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Efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection for the treatment of renal anemia in Chinese hemodialysis patients:A randomized,open-label,parallel-group,noninferiority phase III trial

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Chronic Diseases and Translational Medicine 2022年第2期8卷 134-144页

作者： Bicheng Liu Nan Chen Jinghong Zhao Aiping Yin Xiongfei Wu Changying Xing Gengru Jiang Junzhou Fu Mei Wang Rong Wang jianying Niu Ping Fu Zhaohui Ni Fanfan Hou Jiuyang Zhao Jing Chen Yuqing Chen Wei shi Jianghua Chen Wenge Li Gang Xu Ling Zhong Wenhu Liu guohua Ding Yuichiro Kondo Changhe Yue Changlin Mei Department of Nephrology Zhongda Hospital Southeast UniversityNanjingJiangsu 210009China Department of Nephrology Ruijin Hospital Shanghai Jiaotong University School of MedicineShanghai 200025China Department of Nephrology Xinqiao Hospital of Army Medical UniversityChongqing 400037China Department of Nephrology First Affiliated Hospital of Xi'an liaotong UniversityXi'anShaanxi 710061China Department of Nephrology Southwest Hospital of Army Medical UniversityChongqing 400039China Department of Nephrology Jiangsu Provincial HospitalNanjingJiangsu 210036China Department of Nephrology Xinhua Hospital Affiliated to Shanghai丨iao Tong University School of MedicineShanghai 200092China Department of Nephrology Guangzhou First People's HospitalCiuaiigzhouGuangdong 510180China Department of Nephrology Peking University People's HospitalBeijing 100044China Department of Nephrology Shandong Provincial HospitallinanShandong 250021China Department of Nephrology Shanghai Fifth People's HospitalFudan UniversityShanghai 200240China Department of Nephrology West China HospitalSichuan UniversityChengduSichuan 610041China Department of Nephrology Henji Hospital Shanghai Jiaotong University School of MedicineShanghai 200001China Department of Nephrology Nanfang Hospital Southern Medical UniversityGuangzhouGuangdong 510510China Department of Nephrology The Second Hospital of Dalian Medical UniversityDalianLiaoning 116023China Department of Nephrology Huashan HospitalFudan UniversityShanghai 200040China Department of Nephrology Peking University First HospitalBeijing 100034China Department of Nephrology Guangdong Provincial People's HospitalGuangzhouGuangdong 510080China Department of Nephrology The First Affiliated HospitalZhejiang University School of MedicineHangzhouZhejiang 310003China Department of Nephrology China-Japan Friendship HospitalBeijing 100029China Department of Nephrology Tongji Hospital Tongji Medical College Huazhong University of Science and TechnologyWuhanHubei

Background:This study was to explore the clinical efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection(recombinant human erythropoietin injection,rHuEPO)for the treatment of anemia associated with chronic kidney failure in Chinese patients undergoing ***:This study was a multicenter,randomized,open-label,intergroup parallel control phase III noninferiority trial from April 19,2013 to September 9,2014 at 25 *** this study,the members of the darbepoetin alfa group underwent intravenous administration once per week or once every two *** members of the control drug epoetin alfa group underwent intravenous administration two or three times per *** subjects underwent epoetin alfa administration during the 8-week baseline *** that,subjects were randomly assigned to the darbepoetin alfa group or epoetin alfa *** noninferiority in the changes of the average Hb concentrations from the baseline to the end of the evaluation period(noninferiority threshold:-1.0 g/dl)was tested between the two *** time-dependent hemoglobin(Hb)concentration and the maintenance rate of the target Hb concentration(the proportion of subjects with Hb concentrations between 10.0 and 12.0 g/dl)were also *** metabolism,including changes in the serum iron,total iron-binding capacity,ferritin,transferrin saturation,and comparisons of the dose adjustments between the two groups during the treatment period were analyzed *** events(AEs)were also observed and compared,and the safety was analyzed between the two treatment *** conversion rate switching from epoetin alfa to darbepoetin alfa was also ***?software version 9.2 was used to perform all statistical *** statistics were used for all efficacy,safety,and demographic variable analyses,including for the primary efficacy ***:Four hundred and sixty-six patients were enrolled in this study,and ultimately

关键词： anemia conversion ratio darbepoetin alfa epoetin alfa hemodialysis

Darbepoetin alfa injection versus epoetin alfa injection for treating anemia of Chinese hemodialysis patients with chronic kidney failure:A randomized,open-label,parallel-group,non-inferiority Phase III trail

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Chronic Diseases and Translational Medicine 2022年第1期8卷 59-70页

作者： Nan Chen Changying Xing jianying Niu Bicheng Liu Junzhou Fu Jiuyang Zhao Zhaohui Ni Mei Wang Wenhu Liu Jinghong Zhao Ling Zhong Xiongfei Wu Wenge Li Yuqing Chen Wei shi Jianghua Chen Aiping Yin Ping Fu Rong Wang Gengru Jiang Fanfan Hou guohua Ding Jing Chen Gang Xu Yuichiro Kondo Yuliang Su Changlin Mei Department of Nephrology Ruijin Hospital Shanghai Jiaotong University School of MedicineShanghai 200025China Department of Nephrology Jiangsu Provincial HospitalNanjingJiangsu 210036China Department of Nephrology Shanghai Fifth People's HospitalFudan UniversityShanghai 200240China Department of Nephrology Zhongda Hospital Southeast UniversityNanjingJiangsu 210009China Department of Nephrology Guangzhou First People's HospitalGuangzhouGuangdong 510180China Department of Nephrology The Second Hospital of Dalian Medical UniversityDalianLiaoning 116027China Department of Nephrology Renji Hospital Shanghai Jiaotong University School of MedicineShanghai 200001China Department of Nephrology Peking University People's HospitalBeijing 100044China Department of Nephrology Beijing Friendship HospitalCapital Medical UniversityBeijing 100050China Department of Nephrology Xinqiao Hospital of Army Medical UniversityChongqing 400037China Department of Nephrology The Second Affiliated Hospital of Chongqing Medical UniversityChongqing 400010China Department of Nephrology Southwest Hospital of Army Medical UniversityChongqing 400039China Department of Nephrology China-Japan Friendship HospitalBeijing 100029China Department of Nephrology Peking University First HospitalBeijing 100034China Department of Nephrology Guangdong Provincial People's HospitalGuangzhouGuangdong 510080China Department of Nephrology The First Affiliated HospitalZhejiang University School of MedicineHangzhouZhejiang 310003China Department of Nephrology First Affiliated Hospital of Xi'an Jiaotong UniversityXi'anShaanxi 710061China Department of Nephrology West China HospitalSichuan UniversityChengduSichuan 610041China Department of Nephrology Shandong Provincial HospitalJinanShandong 250021China Department of Nephrology Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghai 200092China Department of Nephrology Nanfang Hospital Southern Medical UniversityGuangzhouGuangdong 5105

Background:Erythropoietin is a glycoprotein that mainly regulates *** patients with chronic renal failure with anemia,darbepoetin alfa can stimulate erythropoiesis,correct anemia,and maintain hemoglobin *** study was designed to demonstrate the efficacy and safety of darbepoetin alfa injections as being not inferior to epoetin alfa injections(Recombinant Human Erythropoietin injection,rHuEPO)when maintaining hemoglobin(Hb)levels within the target range(10.0-12.0 g/dL)for the treatment of renal ***:Ninety-five patients were enrolled in this study from April 15,2013 to April 10,2014 at 25 *** this study,patients(n=95)aged 18-70 years were randomized into a once per week intravenous darbepoetin alfa group(n=56)and a twice or three times per week intravenous epoetin alfa group(n=39)for 28 weeks,who had anemia with hemoglobin levels between 6 g/dL and 10 g/dL due to chronic kidney disease(CKD)and were undergoing hemodialysis or hemofiltration with ESA-naive(erythropoiesis stimulating agent-naive).The primary efficacy profile was the mean Hb level(the non-inferiority margin was-1.0 g/dL,week 21-28);the secondary efficacy profiles were the Hb increase rate(week 0-4),the target Hb achievement cumulative rate and time,the change trends of the Hb levels,and the target Hb maintenance *** events(AEs)were observed and compared,and the efficacy and safety were analyzed between the two treatment ***,the frequencies of dose adjustments between the darbepoetin alfa and epoetin alfa groups were compared during the treatment ***?software version 9.2 was used to perform all statistical *** statistics were used for all efficacy,safety,and demographic variable analyses,including for the primary efficacy ***:The mean Hb level was 11.3 g/dL in the darbepoetin alfa group and 10.7 g/dL in the epoetin alfa group,respectively;the difference of the lower limits of the 95%confidence intervals(C

关键词： anemia chronic renal failure darbepoetin alfa hemodialysis recombinant human erythropoietin

脐带搏动停止后实施断脐操作对母婴结局的影响

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临床医学研究与实践 2020年第25期5卷 153-155页

作者：刘小非王剑鹰刘晶孙育王莎莎童嘉雯西北妇女儿童医院陕西西安710000

目的研究脐带搏动停止后实施断脐操作对母婴结局的影响。方法选取2016年4月至2017年4月在本院进行阴道分娩的5000例产妇为研究对象,根据随机数字表法将其分为对照组和观察组,各2500例。对照组进行早断脐操作,观察组于脐带搏动停止后实... 详细信息

目的研究脐带搏动停止后实施断脐操作对母婴结局的影响。方法选取2016年4月至2017年4月在本院进行阴道分娩的5000例产妇为研究对象,根据随机数字表法将其分为对照组和观察组,各2500例。对照组进行早断脐操作,观察组于脐带搏动停止后实施断脐操作。比较两组产妇分娩情况及新生儿健康状况。结果观察组产后24 h出血量显著少于对照组(P1、7天的Hb及HCT水平均显著高于对照组(P1天(P1、7天的TCB及STB水平比较,差异无统计学意义(P>0.05);两组新生儿产后第7天的TCB及STB水平均高于产后第1天(P<0.05)。观察组新生儿的窒息、贫血发生率均明显低于对照组(P<0.05)。结论在脐带搏动停止后实施断脐操作能够减少产妇产后出血量,改善新生儿结局,有助于保证母婴安全。

关键词：断脐阴道分娩脐带搏动停止

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被动吸烟对雄性大鼠精子质量的影响

中国男科学杂志 2015年第11期29卷 23-26页

作者：童寅严建平洪剑英吴志平石家齐谷江方艺玉山县人民医院江西上饶334700 贵阳医学院附属医院泌尿外科

目的探讨被动吸烟对雄性大鼠精子质量的影响。方法将40只8周龄的雄性SD大鼠随机分成4组，分别为对照组、轻度、中度、重度吸烟组，8周后成功建立大鼠被动吸烟毒性模型，颈椎脱臼处死大鼠，立即取出附睾组织，制成均浆后测定精子密度、... 详细信息

目的探讨被动吸烟对雄性大鼠精子质量的影响。方法将40只8周龄的雄性SD大鼠随机分成4组，分别为对照组、轻度、中度、重度吸烟组，8周后成功建立大鼠被动吸烟毒性模型，颈椎脱臼处死大鼠，立即取出附睾组织，制成均浆后测定精子密度、精子存活率、精子活动率、精子畸形率。结果实验结果表明，三个被动吸烟实验组大鼠的精子密度、精子存活率、精子活动率、精子畸形率与对照组比较差异有统计学意义（P〈0．05）。结论雄性大鼠的精子密度、精子存活率、精子活动率随着吸烟量的增大而减少，精子畸形率随着吸烟量的增大而增加。

关键词：烟草烟污染大鼠精子计数精子能动性

综合性化学实验设计:中空介孔有机硅纳米材料制备与表征

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大学化学 2021年第4期36卷 140-145页

作者：佟宇婷代金玉赵剑英王润伟四川大学化学工程学院成都610065 吉林大学化学学院无机合成与制备化学国家重点实验室长春130012 山东理工大学化学化工学院山东淄博255049

本实验围绕中空介孔有机硅纳米材料前沿制备方法,采用逐层包覆与同步生长诱导腐蚀法相结合的方法,设计了一个简单、有效和可控的PMO系列材料制备的综合性教学实验,分别制备了单分散SiO2纳米球和中空介孔有机硅纳米球(Et-HPMO),并通过红... 详细信息

本实验围绕中空介孔有机硅纳米材料前沿制备方法,采用逐层包覆与同步生长诱导腐蚀法相结合的方法,设计了一个简单、有效和可控的PMO系列材料制备的综合性教学实验,分别制备了单分散SiO2纳米球和中空介孔有机硅纳米球(Et-HPMO),并通过红外光谱(IR)、扫描电镜(SEM)、透射电镜(TEM)及粉末X射线衍射(PXRD)表征纳米材料的化学组成、微观形貌及介孔结构。使学生学习PMO系列纳米材料的设计、制备及表征方法,提高学生的综合性和系统性实验技能,为学生从事先进材料制备打下基础。

关键词：介孔有机硅纳米材料综合性实验

中国HIV阴性宿主肺隐球菌病前瞻性多中心临床研究

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中华结核和呼吸杂志 2021年第1期44卷 14-27页

作者：陈良安佘丹阳梁志欣梁丽玲陈荣昌叶枫李玉苹周颖陈晓红方素芳赖国祥胡群谢宝松姚秀娟施毅苏欣何礼贤周建英钟素成张齐龙熊盛道瞿介明童朝晖姜淑娟刘晶许飞贺蓓李尔然袁雅冬张湘燕孙铁英刘又宁解放军总医院第一医学中心呼吸与危重症医学科北京100853 广州医科大学附属第一医院广州呼吸健康研究院 510120 温州医科大学附属第一医院呼吸与危重症医学科 325000 福建省福州肺科医院呼吸与危重症医学科 350008 联勤保障部队第九〇〇医院呼吸与危重症医学科福州350025 福建省立医院呼吸与危重症医学科福州350001 东部战区总医院呼吸与危重症医学科南京210002 复旦大学附属中山医院呼吸与危重症医学科上海200032 浙江大学医学院附属第一医院呼吸与危重症医学科杭州310003 福建医科大学附属龙岩第一医院呼吸与危重症医学科 364000 江西省胸科医院神经内科南昌330006 华中科技大学同济医学院附属同济医院呼吸与危重症医学科武汉430030 复旦大学附属华东医院呼吸与危重症医学科上海200040 首都医科大学附属北京朝阳医院呼吸与危重症医学科 100020 山东大学附属省立医院呼吸与危重症医学科济南250021 吉林大学第二医院呼吸与危重症医学科长春130041 南昌大学第一附属医院呼吸与危重症医学科 330006 北京大学第三医院呼吸与危重症医学科 100191 中国医科大学附属第一医院呼吸与危重症医学科沈阳110001 河北医科大学第二医院呼吸与危重症医学科石家庄050000 贵州省人民医院呼吸与危重症医学科贵阳550002 北京医院呼吸与危重症医学科 100730

目的了解我国呼吸学科肺隐球菌病的诊疗现状,完善对HIV阴性肺隐球菌病临床特征的认识。方法采用前瞻性、多中心、开放性队列研究设计,通过涂片培养、抗原检测及组织病理学检查等病原学诊断方法,在22家参研单位呼吸科普通病房和呼吸重症... 详细信息

目的了解我国呼吸学科肺隐球菌病的诊疗现状,完善对HIV阴性肺隐球菌病临床特征的认识。方法采用前瞻性、多中心、开放性队列研究设计,通过涂片培养、抗原检测及组织病理学检查等病原学诊断方法,在22家参研单位呼吸科普通病房和呼吸重症监护室筛检肺隐球菌病,连续纳入研究期间收治的所有HIV阴性肺隐球菌病病例,采集并分析主要临床资料。结果共入选肺隐球菌病患者457例,其中播散性感染占3.28%(15/457),病死率0.88%(4/457),主要的诊断依据为组织标本病理检查的阳性结果(74.40%,340/457)和隐球菌抗原检测的阳性结果(37.64%,172/457)。肺隐球菌病占同时期呼吸科住院患者总人数的2.04‰(457/223 748),华南地区、华东地区该比例最高;70.24%(321/457)的患者不合并任何基础疾病,87.75%(401/457)的患者无已知免疫缺陷;咳嗽、咳痰为最常见的临床症状,25.16%(115/457)的患者无任何临床症状和体征。在影像表现方面,肺内多发病变多于孤立病变,胸膜下病变多于肺门周围或内中带病变,形态上则以直径1~5 cm的中等大小结节和直径3 mm~1 cm的小结节最为常见。血清隐球菌抗原的敏感率为71.99%(203/282), 抗原阳性患者在基础免疫状态、临床症状、影像学表现以及感染类型等方面均有别于抗原阴性患者。免疫缺陷患者在临床症状和体征、感染相关炎症指标水平、影像学特点、血清隐球菌抗原阳性率以及预后等方面有别于非免疫缺陷患者。结论我国HIV阴性肺隐球菌病多数无合并基础疾病或免疫缺陷,总体预后良好,但临床类型多样,临床表现和影像表现复杂多变,早期诊断难度较大。

关键词：肺隐球菌病临床特征诊断治疗预后

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浮萍覆盖对稻田杂草群落组成及多样性的影响

中国生态农业学报（中英文） 2021年第4期29卷 672-682页

作者：王丰赖彦岑唐宗翔郑敏敏史俊顾麦云沈健英曹林奎沙之敏上海交通大学农业与生物学院上海200240 宁波市农业科学研究院宁波315040 上海自在青西农业发展有限公司上海201799

在农业可持续发展的背景下,稻田杂草防控需要兼顾生物多样性的保护。为了解浮萍覆盖对稻田杂草群落组成及物种多样性的影响,运用群落生态学的方法,研究了多根紫萍覆盖(SP)、少根紫萍覆盖(LP)和不投放浮萍(CK)3种处理下稻田杂草发生量和... 详细信息

在农业可持续发展的背景下,稻田杂草防控需要兼顾生物多样性的保护。为了解浮萍覆盖对稻田杂草群落组成及物种多样性的影响,运用群落生态学的方法,研究了多根紫萍覆盖(SP)、少根紫萍覆盖(LP)和不投放浮萍(CK)3种处理下稻田杂草发生量和群落多样性在水稻4个生育期(分蘖期、孕穗期、扬花期和成熟期)的动态变化,并对水稻产量进行分析。结果表明:SP和LP处理在前两生育期分别比CK显著降低杂草密度60.3%~75.8%和81.1%~90.4%,在整个水稻生育期能分别降低杂草鲜重生物量48.0%以上和81.3%以上,杂草群落中阔叶类杂草比例明显下降。不同处理下,稻田最主要杂草类别均是莎草科杂草;不同处理的杂草群落中重要杂草的种类和相对重要程度都有较大差异,SP和LP处理重要值较高的杂草均为莎草科的萤蔺和碎米莎草,CK处理重要值较高的杂草则为阔叶类的鸭舌草;在多数生育期,两种浮萍覆盖下的杂草群落的Margalef丰富度指数、Shannon-Wiener多样性指数和Simpson优势度指数均与CK无显著差异。SP和LP处理水稻的每穗粒数和穗重均有不同程度显著提高,SP处理的水稻产量显著提高28.0%。综合上述分析,稻田投放初始覆盖面积70.0%的多根紫萍和少根紫萍都能在降低稻田杂草密度和生物量的同时维持杂草群落的多样性,且多根紫萍覆盖能促进水稻产量增长,对保护稻田生物多样性和促进农业可持续发展有重要意义。

关键词：可持续农业稻田浮萍覆盖杂草防控群落结构生物多样性

白藜芦醇对阿霉素诱导心肌细胞凋亡的保护作用及机制研究

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国际心血管病杂志 2019年第6期46卷 341-345页

作者：俞健颖潘建安张俊峰王长谦顾俊上海交通大学医学院附属第九人民医院心血管内科

目的:探讨白藜芦醇(RSV)对阿霉素诱导的心肌细胞凋亡的保护作用及对E2F转录因子1(E2F1)/腺苷酸活化蛋白激酶α2(AMPKα2)信号通路的影响.方法:用小干扰RNA siE2F1转染H9c2心肌细胞,将H9c2细胞分为对照组、阿霉素组、siE2F1组、阿霉素+si... 详细信息

目的:探讨白藜芦醇(RSV)对阿霉素诱导的心肌细胞凋亡的保护作用及对E2F转录因子1(E2F1)/腺苷酸活化蛋白激酶α2(AMPKα2)信号通路的影响.方法:用小干扰RNA siE2F1转染H9c2心肌细胞,将H9c2细胞分为对照组、阿霉素组、siE2F1组、阿霉素+siE2F1组、RSV组、阿霉素+RSV组,阿霉素终浓度为1μmol/L,RSV终浓度为20μmol/L.各组干预24 h后,检测E2F1、AMPKα2和胱天蛋白酶-3剪切体(cleaved caspase-3)的蛋白表达水平及心肌细胞凋亡率.结果:与对照组相比,阿霉素组E2F1、AMPKα2和cleaved caspase-3的蛋白表达水平和心肌细胞凋亡率均显著增加(P均2F1显著抑制E2F1的表达.与阿霉素组相比,阿霉素+siE2F1组E2F1、AMPKα2和cleaved caspase-3的蛋白表达水平及心肌细胞凋亡率显著降低(P均2F1、AMPKα2和cleaved caspase-3的蛋白表达水平显著降低(P均2F1/AMPKα2通路的激活有关.

关键词：阿霉素心肌细胞凋亡 E2F转录因子1 白藜芦醇

头孢呋辛和罗红霉素联合治疗老年肺炎比较研究

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北华大学学报（自然科学版） 2001年第5期2卷 390-391,402页

作者：刘健英佳男李敏陈霞佟晓欧吉林化学工业集团公司总医院吉林吉林132022

目的比较头孢呋辛单用和联合罗红霉素治疗老年人获得性肺炎的疗效和安全性.方法 192例患者随机分成2组,单用头孢呋辛组(Ⅰ组)95例,用3 g/d静脉滴注;联合罗红霉素组(Ⅱ组)97例,加用罗红霉素300mg/d.结果 2组临床总有效率分别为78.9%和80.... 详细信息

目的比较头孢呋辛单用和联合罗红霉素治疗老年人获得性肺炎的疗效和安全性.方法 192例患者随机分成2组,单用头孢呋辛组(Ⅰ组)95例,用3 g/d静脉滴注;联合罗红霉素组(Ⅱ组)97例,加用罗红霉素300mg/d.结果 2组临床总有效率分别为78.9%和80.4%,差异无显著意义(P＞0.05),细菌阳性率34.9%(67/192),细菌清除率分别为77.1%和79.5%,在统计学上差异无显著意义(P＞0.05).患者用药过程中无不可耐受的副作用.结论在治疗老年人获得性肺炎中,头孢呋辛单用和联合罗红霉素都是安全有效的,未见联合用药组的疗效提高或降低.

关键词：肺炎头孢呋辛罗红霉素联合用药治疗方法疗效评价细菌清除率