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 examine the spatial and temporal distribution characteristics of first-time callers with suicidal ideation and risk factors related to suicidal ideation in a psychological assistance hotline in Henan Province.Methods:The computerised counselling operating system of the Henan Provincial Psychological Assis-tance Hotline was used to extract data from 31 401 callers who called the hotline between January 2020 and October 2023.A circular distribution and kernel density analysis were employed to investigate the spatial and temporal distri-bution of first-time callers with suicidal ideation.Binary logistic regression analysis was employed to investigate the risk factors for suicidal ideation.Results:A total of 5 494 first-time callers were included in the study,of whom 1 697(30.9％)reported suicidal ideation in the previous two weeks.The temporal distribution of suicidal ideation calls indicated a peak between 12:36 and 01:08.The weekly distribution further revealed that the majority of calls occurred on Fridays.In terms of spatial distribution,the primary hotspots for callers with suicidal ideation were clus-tered around Zhengzhou and Xinxiang.Meanwhile,the secondary hotspots exhibited a dispersed distribution across multiple centers within the province.Logistic regression analysis revealed that being under 20 years old(OR=11.85),being unemployed(OR=1.78),having psychological issues(OR=5.03),experiencing family relation-ship problems(OR=3.67),and facing economic hardships(OR=7.08)were risk factors for suicidal ideation.Conclusion:The time distribution of calls from individuals with suicidal ideation to the psychological as-sistance hotline in Henan Province exhibits a centralized trend,while the spatial distribution of calls demonstrates an imbalance.When receiving initial calls from individuals with suicidal ideation,particular attention should be paid to those aged 20 years old or younger,those who are unemployed,and those experiencing psychiatric,psychological,familial,and economic difficulties.

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 examine the spatial and temporal distribution characteristics of first-time callers with suicidal ideation and risk factors related to suicidal ideation in a psychological assistance hotline in Henan Province.Methods:The computerised counselling operating system of the Henan Provincial Psychological Assis-tance Hotline was used to extract data from 31 401 callers who called the hotline between January 2020 and October 2023.A circular distribution and kernel density analysis were employed to investigate the spatial and temporal distri-bution of first-time callers with suicidal ideation.Binary logistic regression analysis was employed to investigate the risk factors for suicidal ideation.Results:A total of 5 494 first-time callers were included in the study,of whom 1 697(30.9％)reported suicidal ideation in the previous two weeks.The temporal distribution of suicidal ideation calls indicated a peak between 12:36 and 01:08.The weekly distribution further revealed that the majority of calls occurred on Fridays.In terms of spatial distribution,the primary hotspots for callers with suicidal ideation were clus-tered around Zhengzhou and Xinxiang.Meanwhile,the secondary hotspots exhibited a dispersed distribution across multiple centers within the province.Logistic regression analysis revealed that being under 20 years old(OR=11.85),being unemployed(OR=1.78),having psychological issues(OR=5.03),experiencing family relation-ship problems(OR=3.67),and facing economic hardships(OR=7.08)were risk factors for suicidal ideation.Conclusion:The time distribution of calls from individuals with suicidal ideation to the psychological as-sistance hotline in Henan Province exhibits a centralized trend,while the spatial distribution of calls demonstrates an imbalance.When receiving initial calls from individuals with suicidal ideation,particular attention should be paid to those aged 20 years old or younger,those who are unemployed,and those experiencing psychiatric,psychological,familial,and economic difficulties.

Objective To investigate the application value of the global myocardial work parameters in the non-invasive pressure-strain loop (PSL) technology for early assessment of left ventricular systolic function in patients with chronic kidney disease (CKD). Methods A retrospective analysis was performed on 74 patients with normal left ventricular ejection fraction (LVEF) who were hospitalized in the Nephrology Department of Zhongshan Hospital (Xiamen Branch), Fudan University, from August 2021 to December 2021. Based on CKD stages, patients were divided into early group (CKD stages 1-3) and advanced group (CKD stages 4-5). Additionally, 30 healthy volunteers matched for age and gender were selected as the control group. General clinical data, routine left ventricular ultrasound indicators, myocardial strain, and global myocardial work parameters were collected and compared among the three groups. Correlation analysis and multiple linear regression were used to assess the influencing factors of myocardial work. Results There were no statistically significant differences in global work index (GWI) and global constructive work (GCW) among the three groups. Compared to the control group, both CKD groups showed significantly reduced global work efficiency (GWE), along with significantly increased global waste work (GWW, P＜0.05). The absolute value of global longitudinal strain (GLS) in the advanced CKD group (n＝42) was significantly lower than that in the early CKD group (n＝32; [﹣17.09±0.82]% vs [﹣18.33±0.90]%, P＜0.05), and GWE was also significantly lower (93.00%[90.00%, 95.00%] vs 96.00%[92.25%, 96.75%], P＜0.05), while GWW was significantly higher than that in the early CKD group (150.00 mmHg%[105.25 mmHg%, 215.00 mmHg%] vs 88.00 mmHg%[64.25 mmHg%, 144.50 mmHg%], P＜0.05). Correlation analysis showed that GWE was negatively correlated with the absolute value of GLS and peak strain dispersion (PSD; r＝﹣0.396, ﹣0.558, P＜0.05), GWW was positively correlated with absolute value of GLS, and PSD (r＝0.341, 0.610, P＜0.01). Multiple linear regression results indicated that PSD was an independent influencing factor for GWE (β＝﹣0.558, P＜0.001) and GWW (β＝0.538, P＜0.001). Conclusions The myocardial work parameters GWE and GWW in non-invasive left ventricular PSL technology can identify subclinical left ventricular systolic dysfunction in patients with CKD early and quantitatively.

Objective To explore the coronary flow reserve(CFR)in patients with coronary slow flow(CSF)and the diagnostic value of non-invasive myocardial work indices derived from echocardiography for CSF.Methods A retrospective study was conducted on 65 patients who underwent coronary angiography at the Zhongshan Hospital(Xiamen Branch),Fudan University due to angina pectoris,coronary artery risk factors,or electrocardiographic abnormalities from August 2020 to November 2023.Patients were divided into two groups based on the corrected TIMI frame count(cTFC):the CSF group(n=35)and the normal coronary blood flow velocity group(control group,n=30).Both groups underwent an adenosine triphosphate(ATP)drug load test to measure their coronary flow reserve(CFR).Conventional indices and myocardial work indices via echocardiography and two-dimensional speckle-tracking imaging(2D-STI)were acquired:left ventricular end-diastolic diameter(LVEDD),left ventricular end-systolic diameter(LVESD),left ventricular ejection fraction(LVEF),E/e'ratio,global longitudinal strain(GLS),global constructive work(GCW),global wasted work(GWW),global work index(GWI),and global work efficiency(GWE).Receiver operating characteristic(ROC)curves were used to evaluate the diagnostic value of myocardial work indices for CSF.Results There was no significant difference in CFR values between the two groups,but the proportion of CSF group with CFR less than 2 was higher than that of the control group(P=0.023).Compared with the control group,the CSF group showed significantly lower levels of GLS,GWI,and GCW(P＜0.05).ROC curve analysis revealed that the GLS diagnostic threshold for CSF was-19.5%,with a sensitivity of 64.7%,specificity of 78.6%,and AUC of 0.793.Among the myocardial work indices,the AUC of GWI was the highest(0.825),with a sensitivity of 88.2% and specificity of 75.0% .Conclusions Some CSF patients retain coronary microcirculatory blood flow reserve function,but the proportion of patients with reduced CFR function is increasing.The left ventricular myocardial work indices can identify early myocardial work abnormalities and monitor myocardial ischemic damage in CSF patients.

Animals ; Mice ; Chlamydia muridarum ; Mice, Inbred BALB C ; Antigens, Bacterial ; Chlamydia Infections

Objective:To analyze the incidence of human papillomavirus (HPV) infection in 1 902 patients and to evaluate the efficacy of drug treatment in 266 patients, aiming to provide reference for the treatment of HPV infection.Methods:The subtypes of HPV isolated from 1 902 patients aged 15-86 years visiting the venereology outpatient clinic of Tianjin Medical University General Hospital from October 2019 to May 2021 were identified by polymerase chain reaction-reverse dot blot hybridization. Drug treatment efficacy in 266 patients of them was retrospectively analyzed.Results:The overall incidence of HPV infection in the 1 902 patients was as high as 53.84% (1 024/1 902). It was 52.60% (689/1 310) in males and 56.59% (335/592) in females. There was no significant difference in the incidence between males and females ( P>0.05). The most common HPV genotype in males and females was HPV6 [15.27% (200/1 310) and 21.96% (130/592)], followed by HPV16 [10.61% (139/1 310) and 9.46% (56/592)], HPV11 [9.31% (122/1 310) and 8.61% (51/592)], HPV52 [6.79% (89/1 310) and 8.95% (53/592)] and HPV43 [5.64% (87/1 310) and 8.45% (50/592)]. The majority of HPV-positive patients were aged between 20 and 39 years. There were 476 cases (25.03%, 476/1 902) of single-type infection and 548 cases (28.81%, 548/1 902) of multiple infection. The incidence of multiple infection was higher than that of single-type infection ( P<0.05). The incidence of multiple infection in females was higher than that in males ( P<0.05). Among the 266 patients, 106 were treated with Paiteling, a traditional Chinese medicine (TCM) preparation, and 68 of them tested negative (64.15%) after treatment. Fifty-eight patients were treated with recombinant human interferon α2b and 22 of them (37.93%) tested negative after treatment. Twenty out of the 56 subjects treated with imiquimod tested negative after treatment. Eight out of the 46 patients without treatment also turned negative. Conclusions:The incidence of HPV infection in the 1 902 patients visiting the venereology outpatient clinic was very high, and most of them were young adults. Multiple infection was more common than single-type infection. Topical application of drugs such as Paiteling, recombinant human interferon α2b and imiquimod was effective in treating HPV infection.

Objective:To explore the potential mechanism of Jiajian Xuezheng Decotion in infiltrative gastric cancer by network pharmacology and proteomics.Methods:The Traditional Chinese Medicine Systems Pharmacology Database (TCMSP) database was used to find the compounds and their targets of Jiajianxuezhengtang, and the targets of invasive gastric cancer were determined by high performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS). The predicted target gene of Jiajian Xuezheng Decotion and the target protein data of infiltrative gastric cancer were analyzed by Venny to obtain the target gene. The target gene set was analyzed by Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment by the David. The protein interaction network diagram (PPI) was obtained by the String method, displaying the prescription-drug-compound-gene network in Cytoscape software.Results:69 active ingredients and 215 drug targets were screened from Jiajian Xuezheng Decotion; 660 proteins were significantly up-expressed in infiltrative gastric cancer, and 10 drug targets and gene targets were the common targets. There were 10 protein nodes in the PPI network, of which 3 core nodes were CASP3, BCL2L1 and STAT1. The 11 KEGG pathways were significantly enriched such as include PI3K-Akt signaling pathway, p53 signaling pathway, proteoglycan in cancer, apoptosis, Jak-STAT signaling pathway and other pathways.Conclusions:Jiajian Xuezheng Decotion plays an anti-infiltrative gastric cancer effect possibly regulated apoptosis through PI3K-Akt signaling pathway, p53 signaling pathway and Jak-STAT signaling pathway. This study provides a theoretical basis for further research on the mechanism of Jiajian Xuezheng Decotion in the treatment of invasive gastric cancer.

Objective To analyze the effects of five proteins secreted by Chlamydia trachomatis on the phagocytosis of macrophages and dendritic cells derived from bone marrow cells of C3H/HeJ mice. Methods Glutathione S-transferase ( GST)-CT311, GST-GIgA, GST-cHtrA, GST-OmcBc and GST-Pgp3 proteins were prepared through an Escherichia coli prokaryotic expression system and purified by GST Mag-Beads. Chlamydia membrane protein GST-IncA was also prepared as a control. Proteins of interest were ob-tained by cleaving off GST-tag with PreScission protease. Macrophages (MΦ) and dendritic cells (DC) were prepared from bone marrow cells of C3H/HeJ mice and pretreated with either 100 μg/ml or 500 μg/ml of the above proteins. LPS was used as a control to testify the specificity of the proteins' functions. Four hours after pretreatment,fluorescent beads were added to culture media to evaluate the changes in phagocytosis with direct immunofluorescence assay. Results LPS and low concentration (100 μg/ml) of these proteins had no significant influence on the phagocytosis of DC and MΦ,while high concentration (500 μg/ml) of Pgp3, cHtrA and CT311 could significantly promote the phagocytosis of DC and MΦ. Conclusion Pgp3, cHtrA and CT311 can promote the in vitro phagocytosis of DC and MΦ,which may facilitate the in vivo dissemina-tion of Chlamyida trachomatis.