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.

It is believed that the pathogenesis of oculomotor nerve palsy is insufficient marrow sea （髓海）， withered yang qi， poor contraction of eyelids and periocular meridians， and inability to open and close the eyes. The eye system is connected to the marrow sea， as well as the the foot taiyang （太阳） channel， foot yangming （阳明） channel， foot jueyin （厥阴） channel， yinqiao mai （阴跷脉） and yangqiao mai （阳跷脉）， and is nourished by the liver， spleen and kidney. Treatment should take into account both the branch and the root cause. It is suggested to treat the root by regulating the marrow sea， and treat the branch by unblocking the meridians and dredging the collaterals， thereby balancing the mild and the urgency of the yinqiao mai and yangqiao mai. Using the "Gen （根）-Liu（溜）-Zhu （注）-Ru （入）"acupoints to bypass the various meridians and taking the gallbladder meridian according to twelve major meridians that run on both sides of the body， both of which can provide ideas for improving symptoms such as ptosis and limited eye movement caused by oculomotor nerve palsy.

Objective To investigate the clinical characteristics,diagnosis,treatment,and prognosis of descending necrotizing mediastinitis(DNM)to provide a reference for the early diagnosis and timely treatment of DNM.Methods Data on DNM in China was electronically retrieved from the core databases and comprehensively reviewed from June 2012 to June 2023.The infection,pathogenic microorganisms,main symptoms,comorbidities and treatment methods of DNM were analyzed.Results The data of a total of 781 DNM patients,with an average age of(52.97±5.64)years,were retrieved,including 554 males and 227 females.Odontogenic source,tonsillitis,pharyngeal abscess,sialoadenitis,upper respiratory tract infection,foreign body injury,or iatrogenic traumatic procedures are common causes.Among these,odontogenic infection is the most common source.Streptococcus sp.(n=217)and Staphylococcus sp.(n=82)were most isolated,followed by Klebsiella pneumoniae and Pseudomonas aeruginosa(equally n=59).A total of 69.4％(542/781)of DNM patients recruited in this study were discovered to have various comorbidities,and more than one-third of these patients(n=185)had diabetes.Of the broad antibiotics,carbapenem was most frequently used as treatment,and vancomycin was the most frequently coadministered.The mediastinal drainage approach varies widely,and the optimal regimen is still unknown.Seventy-two patients were treated with video-assisted thoracoscopic/mediastinoscopic surgical drainage,22 patients were treated with percutaneous catheter drainage,30 underwent the transcervical approach,and 40 underwent thoracotomy.A total of 617 patients who were selected underwent the appropriate combined operation for surgical drainage according to the specific location of the infected focus.The overall mortality rate of all 781 DNM pa-tients included was 11.2％.Conclusion The most effective diagnosis and treatment of DNM is a high degree of clini-cal vigilance followed by prompt and adequate drainage with intensive care,including hemodynamic monitoring,nutri-tional support,computer tomographic scanning repeated as necessary,and combined use of systemic antibiotics.

Traditional Chinese medicine(TCM)is extensively utilized for clinical disease prevention and treatment.However,due to the intricate nature of its material basis and the multiple factors involved in the preparation process,ensuring comprehensive quality control of TCM proves to be challenging.By instilling a clear understanding of its effective and harmful substances and implementing control over the content and limit of TCM during the preparation process,the controllability and repeatability of its quality can be guaranteed.Currently,China is facing a dearth of innovative technology for drug development,necessitating an increase in research and development efficiency,especially in the realm of high-throughput precision analytical equipment.The country has long relied on imported pharmaceutical analysis equipment with a particular efficiency in high-end intelligent analysis equipment.This is especially concerning considering the urgent requirement to establish a"pharmaceutical intelligent analysis system."This project,supported by the Major Instrument Development Project of the National Science and Technology Funds,employs cell membrane chromatography technology,complemented by biotechnology and artificial intelligence technology,to devise a two-dimensional cell membrane chromatography(2D/CMC)analyzer.The project has successfully conducted a demonstration application of the"2D/CMC-Traditional Chinese Medicine Pharmacodynamic Substance Analyzer"and the"2D/CMC-Traditional Chinese Medicine Injection Allergen Analyzer".These tools have enhanced the screening and discovery efficiency of TCM's effective substances and allergen components.Moreover,the equipment amalgamates qualitative and quantitative analysis,thereby serving as an effective analytical tool to enhance the quality and efficacy of traditional Chinese medicine.

Objective To study the effect of Salidroside(Sal)on platelet activation and aggregation and the interaction between human platelets and MDA-MB-468 cells of breast cancer.Methods Human platelets were collected,platelet sus-pension was prepared,and platelets were treated with different concentrations of Sal.The effects of Sal on platelet activation and aggregation were detected by thromboelastogram(TEG)and flow cytometry.Breast cancer MDA-MB-468 cells were cul-tured in vitro,and human platelets were treated with different concentrations of Sal,and then activated by thrombin.The effects of Sal on the interaction between platelets and MDA-MB-468 cells were analyzed by adhesion test and scratch test.Re-sults TEG detection:The ADP inhibition rate in the blank control group was(10.97±12.69)%,and the ADP inhibition rate in all Sal intervention groups was higher than that in the blank control group(P＜0.05).The AA inhibition rate was(8.11±7.84)%in the control group and(25.96±15.18)%in the 5 μmol/L Sal intervention group,and the difference was statistically significant(P＜0.05).Flow cytometry:The expression of CD62P on platelet surface in 40 and 60 μmol/L Sal groups was(56.5±0.17)%and(65.50±0.36)%,respectively,and the difference was statistically significant compared with the positive control group(76.53±0.49)%(P＜0.05).The percentages of PAC-1 expression on platelet surface in 40 and 60 μmol/L Sal groups were(62.20±0.10)%and(58.47±0.15)%,and the difference was statistically significant com-pared with the positive control group(72.10±0.20)%(P＜0.05).Adhesion experiment:Platelets can have adhesion with MDA-MB-468 cells,and activated platelets have stronger adhesion ability.The adhesion rate in the Sal group was signifi-cantly lower than that in the positive control group,and was negatively correlated with the concentration of Sal.Scratch test:The cell mobility at 24 h in the positive control group was(12.71±0.70)%,and the cell mobility in each Sal treatment group was(4.51±0.44)%,(3.85±0.11)%,(5.37±0.36)%,(4.15±0.13)%and(3.55±0.38)%,respectively,showing significant decrease compared with the positive control group(P＜0.05).After 48 h of Sal treatment,the cell mobility of 10,20,40 and 60μmol/L Sal groups decreased,and there was a statistical difference compared with the positive control group(P＜0.05).Conclusion Sal can inhibit the adhesion between activated platelets mediated by thrombin and MDA-MB-468 cells and the migration of MDA-MB-468 cells.

Objective To screen differentially expressed long non-coding RNAs (lncRNAs) in the liver of mice infected with Schistosoma japonicum during the chronic pathogenic stage and identify their functions, so as to provide insights into unravelling the role of lncRNAs in S. japonicum infection-induced liver disorders. Methods Twenty 6-week-old C57BL/6 mice were randomly divided into two groups, of 10 animals each group. Each mouse in the experimental group was infected with (15 ± 2) S. japonicum cercariae via the abdomen for modeling chronic S. japonicum infection in mice, and distilled water served as controls. All mice were sacrificed 70 days post-infection, and mouse liver specimens were sampled for RNA extraction and library construction. All libraries were sequenced on the Illumina NovaSeq 6000 sequencing platform. Data cleaning was performed using the fastp software, and reference genome alignment and gene expression (FPKM) calculation were performed using the HISAT2 software. Potential lncRNA sequences were predicted using the software CNIC, CPC, Pfam, and PLEK, and potential lncRNAs were screened. Differentially expressed lncRNAs were screened with the DESeq2 software and subjected to Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analyses to identify biological processes and metabolic pathways involved in target genes of differentially expressed lncRNAs. Results A total of 333 potential lncRNAs were screened, and 67 were identified as differentially expressed lncRNAs, including 49 up-regulated and 18 down-regulated lncRNAs. A total of 53 target genes were predicted for differentially expressed lncRNAs. GO enrichment analysis showed that these target genes were mainly enriched in biological process and molecular function, among which Sema7a, Arrb1, and Ccl21b genes may be hub target genes for positive regulation of extracellular regulated protein kinase 1 (ERK1) and ERK2 cascades and may participate in the regulation of collagen expression. KEGG enrichment analysis showed that the target genes of differentially expressed lncRNAs were mainly enriched in cytokine-cytokine receptor interaction, viral protein interactions with cytokines and cytokine receptors, chemokine signaling pathway, and nuclear factor kappa-B (NF-κB) signaling pathway. Conclusions This study identifies differentially expressed lncRNAs and functional enrichment of their target genes in the liver of mice during the chronic pathogenic stage of S. japonicum infection. Up-regulated lncRNAs may affect biological processes of ERK1/2 cascades and chemokine signaling pathways via target genes Sema7a, Arrb1, and Ccl21b, thereby affecting collagen expression and inflammatory signal pathways, ultimately affecting the development of liver disorders.

Objective To investigate the influences of arctigenin(ATG)on ventricular remodeling and inflammatory reaction in chronic heart failure(CHF)rats,and to analyze its potential mecha-nism.Methods A total of 79 SD rats were randomly divided into sham operation group(n=12),and the remaining rats were inflicted with abdominal aortic coarctation to establish a rat CHF model.After modeling,60 CHF rats were randomly divided into CHF group,low and high dose ATG group(ATG-L and ATG-H groups,10 and 20 mg/kg,respectively),ATG+NC group[20 mg/kg ATG+100 μl high mobility group protein B1(HMGB1)negative control plasmid],and ATG+HMGB1 group(20 mg/kg ATG+100 pl HMGB1 overexpression plasmid),with 12 rats per group.After 4 weeks of corresponding intervention,heart function,levels of B-type brain na-triuretic peptide(BNP),N-terminal B-type brain natriuretic peptide precursor(NT-proBNP)andIL-6 and TNF-α,heart mass index(HMI)and left ventricular mass index(LVMI),pathological changes of myocardial tissue,cross-sectional area of myocardial cells and myocardial collagen vol-ume fraction(CVF)and protein expression of HMGB1/Toll-like receptor 4(TLR4)/NF-κB sig-naling pathway in left ventricular myocardial tissue were measured.Results Compared with the sham operation group,myocardial tissue HMGB1(0.42±0.05 vs 0.15±0.02)and TLR4(0.70± 0.09 vs 0.21±0.04)protein levels,and phosphorylated NF-κB p65(p-NF-κB p65)/NF-κB p65(0.73±0.09 vs 0.26±0.05)protein ratio were obviously increased in the CHF group,while the left ventricular ejection fraction(LVEF)and left ventricular short-axis fractional shortening(LVFS)were obviously decreased(P＜0.05).Myocardial tissue HMGB1(0.33±0.04、0.24±0.04 vs 0.42±0.05)and TLR4(0.56±0.06、0.41±0.05 vs 0.70±0.09)protein levels,and p-NF κB p65/NF-KB p65(0.61±0.08、0.49±0.06 vs 0.73±0.09)protein ratio were decreased,and the LVEF and LVFS were increased in the ATG-L group and ATG-H group than the CHF group(P＜0.05).Overexpression of HMGB1 obviously attenuated the inhibitory effects of ATG on HMGB1/TLR4/NF-κB signaling pathway,ventricular remodeling,and inflammatory reaction in CHF rats(P＜0.05).Conclusion ATG may suppress ventricular remodeling in CHF rats by in-hibiting HMGB1/TLR4/NF-κB signaling inflammatory pathway.

Objective To investigate the effect of Yiqi Huoxue Tongluo Decoction on microRNA-126a-5p(miR-126a-5p)and vascular endothelial growth factor(VEGF)signaling pathway in cervical spondylotic myelopathy model rats.Methods Thirty healthy male SD rats were divided into the sham operation group,the model group and the traditional Chinese medicine(TCM)group by random number table method.Cervical spondylotic myelopathy models were prepared in the model group and the TCM group.The TCM group was given intragastric administration of Yiqi Huoxue Tongluo Decoction,while the sham operation group and the model group were given intragastric administration of normal saline for 12 weeks.After intervention,the threshold of mechanical stimulation and retraction time of thermal stimulation in each group were measured by behavior tests.Rats were sacrificed to collect intervertebral disc tissue for hematoxylin-eosin(HE)staining and observe the number of vascular buds in intervertebral disc.Rat intervertebral disc annulus fibrosus cells were subjected to terminal dexynucleotidyl transferase-mediated dUTP nick end labeling(TUNEL)staining.The miR-126a-5p and VEGF mRNA of rat intervertebral disc tissue were detected by real-time fluorescence quantitative polymerase chain reaction(RT-PCR).The expression of VEGF protein of rat intervertebral disc tissue was detected by Western blot assay.Results Compared with the sham operation group,the number of vascular buds in intervertebral disc was decreased in the model group and the TCM group.The cell destruction of intervertebral disc annulus was obvious in rats,and apoptosis was high and cell density decreased.Mechanical stimulation threshold decreased,and mechanical stimulation threshold decreased.The level of miR-126a-5p was decreased,and the expression levels of VEGF mRNA and protein were increased.Compared with the model group,the number of vascular buds in intervertebral disc was increased in the TCM group.The destruction of intervertebral disc annulus cells was alleviated in rats.The apoptosis of annulus fibrosus cells in intervertebral disc decreased and cell density increased.The threshold of mechanical stimulation increased,and the retraction time of thermal stimulation was prolonged.The level of miR-126a-5p increased,and the expression levels of VEGF mRNA and protein decreased(P＜0.05).Conclusion The mechanism of Yiqi Huoxue Tongluo Decoction in the treatment of cervical spondylotic myelopathy may be related to the up-regulation of miR-126a-5p expression and the down-regulation of VEGF expression.