1.Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex ? for patients with premenopausal breast cancer
Xiying SHAO ; Qingyuan ZHANG ; Zhaofeng NIU ; Man LI ; Jingfen WANG ; Zhanhong CHEN ; Ruizhen LUO ; Guangdong QIAO ; Jianguo WANG ; Liyuan QIAN ; Ronghua YANG ; Zhendong CHEN ; Jian WANG ; Yumin YAO ; Jianghua OU ; Tao SUN ; Qiao CHENG ; Yongsheng WANG ; Jian HUANG ; Hongying ZHAO ; Wuyun SU ; Zhong OUYANG ; Yu DING ; Lilin CHEN ; Sumei YANG ; Mengsheng CUI ; Aimin ZANG ; Enxiang ZHOU ; Peizhi FAN ; Jing ZHANG ; Qiang LIU ; Yuee TENG ; Hui LI ; Jianyun NIE ; Jin YANG ; Xiaojia WANG ; Zefei JIANG
Chinese Journal of Oncology 2025;47(4):340-348
Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.
2.Clinical guideline for diagnosis and treatment of nonunion of osteoporotic vertebral fractures (version 2025)
Haipeng SI ; Le LI ; Junjie NIU ; Wencan ZHANG ; Fuxin WEI ; Jinqiu YUAN ; Qiang YANG ; Hongli WANG ; Guangchao WANG ; Shihong CHEN ; Yunzhen CHEN ; Xiaoguang CHENG ; Jianwen DONG ; Shiqing FENG ; Rui GU ; Yong HAI ; Tianyong HOU ; Bo HUANG ; Xiaobing JIANG ; Lei ZANG ; Chunhai LI ; Nianhu LI ; Hua LIN ; Hongjian LIU ; Peng LIU ; Xinyu LIU ; Sheng LU ; Shibao LU ; Chunshan LUO ; Lvy CHAOLIANG ; Lvy WEIJIA ; Xuexiao MA ; Wei MEI ; Chunyang MENG ; Cailiang SHEN ; Chunli SONG ; Ruoxian SONG ; Jiacan SU ; Honglin TENG ; Hui SHENG ; Beiyu WANG ; Bingwu WANG ; Liang WANG ; Xiangyang WANG ; Nan WU ; Guohua XU ; Yayi XIA ; Jin XU ; Youjia XU ; Jianzhong XU ; Cao YANG ; Maowei YANG ; Zibin YANG ; Xiaojian YE ; Hailong YU ; Xijie YU ; Hua YUE ; Zhili ZENG ; Xinli ZHAN ; Hui ZHANG ; Peixun ZHANG ; Wei ZHANG ; Zhenlin ZHANG ; Jianguo ZHANG ; Tengyue ZHU ; Qiang LIU ; Huilin YANG
Chinese Journal of Trauma 2025;41(10):932-945
Nonunion of osteoporotic vertebral fractures (OVF), predominantly affecting the elderly, can lead to intractable pain, vertebral collapse, progressive kyphotic deformity, and neurological impairment, significantly compromising patients′ quality of life. There exists considerable debate on diagnosis and management of OVF, encompassing key issues such as clinical diagnosis and staging criteria for nonunion, surgical indications and procedure selection, and postoperative rehabilitation planning. Currently, there lacks standardized clinical guideline and expert consensus on the diagnosis and management of OVF nonunion in China. To address this gap, Minimally Invasive Surgery Group of Chinese Orthopedic Association, Osteoporosis Committee of Chinese Association of Orthopedic Surgeons, Prevention and Rehabilitation Committee for Osteoporosis of Chinese Association of Rehabilitation Medicine and Minimally Invasive Orthopedic Surgery Branch of China Association for Geriatric Care jointly organized domestic experts in spinal surgery, endocrinology, and rehabilitation to formulate the Clinical guideline for the diagnosis and treatment for nonunion of osteoporotic vertebral fractures ( version 2025), based on existing literature and clinical experience and adhering to principles of scientific rigor and practicality. The guideline provided 13 evidence-based recommendations encompassing diagnosis and treatment of OVF nonunion, aiming to standardize its clinical management.
3.Clinical guideline for diagnosis and treatment of nonunion of osteoporotic vertebral fractures (version 2025)
Haipeng SI ; Le LI ; Junjie NIU ; Wencan ZHANG ; Fuxin WEI ; Jinqiu YUAN ; Qiang YANG ; Hongli WANG ; Guangchao WANG ; Shihong CHEN ; Yunzhen CHEN ; Xiaoguang CHENG ; Jianwen DONG ; Shiqing FENG ; Rui GU ; Yong HAI ; Tianyong HOU ; Bo HUANG ; Xiaobing JIANG ; Lei ZANG ; Chunhai LI ; Nianhu LI ; Hua LIN ; Hongjian LIU ; Peng LIU ; Xinyu LIU ; Sheng LU ; Shibao LU ; Chunshan LUO ; Lvy CHAOLIANG ; Lvy WEIJIA ; Xuexiao MA ; Wei MEI ; Chunyang MENG ; Cailiang SHEN ; Chunli SONG ; Ruoxian SONG ; Jiacan SU ; Honglin TENG ; Hui SHENG ; Beiyu WANG ; Bingwu WANG ; Liang WANG ; Xiangyang WANG ; Nan WU ; Guohua XU ; Yayi XIA ; Jin XU ; Youjia XU ; Jianzhong XU ; Cao YANG ; Maowei YANG ; Zibin YANG ; Xiaojian YE ; Hailong YU ; Xijie YU ; Hua YUE ; Zhili ZENG ; Xinli ZHAN ; Hui ZHANG ; Peixun ZHANG ; Wei ZHANG ; Zhenlin ZHANG ; Jianguo ZHANG ; Tengyue ZHU ; Qiang LIU ; Huilin YANG
Chinese Journal of Trauma 2025;41(10):932-945
Nonunion of osteoporotic vertebral fractures (OVF), predominantly affecting the elderly, can lead to intractable pain, vertebral collapse, progressive kyphotic deformity, and neurological impairment, significantly compromising patients′ quality of life. There exists considerable debate on diagnosis and management of OVF, encompassing key issues such as clinical diagnosis and staging criteria for nonunion, surgical indications and procedure selection, and postoperative rehabilitation planning. Currently, there lacks standardized clinical guideline and expert consensus on the diagnosis and management of OVF nonunion in China. To address this gap, Minimally Invasive Surgery Group of Chinese Orthopedic Association, Osteoporosis Committee of Chinese Association of Orthopedic Surgeons, Prevention and Rehabilitation Committee for Osteoporosis of Chinese Association of Rehabilitation Medicine and Minimally Invasive Orthopedic Surgery Branch of China Association for Geriatric Care jointly organized domestic experts in spinal surgery, endocrinology, and rehabilitation to formulate the Clinical guideline for the diagnosis and treatment for nonunion of osteoporotic vertebral fractures ( version 2025), based on existing literature and clinical experience and adhering to principles of scientific rigor and practicality. The guideline provided 13 evidence-based recommendations encompassing diagnosis and treatment of OVF nonunion, aiming to standardize its clinical management.
4.Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex ? for patients with premenopausal breast cancer
Xiying SHAO ; Qingyuan ZHANG ; Zhaofeng NIU ; Man LI ; Jingfen WANG ; Zhanhong CHEN ; Ruizhen LUO ; Guangdong QIAO ; Jianguo WANG ; Liyuan QIAN ; Ronghua YANG ; Zhendong CHEN ; Jian WANG ; Yumin YAO ; Jianghua OU ; Tao SUN ; Qiao CHENG ; Yongsheng WANG ; Jian HUANG ; Hongying ZHAO ; Wuyun SU ; Zhong OUYANG ; Yu DING ; Lilin CHEN ; Sumei YANG ; Mengsheng CUI ; Aimin ZANG ; Enxiang ZHOU ; Peizhi FAN ; Jing ZHANG ; Qiang LIU ; Yuee TENG ; Hui LI ; Jianyun NIE ; Jin YANG ; Xiaojia WANG ; Zefei JIANG
Chinese Journal of Oncology 2025;47(4):340-348
Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.
5.Influences of sufentanil on inflammatory response and chondrocyte apoptosis in osteoarthritis rats by modulating Ras/Raf/MEK/ERK signaling pathway
Hongyuan ZHANG ; Teng ZHANG ; Jianguo DU ; Hong TAO
Chinese Journal of Immunology 2024;40(10):2071-2075,2082
Objective:To investigate the influences of sufentanil(Suf)on the inflammatory response and chondrocyte apopto-sis in rats with osteoarthritis(OA)by modulating Ras/Raf/mitogen-activated protein kinase kinase(MEK)/extracellular signal-regulated kinase(ERK)signaling pathway.Methods:SD rats were grouped into normal control group(NC group),blank control group(Blank group),low-dose Suf group(Suf-L group,1 μg/kg),high-dose Suf group(Suf-H group,5 μg/kg),Diacerein group(DC group,54 mg/kg),and Suf-H+ML-099(Ras/Raf/MEK/ERK pathway activator)group(5 μg/kg Suf+11.7 mg/kg ML-099),with 12 rats in each group.Except for the NC group,the other groups were all constructed OA rat models by transection of the medial meniscus tibial ligament of the right knee joint.After the modeling was successful,the corresponding drug treatment was carried out,and the rats in the NC group and the Blank group were intraperitoneally injected and gavaged with the same amount of normal saline,administer once a day for 3 weeks.Twenty-four hours after the last administration,the changes of tenderness threshold and thermal pain threshold of rats were monitored;serum levels of TNF-α,IL-1β and IL-6 were detected by ELISA;Safranin O-Fast green staining was used to detect the pathological changes of cartilage tissue;TUNEL staining was used to detect chondrocyte apoptosis;Western blot was used to detect the expressions of Ras/Raf/MEK/ERK signaling pathway protein and matrix metalloproteinase 13(MMP-13)protein in carti-lage tissue.Results:Compared with NC group,the tenderness threshold and heat pain threshold of rats in Blank group were decreased(P<0.05),and the pathological injury of cartilage tissue was serious,TNF-α,IL-1β,IL-6 levels,Mankin score,chondrocyte apopto-sis rate,Ras,Raf,MEK,p-ERK1/2,MMP-13 protein expressions were increased(P<0.05);compared with the Blank group,the change trends of the corresponding indicators in Suf-L group,Suf-H group and DC group were opposite to the above(P<0.05);ML-099 attenuated the effect of high dose Suf on OA rats.Conclusion:Suf may attenuate the inflammatory response and chondrocyte apoptosis in OA rats by inhibiting the Ras/Raf/MEK/ERK signaling pathway.
6.The mechanism of iNKT2 cell improving lipid deposition in the liver of nonalcoholic fatty liver mice
Jingfang TENG ; Xiang GAO ; Jianguo WANG ; Rui LIANG ; Dongzhi CHEN ; Ming MENG
Chinese Journal of Endocrinology and Metabolism 2021;37(9):813-819
Objective:To investigate the mechanism of invariant natural killer T (iNKT)2 cell improving hepatic fat deposition in nonalcoholic fatty liver (NAFL).Methods:NAFL model was established by feeding C57BL/6J mice with high fat diet. The levels of serum total cholesterol, triglyceride, high density lipoprotein-cholesterol (HDL-C), low density lipoprotein-cholesterol (LDL-C), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) in the peripheral blood of mice were analyzed using automatic biochemical analyzer. The pathological changes of liver were observed with HE staining. The cell frequencies of iNKT, iNKT1, and iNKT2 in liver were detected by flow cytometry. Western blotting was used to detect the expression of sterol regulatory element binding protein 1c (SREBP-1c), peroxisome proliferator activated receptor (PPAR)-α, and nuclear factor-κB (NF-κB) in liver tissues.Results:Compared with control group, the body weight of NAFL mice increased, the levels of total cholesterol, HDL-C, LDL-C, ALT, and liver fat deposition increased, the protein expression of SREBP-1c and PPAR-α in liver increased as well as the the protein phosphorylation level of NF-κB. After intraperitoneal injection of α-galactosylceramide (α-GalCer), the levels of total cholesterol, HDL-C, and LDL-C, liver fat deposition decreased, liver SREBP-1c was down-regulated, PPAR-α expression was up-regulated, and the proportion of liver iNKT2 subgroup increased in NAFL mice.Conclusion:iNKT2 cells improve NAFL liver fat deposition, which is related to the down-regulation of SREBP-1c and up-regulation of PPAR-α.
7.Clinicopathological characteristics and risk factors of female breast hyperplasia in different age groups
Fei WANG ; Shuohao SHEN ; Liyuan LIU ; Qi WANG ; Hongchuan JIANG ; Lisong TENG ; Zhimin FAN ; Cuizhi GENG ; Feng JIN ; Lili TANG ; Jianguo ZHANG ; Xiang WANG ; Shu WANG ; Xuening DUAN ; Lixiang YU ; Fei ZHOU ; Yujuan XIANG ; Shuya HUANG ; Chao ZHENG ; Qinye FU ; Dezong GAO ; Liang LI ; Zhongbing MA ; Qiang ZHANG ; Zhigang YU
Chinese Journal of General Surgery 2019;34(3):235-239
Objective To analyze clinicopathological characteristics and the potential risk-related factors of female breast hyperplasia in different age groups.Method From Jan 2015 to Dec 2016,patients diagnosed with breast hyperplasia in 12 hospitals were evaluated.All patients completed the self-designed questionnaires on women'health,including basic demographic information,clinic examination information,radiologic information and pathologic results.The patients were divided into a young group (< 45 years old) and an elderly group (from 45 to 75 years old).Results There were 3 684 cases of breast hyperplasia,including 2 291 cases in young group and 1 393 cases in elder group,respectively Clinically breast pain type were most commonly observed in both young and older groups (50.3% vs.42.7%,P < 0.001).While pathological research based on biopsy showed that breast adenopathy were the most common changes in both groups (67.9% vs.61.7%,P <0.001).More breast cancer cases were identified in elder group than that in young group,especially in clinically lump type patients (9.4% vs.4.2%,P < 0.001).Compared with elder group,patients in young group have different distribution characteristics regarding to fertility factors,lifestyle factors and psychology scale including anxiety and depression.Conclusion Distributions of clinicopathological characteristics and risk factors of female breast hyperplasia differ across different age groups.
8.Comparison of two methods for the internal fixation treatment of 26 patients with ipsilateral femoral proximal and shaft fractures
Jianguo TENG ; Xiaohai FAN ; Ping ZHEN ; Yun XUE ; Shungang ZHOU ; Xiaowen DENG ; Peisheng SHI
Chinese Journal of Postgraduates of Medicine 2016;39(8):730-734
Objective To compare the curative effect of internal fixation treatment between reconstruction-type intramedullary nailing and long anatomic proximal femoral locking plate for patients with ipsilateral femoral proximal and shaft fractures. Methods Twenty-six patients with ipsilateral femoral proximal and shaft fractures were selected, among whom 12 patients were treated with reconstruction-type intramedullary nailing internal fixation treatment (group A), and 14 patients were treated with long anatomic proximal femoral locking plate internal fixation treatment (group B). The fracture to operation time, operation time, intraoperative blood loss, fracture healing time and hip joint function according to Majeed function score were compared between 2 groups. Results The fracture to operation time, operation time, intraoperative blood loss, proximal femoral fracture healing time, femoral shaft fracture healing time and Majeed function score in group A were (6.65 ± 4.11) d, (131.08 ± 20.70) min, (470.83 ± 96.43) ml, (17.83 ± 2.70) weeks, (20.08 ± 3.97) weeks and (83.83 ± 8.13) scores, and those in group B were (7.13 ± 4.56) d, (141.86 ± 27.30) min, (553.57 ± 127.80) ml, (18.29 ± 5.12) weeks, (21.55 ± 4.19) weeks and (83.21 ± 9.58) scores, and there were no statistical differences (P>0.05). According to Majeed function score, in group A excellent was in 7 cases, good in 4 cases, and general in 1 case; in group B excellent was in 9 cases, good in 3 cases, and general in 2 cases. Conclusions A fixation device fixes two fracture is preferred. Both treatment methods used in the present study could achieve satisfactory curative effect, and should be chosen according to the fracture type of the patients and the surgeon′s familiarity for the methods of internal fixation chosen. The proximal femoral fracture should preferably be reduced and stabilized first. A delay of 5 - 6 d would not affect the ultimate curative effect.
9.Quality of life and its influencing factors of advanced schistosomiasis patients in Qingpu District,Shanghai
Guifu LI ; Zhen TENG ; Jianguo TIAN ; Xi YU ; Xueqin YU ; Xiaodong SUN
Chinese Journal of Schistosomiasis Control 2014;(3):303-307
Objective To assess the quality of life(QOL)of advanced schistosomiasis patients,and understand its influenc-ing factors. Methods A questionnaire survey was carried out by using WHOQOL-BREF,and the information of demography, family,illness,health status,and health service was collected. Results Among the 217 advanced patients,the average age was (75.33±6.94)years,the ratio of male to female was 2∶5,89.86%of them were farmers,75.58%were illiterate or semi-illiterate, and 88.94%belonged to the splenomegaly type. Totally 61.29%of the cases had the scores over average for the overall QOL,but the scores for the health and well-being were lower. There were a significant difference among the average scores of different do-mains of QOL(χ2 =23.46,P<0.01). Both the year of being diagnosed and clinical classification was not associated with the scores of QOL. Regularly taking physical activities was significantly associated with each of all the 4 domains. The factors such as onset of acute disease in 2 weeks,taking therapeutic pills daily,marital status,age,etc. impacted the specific domains of QOL. The overall QOL and the 4 domains of the patients were at medium level;meanwhile,the score of physiological domain was lower than the scores of the other 3 domains. Conclusions The QOL(s)of advanced schistosomiasis patients in Qingpu District are rel-atively good. It is important to provide effective community health services and encourage the patients to take part in tempered sports or physical activities in order to keep their normal activities of daily living.
10.A Study of Homologous Recombination in Foot-and-mouth Disease Virus in China
Zhiyin WU ; Chengqiang HE ; Yingying LIU ; Qian FENG ; Junlin TENG ; Jianguo CHEN
Progress in Biochemistry and Biophysics 2006;0(06):-
Foot-and-mouth disease virus (FMDV) is a positive-sense RNA virus which has caused severe damage to world-wide livestock industry. The extensive genetic and antigenic diversity observed in the evolution of FMDV is generally the obstacle for controlling the disease. The homologous recombination, as a significant force driving the evolution of virus, has also effect on the epidemiological trait of FMDV. However,the role of homologous recombination in the diversification of FMDV in China has not investigated. So it is necessary to study the homologous recombination underlying the evolution of FMDV to control FMD. Based on a sound evolutionary framework, molecular evolutionary analysis was used to identify the putative recombinants. All complete FMDV genomes from China were respectively retrieved from GenBank. Homologous recombination was identified using Simplot program. Phylogenetic relations were analyzed to determine the recombination events among these FMDV isolates by using MEGA 4. The isolates O/NY00, O/China/1/99Tibet, O/Tibet/CHA/99, O/OMIII and O/ES/2001 among 16 FMDVs were identified as putative recombinants by analyzing the FMDV genomic sequences extracted from GenBank. The recombination events frequently happen between serological type Asia1 and O which are endemic FMDV circulating in China, suggesting frequent cross infection of FMDV in China. This situation further makes controlling FMDV in China more difficult. Moreover, serotypic conversion of FMDV between Asia1 and O was detected to be due to homologous recombination. These results provided clues for understanding the antigenic and genetic diversification in FMDV, and shed lights on the potential vaccination and treatment of FMD.

Result Analysis
Print
Save
E-mail