1.Screening of diagnostic markers for endothelial cell Senescence in mice with radiation-induced heart disease and analysis of immune infiltration
Jiaming LAI ; Yuling SONG ; Zixi CHEN ; Jinghuan WEI ; Hao CAI ; Guoquan LI
Chinese Journal of Tissue Engineering Research 2026;30(6):1450-1463
BACKGROUND:Radiotherapy significantly improves survival rates in patients with various malignant tumors.However,with prolonged post-treatment survival,many patients face the risk of radiation-related cardiac toxicity.This is especially true after chest radiotherapy,where the risk of radiation-induced heart disease significantly increases,becoming one of the most severe complications affecting prognosis survival.OBJECTIVE:To identify diagnostic markers of endothelial cellular senescence in radiation-induced heart disease through systematic transcriptomic analysis.METHODS:Firstly,genes associated with cellular senescence were screened from the CellAge database and intersected with the transcriptomic training dataset of a mouse model of radiation-induced heart disease to identify differentially expressed senescence-related genes.Secondly,weighted gene co-expression network analysis and machine learning were used to identify key hub genes that play critical roles in radiation-induced heart disease.The expression of these genes was validated using a dataset of radiation-induced endothelial injury.Additionally,the quanTlseq method was employed to assess the immune infiltration status related to radiation-induced heart disease.The expression levels of key genes and their association with survival in esophageal squamous cell carcinoma patients receiving chest radiotherapy were explored through the analysis of The Cancer Genome Atlas database.RESULTS AND CONCLUSION:(1)Systematic transcriptomic analysis identified CCND1 as the core gene of endothelial cellular senescence in radiation-induced heart disease,and this finding was validated in the mouse model of radiation-induced heart disease.(2)The diagnostic model constructed from these data indicated that CCND1 had high specificity and sensitivity for diagnosing radiation-induced heart disease.(3)Immune infiltration analysis revealed significant immune response dysregulation in the mouse model of radiation-induced heart disease,and CCND1 was closely related to various immune cells.(4)Kaplan-Meier survival analysis showed that CCND1 was associated with poorer disease-specific survival in esophageal squamous cell carcinoma patients receiving chest radiotherapy.This study systematically uncovers,for the first time,the pivotal role of CCND1 in endothelial cell senescence associated with radiation-induced heart disease.CCND1,a gene integral to cell cycle regulation,can induce cellular senescence when abnormally expressed.Furthermore,the findings highlight its potential as an early diagnostic marker.
2.Screening of diagnostic markers for endothelial cell Senescence in mice with radiation-induced heart disease and analysis of immune infiltration
Jiaming LAI ; Yuling SONG ; Zixi CHEN ; Jinghuan WEI ; Hao CAI ; Guoquan LI
Chinese Journal of Tissue Engineering Research 2026;30(6):1450-1463
BACKGROUND:Radiotherapy significantly improves survival rates in patients with various malignant tumors.However,with prolonged post-treatment survival,many patients face the risk of radiation-related cardiac toxicity.This is especially true after chest radiotherapy,where the risk of radiation-induced heart disease significantly increases,becoming one of the most severe complications affecting prognosis survival.OBJECTIVE:To identify diagnostic markers of endothelial cellular senescence in radiation-induced heart disease through systematic transcriptomic analysis.METHODS:Firstly,genes associated with cellular senescence were screened from the CellAge database and intersected with the transcriptomic training dataset of a mouse model of radiation-induced heart disease to identify differentially expressed senescence-related genes.Secondly,weighted gene co-expression network analysis and machine learning were used to identify key hub genes that play critical roles in radiation-induced heart disease.The expression of these genes was validated using a dataset of radiation-induced endothelial injury.Additionally,the quanTlseq method was employed to assess the immune infiltration status related to radiation-induced heart disease.The expression levels of key genes and their association with survival in esophageal squamous cell carcinoma patients receiving chest radiotherapy were explored through the analysis of The Cancer Genome Atlas database.RESULTS AND CONCLUSION:(1)Systematic transcriptomic analysis identified CCND1 as the core gene of endothelial cellular senescence in radiation-induced heart disease,and this finding was validated in the mouse model of radiation-induced heart disease.(2)The diagnostic model constructed from these data indicated that CCND1 had high specificity and sensitivity for diagnosing radiation-induced heart disease.(3)Immune infiltration analysis revealed significant immune response dysregulation in the mouse model of radiation-induced heart disease,and CCND1 was closely related to various immune cells.(4)Kaplan-Meier survival analysis showed that CCND1 was associated with poorer disease-specific survival in esophageal squamous cell carcinoma patients receiving chest radiotherapy.This study systematically uncovers,for the first time,the pivotal role of CCND1 in endothelial cell senescence associated with radiation-induced heart disease.CCND1,a gene integral to cell cycle regulation,can induce cellular senescence when abnormally expressed.Furthermore,the findings highlight its potential as an early diagnostic marker.
3.Relationship between Serum PRDX6 and ANXA1 Levels and Severity and Prognosis in Patients with AECOPD Complicated with Type Ⅱ Respiratory Failure
Yuling ZHANG ; Yusi CHEN ; Lan SUN
Journal of Modern Laboratory Medicine 2025;40(6):97-103
Objective To investigate the relationship between serum peroxiredoxin 6(PRDX6)and annexin A1(ANXA1)levels and the severity and prognosis of patients with acute exacerbation of chronic obstructive pulmonary disease(AECOPD)compli-cated with type II respiratory failure.Methods A total of 257 patients with AECOPD complicated with type II respiratory failure(respiratory failure group),130 patients with stable COPD(stable COPD group)and 130 healthy subjects(control group)were selected from the Panzhihua University Affiliated Hospital from December 2021 to December 2023.According to the oxygenation index,AECOPD patients with type II respiratory failure were divided into mild respiratory failure group(n=101),moderate respi-ratory failure group(n=80)and severe respiratory failure group(n=76).According to the 28-day prognosis,they were divided into death group(n=62)and survival group(n=195).Serum PRDX6 and ANXA1 levels were detected by enzyme-linked immu-nosorbent assay(ELISA).The correlation between serum PRDX6,ANXA1 levels and oxygenation index in AECOPD patients with type II respiratory failure was analyzed by Spearman correlation coefficient.Multivariate Logistic regression model was used to analyze the influencing factors of poor prognosis in patients with AECOPD complicated with type II respiratory fail-ure,and receiver iperating characteristic(ROC)curve was drawn to evaluate the predictive value of serum PRDX6 and ANXA1.Results The serum PRDX6 level in the respiratory failure group(41.54±4.28 pg/ml)was lower than that in the stable COPD group(61.38±4.94 pg/ml)and the control group(80.65±8.93 pg/ml),and the ANXA1 level(3.35±0.69 μg/L)was higher than that in the stable COPD group(2.13±0.61 μg/L)and the control group(1.03±0.14 μg/L),the differences were statistically sig-nificant(t=-33.894~21.727,all P<0.001).The serum level of PRDX6 in severe respiratory failure group(34.54±5.05 pg/ml)was lower than that in moderate respiratory failure group(43.90±4.72 pg/ml)and mild respiratory failure group(54.28±6.34 pg/ml),the serum level of ANXA1 in severe respiratory failure group(3.94±0.43 μg/L)was higher than that in moderate respi-ratory failure group(3.57±0.46 μg/L)and mild respiratory failure group(2.70±0.43 μg/L),the differences were statistically sig-nificant(t=-19.018~22.338,all P<0.001).Oxygen index was positively correlated with serum PRDX6(r=0.815,P<0.001)and negatively correlated with ANXA1(r=-0.781,P<0.001)in AECOPD patients with type II respiratory failure.The mortality rate of 257 AECOPD patients with type II respiratory failure was 24.12%(62/257)after 28 days of follow-up.Increase forced expi-ratory volume in the first second(FEV1)as a percentage of the predicted value,increased oxygenation index and increased PRDX6 were independent protective factors for the poor prognosis of AECOPD patients with type II respiratory failure(Wald χ2=-0.154,-0.014,-0.173,all P<0.05),increased ANXA1 was an independent risk factor(Wald χ2=0.250,P<0.05).The area un-der the curve of serum PRDX6 and ANXA1 combined to predict the poor prognosis of AECOPD patients with type II respiratory failure was 0.906,which was greater than 0.788 and 0.781 predicted by the two indicators alone,and the differences were statisti-cally significant(Z=4.243,4.224,all P<0.001).Conclusion The decrease of serum PRDX6 level and the increase of ANXA1 level are related to the aggravation and poor prognosis of AECOPD patients with type II respiratory failure.The value of serum PRDX6 combined with ANXA1 in predicting the prognosis of AECOPD patients with type II respiratory failure is high.
4.Research progress of immune cells in pathogenesis of lupus nephritis
Shuangyu DAI ; Shuqiang QU ; Hanchen CHEN ; Yuling ZHENG
Journal of Chinese Physician 2025;27(2):318-320
Lupus nephritis (LN) is the most common complication of systemic lupus erythematosus (SLE). The immune pathogenesis is closely related to the progression and clinical treatment of LN. This review reviews the relevant literature on the role of immune cells in the pathogenesis of LN at home and abroad. This paper summarized and analyzed the pathogenesis of immune cells in the pathogenesis of LN and the research progress of related targeted therapy, aiming to improve the understanding of the pathogenesis of immune cells in LN, improve the treatment status of LN and better improve the prognosis.
5.The effects of tripterygium glycosides on adipocyte differentiation,inflamma-tion,and fibrosis of orbital fibroblasts in thyroid associated ophthalmopathy
Jin ZHU ; Shu ZHU ; Yuling ZHONG ; Hong CHEN ; Wenjie LIN
Recent Advances in Ophthalmology 2025;45(3):202-210
Objective To explore the effects of tripterygium glycosides(TGs)on adipocyte differentiation,inflam-mation,and fibrosis of orbital fibroblasts(OFs)in thyroid associated ophthalmopathy(TAO).Methods OFs isolated from 12 TAO patients were cultured and identified.CCK-8 experiment was used to detect the effect of different concentra-tions of TGs(0,12.5,25.0,50.0,100.0 mg·L-1)on the activity of OFs.Then,adipocyte differentiation phenotypes of OFs were induced and divided into a control group,an adipocyte differentiation group(DM),and TG groups(12.5,25.0,and 50.0 mg·L-1 TGs).Inflammation phenotypes of OFs were induced and divided into a control group,an IL-1 β group,and TG groups(12.5,25.0,and 50.0 mg·L-1 TGs).Fibrosis phenotypes of OFs were induced and divided into a control group,a TGF-βi group,and TG groups(12.5,25.0,and 50.0 mg·L-1 TGs).Oil red O staining was used to detect the formation of lipid droplets in OFs of adipocyte differentiation phenotype.ELISA was used to measure IL-6 and TNF-α levels in OFs of inflammation phenotype and HA levels in OFs of fibrosis phenotype.Transwell experiment was used to detect the cell migration rate of OFs of fibrosis phenotype.Real time quantitative polymerase chain reaction(RT-qPCR)and Western blot were used to detect the expression levels of PPAR-γ,c/EBP-α,FABP-4,perilipin-1,and adiponectin mRNAs and pro-teins in OFs of adipocyte differentiation phenotype,the expression levels of IL-6,TNF-α,COX-2,MCP-1 and ICAM-1 mR-NAs and proteins in OFs of inflammation phenotype,and the expression levels of Vimentin,Fibronectin,COL1A1,COL1A2 and ACTA2 mRNAs and proteins in OFs of fibrosis phenotype.Results The cells were identified as OFs.12.5,25.0,and 50.0 mg·L-1 of TGs had no significant effect on OF activity and these three concentrations were used in the subsequent ex-periment.In OFs of adipocyte differentiation phenotype,the number of orange red lipid droplets greatly decreased after TG treatment.The expression levels of PPAR-γ,c/EBP-α,FABP-4,perilipin-1,and adiponectin mRNAs and proteins in cells of TG groups were significantly lower than those of the DM group(all P<0.05).In OFs of inflammation phenotype,IL-6 and TNF-α levels in supernatant and cells of TG groups were significantly decreased,compared with those of the IL-1βgroup(all P<0.05).The expression levels of COX-2,MCP-1,and ICAM-1 mRNAs and proteins in cells of TG groups were significantly lower than those of the IL-1 β group(all P<0.05).In OFs of fibrosis phenotype,the cell migration rates,HA levels in cell culture supernatant,and the expression levels of Vimentin,Fibronectin,COL1A1,COL1A2,and ACTA2 mR-NAs and proteins in cells of TG groups were significant lower than those of the TGF-β1 group(all P<0.05).Conclusion TGs can inhibit the adipocyte differentiation,IL-1 β-induced inflammatory responses and TGF-β1-induced fibrosis of TAO-OFs.
6.Relationship between Serum PRDX6 and ANXA1 Levels and Severity and Prognosis in Patients with AECOPD Complicated with Type Ⅱ Respiratory Failure
Yuling ZHANG ; Yusi CHEN ; Lan SUN
Journal of Modern Laboratory Medicine 2025;40(6):97-103
Objective To investigate the relationship between serum peroxiredoxin 6(PRDX6)and annexin A1(ANXA1)levels and the severity and prognosis of patients with acute exacerbation of chronic obstructive pulmonary disease(AECOPD)compli-cated with type II respiratory failure.Methods A total of 257 patients with AECOPD complicated with type II respiratory failure(respiratory failure group),130 patients with stable COPD(stable COPD group)and 130 healthy subjects(control group)were selected from the Panzhihua University Affiliated Hospital from December 2021 to December 2023.According to the oxygenation index,AECOPD patients with type II respiratory failure were divided into mild respiratory failure group(n=101),moderate respi-ratory failure group(n=80)and severe respiratory failure group(n=76).According to the 28-day prognosis,they were divided into death group(n=62)and survival group(n=195).Serum PRDX6 and ANXA1 levels were detected by enzyme-linked immu-nosorbent assay(ELISA).The correlation between serum PRDX6,ANXA1 levels and oxygenation index in AECOPD patients with type II respiratory failure was analyzed by Spearman correlation coefficient.Multivariate Logistic regression model was used to analyze the influencing factors of poor prognosis in patients with AECOPD complicated with type II respiratory fail-ure,and receiver iperating characteristic(ROC)curve was drawn to evaluate the predictive value of serum PRDX6 and ANXA1.Results The serum PRDX6 level in the respiratory failure group(41.54±4.28 pg/ml)was lower than that in the stable COPD group(61.38±4.94 pg/ml)and the control group(80.65±8.93 pg/ml),and the ANXA1 level(3.35±0.69 μg/L)was higher than that in the stable COPD group(2.13±0.61 μg/L)and the control group(1.03±0.14 μg/L),the differences were statistically sig-nificant(t=-33.894~21.727,all P<0.001).The serum level of PRDX6 in severe respiratory failure group(34.54±5.05 pg/ml)was lower than that in moderate respiratory failure group(43.90±4.72 pg/ml)and mild respiratory failure group(54.28±6.34 pg/ml),the serum level of ANXA1 in severe respiratory failure group(3.94±0.43 μg/L)was higher than that in moderate respi-ratory failure group(3.57±0.46 μg/L)and mild respiratory failure group(2.70±0.43 μg/L),the differences were statistically sig-nificant(t=-19.018~22.338,all P<0.001).Oxygen index was positively correlated with serum PRDX6(r=0.815,P<0.001)and negatively correlated with ANXA1(r=-0.781,P<0.001)in AECOPD patients with type II respiratory failure.The mortality rate of 257 AECOPD patients with type II respiratory failure was 24.12%(62/257)after 28 days of follow-up.Increase forced expi-ratory volume in the first second(FEV1)as a percentage of the predicted value,increased oxygenation index and increased PRDX6 were independent protective factors for the poor prognosis of AECOPD patients with type II respiratory failure(Wald χ2=-0.154,-0.014,-0.173,all P<0.05),increased ANXA1 was an independent risk factor(Wald χ2=0.250,P<0.05).The area un-der the curve of serum PRDX6 and ANXA1 combined to predict the poor prognosis of AECOPD patients with type II respiratory failure was 0.906,which was greater than 0.788 and 0.781 predicted by the two indicators alone,and the differences were statisti-cally significant(Z=4.243,4.224,all P<0.001).Conclusion The decrease of serum PRDX6 level and the increase of ANXA1 level are related to the aggravation and poor prognosis of AECOPD patients with type II respiratory failure.The value of serum PRDX6 combined with ANXA1 in predicting the prognosis of AECOPD patients with type II respiratory failure is high.
7.Prospective memory activation brain network in civil pilots based on functional magnetic resonance imaging
Qingsong SONG ; Weitao LIU ; Xiaojun ZUO ; Yuling LUO ; Peiran XU ; Yu ZHANG ; Xiaoying SUN ; Xi CHEN ; Cheng LUO
Chinese Journal of Aerospace Medicine 2025;36(2):93-100
Objective:To analyze the patterns of change of brain function among civil pilots in prospective memory tasks by using task-state functional magnetic resonance imaging (fMRI) and a cue-based repetitive search task.Methods:A total of 85 subjects were enrolled, including 47 civil pilots (pilot group) and 38 ordinary workers (control group). The task-state fMRI data during the execution of the prospective memory task was analyzed using a general linear model to find out about the activation patterns of brain functions in the 2 groups in the 3 phases of encoding, maintenance, and retrieval of the prospective memory task. The differences in activation patterns between the 2 groups and correlations between regions of interest and the rate of accuracy, reaction time and flying hours were analyzed.Results:The repeated measurement analysis of variance showed that there were no interactions of reaction time or of the rate of accuracy between the task and grouping ( P>0.05), and that the difference in the main effect of grouping was significant ( F=5.67, 15.46, P=0.020, <0.001). The difference in the main effect of grouping on the rate of accuracy was significant ( F=5.42, P=0.022), and the rate of accuracy in the pilot group was higher than in the control group ( P=0.048). In the phase of encoding, the activation in the bilateral cerebellum, bilateral superior frontal gyrus, bilateral fusiform gyrus, and temporal lobe regions decreased in the pilot group compared with the control group ( t=2.68-4.13, all P<0.05), while the activation in the fusiform gyrus and the right parietal superior gyrus increased, and the differences were statistically significant ( t=3.28, 3.35, 3.02, P=0.038, 0.024, 0.042). During the phase of maintenance, the pilot group showed significantly reduced activation in the bilateral cerebellum, bilateral medial superior frontal gyrus, bilateral middle occipital gyri, and the right middle temporal gyrus compared with the control group ( t=2.24-3.36, P<0.05 or 0.01). In the retrieval phase, activation in the right peri-calcarine cortex, bilateral caudate nuclei, and bilateral precentral and postcentral gyri was enhanced in the pilot group compared with the control group ( t=2.57-3.35, all P<0.05), especially in the right middle frontal gyrus ( t=3.12, P=0.007). In the encoding phase, activation was increased in the left fusiform gyrus and right parietal superior gyrus of the pilot group, which was positively correlated with flying hours in the last 3 months ( r=0.347, 0.418, P=0.020, 0.005). Conclusions:Due to long-term flights, the way in which such regions as the frontal lobe, cerebellum, and default mode network are activated in civil pilots is likely to undergo some changes during prospective memory activities, which is why they have higher processing efficiency when performing prospective memory tasks.
8.Current status of pruritus care in dermatology departments in China: a survey of 607 nurses from 85 public hospitals
Yuling ZHONG ; Ya LE ; Jinlian FENG ; Mudiao CHEN
Chinese Journal of Dermatology 2025;58(7):613-617
Objective:To investigate the current status of pruritus care in dermatology departments of public hospitals in China.Methods:A multicenter, cross-sectional survey was conducted. By convenience sampling, dermatology nurses were selected from 85 public hospitals across 17 provinces in China from September 2 to September 14, 2024, and a self-designed pruritus care questionnaire survey was conducted. The survey content included two parts: general information (e.g., education levels, professional titles, regions, hospital grades) and current status of pruritus care (e.g., pruritus care systems or standards, establishment of pruritus clinics, pruritus assessment, pruritus intervention measures, pruritus nursing training, and challenges in pruritus care) .Results:A total of 607 nurses were investigated, including 322 (53.0%) from general hospitals and 285 (47.0%) from specialized hospitals; 359 (59.1%) were from tertiary grade-A hospitals. In total, 264 (43.5%) nurses reported that pruritus clinics had been established in their hospitals, 218 (35.9%) reported that pruritus nursing teams had been set up, and 283 (46.6%) noted a lack of pruritus care systems or standards in their hospitals. The most commonly used anti-pruritus measures were physical therapy (51.2%) , drug treatment (37.9%) , and environmental management (10.9%) . There were 418 (68.9%) nurses who had received pruritus nursing training. The most frequently used pruritus assessment tools were the numeric rating scale ( n = 341, 56.2%) and the visual analog scale ( n = 268, 44.2%) , while 165 (27.2%) nurses had not used any assessment tools. The most challenging issues in pruritus care were the selection of pruritus assessment tools ( n = 303, 49.9%) and poor efficacy of pruritus control ( n = 113, 18.6%) . Tertiary grade-A hospitals and hospitals with pruritus clinics exhibited higher rates of establishing pruritus care systems/standards and providing pruritus nursing training compared with non-tertiary grade-A hospitals and hospitals without pruritus clinics respectively (all P < 0.05) . Conclusions:Public hospitals in China currently face issues such as inadequate pruritus care management systems, non-standardized pruritus assessment, and insufficient pruritus nursing training. Pruritus nursing levels were variable among different hospitals, and the standardization and homogeneity of pruritus nursing urgently need to be improved.
9.Research progress of serine hydroxymethyltransferase inhibitors in tumor treatment
Yili CHEN ; Peisen WANG ; Yuling CHEN ; Yuanyuan ZENG
Chinese Journal of Clinical Medicine 2025;32(1):125-134
Tumor is the result of long-term and unlimited proliferation of cells. Tumor cells adjust various metabolic fluxes to meet increased bioenergy and biosynthetic requirements. Serine is one of the eight non-essential amino acids in the human body. It plays an important role in a variety of physiological activities and can provide one carbon unit, glycine, etc. for cell proliferation. Serine hydroxymethyltransferase (SHMT) is a key enzyme that catalyzes the conversion of glycine and serine. It is highly expressed in a variety of tumors and is a potential target for anti-tumor drugs. This article focuses on the potential of SHMT as a new target for cancer treatment and the preliminary application of its inhibitors in preclinical studies of tumors, providing reference for the development of new targeted drugs for tumors.
10.Clinical efficacy and safety of a domestic calcipotriol/betamethasone dipropionate ointment in the treatment of stable plaque psoriasis: a multicenter, randomized, double-blind, controlled study
Lixin XIA ; Guang XIANG ; Qingchun DIAO ; Kun HUANG ; Shoumin ZHANG ; Shanshan LI ; Yumei LI ; Zhiqiang SONG ; Qing SUN ; Xiumin YANG ; Meng PAN ; Yuling SHI ; Shuping GUO ; Huiping WANG ; Tiechi LEI ; Xiaoyong ZHOU ; Songmei GENG ; Suchun HOU ; Juan SU ; Yong CUI ; Rixin CHEN ; Yanyan FENG ; Hongxia FENG ; Rushan XIA ; Zudong MENG ; Fang YIN ; Jingjing WANG ; Xinghua GAO
Chinese Journal of Dermatology 2025;58(11):1020-1026
Objective:To evaluate the clinical equivalence between a domestic calcipotriol/betamethasone dipropionate ointment and the originator product in the treatment of stable plaque psoriasis.Methods:A multicenter, randomized, double-blind, three-arm, parallel-group, active- and placebo-controlled study was conducted, and 449 patients aged 18 - 65 years with stable plaque psoriasis were enrolled from 25 hospitals (such as the First Affiliated Hospital of China Medical University). Eligible patients had a baseline physician's global assessment (PGA) score of ≥ 3 points, baseline body surface area (BSA) involvement of 5% - 30%, and a target lesion psoriasis area and severity index (TL-PASI) for plaque elevation of ≥ 3 points. Participants were randomly assigned in a 2:2:1 ratio to the test group ( n = 179), reference group ( n = 180), and placebo group ( n = 90), and applied the domestic calcipotriol/betamethasone dipropionate ointment, originator product, and ointment base respectively, once daily in the evening for 4 weeks. Efficacy and safety were assessed at weeks 1, 2, and 4. The primary efficacy endpoints were the treatment success rates and clinical success rates in each group at week 4. The per-protocol set (PPS) was used for the primary efficacy analysis, and the intention-to-treat (ITT) set for supplementary efficacy analysis. Equivalence between the test and reference preparations was tested using the Cochran-Mantel-Haenszel method adjusted for randomization strata. Superiority of the test and reference preparations over the placebo was also tested. Measurement data were compared among the 3 groups using analysis of variance or non-parametric tests, while treatment success rates, clinical success rates, and incidence rates of adverse reactions were compared using the chi-square test. Results:The ITT, PPS, and safety sets included 447, 420, and 448 patients, respectively. In the ITT set, patients were aged 43.6 ± 12.8 years, including 320 (71.6%) males and 127 (28.4%) females, and the disease duration was 11.21 ± 9.05 years; 316 (70.7%) had a PGA score of 3 points and 131 (29.3%) had a PGA score of 4 - 5 points. No significant differences in the baseline characteristics (including age, sex, disease duration and disease severity) were observed among the 3 groups (all P > 0.05). Based on the PPS analysis, the treatment success rates were 57.9% (99/171) in the test group, 50.3% (86/171) in the reference group, and 7.7% (6/78) in the placebo group, and the clinical success rates were 57.9% (99/171), 50.3% (86/171), and 10.3% (8/78), respectively; both the test and reference groups were superior to the placebo group in both treatment and clinical success rates (all P < 0.001) ; the rate differences for treatment success (90% confidence interval [ CI]: -1.3% - 16.4%) and clinical success (90% CI: -1.3% - 16.3%) between the test and reference groups were entirely within the pre-defined equivalence margin (-20% - 20%). Subgroup analyses by baseline PGA scores: for patients with a baseline PGA score of 3 points, the treatment success rates in the test, reference, and placebo groups were 60.8% (73/120), 52.1% (62/119), and 11.1% (6/54), respectively, and the corresponding clinical success rates were 61.7% (74/120), 53.8% (64/119), and 13% (7/54), respectively; the test and reference groups did not differ significantly in treatment or clinical success rates (both P > 0.05), but both showed higher success rates than the placebo group (all P < 0.001) ; the results of statistical comparisons among the 3 groups in patients with a baseline PGA score of 4 - 5 points were consistent with those observed in patients with a baseline PGA score of 3 points. The percentage reductions in PGA and TL-PASI scores from baseline to weeks 1, 2, and 4 showed significant differences among the 3 groups, which were significantly higher in the test and reference groups than in the placebo group (all P < 0.001), but did not differ between the test and reference groups (all P > 0.05). The primary adverse reactions were local skin reactions, such as pruritus, pain, and erythema. The incidence rates of adverse reactions were 8.9% (16/179) in the test group, 7.3% (13/179) in the reference group, and 7.8% (7/90) in the placebo group, with no significant difference among the 3 groups ( P > 0.05) . Conclusions:The domestic calcipotriol/betamethasone dipropionate ointment demonstrated clinical equivalence to the originator product in the treatment of stable plaque psoriasis, and the two agents exhibited comparable efficacy for patients with varying degrees of disease severity, and were comparable in the speed and degree of clinical improvement, with similar favorable safety profiles.

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