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.

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.

Objective:To investigate the value of nomograms based on clinical parameters, apparent diffusion coefficient (ADC) and MRI-derived radiomics in predicting survival of patients with locally advanced cervical cancer (LACC) after concurrent chemoradiotherapy (CCRT).Methods:Clinical data of 423 patients with IB-IVA cervical cancer treated with CCRT at Anhui Provincial Hospital Affiliated to Anhui Medical University from March 2014 to March 2020 were retrospectively analyzed and randomly divided into the training and validation groups at a ratio of 2∶1 using the simple randomization method. The values of ADC min, ADC mean, ADC max and 3D texture parameters of diffusion weighted imaging (DWI), T 2WI, T 2WI-fat suppression of pre-treatment primary lesions in all patients were measured. The least absolute shrinkage and selection operator (LASSO) algorithm and logistic regression analysis were used to screen the texture features and calculate radiomics score (Rad-score). Cox regression analysis was employed to construct nomogram models for predicting overall survival (OS) and cancer-specific survival (CS) of patients with LACC after CCRT, which were subject to internal and external validation. Results:Squamous cell carcinoma antigen (SCC-Ag), external beam radiotherapy dose, ADCmin and Rad-score were the independent prognostic factors for OS and CS of LACC patients after CCRT and constituted predictive models for OS and CS. The area under the receiver operating characteristic (ROC) curve (AUC) of two models in predicting 1-year, 3-year, 5-year OS and CS was 0.906, 0.917, 0.916 and 0.911, 0.918, 0.920, with internally validated consistency indexes (C-indexes) of 0.897 and 0.900. Then, models were brought into the validation group for external validation with AUC of 0.986, 0.942, 0.932 and 0.986, 0.933, 0.926 in predicting 1-year, 3-year, 5-year OS and CS.Conclusion:The nomograms based on clinical parameters, ADC values and MRI-derived radiomics are of high clinical value in predicting OS and CS of patients with LACC after CCRT, which can be used as prognostic markers for patients with cervical cancer to certain extent.

Background and Objectives: Acute myocardial infarction (AMI) often occurs suddenly and leads to fatal consequences. Ferroptosis is closely related to the progression of AMI.However, the specific mechanism of ferroptosis in AMI remains unclear. Methods: We constructed a cell model of AMI using AC16 cells under oxygen and glucose deprivation (OGD) conditions and a mice model of AMI using the left anterior descending (LAD) ligation. The 3-(4, 5-dimethylthiazol-2-yl)-2, 5 diphenyltetrazolium bromide was employed to determine cell viability. The levels of lactate dehydrogenase, creatine kinase, reactive oxygen species (ROS), glutathione (GSH), malondialdehyde (MDA), and iron were measured using corresponding kits. Dual luciferase reporter gene assay, RNAbinding protein immunoprecipitation, and RNA pull-down were performed to validate the correlations among AC005332.7, miR-331-3p, and cyclin D2 (CCND2). Hematoxylin and eosin staining was employed to evaluate myocardial damage. Results: AC005332.7 and CCND2 were lowly expressed, while miR-331-3p was highly expressed in vivo and in vitro models of AMI. AC005332.7 sufficiency reduced ROS, MDA, iron, and ACSL4 while boosting the GSH and GPX4, indicating that AC005332.7 sufficiency impeded ferroptosis to improve cardiomyocyte injury in AMI. Mechanistically, AC005332.7 interacted with miR-331-3p, and miR-331-3p targeted CCND2. Additionally, miR-331-3p overexpression or CCND2 depletion abolished the suppressive impact of AC005332.7 on ferroptosis in OGD-induced AC16 cells. Moreover, AC005332.7 overexpression suppressed ferroptosis in mice models of AMI. Conclusions AC005332.7 suppressed ferroptosis in OGD-induced AC16 cells and LAD ligation-operated mice through modulating miR-331-3p/CCND2 axis, thereby mitigating the cardiomyocyte injury in AMI, which proposed novel targets for AMI treatment.

Objective:To investigate the value of nomogram based on intravoxel incoherent motion diffusion weighted imaging (IVIM-DWI) and MRI-derived radiomics for predicting recurrence after concurrent chemoradiotherapy (CCRT) in patients with locally advanced cervical cancer (LACC).Methods:Clinical data of 111 patients with ⅠB-ⅣA cervical cancer who underwent CCRT at Anhui Provincial Hospital from December 2014 to December 2019 and were continuously followed up were retrospectively analyzed. Pre-treatment IVIM-DWI parameters (ADC, D, D * and f) and pre- and post-treatment 3D texture parameters (from axial T 2WI) of the primary lesions were measured. Least absolute shrinkage and selection operator (LASSO) algorithm and multivariate logistic regression analysis were used to filter texture features and calculate radiomics score (Rad-score). A Cox regression model was used to analyze independent risk factors for recurrence after CCRT in patients with LACC and construct a nomogram. Results:External beam radiotherapy dose, f value , pre-treatment Rad-score and post-treatment Rad-score ( HR=0.204, 3.253, 2.544, 7.576) were the independent prognostic factors for recurrence after CCRT in cervical cancer patients and jointly formed the nomogram. The area under curve (AUC) of the nomogram for predicting 1-, 3- and 5-year disease-free survival (DFS) was 0.895, 0.888 and 0.916, with internal validation C-indexes of 0.859, 0.903 and 0.867, respectively. The decision curves analysis showed that the nomogram has a higher net clinical benefit compared to other models, and the clinical impact curves further visualized its predictive accuracy. Conclusions:The nomogam based on IVIM-DWI and radiomics has high clinical value in predicting recurrence after CCRT in patients with LACC, providing reference for prognostic assessment and individualized treatment of cervical cancer patients.

Objective:To construct the postgraduate teaching case database of rotation in department of cardiology, and to explore its application effect.Methods:The postgraduate teaching case base of rotation in department of cardiology was constructed during April 2020 to December 2020. A total of 32 graduate students rotating in Department of Cardiology of Affiliated Hospital of Guilin Medical University from January 2021 to April 2021 were selected and randomly divided into two groups. The routine group adopted the traditional teaching method, and the research group applied the teaching case base on this basis, both for one month. The examination results, the changes of clinical practice ability before and after the teaching, and the satisfaction with the teaching mode were compared between the two groups. SPSS 22.0 was used for t test and chi-square test. Results:The final results of the theoretical examination and practical operation examination of the two groups were higher than those of the entrance examination ( P<0.05), and the results of the theoretical examination and practical operation examination of the research group were higher than those of the routine group ( P<0.05). The scores of clinical practice ability of inquiry, case analysis, diagnosis, treatment and follow-up in the two groups after teaching were higher than those before teaching ( P<0.05), and the scores of clinical practice ability in the research group after teaching were higher than those in the routine group ( P<0.05). The satisfaction scores on improving examination results, enhancing clinical practice ability, deepening professional understanding and enhancing professional confidence of the teaching mode of the research group were higher than those of the routine group ( P<0.05). Conclusion:The construction and application of postgraduate teaching case base of cardiology rotation can improve the examination results, enhance the clinical practice ability, and achieve the satisfaction of postgraduates.