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雾化吸入布地奈德混悬液在中国健康成年试验参与者的生物等效性研究

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药学与临床研究 2024年第2期32卷 127-131页

作者：程凤吴莎张福成肖大伟南京高新医院Ⅰ期临床试验部南京211899 正大天晴药业集团股份有限公司临床运营部南京211100

目的:评价空腹状态下单剂量雾化吸入布地奈德混悬液受试制剂和参比制剂在中国健康成年试验参与者中的生物等效性和安全性。方法:采用单中心、随机、开放、四周期、两序列、完全重复交叉设计,40例试验参与者被随机分为TRTR序列组和RTRT... 详细信息

目的:评价空腹状态下单剂量雾化吸入布地奈德混悬液受试制剂和参比制剂在中国健康成年试验参与者中的生物等效性和安全性。方法:采用单中心、随机、开放、四周期、两序列、完全重复交叉设计,40例试验参与者被随机分为TRTR序列组和RTRT序列组,每周期单次空腹经口雾化吸入受试制剂或参比制剂2 mL∶0.5 mg,用经方法学验证的液相色谱串联质谱分析方法测定血浆中布地奈德的浓度,Phoenix WinNonlin(8.3.1)软件非房室模型分析方法对血浆中布地奈德的药代动力学(PK)参数进行分析,评价两种制剂的生物等效性;记录给药后至随访结束的所有不良事件。结果:试验参与者空腹吸入受试制剂和参比制剂后,血浆中布地奈德的主要PK参数如下:C_(max)分别为(1210±693)和(1020±494)pg·mL^(-1);AUC_(0~t)分别为(1660±546)和(1530±477)h·pg·mL^(-1);AUC_(0~∞)分别为(1710±554)和(1580±486)h·pg·mL^(-1);t_(max)分别为0.08(0.08,0.75)和0.08(0.08,0.50)h;t_(1/2)分别为(3.57±1.26)和(3.31±0.98)h。受试制剂和参比制剂C_(max)、AUC_(0~t)和AUC_(0~∞)的几何均值比值的90%置信区间分别为104.75%~121.07%、104.93%~111.38%和104.89%~111.22%(均在80.00%~125.00%范围内),不良事件发生率为5.0%。结论:在空腹条件下,雾化吸入布地奈德混悬剂受试制剂和参比制剂具有生物等效性,安全性良好。

关键词：布地奈德混悬剂生物等效性安全性中国健康试验参与者

临床-超声参数模型在继发性甲状旁腺功能亢进症中的应用

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中国医学影像学杂志 2024年第5期32卷 447-453页

作者：马金梅史欣辉康燕飞曹春莉刘文成静李军石河子大学第一附属医院超声医学科新疆石河子832008 石河子大学第一附属医院肾病内科新疆石河子832008

目的探讨临床-超声参数模型在继发性甲状旁腺功能亢进症(SHPT)中的应用价值。资料与方法回顾性收集2020年10月—2022年8月在石河子大学第一附属医院行维持性血液透析的肾功能不全患者86例共134个病灶,根据甲状旁腺激素(iPTH)水平分为1组... 详细信息

目的探讨临床-超声参数模型在继发性甲状旁腺功能亢进症(SHPT)中的应用价值。资料与方法回顾性收集2020年10月—2022年8月在石河子大学第一附属医院行维持性血液透析的肾功能不全患者86例共134个病灶,根据甲状旁腺激素(iPTH)水平分为1组(iPTH<300 pg/ml)、2组(iPTH 300~800 pg/ml)和3组(iPTH≥800 pg/ml),患者均行甲状旁腺灰阶超声及声触诊组织量化成像检查。比较3组两种检查的参数特点,联合相关临床指标,建立临床-超声参数模型,采用多元线性回归分析该模型与iPTH的相关性,探索iPTH的独立危险因素,并评价此模型评估SHPT的价值。结果3组透析龄、血磷、碱性磷酸酶、血肌酐、校正血清钙磷乘积、病灶大小、数目、回声、剪切波速度最大值、中央区剪切波速度值、剪切波速度平均值差异有统计学意义(F/χ^(2)/H=6.396~53.524,P均<0.05);多元线性回归分析显示,透析龄、血磷、碱性磷酸酶、病灶最大剪切波速度与同深度周围腺体剪切波速度比值是iPTH水平的独立影响因素(β=0.514、0.422、0.226、-0.368,P均<0.005);模型以iPTH 300 pg/ml、800 pg/ml诊断SHPT及预测其手术治疗的曲线下面积、敏感度、特异度、准确度分别为0.967、95.00%、100.00%、97.73%和0.824、77.42%、71.43%、90.00%。结论透析龄、血磷、碱性磷酸酶、病灶最大剪切波速度与同深度周围腺体剪切波速度比值是iPTH水平的独立影响因素,临床-超声参数模型对准确评估SHPT严重程度具有重要价值。

关键词：临床-超声参数模型声触诊组织量化成像继发性甲状旁腺功能亢进症甲状旁腺激素超声检查

Reflections on launching Technology in Horticulture

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Technology in Horticulture 2021年第1期1卷 3-4页

作者： Zong-Ming(max)cheng Founder of maximum Academic Press 1833 Highway 85 SouthFayettevilleGA 30215USA Professor Emeritus Department of Plant SciencesUniversity of TennesseeKnoxvilleTN 37996USA

As a founder of maximum Academic Press(***),I am very excited to launch Technology in Horticulture as the first academic journal in the series with a focus on applied *** original'seeds'for this journal were sown over 40 years ago.I was raised in a rural area of Jiangsu Province,on the northern side of Shanghai,*** father was an elementary school teacher,and my mother is a *** is a densely populated area with extremely limited land *** every piece of available land was used to grow staple crops such as wheat,corn,sweet potato,while every tiny piece of land around houses was cultivated for growing vegetables or for putting up a chicken *** to a very limited cash income,I don’t remember eating an apple or an orange,or a juicy peach until I became a teenager.I went through elementary,middle and high school during the'cultural revolution'when knowledge was little *** a teenager,I started to help the family to earn'points'in the commune to get more corncobs,*** school in the summer,I spent most of the time collecting weeds to feed a couple of our pigs and *** though I was the best student in middle school in the entire commune,I was not selected for continuing onto high *** was frustrating that selection for high school was not based on meritocracy,but rather based on local political ***,my father managed to use some ad hoc'connections'so I was finally accepted and completed high school in 1977.

关键词： income culture journal

非洲爪蟾卵母细胞表达系统中N-型电压门控钙离子通道新药筛选模型的建立与优化

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药学学报 2024年第7期59卷 2002-2011页

作者：秦源崔城朱晓鹏长孙东亭于津鹏罗素兰广西大学医学院广西特色生物医药重点实验室广西南宁530004

N-型电压门控钙离子(Ca^(2+))通道(N-type voltage-gated calcium channel,N-type VGCC,Ca_(V)2.2)在突触前末端响应动作电位介导Ca^(2+)内流,并在突触发生、神经递质释放和伤害性信号传递中发挥重要作用,是神经痛(慢性痛)等重大疾病治... 详细信息

N-型电压门控钙离子(Ca^(2+))通道(N-type voltage-gated calcium channel,N-type VGCC,Ca_(V)2.2)在突触前末端响应动作电位介导Ca^(2+)内流,并在突触发生、神经递质释放和伤害性信号传递中发挥重要作用,是神经痛(慢性痛)等重大疾病治疗药物研发的关键靶点。由于钙离子通道体外表达困难,通道电流检测技术复杂,其新药筛选模型极其缺乏。因此,本研究利用非洲爪蟾卵母细胞表达系统,进行Ca_(V)2.2体外重组表达,建立电生理学技术药物筛选模型,并对该表达技术体系进行了优化(本研究获得广西大学伦理委员会审查批准,批准号:GXU-2023-0249)。首先,以大鼠Ca_(V)2.2的主亚基α1B及其辅助亚基α2δ1和β3的cDNA基因为模板,分别在体外进行转录,人工合成了Ca_(V)2.23个亚基的mRNA(cRNA),按照2∶1∶1的质量比混合,将3种cRNA注射到非洲爪蟾卵母细胞中进行表达。随后使用双电极电压钳技术检测Ca_(V)2.2离子通道是否产生细胞膜内向电流,同时对各个表达条件进行了优化,从通道的激活、失活等方面表征了其门控功能。结果显示,在cRNA显微注射后的第3~5天,使用四乙基氢氧化铵(TEAOH)和1,2-双(2-氨基苯氧基)乙烷-N,N,N',N'-四乙酸四酯(BAPTA-AM)处理,可分别消除内源性钾离子通道和Ca^(2+)激活的氯离子通道干扰,成功检测到稳定的Ca_(V)2.2介导的钡离子电流。Ca_(V)2.2的最大激活膜电位为0 mV,当膜电位大于+50 mV时会出现电流方向反转。通过拟合稳态激活和失活曲线获知Ca_(V)2.2的半激活电位和半失活电位分别为-15.9和-60.2 mV。本研究基于非洲爪蟾卵母细胞,通过条件优化,建立了稳定的Ca_(V)2.2表达系统。该体外表达系统可以为靶向Ca_(V)2.2活性化合物或先导药物的筛选提供新的途径。

关键词：电压门控钙离子通道双电极电压钳非洲爪蟾卵母细胞电生理门控特性

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Integrating multiomics data accelerates elucidation of plant primary and secondary metabolic pathways

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aBIOTECH 2023年第1期4卷 47-56页

作者： Feng Zhu Weiwei Wen Yunjiang cheng Saleh Alseekh Alisdair R.Fernie National R&D Center for Citrus Preservation Hubei Hongshan LaboratoryNational Key Laboratory for Germplasm Innovation and Utilization for Fruit and Vegetable Horticultural CropsKey Laboratory of Horticultural Plant BiologyMinistry of EducationHuazhong Agricultural UniversityWuhan 430070China max Planck Institute of Molecular Plant Physiology Am Mühlenberg 1Potsdam-Golm 14476Germany Center of Plant Systems Biology and Biotechnology Plovdiv 4000Bulgaria

Plants are the most important sources of food for humans,as well as supplying many ingredients that are of great importance for human *** an understanding of the functional components of plant metabolism has attracted considerable *** rapid development of liquid chromatography and gas chromatography,coupled with mass spectrometry,has allowed the detection and characterization of many thousands of metabolites of plant ***,elucidating the detailed biosynthesis and degradation pathways of these metabolites represents a major bottleneck in our ***,the decreased cost of genome and transcriptome sequencing rendered it possible to identify the genes involving in metabolic ***,we review the recent research which integrates metabolomic with different omics methods,to comprehensively identify structural and regulatory genes of the primary and secondary metabolic ***,we discuss other novel methods that can accelerate the process of identification of metabolic pathways and,ultimately,identify metabolite function(s).

关键词： Metabolome Transcriptome Genome Crop improvement

替米沙坦片在中国健康受试者的生物等效性研究

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中国临床药理学杂志 2024年第2期40卷 249-253页

作者：孙成张燕房红霞陈桂英章晓娟孙洪勋姜彬淄博万杰肿瘤医院Ⅰ期临床试验研究室山东淄博255213 武汉宏韧生物医药股份有限公司湖北武汉430000 淄博万杰制药有限公司山东淄博255200

目的评价替米沙坦片(80 mg)受试制剂与参比制剂在中国健康受试者中的生物等效性。方法采用单中心、随机、开放、两制剂、单次给药、餐后三周期三序列部分重复交叉和空腹四周期两序列完全重复交叉的生物等效性试验设计。餐后和空腹试验... 详细信息

目的评价替米沙坦片(80 mg)受试制剂与参比制剂在中国健康受试者中的生物等效性。方法采用单中心、随机、开放、两制剂、单次给药、餐后三周期三序列部分重复交叉和空腹四周期两序列完全重复交叉的生物等效性试验设计。餐后和空腹试验分别入组33和32例健康受试者,每周期分别单次口服受试制剂或参比制剂80 mg,用液相色谱-串联质谱法测定血浆中替米沙坦的浓度,用WinNonlin 8.3计算药代动力学参数,并用SAS 9.4进行统计分析。结果空腹条件下口服替米沙坦片受试制剂或参比制剂后的主要药代动力学参数:C_(max)分别为(556.10±456.06)和(580.99±533.50)ng·mL^(-1),AUC_(0-t)分别为(3475.15±3785.16)和(3450.54±3681.02)ng·mL^(-1)·h,AUC_(0-∞)分别为(3214.06±2272.06)和(3194.84±2187.45)ng·mL^(-1)·h,2种制剂C_(max)、AUC_(0-t)和AUC_(0-∞)几何均值比值及其90%置信区间,均落在80.00%~125.00%;餐后条件下口服替米沙坦片受试制剂或参比制剂后的主要药代动力学参数:C_(max)分别为(299.26±124.72)和(291.29±126.34)ng·mL^(-1),AUC_(0-t)分别为(3682.24±2799.72)和(3636.71±2158.42)ng·mL^(-1)·h,AUC_(0-∞)分别为(3544.53±1553.06)和(3969.38±2528.22)ng·mL^(-1)·h,2种制剂C_(max)、AUC_(0-t)和AUC_(0-∞)几何均值比值及其90%置信区间,均落在80.00%~125.00%。结论空腹和餐后条件下,替米沙坦片受试和参比制剂在中国健康受试者中具有生物等效性。

关键词：替米沙坦片生物等效性药代动力学参数

Vault predicting after implantable collamer lens implantation using random forest network based on different features in ultrasound biomicroscopy images

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国际眼科杂志:英文版 2023年第10期16卷 1561-1567页

作者： Bin Fang Qiu-Jian Zhu Hui Yang Li-cheng Fan School of Mechanical and Electrical Engineering Soochow UniversitySuzhou 215100Jiangsu ProvinceChina Lixiang Eye Hospital of Soochow University Suzhou 215021 Jiangsu ProvinceChina

AIM:To analyze ultrasound biomicroscopy(UBM)images using random forest network to find new features to make predictions about vault after implantable collamer lens(ICL)***:A total of 450 UBM images were collected from the Lixiang Eye Hospital to provide the patient’s preoperative parameters as well as the vault of the ICL after *** vault was set as the prediction target,and the input elements were mainly ciliary sulcus shape parameters,which included 6 angular parameters,2 area parameters,and 2 parameters,distance between ciliary sulci,and anterior chamber height.A random forest regression model was applied to predict the vault,with the number of base estimators(n_estimators)of 2000,the maximum tree depth(max_depth)of 17,the number of tree features(max_features)of Auto,and the random state(random_state)of ***:Among the parameters selected in this study,the distance between ciliary sulci had a greater importance proportion,reaching 52%before parameter optimization is performed,and other features had less influence,with an importance proportion of about 5%.The importance of the distance between the ciliary sulci increased to 53% after parameter optimization,and the importance of angle 3 and area 1 increased to 5% and 8%respectively,while the importance of the other parameters remained unchanged,and the distance between the ciliary sulci was considered the most important *** features,although they accounted for a relatively small proportion,also had an impact on the vault *** parameter optimization,the best prediction results were obtained,with a predicted mean value of 763.688μm and an actual mean value of 776.9304μ*** R²was 0.4456 and the root mean square error was ***:A study based on UBM images using random forest network can be performed for prediction of the vault after ICL implantation and can provide some reference for ICL size selection.

关键词： random forest network ultrasound biomicroscopy images vault prediction implantable collamer lens

格列吡嗪片在中国健康受试者中的生物等效性研究

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中国临床药理学杂志 2024年第11期40卷 1628-1632页

作者：郑飞浪程林忠李海菊杨璐刘泽源王素玲长治医学院附属和平医院药剂科山西长治046000 长治医学院附属和平医院药物临床试验机构山西长治046000 中国人民解放军总医院第五医学中心药物临床试验机构北京100039

目的研究2种格列吡嗪片制剂在中国健康受试者的生物等效性。方法用单剂量、随机、开放、两周期、自身交叉对照试验设计,空腹试验、餐后试验各入组28例健康受试者,2个周期分别口服格列吡嗪片受试制剂或参比制剂5 mg。用液相色谱串联质谱... 详细信息

目的研究2种格列吡嗪片制剂在中国健康受试者的生物等效性。方法用单剂量、随机、开放、两周期、自身交叉对照试验设计,空腹试验、餐后试验各入组28例健康受试者,2个周期分别口服格列吡嗪片受试制剂或参比制剂5 mg。用液相色谱串联质谱法测定给药后不同时间点格列吡嗪的血药浓度,用非房室模型计算药代动力学参数,评价2种制剂的生物等效性。结果空腹试验中格列吡嗪受试制剂和参比制剂的主要药代动力学参数:C_(max)分别为(551.60±91.26)和(518.10±105.10)ng·mL^(-1),AUC_(0-t)分别为(3074.33±861.91)和(3026.77±934.25)h·ng·mL^(-1),AUC_(0-∞)分别为(3204.85±990.78)和(3166.35±1107.36)h·ng·mL^(-1)。餐后试验中格列吡嗪受试制剂和参比制剂的主要药代动力学参数C_(max)分别为(517.30±98.97)和(472.80±114.48)ng·mL^(-1),AUC_(0-t)分别为(3001.12±830.87)和(2932.79±736.35)h·ng·mL^(-1),AUC_(0-∞)分别为(3067.00±918.84)和(2997.44±819.14)h·ng·mL^(-1)。受试制剂与参比制剂主要药代动力学参数C_(max)、AUC_(0-t)和AUC_(0-∞)经对数转换后几何均值比值的90%置信区间均在80.00%~125.00%。空腹组与餐后组均未发生严重不良事件。结论2种格列吡嗪片在空腹及餐后状态下均具有生物等效性,且安全性良好。

关键词：格列吡嗪片生物等效性药代动力学安全性

The ALMA-QUARKS Survey.Ⅰ.Survey Description and Data Reduction

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Research in Astronomy and Astrophysics 2024年第2期24卷 104-124页

作者：刘训川 Tie Liu Lei Zhu Guido Garay Hong-Li Liu Paul Goldsmith Neal Evans Kee-Tae Kim Sheng-Yuan Liu Fengwei Xu Xing Lu Anandmayee Tej Xiaofeng Mai Leonardo Bronfman Shanghuo Li Diego Mardones Amelia Stutz Ken'ichi Tatematsu Ke Wang Qizhou Zhang Sheng-Li Qin Jianwen Zhou Qiuyi Luo Siju Zhang Yu cheng Jinhua He Qilao Gu Ziyang Li Zhenying Zhang Suinan Zhang Anindya Saha Lokesh Dewangan Patricio Sanhueza Zhiqiang Shen Shanghai Astronomical Observatory Chinese Academy of SciencesShanghai 200030China Chinese Academy of Sciences South America Center for Astronomy National Astronomical ObservatoriesChinese Academy of SciencesBeijing 100101China Departamento de Astronomía Universidad de ChileLas Condes7591245 SantiagoChile School of Physics and Astronomy Yunnan UniversityKunming 650091China Jet Propulsion Laboratory California Institute of Technology4800 Oak Grove DrivePasadena CA 91109USA Department of Astronomy The University of Texas at AustinTX 78712-1205USA Korea Astronomy and Space Science Institute 776 Daedeokdae-roYuseong-guDaejeon 34055Republic of Korea Institute of Astronomy and Astrophysics Academia SinicaRoosevelt RoadTaipei 10617China Kavli Institute for Astronomy and Astrophysics Peking UniversityBeijing 100871China Department of Astronomy School of PhysicsPeking UniversityBeijing 100871China Indian Institute of Space Science and Technology Thiruvananthapuram 695547KeralaIndia max Planck Institute for Astronomy Königstuhl 17D-69117 HeidelbergGermany Departamento de Astronomía Universidad de ConcepciónCasilla 160-CConcepciónChile Nobeyama Radio Observatory National Astronomical Observatory of JapanNational Institutes of Natural Sciences462-2 NobeyamaMinamimakiMinamisakuNagano 384-1305Japan Center for Astrophysics∣Harvard&Smithsonian 60 Garden StreetCambridgeMA 02138USA max-Planck-Institut für Radioastronomie Auf dem Hügel 69D-53125 BonnGermany School of Astronomy and Space Sciences University of Chinese Academy of SciencesBeijing 100049China National Astronomical Observatory of Japan 2-21-1 OsawaMitakaTokyo181-8588Japan Yunnan Observatories Chinese Academy of SciencesKunming 650216China Physical Research Laboratory NavrangpuraAhmedabad-380009India Astronomical Science Program The Graduate University for Advanced StudiesSOKENDAI2-21-1 OsawaMitakaTokyo 181-8588Japan University of Science and Technology Korea(UST)217 Gajeong-roYuseong-guDaejeon 34113Republic o

This paper presents an overview of the QUARKS survey,which stands for Querying Underlying mechanisms of massive star formation with ALMA-Resolved gas Kinematics and Structures."The QUARKS survey is observing139 massive clumps covered by 156 pointings at Atacama Large Millimeter/submillimeter Array(ALMA)Band 6(λ~1.3 mm).In conjunction with data obtained from the ALMA-ATOMS survey at Band 3(λ~3 mm),QUARKS aims to carry out an unbiased statistical investigation of massive star formation process within protoclusters down to a scale of 1000 *** overview paper describes the observations and data reduction of the QUARKS survey,and gives a first look at an exemplar source,the mini-starburst Sgr B2(M).The wide-b and width(7.5 GHz)and high-angular-resolution(~0."3)observations of the QUARKS survey allow for the resolution of much more compact cores than those could be done by the ATOMS survey,and to detect previously unrevealed fainter filamentary *** spectral windows cover transitions of species including CO,SO,N_(2)D^(+),SiO,H_(30)α,H_(2)CO,CH_(3)CN,and many other complex organic molecules,tracing gas components with different temperatures and spatial *** aims to deepen our understanding of several scientific topics of massive star formation,such as the mass transport within protoclusters by(hub-)filamentary structures,the existence of massive starless cores,the physical and chemical properties of dense cores within protoclusters,and the feedback from already formed high-mass young protostars.

关键词： stars formation-stars kinematics and dynamics-ISM clouds-ISM molecules