1.Characterization and Application of Moisture Absorption Kinetics of Traditional Chinese Medicines Based on Double Exponential Model:A Review
Yanting YU ; Lei XIONG ; Yan HE ; Wei LIU ; Jing YANG ; Yao ZHANG ; Jiali CHEN ; Xiaojian LUO ; Xiaoyong RAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(5):340-346
Hygroscopicity research has long been a key focus and hot topic in Chinese materia medica(CMM). Elucidating hygroscopic mechanisms plays a vital role in formulation design, process optimization, and storage condition selection. Hygroscopic models serve as essential tools for characterizing CMM hygroscopic mechanisms, with various types available. The double exponential model is a kinetic mathematical model constructed based on the law of conservation of energy and Fick's first law of diffusion, tailored to the physical properties of CMM extracts. In recent years, this model has been extensively applied to simulate the dynamic moisture absorption behavior of CMM extracts and solid dosage forms under varying humidity conditions. It has revealed the correlation between moisture absorption kinetic parameters and material properties, offering a new perspective for characterizing the moisture uptake behavior of CMM. This paper systematically reviews the application progress of this model in the field of CMM, analyzes its advantages, disadvantages, and challenges in this domain, and explores its potential application trends in other fields. It aims to provide references for elucidating the moisture absorption mechanisms of CMM and researching moisture-proofing technologies, while also offering insights for its broader application in food and polymer materials.
2.Huaier Enhances Efficacy of Oxaliplatin in Treatment of Gastric Cancer by Improving Gut Microbiota
Shenglian ZHANG ; Zhimin DU ; Yi GONG ; Meiqi LAN ; Ping LIU ; Yajun XIONG ; Yanli GONG ; Xiaoyong SONG ; Junli LI ; Ruizhi WANG ; Yuting GAO ; Huanhu ZHANG ; Xinli SHI
Cancer Research on Prevention and Treatment 2026;53(3):176-186
Objective To elucidate the changes in the gut microbiota and molecular mechanism of huaier in
3.Clinical characteristics and influencing factors of extraglandular invasion of prostatic ductal adenocarcinoma.
Xiaoyong YANG ; Fan ZHANG ; Lulin MA ; Cheng LIU
Journal of Peking University(Health Sciences) 2025;57(5):956-960
OBJECTIVE:
To explore the differences in perioperative clinical and pathological characteristics of patients with different pathological types of prostate cancer undergoing radical prostatectomy, and to analyze the influencing factors that may affect the extraglandular invasion of ductal adenocarcinoma of the prostate.
METHODS:
Retrospective collection was made of the radical prostatectomy patients who were admitted to Peking University Third Hospital from December 2011 to April 2021. The patients were screened based on inclusion criteria to obtain basic clinical features and postoperative pathological results. According to the pathological results, the patients were divided into ductal adenocarcinoma group (mixed with ductal adenocarcinoma) and acinar adenocarcinoma group, and a 1 ∶1 propensity score matching was performed to compare the differences in clinical characteristics between the two groups. Univariate and multivariate analyses of the factors related to extraglandular invasion were performed in the matched ductal adenocarcinoma groups.
RESULTS:
A total of 764 patients with prostate cancer were enrolled in this study, of which 62 patients were confirmed to have ductal adenocarcinoma components by postoperative pathology. There was a statistically significant difference in the proportion of the patients with a history of diabetes in baseline characteristics between the two groups before propensity score matching (29.5% vs. 17.7%, P=0.027). A total of 61 patients with simple acinar adenocarcinoma were successfully matched with the patients with ductal adenocarcinoma, and there was no statistically significant difference in baseline characteristics between the two groups after matching (P>0.05). The comparison of perioperative clinical and pathological features showed that International Society of Urology Pathology (ISUP) grade (P=0.003), pT stage (P=0.004), extraglandular invasion rate (P=0.018) and vascular thrombus rate (P=0.019) in ductal adenocarcinoma group were significantly higher than those in simple acinous adenocarcinoma group. Univariate analysis of the influence factors of extraglandular invasion showed that prostate-specific antigen (PSA) level, prostate volume, ISUP grade, seminal vesicle invasion and perineural invasion might be the influencing factors of extraglandular invasion (P < 0.10). Binary Logistic regression analysis showed that perineural invasion was an independent factor of extraglandular invasion (OR=11.78, 95%CI: 1.97-70.56, P=0.007).
CONCLUSION
Prostatic ductal adenocarcinoma has a worse prognosis than simple acinar adenocarcinoma. Perineural invasion is the influencing factor of extraglandular invasion of ductal adenocarcinoma.
Humans
;
Male
;
Prostatic Neoplasms/surgery*
;
Retrospective Studies
;
Prostatectomy
;
Neoplasm Invasiveness
;
Middle Aged
;
Aged
;
Carcinoma, Ductal/surgery*
;
Propensity Score
;
Adenocarcinoma/surgery*
4.Applicability of modified comprehensive interventions in the treatment of non-severe dry eye syndrome in military pilots
Chengcheng HU ; Yong JIA ; Xiaoyong CAO ; Lu LI ; Mengke LIU ; Yajun YI ; Xiao ZHANG ; Zhiyan SUN
Chinese Journal of Aerospace Medicine 2025;36(2):141-145
Objective:To explore the applicability of modified comprehensive interventions in the treatment of non-severe dry eye syndrome in military pilots.Methods:A total of 88 military pilots with non-severe dry eye syndrome admitted to the Special Service Department of the 988th Hospital of the Joint Logistic Support Force between December 2021 and December 2023 were divided into an intervention group and a control group using the random number table method, with 44 cases in each. The intervention group received modified comprehensive interventions, while the control group underwent conventional treatment. The Ocular Surface Disease Index (OSDI), break-up time, tear meniscus height, changes in meibomian gland function, and levels of satisfaction of military pilots were compared between the 2 groups. The correlations between the OSDI, break-up time, tear meniscus height and levels of satisfaction were analyzed.Results:Before treatment, there was no significant difference in the OSDI between the 2 groups ( P>0.05). After 4 weeks of treatment, the changes in the OSDI of military pilots were smaller in the intervention group than in the control group ( t=3.21, P=0.002). After 2 and 4 weeks of treatment, the break-up time (both P<0.001) and tear meniscus height ( P<0.001, =0.012) of pilots in the intervention group exceeded those of the control group. In both groups, the break-up time (all P<0.001) and tear meniscus height (all P<0.001) kept increasing after treatment. After 4 weeks of treatment, there were significant differences in the distribution of meibomian gland function between the 2 groups ( Z=-2.55, -2.41, -2.29, P=0.011, 0.016, 0.022). Clinical care, procedure flow, and health education scored higher in the intervention group than in the control group during the survey on levels of satisfaction with the treatment ( t=6.55, 6.77, 3.63, all P≤0.001). The OSDI was negatively correlated with clinical care, procedure flow and health education ( r=-0.286, -0.275, -0.363, P=0.007, 0.010, 0.001) while the break-up time was positively correlated with clinical care and procedure flow ( r=0.248, 0.278, P=0.020, 0.009). Conclusions:The implementation of modified comprehensive intervention measures for dry eye syndrome in military pilots can effectively improve clinical symptoms and leave military pilots more satisfied.
5.Inhibiting mitochondrial fission protects multiple organ functions in rats with concomitant explosive blast injury and hemorrhagic shock by improving microcirculation and vascular permeability
Yu ZHU ; Qinghui LI ; Yue WU ; Xiaoyong PENG ; Xingnan OUYANG ; Jie ZHANG ; Liangming LIU ; Tao LI
Journal of Army Medical University 2025;47(21):2581-2590
Objective To investigate the protective effect of mitochondrial fission inhibitor 1(Mdivi-1),on organ function in rats with explosive blast injury combined with hemorrhagic shock.Methods A total of 192 SD rats(half male and half female,12 weeks old,weighing about 220 g)were randomly divided into 6 groups:Sham group(only surgical incision along the midline of the abdomen),model group(ESH group,thermal radiation and shock wave injury followed by femoral artery hemorrhage),lactated Ringer's solution resuscitation group(ESH+LR group,LR solution infusion in the femoral vein for resuscitation),and low-,middle-and high-dose Mdivi-1 groups(0.1,0.5 and 1.0 mg/kg Mdivi-1 intervention after infusion of LR solution).Fluorescent protein tracing was used to determine the leakage amount of fluorescent protein in the lung and kidney tissues to evaluate the vascular permeability.Evans blue dye staining was employed to observe the intestinal permeability and pulmonary vascular permeability.Laser Doppler flowmetry was applied to monitor the tissue blood perfusion in the liver,kidneys,and intestine.Serum levels of cardiac injury marker troponin I(TNI),liver function markers aspartate aminotransferase(AST)and alanine aminotransferase(ALT),and renal function markers serum creatinine(Scr)and blood urea nitrogen(BUN)were detected to evaluate the functions of corresponding organs.The water contents of the lungs and brain were calculated by measuring wet weight and dry weight of the lung and brain tissues.Blood pressure,heart rate,and respiratory rate were monitored.The survival time and 72-hour survival rate were recorded and calculated.Results Compared with the Sham group,the ESH group exhibited significantly increased vascular permeability in the lungs and kidneys as well as intestinal tissue(P<0.05),along with obviously elevated water contents in the lungs and brain(P<0.05),and decreased blood perfusion in the liver,kidneys,and intestine by 57.1%,39.2%,and 43.2%of the Sham group,respectively(P<0.05),elevated levels of TNI,AST,ALT,Scr and BUN(P<0.05),mean survival time of 3.8±1.1 h,and a 72-hour survival rate of 0(P<0.05).Although LR solution resuscitation reduced vascular permeability and alleviated organ injury in rats with explosive injury combined with hemorrhagic shock,there were no significant differences compared to the ESH group(P>0.05).Mdivi-1 treatment notably decreased vascular permeability in the lungs and kidneys and intestine,and water contents in the lungs and brain when compared with the LR group(P<0.05),with the dose of 0.5 mg/kg demonstrating the most significant effect.Additionally,Mdivi-1 treatment also significantly enhanced organ perfusion,improved organ functions,prolonged survival time,and increased survival rate.The 0.5 mg/kg treatment resulted in a 72-hour average survival time 55.64 h and a survival rate of 62.5%.Conclusion Mitochondrial fission inhibitor Mdivi-1 can reduce the permeabilities in the lungs,kidneys and intestine,improve tissue blood perfusion,protect the organ functions of the heart,liver and kidneys,and finally prolong survival time and increase survival rate in rats with concomitant explosive blast injury and hemorrhagic shock.
6.Analysis of two pedigrees with congenital hypodysfibrinogenemia caused by two compound heterozygous variations
Qiyu XU ; Xiaoyong ZHENG ; Fei XU ; Longying YE ; Ke ZHANG ; Mingshan WANG ; Lihong YANG
Chinese Journal of Clinical Laboratory Science 2025;43(2):92-97
Objective To analyse phenotype and genetic variation of two congenital hypodysfibrinogenemia(Fg)caused by compound heterozygous variants and preliminary investigate their molecular pathogenic mechanisms.Metheds The proband A and B and their family members(a total of 19 members in 3 generations)who visited the First Hospital of Wenzhou Medical University on 4 May 2023 and 20 May 2023 for"parkinson's disease"and"pre-bilateral eyelid excision"were enrolled for the study.Prothrombin time(TT)and fibrinogen(Fg)activity were measured by coagulation assay and Fg antigen(Fg∶Ag)was measured by immunoturbidimetric assay for the two family members,and Fg aggregation assay was catalysed using human thrombin.FGG gene was amplified by PCR and se-quenced directly.The variant sites were analysed using Chromas software.Multiple sequence comparison was performed by ClustalX-2.1-win software.Pathogenicity analysis of the variant sites was performed using bioinformatics software.The analysis for FGG protein model was performed using PyMOL software.Results Phenotypic results showed TT of proband A and B extended to 27.5 s and 26.1 s,and plasma Fg activity reduced to 0.6 g/L and<0.5 g/L,respectively.Genetic sequencing identified heterozygous c.1129+62_65delAATA on intron 8 of FGG gene in the both probands,resulting in the formation of aberrant amino acids at p.γGly377-Gly388 and an early ter-mination codon at p.γTyr389 site.A heterozygous missense variant c.103C>A(p.AαArg35Ser)was found in exon 2 of the FGA gene of proband A,and a heterozygous missense variant c.569A>G(p.BβAsn190Ser)was found in exon 4 of the FGB gene of proband B.Compared to the control group,the both probands showed significant decreases in peak and rate of Fg aggregation.Multiple sequence comparison analyses showed that all the three variant sites were conserved.Three bioinformatics software predicted both the missense variants were pathogenic.Protein modelling analysis showed that the number of hydrogen bonds in p.γGly377-Gly388 variant region was altered,resulting in steric hinderance.Conclusion All the two types of compound heterozygous variants,i.e.,c.1129+62_65delAATA and p.AαArg35Ser,c.1129+62_65delAATA and p.BβAsn190Ser,have been reported for the first time in Chi-na and worldwide to date,and the three variants may be related to the reduced Fg level and function in the two pedigree.
7.The mechanism of NOL6' effects on the progression of hypertension via mediating ribosome biogenesis to regulate endothelial cell dysfunction
Xiaoyong HU ; Zhaoying YANG ; Qianhua SONG ; Hongjian LI ; Zhongying LÜ ; Rui TANG ; Ying ZHANG
Journal of Xi'an Jiaotong University(Medical Sciences) 2025;46(4):641-649
Objective To explore the role of nucleolin 6(NOL6)in the occurrence and development of hypertension and its mechanism of regulating ribosome biogenesis.Methods Differentially expressed genes were screened based on the GEO database(chip GSE212338),and intersection analysis was conducted in combination with genes related to ribosome generation to obtain genes related to ribosome biogenesis in hypertension.The rats were divided into control group and model group(L-NAME group).The hypertensive rat model was induced by N-nitro-L-arginine methyl ester(L-NAME),and the thickness and pathological changes of the aortic wall in each group were observed by HE staining.The expression of ribosomal RNA(rRNA)in rat aortic tissues was detected by qPCR to reflect ribosome biogenesis,and the protein expression of NOL6 was detected by Western blotting.Human umbilical vein endothelial cells(HUVECs)were cultured and grouped for treatment(control group,L-NAME group,AngⅡ group,AngⅡ+si-NC group,AngⅡ+si-NOL6 group,and AngⅡ+CX-5461 group).The generation of neocRNA in HUVEC was detected by EU.The protein and mRNA expressions of NOL6 in HUVEC were detected by Western blotting and qPCR,respectively.Western blotting was used to detect the protein expressions of endothelial nitric oxide synthase(eNOS)and p-eNOS.Results By combining the differential expression analysis of the GEO hypertension dataset GSE212338 and the ribosome biogenesis gene set,six core genes with significantly altered expression in hypertension and related to ribosome biogenesis were identified.The difference in NOL6 was the most significant.Compared with the control group,the aortic wall thickness of rats in the L-NAME group increased significantly.Ribosomal RNA expression was significantly upregulated;the protein and mRNA expressions of NOL6 were significantly upregulated,too.Compared with the control group,the generation of neoRNA in the cells of the L-NAME group increased significantly;the levels of NOL6 protein and mRNA,ribosomal RNA and neoRNA in the Ang Ⅱ group were significantly increased compared with the control group but significantly decreased compared with the Ang Ⅱ+si-NC group.Compared with the Ang Ⅱ+si-NOL6 group,the protein and mRNA expressions of NOL6 in the AngⅡ+si-NC group and the AngⅡ+CX-5461 group cells were significantly increased.Compared with the AngⅡ+si-NC group,the levels of ribosomal RNA and neoRNA in the AngⅡ+si-NOL6 group and the AngⅡ+CX-5461 group were significantly decreased;the protein expressions of eNOS and p-eNOS were significantly increased.Conclusion NOL6 is associated with abnormal ribosome biogenesis in hypertension.NOL6 can affect the expression of eNOS by regulating ribosome biogenesis,thereby regulating the occurrence and development of hypertension.
8.Analysis of efficacy and prognostic factors of fractionated stereotactic radiotherapy (FSRT) for brain metastases in 52 breast cancer patients
Hu CHEN ; Yutong TAN ; Yasha MU ; Xiaoyong XIANG ; Yuexin YANG ; Lingling FENG ; Xiaoye SU ; Wenjue ZHANG ; Gang XU ; Jing JIN
Chinese Journal of Radiation Oncology 2025;34(3):256-264
Objective:To analyze the efficacy and prognostic factors of fractionated stereotactic radiotherapy (FSRT) for patients with breast cancer brain metastases (BCBM).Methods:Medical records and follow-up data of BCBM patients who underwent FSRT in Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center and Shenzhen People's Hospital from August 2019 to May 2023 were collected. The R Studio platform of the R version 4.2.1 statistical software was applied to analyze patients' baseline characteristics, 1- and 2-year local brain control (LBC), overall survival (OS) and distant brain control (DBC) and corresponding median failure-free survival, draw survival curve using Kaplan-Meier method. Prognostic factors were screened by univariate analysis and multivariate analysis (Cox regression).Results:Cumulatively, 52 patients (163 metastases in total) had a median survival follow-up of 22.1 months, 83% were<60 years old. Molecular typing: 13 cases (25%) were positive for human epidermal growth factor receptor 2 (HER2+) / hormone receptor negative (HR-), 2 cases (4%) were luminal A, 26 cases (50%) were luminal B, and 11 cases (21%) were triple negative. The median number of brain metastases was 2 (range: 1 - 17). Follow-up outcomes: the median OS was 34.0 months, with 1- and 2-year OS rates of 85.6% and 65.4%, respectively; the median LBC was 20.6 months, with 1- and 2-year LBC rates of 79.2% and 45.2%, respectively; and the median DBC was 10.3 months, with 1- and 2-year DBC rates of 46.7% and 28.9%, respectively. During follow-up, 13 patients underwent salvage local therapy (10 FSRT); 5 developed radiation necrosis (1 symptomatic). Prognostic factor analysis: absence of extracranial organ metastases (compared with ≥3) was a protective factor for OS, P<0.05. For LBC, fewer (1 - 2) extracranial organ metastases (compared with ≥3), and single brain metastasis (compared with ≥2) were favorable prognostic factors , while N 3 staging upon initial diagnosis was a poor prognostic factor (all P<0.05). For DBC, brain metastasis after surgery was a good prognostic factor, while complicated with lung metastasis and asymptomatic brain metastasis at the first diagnosis were poor prognostic factors (all P<0.05). Conclusions:FSRT yields relatively good LBC and poor DBC for BCBM patients. A certain percentage of patients require salvage FSRT during follow-up, but OS is maintained acceptable and the radiation necrosis is tolerable. Among the prognostic factors, the absence of extracranial metastatic organs is a good prognostic factor for OS; patients with single brain metastasis, fewer extracranial metastatic organs, and non-N 3 staging upon initial diagnosis can obtain better LBC after FSRT.
9.Diagnosis and clinical significance of extracapsular segmental vein tumor thrombus during partial nephrectomy:a report and discussion of 8 cases
Delai FU ; Geng TIAN ; Xiaoshuang TANG ; Chong YAN ; Kayitare FABRICE ; Xiaoyong CHEN ; Ya ZHANG ; Tie CHONG
Journal of Modern Urology 2025;30(11):927-931
Objective To analyze the clinical characteristics of renal cell carcinoma patients with extracapsular segmental vein tumor thrombus during partial nephrectomy and to explore the clinical significance,thereby contributing to an advanced comprehension of the pathogenesis of cancer thrombus in renal cell carcinoma.Methods A retrospective analysis was conducted on the clinical data of 209 renal cell carcinoma patients(162 with T1a stage,47 with T1b stage)who underwent partial nephrectomy in our hospital during Sep.2023 and Jul.2025.Among them,8 patients with extracapsular segmental vein tumor thrombus were identified,and the clinical and pathological characteristics were analyzed.Results Among the 8 cases of extracapsular segmental vein tumor thrombus,1 was in T1a stage and 7 were in T1b stage.Preoperativc CT revealed roundish,solid renal masses with heterogeneous density on non-contrast scans,significant enhancement on contrast-enhanced scans,and markedly weaker enhancement in the renal parenchymal phase compared to normal renal tissue.The average tumor diameter was(4.9±0.2)cm,with clear boundaries and no evidence of vascular invasion.Postoperative pathology confirmed clear cell carcinoma in all cases,with International Society of Urological Pathology(ISUP)grades ranging from Ⅰ to Ⅳ,and all surgical margins were negative.After surgery,5 patients received adjuvant immunotherapy.In a median follow-up of 10.3(3.8-22.8)months,no tumor recurrence or metastasis was observed.Conclusion Renal cell carcinoma has a high propensity of vascular invasion,and even clinically staged T1 tumors may develop extracapsular segmental vein tumor thrombus.This finding is significant for clinical prognosis.
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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