1.Molecular Crosstalk Mechanisms of Shoutai Wan and Juyuan Jian on Maternal-fetal Interface Subcellular Clusters in CBA/J×DBA/2 Recurrent Pregnancy Loss Model
Jingxin GAO ; Qiuping CHEN ; Xiaoyan ZHENG ; Pengfei ZENG ; Rui ZHOU ; Yancai TANG ; Qian ZENG ; Wenli GUO ; Jinzhu HUANG ; Weijun DING ; Linwen DENG ; Hang ZHOU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(2):70-87
ObjectiveTo systematically compare the differential regulation of the maternal-fetal interface cell lineages and communication networks in the CBA/J×DBA/2 mouse model of recurrent pregnancy loss (RPL) by the two classic therapeutic methods-tonifying the kidney to stabilize the fetus and invigorating the spleen to stabilize the fetus (Shoutai Wan, Juyuan Jian)-of traditional Chinese medicine (TCM) at the single-cell resolution and clarify their modern scientific connotations. MethodsFemale non-pregnant CBA/J mice were caged with male BALB/c (blank group) and DBA/2 (modeling group) mice separately. Pregnant mice in the modeling group were randomly grouped as follows: high/low-dose Shoutai Wan, high/low-dose Juyuan Jian, model (RPL), and positive control (dydrogesterone), with 10 mice in each group. Starting from the day after the detection of the vaginal plug, mice were administrated with drugs or an equal volume of normal saline by gavage for 10 consecutive days. After the intervention, the following indicators were measured. ① Macroscopic evaluation: general conditions, uterine wet weight, embryo loss rate, four coagulation parameters [prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FIB), and thrombin time (TT)], and peripheral blood estradiol (E2) and progesterone (Pg) levels. The decidua with embryos was stained with hematoxylin-eosin (HE) and evaluated by transmission electron microscopy (TEM). The expression of B-cell lymphoma-2 (Bcl-2), vascular endothelial growth factor (VEGF), angiotensin Ⅱ (AngⅡ), matrix metalloproteinase-2 (MMP-2), interleukin-6 (IL-6), leukemia inhibitory factor (LIF), CXC chemokine ligand 12 (CXCL12), and microtubule-associated protein 1 light chain 3 homolog (LC3)Ⅰ/Ⅱ was quantified by Western blot. ② Mechanism analysis at the single-cell level: The decidua with embryos from the blank, model, high-dose Shoutai Wan, and high-dose Juyuan Jian groups (6 mice per group, with 3 single-cell samples per group, totaling 24 mice) were analyzed by the BD Rhapsody™ platform, and the whole-cell atlas was drawn by uniform manifold approximation and projection (UMAP) dimensionality reduction clustering combined with the single-cell mouse cell atlas (scMCA). The differentially expressed genes (DEGs) and cell interaction networks were analyzed via Gene Ontology (GO), Kyoto Encyclopedia of Genes and Genomes (KEGG), and CellChat, and the protein-protein interaction (PPI) map of subtype cells was constructed. The CytoTRACE pseudo-temporal analysis was performed to explore the developmental trajectories of core immune cells (natural killer cells, NK cells) from maternal and fetal sources. Results① Pathological and Western blot results indicated that compared with the blank group, the RPL group showed an increase in the embryo loss rate (P<0.01), down-regulated expression of Bcl-2, LIF, MMP-2, and Vegf in the decidua with embryos (P<0.05), up-regulated protein levels of CXCL-12, AngⅡ, and IL-6 (P<0.05), blocked angiogenesis, apoptosis-inflammation imbalance, and coagulation dysfunction. Both prescriptions dose-dependently reduced the abortion rate and restored the angiogenesis-inflammation balance, and Shoutai pill showed superior performance in restoring the E2 level to the Pg level (P<0.05). ② Single-cell transcriptome analysis indicated that compared with the blank group, the RPL group showed differences in multiple key cell populations such as decidual cells, trophoblast cells, endothelial cells, erythroblasts, NK cells, and macrophages at the maternal-fetal interface. Immunity and angiogenesis were the key links in RPL. Compared with the RPL group, high-dose Shoutai Wan reversed the changes of NK cells in the embryonic layer (upregulating the mRNA levels of 17 genes and downregulating the mRNA levels of 29 genes) and macrophages (upregulating the mRNA levels of 117 genes and downregulating the mRNA levels of 53 genes) through the regulation of gene expression. High-dose Shoutai pill regulated the immune cells to affect unfolded proteins, cell adhesion, and programmed cell death, thereby promoting decidualization and angiogenesis and modulating embryo-membrane development. High-dose Juyuan Jian regulated the key subgroups of NK cells (up-regulating the mRNA levels of 9 genes and down-regulating the mRNA levels of 17 genes) and macrophages (up-regulating the mRNA levels of 110 genes and down-regulating the mRNA levels of 81 genes), which affected decidual inflammation and apoptosis and intervened in glycolysis. ③ The pseudo-temporal analysis and communication network indicated that the communication frequency of the RPL group decreased. High-dose Shoutai Wan restored maternal-fetal tolerance through pathways such as NKG2D, CDH5, GDF, and FASLG. High-dose Juyuan Jian enhanced the IL-6/LIFR/JAK/signal transducer and activator of transcription 3 (STAT3) and desmosome/SEMA6/tumor necrosis factor-like weak inducer of apoptosis (TWEAK) signaling to improve endometrial receptivity. The RPL group showed an increased proportion of toxic dNK7, a decreased proportion of reparative dNK4, and blocked embryo fNK1. High-dose Shoutai Wan down-regulated dNK7 and up-regulated dNK4. High-dose Juyuan Jian inhibited the terminal differentiation of dNK7 and up-regulated LILRB1, thus restoring the balance of cytotoxicity and repair. ConclusionBoth the kidney-tonifying and spleen-invigorating methods are effective in treating RPL. NK and macrophages are the key immune cells in the interaction between the embryo and the membrane. The kidney-tonifying method (Shoutai Wan) has an advantage in regulating the phenotypes of unfolded protein, cell adhesion, and programmed cell death, and shows expression characteristics closer to the physiological state in the regulation of NKG2D and CDH5 signals. The spleen-invigorating method (Juyuan Jian) has an advantage in regulating epithelial-mesenchymal transition (EMT), angiogenesis, and glycolysis and shows higher communication intensity in the IL-6 and LIFR pathways.
2.Standards for the Application of Hemodynamic Monitoring Technology in Critical Care
Hua ZHAO ; Hongmin ZHANG ; Xin DING ; Huan CHEN ; Jun DUAN ; Wei DU ; Bo TANG ; Yuankai ZHOU ; Dongkai LI ; Xinchen WANG ; Cui WANG ; Gaosheng ZHOU ; Xiaoting WANG
Medical Journal of Peking Union Medical College Hospital 2026;17(1):73-85
With the rapid advancement of hemodynamic indices and monitoring technologies, their classification methods and application processes have become increasingly complex. Currently, no unified standard hasbeen established, making it difficult to fully meet the clinical requirements for hemodynamic management. To assist in hemodynamic monitoring assessment and therapeutic decision-making in critically ill patients, the Critical Hemodynamic Therapy Collaborative Group, in conjunction with the Critical Ultrasound Study Group, has jointly developed the Standard for the Application of Hemodynamic Monitoring Techniques in Critical Care. The first part of this standard systematically categorizes hemodynamic indicators into flow indicators, pressure and its derivative indicators, and tissue perfusion indicators, while elaborating on the clinical application of each. The second part establishes a standardized clinical implementation pathway for hemodynamic monitoring. It proposes a tiered monitoring strategy-comprising basic, advanced, indication-specific, and special scenario monitoring-tailored to different clinical settings. It emphasizes the central role of critical care ultrasound across all levels of monitoring and establishes hemodynamic assessment standards for organs such as the brain, kidneys, and gastrointestinal tract. This standard aims to provide a unified framework for clinical practice, teaching, training, and research in critical care medicine, thereby promoting standardized development within the discipline.
3.Clinical characteristics and risk factors of 2 054 cases of mycoplasma pneumoniae pneumonia in children based on imaging and clinical severity classification
Jiao LI ; Jiantao ZHOU ; Qingxu HA ; Shaohu HUO ; Junli DING
Acta Universitatis Medicinalis Anhui 2026;61(1):75-81
ObjectiveTo investigate the clinical characteristics and risk factors of Mycoplasma pneumoniae pneumonia (MPP) in children based on a dual classification integrating imaging features and clinical severity. MethodsMedical records of 2 054 pediatric patients with MPP were retrospectively analyzed. The cohort was stratified into severe consolidation (n=253), severe non-consolidation (n=118), non-severe consolidation (n=393), and non-severe non-consolidation groups (n=1 290) based on clinical and radiological findings. Inter group data and characteristics were compared and multiple regression analysis was conducted to construct a prediction model for severe consolidation group. ResultsSignificant differences were observed among the groups in terms of age, duration of fever, length of hospital stay, presence of pulmonary rales, inflammatory markers [C-reactive protein (CRP) and lactate dehydrogenase (LDH)], the use of hormones, and bronchoscopic treatment (all P < 0.05). Compared with the severe non-consolidation group, non-severe consolidation group, and non-severe non-consolidation group, children in severe consolidation group exhibited the longest duration of fever [8 (6, 11) days vs 6 (2, 9), 7 (6, 9) and 6 (3, 8) days, respectively] and the longest length of hospital stay [7 (5, 8) days vs 6 (5, 8), 6 (5, 8) and 6 (4, 7) days, respectively]. They also had the highest incidence of reduced breath sounds [34 cases (13.4%) vs 2 cases (1.7%), 29 cases (7.4%) and 13 cases (1.0%), respectively] and a substantially higher rate of coinfections, particularly viral infections [63 cases (24.9%) vs 23 cases (19.5%), 60 cases (15.3%) and 190 cases (14.7%), respectively]. Multivariate analysis indicated that the independent risk factors for severe MPP (SMPP) were age > 4.5 years, length of hospital stay > 6.5 days, reduced breath sounds, neutrophil-to-lymphocyte ratio (NLR) > 1.66, LDH > 370.5 U/L, CRP > 9.5 mg/L, and coinfection with viruses. Reduced breath sounds (OR = 5.58, 95% CI: 2.45 - 12.69) and coinfection with bacteria (OR = 3.11, 95% CI: 1.43 - 6.75) were identified as the most significant risk factors for pulmonary consolidation in non-severe MPP children. Additionally, reduced breath sounds, coinfection with viruses, LDH > 365.5 U/L, and CRP > 32.1 mg/L were risk factors for severe pneumonia in children with pulmonary consolidation. For non-consolidation MPP children, the presence of pulmonary dry rales (OR = 2.28, 95% CI: 1.46 - 3.56) was the primary independent risk factor for the development of severe pneumonia. ConclusionThe chest imaging findings of MPP are associated with clinical severity, and the risk factor model constructed based on this imaging-clinical classification can assist in achieving precise hierarchical diagnosis and treatment in clinical practice.
4.Pharmacological Review, Challenges, and Future Prospects of Zhusha Anshenwan
Xiaosong HU ; Zhou LAN ; Ping WANG ; Li DING ; Chun GUI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(9):329-335
Zhusha Anshenwan is a classical traditional Chinese medicine (TCM) formula originating from LI Dongyuan's Treatise on the Differentiation of Endogenous and Exogenous Injuries (Nei Wai Shang Bian Huo Lun) of the Jin-Yuan period. It is composed of five medicinal ingredients: Cinnabaris (Zhusha), Coptidis Rhizoma (Huanglian), Angelicae Sinensis Radix (Danggui), Rehmanniae Radix (Shengdihuang), and Glycyrrhizae Radix et Rhizoma (Gancao). Under the guidance of TCM theory, this formula is used to treat syndromes of disturbed spirit, including insomnia, palpitations, and anxiety, caused by hyperactivity of heart fire and deficiency of Yin-blood, and it also exerts auxiliary anticonvulsant effects in epilepsy and related conditions. However, the potential neurotoxicity, hepatotoxicity, and nephrotoxicity of its monarch drug, Cinnabaris (mainly composed of mercuric sulfide, HgS), together with the risk of in vivo accumulation, have rendered its clinical application controversial, and it has not yet been formally included in the Pharmacopoeia of the People's Republic of China. In addition, restrictions imposed by the Minamata Convention on Mercury have led to an increasing shortage of natural medicinal Cinnabaris resources, making the evaluation of the efficacy and safety of synthetic Cinnabaris particularly urgent. This contradiction highlights the complexity of safety evaluation for traditional medicines. Existing studies indicate that Zhusha Anshenwan exhibits definite pharmacological activities in calming the mind, improving sleep, and regulating emotional disorders. Moreover, other components of the formula may exert antagonistic effects on the toxicity of Cinnabaris, and reports of severe mercury poisoning caused by standardized clinical use of this prescription are extremely rare. Research suggests that other ingredients in the compound formula, such as Rehmanniae Radix, Coptidis Rhizoma, and Glycyrrhizae Radix et Rhizoma, may effectively alleviate the hepatorenal toxicity of Cinnabaris through mechanisms including modulation of the gut microbiota, formation of mercury complexes, and direct protection of target organs. This article aims to systematically review the progress in pharmacodynamic research on Zhusha Anshenwan, to explore its mechanisms of action in depth, and to analyze the toxicokinetic characteristics and safety risks of Cinnabaris, as well as the scientific connotations of toxicity reduction and efficacy enhancement achieved through compound compatibility. In addition, it compares Zhusha Anshenwan with other commonly used sedative formulas, with the aim of providing a scientific basis and forward-looking perspectives for the safe and rational application and in-depth development of this classical prescription in a modern context, and of emphasizing the important value of holistic research on TCM compound formulas in addressing the challenges of single-component toxicity.
5.Short-Term Efficacy and Long-Term Recurrence Rate of Traditional Chinese Medicine Versus Western Surgical Treatment for Mixed Hemorrhoids:A Multi-Center Retrospective Cohort Study Based on Real-World Data
Kang DING ; Zhimin FAN ; Xiaojie ZHOU ; Xiaoxiao WANG ; Yuanyuan GE ; Huiting ZHU ; Yuxin ZHU ; Xia YANG ; Jun DU ; Shicai HUANG ; Yang ZHANG
Journal of Traditional Chinese Medicine 2026;67(7):747-754
ObjectiveTo observe the short-term and long-term efficacy of traditional Chinese medicine (TCM) surgical operations in treating mixed hemorrhoids. MethodsA multi-center retrospective cohort study was conducted, collecting clinical data from 17,831 mixed hemorrhoid surgery patients in 8 top-tier TCM hospitals in Jiangsu Province. Standardized and structured datasets were obtained through artificial intelligence models. Patients who underwent western surgical treatment were categorized into the western surgery group (11,646 cases), and those receiving TCM surgical operations were categorized into the TCM surgery group (6185 cases). Propensity score matching (1∶1 matching) was used to balance baseline data between groups. The primary outcome was the one-year recurrence rate, and secondary outcomes included the main symptoms (rectal bleeding, degree of prolapse) and secondary symptoms (anal distension, anal edema, wound secretion and exudation, anal stenosis, residual skin tags, perianal itching, and anal pain) measured on days 7, 28, and 60 after discharge. ResultsAfter matching, 2194 patients were included in each group. Symptom scores showed that at 28 days after discharge, the TCM surgical group had superior improvement in rectal bleeding [OR=5.786, 95%CI (3.092,10.827)], degree of prolapse [OR=4.510, 95%CI (1.649,12.333)], and anal edema [OR=3.188, 95%CI (1.295,7.845)] compared to the western surgical group. At 60 days post-discharge, the TCM group still showed advantages in improving rectal bleeding [OR=5.237, 95%CI (1.077,25.464)] and anal pain [OR=11.697, 95%CI (1.186,115.336)] (P<0.05). Long-term follow-up showed that the one-year recurrence rate in the TCM surgery group was 1.1% (8/726), while that in the western surgery group was 2.3% (10/444), with no statistically significant difference between the two groups (P>0.05). ConclusionBased on real-world data, TCM surgical treatment for mixed hemorrhoids shows significant short-term symptom improvement, particularly in terms of hemostasis, reducing swelling, and alleviating prolapse of anal masses.
6.Health risk assessment of zearalenone in commercially edible vegetable oils in Ningbo City in 2024
Yanbo GUO ; Jian ZHOU ; Hua GAO ; Keqin DING
Shanghai Journal of Preventive Medicine 2026;38(2):104-107
ObjectiveTo investigate the contamination levels of zearalenone (ZEN) in commercially available edible vegetable oils in Ningbo City and to assess its health risks to local residents. MethodsA total of 330 samples of commercially available edible vegetable oil samples (50 each of peanut oil, corn oil, and olive oil; 40 each of rapeseed oil and blended oil; 30 each of soybean oil, rice oil, and sunflower seed oil; and 10 of camellia oil) were collected in 2024. The samples were tested for ZEN using the first method specified in GB 5009.209‒2016 National Food Safety Standard―Determination of Zearalenone in Food, namely the liquid chromatography method, and the contamination status was analyzed. Additionally, combined with dietary consumption data of residents, the Monte Carlo simulation method was employed to evaluate the health risks of ZEN in edible vegetable oils. ResultsZEN was detected in 267 out of 330 samples, with a detection rate of 80.91%, and the median (P50) and the 25th, 75th percentiles (P25, P75) of ZEN concentrations were 2.02 (0.37, 17.90) μg·kg-1, with a maximum value of 342.00 μg·kg-1. The ZEN detection rates in corn oil, peanut oil, and blended oil were all 100.00%. The daily average exposure (P50) and daily high exposure (P95) to ZEN via edible vegetable oils among Ningbo residents were 0.001 μg·kg-1 (normalized to body weight, same below) and 0.060 μg·kg-1, respectively. However, 1.22% of Ningbo residents had a daily ZEN exposure exceeding the tolerable daily intake (TDI) of 0.25 μg·kg-1. The hazard quotients (HQ) for the daily average exposure (P50) and daily high exposure (P95) levels were 0.004 and 0.020, respectively, both substantially below 1. Nevertheless, the probability of health risk for Ningbo residents due to ZEN exposure from vegetable oil consumption remained at 1.02%. ConclusionEdible vegetable oils in Ningbo City were contaminated with ZEN, but the probability of ZEN exposure exceeding the TDI through edible vegetable oils was relatively low, and the associated health risk probability were also minimal, indicating an overall insignificant health risk.
7.Effect of Wenyang Shengji Ointment (温阳生肌膏) on MGO Content and HIF-1a/VEGF Pathway in Wound Tissue of Diabetic Wound Model Rats with Yin Syndrome
Xinyu HUANG ; Li CHEN ; Yarong DING ; Jun WANG ; Shuihua FENG ; Zhongzhi ZHOU
Journal of Traditional Chinese Medicine 2025;66(4):382-389
ObjectiveTo investigate the possible mechanism of Wenyang Shengji Ointment (温阳生肌膏, WSO) in the treatment of diabetic wounds with yin syndrome. MethodsA total of 24 SD rats were randomly divided into a group (n=6) and modeling group (n=18). The modeling group rats were fed with high-fat diet for 14 days and then were injected intraperitoneally with streptozotocin to induce diabetic model. After steroid injection, full-thickness skin defects were created on the back of the rats to establish a diabetic wound with yin syndrome model. The normal group was fed with regular diet, and full-thickness skin defects were created surgically on the back of the rats. The 18 successfully modeled rats were further divided into three groups, the model group, the WSO group, and the Beifuxin (Recombinant Bovine Basic Fibroblast Growth Factor Gel, BX) group, 6 rats in each group. The WSO group was given the ointment to the wound, the Beifuxin group was givne BX gel, and the normal group and model group was disinfected and treated with saline. All groups had their dressings changed once daily for 14 days. Wound healing was recorded on days 0, 3, 7, and 14, and the wound healing rate was calculated on day 3, 7, and 14. On day 14 after treatment, HE staining was performed to observe the pathological morphology of the wound tissue. Western Blot was used to detect the relative protein levels of hypoxia-inducible factor 1 alpha (HIF-1α) and vascular endothelial growth factor (VEGF). Immunofluorescence was used to measure the fluorescence intensity of HIF-1α in the wound tissue, and ELISA was used to detect the methylglyoxal (MGO) content in the wound tissue. ResultsCompared with the normal group, the model group showed poor wound healing on day 3, 7, and 14, with a low wound healing rate (P<0.01). HE staining showed scab coverage on the wound, with inflammatory cell infiltration and disorganized collagen arrangement. The relative protein levels of VEGF were significantly reduced, while the relative protein levels of HIF-1α and the MGO content significantly increased (P<0.01), and the fluorescence intensity of HIF-1α was enhanced. Compared to the model group, the WSO group and Beifuxin group showed better wound healing on day 3, 7, and 14, with an increased wound healing rate (P<0.01). The wound tissue showed clear and complete epithelial structure, reduced inflammatory cells, mature granulation tissue, and organized collagen arrangement. MGO content was significantly reduced (P<0.01). The relative protein levels of HIF-1α and VEGF both significantly increased in the WSO group, while only VEGF increased in the Beifuxin group (P<0.05 or P<0.01). Compared with the Beifuxin group, the WSO group had a thicker epidermal layer, prominent collagen formation, significantly increased HIF-1α fluorescence expression, reduced MGO content in the wound tissue, and higher relative protein levels of HIF-1α (P<0.05). ConclusionWSO can reduce the accumulation of MGO in diabetic wound tissue with yin syndrome and activate the HIF-1α/VEGF pathway, which could be one of the mechanisms for promoting wound healing.
8.Impact of Donor Age on Liver Transplant Outcomes in Patients with Acute-on-Chronic Liver Failure: A Cohort Study
Jie ZHOU ; Danni YE ; Shenli REN ; Jiawei DING ; Tao ZHANG ; Siyao ZHANG ; Zheng CHEN ; Fangshen XU ; Yu ZHANG ; Huilin ZHENG ; Zhenhua HU
Gut and Liver 2025;19(3):398-409
Background/Aims:
Liver transplantation is the most effective treatment for the sickest patients with acute-on-chronic liver failure (ACLF). However, the influence of donor age on liver transplantation, especially in ACLF patients, is still unclear.
Methods:
In this study, we used the data of the Scientific Registry of Transplant Recipients. We included patients with ACLF who received liver transplantation from January 1, 2007, to December 31, 2017, and the total number was 13,857. We allocated the ACLF recipients by age intogroup I (donor age ≤17 years, n=647); group II (donor age 18–59 years, n=11,423); and group III (donor age ≥60 years, n=1,787). Overall survival (OS), graft survival, and mortality were com-pared among the three age groups and the four ACLF grades. Cox regression was also analyzed.
Results:
The 1-, 3-, and 5-year OS rates were 89.6%, 85.5%, and 82.0% in group I; 89.4%, 83.4%, and 78.2% in group II; and 86.8%, 78.4%, and 71.4% in group III, respectively (p<0.001).When we analyzed the different effects of donor age on OS with different ACLF grades, in groupsII and III, we observed statistical differences. Finally, the cubic spline curve told us that the relative death rate changed linearly with increasing donor age.
Conclusions
Donor age is related to OS and graft survival of ACLF patients after transplanta-tion, and poorer results were associated with elderly donors. In addition, different donor ages have different effects on recipients with different ACLF grades.
9.Effect of central positioning techniques for anterior capsulotomy in femtosecond laser-assisted cataract surgery on intraocular placement and visual quality
Shuaishuai LIU ; Wei ZHOU ; Xiaochen DING ; Shuang ZHANG ; Qiangqiang CHI ; Yong LIU
International Eye Science 2025;25(4):523-529
AIM: To examine how three distinct central positioning techniques for anterior capsulotomy-pupil center, limbus center, and lens apex-affect intraocular lens(IOL)placement and visual quality following femtosecond laser-assisted cataract surgery(FLACS).METHODS: A total of 36 patients(72 eyes)with age-related cataracts who underwent FLACS and ZCB00 aspherical IOL implantation at Aier Eye Hospital Medical Center, Anhui Medical University between January and December 2023 were included in this prospective study. Patients were divided into three groups based on the central positioning mode for anterior capsulotomy: pupil center, limbus center, and lens apex center groups. IOL alignment and displacement were evaluated using the Casia2 device, and the postoperative visual quality was assessed.RESULTS: At 1 d postoperatively, the IOL tilt for the pupil, limbus, and apex groups were 3.96°±1.51°, 4.63°±1.87°, and 3.90°±2.24°, respectively(F=1.07, P=0.35); IOL decentration values were 0.21±0.10 mm, 0.23±0.16 mm, and 0.21±0.12 mm, respectively(F=0.14, P=0.87); total higher-order aberrations were 0.32±0.40 μm, 0.56±0.61 μm, and 0.53±0.60 μm, respectively(F=1.38, P=0.26); and coma aberrations values were 0.13±0.10 μm, 0.16±0.15 μm, and 0.14±0.15 μm, respectively(F=0.3, P=0.74). All results obtained postoperative day 1 did not differ significantly. At 3 mo postoperatively, IOL tilt values were 5.42°±2.00°, 3.96°±1.44°, and 3.20°±1.19°, respectively(F=12.40, P<0.001); IOL decentration values were 0.33±0.07 mm, 0.23±0.11 mm, and 0.21±0.11 mm, respectively(F=4.99, P=0.008); total higher-order aberrations were 0.67±0.29 μm, 0.44±0.37 μm, and 0.42±0.19 μm, respectively(F=5.50, P=0.006); and coma aberrations values were 0.21±0.12 μm, 0.19±0.12 μm, and 0.12±0.11 μm, respectively(F=3.87, P=0.03). All results obtained 3 mo postoperatively were statistically significant.CONCLUSION: Using the lens apex as the central positioning mode for anterior capsulotomy in FLACS improves postoperative IOL stability and reduces postoperative IOL tilt and decentration. If the lens apex cannot be determined intraoperatively, the limbus center-positioning mode is recommended.
10.Establishment of a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection
Rong WU ; Liping WANG ; Jinye LANG ; Yue ZHU ; Jing ZHOU ; Xun LIU ; Jing NI ; Shunbo ZHOU ; Yaling DING
Chinese Journal of Blood Transfusion 2025;38(3):415-420
[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.

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