the BPD group had a significantly higher proportion of infants with pulmonary surfactant(PS)use,neonatal respiratory distress syndrome,apnea,patent ductus arteriosus,and serum levels of Periostin and IL-18,as well as a significantly longer duration of mechanical ventilation,noninvasive respiratory support,and length of hospital stay.The lung function parameters[tidal volume per kilogram(VT/kg),ratio of time to peak tidal expiratory flow to time(TPTEF/TE),ratio of volume to peak tidal expiratory flow to volume(VPEF/VE),expiratory flow at 50％tidal volume(50％TEF),expiratory flow at 75％tidal volume(75％TEF)]and 1,5 min Apgar score of BPD group were lower than that of non-BPD group,and the differences were statistically significant(P＜0.05).The serum levels of Periostin and IL-18 in mild subgroup,moderate subgroup and severe subgroup were increased in turn.The levels of serum Periostin and IL-18 were negatively correlated with pulmonary function indexes(VT/kg,50％TEF,75％TEF,TPTEF/TE,VPEF/VE,P＜0.05).Serum Periostin,IL-18 and neonatal respiratory distress syndrome were independent risk factors for BPD(P＜0.05),and PS was a protective factor(P＜0.05).Serum Periostin,IL-18 and neonatal respiratory distress syndrome were independent risk factors for the severity of BPD(P＜0.05).The area under the curve(95％CI)of serum Periostin and IL-18 alone and in combination for predicting BPD were 0.841(0.814-0.899),0.863(0.820-0.897),0.922(0.878-0.949),respectively.The sensitivity and specificity of combined prediction were 0.902 and 0.825,respectively.The area under the curve of the combination of the two indica-tors for predicting BPD was greater than that of each index alone,and the difference was statistically signifi-cant(Z=5.357,4.894,P＜0.001).Conclusion The levels of serum Periostin and IL-18 are increased in in-fants with BPD,which are related to the severity of BPD and lung function.The combination of serum Perios-tin and IL-18 has a high predictive value for BPD.

Objective To construct an NZB/W(F1)mouse model of systemic lupus erythematosus and evaluate the effects of nicotinamide on each index of lupus nephritis pathogenesis of NZB/W(F1)mice in order to provide data for research on the role of nicotinamide in the treatment of lupus nephritis.Methods Female NZB/W(F1)mice were obtained by crossing male NZW mice with female NZB ones.Urine samples were collected using metabolic cages and proteinuria test strips were used to detect proteinuria.Blood samples were collected through the orbital venous plexus in mice.Enzyme-linked immunosorbent assay(ELISA)was used to detect the level of anti-dsDNA antibody.Levels of serum creatinine and urea nitrogen and liver function indexes were detected using an automatic blood analyzer.Hematoxylin-eosin staining and immunofluorescence technique were used to detect the pathological state of the kidney.Results The levels of proteinuria,double-stranded DNA antibodies,serum creatinine,and urea nitrogen were gradually increased during the natural course of the disease in female NZB/W(F1)mice,indicating that the lupus nephritis disease model was constructed in female NZB/W(F1)mice.Compared to the control group,nicotinamide feeding could obviously decrease the level of proteinuria(P=0.0070),inhibit the production of double-stranded DNA antibodies(P=0.0325),and retard the progression of serum creatinine(P=0.0067)and urea nitrogen indexes(P=0.0166)in serum.In addition,the pathological state of the kidney in the nicotinamide feeding group was significantly alleviated compared with the control group.Conclusion A lupus nephritis disease model is constructed in NZB/W(F1)mice.Nicotinamide feeding can obviously alleviate the disease state of lupus nephritis in NZB/W(F1)mice.

Objective:To investigate the clinicopathological characteristics of SMARCA4-deficient thoracic undifferentiated tumors, and the diagnostic value of the cells in serous effusion.Methods:Eleven cases of SMARCA4-deficient tumor were collected from the Affiliated Hospital of Hebei University, China from January 2018 to July 2023, which were diagnosed using cell block of serous effusion. The clinical, histopathological, immunohistochemical and molecular genetic features were reviewed, along with related literature.Results:All the 11 patients were males with ages ranging from 54 to 77 years (median 64 years). Nine patients were smokers and two had an unknown smoking history. Most of them complained of cough and dyspnea with pleural effusion. The primary tumor sites included lung (9 cases), thoracic wall (1 case), and mediastinum (1 case), while 3 patients had a history of lung surgery. Histologically, tumor cells were large and pleomorphic, with increased nuclear-cytoplasmic ratio. They also showed round nuclei, conspicuous nucleoli, and basophilic cytoplasm in serous effusion. Immunohistochemically, tumor cells in all cases were negative for SMARCA4/BRG1, CKpan and CK7, but positive for SMARCB1/INI1. Some of the cases were positive for CD34 (7/11), synaptophysin (4/11) and SALL4 (2/11). Histologically, monotonous tumor cells formed solid sheets or anastomosing islands with poor cell adhesion and rhabdoid morphology. Brisk mitotic figures were accompanied by large areas of necrosis. Some cases focally exhibited syncytia, and some had bright cytoplasm and vesicular chromatin. The immunohistochemical profiles in the tumor tissues were consistent with those of cytology. Six cases were negative for PD-L1 (22c3). Among the 6 cases analyzed by targeted next generation sequencing, concurrent SMARCA4 and TP53 mutations were detected in all 6 cases. Some of the 6 tumors showed mutations of STK11, CDKN2A, and MET, and amplification of ERBB2, exon deletion of BRCA2, etc. Follow-up information was available in all cases and ranged from 2 to 24 months. The patients showed metastases to various sites, including lymph node, liver, kidney, adrenal gland, brain, bone and other sites. Four patients died of the tumor. The survival time of 4 patients who underwent radical resection or radiofrequency ablation was more than 13 months.Conclusions:SMARCA4-deficient thoracic sarcoma is a rare but highly aggressive tumor with dismal prognosis and rhabdomyoid features. It is difficult to diagnose this disease using only serous effusion samples. This tumor thus warrants careful consideration. Accurate diagnosis can greatly improve early diagnosis and treatment of these tumors.

There is increasing evidence that the activation of glucagon-like peptide-1 receptor(GLP-1R)can be used as a therapeutic intervention for cognitive disorders.Here,we have screened GLP-1 R targeted com-pounds from Scutellaria baicalensis,which revealed baicalein is a potential GLP-1 R small-molecule agonist.Mitophagy,a selective autophagy pathway for mitochondrial quality control,plays a neuro-protective role in multiple cognitive impairment diseases.We noticed that Glp1r knock-out(KO)mice present cognitive impairment symptoms and appear worse in spatial learning memory and learning capacity in Morris water maze(MWM)test than their wide-type(WT)counterparts.Our mechanistic studies revealed that mitophagy is impaired in hippocampus tissue of diabetic mice and Glp1r KO mice.Finally,we verified that the cognitive improvement effects of baicalein on diabetic cognitive dysfunction occur through the enhancement of mitophagy in a GLP-1 R-dependent manner.Our findings shed light on the importance of GLP-1 R for cognitive function maintenance,and revealed the vital significance of GLP-1R for maintaining mitochondrial homeostasis.Furthermore,we identified the therapeutic potential of baicalein in the treatment of cognitive disorder associated with diabetes.