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Recent landscape and trends for industry-sponsored pediatric clinical trials in China from 2013 to 2022

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儿科学研究(英文) 2024年第1期8卷 12-20页

作者： Liu chang Liu Yi Ou Ling qi Yuenan Zhang Jianmin Drug Clinical Trial Institution Children’s Hospital Capital Institute of Pediatrics Beijing China

Importance: Pediatric medication is a challenging issue globally. Promoting trials of medications for children and implementing measures to encourage innovation for addressing unmet medical and health needs are important.Objective: To explore the recent landscape of pediatric clinical trials of new investigational drugs conducted by pharmaceutical enterprises in China from 2013 to 2022 to provide insight into pediatric drug development in the pharmaceutical industry and regulatory policy formulation.Methods: We performed a cross-sectional observational investigation of pediatric clinical trials registered from January 1, 2013, to December 31, 2022, on the Registration and Information Disclosure Platform for Drug Clinical Trials, the official registration platform established in 2013 for trials of new investigational drugs initiated by biopharmaceutical enterprises. Trials that included pediatric participants (under 18 years old) were retrieved, and their relevant characteristics were extracted and analyzed.Results: In total, 895 pediatric clinical trials were collected, accounting for 5.1% of the total registered clinical trials initiated prior to January 1, 2023. The overall average annual growth rate for the number of pediatric clinical trials was 12% (P < 0.001). Phase III trials accounted for the highest proportion (49.1%, 439). Of the 895 trials included, 736 (82.2%) were domestic trials, and 159 (17.8%) were international multicenter trials. In terms of tested drugs, investigations of biological products accounted for the largest proportion of trials (67.4%, 603). Among pediatric clinical trials, studies of vaccines accounted for the largest proportion of trials (41.0%, 367), followed by trials for rare diseases (17.2%, 154). Furthermore, geographical distribution analysis revealed that the largest and smallest numbers of trials were conducted in North China (35.7%, 320) and Northeast China (0.8%, 7), respectively.Interpretation: The growth trends for industry-sponsored clinical trials involving children il

关键词： Geographic distribution Pediatric clinical trials Pediatric medication Rare disease

Long non-coding RNA GATA6-AS1 is mediated by N6-methyladenosine methylation and inhibits the proliferation and metastasis of gastric cancer

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World Journal of Gastrointestinal Oncology 2024年第3期16卷 1019-1028页

作者： Jun-Jie Shen Min-chang Li Shao-qi Tian Wen-Ming Chen Department of Oncology Jiangxi Hospital of Integrated Chinese and Western MedicineNanchang 330000Jiangxi ProvinceChina Department of Hepatopancreatobiliary Surgery Jiangxi Hospital of Integrated Chinese and Western MedicineNanchang 330000Jiangxi ProvinceChina Clinical Medical School Jining Medical UniversityJining 272000Shandong ProvinceChina Department of Oncology Jining No.1 People’s HospitalJining 272011Shandong ProvinceChina

BACKGROUND Through experimental research on the biological function of GATA6-AS1,it was confirmed that GATA6-AS1 can inhibit the proliferation,invasion,and migration of gastric cancer cells,suggesting that GATA6-AS1 plays a role as an anti-oncogene in the occurrence and development of gastric cancer.Further experi-ments confirmed that the overexpression of fat mass and obesity-associated protein(FTO)inhibited the expression of GATA6-AS1,thereby promoting the occurrence and development of gastric cancer.AIM To investigate the effects of GATA6-AS1 on the proliferation,invasion and migration of gastric cancer cells and its mechanism of action.METHODS We used bioinformatics methods to analyze the Cancer Genome Atlas(https://portal.***.cancer.gov/.The Cancer Genome Atlas)and download expression data for GATA6-AS1 in gastric cancer tissue and normal tissue.We also constructed a GATA6-AS1 lentivirus overexpression vector which was transfected into gastric cancer cells to investigate its effects on proliferation,migration and invasion,and thereby clarify the expression of GATA6-AS1 in gastric cancer and its biological role in the genesis and development of gastric cancer.Next,we used a database(http://***/starbase2/)to analysis GATA6-AS1 whether by m6A methylation modify regulation and predict the methyltransferases that may methylate GATA6-AS1.Furthermore,RNA immunoprecipitation experiments confirmed that GATA6-AS1 was able to bind to the m6A methylation modification enzyme.These data allowed us to clarify the ability of m6A methylase to influence the action of GATA6-AS1 and its role in the occurrence and development of gastric cancer.RESULTS Low expression levels of GATA6-AS1 were detected in gastric cancer.We also determined the effects of GATA6-AS1 overexpression on the biological function of gastric cancer cells.GATA6-AS1 had strong binding ability with the m6A demethylase FTO,which was expressed at high levels in gastric cancer and negatively correlated with the expression of GATA6-AS1.Following transfection with s

关键词： Long non-coding RNA GATA6-AS1 N6-methyladenine modification Fat mass and obesity-associated protein Gastric cancer

Degradation behaviors of Nabumetone and its metabolite during UV/monochloramine process:Experimental and theoretical study

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Journal of Environmental Sciences 2024年第8期142卷 103-114页

作者： Xiang Tu Yunsong Bai qing Fu Sheng chang Kunfeng Zhang Yang Pan Ruiyang Xiao Yifu Fu qi Zhang State Key Laboratory of Environmental Criteria and Risk Assessment State Environmental Protection Key Laboratory of Drinking Water Source ProtectionResearch Centre of Lake EnvironmentNational Engineering Laboratory for Lake Pollution Control and Ecological RestorationChinese Research Academy of Environmental SciencesBeijing 100012China School of Environmental Science and Engineering Suzhou University of Science and TechnologySuzhou 215009China Institute of Environmental Engineering School of Metallurgy and EnvironmentCentral South UniversityChangsha 410083China School of Forestry Northeast Forestry UniversityHarbin 150040China

This study investigated degradation behaviors of a nonsteroidal anti-inflammatory drug Nabumetone(NMT)and its major metabolite 6-methoxy-2-naphthylacetic acid(MNA)in the coupling process of ultraviolet and monochloramine(UV/NH2Cl).The second-order rate constants of the contaminants reacting with reactive radicals(HO·,Cl·,Cl_(2)·-,and CO_(3)·^(-))were determined by laser flash photolysis experiments.HO·and Cl·contributed predominantly with 52.3%and 21.7%for NMT degradation and 60.8%and 22.3%for MNA degradation.The presence of chlorides retarded the degradation of NMT,while promoted the destruction of MNA,which was ascribed to the photosensitization effects of MNA under UV irradiation.Density functional theory(DFT)calculations revealed that radical adduct formation(RAF)was dominant pathway for both HO·and Cl·reacting with the contaminants,and hydrogen atom transfer(HAT)preferred to occur on side chains of NMT and MNA.NMT reacted with NO_(2)·through single electron transfer(SET)with the second-order rate constant calculated to be 5.35×10^(7)(mol/L)^(-1)sec^(-1),and the contribution of NO_(2)·was predicted to be 13.0%of the total rate constant of NMT in pure water,which indicated that NO_(2)·played a nonnegligible role in the degradation of NMT.The acute toxicity and developmental toxicity of NMT were enhanced after UV/NH_(2)Cl treatment,while those of MNA were alleviated.The transformation products of both NMT and MNA exhibited higher mutagenicity than their parent compounds.This study provides a deep understanding of the mechanism of radical degradation of NMT and MNA in the treatment of UV/NH2Cl.

关键词： UV/NH_(2)Cl Reactive species Degradation kinetics Reaction mechanism Degradation products

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Host-induced silencing of MpPar6 confers Myzus persicae resistance in transgenic rape plants

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Journal of Integrative Agriculture 2024年第1期23卷 187-194页

作者： qi Zhang Wenqin Zhan Chao Li Ling chang Yi Dong Jiang Zhang State Key Laboratory of Biocatalysis and Enzyme Engineering School of Life SciencesHubei UniversityWuhan 430062China Oil Crops Research Institute Chinese Academy of Agricultural SciencesWuhan 430062China Agricultural Genomics Institute at Shenzhen Chinese Academy of Agricultural SciencesShenzhen 518000China

Plant-mediated RNA interference(RNAi)has emerged as a promising technology for insect control.The green peach aphid,Myzus persicae,feeds on over 400 species of host plants.Brassica napus(rape)is the second most important oilseed crop worldwide.Myzus persicae is highly reproductive and causes severe damage to the rape plants due to its quite flexible life cycle.In this study,we tested the RNAi effects of transgenic rape plants on M.persicae.By in vitro feeding M.persicae with artificial diets containing double-stranded RNAs(dsRNAs)targeting seven aphid genes,we identified a new gene encoding the partitioning-defective protein 6(Par6)as the most potent RNAi target.Tissue-and stage-expression analysis of Par6 suggested this gene is highly expressed in the embryo and adult stage of M.persicae.We next generated transgenic rape plants expressing ds Par6 by Agrobacteriummediated transformation and obtained nine independent transgenic lines.Compared to wild-type control plants,transgenic rape lines expressing ds Par6 showed strong resistance to M.persicae.Feeding assays revealed that feeding transgenic rape plants to M.persicae significantly decreased MpPar6 expression and survival rate and impaired fecundity.Furthermore,we showed that the resistance levels to M.persicae are positively correlated with ds Par6 expression levels in transgenic rape plants.Our study demonstrates that transgenic rape plants expressing ds Par6 are efficiently protected from M.persicae.Interfering with the genes involved in embryo development could be the effective RNAi targets for controlling aphids and potentially other insect pests.

关键词： oilseed rape pest control aphid double-stranded RNA RNA interference

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Durable dual-state duplex Si-HfO_(2)with excellent oxidation and cracking resistance

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Journal of Advanced Ceramics 2024年第3期13卷 388-401页

作者： Lin Chen Jing-Chuan Luo Wen-qi Yang chang-Jiu Li Guan-Jun Yang State Key Laboratory for Mechanical Behavior of Materials School of Materials Science and EngineeringXi’an Jiaotong UniversityXi’an 710049China Xi’an Aerospace Engine Company Limited in CASC Xi’an 710065China

The lifetime of Si bond coatings in environmental barrier coatings is constrained by phase-transition-induced cracking of the SiO_(2)scale.In this study,Si-HfO_(2)dual-state duplex composite materials are proposed to address this issue by partially forming HfSiO_(4)and minimizing the SiO_(2)content.The as-prepared composite exhibited a structure comprising discrete HfO_(2)“bricks”embedded in a continuous Si“mortar”,while the oxidized state transformed into discrete HfSiO_(4)“bricks”within continuous thin SiO_(2)“mortars”.The results indicate that continuous thin SiO_(2)contributes to reducing the oxidation rate to a level comparable to that of pure Si,and discrete HfSiO_(4)particles aid in relieving phase transition-induced stress and inhibiting crack propagation,thereby enhancing oxidation and cracking resistance simultaneously.Consequently,the composite with 20 mol%HfO_(2)and a mean particle size of~500 nm at 1370℃exhibited a service lifetime 10 times greater than that of pure Si.This research provides valuable insights for designing Si-based bond coatings with improved service lifetime.

关键词： oxidation environmental barrier coatings(EBCs) phase transition cracking bond coatings

Population genomic data reveal low genetic diversity,divergence and local adaptation among threatened Reeves's Pheasant(Syrmaticus reevesii)

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Avian Research 2024年第1期15卷 1-11页

作者： qi Lu Pengcheng Wang Jiang chang De Chen Shenghan Gao Jacob Hoglund Zhengwang Zhang Ministry of Education Key Laboratory for Biodiversity Science and Ecological Engineering College of Life SciencesBeijing Normal UniversityBeijing100875China Jiangsu Key Laboratory for Biodiversity and Biotechnology College of Life SciencesNanjing Normal UniversityNanjing210023China State Key Laboratory of Environmental Criteria and Risk Assessment Chinese Research Academy of Environmental SciencesBeijing100012China State Key Laboratory of Microbial Resources Institute of MicrobiologyChinese Academy of SciencesBeijing100101China Department of Ecology and Genetics Animal EcologyUppsala UniversityUppsalaSweden

Population genomic data could provide valuable information for conservation efforts;however,limited studies have been conducted to investigate the genetic status of threatened pheasants.Reeves’s Pheasant(Syrmaticus reevesii)is facing population decline,attributed to increases in habitat loss.There is a knowledge gap in understanding the genomic status and genetic basis underlying the local adaptation of this threatened bird.Here,we used population genomic data to assess population structure,genetic diversity,inbreeding patterns,and genetic divergence.Furthermore,we identified candidate genes linked with adaptation across the current distribution of Reeves’s Pheasant.The present study assembled the first de novo genome sequence of Reeves’s Pheasant and annotated 19,458 genes.We also sequenced 30 individuals from three populations(Dabie Mountain,Shennongjia,qinling Mountain)and found that there was clear population structure among those populations.By comparing with other threatened species,we found that Reeves’s Pheasants have low genetic diversity.Runs of homozygosity suggest that the Shennongjia population has experienced serious inbreeding.The demographic history results indicated that three populations experienced several declines during the glacial period.Local adaptative analysis among the populations identified 241 candidate genes under directional selection.They are involved in a large variety of processes,including the immune response and pigmentation.Our results suggest that the three populations should be considered as three different conservation units.The current study provides genetic evidence for conserving the threatened Reeves’s Pheasant and provides genomic resources for global biodiversity management.

关键词： Conservation genetics Local adaptation Pheasant Whole-genome sequencing

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Nanodiamond/Ti3C2 MXene-coated quartz crystal microbalance humidity sensor with high sensitivity and high quality factor

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Rare Metals 2024年第6期43卷 2719-2729页

作者： Yao Yao qiao Chen Yan-qi Li Xian-He Huang Wei-Wei Ling Zhe-Miao Xie Jia-qi Wang chang-Ming Chen College of Communication Engineering Chengdu University of Information Technology School of Automation Chongqing University of Posts and Telecommunications School of Automation Engineering University of Electronic Science and Technology of China Advanced Micro-/Nano-Devices Lab Department of Systems Design EngineeringUniversity of Waterloo

To address the challenge of achieving both high sensitivity and a high quality factor in quartz crystal microbalance（QCM） humidity sensors,a nanodiamond（ND）/Ti3C2MXene composite-coated QCM humidity sensor was fabricated.The material characteristics of ND,Ti3C2MXene,and ND/Ti3C2MXene composite were analyzed by transmission electron microscopy（TEM） and Fourier transform infrared（FTIR） spectroscopy.The experimental results demonstrated that the hydrophilic ND nanoparticles coated on Ti3C2MXene nanosheet prevented the self-stacking of Ti3C2MXene and enhanced the sensitivity of Ti3C2MXene-based QCM humidity sensor.Moreover,the high mechanical modulus of Ti3C2MXene material helped ND/Ti3C2MXene composite-coated QCM humidity sensor to achieve a high quality factor（> 20,000）.ND/Ti3C2MXene compositecoated QCM humidity sensor exhibited a sensitivity of 82.45 Hz/%RH,a humidity hysteresis of 1.1 %RH,fast response/recovery times,acceptable repeatability,and good stability from 11.3%RH to 97.3%RH.The response mechanism of ND/Ti3C2MXene composite-coated QCM humidity sensor was analyzed in combination with a bi-exponential kinetic adsorption model.Finally,the potential application of ND/Ti3C2MXene composite-coated QCM humidity sensor was demonstrated through its frequency response to wooden blocks with different moisture contents.

关键词： Humidity sensor Quartz crystal microbalance Nanodiamond Ti 3 C 2 MXene High quality factor

Multi-scale analysis on the pulverized coal flow behaviors under high,pressure dense-phase pneumatic conveying

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Particuology 2022年第1期20卷 107-114页

作者： Heming Gao Xiaojuan Wang qi chang School of Mechanical and Precision Instrument Engineering Xi'an University of TechnologyXi'an 710048China

To deeply knowledge of the flow behaviors of pulverized coal particles in dense gas-solid two-phase flow,a multi-scale analysis method based on electrostatic sensor array is applied for the multi-scale characterization of flow behaviors of dense gas-solid flow.The experimental results indicate that:for steady flow,with the increment of conveying pressure difference,the individual particles increase and the particle clusters decrease,the individual particle distribution is always inhomogeneous but the particle cluster distribution tends to be more homogeneous over the cross-section of pipe,while the average flow behavior of pulverized coal particles is always in the relatively static state.For unsteady flow,the average flow behavior of pulverized coal particles is dynamic,and the flow behaviors of the multi-scale flow structures over the cross-section of pipe are all significantly inhomogeneous.Moreover,the effect of particle size on flow behavior of pulverized coal is also investigated and validated.

关键词： Dense-phase pneumatic conveying Pulverized coal Multi-scale Particle charging

In situ autophagy regulation in synergy with phototherapy for breast cancer treatment

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Acta Pharmaceutica Sinica B 2024年第5期14卷 2317-2332页

作者： Huijuan Zhang Xiangyang Xuan Yaping Wang Zijun qi Kexuan Cao Yingmei Tian Chaoqun Wang Junbiao chang Zhenzhong Zhang Lin Hou School of Pharmaceutical Sciences Zhengzhou UniversityZhengzhou 450001China Key Laboratory of Targeting Therapy and Diagnosis for Critical Diseases Zhengzhou 450001China Collaborative Innovation Center of New Drug Research and Safety Evaluation Zhengzhou 450001China School of Chemistry and Molecular Engineering Zhengzhou UniversityZhengzhou 450001China

Autophagy is an important factor in reducing the efficacy of tumor phototherapy(including PTT and PDT).Accurate regulation of autophagy in tumor cells is a new strategy to improve the anti-tumor efficiency of PTT/PDT.This project intended to construct a tumor-activated autophagy regulator to efficiently block PTT/PDT-induced autophagy and realize synergistic sensitization to tumor phototherapy.To achieve this goal,we first synthesized TRANSFERRIN(Tf)biomimetic mineralized nano-tellurium(Tf-Te)as photosensitizer and then used disulfide bond reconstruction technology to induce Tf-Te self-assembly.The autophagy inhibitor hydroxychloroquine(HCQ)and iron ions carried by Tf were simultaneously loaded to prepare a tumor-responsive drug reservoir Tf-Te/HCQ.After entering breast cancer cells through the“self-guidance system”,Tf-Te/HCQ can generate hyperpyrexia and ROS under NIR laser irradiation,to efficiently induce PTT/PDT effect.Meanwhile,the disulfide bond broke down in response to GSH,and the nanoparticles disintegrated to release Fe2+and HCQ at fixed points.They simultaneously induce lysosomal alkalinization and increased osmotic pressure,effectively inhibit autophagy,and synergistically enhance the therapeutic effect of phototherapy.In vivo anti-tumor results have proved that the tumor inhibition rate of Tf-Te/HCQ can be as high as 88.6%on 4T1 tumor-bearing mice.This multifunctional drug delivery system might provide a new alternative for more precise and effective tumor phototherapy.

关键词： Autophagy Tumor phototherapy Synergistic sensitization HCQ TRANSFERRIN Disulfide bond reconstruction GSH Biomimetic mineralized nano-tellurium