1.Dual immune checkpoint inhibitors combined with anlotinib in the treatment of alveolar soft part sarcoma: a case report
Xinghua FANG ; Wei LI ; Yuhong ZHOU
Chinese Journal of Clinical Medicine 2025;32(1):140-144
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.
2.Guidelines for the diagnosis and treatment of prurigo nodularis.
Li ZHANG ; Qingchun DIAO ; Xia DOU ; Hong FANG ; Songmei GENG ; Hao GUO ; Yaolong CHEN ; Chao JI ; Chengxin LI ; Linfeng LI ; Jie LI ; Jingyi LI ; Wei LI ; Zhiming LI ; Yunsheng LIANG ; Jianjun QIAO ; Zhiqiang SONG ; Qing SUN ; Juan TAO ; Fang WANG ; Zhiqiang XIE ; Jinhua XU ; Suling XU ; Hongwei YAN ; Xu YAO ; Jianzhong ZHANG ; Litao ZHANG ; Gang ZHU ; Fei HAO ; Xinghua GAO
Chinese Medical Journal 2025;138(22):2859-2861
3.Clinical efficacy and safety of a domestic calcipotriol/betamethasone dipropionate ointment in the treatment of stable plaque psoriasis: a multicenter, randomized, double-blind, controlled study
Lixin XIA ; Guang XIANG ; Qingchun DIAO ; Kun HUANG ; Shoumin ZHANG ; Shanshan LI ; Yumei LI ; Zhiqiang SONG ; Qing SUN ; Xiumin YANG ; Meng PAN ; Yuling SHI ; Shuping GUO ; Huiping WANG ; Tiechi LEI ; Xiaoyong ZHOU ; Songmei GENG ; Suchun HOU ; Juan SU ; Yong CUI ; Rixin CHEN ; Yanyan FENG ; Hongxia FENG ; Rushan XIA ; Zudong MENG ; Fang YIN ; Jingjing WANG ; Xinghua GAO
Chinese Journal of Dermatology 2025;58(11):1020-1026
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.
4.Effect of differences in vertebral cortical bone reinforcement on biomechanics of osteoporotic vertebral compression fractures
Wei FANG ; Xinghua HUANG ; Bo QU ; Hongsheng YANG
Chinese Journal of Tissue Engineering Research 2025;29(21):4430-4438
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.
5.Clinical efficacy and safety of a domestic calcipotriol/betamethasone dipropionate ointment in the treatment of stable plaque psoriasis: a multicenter, randomized, double-blind, controlled study
Lixin XIA ; Guang XIANG ; Qingchun DIAO ; Kun HUANG ; Shoumin ZHANG ; Shanshan LI ; Yumei LI ; Zhiqiang SONG ; Qing SUN ; Xiumin YANG ; Meng PAN ; Yuling SHI ; Shuping GUO ; Huiping WANG ; Tiechi LEI ; Xiaoyong ZHOU ; Songmei GENG ; Suchun HOU ; Juan SU ; Yong CUI ; Rixin CHEN ; Yanyan FENG ; Hongxia FENG ; Rushan XIA ; Zudong MENG ; Fang YIN ; Jingjing WANG ; Xinghua GAO
Chinese Journal of Dermatology 2025;58(11):1020-1026
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.
6.Effect of differences in vertebral cortical bone reinforcement on biomechanics of osteoporotic vertebral compression fractures
Wei FANG ; Xinghua HUANG ; Bo QU ; Hongsheng YANG
Chinese Journal of Tissue Engineering Research 2025;29(21):4430-4438
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.
7.Liver transplantation for adult hepatolenticular degeneration
Xinghua HUANG ; Lizhi LYU ; Yi JIANG ; Fang YANG ; Jianyong LIU ; Huanzhang HU ; Qiucheng CAI
Chinese Journal of Digestive Surgery 2023;22(S1):91-93
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.
8.Clinical efficacy of liver transplantation for Wilson's disease
Xinghua HUANG ; Yi JIANG ; Lizhi LV ; Yuyang GUO ; Xiangyu PENG ; Huanzhang HU ; Jianyong LIU ; Qiucheng CAI ; Fang YANG ; Chuan JIANG
Chinese Journal of Organ Transplantation 2022;43(6):358-363
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.
9.Quality control of lymph node dissection in radical lung cancer resection
CHENG Xinghua ; YAO Feng ; LUO Qingquan ; FANG Wentao
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2018;25(12):1020-1026
As a standard of care, lymph node dissection is an indispensible step in lung cancer surgery. The quality of dissection determines completeness of surgery and the accuracy of N staging. Hereby, we suggest labeling all surgically resected nodes according to the new lymph node map in the 8th TNM classification for lung cancer. As systematic lymph node dissection remains the gold standard of lymphadenectomy, at least three mediastinal stations and ten nodes should be removed in an en-bloc fashion, if possible. For patients with stage Ⅰ lung cancer, lymph node dissection via video-assisted thoracoscopic surgery (VATS) or open thoracotomy may has similar oncological outcome. Besides, limited lymph node sampling in selected patients with early staged lung cancer to minimize unnecessary surgical damage still need further investigation.
10.Biliary complications and recovery of liver function after liver transplantation from citizen's deceased donors versus standard criteria donors
Huaxiang WANG ; Ruisheng KE ; Yi JIANG ; Fang YANG ; Qiucheng CAI ; Xinghua HUANG ; Jianyong LIU ; Dongmei YE ; Aiping WU
Chinese Journal of Hepatobiliary Surgery 2018;24(7):437-441
Objective To investigate the biliary complications and recovery of liver function after liver transplantation from citizen's deceased donors (DCD) versus standard criteria donors (SCD).Method The clinical data of 269 patients who underwent orthotopic liver transplantation from January 2009 to December 2016 at the Fuzhou General Hospital were collected.197 livers were from SCD and 72 from DCD.Propensity score matching (PSM) was used to compare the biliary complications and recovery of liver function after liver transplantation in the two groups.Results PSM matched 61 pairs of patients.There were 10 (16.4%) and 8 (13.1%) biliary complications in the DCD and the SCD groups,respectively,with no significant difference between them (P > 0.05).The recovery of liver function was significantly delayed in the DCD group when compared with the SCD group.The levels of ALT,AST,GGT and AKP in the DCD group were significant different on the postoperative first,third,fifth,seventh and fourteenth day (P < 0.05).At 30 days after surgery,there was no significant difference in liver function between the two groups.Conclusions Liver grafts from DCD had a significant impact on the recovery of liver function.When compared with the SCD group,the DCD group recovered significantly slower in liver function.There was no significant increase in the incidence of biliary complications.


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