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:The cortical bone reinforcement area of bone cement in the vertebral body during percutaneous vertebroplasty for osteoporotic vertebralcompression fractures has an important influence on spinal biomechanics and clinical efficacy,but previous studies were mostly limited to the two-dimensional level. OBJECTIVE:To investigate the effect of the difference in cortical bone reinforcement of bone cement in the three-dimensional plane of the vertebral bodyon the biomechanical distribution of the vertebral body,adjacent intervertebral disc and endplate in osteoporotic vertebral compression fractures by finite element analysis during percutaneous vertebroplasty,so as to evaluate its effect.METHODS:The finite element model of percutaneous vertebroplasty for osteoporotic vertebral compression fractures of T12 vertebrae was established. The presence or absence of cortical reinforcement of bone cement was analyzed in groups from the transverse,sagittal and coronal planes. The effects of cortical reinforcement on the biomechanics of T12 vertebral cancellous bone,cortical bone,T11/T12 intervertebral disc,T12/L1 intervertebral disc,T11 lower endplate,and L1 upper endplate under different body position changes were studied.RESULTS AND CONCLUSION:(1) Under the effect of vertical compression force,percutaneous vertebroplasty cortical reinforcement with or without bone cement had no significant changes in structural stress except for the injured vertebral cortical bone. (2) The Von Mises stress value of the injured cortical bone was significantly different in human forward flexion,left/right bend,and left/right axial rotation. The maximum Von Mises stress value in the best group of cortical reinforcement was significantly smaller than that in the non-cortical reinforcement group. The Von Mises stress value showed a downward trend with extensive cortical reinforcement in the same plane. (3) It is indicated that when percutaneous vertebroplasty is performed,bone cement should be distributed as broadly and symmetrically horizontally along the cortical edge of the vertebral body as far as possible in cross section. Bone cement in sagittal plane should be widely distributed longitudinally near the upper and lower endplates and the anterior and posterior walls. Bone cement in coronal plane should be widely distributed on both sides of the midline while symmetrically touching the upper and lower endplates and lateral walls. It can effectively avoid the risk of refracture of the injured vertebra and does not increase the risk of adjacent vertebral fracture and residual discogenic pain.

Clinical data of a patient with alveolar soft part sarcoma (ASPS) treated at Zhongshan Hospital, Fudan University were retrospectively analyzed. The patient was initially diagnosed with abdominal ASPS with multiple lung metastases. After 6 weeks of treatment with nivolumab and ipilimumab, the patient achieved stable disease (SD). In the 7th week, the treatment was changed to a combination of nivolumab (30 mg, d1, q3w), anlotinib (8 mg, d1-14, q3w) and ipilimumab (50 mg, d1, q6w). The patient remained SD at the 12th week. The patient then underwent iliac artery embolization and intensity-modulated radiation therapy for the lesion in the psoas major muscle, while continuing the combination treatment. By the 24th week, the evaluation showed partial remission (PR) of both primary tumor and lung metastases. The patient experienced mild adverse reactions during treatment.

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:The cortical bone reinforcement area of bone cement in the vertebral body during percutaneous vertebroplasty for osteoporotic vertebralcompression fractures has an important influence on spinal biomechanics and clinical efficacy,but previous studies were mostly limited to the two-dimensional level. OBJECTIVE:To investigate the effect of the difference in cortical bone reinforcement of bone cement in the three-dimensional plane of the vertebral bodyon the biomechanical distribution of the vertebral body,adjacent intervertebral disc and endplate in osteoporotic vertebral compression fractures by finite element analysis during percutaneous vertebroplasty,so as to evaluate its effect.METHODS:The finite element model of percutaneous vertebroplasty for osteoporotic vertebral compression fractures of T12 vertebrae was established. The presence or absence of cortical reinforcement of bone cement was analyzed in groups from the transverse,sagittal and coronal planes. The effects of cortical reinforcement on the biomechanics of T12 vertebral cancellous bone,cortical bone,T11/T12 intervertebral disc,T12/L1 intervertebral disc,T11 lower endplate,and L1 upper endplate under different body position changes were studied.RESULTS AND CONCLUSION:(1) Under the effect of vertical compression force,percutaneous vertebroplasty cortical reinforcement with or without bone cement had no significant changes in structural stress except for the injured vertebral cortical bone. (2) The Von Mises stress value of the injured cortical bone was significantly different in human forward flexion,left/right bend,and left/right axial rotation. The maximum Von Mises stress value in the best group of cortical reinforcement was significantly smaller than that in the non-cortical reinforcement group. The Von Mises stress value showed a downward trend with extensive cortical reinforcement in the same plane. (3) It is indicated that when percutaneous vertebroplasty is performed,bone cement should be distributed as broadly and symmetrically horizontally along the cortical edge of the vertebral body as far as possible in cross section. Bone cement in sagittal plane should be widely distributed longitudinally near the upper and lower endplates and the anterior and posterior walls. Bone cement in coronal plane should be widely distributed on both sides of the midline while symmetrically touching the upper and lower endplates and lateral walls. It can effectively avoid the risk of refracture of the injured vertebra and does not increase the risk of adjacent vertebral fracture and residual discogenic pain.

A 24-year-old male patient was admitted to the Organ Transplant Department of the 900th Hospital of the Joint Logistic Support Force on March 13, 2000, due to repeated abdominal distension accompanied by edema of both lower limbs for more than 7 months and aggravated for 1 month. Clinical diagnosis: hepatolenticular degeneration, metabolic encephalopathy, decompensated stage of cirrhosis. Orthotopic liver transplantation was performed under general anesthesia on March 24, 2000. The postoperative recovery is smooth, and the patient has survived for more than 23 years, with normal life and work.

Objective:To explore the clinical efficacy of liver transplantation for Wilson's disease(WD).Methods:From January 1999 to November 2021, clinical data were retrospectively reviewed for 16 recipients with WD undergoing liver transplantation.There were 9 males and 7 females with an age range of 29.5(14~54)years.They were followed up by telephone, outpatient services and hospitalization.The starting point of follow-up was operation date.And recipient death was an endpoint.Postoperative survival, improvement of neuropsychiatric symptom, changes of corneal K-F ring, altered levels of liver function and serum copper-protein at Month 1 post-operation were observed.The follow-up deadline was November 24, 2021.Results:15 recipients underwent classical orthotopic liver transplantation and the other one recipient underwent living-related liver transplantation.No perioperative deaths occurred.All 16 recipients were followed up for 122(6~260)months.The 1-, 5-, and 10-year survival rates were 93.8%、85.2%and 75.8%, respectively.Among 10 recipients with corneal K-F ring positive with varying degrees after operation and was disappeared in 2 recipients at 7 and 11 months.Among 5 recipients with neuropsychiatric manifestation, 4 recipients showed ameliorative neuropsychic symptoms with varying degrees after operation and 1 recipient died.All the levels of liver function and serum copper-protien of all recipients recovered obviously in 1 month and the 1-, 5-, and 10-year post-operation.Conclusions:Classical orthotopic liver transplantation and living-related liver transplantation not only effectively improves copper metabolism of patient with WD and relieves their severe neurological manifestation, but also improves their life and prolongs survival, which is worthy of clinical promotion.

Objective To study the clinical value of the conventional liver function tests in liver reserve function assessment for large hepatocellular carcinoma.Methods The clinicopathological data of 113 patients with ChildPugh A hepatocellular carcinoma who underwent radical resection with large hepatocellular carcinoma in the Department of Hepatobiliary Surgery of Fuzhou General Hospital of People's Liberation Army from January 2014 to December 2016 were retrospectively analyzed.The patients were divided into two groups according to the recovery of postoperative liver function,which 105 patients recovered well and 8 patients had hepatic decompensation among them.The liver function index of two groups were analyzed.Measurement data with approximately normal distribution were represented by and groups were compared using t test;measurement data with skewed or uneven disstribution were represented by M (range)and group werecompared using Man-Whitney U test;count data were compared using Fisher exact test;risk factors for postoperative liver dysfunction were analyzed using Logistic single factor and multivariate and ROC curve were drawn.Results Preoperative prothrombin time,international standardization ratio,platelet,prealbumin,total bilirubin,alkaline phosphatase,γ-glutamyl transpeptidase comparison between the two groups were statistically significant (Z =-1.983,-2.180,-2.608,-2.007,-3.577,-2.228,-2.575,P ＜ 0.05).Logistic univariate analysis showed that platelet,total bilirubin and prealbumin were the risk factors for the recovery of liver function of radical resection hepatic decompensation with large hepatocellular carcinoma.Logistic multivariate regression analysis showed that preoperative high total bilirubin and low preabumin were independent risk factors of radical resection hepatic decompensation with large hepatocellular carcinoma.Logistic univariate analysis showed that preoperative high total bilirubin and low prealbumin were not risk factors of radical resection liver failure with large hepatocellular carcinoma.The area under the curve of total bilirubin was 0.880,P =0.000,95％ CI:0.808-0.953,the sensitivity was 87.5％,specificity was 84.8％ and the area under prealbumin curve was 0.769,P =0.011,95％ CI:0.648-0.891,sensitivity was 75.2％,specificity was 77.5％ by the ROC curve.The best threshold of total bilirubin and prealbumin after radical resection with large hepatocellular carcinoma were 17.55 μmol/L and 0.18 g/L respectively by the ROC curve.Conclusion The Child-Pugh A patients in radical resection hepatic decompensation with large hepatocellular carcinoma recover well when the preoperative liver function is as follows:total bilirubin ＜ 17.55 μmol/L and prealbumin ≥0.18 g/L.

Objective To investigate the feasibility of liver transplantation in the treatment of inoperable hilar cholangiocarcinoma. Methods The clinical data for 3 patients with unresectable hilar cholangiocarcinoma who underwent liver transplantation in the Department of Hepatobiliary Surgery of Fuzhou General Hospital of People's Liberation Army from January 2006 to December 2012 were retrospectively analyzed. The patients were followed up by phone, outpatient service, and hospitalization. The starting point of the follow-up was the operation date. The patients death was the end point. The clinical and pathological features, postoperative survival, tumor recurrence, and prognostic factors were observed. The follow-up deadline was December 2017. Results All 3 patients underwent classical orthotopic liver transplantation using retrograde perfusion through inferior vena cava and no perioperative deaths occurred. All 3 patients were followed up for 10 to 132 months. During the follow-up period, of 1 patient who died of tumor recurrence, the pathological TNM stage was T4a N1 M0, and both had Union for International Cancer Control stage Ⅳa, and the tumor-free survival time was 3 months, and the survival time was12 months. Of 1 patient who died of other causes, the pathological TNM stage was T3N1 M0, and both had Union for International Cancer Control stage Ⅲ, and the tumor-free survival time was 12 months, and the survival time was12 months. One case as of the end of follow-up, the patient has survived for 132 months, the pathological TNM staging was T2a NOM0, and both had Union for International Cancer Control stage Ⅱ. Conclusions Lymph node positive and high pathological TNM stage were poor prognosis factor for hilar cholangiocarcinoma who underwent liver transplantation. Patients with early hilar cholangiocarcinoma who don't have lymph node metastasis are expected to benefit from liver transplantation.