1.Protective Effect of Gegen Qianliantang on Intestinal Mucosal Barrier in Ulcerative Colitis Mice via STAT3/NF-κB Axis Regulating Th1/Treg Differentiation
Beilei DENG ; Anan WANG ; Wenya FENG ; Lixin WANG ; Tiansong ZHANG ; Chengyong MA ; Xiutian GUO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(20):12-21
ObjectiveTo explore the protective effect and mechanism of Gegen Qianliantang (GQT) on intestinal mucosal barrier function in dextran sulfate sodium (DSS)-induced ulcerative colitis (UC) model mice. MethodsA UC model was established in C57BL/6 mice using a 2.5% DSS solution. Mice were randomly divided into five groups (n=8 per group): blank group, model group, mesalazine sustained-release granule group (0.52 g·kg-1), high-dose GQT group (2.23 g·kg-1), and low-dose GQT group (1.12 g·kg-1). Fecal characteristics and body weight changes were observed before and after treatment. The body weight loss and disease activity index (DAI) of UC mice were calculated to evaluate symptom severity. Hematoxylin-eosin (HE) staining and Alizarin blue-periodic acid-Schiff (AB-PAS) staining were used to detect histological changes in colon tissue. Immunohistochemistry was used to detect the expression of zonula occludens-1 (ZO-1) and mucin 2 (MUC2). Enzyme-linked immunosorbent assay (ELISA) was used to detect serum levels of pro-inflammatory cytokines interferon-γ (IFN-γ), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), IL-17A, and anti-inflammatory cytokine IL-10. Flow cytometry was used to detect the activation of helper T lymphocyte subsets (Th1, Th17), regulatory T cells (Treg), and regulatory B cells (Breg) in spleen and colon tissues. Western blot was used to detect the expression levels of T-bet, forkhead box protein P3(FoxP3), nuclear transcription factor(NF)-κB p65, phosphorylated NF-κB p65 (p-NF-κB p65), signal transducer and activator of transcription 3(STAT3), and phosphorylated STAT3 (p-STAT3). ResultsCompared with the model group, both high- and low-dose GQT groups significantly improved the body weight loss and DAI scores (P<0.05), alleviated colonic inflammation, and showed optimal efficacy in the high-dose group. AB-PAS staining showed that compared with the model group, both the high- and low-dose GQT groups significantly increased goblet cell proliferation and mucin secretion, indicating improved mucosal barrier function. GQT upregulated the expression of ZO-1 and MUC2 in colon tissue (P<0.05), suppressed IFN-γ, IL-6, and TNF-α secretion (P<0.05), elevated IL-10 secretion (P<0.05), but had no significant effect on IL-17A. At the same time, high- and low-dose GQT intervention increased the activation of CD4+ FoxP3+ Treg cells (P<0.05) and suppressed activation of CD4+ IFN-γ+ Th1 cells (P<0.05). Western blot showed that GQT downregulated T-bet, NF-κB p65, and STAT3 protein expression (P<0.05), upregulated FoxP3 (P<0.05), and also reduced phosphorylation levels of p-NF-κB p65 and p-STAT3 (P<0.05). ConclusionGQT can upregulate the activation of CD4+ FoxP3+ Treg cells, reduce the activation of CD4+ IFN-γ+ Th1 cells, inhibit the secretion of IFN-γ, IL-6, and TNF-α, and increase the secretion of IL-10. It enhances the expression of MUC2 and ZO-1 in colon tissue, thereby alleviating inflammatory damage to the intestinal mucosa and restoring mucosal barrier integrity. These effects may be related to its regulation of NF-κB p65 and STAT3 signaling pathways, ultimately regulating the activation of transcription factors T-bet and FoxP3.
2.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.
3.Survey on anesthesia and perioperative management of elderly patients in Beijing tertiary hospitals in 2024
Lixin AN ; Siqi HAO ; Shuai FENG ; Tianlong WANG
Chinese Journal of Anesthesiology 2025;45(10):1326-1329
Objective:To investigate the anesthesiology and perioperative management status of elderly patients in Beijing tertiary hospitals in 2024.Methods:Using the cluster sampling, a questionnaire was distributed to hospitals affiliated with members of the Geriatric Anesthesiology Group under the Beijing Society of Anesthesiology. The survey primarily included: ① the current status of anesthesia for elderly patients in 2024; ② the continuing education landscape related to anesthesia for elderly patients; and ③ the current practices in anesthesia management of elderly patients. The questionnaires were completed by anesthesiologists responsible for quality control data at each hospital.Results:The survey data were collected from 34 hospitals in Beijing. In 2024, the total number of anesthesia procedures performed across these hospitals was 1, 285, 620, of which 264, 257 were performed on elderly patients (age ≥ 65 yr), representing 20.55% of the total. General anesthesia remained the dominant method of anesthesia for elderly patients 77.00%(203, 478/264, 257), and sedation and anesthesia for diagnostic and therapeutic procedures accounted for 58.00% (153, 269/264, 257). Fewer than 20% of hospitals routinely conducted preoperative cognitive function assessment and frailty assessment. Intraoperative monitoring of anesthesia depth was routinely implemented in 82% (28/34) of the hospitals, and routine monitoring of muscle relaxation only accounted for 9% (3/34 hospitals). The use of dexmedetomidine during the perioperative period to prevent postoperative delirium accounted for 38% (13/34), the use of target-oriented fluid management combined with vasoconstrictors to maintain circulatory stability strategy accounted for 53% (15/34), and the use of lung-protective ventilation strategy accounted for 68% (23/34). After surgery, 90% of elderly patients returned to postanesthesia care unit, and the proportion of patients returning to intensive care unit/anesthesia unit intensive care was about 10.00% (26, 426/264, 257). In 85% of hospitals, extubation of endotracheal tubes and removal of laryngeal mask airways were performed in the operating room. Additionally, 68% of hospitals reported having an acute pain management team, with an average incidence of moderate-to-severe postoperative pain of 20%.Conclusions:In 2024, the proportion of elderly patients receiving anesthesia in Beijing tertiary hospitals is high. Preoperative assessment of cognitive function and frailty is insufficient, but routine monitoring for geriatric anesthesia and perioperative management strategies are good, and postoperative pain management is acceptable. The overall status of perioperative anesthesia management of elderly patients is good but still needs improvement.
4.Finite element modeling of knee joint based on semi-automatic segmentation technology
Feng YAN ; Nan ZHANG ; Qinghua MENG ; Chunyu BAO ; Lixin YE ; Jia YU
Chinese Journal of Tissue Engineering Research 2025;29(33):7055-7062
BACKGROUND:Knee finite element modelling can provide insight into knee mechanics,but its complex image segmentation is more difficult for researchers.With the development of deep learning techniques,deep learning techniques have been widely used in knee joint finite element modelling.OBJECTIVE:To replace the manual segmentation step in finite element modelling of the knee joint by using 3D Swin UNETR in combination with a semi-automatic segmentation technique for statistical shape models.METHODS:Manual(artificial)knee joint finite element model was developed based on MR and semi-automatic knee joint finite element model was developed based on 3D Swin UNETR+statistical shape model segmentation.The same loads and boundary conditions were applied to both models.Validation was performed by calculating the Dice similarity coefficient,mean distance,and comparing the peak equivalent stresses,maximum principal stresses,and maximum shear stresses of the two models.RESULTS AND CONCLUSION:(1)The Dice similarity coefficients of the manual and semi-automatic segmented femur and tibia were more than 98%,and the average distances were less than or equal to(0.35±0.08)mm.(2)With the longitudinal load of 750 N and 10 Nm internal overturning moment applied to the femur tip of both manual and semi-automatic finite element models,the peak equivalent stress,maximum principal stress,and maximum shear stresses of meniscus in manual finite element model were 14.12,18.54,and 7.35 MPa;peak equivalent force,maximum principal stress,and maximum shear stress of femoral cartilage were 2.22,2.15,and 1.18 MPa;peak equivalent force,maximum principal stress,and maximum shear stress of tibial cartilage were 2.50,1.91,and 1.41 MPa;semi-automatic finite element model of meniscus:peak equivalent force,maximum principal stress,and maximum shear stress were 14.93,18.53,and 7.75 MPa.The peak equivalent force,maximum principal stress,and maximum shear stress of femoral cartilage were 2.26,2.18,and 1.20 MPa;the peak equivalent stress,maximum principal stress,and maximum shear stress of tibial cartilage were 2.60,1.91,and 1.46 MPa.The peak equivalent stress,maximum principal stress,and maximum shear stress of manual and semi-automatic finite element models were basically consistent,with no significant difference(P>0.05).(3)The semi-automatic segmentation technique proposed in this study can replace manual segmentation in creating accurate finite element models of the knee joint.
5.Analysis of the impact of phase Ⅱ cardiac rehabilitation on the rehabilitation needs and physical activity of patients with coronary heart disease after interventional surgery
Ying ZHANG ; Xiwei ZHANG ; Jiahui WU ; Wenxian LIU ; Yan FENG ; Nan LI ; Yong SHAO ; Lixin ZHANG ; Yuan TIAN ; Zhiying LI ; Yin LI
Chongqing Medicine 2025;54(5):1080-1084
Objective To investigate the impact of phase Ⅱ cardiac rehabilitation on the rehabilitation needs and physical activity status of patients after coronary heart disease intervention.Methods A total of 90 patients with coronary heart disease who underwent percutaneous coronary intervention(PCI)in the Coronary Heart Disease Center of the hospital from August 2023 to August 2024 were selected as the research subjects.They were subjected to a 12-week standardized phase Ⅱ cardiac rehabilitation training.General data survey forms,cardiac rehabilitation scales,and the International Physical Activity Questionnaire were used for scale surveys to understand the patients' needs before and after rehabilitation and their weekly physical activity en-ergy expenditure.The cardiopulmonary exercise test gold standard,which reflects exercise capacity through three indicators-maximum oxygen uptake(VO2 max),anaerobic threshold(AT),and metabolic equivalents(MET),were used to compare the physical activity status before and after cardiac rehabilitation.Results Compared with before the implementation,after the implementation of cardiac rehabilitation,the autonomy score in-creased(21.36±1.85 vs.16.73±3.28),the process anxiety(12.60±3.87 vs.14.27±2.12)and outcome anxiety scores(2.31±1.76 vs.4.56±3.56)decreased,the level of low-intensity physical activity decreased[(2 711.62±1 487.09)min/week vs.(3 845.97±2 083.71)min/week],the levels of moderate-intensity[(1 314.67±783.54)min/week vs.(686.22±126.79)min/week],high-intensity[(1 861.33±798.27)min/week vs.(112.00±40.77)min/week],and total physical activity increased[(5 887.62±2 843.54)min/week vs.(4 644.19±2 287.16)min/week].The levels of VO2 max[(28.11±14.28)mL·min-1·kg-1 vs.(23.82±12.34)mL·min-1·kg-1],AT[(16.06±5.41)mL·min-1·kg-1 vs.(13.53±4.56)mL·min-1·kg-1],and MET[(6.89±1.59)mL·min-1·kg-1 vs.(5.78±1.21)mL·min-1·kg-1]all in-creased,with statistically significant differences(P<0.05).Conclusion Phase Ⅱ rehabilitation after PCI can effectively improve patients' physical activity levels.
6.Effect of Zaogong Erteng decoction on endometritis and TLR4-mediated signaling pathways
Yaqiu LI ; Qingcan GUAN ; Lixin WANG ; Nan KANG ; Huiling LIU ; Feng YAN ; Jinyu ZHANG ; Xuenan WANG ; Xiaoyan PAN
Chinese Journal of Reproduction and Contraception 2025;45(3):255-266
Objective:To investigate the possible mechanism of Zaogong Erteng decoction (ZGETD) in the treatment of endometritis.Methods:Femal mice were injected 2.5 mg/mL lipopolysaccharide into uterine horn to induce endometritis model. After modelling, low-dose ZGETD, high-dose ZGETD or amoxicillin was given once a day for 7 d. The appearance of the uterus and pathological changes of uterine tissue were observed 7 d later, and the uterine index was calculated. The expression of tumor necrosis factor (TNF)-α, interleukin (IL)-1β and IL-6 in mouse uterine tissue was detected by enzyme-linked immunosorbent assay. The activity of myeloperoxidase (MPO) in mouse uterine tissue was measured by redox reaction. The active ingredients of ZGETD and the target and signal pathway of treatment of endometritis were analyzed by network pharmacology. Western blotting and qRT-PCR were used to detect the expressions of Toll-like receptor 4 (TLR4), P65, p-P65, interferon regulatory factor 3 (IRF3) and p-IRF3 proteins and chemokines CXCL5 and CXCL8 in the mouse uterus, respectively. Terminal dUTP nick end labeling detected endometrial cell apoptosis and endometrial thickness was measured. After treatment, the female rats were mated with the male rats, and the mating rate, the pregnancy rate and the number of implantation sits in the injected uterine horn on day 8 of gestation were counted. Results:Both ZGETD and amoxicillin have atherapeutic effect on endometritis, but compared with low-dose ZGETD and amoxicillin, high-dose ZGETD can significantly alleviate the edema and congestion of uterine tissue and reduce the uterine index (all P=0.001). After treatment, the uterine cavity epithelium of mice was smooth and complete, the uterine gland structure was normal, and no bleeding area and inflammatory cell aggregation were observed. Compared with amoxicillin, high-dose ZGETD significantly decreased the expression of inflammatory factors (TNF-α, IL-1β and IL-6) and MPO activity (all P<0.001). The expression of chemokines ( CXCL5 and CXCL8) was significantly reduced (all P<0.05). The signaling pathways TLR4, nuclear factor kappa-B (NF-κB) and TNF related to the treatment of endometritis by ZGETD were screened by network pharmacology, and their action targets (TLR4, NF-κB and IRF3) were verified. Quercetin, fisetin and luteolin were found to be the most active ingredients acting on these targets. High-dose ZGETD significantly inhibited the activation of TLR4/NF-κB and TLR4/IRF3 pathways ( P<0.05), decreased endometrial cell apoptosis ( P<0.05), and increased endometrial thickness ( P<0.001), mating rate ( P<0.001), pregnancy rate ( P<0.001) and implantation site number of uterine horn on the injection side of LPS after treatment ( P=0.001). Conclusion:High-dose ZGETD has a significant therapeutic effect on endometritis, which may be closely related to the down-regulation of TLR4 signaling pathway.
7.Effect of Zaogong Erteng decoction on endometritis and TLR4-mediated signaling pathways
Yaqiu LI ; Qingcan GUAN ; Lixin WANG ; Nan KANG ; Huiling LIU ; Feng YAN ; Jinyu ZHANG ; Xuenan WANG ; Xiaoyan PAN
Chinese Journal of Reproduction and Contraception 2025;45(3):255-266
Objective:To investigate the possible mechanism of Zaogong Erteng decoction (ZGETD) in the treatment of endometritis.Methods:Femal mice were injected 2.5 mg/mL lipopolysaccharide into uterine horn to induce endometritis model. After modelling, low-dose ZGETD, high-dose ZGETD or amoxicillin was given once a day for 7 d. The appearance of the uterus and pathological changes of uterine tissue were observed 7 d later, and the uterine index was calculated. The expression of tumor necrosis factor (TNF)-α, interleukin (IL)-1β and IL-6 in mouse uterine tissue was detected by enzyme-linked immunosorbent assay. The activity of myeloperoxidase (MPO) in mouse uterine tissue was measured by redox reaction. The active ingredients of ZGETD and the target and signal pathway of treatment of endometritis were analyzed by network pharmacology. Western blotting and qRT-PCR were used to detect the expressions of Toll-like receptor 4 (TLR4), P65, p-P65, interferon regulatory factor 3 (IRF3) and p-IRF3 proteins and chemokines CXCL5 and CXCL8 in the mouse uterus, respectively. Terminal dUTP nick end labeling detected endometrial cell apoptosis and endometrial thickness was measured. After treatment, the female rats were mated with the male rats, and the mating rate, the pregnancy rate and the number of implantation sits in the injected uterine horn on day 8 of gestation were counted. Results:Both ZGETD and amoxicillin have atherapeutic effect on endometritis, but compared with low-dose ZGETD and amoxicillin, high-dose ZGETD can significantly alleviate the edema and congestion of uterine tissue and reduce the uterine index (all P=0.001). After treatment, the uterine cavity epithelium of mice was smooth and complete, the uterine gland structure was normal, and no bleeding area and inflammatory cell aggregation were observed. Compared with amoxicillin, high-dose ZGETD significantly decreased the expression of inflammatory factors (TNF-α, IL-1β and IL-6) and MPO activity (all P<0.001). The expression of chemokines ( CXCL5 and CXCL8) was significantly reduced (all P<0.05). The signaling pathways TLR4, nuclear factor kappa-B (NF-κB) and TNF related to the treatment of endometritis by ZGETD were screened by network pharmacology, and their action targets (TLR4, NF-κB and IRF3) were verified. Quercetin, fisetin and luteolin were found to be the most active ingredients acting on these targets. High-dose ZGETD significantly inhibited the activation of TLR4/NF-κB and TLR4/IRF3 pathways ( P<0.05), decreased endometrial cell apoptosis ( P<0.05), and increased endometrial thickness ( P<0.001), mating rate ( P<0.001), pregnancy rate ( P<0.001) and implantation site number of uterine horn on the injection side of LPS after treatment ( P=0.001). Conclusion:High-dose ZGETD has a significant therapeutic effect on endometritis, which may be closely related to the down-regulation of TLR4 signaling pathway.
8.Value of Anti-CCP Antibody and RF in Cardiovascular Disease in Patients with Rheumatoid Arthritis and the Construction of Prediction Model
Feiyu HUANG ; Lixin FENG ; Jing SUN
Journal of Medical Research 2025;54(3):108-113
Objective To construct a nomogram prediction model based on anti-cyclic citrullinated peptide antibody(anti-CCP an-tibody)and rheumatoid factor(RF)to predict the probability of cardiovascular disease(CVD)in patients with rheumatoid arthritis(RA).Methods A total of 437 RA patients admitted to Zhengzhou Central Hospital Affiliated to Zhengzhou University from January 2018 to February 2024 were selected as the study objects,the clinical data of the patients were collected,and they were divided into RA+CVD group(n=88)and RA group(n=349)according to the follow-up results.The risk factors of CVD in RA patients were screened by univariate and multivariate Logistic regression analysis,and the prediction model of CVD in RA patients was constructed and internally validated.Results Multivariate Logistic regression analysis showed that age,course of disease,uric acid,C-reactive protein,hyperten-sion and diabetes,anti-CCP antibody and RF were independent risk factors for CVD in RA patients(P<0.05).The constructed mod-el was internally validated.The area under the area(AUC)of the training set and the validation set were 0.891(95%CI:0.851-0.930)and 0.867(95%CI:0.790-0.944).Conclusion The prediction model constructed in this paper has good predictive and dis-crimination ability,and has a high predictive value for whether RA patients are complicated with CVD.
9.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.
10.Survey on anesthesia and perioperative management of elderly patients in Beijing tertiary hospitals in 2024
Lixin AN ; Siqi HAO ; Shuai FENG ; Tianlong WANG
Chinese Journal of Anesthesiology 2025;45(10):1326-1329
Objective:To investigate the anesthesiology and perioperative management status of elderly patients in Beijing tertiary hospitals in 2024.Methods:Using the cluster sampling, a questionnaire was distributed to hospitals affiliated with members of the Geriatric Anesthesiology Group under the Beijing Society of Anesthesiology. The survey primarily included: ① the current status of anesthesia for elderly patients in 2024; ② the continuing education landscape related to anesthesia for elderly patients; and ③ the current practices in anesthesia management of elderly patients. The questionnaires were completed by anesthesiologists responsible for quality control data at each hospital.Results:The survey data were collected from 34 hospitals in Beijing. In 2024, the total number of anesthesia procedures performed across these hospitals was 1, 285, 620, of which 264, 257 were performed on elderly patients (age ≥ 65 yr), representing 20.55% of the total. General anesthesia remained the dominant method of anesthesia for elderly patients 77.00%(203, 478/264, 257), and sedation and anesthesia for diagnostic and therapeutic procedures accounted for 58.00% (153, 269/264, 257). Fewer than 20% of hospitals routinely conducted preoperative cognitive function assessment and frailty assessment. Intraoperative monitoring of anesthesia depth was routinely implemented in 82% (28/34) of the hospitals, and routine monitoring of muscle relaxation only accounted for 9% (3/34 hospitals). The use of dexmedetomidine during the perioperative period to prevent postoperative delirium accounted for 38% (13/34), the use of target-oriented fluid management combined with vasoconstrictors to maintain circulatory stability strategy accounted for 53% (15/34), and the use of lung-protective ventilation strategy accounted for 68% (23/34). After surgery, 90% of elderly patients returned to postanesthesia care unit, and the proportion of patients returning to intensive care unit/anesthesia unit intensive care was about 10.00% (26, 426/264, 257). In 85% of hospitals, extubation of endotracheal tubes and removal of laryngeal mask airways were performed in the operating room. Additionally, 68% of hospitals reported having an acute pain management team, with an average incidence of moderate-to-severe postoperative pain of 20%.Conclusions:In 2024, the proportion of elderly patients receiving anesthesia in Beijing tertiary hospitals is high. Preoperative assessment of cognitive function and frailty is insufficient, but routine monitoring for geriatric anesthesia and perioperative management strategies are good, and postoperative pain management is acceptable. The overall status of perioperative anesthesia management of elderly patients is good but still needs improvement.

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