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 observe the clinical efficacy of 8-0 polypropylene scleral-sutured fixed intraocular lens(IOL)suspension implantation with the double knots technique in aphakic eyes.METHODS: Retrospective case series study. The data of 30 aphakic cases(31 eyes, 22 males)that underwent IOL suspension in our hospital from January 2021 to November 2022 were collected. The suspension of IOL(AcrySof IQ or Tecnis ZCB00)was performed by 8-0 polypropylene scleral-sutured with the double knots technique. The visual acuity, intraocular pressure(IOP), IOL position and complications with at least 6 mo of follow-up were observed.RESULTS: The mean preoperative uncorrected visual acuity(UCVA, LogMAR)and best-corrected visual acuity(BCVA, LogMAR)were 2.53±0.78 and 0.35±0.26, respectively, which were 0.58±0.26 and 0.36±0.27 at 6 mo postoperatively, respectively. And the differences in UCVA were statistically significant(t=15.408, P<0.01), whereas the difference in BCVA was not(t=-1.677, P=0.104). There were no intraoperative complications, with IOL position all centered, but 3 eyes had IOL tilt, 2 eyes had intraocular hypertension, 5 eyes had corneal edema, and 1 eye had suture exposure postoperatively. There were no complications such as hyphema, vitreous hemorrhage, macular edema, corneal endothelial decompensation, hypotony, choroidal detachment, retinal detachment, fulminant superior choroidal hemorrhage, endophthalmitis, or others.CONCLUSION: The 8-0 polypropylene scleral-sutured fixed intraocular lens suspension implantation with the double knots technique can improve the postoperative visual acuity of aphakic patients, and fewer complications, which is an option for the treatment of aphakia, dislocation of the lens and ligament abnormalities.

OBJECTIVE To investigate the improvement effects of azithromycin on bronchopulmonary dysplasia （BPD） in neonatal rats based on hypoxia-inducible factor-1α（HIF-1α）/HIF-2α/vascular endothelial growth factor （VEGF） pathway. METHODS Sixty newborn SD rats were randomly divided into negative control group （NC）， BPD group， azithromycin group and budesonide group （positive control）， with 15 rats in each group. Rats in NC group were given normal breathing air， while rats in other three groups were exposed to high-concentration oxygen for 14 days to establish BPD rat models. After successful modeling， rats in azithromycin group were intraperitoneally injected with azithromycin 200 mg/kg， and rats in budesonide group were atomized with budesonide 1.5 mg/kg once a day for 14 consecutive days， while rats in BPD group and NC group were not treated. Pathological changes of lung tissue， radial alveolar count and mean alveolar intercept of rats were observed in each group. The white blood cell count in bronchoalveolar lavage fluid （BALF） and the levels of tumor necrosis factor-α （TNF-α）， interleukin-6 （IL-6）， IL-1β， superoxide dismutase （SOD）， catalase （CAT） and malondialdehyde （MDA） were detected； mRNA and protein expressions of VEGF， HIF-1α， HIF-2α were also detected. RESULTS Compared with NC group， the lung tissue in BPD group was obviously damaged； the white blood cell count， average alveolar intercept and the levels of TNF-α， IL-6， IL-1β and MDA were significantly increased； the radial alveolar count， SOD and CAT levels， the relative expressions of VEGF， HIF-1α， HIF-2α mRNA and protein were significantly decreased （P＜0.05）. Compared with BPD group， the changes of the above indexes in azithromycin group and budesonide group were significantly reversed （P＜0.05）. CONCLUSIONS Azithromycin can obviously improve the symptoms of BPD in rats， reduce inflammation and oxidative stress， and exert lung protection， the mechanism of which may be realized by activating HIF-1α/HIF-2α/VEGF pathway.

AIM:To establish a nomogram model to predict the effect of serum ferritin on diabetic retinopathy and evaluate the model.METHODS:A total of 21 variables, including ferritin, were screened by univariate and multivariate regression analysis to determine the risk factors of diabetic retinopathy. A nomogram prediction model was established for evaluation and calibration.RESULTS:Ferritin, duration of diabetes, hemoglobin, urine microalbumin, regularity of medication and body mass index were included in the nomogram model. The consistency index of the prediction model with serum ferritin was 0.813(95%CI: 0.748-0.879). The calibration curves of internal and external verification showed good performance, and the probability of the threshold suggested by the decision curve was in the range 10% to 90%. The model had a high net profit value.CONCLUSIONS:Serum ferritin is an important risk factor for diabetic retinopathy. A new nomogram model, which includes body mass index, duration of diabetes, ferritin, hemoglobin, urine microalbumin and regularity of medication, has a high predictive accuracy and could provide early prediction for clinicians.

AIM: To compare the outcome of C3F8 versus silicone oil tamponade after pars plana vitrectomy(PPV)and inverted internal limiting membrane(ILM)for the treatment of highly myopic macular hole retinal detachment(MHRD).METHODS: Retrospective clinical study. Totally 45 patients(45 eyes)with highly myopic MHRD who visited our hospital between January 2019 and August 2022 were selected as the research subjects. The patients were divided into two groups according to different intraocular tamponade agents: C3F8(22 eyes)and silicone oil(23 eyes)groups. All patients underwent conventional three-incision PPV, ILM was tamped, a venous blood clot was placed on the tamped ILM, and 15% C3F8 and silicone oil were used as tamponade, respectively. The best corrected visual acuity(BCVA), multifocal electroretinogram(mfERG), the closure of the macular hole, retinal reattachment and the complications were observed.RESULTS: The macular hole closure rate was 77% in the C3F8 group and 83% in the silicone oil group, respectively(P>0.05), and retinal reattachment rates were 95% and 96%, respectively(P>0.05). The visual acuity of the two groups significantly improved, which was 0.99±0.34 and 1.22±0.37, respectively, and the C3F8 group was better than that of the silicone oil group(t=-2.156, P=0.037). After operation, the response density of the first ring of P1 wave in the first order kernel in mfERG was 114.27±26.37 nV/deg2 for the C3F8 group and 98.08±24.36 nV/deg2 for the silicone oil group, and the response density of the second ring of P1 wave was 80.45±14.94 nV/deg2 for the C3F8 group and 67.73±15.33 nV/deg2 for the silicone oil group, all of which were significantly higher compared to pre-operation [the response density of the first ring of P1 wave: 58.13±13.96 nV/deg2 for the C3F8 group and 55.30±10.48 nV/deg2 for the silicone oil group, the response density of the second ring of P1 wave: 51.18±8.19 nV/deg2 for the C3F8 group and 47.43±11.97 nV/deg2 for the silicone oil group](all P<0.05). It was found that the response density of the first ring of P1 wave was lower in the silicone oil group than in the C3F8 group(P<0.05). There was no statistically significant difference in the incidence of complications between the two groups(P>0.05).CONCLUSION: Silicone oil tamponade or C3F8 tamponade after PPV combined with ILM can both promote retinal reattachment and macular hole closure in patients with MHRD, and the C3F8 tamponade was superior to silicone oil in visual function recovery.

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.

BACKGROUND:In the process of exploring the mechanism of Alzheimer's disease,the important role of bioinformatics for common target screening has been revealed,enabling the use of its screening results as a basis for exploring the therapeutic effects of drugs on the disease. OBJECTIVE:To predict the targets of liraglutide,a glucagon-like peptide-1 receptor agonist,in the treatment of Alzheimer's disease by bioinformatics and molecular biology. METHODS:DisGeNET database and SEA database were used to obtain the common genes of Alzheimer's disease and liraglutide.GO/KEGG enrichment analysis of common targets was conducted using DAVID online database.Protein-protein interaction networks were constructed using STRING database.The optimal dosage of liraglutide was determined using cell counting kit-8 assay.Expression of key proteins was analyzed using immunofluorescence and immunoblotting techniques.The mouse hippocampal neuron HT22 cell line was used for ex vivo experiments,and the cells were randomly divided into three groups:HT22 group,HT22+Aβ group,and HT22+Aβ+Lir group.No special treatment was done in the HT22 group,while Aβ1-42 was used to intervene in the HT22 cell line for 24 hours to construct an Aβ injury cell model in the HT22+Aβ group.In additional to modeling,liraglutide was added to the HT22+Aβ+Lir group for 12 hours. RESULTS AND CONCLUSION:A total of 3 333 genes associated with Alzheimer's disease were screened from DisGeNET database.Then 147 potential targets of liraglutide were obtained from SEA database.Finally,64 common targets of Alzheimer's disease and Liraglutide were determined using R packets.GO/KEGG analysis of common targets using DAVID online database suggested that common targets were mainly enriched in the following biological processes:neuroactive ligand-receptor interaction,renin-angiotensin system,bladder cancer,endopeptidase activity,peptide receptor activity,G protein-coupled peptide receptor activity,and transport vesicles.The obtained 64 common target proteins were imported into SRTING online database for protein-protein interaction network construction,and the top three genes,matrix metalloproteinases 2,9 and interleukin 1β,were obtained.The activity of cultured cells was detected by the cell counting kit-8 kit.Liraglutide at 100 nmol/L was the optimal concentration for antagonizing Aβ1-42.In the western blot and immunofluorescence assays,the expression of matrix metalloproteinases 2,9 and interleukin 1β was significantly increased in the HT22+Aβ group compared with the HT22 group(P＜0.05)but significantly decreased in the HT22+Aβ+Lir group compared with the HT22+Aβ group(P＜0.05).To conclude,the above bioinformatics data and secondary validation of differential genes in the GEO database suggest that both matrix metalloproteinases 2,9 and interleukin 1β could be potential targets of liraglutide in the treatment of Alzheimer's disease.

By analysing the similarity between defense qi and leukocytes in terms of function， site of action， and circadian rhythm， it is proposed that in traditional Chinese medicine （TCM）， the pathogenesis of leukopenia is defense qi deficiency. By analyzing the relevant discussions on the generation and transmission of defense qi in TCM classics， it is believed that the original qi in lower jiao （焦） is the source of defense qi， while the water and grain qi in middle jiao enriches defense qi， and the upper jiao transmits and distributes defense qi to the whole body. Therefore， when treating leukopenia after chemotherapy with TCM， Guilu Erxian Gelatin （龟鹿二仙胶） and Yougui Pill （右归丸） are often used to tonify the kidney and supplement essence， and moxibustion at Guanyuan （CV 4） and Qihai （CV 6） is usually accompanied to replenish the original qi in lower jiao and enrich the source of defense qi. Guipi Decoction （归脾汤）， Buzhong Yiqi Decoction （补中益气汤）， Shenling Baizhu Powder （参苓白术散）， and Sijunzi Decoction （四君子汤） are often suggested to strengthen spleen and replenish qi， in combination with moxibustion at Zhongwan （CV 12） and Zusanli （ST 36） to transport the spleen and stomach in the middle jiao to enrich the defense qi. Modified Guizhi Decoction （桂枝汤） to harmonize nutrient and defensive aspects is often used， and moxibustion at Dazhui （GV 14） and Feishu （BL 13） or scraping is added to dredge the striae and interstice in the upper jiao and promote transmission and dissemination of the defense qi. Considering the whole process of generation and distribution of defense qi， it is suggested to choose the most appropriate treatment modality flexibly， and combine internal treatment with external treatment， in order to provide ideas for the treatment of leukopenia in tumour patients.

Objective To explore the dilution conditions and standards in detecting the semen samples with high sperm concentration using computer-aided sperm analysis(CASA)systems.Methods CASA systems with 10 μm depth disposable counting chambers were used for the examination.The samples were divided into undiluted group(Group 1∶sperm concentration＜50×106/mL)and diluted groups(Group 2∶50×106/mL≤ sperm concentration＜100× 106/mL;Group 3∶sperm concentration≥100× 106/mL).When sperm concentration＜50×106/mL,no dilution was performed.When sperm concentration≥50× 106/mL,the samples were diluted with saline at 1∶n/(50×106)ratio(n=sperm concentration,n/[50×106]rounded down)to＜50×106/mL of sperm concentration.The sperm concentration,progressive motility(PR),non-progressive motility(NP),total motility(PR+NP)and immotile sperm percent-age(IM)were analyzed before and after dilution.The consistency of results pre-and post-dilution was compared.ROC curve was used to analyze the optimal dilution threshold.Results The differences in the parameters pre-and post-dilution gradually rosed with the increased sperm concentration.ROC curve analysis showed optimal dilution thresholds were 133.05 × 106/mL,101.75 × 106/mL,118.60×106/mL,90.90×106/mL,111.83×106/mL for the sperm concentration,PR+NP,PR,NP and IM respectively.Considering sperm concentration and NP were most affected the undiluted high concentration samples,the optimal comprehensive dilution threshold was determined as 125.08× 106/mL.Conclusion When sperm concentration exceeds 125×106/mL,it is recommended to dilute semen sample with normal saline.