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Regulatory perspectives of combination products

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Bioactive Materials 2022年第4期7卷 492-503页

作者： Jiaxin Tian xu song Yongqing Wang Maobo Cheng Shuang Lu Wei xu Guobiao Gao Lei Sun Zhonglan Tang Minghui Wang Xingdong Zhang Center for Medical Device Evaluation National Medical Products AdministrationBeijingChina NMPA Key Laboratory for Quality Research and Control of Tissue Regenerative Biomaterial&Institute of Regulatory Science for Medical Devices&NMPA Research Base of Regulatory Science for Medical Devices Sichuan UniversityChengduChina National Engineering Research Center for Biomaterials&College of Biomedical Engineering Sichuan UniversityChengduChina Center for Drug Evaluation National Medical Products AdministrationBeijingChina

Combination products with a wide range of clinical applications represent a unique class of medical products that are composed of more than a singular medical device or drug/biological *** product research and development,clinical translation as well as regulatory evaluation of combination products are complex and *** review firstly introduced the origin,definition and designation of combination *** areas of systematic regulatory review on the safety and efficacy of device-led/supervised combination products were then *** and clinical evaluation of combination products was ***,the research prospect of regulatory science for combination products was *** tools of computational modeling and simulation,novel technologies such as artificial intelligence,needs of developing new standards,evidence-based research methods,new approaches including the designation of innovative or breakthrough medical products have been developed and could be used to assess the safety,efficacy,quality and performance of combination *** together,the fast development of combination products with great potentials in healthcare provides new opportunities for the advancement of regulatory review as well as regulatory science.

关键词： Combination products Definition Designation Safety and efficacy Regulatory science

热淋清颗粒治疗尿路感染的多中心、开放性、Ⅳ期临床研究

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医学新知 2024年第7期34卷 786-795页

作者：王树声张俊华于雷唐汇龙宋旭叶纯华广东省中医院泌尿外科广州510120 天津中医药大学中医药研究院天津301617 黑龙江省医院泌尿外科哈尔滨150036 湖南中医药大学第一附属医院泌尿外科长沙410021 上海市第七人民医院泌尿外科上海200137 杭州师范大学附属医院泌尿外科杭州310015

目的评价热淋清颗粒在临床使用中的安全性与有效性,以指导优化临床给药方案和提高合理用药水平。方法在51家医院进行开放性、Ⅳ期临床试验,受试者为下焦湿热型单纯性或复杂性尿路感染,单纯性尿路感染患者给予热淋清颗粒每次8 g、每天3次... 详细信息

目的评价热淋清颗粒在临床使用中的安全性与有效性,以指导优化临床给药方案和提高合理用药水平。方法在51家医院进行开放性、Ⅳ期临床试验,受试者为下焦湿热型单纯性或复杂性尿路感染,单纯性尿路感染患者给予热淋清颗粒每次8 g、每天3次,疗程5 d。复杂性尿路感染患者给予热淋清颗粒每次8 g、每天3次,同时联合喹诺酮类抗生素,疗程7~14 d。结局指标为临床疗效、中医证候疗效、细菌清除率以及安全性。结果共纳入2009例受试者,其中11患者失访脱落。全分析集纳入1998例,其中单纯性尿路感染患者1532例,复杂性尿路感染患者466例。临床治愈率为68.57%,单纯性和复杂性尿路感染患者分别为74.41%和49.36%。中医证候痊显率为72.22%,单纯性和复杂性尿路感染患者分别为75.13%和62.66%。单纯性尿路感染中细菌培养阳性者的细菌转阴率为57.75%,细菌清除率为58.02%;复杂性尿路感染中细菌培养阳性者的细菌转阴率为45.59%,细菌清除率为43.92%。药物相关的不良反应发生24例次,其中单纯性尿路感染17例次,复杂性尿路感染7例次。结论热淋清颗粒治疗单纯性尿路感染的有效性和安全性较好,也可改善下焦湿热证中医证候。

关键词：热淋清颗粒尿路感染 Ⅳ期临床试验临床疗效安全性

Stable 4.5 V LiCoO_(2)cathode material enabled by surface manganese oxides nanoshell

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Nano Research 2023年第2期16卷 2480-2485页

作者： Jun Wang Si-Dong Zhang Si-Jie Guo Si-Qi Lu Yan-song xu Jin-Yang Li An-Min Cao Li-Jun Wan CAS Key Laboratory of Molecular Nanostructure and Nanotechnology and Beijing National Laboratory for Molecular Sciences Institute of ChemistryChinese Academy of Sciences(ICCAS)Beijing 100190China University of Chinese Academy of Sciences(UCAS) Beijing 100049China

Charging the LiCoO_(2)(LCO)cathode to a higher voltage,for example 4.5 V compared to the commonly used 4.2 V,is now intensively pursued so as to achieve a higher specific ***,it suffers severe surface structural degradation and detrimental interfacial side reactions between cathode and electrolyte,which lead to the fast capacity fading during long-term ***,a surface coating strategy was developed for the protection of 4.5 V LCO by constructing a manganese oxides(MOs)nanoshell around LCO particles,which was achieved through a solution-based coating process with success in controlling the growth kinetics of the coating *** found that the introduction of the MOs nanoshell is highly effective in alleviating the organic electrolyte decomposition at the cathode surface,thus ensuring a much more stable LiF-rich cathode-electrolyte interface and an obvious lower interfacial resistance during electrochemical ***,this protection layer can effectively improve the structural stability of the cathode by hindering the cracks formation and structural degradation of LCO ***,the MOs modified LCO exhibited excellent rate performance and a high discharge capacity retention of 81.5%after 100 cycles at 1 C compared with the untreated LCO(55.2%),as well as the improved thermal stability and cyclability at the elevated *** is expected that this discovery and fundamental understanding of the surface chemistry regulation strategy provide promising insights into improving the reversibility and stability of LCO cathode at the cut-off voltage of 4.5 V.

关键词： lithium-ion battery 4.5 V LiCoO_(2) manganese oxides surface coating interfacial stability regulation

A star-like photodetector for angle-based light sensing in 3D space

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Nano Research 2024年第8期17卷 7567-7573页

作者： Qi Pan Sisi Chen Hongfei Xie Qiling xu Meng Su Yanlin song College of Chemistry Zhengzhou UniversityZhengzhou 450051China Key Laboratory of Green Printing CAS Research/Education Center for Excellence in Molecular SciencesInstitute of ChemistryChinese Academy of Sciences(ICCAS)Beijing Engineering Research Center of Nanomaterials for Green Printing TechnologyBeijing National Laboratory for Molecular Sciences(BNLMS)Beijing 100190China University of Chinese Academy of Sciences Beijing 100049China

The development of three-dimensional(3D)space light angle detection is vital in optical technology for applications such as 3D imaging,computer vision,and augmented *** methods involve advanced sensors and algorithms,including time-offlight cameras,which need multiple cameras and light sources to improve ***,it is a great challenge to integrate these complex components into compact *** semiconductor structures offer optical resonance characteristics,enabling precise light–matter interaction regulation.A 3D star-like photodetector,fabricated using a template assistant printing strategy,demonstrates optical resonances of the subwavelength facade and the shielding effect of spatial *** achieves light angle detection with the resolution of 10°in vertical space and the resolution of 36°in horizontal space,making it a promising prototype for various applications.

关键词： photodetector light angle detection printing subwavelength structure shielding effect

Tribological properties and tribomechanism of nickel nanoparticles in-situ synthesized in rapeseed oil

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Friction 2024年第3期12卷 474-489页

作者： Wenya xu Guangbin YANG Shengmao ZHANG Jun xu Yujuan ZHANG Tianhua SUN Ningning song Laigui YU Pingyu ZHANG Engineering Research Center for Nanomaterials Henan UniversityKaifeng 475004China State Key Laboratory of Tribology in Advanced Equipment Tsinghua UniversityBeijing 100084China

Nickel(Ni)nanoparticles can be enriched on the surface of iron-based frictional pairs,which provides the possibility to get rid of the competitive adsorption between the polar species of vegetable oil and the surface-active nano-additives *** this paper,nickel acetylacetonate was used as a precursor to in-situ synthesize nickel nanoparticles with an average diameter of about 12 nm in rapeseed oil(RO)as the reducing agent,surface modifier,and solvent as *** tribological properties of the as-synthesized Ni nanoparticles were evaluated with a four-ball tribometer,and their tribomechanism was investigated based on the characterizations of the tribofilm on rubbed steel surfaces by the scanning electron microscopy(SEM),transmission electron microscopy(TEM),and X-ray photoelectron spectroscopy(XPS).It was found that the Ni nanoparticles in-situ prepared in the RO with a mass fraction of 0.3%can reduce the wear scar diameter(WSD)of the steel ball by 36%.This is because,on the one hand,the Ni nanoparticles are adsorbed on the rubbed steel surfaces to repair or fill up the micro-pits and grooves *** the other hand,Ni nanoparticles participate in tribochemical reactions with atmospheric O and steel substrate to form the tribochemical reaction film on the rubbed steel surfaces with the assistance of friction-induced heat and applied normal *** addition,an amorphous carbon film is formed on the rubbed surface via the carbonization of base oil under the catalysis of Ni *** adsorbed Ni layer,the tribochemical reaction film,and the carbon layer comprise a composite tribofilm composed of amorphous carbon,polar fatty acid,metallic nickel,iron oxides,and nickel oxides on the rubbed steel surfaces,which contributes to significantly improving the antiwear ability and load-carrying capacity of the RO for the steel-steel sliding pair.

关键词： nickel(Ni)nanoparticles rapeseed oil(RO) in-situ synthesis tribological properties tribomechanism

HCRVD: A Vulnerability Detection System Based on CST-PDG Hierarchical Code Representation Learning

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Computers, Materials & Continua 2024年第6期79卷 4573-4601页

作者： Zhihui song Jinchen xu Kewei Li Zheng Shan School of Cyberspace Security Information Engineering UniversityZhengzhou450001China

Prior studies have demonstrated that deep learning-based approaches can enhance the performance of source code vulnerability detection by training neural networks to learn vulnerability patterns in code ***,due to limitations in code representation and neural network design,the validity and practicality of the model still need to be ***,due to differences in programming languages,most methods lack cross-language detection *** address these issues,in this paper,we analyze the shortcomings of previous code representations and neural *** propose a novel hierarchical code representation that combines Concrete Syntax Trees(CST)with Program Dependence Graphs(PDG).Furthermore,we introduce a Tree-Graph-Gated-Attention(TGGA)network based on gated recurrent units and attention mechanisms to build a Hierarchical Code Representation learning-based Vulnerability Detection(HCRVD)*** system enables cross-language vulnerability detection at the *** experiments show that HCRVD surpasses many competitors in vulnerability detection *** benefits from the hierarchical code representation learning method,and outperforms baseline in cross-language vulnerability detection by 9.772%and 11.819%in the C/C++and Java datasets,***,HCRVD has certain ability to detect vulnerabilities in unknown programming languages and is useful in real open-source *** shows good validity,generality and practicality.

关键词： Vulnerability detection deep learning CST-PDG code representation tree-graph-gated-attention network cross-language

Exploiting the potential of the ubiquitin-proteasome system in overcoming tyrosine kinase inhibitor resistance in chronic myeloid leukemia

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Genes & Diseases 2024年第5期11卷 140-162页

作者： xudong Li Wei Li Yanli Zhang Linping xu Yongping song Department of Hematology Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer HospitalZhengzhouHenan 450008China Academy of Medical Sciences Zhengzhou UniversityZhengzhouHenan 450052China Department of Hematology The First Affiliated Hospital of Zhengzhou UniversityZhengzhouHenan 450052China

The advent of tyrosine kinase inhibitors(TKI)targeting BCR-ABL has drastically changed the treatment approach of chronic myeloid leukemia(CML),greatly prolonged the life of CML patients,and improved their ***,TKI resistance is still a major problem with CML patients,reducing the efficacy of treatment and their quality of *** resistance is mainly divided into BCR-ABL-dependent and BCR-ABL-independent ***,the main clinical strategy addressing TKI resistance is to switch to newly developed ***,data have shown that these new drugs may cause serious adverse reactions and intolerance and cannot address all resistance ***,finding new therapeutic targets to overcome TKI resistance is crucial and the ubiquitin-proteasome system(UPS)has emerged as a *** UPS mediates the degradation of most proteins in organisms and controls a wide range of physiological *** recent years,the study of UPS in hematological malignant tumors has resulted in effective treatments,such as bortezomib in the treatment of multiple myeloma and mantle cell *** CML,the components of UPS cooperate or antagonize the efficacy of TKI by directly or indirectly affecting the ubiquitination of BCR-ABL,interfering with CML-related signaling pathways,and negatively or positively affecting leukemia stem *** of these molecules may help overcome TKI resistance and treat *** this review,the mechanism of TKI resistance is briefly described,the components of UPS are introduced,existing studies on UPS participating in TKI resistance are listed,and UPS as the therapeutic target and strategies are discussed.

关键词： Chronic myeloid leukemia Deubiquitinases E3 ligase PROTAC TKI resistance Ubiquitin-proteasome system

Designed imidazole-based supramolecular catalysts for accelerating oxidation/hydrolysis cascade reactions

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Nano Research 2024年第6期17卷 4916-4923页

作者： Yuanxi Liu Wenjie xu Shichao xu Haifeng Wu Baoli Zhang Li song Zhen-Gang Wang State Key Laboratory of Organic-Inorganic Composites Key Lab of Biomedical Materials of Natural Macromolecules(Ministry of Education)Beijing Laboratory of Biomedical MaterialsCollege of Materials Science and EngineeringBeijing University of Chemical TechnologyBeijing 100029China National Synchrotron Radiation Laboratory CAS Center for Excellence in NanoscienceUniversity of Science and Technology of ChinaHefei 230029China

Reconstructing enzymatic active sites presents a significant challenge due to the intricacies involved in achieving enzyme-like scaffold folding and spatial arrangement of essential functional *** is also a growing interest in building biocatalytic networks,wherein multiple enzymatic active sites are localized within a single artificial system,allowing for cascaded *** this work,we report the self-assembly of imidazole or its derivatives with fluorenylmethyloxycarbonyl-modified histidine and Cu2+to fabricate a supramolecular catalyst,which possesses catechol oxidase-like dicopper center with multiple imidazole as the coordination *** electron microscopy,low-temperature X-band continuous-wave electron paramagnetic resonance,K-edge X-ray absorption spectra/the extended X-ray absorption fine structure analysis,and density functional theory modeling were used for the structural characterization of the *** phenol derivatives and the dissolved oxygen were used as the substrates,with the addition of 4-aminoantipyrine to generate a red adduct with a maximum absorbance at 510 nm,for obtaining time-dependent absorbance change curves and estimating the *** results reveal that the addition of imidazole synergistically accelerates the oxidative activity about 10-fold and the hydrolysis activity about 14-fold than fluorenylmethyloxycarbonyl modified-histidine/Cu2+.The supramolecular nanoassembly also exhibits the ability to catalyze oxidation/hydrolysis cascade reactions,converting 2′,7′-dichlorofluorescin diacetate into 2′,7′-*** process can be regulated through the methylation of the imidazole component at various *** work may contribute to the design of advanced biomimetic catalysts,and shed light on early structural models of the active sites of the primitive copper-dependent enzymes.

关键词： enzyme mimic self-assembly supramolecular catalyst cascade reactions

Divergent defluorocarboxylation of α-CF_(3) alkenes with formate via photocatalyzed selective mono-or triple C-F bond cleavage

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Science China Chemistry 2024年第1期67卷 368-373页

作者： Xing-Yu Wang Pei xu Wen-Wen Liu Hao-Qiang Jiang song-Lei Zhu Dong Guo xu Zhu Jiangsu Key Laboratory of New Drug Research and Clinical Pharmacy School of PharmacyXuzhou Medical UniversityXuzhou 22100China

Unprecedented divergent synthesis of gem-difluorovinylacetic acid and glutaric acid derivatives fromα-CF_(3)alkenes with formate as the carbonyl source was *** reaction can undergo selective mono-or triple C-F bond cleavage by simply switching the photocatalyst and hydrogen atom transfer(HAT)catalyst under visible-light-induced conditions at room *** acts as both the C1 source and the reductant through the generation of CO_(2)^(·-)species,which underwent Giese radical addition to electron-deficient alkenes to trigger the consecutive C-F bond cleavage and carboxylation process.

关键词： C-F bond activation defluorocarboxylation carbon dioxide radical anion visible light