1.Resveratrol attenuates hepatic inflammation and oxidative stress in rheumatoid arthritis via Nrf2/Keap1 pathway
Xue-fei FAN ; Jian ZHOU ; Su-huan CHEN ; Meng-yan ZHANG ; Hao-miao LIU ; Rui SU ; Guang-yi CHEN ; Yu-bao SHAO ; Tao YAO ; Xiao-yu CHEN
Chinese Pharmacological Bulletin 2025;41(5):861-867
Aim To explore the therapeutic effects of resveratrol(Res)on hepatic inflammation and oxida-tive stress in rheumatoid arthritis(RA),and to eluci-date the relationship of the regulatory mechanism of the Nrf2/Keap1 signaling pathway in it.Methods A mouse model of arthritis was induced using chicken type Ⅱ collagen in combination with complete Freund's adjuvant,and Res was administered by tube feeding for treatment.Serum liver function indices and levels of hepatic inflammation and oxidative stress were detected in mice.An in vitro cellular model of hepatic inflam-mation and oxidative stress was established by treating mouse primary hepatocytes(MPHs)with TNF-α(5μg·L-1),cell proliferation inhibition was detected by CCK-8,and inflammation and oxidative stress-relat-ed indices were detected by protein blotting.The in-trinsic mechanisms by which Res attenuated hepatic in-flammation and oxidative stress in rheumatoid arthritis were explored by treating MPHs with Nrf2 inhibitor and Keap1 overexpression plasmid.Results Res signifi-cantly reduced the levels of inflammation and oxidative stress in hepatic tissues of collagen-induced arthritis mice as well as TNF-α-treated MPHs,and activated the Nrf2/Keap1 signaling pathway.Inflammation and oxidative stress levels in MPHs were exacerbated by the use of Nrf2 inhibitors and Keap1 overexpression,which promoted apoptosis.Conclusion Res attenuates he-patic inflammation and oxidative stress in rheumatoid arthritis via the Nrf2/Keap1 pathway.
2.Risk factors for adverse outcomes in elderly patients with nonvalvular atrial fibrillation after percuta-neous left atrial appendage closure combined with radiofrequency ablation
Xiu-tian SU ; Hua WANG ; Guang-qiang WANG ; Ting YU ; Meng-meng REN ; Lin ZHONG
Chinese Journal of cardiovascular Rehabilitation Medicine 2025;34(2):162-167
Objective:To investigate the risk factors for adverse outcomes in elderly patients with nonvalvular atrial fibrilla-tion(AF)after percutaneous left atrial appendage closure(LAAC)combined with radiofrequency ablation(RFA).Meth-ods:A total of 199 elderly AF patients who admitted in Department of Cardiology,Yuhuangding Hospital between Jan 1st,2019 and Aug 17th,2023 and underwent LAAC combined RFA were enrolled.The patients were divided into case group(n=78)and control group(n=121)according to presence of atrial arrhythmia and/or cerebral infarction(CI)within one year after operation.Baseline clinical data,laboratory indexes and color Doppler ultrasound indexes were compared be-tween the two groups,and multivariate Logistic regression was used to analyze the risk factors for postoperative atrial ar-rhythmia and/or CI.Receiver operating characteristic(ROC)curve was constructed to analyze the predictive efficacy of risk factors for atrial arrhythmia and/or CI after operation.Results:Univariate analysis indicated that compared with pa-tients in control group,those in case group had significant higher proportions of preoperative persistent atrial fibrillation(52.60% vs.37.20%),old myocardial infarction(OMI)(11.50%vs.1.70%)and left atrial diameter(LAD)[(45.47±6.90)mm vs.(43.34±6.64)mm](P<0.05 or<0.01).Multivariate Logistic regression analysis indicated history of OMI(OR=8.736,95%CI 1.772~43.069,P=0.008)and LAD(OR=1.053,95%CI 1.006~1.102,P=0.027)were independent risk factors of adverse outcomes in elderly AF patients after LAAC+RFA.ROC analysis indicated that predic-tive efficacy of combined detection of OMI and LAD(AUC=0.663,95%CI 0.593~0.728)for adverse outcomes within 1 year in elderly AF patients after LAAC+RFA was significantly better than those of OMI(AUC=0.549,95%CI 0.477~0.620)and LAD(AUC=0.602,95%CI 0.531~0.671)alone(Z=3.045,2.312,P=0.002,0.021).Conclusion:His-tory of old myocardial infarction and left atrial diameter are independent risk factors for atrial arrhythmia and/or cerebral infarction within 1 year after percutaneous left atrial appendage closure combined with radiofrequency ablation in elderly patients with atrial fibrillation,and the combination has good predictive performance.
3.Risk factors for adverse outcomes in elderly patients with nonvalvular atrial fibrillation after percuta-neous left atrial appendage closure combined with radiofrequency ablation
Xiu-tian SU ; Hua WANG ; Guang-qiang WANG ; Ting YU ; Meng-meng REN ; Lin ZHONG
Chinese Journal of cardiovascular Rehabilitation Medicine 2025;34(2):162-167
Objective:To investigate the risk factors for adverse outcomes in elderly patients with nonvalvular atrial fibrilla-tion(AF)after percutaneous left atrial appendage closure(LAAC)combined with radiofrequency ablation(RFA).Meth-ods:A total of 199 elderly AF patients who admitted in Department of Cardiology,Yuhuangding Hospital between Jan 1st,2019 and Aug 17th,2023 and underwent LAAC combined RFA were enrolled.The patients were divided into case group(n=78)and control group(n=121)according to presence of atrial arrhythmia and/or cerebral infarction(CI)within one year after operation.Baseline clinical data,laboratory indexes and color Doppler ultrasound indexes were compared be-tween the two groups,and multivariate Logistic regression was used to analyze the risk factors for postoperative atrial ar-rhythmia and/or CI.Receiver operating characteristic(ROC)curve was constructed to analyze the predictive efficacy of risk factors for atrial arrhythmia and/or CI after operation.Results:Univariate analysis indicated that compared with pa-tients in control group,those in case group had significant higher proportions of preoperative persistent atrial fibrillation(52.60% vs.37.20%),old myocardial infarction(OMI)(11.50%vs.1.70%)and left atrial diameter(LAD)[(45.47±6.90)mm vs.(43.34±6.64)mm](P<0.05 or<0.01).Multivariate Logistic regression analysis indicated history of OMI(OR=8.736,95%CI 1.772~43.069,P=0.008)and LAD(OR=1.053,95%CI 1.006~1.102,P=0.027)were independent risk factors of adverse outcomes in elderly AF patients after LAAC+RFA.ROC analysis indicated that predic-tive efficacy of combined detection of OMI and LAD(AUC=0.663,95%CI 0.593~0.728)for adverse outcomes within 1 year in elderly AF patients after LAAC+RFA was significantly better than those of OMI(AUC=0.549,95%CI 0.477~0.620)and LAD(AUC=0.602,95%CI 0.531~0.671)alone(Z=3.045,2.312,P=0.002,0.021).Conclusion:His-tory of old myocardial infarction and left atrial diameter are independent risk factors for atrial arrhythmia and/or cerebral infarction within 1 year after percutaneous left atrial appendage closure combined with radiofrequency ablation in elderly patients with atrial fibrillation,and the combination has good predictive performance.
4.Influence of Hyperbaric Oxygen Combined with Huperzine A Treatment on Cognitive Function and Neuroinflammation in Patients with Vascular Cognitive Impairment after Cerebral Infarction
Liu-fang SU ; Guang-yan XU ; Xin-jing LIN
Progress in Modern Biomedicine 2025;25(14):2343-2350
Objective:To observe the effects of hyperbaric oxygen combined with huperzine A treatment on cognitive function and neuroinflammation in patients with vascular cognitive impairment(VCI)after cerebral infarction.Methods:This study was a retrospective study.34 patients with VCI after cerebral infarction who were treated with hyperbaric oxygen combined with huperzine A in our hospital from January 2023 to October 2024 were selected as the observation group.Additionally using 1∶1 matched case-control study method,34 patients who were treated with hyperbaric oxygen alone during the same period were selected as the control group 1,and 34 patients who were treated with huperzine A alone were selected as the control group 2.Compared the clinical efficacy,cognitive function[mini mental state examination(MMSE)score,montreal cognitive assessment(MoCA)score],activities of daily living(Barthel index),neurological function[national institutes of health stroke scale(NIHSS),neuron specific enolase(NSE),brain-derived neurotrophic factor(BDNF)],inflammatory mediators[high-sensitivity C-reactive protein(hs-CRP),tumor necrosis factor-α(TNF-α),interleukin-1β(IL-1 β)]and incidence of adverse reactions among three groups.Results:The total clinical effective rate of the observation group was higher than that of control group 1 and control group 2(P<0.05).After the treatment,the MMSE score,MoCA score and Barthel index of the observation group were higher than those of control group 1 and control group 2(P<0.05).After the treatment,the NIHSS and NSE in the observation group were lower than those in control group 1 and control group 2,and the BDNF was higher than that in control group 1 and control group 2(P<0.05).After the treatment,the levels of hs-CRP,IL-1β and TNF-α in the observation group were lower than those in control group 1 and control group 2(P<0.05).There was no difference in the incidence of adverse reactions among the three groups(P>0.05).Conclusion:Hyperbaric oxygen combined with huperzine A in the treatment of VCI after cerebral infarction can increase the total clinical effective rate,improve patients' cognitive function and reduce levels of neuroinflammation.
5.Resveratrol attenuates hepatic inflammation and oxidative stress in rheumatoid arthritis via Nrf2/Keap1 pathway
Xue-fei FAN ; Jian ZHOU ; Su-huan CHEN ; Meng-yan ZHANG ; Hao-miao LIU ; Rui SU ; Guang-yi CHEN ; Yu-bao SHAO ; Tao YAO ; Xiao-yu CHEN
Chinese Pharmacological Bulletin 2025;41(5):861-867
Aim To explore the therapeutic effects of resveratrol(Res)on hepatic inflammation and oxida-tive stress in rheumatoid arthritis(RA),and to eluci-date the relationship of the regulatory mechanism of the Nrf2/Keap1 signaling pathway in it.Methods A mouse model of arthritis was induced using chicken type Ⅱ collagen in combination with complete Freund's adjuvant,and Res was administered by tube feeding for treatment.Serum liver function indices and levels of hepatic inflammation and oxidative stress were detected in mice.An in vitro cellular model of hepatic inflam-mation and oxidative stress was established by treating mouse primary hepatocytes(MPHs)with TNF-α(5μg·L-1),cell proliferation inhibition was detected by CCK-8,and inflammation and oxidative stress-relat-ed indices were detected by protein blotting.The in-trinsic mechanisms by which Res attenuated hepatic in-flammation and oxidative stress in rheumatoid arthritis were explored by treating MPHs with Nrf2 inhibitor and Keap1 overexpression plasmid.Results Res signifi-cantly reduced the levels of inflammation and oxidative stress in hepatic tissues of collagen-induced arthritis mice as well as TNF-α-treated MPHs,and activated the Nrf2/Keap1 signaling pathway.Inflammation and oxidative stress levels in MPHs were exacerbated by the use of Nrf2 inhibitors and Keap1 overexpression,which promoted apoptosis.Conclusion Res attenuates he-patic inflammation and oxidative stress in rheumatoid arthritis via the Nrf2/Keap1 pathway.
6.Epidemiological characteristics of common viral respiratory infections before and after the COVID-19 pandemic in Huzhou,Zhejiang Province
Min-yi YANG ; Yan LIU ; Su-yi ZHANG ; Qiang WANG ; Guang-tao LIU ; Bo ZHENG ; Xin-yu WANG ; Dan-ni ZHAO ; Jian-yong SHEN ; Wei-bing WANG
Fudan University Journal of Medical Sciences 2025;52(6):819-828
Objective To investigate and compare the epidemiological characteristics of common respiratory viruses among influenza-like illness(ILI)and severe acute respiratory infection(SARI)cases in Huzhou,Zhejiang Province before and after the COVID-19 pandemic,so as to provide a basis for formulating and adjusting the prevention and control strategies for viral respiratory infectious diseases.Methods ILI and SARI cases at two influenza surveillance sentinel hospitals in Huzhou and had throat swab samples collected during Nov 2017 to Feb 2020(pre-COVID-19 pandemic period)and Dec 2022 to Apr 2024(post-COVID-19 mitigation phase)were selected as the participants.Seven common viral respiratory pathogens were tested,including influenza A virus(H1N1 and H3N2 subtypes),influenza B virus(Victoria lineage,FluB),respiratory syncytial virus(RSV),rhinovirus(HRV),adenovirus(ADV),and severe acute respiratory syndrome coronavirus-2(SARS-CoV-2).The positive rates of respiratory pathogens before and after the COVID-19 pandemic were compared across different age groups and different time.Results A total of 7 948 ILI samples and 2 294 SARI samples were included.The overall positive rate of ILI samples increased from 33.6%to 47.1%,primarily due to the increase in influenza and COVID-19 infections;the overall positive rate of SARI samples decreased from 31.4%to 24.8%,mainly due to the reduction in HRV and ADV infections.During the post-COVID-19 mitigation phase,SARS-CoV-2(22.1%),H3N2(12.7%),and FluB(6.0%)were the primary pathogens in ILI samples,while RSV(7.1%),H3N2(5.3%),and HRV(4.5%)dominated in SARI samples.During the post-COVID-19 mitigation phase,the influenza virus circulation period was shortened.Before the COVID-19 pandemic,RSV was mainly detected in autumn and winter,while during the post-COVID-19 mitigation phase,out-of-season RSV epidemics were observed in spring and summer.Co-infection rate in ILI cases increased significantly in the post-COVID-19 mitigation phase,predominantly consisting of co-infections of COVID-19 and influenza A virus,while co-infection rate in SARI cases showed a decline.Conclusion We found important epidemiological changes in respiratory viruses in Huzhou during the post-COVID-19 mitigation phase compared to pre-COVID-19 period,including increased positive rates of influenza and COVID-19,and disruptions to the seasonal patterns of influenza and RSV.The prevention and control strategies should be adjusted in a timely manner based on the monitoring data.
7.Influence of Hyperbaric Oxygen Combined with Huperzine A Treatment on Cognitive Function and Neuroinflammation in Patients with Vascular Cognitive Impairment after Cerebral Infarction
Liu-fang SU ; Guang-yan XU ; Xin-jing LIN
Progress in Modern Biomedicine 2025;25(14):2343-2350
Objective:To observe the effects of hyperbaric oxygen combined with huperzine A treatment on cognitive function and neuroinflammation in patients with vascular cognitive impairment(VCI)after cerebral infarction.Methods:This study was a retrospective study.34 patients with VCI after cerebral infarction who were treated with hyperbaric oxygen combined with huperzine A in our hospital from January 2023 to October 2024 were selected as the observation group.Additionally using 1∶1 matched case-control study method,34 patients who were treated with hyperbaric oxygen alone during the same period were selected as the control group 1,and 34 patients who were treated with huperzine A alone were selected as the control group 2.Compared the clinical efficacy,cognitive function[mini mental state examination(MMSE)score,montreal cognitive assessment(MoCA)score],activities of daily living(Barthel index),neurological function[national institutes of health stroke scale(NIHSS),neuron specific enolase(NSE),brain-derived neurotrophic factor(BDNF)],inflammatory mediators[high-sensitivity C-reactive protein(hs-CRP),tumor necrosis factor-α(TNF-α),interleukin-1β(IL-1 β)]and incidence of adverse reactions among three groups.Results:The total clinical effective rate of the observation group was higher than that of control group 1 and control group 2(P<0.05).After the treatment,the MMSE score,MoCA score and Barthel index of the observation group were higher than those of control group 1 and control group 2(P<0.05).After the treatment,the NIHSS and NSE in the observation group were lower than those in control group 1 and control group 2,and the BDNF was higher than that in control group 1 and control group 2(P<0.05).After the treatment,the levels of hs-CRP,IL-1β and TNF-α in the observation group were lower than those in control group 1 and control group 2(P<0.05).There was no difference in the incidence of adverse reactions among the three groups(P>0.05).Conclusion:Hyperbaric oxygen combined with huperzine A in the treatment of VCI after cerebral infarction can increase the total clinical effective rate,improve patients' cognitive function and reduce levels of neuroinflammation.
8.Horticultural Therapy Combined with Intradermal Needling for Patients with Generalized Anxiety Disorder of Liver Depression Transforming into Fire Syndrome Under Transcranial Magnetic Stimulation and Psychological Therapy:Clinical Observation of 60 Cases
Wanyun ZHANG ; Jiayi YAN ; Qingyi QIU ; Yumei PENG ; Xiaoling ZHONG ; Jinwen ZHANG ; Rundong TANG ; Miao WU ; Dan HU ; Guang SU
Journal of Traditional Chinese Medicine 2025;66(1):50-58
ObjectiveTo observe the clinical effectiveness of horticultural therapy involving the planting of Chinese medicinal herbs (mint and lily potted plants) combined with intradermal needling therapy for generalized anxiety disorder (GAD) of liver depression transforming into fire syndrome under transcranial magnetic stimulation and basic psychological therapy, and to explore the possible mechanisms of action. MethodsA total of 180 patients with GAD of liver depression transforming into fire syndrome were randomly divided into three groups, horticultural therapy group, intradermal needling group, and horticultural therapy+intradermal needling group, with 60 patients in each. All groups received basic treatment including basic psychological therapy and transcranial magnetic stimulation. The horticultural therapy group received horticultural therapy in addition to the basic treatment; the intradermal needling group received intradermal needling therapy once a week for 8 weeks in addition to the basic treatment; the horticultural therapy+intradermal needling group received both horticultural therapy and intradermal needling therapy, following the same procedures and duration. Hamilton Anxiety Rating Scale (HAMA), Self-Rating Anxiety Scale (SAS), and Pittsburgh Sleep Quality Index (PSQI) scores were assessed at baseline and after 2, 4, 6, and 8 weeks of treatment. Serum levels of adrenocorticotropic hormone (ACTH) and corticosterone (CORT) were measured before treatment and after 8 weeks of treatment. Motor-evoked potential (MEP) baseline levels were recorded before treatment, and MEP amplitude ratios were compared after 1 week and 8 weeks of treatment. Clinical effectiveness and safety were evaluated after 8 weeks of treatment. Pearson correlation analysis was used to examine the relationships between serum ACTH and CORT levels, MEP amplitude, and anxiety. ResultsIn the horticultural therapy group and intradermal needling group, HAMA, SAS and PSQI scores after 4, 6, and 8 weeks treatment were lower than baseline scores (P<0.05). In the horticultural therapy+intradermal needling group, these scores showed a significant decline starting after 2 weeks treatment and continuing through 8 weeks after treatment (P<0.05). The HAMA, SAS, and PSQI scores in the horticultural therapy+intradermal needling group were significantly lower than those in the other two groups after 2, 4, 6, and 8 weeks treatment (P<0.05). After 8 weeks of treatment, serum CORT and ACTH levels in the horticultural therapy+intradermal needling group were significantly lower than baseline levels (P<0.05) and were also lower than those in the horticultural therapy group and intradermal needling group at the same time point (P<0.01). When comparing the level after 8 weeks treatment to that after 1 week treatment, under PAS10 stimulation, the MEP amplitude ratio in the intradermal needling group decreased at 30 minutes, while in the horticultural therapy+intradermal needling group, the MEP amplitude ratio decreased at all time points (P<0.05 or P<0.001); under PAS25 stimulation, the MEP amplitude ratio in the horticultural therapy group increased at 20 minutes, and in the intradermal needle group at 10 minutes (P<0.05). In the horticultural therapy+intradermal needling group, the MEP amplitude ratio increased significantly at all time points after treatment (P<0.001). The cure rate in the horticultural therapy+intradermal needling group (74.14%, 43/58) was significantly higher than that in the horticultural therapy group (30.00%, 18/60) and the intradermal needling group (48.28%, 28/58, P<0.05). Correlation analysis revealed that serum ACTH and CORT levels were positively correlated with HAMA scores (r = 0.488, P<0.01; r = 0.428, P<0.01). Following PAS10 intervention, the MEP amplitude ratio was positively correlated with HAMA scores (r = 0.458, P<0.01), whereas after PAS25 intervention, the MEP amplitude ratio was negatively correlated with HAMA scores (r = -0.562, P<0.01). ConclusionHorticultural therapy combined with intradermal needling treatment, under transcranial magnetic stimulation and basic psychological therapy, demonstrates significant clinical effectiveness in patients with GAD of liver depression transforming into fire syndrome. Its mechanism of action may be related to the regulation of hyperactivation of the hypothalamic-pituitary-adrenal (HPA) axis and the reduction of cortical excitability.
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.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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