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| 1 | Phase 1 studies comparing safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01(a rituximab biosimilar) to reference rituximab in Chinese patients with CD20-positive B-cell lymphoma显示文摘Objective: This study aimed to compare the pharmacokinetic, pharmacodynamic and safety profiles of HLX01(a rituximab biosimilar) and reference rituximab sourced from China(Mab Thera?;rituximab-CN).Methods: Here we report the results of two phase 1 studies. In the phase 1 a, open-label, dose-escalation study(NCT03218072, CTR20140400), eligible patients received 250, 375 and 500 mg/m^(2) HLX01 sequentially at 7-day intervals, after confirming no dose-limiting toxicity(DLT). In the phase 1 b, double-blind study(NCT02584920,CTR20140764), eligible patients were given a single dose of 375 mg/m^(2) HLX01 or rituximab-CN. The primary endpoints included safety and tolerability parameters for the phase 1 a and the area under the plasma concentrationtime curve from time zero to day 91(AUC0-91 d) for the phase 1 b study. Equivalence was concluded if 90%confidence interval(90% CI) for the geometric least squares mean ratio(GLSMR) fell in the pre-specified equivalence criteria(80%-125%).Results: Between June 20, 2014 and January 5, 2015, 12 patients were enrolled in the phase 1 a study. The pharmacokinetics of HLX01 showed dose proportionality and accumulation to steady state. HLX01 was well tolerated, with no serious adverse events(AEs), discontinuations or DLTs. Between November 8, 2014 and August13, 2015, 87 eligible patients were enrolled in the phase 1 b study, including 43 who received HLX01 and 44 who were treated with rituximab-CN. The equivalence endpoint was met with GLSMR for AUC0-91 d being 89.6%(90% CI: 80.4%-99.8%). AEs, anti-drug antibodies, and CD19+ and CD20+ B lymphocyte counts were similar between the HLX01 and rituximab-CN treatment groups.Conclusions: Treatment with HLX01 was safe and well tolerated in Chinese patients with B-cell lymphoma.HLX01 and rituximab-CN have similar pharmacokinetic, pharmacodynamic and safety profiles. | Yuankai Shi Qingyuan Zhang Xiaohong Han Yan Qin Xiaoyan Ke Hang Su Li Liu Jinxiang Fu Jie Jin Jifeng Feng Xiaonan Hong Xiaohong Zhang Depei Wu Bin Jiang Xiaodong Dong | 2021 | Chinese Journal of Cancer Research2021,33,3: | 5 |
| 2 | The flexural property and its synergistic mechanism of multibody molded beetle elytron plates显示文摘To improve the applications of beetle elytron plates(BEPs,which are biomimetic sandwich plates inspired by beetle elytra),the flexural performance and its synergistic mechanism of multibody molded BEPs were investigated via cantilever testing and finite element method(FEM).The results are summarized as follows.(1)Although debonding damage causes failure of the multibody molded BEPs and honeycomb plate and the reasonable range of trabecular size for BEPs is narrow,both the optimal loading capacity per mass and failure deformation of the BEPs are over two times those of the honeycomb plate.(2)A flexural synergistic mechanism is revealed in the trabecular-honeycomb core structure of BEPs;this mechanism causes the maximum deformation of core structure to gradually transfer from the honeycomb wall to the trabeculae with the increase inη(the ratio of the trabecular radius to the distance between the center points of two trabeculae),which means the different stretching behaviors in these core structures.(3)Unlike the compressive mechanism of BEPs,by controlling and balancing the deformation degrees of the trabeculae and honeycomb walls,the flexural mechanism achieves a minimum core deformation and an optimal flexural performance.These results suggest a qualitative relationship between the deformation behavior of trabecular-honeycomb core structure and bending performance of the whole BEP,and provide a solid foundation for subsequent research and the considerable application potential of this biomimetic sandwich structure in many fields. | YU XinDi ZHANG XiaoMing CHEN JinXiang ZHAO CaiQi ZHAO TiDong FU YaQin | 2020 | Science China(Technological Sciences)2020,63,5: | 2 |
| 3 | Carfilzomib promotes the osteogenic differentiation potential of mesenchymal stem cells derived from myeloma patients by inhibiting notch1 activity in vitro显示文摘 | Yali Li Jun Li Wenzhuo Zhuang Qian Wang Xueping Ge Xiaohui Zhang Ping Chen Jinxiang Fu Bingzong Li | 2014 | Leukemia Research2014,,: | 1 |
| 4 | A study on coagulate method control expansion of sludge 显示文摘 | Zhao Yuhua Ju Ran Fu Jinxiang | 2005 | Shenyang Architecture University Transaction2005,21,6: | 1 |
| 5 | Vibration properties and transverse shear characteristics of multibody molded beetle elytron plates显示文摘This study utilized cantilever experiments to investigate the vibration properties of multibody molded beetle elytron plates(BEPs),which is a type of biomimetic sandwich plate inspired by beetle elytra;the corresponding shear characteristics were further revealed by a finite element method(FEM). The following results were obtained:(1) Experimental results suggest that the maximum displacement response of the BEPs was about 25% less than that of a honeycomb plate with almost the same first natural frequency,which indicates that a BEP with reasonable structural parameters has the potential to replace a honeycomb plate to achieve better vibration performance;(2) The trabecular structure not only enhanced the shear stiffness of the core layer in column areas but also the skins in the honeycomb wall areas,thus changing the distribution of the shear force in the different components and improving the mechanical performances of the BEP;and(3) Although this enhancement effect from trabeculae was not uniform,the average shear force proportion of the skins(or core structure) in the entire BEP structure was very close to that of the honeycomb plate. Therefore,the shear calculation assumption used for honeycomb plates is still applicable in the BEP.The results provide an experimental basis for the design and application of BEPs and inspiration for the development of related products in vibrational environments. | ZHANG XiaoMing YU XinDi CHEN JinXiang PAN LongCheng HU LiPing FU YaQin | 2020 | Science China(Technological Sciences)2020,63,12: | 1 |
| 6 | The influence of inorganic carbon on anaerobic ammonia oxidation 显示文摘 | Fu Jinxiang Jiang Xi Zhao Jun | 2013 | Applied Mechanics and Materials2013,27,: | 1 |
| 7 | Influence of the Chamfer on the Flexural Properties of Beetle Elytron Plates显示文摘To improve the flexural properties of Beetle Elytron Plates(BEPs)and clarify the effect of the transition arcs(chamfers)between the skins and the trabeculae,the chamfers were set in BEPs,and then the influence of the chamfer on BEPs'mechanical properties was investigated via experimentation and the Finite Elemnent Method simulation(FEM).The results indicate that the influence of the chamfer on the flexural properties and ductility was most obvious in the Trabecular Beetle Elytron Plates(TBEPs),less obvious in the Honeycomb Plates(HPs)and basically no efiect was observed on End-trabecular Beetle Elytron Plates(EBEPs).The chamfer can improve the mechanical stability of EBEPSs.As the chamfer diameter increased in the BEPs,the length of the residual trabecular root on the skin increased when failure occurred in the TBEPs.The crack position in the honeycomb wallsof the HPs gradually shifted from the skin to the center.The EBEPs continued to exhibit oblique cracks.From the perspective of the force characteristics of these BEPs.combined with numerical simulation,the influence mechanism of the chamfer on their flcxural propertics was investigated. | Ning Hao Mengye Xu Jinxiang Chen Yiheng Song Zhijie Zhang Yaqin Fu | 2021 | Journal of Bionic Engineering2021,18,1: | 0 |
| 8 | Influence Mechanism of the Trabecular and Chamfer Radii on the Three-point Bending Properties of Trabecular Beetle Elytron Plates显示文摘To improve the mechanical properties of Trabecular Beetle Elytron Plates(TBEPs,a type of biomimetic sandwich structure inspired by the beetle elytron)under transverse loads,three-point bending tests are performed to investigate the influence of the trabecular and chamfer radii of the core structure on the mechanical performance of TBEPs manufactured by 3D printing technology.The results show that the three-point bending performance of TBEPs can be improved by setting reasonable trabecular and chamfer radii;however,excessive increases in these radii can cause a decline in the mechanical performance.For the reason,these two structural parameters can enhance the deformation stiffness of the whole structure and the connection property between the core and skin,which is also the mechanical reason why Prosopocoilus inclinatus beetle elytra have thick,short trabeculae with a large chamfer radius.However,when these radii increase to a certain extent,the cracks are ultimately controlled between two adjacent trabeculae,and the failure of the plate is determined by the skin rather than the core structure.Therefore,this study suggests a reasonable range for trabecular and chamfer radii,and indicates that TBEPs are better suited for engineering applications that have high compression requirements and general bending requirements. | Xiaoming Zhang Xindi Yu Jinxiang Chen Caiqi Zhao Sujun Guan Yaqin Fu | 2021 | Journal of Bionic Engineering2021,18,2: | 0 |
| 9 | Local low-dose X-ray radiation promotes homing of mesenchymal stem cells to the injured mouse spinal cord显示文摘BACKGROUND: Bone marrow-derived mesenchymal stem cells (BMSCs) are a potentially useful source for cell replacement therapy following spinal cord injury.However,the homing characteristics of BMSCs in vivo remain unclear.Low-dose radiation has been shown to promote homing of BMSCs to exposed sites.OBJECTIVE: To investigate the effects of low-dose local radiation to non-injured areas on the ability of human BMSCs to home to the injured mouse spinal cord,as well as recovery of spinal cord injury.DESIGN,TIME AND SETTING: A randomized,controlled,animal experiment was performed at the Central Laboratory,Second Affiliated Hospital of Soochow University between October 2007 and October 2008.MATERIALS: BMSCs were isolated from four adult,human donors.METHODS: Fifty adult,female,Balb/c mice were subjected to adjusted weight-drop impact resulting in complete paraplegia.Three days later,mice were randomly assigned to a radiation + transplantation group (n = 23) and a transplantation group (n = 20).In total,2 × 106 carboxyfluorescein diacetate succinimidyl ester-labeled BMSCs were injected into each mouse via the caudal vein.Mice in the radiation + transplantation group received 2.5 Gy local X-ray irradiation 2 hours before BMSCs injection.MAIN OUTCOME MEASURES: The homing of BMSCs to injured cord and irradiated skin after transplantation was observed by fluorescence microscope;the structure recovery of injured cord was assessed by magnetic resonance imaging.RESULTS: Compared with the transplantation group,at 24 hours after transplantation,the number of BMSCs was significantly increased in the injured area and the exposed site (P < 0.05),and inflammation and edema were significantly alleviated in the injured cord in the radiation + transplantation group.CONCLUSION: Local low-dose radiation has the potential to promote homing of BMSCs and recovery of spinal cord injury,although the radiated region was not injured area. | Panjun Wang Xiaohui Zhang Leixi Xue Yu Sun Songguang Ju Liesong Chen Jiasheng Hu Hong Zhang Xueguang Zhang Jinxiang Fu | 2010 | Neural Regeneration Research2010,5,5: | 0 |
| 10 | Expert consensus on emergency medicine procedure optimization guided by routine prevention and control strategy for COVID-19显示文摘The outbreak of coronavirus disease 2019(COVID-19)was declared a global public health emergency on 31 January 2020.Emergency medicine procedures in Emergency Department should be optimized to cope with the current COVID-19 pandemic by providing subspecialty services,reducing the spread of nosocomial infections,and promoting its capabilities to handle emerging diseases.Thus,the Chinese Society of Emergency Medicine and Wuhan Society of Emergency Medicine drafted this consensus together to address concerns of medical staffs who work in Emergency Department.Based on in-depth review of COVID-19 diagnosis and treatment plans,literatures,as well as management approval,this consensus proposes recommendations for improving the rationalization and efficiency of emergency processes,reducing the risk of nosocomial infections,preventing hospital viral transmission,and ensuring patient safety. | Weiyong Sheng Biao Chen Shanjie Fan Zhuanglin Zeng Ying Zhou Kunpeng Huang Xing Cheng Chunyan Cao Banghong Da Ning Zhou Qidi Zhou Qinghua Wang Jun Guo Peng Sun Chuanzhu Lv Xiaoling Fu Jinxiang Zhang | 2021 | Asian Pacific Journal of Tropical Medicine2021,14,4: | 0 |