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A phase Ⅰ study of Hemay022, an irreversible dual EGFR/HER2 tyrosine kinase inhibitor in Chinese patients with HER2-positive advanced breast cancer

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Chinese Journal of Cancer Research 2024年第1期36卷 46-54页

作者： Pin Zhang Lin wang Yueying Zhen zhihong wang Hesheng Zhang Richard Jones Binghe Xu Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Tianjin Hemay Pharmaceutical Co. LTDTianjin 300308China

Objective: Hemay022 is a novel small-molecule and an irreversible tyrosine kinase inhibitor with the target of epidermal growth factor receptor(EGFR)/human epidermal growth factor receptor 2(HER2), which demonstrated anti-tumor activity in preclinical studies. This first-in-human study evaluated the safety, pharmacokinetics,tolerability and preliminary anti-tumor activity of Hemay022 in HER2-positive advanced breast cancer patients.Methods: Heavily pretreated patients with HER2-positive advanced breast cancer were assigned to eight dose cohorts in a 3+3 dose-escalation pattern at doses of 50-600 mg QD and 300 mg BID. Eligible patients were given a single dose of Hemay022 on d 1 in week 0, followed by once daily continuous doses for four weeks in 28-day cycles.Pharmacokinetic samples were obtained on d 1 and d 28. Clinical responses were assessed every eight weeks.Results: Twenty-eight patients with advanced breast cancer were treated with Hemay022. The most frequently reported drug-related adverse events were diarrhoea(85.7%), vomiting(28.6%), nausea(25.0%) and decreased appetite(17.9%). No grade 4 drug-related adverse events were reported. At 50-600 mg doses, steady state areas under the concentration-time curve and peak concentrations increased with doses. One patient achieved complete response(CR), and three achieved partial response(PR). The objective response rate(ORR) and disease control rate(DCR) were 14.3% and 46.4% in 28 patients, respectively. The median progression-free survival(PFS) was3.98 months.Conclusions: Hemay022 at the dose of 500 mg once daily was well tolerated. The pharmacokinetic properties and encouraging anti-tumor activities of Hemay022 in advanced breast cancer patients warranted further evaluation of Hemay022 for treating breast cancer patients in the current phase Ⅲ trial(No. NCT05122494).

关键词： Advanced breast cancer HER2-positive Hemay022 first-in-human trial

Effects of anterior sciatic nerve acupuncture on lower limb paralysis after cerebral infarction:study protocol for a randomized controlled trial

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Journal of Traditional Chinese Medicine 2024年第1期44卷 205-211页

作者： LI Menghan wang Yu RAN Dawei YANG Xinming DENG Shizhe SHI Lei MENG zhihong Department of Acupuncture First Teaching Hospital of Tianjin University of Traditional Chinese MedicineTianjin 300193China National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion Tianjin 300193China Graduate department Tianjin University of Traditional Chinese MedicineTianjin 301617China Department of Massage and Rehabilitation Second Affiliated Hospital of Tianjin University of Traditional Chinese MedicineTianjin 300250China

Stroke is the main cause of disability in the middle and old age.Hemiplegia,especially lower limb paralysis,often leads to the loss of self-care ability and a series of secondary injuries.The main method to improve hemiplegic limb movement is exercise therapy,but there are still many patients with disabilities after rehabilitation treatment.As one of the non-pharmacological therapies for stroke,acupuncture has been recognized to improve motor function in patients.Here,we propose a new method,anterior sciatic nerve acupuncture,which can stimulate both the femoral nerve and the sciatic nerve.We designed this study to determine the effect of this method on lower limb motor function.Sixty participants recruited with hemiplegia after cerebral infarction will be randomly assigned to the test group or control group in a 1:1 ratio.The control group will receive Xingnao Kaiqiao acupuncture,and the test group will receive anterior sciatic nerve acupuncture on this basis.All participants will get acupuncture treatment once a day,6 times a week for 2 weeks.The primary outcome is Fugl-Meyer Assessment of Lower Extremity and the secondary outcomes are Modified Ashworth Scale and Modified Barthel Index.Data will be collected before treatment,1week after treatment,and 2 weeks after treatment,and then statistical analysis will be performed.This study can preliminarily verify the effect of anterior sciatic nerve acupuncture on improving lower limb motor function in patients with cerebral infarction,which may provide an alternative approach for clinical treatment of hemiplegia.

关键词： anterior sciatic nerve acupuncture paralysis cerebral infarction Xingnao Kaiqiao clinical protocols

Feedback linearization and equivalent-disturbance compensation control strategy for piezoelectric stage

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Nanotechnology and Precision Engineering 2024年第2期7卷 49-59页

作者： Tao Huang Yingbin wang zhihong Luo Huajun Cao Guibao Tao Mingxiang Ling State Key Laboratory of Mechanical Transmissions for Advanced Equipment Chongqing UniversityChongqing 400044China College of Mechanical and Vehicle Engineering Chongqing UniversityChongqing 400044China Hongdu Aviation Industry Group NanchangJiangxi 330000China Robotics and Microsystems Center Soochow UniversitySuzhou 215123China

Piezoelectric stages use piezoelectric actuators and flexure hinges as driving and amplifying mechanisms,respectively.These systems have high positioning accuracy and high-frequency responses,and they are widely used in various precision/ultra-precision positioning fields.However,the main challenge with these devices is the inherent hysteresis nonlinearity of piezoelectric actuators,which seriously affects the tracking accuracy of a piezoelectric stage.Inspired by this challenge,in this work,we developed a Hammerstein model to describe the hysteresis nonlinearity of a piezoelectric stage.In particular,in our proposed scheme,a feedback-linearization algorithm is used to eliminate the static hysteresis nonlinearity.In addition,a composite controller based on equivalent-disturbance compensation was designed to counteract model uncertainties and external disturbances.An analysis of the stability of a closed-loop system based on this feedback-linearization algorithm and composite controller was performed,and this was followed by extensive comparative experiments using a piezoelectric stage developed in the laboratory.The experimental results confirmed that the feedback-linearization algorithm and the composite controller offer improved linearization and trajectory-tracking performance.

关键词： Piezoelectric stage Hysteresis nonlinearity Feedback linearization Equivalent-disturbance compensation

Analysis on unit maximum capacity of orthogonal multiple watermarking for multimedia signals in B5G wireless communications

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Digital Communications and Networks 2024年第1期10卷 38-44页

作者： Mianjie Li Senfeng Lai Jiao wang zhihong Tian Nadra Guizani Xiaojiang Du Chun Shan School of Electronics and Information Guangdong Polytechnic Normal UniversityGuangzhou510665China Cyberspace Institute of Advanced Technology Guangzhou UniversityGuangzhou510006China Schoolof Electrical Engineering and Computer Science Washington State UniversityPullmanWA99164UsA Department of Computer and Information Science Temple UniversityPhiladelphiaPA19122USA

Beyond-5G(B5G)aims to meet the growing demands of mobile traffic and expand the communication space.Considering that intelligent applications to B5G wireless communications will involve security issues regarding user data and operational data,this paper analyzes the maximum capacity of the multi-watermarking method for multimedia signal hiding as a means of alleviating the information security problem of B5G.The multiwatermarking process employs spread transform dither modulation.During the watermarking procedure,Gram-Schmidt orthogonalization is used to obtain the multiple spreading vectors.Consequently,multiple watermarks can be simultaneously embedded into the same position of a multimedia signal.Moreover,the multiple watermarks can be extracted without affecting one another during the extraction process.We analyze the effect of the size of the spreading vector on the unit maximum capacity,and consequently derive the theoretical relationship between the size of the spreading vector and the unit maximum capacity.A number of experiments are conducted to determine the optimal parameter values for maximum robustness on the premise of high capacity and good imperceptibility.

关键词： B5G Multimedia information security Spread transform dither modulation Spreading vector measurement Unit maximum capacity

Multi-field Coupled Inverse Hall–Petch Relations for Ferroelectric Nanocrystals

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Acta Mechanica Solida Sinica 2024年第1期37卷 139-147页

作者： Xiaodong Zhang Wei Yan Xuhui Lou Yujun Chen zhihong Zhou Qingyuan wang Lianhua Ma Xiaobao Tian Non-Destructive Testing Laboratory School of Quality and Technical SupervisionHebei UniversityBaoding 071002China AVIC Huiyang Aviation Propeller Co. LtdBaoding 071051China Department of Mechanics and Engineering Sichuan UniversityChengdu 610065China Yibin Institute of Industrial Technology Sichuan University Yibin ParkYibin 644000China Research Institute of Interdisciplinary Sciences(RISE) Dongguan University of TechnologyDongguan 523808China School of Materials Science and Engineering Dongguan University of TechnologyDongguan 523808China

Tailoring grain size can improve the strength of polycrystals by regulating the proportion of grains to grain boundaries and the interaction area.As the grain size decreases to the nanoscale,the deformation mechanism in polycrystals shifts from being primarily mediated by dislocations to deformation occurring within the grains and grain boundaries.However,the mechanism responsible for fine-grain strengthening in ferroelectric materials remains unclear,primarily due to the complex multi-field coupling effect arising from spontaneous polarization.Through molecular dynamics simulations,we investigate the strengthening mechanism of barium titanate(BaTiO3),with extremely fine-grain sizes.This material exhibits an inverse Hall–Petch relationship between grain size and strength,rooting in the inhomogeneous concentration of atomic strain and grain rotation.Furthermore,we present a theoretical model to predict the transition from the inverse Hall–Petch stage to the Hall–Petch stage based on strength variations with size,which aligns well with the simulation results.It has been found that the piezoelectric properties of the BaTiO3 are affected by polarization domain switching at various grain sizes.This study enhances our understanding of the atomic-scale mechanisms that contribute to the performance evolution of fine-grain nano-ferroelectric materials.It also provides valuable insights into the design of extremely small-scale ferroelectric components.

关键词： Ferroelectrics Multi-field coupling Molecular dynamics Fine-grain reinforcement Inverse Hall-Petch effect

Single-cell mass spectrometry studies of drug metabolism heterogeneity and primary resistance to gefitinib in non-small cell lung cancer cells

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Chinese Chemical Letters 2024年第2期35卷 436-440页

作者： Guizhen Zhu Yaoyao Zhao Wenmei Zhang Yuanyuan Wu Yuanxing Liu Guangsheng Guo Xiayan wang zhihong Liu Center of Excellence for Environmental Safety and Biological Effects Beijing Key Laboratory for Green Catalysis and SeparationDepartment of ChemistryBeijing University of TechnologyBeijing 100124China Minzu University of China Beijing 100081China Key Laboratory for the Synthesis and Application of Organic Functional Molecules College of Health Science and EngineeringHubei UniversityWuhan 430062China

Patients with epidermal growth factor receptor(EGFR)wild-type non-small cell lung cancer(NSCLC)often show primary resistance to gefitinib therapy.It is thus necessary to study the metabolism of gefitinib in NSCLC cells to comprehensively reveal the reasons for the primary resistance of tumors.Herein,we develop a platform for studying drug metabolism heterogeneity based on single-cell mass spectrometry(sDMH-scMS)by integrating living-cell electrolaunching ionization MS(ILCEI-MS)and high-performance liquid chromatography-MS(HPLC-MS)analysis,and the primary resistance of NSCLC cells to gefitinib was studied using this platform.The ILCEI-MS analysis showed that approximately 11.9%of NSCLC single cells contained the gefitinib metabolite M11;HPLC-MS detection diluted the intensity of M11 in subpopulations and concealed the heterogeneity of drug metabolism in tumor single cells.The intensity of gefitinib in EGFR wild-type A549 cells was markedly lower than in mutant PC9 cells,and the intensity of gefitinib metabolites was significantly higher than in PC9 cells,suggesting that the primary resistance of NSCLC cells is related to gefitinib metabolism.Moreover,the combination of gefitinib and the drug-metabolizing enzyme inhibitorα-naphthoflavone was shown to overcome the primary resistance of the NSCLC cells.Overall,the results of this study are expected to be applicable for clinical drug resistance diagnosis and treatment at the single-cell level.

关键词： Single-cell mass spectrometry Drug metabolism Non-small cell lung cancer Gefitinib Primary resistance

Effect of fracture fluid flowback on shale microfractures using CT scanning

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Journal of Rock Mechanics and Geotechnical Engineering 2024年第2期16卷 426-436页

作者： Jiale He zhihong Zhao Yiran Geng Yuping Chen Jianchun Guo Cong Lu Shouyi wang Xueliang Han Jun Zhang State Key Laboratory of Oil and Gas Reservoir Geology and Exploitation Southwest Petroleum UniversityChengdu610500China Key Laboratory of Thermo-Fluid Science and Engineering of Ministry of Education School of Energy and Power EngineeringXi’an Jiaotong UniversityXi’an710049China Drilling Test Engineering Department of Longdong Oil and Gas Development Company Changqing OilfieldPetroChina Company LimitedQingyang745000China Tight Oil and Gas Exploration and Development Project Department PetroChina Southwest Oil and Gas Field CompanyChengdu610056China No.11 Oil Production Plant Changqing Oilfield CompanyPetroChina Company LimitedQingyang745000China

The field data of shale fracturing demonstrate that the flowback performance of fracturing fluid is different from that of conventional reservoirs,where the flowback rate of shale fracturing fluid is lower than that of conventional reservoirs.At the early stage of flowback,there is no single-phase flow of the liquid phase in shale,but rather a gas-water two-phase flow,such that the single-phase flow model for tight oil and gas reservoirs is not applicable.In this study,pores and microfractures are extracted based on the experimental results of computed tomography(CT)scanning,and a spatial model of microfractures is established.Then,the influence of rough microfracture surfaces on the flow is corrected using the modified cubic law,which was modified by introducing the average deviation of the microfracture height as a roughness factor to consider the influence of microfracture surface roughness.The flow in the fracture network is simulated using the modified cubic law and the lattice Boltzmann method(LBM).The results obtained demonstrate that most of the fracturing fluid is retained in the shale microfractures,which explains the low fracturing fluid flowback rate in shale hydraulic fracturing.

关键词： Shale Flowback of fracturing fluid Microfracture Lattice Boltzmann method(LBM)

Giant low-field reversible magnetocaloric effect at liquid helium temperature of niobium and iron co-substituted EuTiO_(3) compounds

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Journal of Rare Earths 2024年第4期42卷 710-715页

作者： zhihong Hao Quanyi Liu Huicai Xie Yan Zhang Zhaojun Mo School of Rare Earth and New Materials Engineering Ganzhou Innovation Center of Rare Earth Permanent Magnet Material Advanced Manufacturing and Intelligent Equipment TechnologyGannan University of Science and TechnologyGanzhou341000China Ganjiang Innovation Academy Chinese Academy of SciencesGanzhou34119China School of Materials Science and Engineering Taiyuan University of Science and TechnologyTaiyuan030024China

Giant magnetocaloric effect(MCE)materials in the liquid helium temperature region have attracted a lot of attention in the field of low-temperature magnetic refrigeration(MR).In this study,a series of niobium(Nb)and iron(Fe)co-substituted EuTiO_(3) perovskites with cubic structure(space group pm3m)was successfully fabricated,and their magnetic properties as well as cryogenic magnetocaloric effects were investigated in detail.As expected,the introduction of Nb and Fe can significantly modulate the magnetic phase transition and magnetocaloric effect of the EuTiO_(3) compounds.With increasing Fe concentration,two local minima corresponding to the AFM-FM magnetic phase transition near 5.0 K and FM-PM transition near 10 K with no hysteresis in the thermomagnetic curves are observed,which is attributed to an enhancement of FM coupling.At the same time,the gradually widened-ΔSM-T curves and the two peaks with a broad shoulder lead to considerable refrigeration capacity(RC).With the field change ofΔH=2 T,the calculated values of-ΔS_(M)^(max) for the EuTi_(0.9375-x)Nb_(0.0625)Fe_(x)O_(3)(x=0.075,0.1,0.125,0.15)compounds are 24.2,17.6,14.5 and 14.0 J/(kg·K),respectively.The corresponding RC values were calculated to be 144.6,138.3,151.2 and 159 J/kg,respectively.Especially,the values of-ΔS_(M)^(max) for EuTi_(0.8625)Nb_(0.0625)Fe_(0.075)O_(3) are 8.6 and 15.1 J/(kg·K)under low field changes of 0.5 and 1 T,respectively.The giant low-field reversible magnetocaloric effect makes them attractive candidates for magnetic refrigeration in the liquid helium temperature region.

关键词： Magnetocaloric effect Refrigeration capacity Magnetic entropy change Rareearths

Machine Learning-Based Research on Tensile Strength of SiC-Reinforced Magnesium Matrix Composites via Stir Casting

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Acta Metallurgica Sinica(English Letters) 2024年第3期37卷 453-466页

作者： zhihong Zhu Wenhang Ning Xuanyang Niu Yuhong Zhao Beijing Advanced Innovation Center for Materials Genome Engineering University of Science and Technology BeijingBeijing 100083China School of Materials Science and Engineering Collaborative Innovation Center of Ministry of Education and Shanxi Province for High-Performance Al/Mg Alloy MaterialsNorth University of ChinaTaiyuan 030051China Institute of Materials Intelligent Technology Liaoning Academy of MaterialsShenyang 110004China

SiC is the most common reinforcement in magnesium matrix composites,and the tensile strength of SiC-reinforced magnesium matrix composites is closely related to the distribution of SiC.Achieving a uniform distribution of SiC requires fine control over the parameters of SiC and the processing and preparation process.However,due to the numerous adjustable parameters,using traditional experimental methods requires a considerable amount of experimentation to obtain a uniformly distributed composite material.Therefore,this study adopts a machine learning approach to explore the tensile strength of SiC-reinforced magnesium matrix composites in the mechanical stirring casting process.By analyzing the influence of SiC parameters and processing parameters on composite material performance,we have established an effective predictive model.Furthermore,six different machine learning regression models have been developed to predict the tensile strength of SiC-reinforced magnesium matrix composites.Through validation and comparison,our models demonstrate good accuracy and reliability in predicting the tensile strength of the composite material.The research findings indicate that hot extrusion treatment,SiC content,and stirring time have a significant impact on the tensile strength.

关键词： Machine learning Stirring casting Magnesium matrix composite Tensile strength