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 characteristics and pathogenic variant in a child with Cantú syndrome (CS).Methods:A male who was admitted to the Children′s Hospital Affiliated to Zhengzhou University on February 23, 2022 was selected as the study subject. Clinical data of the child was collected. Peripheral blood samples of the child and his parents were collected and subjected to whole-exome sequencing (WES). Candidate variant was verified by Sanger sequencing. This study was approved by Medical Ethics Committee of the Children′s Hospital Affiliated to Zhengzhou University (Ethics No. 2023-K-087).Results:The child, a 3-year-and-2-month-old male, was born with hirsutism, with heavy hair all over the body and peculiar facial features. Routine echocardiography 1 month before had discovered atrial septal defect. Sequencing revealed that the child has harbored a heterozygous c. 2438G>C (p.S813T) variant of the ABCC9 gene, which was de novo in origin. Based on the guidelines from the American College of Medical Genetics and Genomics (ACMG), the c. 2438G>C variant was classified as likely pathogenic (PS2+ PM2_Supporting+ PP3). Conclusion:The heterozygous c. 2438G>C variant of the ABCC9 gene probably underlay the pathogenesis of CS in this child.

Objective To establish and validate a risk prediction model based on multiple blood routine parameters for preliminary differential diagnosis of influenza A and influenza like illness(ILI)in children.Methods Children with influenza A(n=2 686)and ILI(n=1 369)who were treated in Department of Pediatrics,The First Affiliated Hospital of Naval Medical University(Second Military Medical University)from Jul.1,2022 to Jun.30,2023 were enrolled,and their clinical and laboratory features were collected for retrospective analysis.According to age,patients were divided into 2 subgroups:1 year≤age≤6 years and 6 years＜age≤16 years.Patients in each subgroup were randomly divided into training set(70%)and internal validation set(30%).Children with influenza A(n=204)and ILI(n=404)who were treated in Department of Pediatrics of The Second Affiliated Hospital of Naval Medical University(Second Military Medical University)and Naval Hospital of PLA Eastern Theater Command from Jul.1,2022 to Jun.30,2023 were selected as the external validation set.Multivariate logistic regression analysis was performed on the training set to obtain the independent influencing factors of influenza A.The prediction model based on these factors were displayed as a nomogram.Receiver operating characteristic(ROC)curve,Hosmer-Lemeshow test,and decision curve analysis(DCA)were used to evaluate the performance of the model from 3 aspects:discrimination,calibration,and clinical practicality,respectively.The diagnostic performance of the model was verified in both internal validation set and external validation set.Results In the subgroup of 1 year≤age≤6 years,age,white blood cell count,lymphocyte count and C reactive protein were the independent influencing factors of influenza A(all P＜0.01);the area under the curve(AUC)value of the established nomogram prediction model for identifying influenza A was 0.746 in the training set,0.771 in the internal validation set,and 0.753 in the external validation set;the predicted probability of the model was highly consistent with the actual probability(P=0.216);and taking intervention measures within a threshold probability range of 16%-60%could yield net benefits.In the subgroup of 6 years＜age≤16 years,gender,white blood cell count and lymphocyte count were the independent influencing factors of influenza A(all P＜0.01);the AUC value of the established nomogram prediction model for identifying influenza A was 0.733,0.747 in the internal validation set,and 0.753 in the external validation set;the predicted probability of the model was highly consistent with the actual probability(P=0.06);and taking intervention measures within a threshold probability range of 12%-58%could yield net benefits.Conclusion This risk prediction model based on easily obtainable blood routine parameters shows good diagnostic performance for influenza A,with high accuracy and clinical practicality.

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 analgesic effect of multi-site multiple paravertebral nerve blocks on patients undergoing radical lung cancer surgery and the impact on their serum indices and prognosis.Methods Ninety-eight cases of patients undergoing thoracoscopic radical lung cancer surgery in our hospital were selected from March 2021 to January 2023 and divided into 2 groups according to the difference in anaesthesia.Among them,42 patients in the study group were treated with preoperative and postoperative multipoint paravertebral nerve block combined with general anaesthesia,while 56 patients in the control group were treated with preoperative multipoint paravertebral nerve block combined with general anaesthesia,and the analgesic effect and other differences between the two groups were compared.Results In the study group,extubation time,recovery time,propofol dosage and postoperative VAS score were(150.2±15.2)min,(19.1±5.1)min,(738.2±36.5)mg and(4.2±0.7)points,respectively.The control group was(151.9±12.6)min,(22.6±7.3)min,(902.1±49.0)mg and(2.3±0.3)min,respectively,and the difference between the two groups was statistically significant(P＜0.05).The differences of heart rate,mean arterial pressure and before and after half an hour after surgery in control group were higher than those in study group,and the differences of norepinephrine,epinephrine and before and after surgery were higher than those in study group,with statistical significance(P＜0.05).The total complication rate of the study group was 7.2％,and that of the control group was 23.2％.The QoR score of the control group was lower than that of the study group,and the difference between the two groups was statistically significant(P＜0.05).Conclusion Preoperative and postoperative multi-point paravertebral nerve block combined with general anaesthesia has a better analgesic effect on patients undergoing radical lung cancer surgery,which can not only reduce the inflammatory reaction of the patients,but also have less impact on their haemodynamic indexes and lower rate of postoperative adverse reactions,and ultimately improve the quality of life of the patients.

Objective To evaluate the effectiveness and safety of quadruple regimen in preventing multi-day cisplatin-based chemotherapy-induced nausea and vomiting(CINV).Methods A total of 112 patients with malignant tumors who underwent cisplatin-based chemotherapy.According to the random number table method,patients were divided into the experimental group and the control group,with 56 cases in each group.The control group received cisplatin-based chemotherapy and triple therapy of fosapreitant dimeglumine,ondansetron hydrochloride and dexamethasone tablets.On this basis,the experimental group was given quadruple therapy containing olanzapine tablets.The occurrence of nausea and vomiting,as well as changes in FLIE and HAD scores were observed in both groups.Results The incidence of nausea and vomiting was lower from day 1(D1)to day 9(D9)after the beginning of chemotherapy in the experimental group than that in the control group(P＜0.05).The incidence of nausea and vomiting in the experimental group was lower than that in the control group.On D9 after the beginning of chemotherapy,the nausea score,vomiting score and total score of FILE were higher in the experimental group than those in the control group(P＜0.05).There were no significant differences in depression or anxiety score and incidence of adverse reactions on D1 and D9 after the beginning of chemotherapy between the two groups(P＞0.05).Conclusion The quadruple antiemetic regimen can improve the control rate of CINV induced by multi-day cisplatin-based chemotherapy,especially for the control of delayed nausea and vomiting,and improve the quality of life of patients during chemotherapy,with good safety.

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.