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.

BACKGROUND/OBJECTIVES: To identify modifiable risk factors for type 2 diabetes mellitus and explore the relationship between diet sodium intake and blood glucose levels.MATERIALS/METHODS: Based on inclusion and exclusion criteria, we extracted, analyzed, and assessed the available crossover studies of dietary salt intake restriction and insulin resistance in PubMed, Web of Science, MEDLINE, Embase, Wanfang, and CNKI databases. RESULTS: We included 6 studies with 8 sets of data, covering 485 subjects. I2 statistics results showed insignificant heterogeneity among all data (I 2 = 39.2% < 50%). Thus, a fixed-effect model was adopted for the final pooled effect size. Weighted mean difference and its 95% confidence interval (CI) value was 0.193 (95% CI, 0.129–0.257), and the test of the overall effect showed P < 0.001. The results revealed that the blood glucose levels in the subjects in the low-salt intake group were significantly higher than those in the normal or high-salt intake groups. We also found no significant change occurred after the removal of any study through sensitivity analysis, which confirmed that the outcome we calculated was prudent and credible. The quantitative Egger’s test (P = 0.109 > 0.05) indicated that insignificant publication bias existed. CONCLUSION This meta-analysis highlights the relationship between dietary sodium intake and blood glucose levels. Our findings show that higher blood glucose levels might be expected in hypertensive or normal people with low-salt consumption compared to those with normal or high-salt consumption, although these differences were not clinically significant.Trial Registration: PROSPERO Identifier: CRD42021256998

Objective:To retrospectively analyze the pregnancy outcomes of patients with adenomyosis requiring fertility in a single center under real world condition.Methods:From June 2015 to May 2020, 231 cases of pregnancy complicated with adenomyosis diagnosed by ultrasound with fertility requirements were treated in the Women′s and Children′s Hospital Affiliated to Qingdao University with complete clinical data. And they were divided into three groups according to the treatment of adenomyosis before pregnancy: expectation group, drug group and operation group. The relevant data before pregnancy of the three groups were analyzed, and the pregnancy outcomes of the patients were summarized. According to whether the early pregnancy was treated with medication, the patients who were naturally conceived without symptoms of threatened abortion were divided into observation group and fetus protection group, and the pregnancy outcomes of the two groups were compared.Results:(1) Compared with the expectation group, the ages of patients in the drug group and the operation group were larger [(31.5±1.8) vs (34.1±3.7) vs (36.9±3.6) years old], and the difference was statistically significant ( P<0.05). Only 9 patients (11.5%, 9/78) had clinical symptoms in the expectation group, while the patients in the drug group and the operation group had a higher proportion of dysmenorrhea and increased menstrual volume. The uterine volume of the drug group and the operation group were larger than that of the expectation group [(151±46) vs (166±27) vs (97±18) cm 3], the difference was statistically significant ( P<0.05). 78.6% (33/42) of the operation group were focal adenomyosis. The proportion of natural pregnancy in the expectation group was 97.4% (76/78), and in vitro fertilization and embryo transfer was mainly used in the drug group and the operation group. (2) The abortion rates of the three groups were 48.7% (26/111), 4/17, 67.5% (27/78) respectively. Compared with the drug group and the operation group, the preterm birth rate was lower [55.9% (33/111) vs 11/17 vs 12.5% (5/78)] and the natural delivery rate was higher [44.1% (26/111) vs 4/17 vs 67.5% (27/78)] in the expectation group. (3) There were 89 cases of spontaneous pregnancy without threatened abortion symptoms, including 31 cases in the observation group and 58 cases in the fetus protection group. Compared with the observation group, the abortion rate of patients in the fetus protection group was lower [41.9% (13/31) vs 34.5% (20/58)], and the difference was statistically significant ( P<0.05). Conclusions:Patients with adenomyosis who have fertility requirements should be comprehensively evaluated and individualized treatment plans should be given. Pregnancy patients with adenomyosis have a high rate of miscarriage, and they should be included in the management of high-risk pregnant women. Active fetal protection treatment during early pregnancy might improve pregnancy outcomes.

Tumor radiotherapy is established on the basis of clinical oncology, radio-physics and radiobiology, and has become one of the three major therapeutic methods for malignant tumors. With the pace of socialist construction in China, the subject of radiotherapy in Shanxi province has developed from scratch and from small to large for more than 60 years. Remarkable achievements have been made in the establishment of departments, the updating of technical equipment, the increase of employees and clinical scientific research. This article reviews and summarizes the development history of tumor radiotherapy in Shanxi province.

This paper summarized nursing points for caring 12 cases undergoing endoscopic ultrasonography guided biliary drainage(EUS-BD) in the treatment of malignant obstructive jaundice.All patients received EUS-BD after unsuccessful endoscopic retrograde cholangiopancreatography,including 5 patients undergoing EUS guided hepaticogastrostomy(EUS-HGS) and 7 patients undergoing EUS guided choledochoduodenostomy(EUS-CDS).Nursing points included:preoperative assessment,psychological care,preoperative gastrointestinal preparation,intraoperative cardiopulmonary function monitoring,collaboration in operation,postoperative monitoring,observation and nursing care for complications such as bleeding,bile leakage and the others.The average hospital stay was 10～16 d.Two patients developed complications(16.67％).A patient undergoing EUS-HGS developed bile leakage,biliary peritonitis,and pneumoperitoneum after the procedure,but was successfully recovered by placement of a second fully covered self-expendable metal stent in the primary metal stent,percutaneous abdominal drainage and antibiotic treatment.A patient undergoing EUS-CDS developed gastrointestinal bleeding,and was successfully treated with radiological intervention.

Objective To analyze the efficacy of endoscopic ultrasonography-guided biliary drainage ( EUS-BD) for malignant obstructive jaundice and the management of adverse events. Methods Clinical data of 12 patients with malignant obstructive jaundice, who underwent EUS-BD between April 2016 and January 2017, were retrospectively analyzed. All patients received EUS-BD after unsuccessful ERCP, including EUS-guided hepaticogastrostomy ( EUS-HGS ) , EUS-guided antegrade stenting ( EUS-AS ) , and EUS-guided choledochoduodenostomy(EUS-CDS). Procedure outcomes, serum bilirubin and liver enzyme levels before the procedure and 1 week after, complications, treatment results, hospitalization time and follow-up were recorded. Results Two patients underwent EUS-HGS, 3 underwent EUS-AS, and 7 underwent EUS-CDS. Total bilirubin ( t=3. 462, P=0. 005 ) , direct bilirubin ( t=3. 351, P=0. 006 ) , alanine transaminase (t=2. 399, P=0. 037), γ-glutamate transpeptidase (t=3. 256, P=0. 031) reduced significantly after the procedure. Two patients ( 16. 67％) developed complications. A patient undergoing EUS-HGS developed bile leakage, biliary peritonitis, and pneumoperitoneum. A patient undergoing EUS-CDS developed upper gastrointestinal bleeding. Both patients were successfully treated. There were no other adverse events, such as acute pancreatitis, subcutaneous emphysema, pneumothorax and emphysema. No procedure-related death occurred. The mean hospital stay was 13. 75 ± 6. 92 days ( range 5-26 days ) . Conclusion EUS-BD is a safe substitute after unsuccessful ERCP when performed by experienced biliary endoscopists. However, intensive care is necessary after the procedure for early detection and management of complications.

Objective To evaluate effects of flush fluid of different temperatures on pain, comfort and adverse reactions in patients receiving choledochoscopy via T tube for residual bile duct stones. Methods Patients who underwent choledochoscopy were divided into the experimental group ( 36℃ saline was used as flush fluid) and control group ( room temperature saline was used as flush fluid) randomly. Pain degree, comfort degree, procedure time, the total amount of flush fluid, infusion speed and adverse reactions were recorded and analyzed. Results A total of 100 cases were included, 50 cases in each group. There was no significant difference between the two groups in their education level, working condition, operation methods, T-tube size, necessity for lithotripsy, procedure time, total amount of flush fluid and infusion speed (all P>0. 05). The pain scores were 1. 0(1. 00, 2. 00) and 2. 0(1. 00, 3. 25) (Z=-2. 158,P=0. 031) and the comfort scores were 6. 0(5. 00, 7. 25) and 5. 0(2. 00, 6. 00) (Z=-3. 384,P=0. 001) in the experimental group and the control group, respectively. There was significant difference in the change rate of heart rate during and before procedure between the two groups (-4. 07％± 10. 76％ VS 0. 30％± 10. 23％, P=0. 046) . The incidence of postoperative diarrhea in the experimental group and the control group was 6％( 3/50) and 22％ ( 11/50 ) , respectively (χ2=5. 316, P=0. 021 ) . Conclusion 36℃ saline flush can reduce pain scores, improve comfort degree and reduce the incidence of postoperative diarrhea after procedure in patients undergoing choledochoscopy via T tube.

Objective To evaluate the anatomic morphology of submandibular fossa. Methods Cone-beam computed tomography (CBCT) was used to analyze the anatomic morphology of submandibular fossa. Implants of various dimensions were virtually placed into the mandibular 1st and 2nd molar region. Spatial relationships among submandibular fossa , mandibular canal and implant were analyzed. Results The depth of the submandibular fossa was (1.0 ± 0.61)mm in the 1st molar region and (1.5 ± 0.61)mm in the 2nd molar region. There were no significant statistical difference in genders, sides, and tooth loss. The length of the implants was (19.7 ± 3.75)mm (d = 4 mm) and (18.6 ± 3.73)mm (d = 5 mm) in the 1st molar region and (16.2 ± 3.46) mm (d = 4 mm) and (15.2 ± 3.09)mm (d = 5 mm) in the 2nd molar region in patiens with teeth and lingual perforation; the length of the implants was (17.1 ± 3.77)mm (d = 4 mm) and (15.6 ± 3.85)mm (d = 5 mm), and (14.2 ± 4.05)mm (d = 4 mm) and (13.2 ± 4.27)mm (d = 5 mm) in patients with tooth loss, respectively. Conclusions Determination of spatial relationships among submandibular fossa , mandibular canal and implants by using CBCT has important significance in guiding dental implant surgery.

Objective:This study aims to determine the efficacy of chemotherapy and to identify potential chemotherapy agents for advanced primary duodenal carcinoma (PDC). Methods:Fifty-six patients with advanced PDC, who did and did not receive chemo-therapy, were involved in this study. Response rates (RR), disease control rates (DCR), progression-free survival (PFS), and overall sur-vival (OS) were analyzed. Results:The overall RR and DCR of 43 patients were 19.04%and 71.42%, respectively. The patients who re-ceived chemotherapy agents fluorourzcil and oxaliplatin exhibited higher RR compared with patients who received other chemotherapy combinations (35.29%vs. 7.69%, P=0.010 9). Palliative chemotherapy improved the OS of patients with advanced PDC compared with patients who did not receive chemotherapy (13.35 months vs. 5.65 months, HR=0.203, 95%CI:0.083 to 0.497, P=0.000 5). Compared with the use of other chemotherapy regimens, treatment with a fluorourzcil-based chemotherapy agent resulted in a longer PFS (5.08 months vs. 1.08 months, HR=0.004, 95%CI:0.000 to 0.315, P=0.013 2). Multivariate analysis indicated mucinous histology and lymph mode metastasis as factors predictive of poor prognosis in patients with advanced PDC. Conclusion:Palliative chemotherapy may im-prove the OS of patients with advanced PDC.