1.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.
2.Research on MBSE model microservice aggregation and adaptive integration methods for products based on intelligent cloud architecture
Taihui YIN ; Lizhi WANG ; Jiawei HE ; Shenmao HOU ; Shanshan ZHANG
Space Medicine & Medical Engineering 2025;36(5):473-478
To address the challenges of complex digital model management and difficulties in model interoperability during the development of sophisticated products,this paper proposes an intelligent cloud architecture-based method for MBSE(model-based systems engineering)model microservice aggregation and adaptive integration.By introducing ontology semantic annotation and hash encoding mechanisms,we achieve unified encapsulation and service-oriented management of heterogeneous modeling tool resources.Combined with model virtual execution modes and dynamic resource orchestration technology,we design a task-oriented of Model-Based Microservice Deployment Framework,significantly improving model service scheduling efficiency and resource utilization.Leveraging a service-cluster-based model aggregation approach,we employ Hamming distance to calculate model capability compatibility,optimizing model discovery and orchestration processes.The prototype implementation and multi-phase experimental validation conducted in a domestic private cloud environment demonstrate that the proposed method effectively supports digital development across the entire lifecycle of aerospace products,enhancing model resource sharing and system integration efficiency.
3.Investigation and analysis of the current situation of occupational stress of radiation workers in China
Qi ZHANG ; Jianfei LU ; Peng TONG ; Haoran SUN ; Shanshan KOU ; Xiaolan ZHOU ; ·Yusufu AIKEBAIER ; Weiguo ZHU ; Changsong HOU
Chinese Journal of Radiological Health 2025;34(1):46-54
Objective To investigate and analyze the occupational stress levels and influencing factors among radiation workers in China, and provide a reference for alleviating occupational stress and promoting mental health. Methods Using the general situation questionnaire, Effort-Reward Imbalance questionnaire, and radiation protection knowledge questionnaire, a convenience sampling method was adopted to investigate the occupational stress of 243 radiation workers in Liaoning, Fujian, Guangdong, and Xinjiang provinces. The independent samples t-test, one-way analysis of variance, chi-square test, and binary logistic regression were used to analyze the influencing factors. Results The average score of Effort-Reward Imbalance was 0.97 ± 0.22, and 100 (41.15%) radiation workers had occupational stress. There were significant differences in the detection rate of occupational stress among radiation workers of different ages, working years in radiation positions, monthly incomes, daily sleep durations, and daily working hours (P < 0.05). Logistic regression analysis identified daily working hours as a factor contributing to occupational stress. Conclusion The occupational stress among radiation workers in China is relatively severe. It is recommended to pay attention to the associated risks and implement targeted intervention measures to reduce the impact of occupational stress.
4.Mechanism of Mingshi Prescription in Regulating Opn4-dopamine Axis to Inhibit Endoplasmic Reticulum Stress and Delay Myopia Progression
Baohua LI ; Zefeng KANG ; Lulu WANG ; Xin YAN ; Jianquan WANG ; Xinyue HOU ; Bobiao NING ; Shanshan YE ; Mengyu LIU ; Yipeng SHI ; Danyu LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(18):58-67
ObjectiveTo investigate the mechanism by which Mingshi prescription regulates the retinal melanopsin-dopamine (Opn4-DA) axis in myopic mice to inhibit endoplasmic reticulum (ER) stress in the retina and sclera, thereby delaying axial elongation associated with myopia. MethodsSixty 4-week-old male SPF-grade C57BL/6J mice were randomly divided into a normal group, a form-deprived myopia group (FDM group), an intrinsically photosensitive retinal ganglion cells ablation group (ipRGCs group), a Mingshi Prescription group (MSF group, 5.2 g·kg-1), and an ipRGCs + MSF group (5.2 g·kg-1). Except for the normal group, all other groups underwent FDM modeling. Additionally, the ipRGCs and ipRGCs + MSF groups received retinal ipRGC ablation. Three weeks after modeling, the MSF and ipRGCs + MSF groups were administered Mingshi prescription via continuous gavage for six weeks. After refraction and axial length were measured in all mice, eyeballs were collected along with retinal and scleral tissues. Pathological and morphological changes in the retina, choroid, and sclera were observed using periodic acid-Schiff (PAS) staining. Western blot was employed to detect the relative protein expression levels of dopamine D1 receptor (DRD1), C/EBP homologous protein (CHOP), and glucose-regulated protein 78 (GRP78) in the retina, and CHOP and GRP78 in the sclera. Real-time PCR was used to detect the relative mRNA expression of Opn4, CHOP, and GRP78 in the retina, and CHOP and GRP78 in the sclera. Immunofluorescence staining (IF) was performed to detect the expression of Opn4 and DRD1 in retinal tissues. ResultsCompared with the normal group, the FDM group showed a significant myopic shift in refraction (P<0.05) and a significant increase in axial length (P<0.05). The retinal layers were thinner, the number of ganglion cells was reduced, and collagen fibers in the sclera were loosely arranged with evident gaps. Opn4 and DRD1 protein and mRNA expression in the retina were significantly decreased (P<0.05), while CHOP and GRP78 protein and mRNA expression in both retinal and scleral tissues were significantly increased (P<0.05). Compared with the FDM group, the ipRGCs group exhibited further increases in myopic refraction and axial length (P<0.05), more pronounced thinning and looseness in the retinal, choroidal, and scleral layers, lower expression of Opn4 and DRD1 protein and mRNA in the retina (P<0.05), and higher expression of CHOP and GRP78 protein and mRNA in the retina and sclera (P<0.05). Compared with the FDM group, the MSF group showed significantly reduced refractive error and axial length (P<0.05), with improved cellular number, arrangement, and thickness in ocular tissues, increased Opn4 and DRD1 protein and mRNA expression in the retina (P<0.05), and reduced CHOP and GRP78 protein and mRNA expression in both retina and sclera (P<0.05). Similarly, the ipRGCs + MSF group showed significant improvements in terms of the above items compared with the ipRGCs group (P<0.05). ConclusionMingshi Prescription delays myopic axial elongation and refractive progression by regulating the Opn4-DA axis in the retina of myopic mice, thereby inhibiting ER stress in the retina and sclera. This intervention promotes Qi and blood nourishment of the eyes, softens the fascia, and restores ocular rhythm.
5.Construction of a key technical indicator system for in-hospital treatment and nursing of patients with nuclear radiation injury
Liu LIU ; Bei HOU ; Yanan ZHU ; Lei ZHU ; Yan GAO ; Yingfeng LIANG ; Shanshan GUO
Chinese Journal of Radiological Health 2025;34(4):595-601
Objective To construct a key technical indicator system for in-hospital treatment and nursing of patients with nuclear radiation injury, and provide a basis for the implementation of such treatment and nursing. Methods The draft of the key technical indicator system for in-hospital treatment and nursing of patients with nuclear radiation injury was determined by literature review, case study, and field investigation. The indicators of the system were determined through two rounds of Delphi consultation and using the precedence chart method. According to the criteria of indicator evaluation, the reliability of expert opinions, and the opinions of the research group, the indicators were refined and evaluated. Results Twenty experts were included for two rounds of consultation via mailed inquiries, with a 100% effective response rate in both rounds. The expert authority coefficients were both 0.945, and the Kendall’s W values were 0.347 and 0.448, respectively (P < 0.05). Following the expert consultations, 1 indicator was deleted, 12 indicators were added, and 6 indicators were modified. The key technical indicator system for in-hospital treatment and nursing of patients with nuclear radiation injury established in this study included 4 first-level indicators, 17 second-level indicators, and 73 third-level indicators. The means of importance assignment for all indicators were > 4.00, and the coefficients of variation were < 0.25. Conclusion The key technical indicator system for in-hospital treatment and nursing of patients with nuclear radiation injury established in this study is scientifically rigorous and practically grounded. The indicators demonstrate strong professional relevance and provide important guidance for in-hospital treatment and nursing of patients with nuclear radiation injury.
6.Alzheimer's disease diagnosis among dementia patients via blood biomarker measurement based on the AT(N) system.
Tianyi WANG ; Li SHANG ; Chenhui MAO ; Longze SHA ; Liling DONG ; Caiyan LIU ; Dan LEI ; Jie LI ; Jie WANG ; Xinying HUANG ; Shanshan CHU ; Wei JIN ; Zhaohui ZHU ; Huimin SUI ; Bo HOU ; Feng FENG ; Bin PENG ; Liying CUI ; Jianyong WANG ; Qi XU ; Jing GAO
Chinese Medical Journal 2025;138(12):1505-1507
7.Correlation Study on the Odor Spectrum and Gut Microbiota in Chronic Atrophic Gastritis with Yin Deficiency Syndrome
Yuyu XIE ; Long ZHU ; Mengting ZHANG ; Xuejuan LIN ; Shanshan DING ; Xiaofen HOU
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(11):163-171
Objective To collect oral exhaled odor spectrum of patients of chronic atrophic gastritis(CAG)with yin deficiency syndrome and detect their gut microbiota;To elucidate the mechanism of odor changes from the perspective of gut microbiota changes;To provide a basic research for the objectification of TCM olfactory diagnosis in CAG.Methods Totally 110 patients with CAG,including 55 patients with CAG yin deficiency syndrome,55 patients with CAG non-yin deficiency syndrome,and 30 healthy individuals were collected.The electronic nose technology was used to collect the oral exhaled odor spectrum of all subjects,and an improved Transformer model was used to identify the breath odor spectrum of CAG yin deficiency syndrome patients and healthy individuals,CAG non-yin deficiency syndrome patients and healthy individuals,CAG yin deficiency syndrome patients and CAG non-yin deficiency syndrome patients.At the same time,16S rRNA high-throughput sequencing method was used to detect the gut microbiota of the subjects'fecal samples,and the correlation analysis between the odor spectrum characteristics of CAG yin deficiency syndrome and gut microbiota was conducted.Results ① Analysis and recognition of odor spectrum characteristic.Amplitude characteristics:The response curves A,C,D,G,H,I and J of the odor spectrum in the CAG yin deficiency syndrome group and the CAG non-yin deficiency syndrome group were all lower in amplitude than those in the healthy group(P<0.01,P<0.05).Slope characteristics:The slopes of response curves A,B,C,D,E,G,H,I and J in the odor spectrum of the CAG yin deficiency syndrome group and the CAG non-yin deficiency syndrome group were lower than those of the healthy group(P<0.01,P<0.05).Pattern recognition:The accuracy of pattern recognition between the CAG yin deficiency syndrome group and the healthy group reached 0.904,with an area under ROC curve(AUC)of 0.91;the accuracy of pattern recognition between the CAG non-yin deficiency syndrome group and the healthy group reached 0.885,AUC=0.89;the accuracy of pattern recognition between the CAG yin deficiency syndrome group and the CAG non-yin deficiency syndrome group reached 0.747,AUC=0.75.② Species composition:At the genus level,compared with the healthy group,the abundance of Actinomyces,Escherichia-Shigella and Tyzzerella in the CAG yin deficiency syndrome group increased(P<0.05),while the abundance of Prevotella,Sutterella and Subdoligranulum decreased(P<0.05);the abundance of[Ruminococcus]_gnavus_group and Escherichia-Shigella in the CAG non-yin deficiency syndrome group increased significantly(P<0.01),while the abundance of Prevotella and Subdoligranulum decreased(P<0.05).Compared with the CAG yin deficiency syndrome group,the non-yin deficiency syndrome group showed significant enrichment of the Dialister(P<0.05).③ Correlation analysis between odor spectrum characteristics and gut microbiota in CAG yin deficiency syndrome:This study identified 17 bacterial genera that showed positive and negative correlations with the amplitude and slope characteristics of the odor spectrum in CAG yin deficiency syndrome,namely Lachnospiraceae_NK4A136_group,Lachnospiraceae_ND3007_group,Faecalibacterium,UCG-002,UCG-005,Coprococcus,CAG-352,Parabacteroides,Actinomyces,Streptococcus,Anaerostipes,Blautia,Dorea,[Eubacterium]_hallii_group,Phascolarctobacterium,Clostridium_sensu_stricto_1,Enterobacter.The above-mentioned bacterial genera could be classified into the following bacterial families:Trichomonas,Clostridia,Porphyromonas,Actinobacteria,Ruminococcus,Streptococcus,Bacteroidetes,Clostridium,Veillonellaceae and Enterobacteriaceae.Conclusion The use of electronic nose technology can accurately identify the oral exhaled odor of patients with CAG yin deficiency syndrome,CAG non-yin deficiency syndrome,and healthy individuals;the odor spectrum characteristics of patients with CAG yin deficiency syndrome are correlated with multiple bacterial genera,and the changes in related metabolites and gases produced by the disruption of their gut microbiota may be one of the biological bases for the changes in oral exhaled odor in CAG yin deficiency syndrome.
8.Evaluating the relationship between glucose metabolic status and neonatal weight by using regression discontinuity analysis
Ran ZHANG ; Shanshan HOU ; Junfeng MA ; Ying MENG ; Mingyuan JIAO
Chinese Journal of Clinical Laboratory Science 2025;43(8):591-595
Objective To explore relationship between glucose metabolism and neonatal weight in high-risk gestational diabetes melli-tus(GDM).Method A retrospective study was conducted on 779 pregnant women who underwent prenatal examinations at Tongzhou Maternity and Child Health Care Hospital in Beijing from March to June 2022.The data on pre-pregnancy weight,mid-and late-preg-nancy glycated albumin(GA)and glycated hemoglobin(HbA1c),pre-delivery weight,gestational weight gain,and neonatal birth weight were collected.A GDM risk assessment model was established using multivariate logistic regression to classify pregnant women into high-risk and low-risk groups for GDM,followed by separate management strategies.Regression discontinuity(RD)analysis was applied to evaluate the relationship between gestational glucose metabolism status and neonatal birth weight.Results Among the 779 pregnant women,the overall incidence of macrosomia was 7.32%.The high-risk GDM group exhibited significantly higher pre-pregnan-cy weight,late-pregnancy HbA1c,and GA levels compared to the low-risk group(all P<0.001).Neonatal birth weight in the high-risk group was significantly higher than that in the low-risk group(P<0.05),with a significantly increased macrosomia incidence(13.55%vs 5.77%,P<0.05).RD analysis revealed a jump reduction of 199.59 g(P=0.029)in neonatal birth weight at the risk score thresh-old.Conclusion Lifestyle glucose metabolism management in high-risk GDM pregnant women may effectively reduce neonatal birth weight,mitigated the trend of excessive gestational weight gain,and improved late-pregnancy HbA1c and GA levels,providing evi-dence-based support for maternal and child health services.
9.Effect of overweight/obesity on female ART outcomes and its mechanisms
Siru HOU ; Shanshan WU ; Siwen ZHANG ; Shan GAO ; Jichun TAN
Chinese Journal of Reproduction and Contraception 2025;45(6):632-636
In recent years, the incidence of infertility has been steadily increasing. Obesity, recognized as a chronic inflammatory condition, can not only lead to various chronic diseases such as hypertension and diabetes, but also adversely affects female reproductive health,including rare ovulation, anovulation, menstrual irregularities, and even infertility. The reproductive outcomes of overweight/obese women are not optimistic even among people undergoing assisted reproductive technology (ART).However, the mechanisms of overweight and obesity on ART outcomes remain poorly understood. This review aims to summarize current evidence on the impact of overweight and obesity on ART outcomes in women and explore the potential mechanisms.
10.Development of a Preoperative Risk Scoring System for Heart Transplantation Based on Characteristics of the Chinese Population
Shanshan ZHENG ; Zhe ZHENG ; Jie HUANG ; Zhongkai LIAO ; Jianfeng HOU ; Hanwei TANG ; Sheng LIU
Chinese Circulation Journal 2025;40(4):331-339
Objectives:Using data from the heart transplant patient dataset of our center,we aimed to develop a preoperative risk scoring model specifically suitable for the Chinese population undergoing heart transplantation.This model was established to predict the likelihood of graft failure within the first year post-surgery and classify recipients according to their risk level.Methods:A retrospective study was conducted at a single center on 1 210 consecutive heart transplant recipients between June 2004 and December 2022.Risk factor screening was performed using univariate and multivariate logistic regression analyses.Variable selection was carried out through a stepwise backward procedure based on the Akaike Information Criterion(AIC).The regression coefficients obtained from the final model were employed as weighting factors in the multifactor analysis.The study utilized the area under the receiver operating characteristic(ROC)area under curve(AUC)as a metric to evaluate the performance of the model.Patients were stratified into low,medium,and high-risk groups based on the distribution of the calculated scores.Survival analysis was conducted on the various risk groups using the Kaplan-Meier method,with statistical comparisons performed using the log-rank test.A significance level of P<0.05 was deemed statistically significant.Results:A risk scoring model,denoted as the heart transplant(HTx)score,was developed,comprising 11 variables and yielding a total score of 20.6 points.In comparison to the low-risk group,the OR for 1-year graft failure in the medium-risk group was 2.0(95%CI:1.1-3.6,P=0.02),while the high-risk group had an OR of 9.8(95%CI:5.4-17.7,P<0.01).The risk scoring model exhibited strong discriminative ability with an AUC of 0.712(95%CI:0.646-0.778)and an internally validated bias-corrected AUC of 0.713.The results of the Hosmer-Lemeshow goodness-of-fit test indicated that the predictive model demonstrated a strong calibration ability(Hosmer-Lemeshow χ2=2.92,P=0.71).Within the cohort,the AUC values for the IMPACT score,UNOS score,RSS score,Mayo score,BO score,and TRS score models were 0.645,0.651,0.632,0.589,0.610,and 0.604,respectively.These findings suggest that the HTx scoring model exhibited superior predictive performance compared to the aforementioned models in forecasting outcomes within our cohort.The Kaplan-Meier survival analysis revealed statistically significant differences in long-term survival rates between the three risk groups,a noticeable decrease in long-term survival rates were observed with increasing levels of HTx risk stratification(P<0.05).Conclusions:Present results indicate a significant association between the developed HTx risk scores and graft failure within the initial year post-surgery,present model effectively categorizes the heart transplant recipients into low,medium,and high-risk groups and is valuable for risk stratification.

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