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2013年（第三届）中国药物毒理学年会暨药物非临床安全性评价研究论坛

作者： LI Yin-chao HE Yong-xia SUN Man CHEN Hui-fang XU Ping-hua WANG Sui-hua LIU Hong-min Research Center of Zhengzhou University drug Safety Evaluation

OBJECTIVE Giving the alcoholic extract from Rabdosia rubescens through ig administration for 30 d,observing whether it occurs accumulation toxicity of liver and kidney in rats,and providing a reference for the follow-up safety *** Observing the requirements of the second draft of Chinese medicine,and natural drug long-term toxicity research technology guidance principles under([Z]GPT 3-1),select 80 large rats,female and male the half, physique volume(200±20) *** were divided into 4 groups by weight tiered random,that is Rabdosia rubescens alcohol extracts high,medium and low dose groups and dissolved vector controlled *** were 10 female and male animals in each *** rats were administered to give the Rabdosia rubescens alcohol extract 0.96 g·kg(equivalent to native herbs 20.84 g·kg),0.71 g·kg(equivalent to native herbs 15.41 g·kg),0.46 g·kg(equivalent to native herbs 9.99 g·kg) *** administration continuously for 30 d and recovery 14 *** the end of the medication and recovery period,one-second of male and female animals in each group were killed to have blood biochemical examinations and system autopsy and histopathological examination and record the rats’ general condition,body weight, food *** Except a male death of the high dose group,there was no animal death in other groups. During the administration,the high and medium does of the Rabdosia rubescens alcohol extracts can make the rats lose weight,react slowly and erect *** Rabdosia rubescens alcohol extracts low dose group and dissolved vector controlled group,the rats are generally in good *** blood biochemical index(ALT,BUN) levels of male rats in the Rabdosia rubescens alcohol extracts high dose group and the blood biochemical index(BUN) levels of female rats in the medium does all rise significantly higher(P<0.05) than that of the dissolved vector controlled *** the end of the medication, compared to the dissolved vector controlled g

关键词： Rabdosia rubescens alcoholic extract hepatic toxicity renal

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Immuno-oncology combinations： raising the tail of the survival curve

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Cancer Biology & Medicine 2016年第2期13卷 171-193页

作者： Samuel J. Harris Jessica Brown Juanita Lopez Timothy A. Yap drug Development Unit Royal Marsden Hospital and The Institute of Cancer Research London SM2 5PT UK Lung Unit Royal Marsden Hospital and The Institute of Cancer Research London SM2 5PT UK

There have been exponential gains in immuno-oncology in recent times through the development of immune checkpoint inhibitors. Already approved by the U.S. food and drug administration for advanced melanoma and non-small cell lung cancer,immune checkpoint inhibitors also appears to have significant antitumor activity in multiple other tumor types. An exciting component of immunotherapy is the durability of antitumor responses observed, with some patients achieving disease control for many years. Nevertheless, not all patients benefit, and efforts should thus now focus on improving the efficacy of immunotherapy through the use of combination approaches and predictive biomarkers of response and resistance. There are multiple potential rational combinations using an immunotherapy backbone, including existing treatments such as radiotherapy, chemotherapy or molecularly targeted agents, as well as other immunotherapeutics. The aim of such antitumor strategies will be to raise the tail on the survival curve by increasing the number of long term survivors, while managing any additive or synergistic toxicities that may arise with immunotherapy combinations. Rational trial designs based on a clear understanding of tumor biology and drug pharmacology remain paramount. This article reviews the biology underpinning immuno-oncology, discusses existing and novel immunotherapeutic combinations currently in development, the challenges of predictive biomarkers of response and resistance and the impact of immuno-oncology on early phase clinical trial design.

关键词： Combination drug therapy oncology clinical trials PD-1 PD-L1 CTLA4 biomarkers immunotherapy

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Regulation of enolase activation to promote neural protection and regeneration in spinal cord injury

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Neural Regeneration Research 2023年第7期18卷 1457-1462页

作者： Hannah MMcCoy Rachel Polcyn Naren LBanik Azizul Haque Department of Microbiology and Immunology Medical University of South CarolinaCharlestonSCUSA Department of Neurosurgery Medical University of South CarolinaCharlestonSCUSA Ralph H.Johnson Veterans administration Medical Center CharlestonSCUSA

Spinal cord injury(SCI)is a debilitating condition characterized by damage to the spinal cord resulting in loss of function,mobility,and sensation with no *** and drug administration-approved ***,a multifunctional glycolytic enzyme upregulated after SCI,promotes pro-and anti-inflammatory events and regulates functional recovery in *** is normally expressed in the cytosol,but the expression is upregulated at the cell surface following cellular injury,promoting glial cell activation and signal transduction pathway ***-induced microglia activation triggers pro-inflammatory mediators at the injury site,activating other immune cells and metabolic events,i.e.,Rho-associated kinase,contributing to the neuroinflammation found in *** surface expression also activates cathepsin X,resulting in cleavage of the C-terminal end of neuron-specific enolase(NSE)and non-neuronal enolase(NNE).Fully functional enolase is necessary as NSE/NNE C-terminal proteins activate many neurotrophic processes,i.e.,the plasminogen activation system,phosphatidylinositol-4,5-bisphosphate 3-kinase/protein kinase B,and mitogen-activated protein kinase/extracellular signal-regulated *** here suggest an enolase inhibitor,ENOblock,attenuates the activation of Rho-associated kinase,which may decrease glial cell activation and promote functional recovery following ***,ENOblock inhibits cathepsin X,which may help prevent the cleavage of the neurotrophic C-terminal protein allowing full plasminogen activation and phosphatidylinositol-4,5-bisphosphate 3-kinase/mitogen-activated protein kinase *** combined NSE/cathepsin X inhibition may serve as a potential therapeutic strategy for preventing neuroinflammation/degeneration and promoting neural cell regeneration and recovery following *** role of cell membrane-expressed enolase and associated metabolic events should be investigated to determine if the same strategies can be applied to other neu

关键词： cathepsin X ENOblock enolase glia mitogen-activated protein kinase/extracellular signal-regulated kinase neurodegeneration neuroinflammation phosphatidylinositol-4,5-bisphosphate 3-kinase/protein kinase B Rho-associated protein kinase spinal cord injury

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Hepatotoxicity and nephrotoxicity of the alcoholic extract from Rabodasia rubescens

Hepatotoxicity and nephrotoxicity of the alcoholic extract f...

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作者： LI Yin-chao HE Yong-xia SUN Man CHEN Hui-fang XU Ping-hua WANG Sui-hua LIU Hong-min Research Center of Zhengzhou University drug Safety Evaluation

OBJECTIVE Giving the alcoholic extract from Rabdosia rubescens through ig administration for 30 d,observing whether it occurs accumulation toxicity of liver and kidney in rats,and providing a reference for the follow-up safety *** Observing the requirements of the second draft of Chinese medicine,and natural drug long-term toxicity research technology guidance principles under([Z]GPT 3-1),select 80 large rats,female and male the half, physique volume(200±20) *** were divided into 4 groups by weight tiered random,that is Rabdosia rubescens alcohol extracts high,medium and low dose groups and dissolved vector controlled *** were 10 female and male animals in each *** rats were administered to give the Rabdosia rubescens alcohol extract 0.96g·kg~(-1)(equivalent to native herbs 20.84 g·kg~(-1)),0.71 g·kg~(-1)(equivalent to native herbs 15.41 g·kg~(-1)),0.46 g·kg~(-1)(equivalent to native herbs 9.99 g·kg~(-1)) *** administration continuously for 30 d and recovery 14 *** the end of the medication and recovery period,one-second of male and female animals in each group were killed to have blood biochemical examinations and system autopsy and histopathological examination and record the rats'''' general condition,body weight, food *** Except a male death of the high dose group,there was no animal death in other groups. During the administration,the high and medium does of the Rabdosia rubescens alcohol extracts can make the rats lose weight,react slowly and erect *** Rabdosia rubescens alcohol extracts low dose group and dissolved vector controlled group,the rats are generally in good *** blood biochemical index(ALT,BUN) levels of male rats in the Rabdo sia rubescens alcohol extracts high dose group and the blood biochemical index(BUN) levels of female rats in the medium does all rise significantly higher(P<0.05) than that of the dissolved vector controlled *** the end of the medication, compared to

关键词：

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QuaPra: Efficient transcript assembly and quantification using quadratic programming with Apriori algorithm

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Science China(Life Sciences) 2019年第7期62卷 937-946页

作者： Xiangjun Ji Weida Tong Baitang Ning Christopher E. Mason David P. Kreil Pawel P. Labaj Geng Chen Tieliu Shi The Center for Bioinformatics and Computational Biology Shanghai Key Laboratory of Regulatory BiologyInstitute of Biomedical Sciences and School of Life SciencesEast China Normal UniversityShanghai 200241China National Center for Toxicological Research U.S. Food and Drug Administration3900 NCTR RDJefferson AR 72079USA Department of Physiology and Biophysics Weill Cornell MedicineNew York 10065USA The HRH Prince Alwaleed Bin Talal Bin Abdulaziz Alsaud Institute for Computational Biomedicine New York 10021USA Feil Family Brain & Mind Research Institute New York 10065USA Chair of Bioinformatics Research Group Boku UniversityVienna A-1190Austria Malopolska Centre of Biotechnology Jagiellonian UniversityKrakow 30-387Poland APART Fellow Austrian Academy of ScienceVienna A-1190Austria National Center for International Research of Biological Targeting Diagnosis and Therapy Guangxi Key Laboratory of Biological Targeting Diagnosis and Therapy ResearchCollaborative Innovation Center for Targeting Tumor Diagnosis and TherapyGuangxi Medical UniversityNanning 530021China

RNA sequencing(RNA-seq) has greatly facilitated the exploring of transcriptome landscape for diverse ***,transcriptome reconstruction is still challenging due to various limitations of current tools and sequencing ***,we introduce an efficient tool,QuaPra(Quadratic Programming combined with Apriori),for accurate transcriptome assembly and *** could detect at least 26.5% more low abundance(0.1–1 FPKM) transcripts with over 2.7% increase of sensitivity and precision on simulated data compared to other currently popular ***,around one-quarter more known transcripts were correctly assembled by QuaPra than other assemblers on real sequencing *** is freely available at http://***/QuaPra/.

关键词： RNA-Seq transcriptome reconstruction transcript assembly transcript quantification

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Group Purchasing Organizations (GPOs) in the U.S.: Development and Reform

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Asian Journal of Social Pharmacy 2019年第3期14卷 100-109页

作者： Jin Jing Xiong Jiamei Yang Yue Huang Zhe School of Business administration Shenyang Pharmaceutical University Shenyang 110016 China International Center for food and drug Policy and Law Research Shenyang Pharmaceutical University Shenyang 110016 China

Objective To study the characteristics, specific functions and policy improvement process of the Group Purchasing Organizations (GPOs) in the U.S. and to provide references for drug group purchasing practices in China. Methods Domestic and foreign relevant literatures, websites were reviewed or searched to analyze the functions and policy improvement process of the GPOs in the U.S. so as to provide references for drug group purchasing practices in China. Results and Conclusion As a third party in the U.S. GPOs has formed a relatively integrated business process and projects service system after long-term development. Supported by corresponding policies and industrial regulations, GPOs have made a great contribution to control the growth of medical and healthcare expenses and improve the efficiency of medical institutions, and its development experience can enlighten the practices in China.

关键词： group purchasing organization (GPO) drug purchase the U.S.

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Research and Reference of the Authorized Generic drug System in the US

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Asian Journal of Social Pharmacy 2021年第1期16卷 11-22页

作者： Wang Hongwei Yang Yue School of Business administration Shenyang Pharmaceutical UniversityShenyang 110016China International Center for food and drug Policy and Law Research Shenyang Pharmaceutical UniversityShenyang 110016China

Objective To study the significance of authorized generic drugs due to the successive relevant documents issued by China’s government in recent years,which clearly stipulated that China should establish a drug patent linkage *** The authorized generic drugs play an important role in keeping the balance between brandname drugs and generic drugs in the ***,this system was investigated,focusing on its difference from independent generics,marketing procedures,application in patent litigation and legitimacy analysis through case *** analogy analysis could provide a reference for the research of authorized generic drug systems in *** and Conclusion As an important factor affecting the balance between brand-name drugs and generic drugs,authorized generic drugs should be comprehensively analyzed and discussed,and a suitable system for China’s national conditions should be established by referring to the experiences of the US.

关键词： authorized generic drug patent linkage system drug settlement patent litigation

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Clinical Efficacy and Safety of Oxaliplatin-tegafur,Gimeracil and Oteracil Potassium and Vinorelbine-Pt in the Treatment of Advanced Triple Negative Breast Cancer

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Advances in Modern Oncology Research 2019年第5期5卷 21-24页

作者： Miroslav Samaržija Lela Bitar US food and drug administration Center for Biologics Evaluation and ResearchOffice of Biostatistics and EpidemiologySilver SpringMD Memorial Sloan Kettering Cancer Center New YorkNY

The purpose of this study was to investigate the efficacy and safety of oxaliplatin combined with tegafur,gimeracil and oteracil potassium(SOX regimen)and vinorelbine combined with Pt(NP regimen)in the treatment of advanced triple negative breast cancer(TNBC).First of all,88 patients with advanced breast cancer were selected and divided into observation group and control group with 44 cases each by random number *** groups received conventional supportive *** this basis,SOX regimen was adopted in the observation group and NP regimen in the control group,and the efficacy,occurrence of toxic and side effects in the two groups were *** results showed that the objective effective rates and clinical benefit rates of the two groups were statistically significant(P<0.05).In addition,both groups had hand foot syndrome,diarrhea,liver function damage,decreased platelet(PLT)and other toxic side effects,but the incidence of rash,oral ulcer and pigmentation in the observation group was significantly lower than that in the control group(P<0.05).Therefore,both SOX regimen and NP regimen can effectively treat advanced TNBC adverse reactions,but SOX regimen was more effective.

关键词： Oxaliplatin Tegafur,gimeracil and oteracil potassium Vinorelbine Pt

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同域分布的鹿类动物多空间尺度下取食生境利用及其相互作用关系的研究(英文)

同域分布的鹿类动物多空间尺度下取食生境利用及其相互作用关系的...

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第七届全国野生动物生态与资源保护学术研讨会

作者： PHILIP STOTT State Forestry administration College of Wildlife ResourcesNortheast Forestry University26 Hexing RoadHarbin 150040People’s Republic of China School of Agriculture Food and WineRoseworthy CampusThe University of Adelaide South Australia 5371Australia

Moose(Alces alces)and roe deer(Capreolus pygargus)are sympatric in the forest region of northeastern *** univariate analyses of feeding sign data,we found the 2 species were positively associated,but there were distinctions between their use of forage resources across landscape, patch,and microhabitat *** used resource selection function models to predict the influence of environmental covariates on moose and roe deer foraging;we detected covariate effects at the landscape and microhabitat scales but not at the patch *** resources used by the 2 species were similar, but moose used wetter areas and more low-visibility habitats than did roe deer,which strongly avoided areas with sparse *** species were influenced by forage abundance and distribution at the microhabitat scale but exhibited differences in intensity of use of plant species and *** used areas with deeper snow and avoided hiding cover;roe deer avoided areas with higher total basal areas of tree stems and preferred areas with high plant species *** moose,there was a tradeoff in the use of concealment cover between the landscape and microhabitat *** detected avoidance by moose of roads where roe deer *** deer exhibited more capacity for coping with human disturbance and interspecific *** areas similar to our study area,road closures and suppression of roe deer near roads within 3-5 years postlogging may benefit ***,a mosaic of areas with different logging intervals may contribute to spatial separation of moose and roe deer and promote their coexistence.

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Preliminary study of blended silk fibroin for contact lens-based ophthalmic drug delivery

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Asian Journal of Pharmaceutical Sciences 2016年第1期11卷 136-137页

作者： Rachasit Jeencham Waree Tiyaboonchai Manote Sutheerawattananonda Faculty of Pharmaceutical Sciences Naresuan UniversityPhitsanulokThailand School of food Technology Suranaree University of TechnologyNakhon RatchasimaThailand

Topical drug administration is acommonapproach to treat ocular ***,the topical route of administration enables poor drug *** drawbacks stem from limited permeability across the cornea,rapid clearance of the instilled drop,and significant absorption into the conjunctival vasculature[1].Recently,contact lens based ophthalmic drug delivery systems have been proposed as alternative ophthalmic drug delivery systems to increase ocular drug bioavailability[2].Silk fibroin,a natural fiber polymer produced by the silk worm,Bombyx mori,has excellent properties for ocular drug delivery systems,i.e.,biocompatibility,chemical and mechanical stability,wetting ability,and high oxygen permeability[3].

关键词： Ophthalmic drug delivery Silk fibroin Contact lens Light transparency Mechanical properties Water content

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