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Evolution of drug regulations and regulatory innovation for anticancer drugs in China

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Acta Pharmaceutica Sinica B 2022年第12期12卷 4365-4377页

作者： Yang Liu Ning Zhang Cuicui Xie Yale Jiang Yunhe Qin Liyun Zhou Yi Fan Lianjie Ren Chen Yin Huan Yang wei Xie Qing Zhai Guanqiao Li Hongzhuan Chen xiaoyuan Chen Tsinghua Clinical Research Institute(TCRI) School of MedicineTsinghua UniversityBeijing 100084China Center for Drug Evaluation National Medical Products AdministrationBeijing 100038China Pharmcube(Beijing)Co. Ltd.Beijing 100102China Department of Clinical Pharmacy Cancer Hospital of Fudan UniversityShanghai 200032China Vanke School of Public Health Tsinghua UniversityBeijing 100084China Shanghai Collaborative Innovation Center for Translational Medicine Shanghai University of Traditional Chinese MedicineShanghai 201203China Office of Clinical Trial Institute Beijing Tsinghua Changgung HospitalBeijing 102218China

Over the past two decades,China has introduced significant changes to drug regulations through regulatory innovations to accelerate drug review and approvals,keeping in line with the rapidly growing scientific innovation in drug research and development(R&D).In this study,we outlined the revolution of drug regulation in China since the establishment of the State Drug Administration in *** particularly,we performed a comprehensive analysis of newly approved anticancer drugs in China from the year 2005 to May 2021,as a powerful illustration of how the revolution has changed the drug R&D *** drug development in China has boomed,benefiting in particular from pro-innovation policies as well as expedited program designations by the *** found a significant increase in the number of both imported and domestic new anticancer drugs from 2005 to 2021,with the emergence of drugs with novel mechanisms of action,including immune checkpoint inhibitors and cell therapy *** lag has also been dramatically shortened by more than 70%for imported drugs in years 2016-2020 compared to years ***,we provide an insight into the potential approaches to further optimize the science-based and clinical value-based regulatory and R&D drug ecosystem in *** review provides evidence of significant impacts of regulations and policies on drug R&D and suggests that the constantly adapting regulatory ecosystem will speed up drug development in China and worldwide.

关键词： Regulatory innovations Drug R&D Anticancer drugs Innovative drugs Expedited program designations Drug lag Globalization Unmet medical need

白介素-17在慢性阻塞性肺疾病中的表达变化研究概况

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中国民族民间医药 2016年第12期25卷 55-57页

作者：周鹏梁爱武张惠敏韦筱园骆盅霖广西中医药大学广西南宁530001 广西中医药大学附属瑞康医院广西南宁530001

目的:探讨慢性阻塞性肺疾病的发病机制和白介素-17在该病中的作用机理和表达情况。方法:检索近15年来有关文献进行整理和分析。结果:该病是一种慢性炎症疾病,且白介素-17在该病炎症中发挥了重要的介导炎症作用;目前研究认为该病患者的... 详细信息

目的:探讨慢性阻塞性肺疾病的发病机制和白介素-17在该病中的作用机理和表达情况。方法:检索近15年来有关文献进行整理和分析。结果:该病是一种慢性炎症疾病,且白介素-17在该病炎症中发挥了重要的介导炎症作用;目前研究认为该病患者的痰液、血液中均存在白介素-17水平异常升高,且与该病的严重程度相关。结论:目前关于白介素-17与慢阻肺的防治仍有诸多方面可发掘、探讨和研究,且临床意义重大。

关键词：慢性阻塞性肺疾病白介素-17 综述

Polyethyleneimine-modified calcium carbonate nanoparticles for p53 gene delivery

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Regenerative Biomaterials 2016年第1期3卷 57-63页

作者： Cen Chen Huafeng Han wei Yang xiaoyuan Ren Xiangdong Kong Bio-X Center College of Life SciencesZhejiang Sci-Tech UniversityHangzhou 310018China Institute of Biomaterials and Marine Biological Resources College of Life SciencesZhejiang Sci-Tech UniversityHangzhou 310018China

In this study,calcium carbonate(CaCO3)nanoparticles with spherical structure were regulated by arginine and successfully synthesized via a facile co-precipitation *** average particle size of as-prepared CaCO3 was about 900 *** properties of nanostructured CaCO3 particles were characterized by scanning electron microscope,Fourier transform infrared spectroscopy,Xray diffraction and size *** modified with polyethyleneimine(PEI),the ability of PEICaCO3 nanoparticles to carry GFP-marked p53 gene(pEGFP-C1-p53)into cancer cells to express P53 protein were ***,the cytotoxicity,transfection efficiency,cells growth inhibition and the ability to induce apoptosis by expressed P53 protein were conducted to evaluate the performances of PEI-CaCO3 *** results show that prepared PEI-CaCO3 nanoparticles had good biocompatibility and low cytotoxicity in a certain concentration ***-CaCO3 effectively transfected pEGFP-C1 gene into epithelial-like cancer *** with the expression of GFP-P53 fusion protein,pEGFP-C1-p53-gene-loaded PEI-CaCO3 particles significantly reduced the proliferation of cancer *** findings indicate that our PEI-modified CaCO3 nanoparticles are potential to be successfully used as carriers for gene therapy.

关键词： calcium carbonate gene therapy nanoparticles polyethyleneimine p53

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石墨烯量子点对环氧树脂抗辐照性能的影响

辐射研究与辐射工艺学报 2024年第1期42卷 38-44页

作者：候金霞刘胜凯裴晓园王维尹跃周新科徐志伟天津工业大学纺织科学与工程学院天津300387

探究高能辐照下环氧树脂损伤降解机理,以提高环氧树脂在辐照环境下的稳定性。本研究将石墨烯量子点(GQDs)作为自由基清除剂,减缓γ辐照环境下环氧树脂的降解,并研究了GQDs对环氧树脂抗辐照性能的影响机制。结果表明:经过辐照后环氧树脂... 详细信息

探究高能辐照下环氧树脂损伤降解机理,以提高环氧树脂在辐照环境下的稳定性。本研究将石墨烯量子点(GQDs)作为自由基清除剂,减缓γ辐照环境下环氧树脂的降解,并研究了GQDs对环氧树脂抗辐照性能的影响机制。结果表明:经过辐照后环氧树脂力学性能下降49%,玻璃化转变温度下降4.4℃;石墨烯量子点/环氧树脂(GQDs/EP)复合材料的力学性能下降35%,玻璃化转变温度下降2.2℃;GQDs的引入使得辐照后的GQDs/EP复合材料产生的自由基含量显著低于纯树脂自由基的含量。GQDs纳米颗粒也改善了辐照前后环氧树脂的力学性能和热学稳定性。因此,GQDs纳米颗粒可以作为自由基清除剂,有效地提高环氧树脂的辐照稳定性。GQDs清除自由基机制与sp2碳域和表面的官能团有密切相关。本研究为提高环氧树脂在γ射线辐照下的稳定性提供了新的思路和方法。

关键词：环氧树脂纳米颗粒抗辐照性能

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急性呼吸窘迫综合征的代谢组学研究进展

中华危重病急救医学 2022年第4期34卷 434-439页

作者：段晓媛许巍中国医科大学附属盛京医院儿科重症监护病房辽宁沈阳110004

急性呼吸窘迫综合征(ARDS)是一种临床上和生物学上的异质性临床综合征。考虑到由于病因、临床和分子表现形式的广泛差异而导致的ARDS异质性,目前的科学共识是,ARDS不是一种单一的疾病,而是一系列需要进一步研究以进行适当分类、识别和... 详细信息

急性呼吸窘迫综合征(ARDS)是一种临床上和生物学上的异质性临床综合征。考虑到由于病因、临床和分子表现形式的广泛差异而导致的ARDS异质性,目前的科学共识是,ARDS不是一种单一的疾病,而是一系列需要进一步研究以进行适当分类、识别和鉴定的病理生理过程。代谢组学是一个迅速发展的系统生物学领域,在作为跨学科平台的科学和医学领域取得了许多突破。代谢组学为ARDS诊断中生物标志物的发现和分析提供了重要的机遇,有望揭示ARDS背后的生物学过程,并在解决ARDS异质性和严重程度评估方面展现出巨大潜力。为此,本文对有关ARDS代谢组学的研究进行了阐述,并讨论了ARDS代谢组学研究的进展和遇到的主要障碍。

关键词：急性呼吸窘迫综合征急性肺损伤代谢组学生物标志物异质性

No association between elevated homocysteine levels and carotid atherosclerosis in a rural population in China

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Stroke & Vascular Neurology 2016年第4期1卷 154-160页

作者： Yang Li Li Wang wei Zhang Yalan Fang xiaoyuan Niu Department of Neurology First Hospital of Shanxi Medical UniversityTaiyuanChina

Objectives:We wish to determine if homocysteine(Hcy)is an independent risk factor for carotid atherosclerosis in a rural Chinese ***:2291 individuals(1016 men and 1275 women),aged 64.6±7.4 years,from Lvliang,China participated in this *** performed included carotid artery ultrasound scan and blood analysis,to measure Hcy levels and other blood ***:The mean serum Hcy level was 24.7±18.0μmol/*** overall detection rate of carotid atherosclerotic lesions was 76.3%and the detection rate of plaque was 48.6%.Participants were divided into 4 groups based on their Hcy levels,0.05),*** controlling for demographic variables(age,gender,current smoker,fasting blood glucose,low-density lipoprotein and systolic blood pressure)the OR of carotid plaque(s)in the third and fourth quartiles were 1.246(95%CI 0.967 to 1.606)and 1.259(95%CI 0.963 to 1.646;p>0.05).Conclusions:The mean value of Hcy among participants in this study was much higher than that previously ***,no significant correlation between elevated Hcy and carotid atherosclerosis was found.

关键词： elevated carotid atherosclerosis

On the designing principles and optimization approaches of bio-inspired self-organized network: a survey

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Science China(Information Sciences) 2013年第7期56卷 5-32页

作者： ZHANG ZhongShan HUANGFU wei LONG KePing ZHANG Xu LIU xiaoyuan ZHONG Bin Institute of Advanced Network Technology and New Services (ANTS) University of Science and Technology Beijing (USTB) Beijing Engineering and Technology Center for Convergence Networks and Ubiquitous Services University of Science and Technology Beijing (USTB)

A plethora of studies on self-organization has been carried out in broad areas including chemistry, biology, astronomy, medical science, telecommunications, etc., in both academia and industry. Following the studies on swarm intelligence observed in social species, the artificial self-organized systems are expected to exhibit some intelligent features (e.g., flexibility, robustness, decentralized control, self-evolution, etc.) that may have made social species so successful in the biosphere. In this paper, the application of swarm intelligence in communications networks will be studied, and we survey different aspects of bio-inspired mechanisms and examine various algorithms that have been proposed to improve the performance of artificial systems. Some fundamental self-organized networking (SON) mechanisms, designing principles and optimization approaches for artificial systems will then be investigated, followed by some well-known bio-inspired algorithms (e.g., cooperation, division of labor, distributed network synchronization, load balancing, etc.) as well as their applications to the maintenance/operation/optimization of artificial systems being analyzed. Besides, some new emerging technologies, such as the Self-X capabilities and cognitive machine-to-machine (M2M) optimization for the 3rd Generation Partnership Project (3GPP) Long Term Evolution (LTE)/LTE-Advanced systems, are also surveyed. Finally, the remaining challenges to be faced in designing the future heterogeneous systems will be discussed.

关键词： self-organized networking heterogeneous cognitive radio bio-inspired swarm intelligence decentralized load balancing cooperation

Unfolded protein response activation compensates endoplasmic reticulum-associated degradation deficiency in Arabidopsis

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Journal of Integrative Plant Biology 2017年第7期59卷 506-521页

作者： Qingliang Li Hai wei Lijing Liu xiaoyuan Yang Xiansheng Zhang Qi Xie State Key Laboratory of Plant Genomics National Center for Plant Gene Research Institute of Genetics and Developmental Biology Chinese Academy of Sciences State Key Laboratory of Crop Biology Shandong Key Laboratory of Crop Biology College of Life Sciences Shandong Agricultural University

Abiotic stresses often disrupt protein folding and induce endoplasmic reticulum （ER） stress. There is a sophisticated ER quality control （ERQC） system to mitigate the effects of malfunctioning proteins and maintain ER homeostasis. The accumulation of misfolded proteins in the ER activates the unfolded protein response （UPR） to enhance ER protein folding and the degradation of misfolded proteins mediate by ER- associated degradation （ERAD）. That ERQC reduces abiotic stress damage has been well studied in mammals and yeast. However, in plants, both ERAD and UPR have been studied separately and found to be critical for plant abiotic stress tolerance. In this study, we discovered that UPR-associated transcription factors AtbZlP17, AtbZIP28 and AtbZIP60 responded to tunicamycin （TM） and NaCl induced ER stress and subsequently enhanced Arabidopsis thaliana abiotic stress tolerance. They regulated the expression level of ER chaperones and the HRD1-complex components. Moreover, overexpression of AtbZIP17, AtbZIP28 and AtbZIP60 could restore stress tolerance via ERAD in the HRD1-complex mutant hrd3a-2, which suggested that UPR and ERAD have an interactive mechanism in Arabidopsts.

关键词： ZIP ERAD HRD in of UPR

中南某市地铁站和车厢室内空气细菌污染状况及菌群分布特征

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环境与职业医学 2024年第7期41卷 801-806+813页

作者：程淑燕桂卓嘉苏丽琴田国忠葛覃兮罗姣邵冉起李峰奚伟豪周纯良彭蔚彭敏兰杨敏张必科王先良姚孝元中国疾病预防控制中心环境与健康相关产品安全所/中国疾病预防控制中心环境与人群健康重点实验室贵州医科大学公共卫生与健康学院/环境污染与疾病监控教育部重点实验室湘潭市疾病预防控制中心中国疾病预防控制中心传染病预防控制所湖南省疾病预防控制中心环境健康科

[背景]细菌是地铁室内空气中种类最多、来源最广泛的微生物，其中的病原菌可通过空气在人群中传播，导致健康风险增加。[目的]了解中南某城市地铁站内及车厢内空气细菌污染状况及其菌群分布特征，为制定改善地铁室内空气细菌污染干预措... 详细信息

[背景]细菌是地铁室内空气中种类最多、来源最广泛的微生物，其中的病原菌可通过空气在人群中传播，导致健康风险增加。[目的]了解中南某城市地铁站内及车厢内空气细菌污染状况及其菌群分布特征，为制定改善地铁室内空气细菌污染干预措施提供科学依据。[方法]根据客流量差异，选择中南某市三个地铁站及停靠列车车厢进行同步空气采样监测。采用直读法测定温度、湿度、风速、二氧化碳（CO2）、细颗粒物(PM2.5)和可吸入颗粒物(PM10)。按照GB/T 18204.3—2013《公共场所卫生检验方法第3部分：空气微生物》要求，以28.3 L·min-1流量采集空气样本，培养检测细菌总数，对细菌微生物种类进行质谱鉴定，根据国家卫生健康委员会制定的《人间传染的病原微生物目录》区分病原菌和非病原菌。采用Kruskal-Wallis H检验进行不同区域和时段地铁卫生指标的比较分析，采用Bonferroni检验进行两两比较，采用Spearman相关性检验对CO2浓度与细菌总数进行关联性分析。[结果]地铁站内和车厢内空气细菌总数、PM2.5和PM10合格率均为100.0%，温度、风速合格率均为94.4%,CO2合格率为98.6%，湿度合格率为0%。地铁站内和车厢内空气细菌总数的中位数及第25、75百分位数为177（138, 262）CFU·m-3；不同区域、不同时段的比较分析显示，空气细菌总数站厅高于站台，早高峰高于晚高峰，差异均具有统计学意义（P 9分；空气细菌优势菌为藤黄微球菌（52.2%）和人葡萄球菌（9.8%）。在3个地铁站内和车厢内检出表皮葡萄球菌（2.2%）、鲍氏不动杆菌（0.3%）和纹带棒杆菌（0.1%）这3种病原菌共23例（2.6%），检出位置主要分布于晚高峰时的车厢内。[结论]地铁室内不同区域、不同时段空气细菌总数存在差异，且存在一定的条件致病菌感染风险，应加强客流高峰时段及各区域的清洁与消毒。

关键词：地铁室内空气细菌总数菌种鉴定致病菌