[Objective] To establish a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection. [Methods] By adding the sample and factor Ⅶ deficient plasma to the sample cup and activating the reaction with prothrombin time assay reagent (PT reagent), the coagulation time of the sample was determined by the change in magnetic bead swing amplitude in the sample cup. The logarithm of coagulation time was inversely proportional to the logarithm of human factor Ⅶa potency. [Results] Under the experimental conditions, the specificity of the methodology was evaluated through spiked recovery, and the recovery rates ranged from 90.0% to 110.0%. Within the range from 0.125 to 1.000 IU/mL, there was a good linear response between the potency and coagulation time of the standard and sample, with correlation coefficients r>0.99. As for the accuracy and repeatability, the recovery rates of various concentrations detected in the stock solution were 101.0%, 100.0% and 112.0%, respectively, with RSD values of 2.6%, 4.0% and 0.0%, respectively. The recovery rates of various concentrations in finished product testing were 104.0%, 94.7% and 112.0%, respectively, with RSD values of 1.9%, 2.4% and 0.0%, respectively. As for the intermediate precision, the RSD were 4.5% and 3.7%, respectively. After treated with sample diluent, the sample was tested at room temperature for 6 hours and still exhibited relatively stable biological activity. [Conclusion] This detection method is accurate, stable, easy to operate and highly automated, and is suitable for detecting the potency of recombinant human coagulation factor Ⅶa for Injection.

Objective:To investigate the incidence of collateral circulation in high-risk patients with sleep apnea and stroke treated by continuous positive airway pressure （CPAP） ventilation and to analyze the influencing factors. Methods:A total of 152 patients diagnosed with obstructive sleep apnea-hypopnea syndrome （OSAHS） combined with acute ischemic stroke （AIS） who were admitted to our hospital from January 2020 to June 2022 were selected for this study. Based on the apnea-hypopnea index （AHI）, the patients were divided into three groups: mild （n=44）, moderate （n=72）, and severe （n=36）. After treatment, the patients were further classified into a group without collateral circulation （n=30） and a group with collateral circulation （n=26）, which included those with moderate collateral circulation （n=69） and good collateral circulation （n=27）. Clinical data across the different groups were compared, and multiple factor analysis was performed to identify factors affecting the occurrence of collateral circulation. Results:The AHI and IL-6 levels in the severe group were significantly higher than those in the mild and moderate groups, while the levels of NO and PO2 were significantly lower in the severe group compared to the mild and moderate groups, with statistically significant differences among the three groups （P<0.05）. After treatment, all groups showed improvement, and the proportion of patients with collateral circulation was 84.09% in the mild group, 81.94% in the moderate group, and 72.22% in the severe group. Significant differences in age, AHI, NIHSS, NO, MoCA, and MMSE scores were observed between the groups with and without collateral circulation （P<0.05）. In the group with collateral circulation, the scores for age, AHI, and NIHSS in the good collateral circulation subgroup were significantly lower than those in the poor collateral circulation and moderate collateral circulation subgroups, while the scores for NO, MoCA, and MMSE were significantly higher in the good collateral circulation subgroup. Multi-factor analysis revealed that age, AHI, and NIHSS were independent risk factors for collateral circulation, whereas NO, MoCA, and MMSE served as protective factors that were negatively correlated with collateral circulation. Classification tree model results indicated that AHI had the greatest influence on the occurrence of collateral circulation among the five influencing factors, demonstrating good predictive capability. Conclusion:Most high-risk patients with sleep apnea and stroke are likely to develop collateral circulation following continuous positive airway pressure ventilation. Factors such as age, AHI, NIHSS, NO, MoCA, and MMSE are important determinants affecting the occurrence of collateral circulation.
Humans ; Collateral Circulation ; Continuous Positive Airway Pressure ; Stroke/physiopathology* ; Sleep Apnea, Obstructive/physiopathology* ; Risk Factors ; Male ; Incidence ; Female ; Middle Aged ; Aged ; Sleep Apnea Syndromes/physiopathology* ; Interleukin-6/blood*

Early correction of childhood malocclusion is timely managing morphological, structural, and functional abnormalities at different dentomaxillofacial developmental stages. The selection of appropriate imaging examination and comprehensive radiological diagnosis and analysis play an important role in early correction of childhood malocclusion. This expert consensus is a collaborative effort by multidisciplinary experts in dentistry across the nation based on the current clinical evidence, aiming to provide general guidance on appropriate imaging examination selection, comprehensive and accurate imaging assessment for early orthodontic treatment patients.
Humans ; Malocclusion/diagnostic imaging* ; Child ; Consensus

Objective To study the quality comparability of human coagulation factor Ⅷ(FⅧ)produced before and after the change of factory site.Methods A comparative study was carried out on quality quantitative indexes,related im-purities and stability data of FⅧ produced before and after the change of factory site.Results The FⅧ quantitative quality before and after the change of factory site all met the quality standard,and the related impurities including aluminum resi-due,tributyl phosphate residue,polysorbate 80 residue and PEG residue all met the quality standard.Other impurities in-cluding human fibrinogen,fibronectin,plasminogen,IgA,IgM and IgG were extremely low in content and equivalent in quality.The content of VWF(von Willebrand factor)had no obvious change before and after the change of factory site,but was significantly higher than that of other domestic manufacturers'commercial products.The results of accelerated stability and long-term stability tests showed that the titer of FⅧ fluctuated within the methodological error range,and the results all met the quality standard.Conclusion The change of factory site of FⅧ has no effect on the quality.

Objective:Evaluate the safety of the bioresorbable scaffold (BRS) series implanted.Methods:This is a cohort study, which included 377 patients with acute coronary syndrome (ACS) who underwent elective percutaneous coronary intervention (PCI) with Neovas-BRS implantation from July 2019 to April 2022 at the Northern Command General Hospital. The patients were divided into the series BRS group ( n=63) and single BRS group ( n=314). We compared PCI related data between two groups, as well as all-cause death, cardiac death, non-fatal myocardial infarction, target vessel revascularization, stroke, and bleeding of type 2 to 5 defined by the Bleeding Academic Research Consortium of America (BARC) during follow-up. We also compared the major adverse cardiovascular and cerebrovascular events (MACCE), which includes all-cause death, non-fatal myocardial infarction, target vessel revascularization and stroke, as well as the net adverse clinical events (NACE), which includes MACCE and bleeding of BARC type 2 to 5. Procedural immediate success was defined as a residual stenosis of<20% with successful stent implantation and post-PCI target vessel flow grade up to TIMI 3. The images of 11 patients in the series BRS group who underwent optical coherence tomography (OCT) were analyzed. Results:A total of 377 patients were finally enrolled, aged (52.5±10.7) years, including 80.4% (303/377) males . The immediate success rate of PCI was 100% in both groups. The number of ≥50% stenotic lesions, number of target vessels, SYNTAX score, number of post-application expansion balloons, number of guidewires, total stent length, contrast volume and operation time were higher in the series BRS group than in the single BRS group (all P<0.05). There was no significant difference in the proportion of intravascular ultrasound and OCT application between the two groups. One patient in the single BRS group had an ischemic stroke during postoperative hospitalization, but there were no death, non-fatal myocardial infarction, target vessel revascularization, or BARC 2 to 5 bleeding events occurred during hospitalization in both groups. Follow up time was 352.0 (193.0, 421.0) days. There was no statistically significant difference between the two groups in the incidence of all-cause death (0 vs. 0.6% (2/314), P=1.000), cardiogenic death (0 vs. 0.3% (1/314), P=1.000), nonfatal myocardial infarction (0 vs. 1.0% (3/314), P=1.000), target lesion revascularization (3.2% (2/63) vs. 1.6% (5/314), P=0.736), BARC type 2 to 5 bleeding (3.2% (2/63) vs. 5.7% (18/314), P=0.604), MACCE (3.2% (2/63) vs. 2.9% (9/314), P=0.894), and NACE (6.3% (4/63) vs. 8.6% (27/314), P=0.553) during the follow-up period. OCT results of the 11 (17.5%) patients in the series BRS group indicated that 3 patients (27.3%) achieved non-overlapping connection, and the immediate stent expansion rate was (95.47±0.04) %. In 8 patients with BRS overlapping connections, immediate stent expansion rate was (90.32±0.44) %. Conclusion:In patients with low to intermediate-risk ACS, serial implantation of RBS in long coronary lesions is safe and feasible, and achieves the similar short-term outcomes as single BRS implantation.

BACKGROUND: The addition of growth factiors is commonly applied to improve the osteogenic differentiation of stem cells. However, for human pluripotent stem cells (hPSCs), their complex differentiation processes result in the unknown effect at different stages. In this study, we focused on the widely used bone forming peptide-1 (BFP-1) and investigated the effect and mechanisms of its addition on the osteogenic induction of hPSCs as a function of the supplementation period. METHODS: Monolayer-cultured hPSCs were cultured in osteogenic induction medium for 28 days, and the effect of BFP-1 peptide addition at varying weeks was examined. After differentiation for varying days (0, 7, 14, 21 and 28), the differentiation efficiency was determined by RT–PCR, flow cytometry, immunofluorescence, and alizarin red staining assays. Moreover, the expression of marker genes related to germ layers and epithelial-mesenchymal transition (EMT) was investigated at day 7. RESULTS: Peptide treatment during the first week promoted the generation of mesoderm cells and mesenchymal-like cells from hiPSCs. Then, the upregulated expression of osteogenesis marker genes/proteins was detected in both hESCs and hiPSCs during subsequent inductions with BFP-1 peptide treatment. Fortunately, further experimental design confirmed that treating the BFP-1 peptide during 7–21 days showed even better performance for hESCs but was ineffective for hiPSCs. CONCLUSION The differentiation efficiency of cells could be improved by determining the optimal treatment period.Our study has great value in maximizing the differentiation of hPSCs by adding osteogenesis peptides based on the revealed mechanisms and promoting the application of hPSCs in bone tissue regeneration.

【Objective】 To investigate the effects and mechanisms of different doses of fingolimod (FTY720) on non-antibody-mediated transfusion-related acute lung injury (TRALI). 【Methods】 A TRALI mouse model was constructed using lipopolysaccharide (LPS) pre-stimulation and platelets (Plt) of different storage days for second strike. The success of the modeling was determined by protein concentration in lung tissue homogenates, myeloperoxidase (MPo) activity, lung wet/dry weight ratio (W/D ratio), lung tissue damage score and pathological sections. Ceramide and sphingosine-1-phosphate (S1P) contents in platelets of different storage days were detected. FTY720 was administered 1 h after LPS injection to investigate the role of FTY720 in TRALI. The expression levels of vascular endothelial cadherin (VE-cadherin) and zonula occludens-1 (ZO-1) were analyzed by WB. 【Results】 Mice infused with stored 5-day Plt (d5Plt group) exhibited typical signs of TRALI, and the differences in lung tissue homogenate protein concentration (6 546.38±409.50) μg/mL, MPO activity (49.38±4.43) U/L, W/D ratio 4.79±0.21, and lung tissue damage score 7.24±0.38 from the rest of the groups were statistically significant (P<0.05). With the increase of platelet storage time, the ceramide content gradually increased and S1P content gradually decreased, and the ratio of the two was imbalanced. d5Plt showed statistically significant differences (P<0.01) in ceramide content (58.37±5.69) μmol/L and S1P content (149.81±4.86) nmol/L from the rest of the groups. After preventive administration of FTY720, 1 mg/kg FTY720 had no significant effect on TRALI mice, whose lung tissue homogenate protein concentration (6 170.26±545.50) μg/mL, MPO activity (45.97±4.79) U/L, W/D ratio 4.88±0.25, and lung tissue damage score 7.92±0.65 were significantly higher than those of the normal and LPS control groups (P<0.01). The low-dose (0.5, 0.2, and 0.1 mg/kg) FTY720 group alleviated lung injury, and its protein concentration, MPO activity, W/D ratio, and lung tissue injury score were significantly lower than those of the d5Plt group (P<0.05). Pathological sections also showed similar results. In terms of endothelial intercellular junction protein expression, the VE-cadherin expression levels in the 1 mg/kg FTY720 group were significantly lower than those in the normal and LPS control groups (P<0.05), and the VE-cadherin and ZO-1 expression levels in the low-dose (0.5, 0.2, and 0.1 mg/kg) FTY720 group were significantly higher than those in the d5Plt group (P<0.05), which tended to be normalized. 【Conclusion】 In this study, a TRALI mouse model was successfully established by one strike of LPS and two strikes of d5Plt. Low doses of FTY720 (0.5, 0.2, 0.1 mg/kg) were protective against TRALI, while high doses of FTY720 (1 mg/kg) may aggravate the symptoms of TRALI. This protective effect may be somewhat dependent on the expression of VE-cadherin and ZO-1.

Humans ; Cytomegalovirus ; Cytomegalovirus Infections ; Antigens, Viral ; Immunity ; Autoimmune Diseases ; CD8-Positive T-Lymphocytes