1.Prognostic significance of TRIM28 elevation in non-M3 acute myeloid leukemia
Siqi GONG ; Cong LI ; Mengmeng FAN ; Huiping WANG ; Wanqiu ZHANG ; Xue LIANG ; Qianshan TAO ; Qiang HONG ; Zhimin ZHAI
Acta Universitatis Medicinalis Anhui 2026;61(2):301-308
ObjectiveTo clarify the expression of TRIM28 in non-M3 acute myeloid leukemia (AML) and its correlation with clinical indicators and prognosis, and to further explore the effect of TRIM28 expression levels on the proliferation and apoptosis of AML cells using small interfering RNA. MethodsThe GSE34577 dataset was analyzed using R software to compare TRIM28 expression between healthy controls and non-M3 acute myeloid leukemia (AML) patients. Clinical samples from non-M3 AML patients were collected, with TRIM28 expression levels measured using real-time quantitative PCR (qPCR). The analysis focused on correlations between TRIM28 expression and various clinical indicators, treatment efficacy, and patient prognosis. Furthermore, small interfering RNA (siRNA) technology was employed to downregulate TRIM28 expression in human primary AML cells (HL60 cell line). The effects on cell proliferation and apoptosis were then assessed through CCK-8 assays and flow cytometry, respectively. ResultsThe results showed that TRIM28 was up-regulated in non-M3 AML of both online database GSE34577 and clinical samples (P<0.000 1), TRIM28 expression of new diagnosis group and relapsed refractory group was higher than iron deficiency anemia group (P<0.01), and there was no significance between different French-American-British classification systems subtype. TRIM28 expression was higher in non-M3 AML patients with a poor genetic prognosis stratified as moderate than in the good prognosis group, and TRIM28 expression was associated with NPM1 combined with the FLT3-ITD mutation, positively correlated with age, bone marrow blast, peripheral blood blast and white blood cell, negatively correlated with hemoglobin. In addition, interference TRIM28 greatly inhibited cell proliferation and promoted cell apoptosis. ConclusionThis study reveals that TRIM28 is highly expressed in non-M3 AML and associated with prognosis, and plays a key role in the proliferation and apoptosis of AML cells, suggesting that TRIM28 may serve as a novel therapeutic target for non-M3 AML.
2.A real-time process monitoring scheme for blood center NAT using the median of internal control CT value
Yuntao XU ; Jiaqiang ZHU ; Zuomei YIN ; Li MU ; Huiping ZHANG ; Xingfeng ZHANG ; Lijing QIAO
Chinese Journal of Blood Transfusion 2026;39(3):391-396
Objective: To establish a real-time quality control scheme based on the median (MD-IC) of internal control cycle threshold value in negative samples (NEG-IC-CT), so as to monitor anomalies such as progressive drift in nucleic acid testing system not covered by conventional internal quality control (IQC) in blood center nucleic acid laboratories, and to verify its feasibility. Methods: The internal control CT values of 54 426 negative samples were retrospectively collected. These samples were from four reagent batches of the two new and old equipment sets during the operation of the Wantai nucleic acid testing system in our blood center. The daily median of NEG-IC-CT values was used as the research indicator. Control limits were calculated using median absolute deviation (MAD) to construct the Median-MAD quality control chart. The monitoring performance of this scheme for the operation status of the testing system was simultaneously evaluated. Results: Statistical analysis showed significant differences in NEG-IC-CT value distribution between the new and old equipment sets, as well as between the two different reagent batches of the old equipment (P<0.000 1). The NEG-IC-CT value performance of the two different reagent batches of the new equipment was no significant difference in distribution (P>0.05). This scheme identified three typies of distinct anomalies. The out-of-control events observed with the old equipment in both the O1 and O2 reagent batches suggested potential performance decay due to equipment aging. The unreported change of reagent batch in time of Phase B with new equipment caused a stepwise drift on the quality control chart. In the later stage of Phase A with the new equipment, an alert was triggered, indicating potential quality risks associated with practices such as the mixed use of the remaining reagents and extremely long operator working hours. Conclusion: The realtime quality control scheme based on NEG-IC-CT value established in this study has been preliminarily validated for its monitoring effectiveness in nucleic acid testing in our blood center. This scheme performed well in detecting differences among testing systems and reagent batches, serving as an effective supplement to routine internal quality control. It can provide an intuitive and effective evaluation method for monitoring the performance of the nucleic acid testing process at blood center.
3.Therapeutic effect and mechanism of modified Chaihu Shugan Powder on a mouse model of gallbladder cholesterol stone with liver depression syndrome
Zhaoyan LI ; Heying WANG ; Renjie LIANG ; Yichun WANG ; Huiping CHEN ; Li MIN
Journal of Clinical Hepatology 2026;42(2):387-399
ObjectiveTo investigate the mechanism of action of modified Chaihu Shugan Powder in the treatment of abnormal gallbladder relaxation in gallbladder cholesterol stone (CS) with liver depression syndrome, and to provide a basis for clinical medication. MethodsMice were given a high-fat lithogenic diet combined with chronic unpredictable mild stress (CUMS) to establish a model of CS. A total of 45 male C57BL/6 mice were randomly divided into blank group (6 mice fed a normal diet) and CS group (39 mice fed a high-fat lithogenic diet). After CS modeling, the CS group was further randomly divided into four subgroups of CS group, CS liver depression group, traditional Chinese medicine group (treated with modified Chaihu Shugan Powder), and Western medicine group (treated with ursodeoxycholic acid), with 9 mice in each group. All subgroups were fed with the high-fat lithogenic diet, and all mice except those in the CS group were given 21 days of CUMS for modeling. Samples were collected after intervention. The serum levels of cholecystokinin (CCK), liver function parameters, and blood lipid profiles were measured; HE staining was performed for liver and gallbladder tissue; qPCR and Western blot were used to measure the mRNA and protein expression levels of G protein-coupled bile acid receptor 1 (TGR5) and glucagon-likepeptide-1/2 (GLP-1/2) in the intestine and TGR5 and glucagon-like peptide-2 receptor (GLP-2R) in gallbladder; metabolomics methods were used to determine bile acid composition in intestinal contents. The independent-samples t-test was used for comparison of continuous data between two groups; a one-way analysis of variance was used for comparison between multiple groups, and the least significant difference t-test or the Games-Howell method was used for further comparison between two groups. ResultsCompared with the blank group, the CS group showed significant gallstone formation, bile turbidity, hepatic steatosis, abnormal gallbladder wall structure, and significant increases in anxiety- and depression-like behaviors based on behavioral tests; significant increases in the level of total cholesterol in bile and the serum levels of alanine aminotransferase, aspartate aminotransferase, and low-density lipoprotein and significant reductions in the level of total bile acid (TBA) in bile and the serum levels of CCK and high-density lipoprotein (HDL) (all P<0.05); significant increases in the mRNA expression levels of GLP-1/2 and TGR5 in the intestine and the protein expression levels of GLP-2R and TGR5 in the gallbladder and significant reductions in the mRNA expression levels of GLP-2R and TGR5 in the gallbladder (all P<0.05); significant changes in multiple bile acid components in intestinal contents (all P<0.05). Compared with the CS group, the CS liver depression group had further aggravation of pathological and behavioral manifestations, changes in bile acid composition, significant increases in the protein and mRNA expression levels of TGR5 and GLP-1/2 in the intestine, and significant increases in the protein and mRNA expression levels of TGR5 and GLP-2R in the gallbladder (all P<0.01). Compared with the CS liver depression group, both treatment groups had an improvement in gallbladder morphology, alleviation of stones and liver injury, and recovery of liver function and blood lipid levels, as well as significant reductions in the protein and mRNA expression levels of TGR5 and GLP-1/2 in the intestine and TGR5 and GLP-2R in the gallbladder (all P<0.05); the traditional Chinese medicine group showed significant increases in glycodeoxycholic acid (GDCA), tauro-α-muricholic acid (T-α-MCA), and taurochenodeoxycholic acid (TCDCA) (all P<0.05), while the Western medicine group showed significant increases in taurohyodeoxycholic acid, T-α-MCA, TCDCA, GDCA, and glycoursodeoxycholic acid (all P<0.05). Compared with the Western medicine group, the traditional Chinese medicine group had significantly greater behavioral improvements, significantly higher levels of TBA in bile and serum HDL (both P<0.01), significant reductions in the protein expression levels of TGR5 and GLP-1/2 in the intestine and TGR5 and GLP-2R in the gallbladder, and a significant reduction in the mRNA expression level of TGR5 in the intestine (all P<0.01), as well as a significant increase in tauroursodeoxycholic acid and significant reductions in glycoursodeoxycholic acid, taurohyodeoxycholic acid, TCDCA, and taurolithocholic acid (all P<0.05). ConclusionModified Chaihu Shugan Powder can improve liver function and abnormal gallbladder relaxation in CS with liver depression syndrome by regulating the bile acid-TGR5 axis, thereby exerting the therapeutic effect of soothing the liver, resolving depression, moving Qi, and promoting bile flow.
4.Exploration of ethical issues in the multiple disciplinary team model for children with 46, XY disorders of sex development
Lili PAN ; Zhe SU ; Wei SU ; Ying ZU ; Chenxi LI ; Huiping SU ; Jingyu YOU ; Kexin JIN ; Rongfei ZHENG
Chinese Medical Ethics 2026;39(6):718-723
ObjectiveTo explore the ethical issues and coping strategies in the diagnosis and treatment of 46, XY disorders of sex development (46, XY DSD) under a multidisciplinary team (MDT) model, and to deepen the understanding of relevant ethical issues while accumulating experience. MethodsA retrospective collection was conducted on the data of children with 46, XY disorders of sex development under a single-center MDT model from January 2017 to December 2024, and the ethical issues involved in the diagnosis and treatment process were analyzed. ResultsA total of 24 MDT discussion documents involving 20 children were collected, including 17 with female social gender and 3 with male social gender. The age ranged from 0.5 to 15.8 years, with children under 8 years accounting for 75%. The ethical issues primarily involved how to ensure adequate informed consent, whether surgery was necessary and its timing, and whether gender selection is reasonable and its timing. Among the 10 children raised as females who completed the gender role psychological scale assessment, 5 demonstrated masculine tendencies, all of whom had pathogenic genetic variants. Furthermore, only 1 patient changed the social gender to male. ConclusionThe diagnosis and treatment of 46, XY DSD is relatively complex, requiring multidisciplinary collaboration. This process involves numerous ethical issues and necessitates adhering to medical ethical principles. Ensuring adequate informed consent is crucial, especially for younger children. The surgery and its timing selection must adhere to the principles of beneficence, non-maleficence, and leaving room for the future. Gender selection constitutes a focus and challenge in diagnosis and treatment. Psychological scales and genetic etiologies are conducive to judgments regarding gender selection, yet multiple factors in the real world may interfere with the gender selection.
5.Childhood trauma and non-suicidal self-injury behavior among hospitalized adolescents: the mediating role of emotional dysregulation and the moderating role of social anxiety
Qiuling HUANG ; Hanqin DING ; Cailan HOU ; Wanqi OU ; Shibin WANG ; Huiping LI
Sichuan Mental Health 2026;39(3):220-226
BackgroundNon-suicidal self-injury (NSSI) behavior has become a global public health concern affecting the physical and mental health of adolescents. The experiential avoidance model posits that childhood trauma contributes to NSSI behavior through the mediating pathway of emotional dysregulation. However, existing research has predominantly focused on isolated psychological or social factors, with limited attention to their interactive effects of emotional dysregulation and social anxiety, both of which fall within the psychosocial domain. ObjectiveTo examine the relationship between childhood trauma and NSSI among adolescents, and to analyze the mediating role of emotional dysregulation and the moderating role of social anxiety, so as to provide evidence for targeted interventions for NSSI behavior of adolescents. MethodsA total of 282 adolescent inpatients who consecutively admitted to the Department of Psychiatry of Guangdong Provincial People's Hospital from March to December 2025 and met the Diagnostic and Statistical Manual of Mental Disorders,fifth edition(DSM-5)criteria for NSSI were enrolled as study participants. Participants were assessed using the general information questionnaire, the Adolescent Self-Harm Questionnaire, the Childhood Trauma Questionnaire (CTQ), the Difficulties in Emotion Regulation Scale (DERS), and the Social Anxiety Scale for Adolescents (SAS-A). Pearson correlation analysis was used to examine correlations among scale scores. model 4 and model 58 of the Process 4.1 were used to test the mediating effect of emotional dysregulation and the moderating effect of social anxiety, respectively. ResultsCTQ score was positively associated with score of the Adolescent Self-Injury Questionnaire (r=0.279, P<0.01). Emotional dysregulation significantly partially mediated the relationship between childhood trauma and NSSI behavior, with a mediating effect of 0.112 (95% CI: 0.043–0.208), accounting for 40.14% of the total effect. Social anxiety moderated the association between childhood trauma and emotional dysregulation,the effect value was 0.102 (95% CI: 0.008–0.196), as well as the relationship between emotional dysregulation and NSSI behavior, the effect value was 0.130 (95% CI: 0.033–0.226). ConclusionEmotional dysregulation may mediate the relationship between childhood trauma and NSSI behavior among hospitalized adolescents, while social anxiety moderates both the first and second paths of this mediating process. [Funded by Guangdong Medical Science and Technology Research Fund Project (number, A2022538)]
6.Research progress on biosynthesis, content determination and biological activity of volatile oil components in Perillae folium
Huiping LI ; Lu CHEN ; Qijin ZHANG ; Baokang HUANG
Journal of Pharmaceutical Practice and Service 2026;44(8):395-399
Perilla leaf volatile oil is rich in monoterpenes, aromatic compounds, and other active constituents, with perillaldehyde as its characteristic marker, exhibiting a wide range of pharmacological activities including antibacterial, anti-inflammatory, and antitumor effects. In recent years, systematic studies have been conducted on its chemical composition and pharmacodynamic basis. The methods for content determination have become increasingly sophisticated, with gas chromatography-mass spectrometry (GC-MS) and other techniques being widely applied for comparative analysis of samples from different sources; however, the results are influenced by multiple factors such as germplasm variation, growth stage, and extraction process. Regarding the biosynthetic pathway, key enzyme genes involved in the mevalonate and shikimate pathways are being progressively elucidated. In terms of bioactivity, in vivo and in vitro experiments have confirmed that its volatile oil components exert synergistic effects through multi-target mechanisms, with applications extended to food preservation, flavor and fragrance industry, and pharmaceutical field. The research progress on the biosynthesis, content determination, and bioactivities of volatile oil components from perilla leaves was reviewed, aiming to further clarify the active material basis and mechanisms of action, and to provide a reference for more in-depth exploration and utilization of the medicinal and edible value of Perilla frutescens.
7.Experience of Using Charcoal-Processed Traditional Chinese Medicine in the Treatment of Gynecological Hemorrhagic Disorders
Xiaolan WU ; Zhaoling YOU ; Guiyun WANG ; Kailing WANG ; Xiaojuan YE ; Lingyu LIAO ; Yueheng LI ; Huiping LIU
Journal of Traditional Chinese Medicine 2025;66(3):308-311
Charcoal-processed traditional Chinese herbal medicine has various therapeutic effects, including astringing, hemostasis, anti-diarrhea, clearing heat, tonifying, and warming the interior. This paper summarizes the clinical application features, compatible experiences, dosages, and precautions for over 20 types of charcoal-processed herbal medicine in the treatment of gynecological bleeding disorders caused by dysfunctions such as dysfunctional uterine bleeding, endometriosis, uterine incision pseudocavity, and vaginal bleeding resulting from threatened miscarriage. The charcoal-processed herbal medicine include Huangqin (Scutellaria Baicalensis) Charcoal, Dahuang (Rheum Palmatum) Charcoal, Cebai (Platycladus Orientalis) Charcoal, Diyu (Sanguisorba Officinalis) Charcoal, Daji (Cirsium Setosum) Charcoal, Xiaoji (Cirsium Japonicum) Charcoal, Shengdi (Rehmannia Glutinosa) Charcoal, Aiye (Artemisia Argyi) Charcoal, Paojiang (Zingiber Officinale) Charcoal, Xuduan (Dipsacus Asper) Charcoal, Duzhong (Eucommia Ulmoides) Charcoal, Qiancao (Rubia Cordifolia) Charcoal, Puhuang (Typha Angustifolia) Charcoal, Shanzha (Crataegus Pinnatifida) Charcoal, Jingjie (Schizonepeta Tenuifolia) Charcoal, Xueyu (Carthamus Tinctorius) Charcoal, Zonglyu (Areca Catechu) Charcoal, Wumei (Prunus Mume) Charcoal, Shudahuang (Rheum Officinale) Charcoal, Lianfang (Nymphaea Alba) Charcoal, Mianmaguanzhong (Clematis Armandii) Charcoal, and Oujie (Nelumbo Nucifera) Charcoal.
8.Distribution and drug resistance of multidrug-resistant organisms in newborns in a three-A children's hospital from 2019 to 2023
Hongyan WU ; Chunai ZHANG ; Jun WANG ; Huiping LIU ; Qin WANG ; Ling ZHANG ; Nan GAO ; Xue LI ; Liyuan FU ; Yun YANG ; Yanjie WANG ; Huayu HAN
Chinese Journal of Nosocomiology 2025;35(16):2485-2489
OBJECTIVE To investigate the distribution and drug resistance of multidrug-resistant bacteria in the neonatal intensive care unit of a three-A children's hospital in Henan Province,and to provide reference for ational drug use in clinical practice.METHODS Clinical specimens from hospitalized newborns in neonatal intensive care unit from a three-A children's hospital from Jan.1,2019 to Dec.31,2023 were subjected to etiological exam-ination and drug sensitivity test,and to analyze the distribution and drug resistance of multidrug-resistant bacteri-a in hospitalized newborns.RESULTS During the 5-year period,1139 strains of multidrug-resistant bacteria were i-solated,including 229 gram-positive bacteria(20.11%)and 910 gram-negative bacteria(79.89%).There were 92 strains of methicillin-resistant Staphylococcus aureus(MRSA)(accounting for 8.08%),57 strains(accounting for 5.00%)of methicillin-resistant coagulase-negative Staphylococcus epidermidis and 28 strains(accounting for 2.46%)of methicillin-resistant coagulase-negative human Staphylococcus.370 strains(accounting for 32.48)of carbapenem-resistant Klebsiella pneumoniae(CRKP),268 strains(accounting for 23.53%)of extenspectrum β-lactamase-producing Escherichia coli and 85 strains(accounting for 7.46%)of K.pneumoniae,there were 767 sputum specimens(67.34%),160 blood specimens from peripheral intravenous puncture and central venous cath-eterization(PICC)(14.05%),63 bronchoalveolar lavage fluid specimens(5.53%),29 secretion specimens(eye and wound secretions)(2.54%),and 120 other specimens(10.54%).K.pneumoniae and E.coli producing su-per-broad spectrum β-lactamase,CRKP and MRSA were the main drug-resistant bacteria.CONCLUSION The sit-uation of drug resistance in neonatal intensive care unit is serious,therefore monitoring bacterial resistance should be strengthened according to the clinical laboratory results,and antibiotics should be applied rationally.
9.A Single-Center Study on the Current Therapeutic Status and Influencing Factors of Rhythm Control versus Rate Control in Elderly Patients with Atrial Fibrillation
Peng LI ; Xue YU ; Junpeng LIU ; Ke CHAI ; Yao JIA ; Xue LI ; Chen SUN ; Huiping ZHANG ; Lei QIU ; Dahai HUANG
Chinese Journal of Geriatrics 2025;44(8):1048-1055
Objective:To explore the current therapeutic status of rhythm control versus rate control in elderly patients with atrial fibrillation(AF)and the related factors that may influence treatment decisions.Methods:A retrospective study was conducted on AF patients aged ≥75 years old who were hospitalized in the Healthcare Department of Beijing Hospital from January 2010 to May 2020.The patients were grouped and compared according to whether they underwent rhythm control or rate control.Multivariate logistic regression analysis was used to investigate the factors that may influence the treatment decision of rhythm control or rate control.Results:A total of 167 patients was included, with a median age of 90 years old.Among them, 21 patients(12.6%)received rhythm control, and 109 patients(65.3%)received rate control.Compared with the group not receiving rhythm control, the rhythm control group had a younger age, higher BMI, higher diastolic blood pressure, a higher proportion of multiple medication use, a lower proportion of chronic kidney disease stage 3 or above, and higher hemoglobin levels(all P<0.05). Compared with the group not receiving rate control, the rate control group had a lower proportion of paroxysmal AF, a faster resting ventricular rate, a higher proportion of smoking history, a higher proportion of multiple medication use, coronary heart disease, pacemaker treatment, chronic obstructive pulmonary disease and/or asthma, and a lower proportion of cognitive impairment(all P<0.05). Multivariate logistic regression analysis revealed that multiple drug use( OR=11.578, 95% CI: 1.341-99.993, P=0.026)was positively associated with rhythm control therapy, while chronic kidney disease stage 3 or above( OR=0.248, 95% CI: 0.063-0.968, P=0.045)was negatively associated with rhythm control therapy.For rate control therapy, multiple drug use( OR=5.056, 95% CI: 2.253-11.347, P<0.001), resting ventricular rate( OR =1.033, 95% CI: 1.005-1.062, P=0.021), and chronic obstructive pulmonary disease(COPD)and/or asthma( OR=2.739, 95% CI: 1.124-6.672, P=0.027)showed positive associations. Conclusions:The application rate of rhythm control therapy is low in elderly AF patients, and ventricular rate control is the main treatment.Complex clinical conditions are the main constraints, and it is urgent to optimize individualized strategies based on prospective studies and develop new treatment techniques to improve clinical practice.
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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