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 effects of nasal endoscopy in curettage of large mandibular cyst.Methods:20 cases of large mandibular cyst admitted to Xianyang Hosptial of Yan'an University from January 2022 to December 2023 were included.The curet-tage of mandibular cyst was performed under general anesthesia through intraoral incision by nasal endoscopy-assisted illumination and enlargement of the lesion area during the operation.The application effects were evaluated from the aspects of surgical incision length,nerve injury and cyst recurrence.Results:During operation,the surgical filed of view was clear and the operation was suc-ceeded in all cases.There was no complication in and after the nasal endoscopy-assisted curettage,no cyst recurrence was observed during 1-year follow-up.Conclusion:Nasal endoscopy-assisted curettage of large mandibular cyst is effective and safe.

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 effects of nasal endoscopy in curettage of large mandibular cyst.Methods:20 cases of large mandibular cyst admitted to Xianyang Hosptial of Yan'an University from January 2022 to December 2023 were included.The curet-tage of mandibular cyst was performed under general anesthesia through intraoral incision by nasal endoscopy-assisted illumination and enlargement of the lesion area during the operation.The application effects were evaluated from the aspects of surgical incision length,nerve injury and cyst recurrence.Results:During operation,the surgical filed of view was clear and the operation was suc-ceeded in all cases.There was no complication in and after the nasal endoscopy-assisted curettage,no cyst recurrence was observed during 1-year follow-up.Conclusion:Nasal endoscopy-assisted curettage of large mandibular cyst is effective and safe.

BACKGROUND: This study aimed to develop a comprehensive instrument for evaluating and ranking clinical practice guidelines, named Scientific, Transparent and Applicable Rankings tool (STAR), and test its reliability, validity, and usability. METHODS: This study set up a multidisciplinary working group including guideline methodologists, statisticians, journal editors, clinicians, and other experts. Scoping review, Delphi methods, and hierarchical analysis were used to develop the STAR tool. We evaluated the instrument's intrinsic and interrater reliability, content and criterion validity, and usability. RESULTS: STAR contained 39 items grouped into 11 domains. The mean intrinsic reliability of the domains, indicated by Cronbach's α coefficient, was 0.588 (95% confidence interval [CI]: 0.414, 0.762). Interrater reliability as assessed with Cohen's kappa coefficient was 0.774 (95% CI: 0.740, 0.807) for methodological evaluators and 0.618 (95% CI: 0.587, 0.648) for clinical evaluators. The overall content validity index was 0.905. Pearson's r correlation for criterion validity was 0.885 (95% CI: 0.804, 0.932). The mean usability score of the items was 4.6 and the median time spent to evaluate each guideline was 20 min. CONCLUSION The instrument performed well in terms of reliability, validity, and efficiency, and can be used for comprehensively evaluating and ranking guidelines.
Reproducibility of Results ; Surveys and Questionnaires ; Practice Guidelines as Topic ; Humans

ObjectiveTo compare the differences in clinical characteristics between kidney deficiency and stasis obstruction syndrome and damp-heat stasis obstruction syndrome in patients with ankylosing spondylitis （AS）， thereby providing reference for clinical differentiation and treatment. MethodsThe clinical data of 2339 patients with AS were collected， including 1075 cases of kidney deficiency and stasis obstruction syndrome and 1264 cases of damp-heat stasis obstruction syndrome. The basic information including age， gender， course of disease， history of ophthalmia， family history and human leukocyte antigen B27 （HLA-B27） positive history， Bath ankylosing spondylitis disease activity index （BASDAI） score， Bath ankylosing spondylitis functional index （BASFI） score， Bath ankylosing spondylitis measurement index （BASMI） score， Depression Anxiety Stress Scale 21 （DASS-21） score， single symptom score in terms of spinal pain， peripheral joint pain， tendon tenderness， morning stiffness degree and morning stiffness time， patient-reported outcomes including patient global assessment （PGA） score， chronic disease therapy function-fatigue scale （FACIT-F） score and night pain visual analog scale （VAS） score， laboratory indicators including serum C-reactive protein （CRP） and erythrocyte sedimentation rate （ESR）， and CT grading of sacroiliitis were measured and compared between groups. ResultsPatients with kidney deficiency and stasis obstruction syndrome were older and had a longer course of disease （P＜0.01）. The BASDAI， BASFI and BASMI scores of the patients with kidney deficiency and stasis obstruction syndrome were 3.84±1.79， 2.78±2.00 and 3.42±2.36， respectively， while those in patients with damp-heat stasis obstruction syndrome were 4.30±1.99， 3.43±2.12， and 2.92±1.76. The BASDAI score， BASFI score， PGA score， FACIT-F score， spinal pain score， peripheral arthralgia score， tendon tenderness score， morning stiffness degree score， depression score， anxiety score， and stress score in patients with damp-heat stasis obstruction syndrome were all higher than those with kidney deficiency and stasis obstruction syndrome， with longer duration of morning stiffness and higher CRP （P＜0.05 or P＜0.01）. BASMI score and night pain VAS score were more higher in patients with kidney deficiency and stasis obstruction syndrome （P＜0.01）. There was no significant difference in the ESR level and CT grading of the sacroiliac joint between the two groups （P＞0.05）. ConclusionAS patients with kidney deficiency and stasis obstruction syndrome have poorer spinal mobility， while those with damp-heat stasis obstruction syndrome have higher disease activity， poorer physical function， and are more prone to adverse psychological reactions.

Objective:To explore the risk factors of surgical site infection after posterior lumbar interbody fusion and internal fixation in elderly patients with lumbar degenerative diseases.Methods:The clinical data of elderly patients who underwent posterior lumbar interbody fusion and internal fixation for degenerative diseases of lumbar spine in Department of Orthopedics, Shanxi Bethune Hospital from January 2019 to December 2021 were retrospectively analyzed.Eighteen elderly patients with postoperative incision infection were included into the infection group, and according to the ratio of 1∶3, 54 elderly patients without incision infection during the same period were randomly selected and included in the non-infection group.The general data of patients, surgical related data and perioperative laboratory indexes were compared between groups using univariate analysis.The screened out indicators with close correlation with incision infection and with significantly statistical significance were included in binary Logistic regression analysis.Risk factors related to postoperative incision infection were analyzed by receiver operating characteristic curve(ROC).The quantitative data of risk factors related to postoperative incision infection were selected for receiver operating characteristic curve(ROC)analysis.Results:When comparing the infected versus non-infected groups, the operative time was(197.1±39.5)min vs.(171.4±37.2)min, preoperative lymphoid count was(1.6±0.5)×10 9/L vs.(1.9±0.6)×10 9/L, and postoperative neutrophil count was[(7.2(6.2-9.5)×10 9/L vs.6.3(4.8-7.2)×10 9/L], percentage of neutrophils(82.5±8.8), % vs.(71.1±6.7), percentage of lymphocytes(1.1±0.6)×10 9/L vs.(1.7±0.7)×10 9/L, percentage of lymphocytes(11.0±5.6)% vs.(19.8±6.0)%, number of neutrophils vs.Lymphocyte count ratio(NLR)[8.5(5.2-15.0) vs.3.6(2.6-4.9)]and serum albumin concentration(31.4±2.5)g/L vs.(33.3±2.4)g/L, all P<0.05).Logistic regression analysis showed that diabetes mellitus( OR=6.649, 95% CI: 1.233-35.853), operation time( OR=1.025, 95% CI: 1.004-1.047), and percentage of postoperative neutrophils( OR=1.261, 95% CI: 1.125-1.414)were independent risk factors of incision infection after posterior interbody fusion and internal fixation in patients with lumbar degenerative diseases(all P<0.05).ROC analysis showed that the area under the curve of operation time was 0.680, and the cut-off value was 177.5 min.The area under the curve of the percentage of neutrophils after operation was 0.841, and the cut-off value was 78.85%. Conclusions:In patients with posterior interbody fusion and internal fixation for lumbar degenerative diseases complicated with diabetes, long operation time, and increased percentage of neutrophils after surgery can independently increase the risk of incision infection.

Objective:To investigate the serotype distribution and phylogenetic analysis of virus complete genome from indigenous dengue patients in Guangzhou in 2019 and provide evidence for the development of prevention and treatment strategies.Methods:Dengue virus serotypes of indigenous dengue cases in 2019 were detected using serotype specific fluorescent PCR kits. Complete genome in the culture was performed on Illumina platform. Phylogenetic analysis was conducted on complete genomes extracted from ViPR and the isolates from this study with MEGA7.0 software.Results:In 2019, three prevalent serotypes of dengue virus were found in Guangzhou, among which serotype 1 accounted for 80.35%, serotype 2 accounted for 12.97% and serotype 3 accounted for 6.68%. There were no significant differences in gender, age and severity among three serotypes. Phylogenetic analysis of virus complete genome showed that serotype 1 belonged to genotypeⅠand had two origins, which was close to the Cambodian strain; serotype 2 belonged to genotype cosmopolitan, which was close to the epidemic strain in Southeast Asia; serotype 3 belonged to genotypeⅢ, which was in the same branch as the Indian strain.Conclusions:The dengue epidemic was caused by dengue virus serotypes 1, 2 and 3 in Guangzhou in 2019. Each serotype belonged to a genotype.

Signal transducer and activator of transcription 3 (STAT3) and Chemokine CX3C ligand 1 (Fractalkine/CX3CL1) play important roles in vascular inflammation and injury. To study if STAT3 promotes vascular endothelial cell proliferation and migration through fractalkine, we overexpressed or knocked down STAT3 in vascular endothelial cells, and used quantitative real-time PCR and Western blotting to determine the effect of STAT3 on fractalkine expression. The wild type and STAT3 binding site mutant fractalkine promoter luciferase reporter plasmids were constructed, and luciferase activity assays were used to explore the effect of STAT3 on the transcriptional activity of the fractalkine promoter. MTT assays were used to detect the effect of overexpression or knockdown of STAT3 or fractalkine on the proliferation rate of vascular endothelial cells. Scratch assays were used to detect the effect of overexpression or knockdown of STAT3 or fractalkine on vascular endothelial cell migration. There results showed that overexpression of STAT3 could promote fractalkine expression, and knockdown of STAT3 could down-regulate fractalkine expression. STAT3 could directly bind to the promoter of fractalkine to promote its transcriptional activity via binding the GAS site of the fractalkine promoter. Knockdown of STAT3 could inhibit the migration of vascular endothelial cell, and overexpression of fractalkine antagonized this inhibition. Our data concluded that STAT3 promotes the proliferation and migration of vascular endothelial cell by binding the GAS site of the fractalkine promoter to promote fractalkine transcriptional activity and expression.
Cell Proliferation ; Chemokine CX3CL1 ; Endothelial Cells ; Promoter Regions, Genetic ; STAT3 Transcription Factor

Objective To explore the guiding role of double volume reconstruction (DVRT) in interventional embolization of intracranial aneurysms. Methods Ninety?six cases of subarachnoid hemorrhage with 115 aneurysms underwent total cerebrovascular angiography and interventional endovascular embolization of intracranial aneurysms in our hospital from January 2017 to December 2017 were retrospectively analyzed. They were randomly divided into observation group (n=48) and control group (n=48) according to random number method. In the control group, guided by the results of 2D?DSA and 3D?DSA 3D reconstruction, the aneurysm neck and tumor were fully exposed with the optimal position. the responsible aneurysms were performed with the interventional endovascular embolization. The operators finished the embolization According to the size and shape of aneurysms and the operative experience. In the observation group, the operators could speculate the embolization density of aneurysms by using the data of 3D reconstruction and digital subtraction reconstruction and adjusted the surgical plan to make the aneurysms had been completely embolized. The baseline data, treatment status, adverse cerebrovascular reaction and recurrence rate of aneurysms were compared between the two groups. All patients in the two groups were operated by Deputy chief surgeons or above of the neurosurgery department. The comparison of the counting data were tested by χ2. The measured data conformed to normal distribution were tested by independent sample t. Results Statistically, There was no significant differences in baseline data including sex, age, blood glucose, blood pressure and cerebral atherosclerosis between the two groups (P>0.05). Comparing the responsible aneurysms in different positions and sizes, the differences was not statistically significant (P>0.05).There was no statistically significant differences in the dosage of contrast media and the cost of operation between the two groups (P>0.05). The radiation dose and operation time in the observation group were smaller and shorter than those in the control group, but there was no statistical differences between the two groups (P<0.05). Statistically, The incidence of rerupture of aneurysm and thrombosis in the observation group was significantly lower than that in the control group (P<0.05). and The incidence of cerebral infarction and the recurrence rate of aneurysm in the observation group were significantly lower than those in the control group (P<0.05). There was no significant difference in sex, age, blood glucose, blood pressure and cerebral atherosclerosis between the two groups (P>0.05).There was no significant difference in the location and size of responsible arterial tumors (χ2=0.148, P=0.929).There was no significant difference in the dosage of contrast agent and the cost of operation between the two groups (t=-0.769, 0.225; P>0.05). The radiation dose and operation time were (479.81 ± 51.21)mGy, (103.52 ± 10.18) minin the observation group and (511.95 ± 53.26)mGy, (114.60 ± 9.51)min in the control group. The difference was statistically significant (t=-1.376,-2.516; P<0.05).There were 1 case of rerupture of aneurysm in the observation group, 4 cases in the control group;There were 0 cases of thrombus, respectively, 3 cases in the control group. The difference was statistically significant (χ2=11.748, 4.256; P<0.05).There were 0 cases postoperative cerebral infarction occurred in the observation group, and aneurysm recurrence in 1 case. Four cases postoperative cerebral infarction occurred in the control group, and aneurysm recurrence in 3 cases, respectively. The difference was statistically significant (χ2=5.719, 10.811; P<0.05). Conclusions The clinical effect of interventional embolization of intracranial aneurysms under the guidance of double volume reconstruction is remarkable, and the effect of interventional embolization and the relationship with the peripheral vessels can be clearly demonstrated. It can reduce the incidence of adverse cerebral vascular reactions and the recurrence rate of aneurysms and reduce the intraoperative risk. It is worthy to be popularized in interventional embolization of intracranial aneurysms and follow?up after operation.