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 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.

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.

Objective To investigate the current status of semen testing in the hospitals without assisted reproductive technology in Hu-nan Province,propose improvement strategies to enhance the diagnosis of male infertility and promote reproductive health services in these hospitals.Methods Questionnaire surveys and on-site investigations were conducted to examine the semen testing status in 67 hospitals without assisted reproductive technology in Hunan Province.The existing problems were summarized,and improvement strate-gies were suggested.Results Among the 67 hospitals,59.7％(40/67)performed semen testing.Of these,45％(18/40)possessed dedicated personnel,60％(24/40)possessed staff received relevant training,and 22.5％(9/40)held certificates.Only 30％(12/40)conducted sperm morphology testing,among them 20％(8/40)able to stain and interpret following WHO standards.The hospitals of 37.5％(15/40)used computer-assisted sperm analysis(CASA)systems,and 22.5％(9/40)were equipped with phase-contrast microscopes.30％(12/40)had dedicated examination areas,and 32.5％(13/40)had independent ejaculation rooms,17.5％(7/40)used disposable slides to observe sperm concentration.In 2022,the hospitals of 57.5％(23/40)had an average daily sample volume＜1.The hospital of 67.5％(27/40)performed standard operating procedures,40％(16/40)followed the WHO 5th la-boratory manual for routine testing,15％(6/40)conducted internal quality control,and 12.5％(5/40)participated in external quali-ty assessment(EQA).Another 55％(22/40)wished to participate in EQA.Conclusion The semen testing capacity in the hospitals,in which assisted reproductive technology is not yet carried out currently,urgently requiring multifaceted improvements.The proposed strategies include emphasizing semen testing,establishing reproductive medicine consortia for comprehensive support,establishing a provincial quality control center for EQA,founding a professional committee for a learning platform,offering training to enhance staff expertise,and including the pre-pregnancy semen testing in public health programs.

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.

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 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.