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| 1 | Effect of SiC whiskers on the oxidation protective properties of SiC coatings for carbon/carbon composites显示文摘以便有效地采用唯一的高温度碳 / 碳的机械性质合成底层,原文如此,涂层增强了由原文如此,络腮胡子被包装硬化方法准备。效果原文如此,单个层的涂层和双层涂层的氧化抵抗性质上的络腮胡子被调查。原文如此络腮胡子在单个层原文如此涂层在反氧化性质上有小效果,但是显然改进热吃惊性质。有内部层的增强的涂层的双层涂层与原文如此内部层的涂层比双层涂层展出更多的完美的反氧化能力。 | SHI Xiaohong LI Hejun FU Qiangang LI Kezhi ZHANG Xiulian | 2006 | Rare Metals2006,25,1: | 33 |
| 2 | A method for gravity anomaly separation based on preferential continuation and its application显示文摘基于 Pawlowski (1995 ) 建议的优先的继续方法,我们在各种各样的来源互相是 uncorrelated 与,继续高度足够大的情况中与优先的向上的继续操作员为严肃异例分离建议一个方法和过程。我们也为估计最佳介绍一个方法向上继续的高度,与不同继续高度基于分析一个综合严肃异例的优先的向上的继续操作员的特征变化。方法在铁存款上在未加工的 Bouguer 严肃数据上被测试。结果证明方法高效地并且清楚地把数据分开成地区性的异例和剩余异例。 | Meng Xiaohong Guo Lianghui Chen Zhaox Li Shuling Shi Lei | 2009 | Applied Geophysics2009,6,3: | 31 |
| 3 | Blockade of Tim-3 Pathway Ameliorates Interferon-γ Production from Hepatic CD8^+ T Cells in a Mouse Model of Hepatitis B Virus Infection显示文摘T cell immunoglobulin-and mucin-domain-containing molecule-3(Tim-3) has been reported to participate in the pathogenesis of inflammatory diseases. However,whether Tim-3 is involved in hepatitis B virus(HBV) infection remains unknown. Here,we studied the expression and function of Tim-3 in a hydrodynamics-based mouse model of HBV infection. A significant increase of Tim-3 expression on hepatic T lymphocytes,especially on CD8+ T cells,was demonstrated in HBV model mice from day 7 to day 18. After Tim-3 knockdown by specific shRNAs,significantly increased IFN-γ production from hepatic CD8+ T cells in HBV model mice was observed. Very interestingly,we found Tim-3 expression on CD8+ T cells was higher in HBV model mice with higher serum anti-HBs production. Moreover,Tim-3 knockdown influenced anti-HBs production in vivo. Collectively,our data suggested that Tim-3 might act as a potent regulator of antiviral T-cell responses in HBV infection. | Ying Ju Nan Hou Xiaoning Zhang Di Zhao Ying Liu Jinjin Wang Fang Luan Wei Shi Faliang Zhu Wensheng Sun Lining Zhang Chengjiang Gao Lifen Gao Xiaohong Liang Chunhong Ma | 2009 | Cellular & Molecular Immunology2009,6,1: | 19 |
| 4 | Recombinant CC16 protein inhibits the production of pro-inflammatory cytokines via NF-KB and p38 MAPK pathways in LPS-activated RAW264,7 macrophages显示文摘积累的证据显示克莱拉房间 protein-16 (CC16 ) 有反煽动性的功能,尽管深奥分子的小径完全没被阐明。这里,我们评估了效果肿瘤坏死因素 alpha (TNF-) 的表示上的 recombinant 老鼠 CC16 (rCC16 ) , interleukin-6 (IL-6 ) ,和在 lipopolysaccharide (LPS ) 的 IL-8 刺激了老鼠巨噬细胞(RAW264.7 房间) 并且探索了内在的分子的机制。rCC16 在两个禁止了导致 LPS 的 TNF- , IL-6,和 IL-8 表示,这被发现送信人 ribonucleicacid (mRNA ) 水平和蛋白质以一种集中依赖者方式铺平,由即时反向的 transcriptase 聚合酶链反应和连接酶的 immunosorbent 试金示威了。如此的镇压效果被 transcriptional 活动和原子因素(NF ) 的脱氧核糖核酸酸绑定活动的抑制伴随 -B 然而并非使活跃之物蛋白质(AP )-1。西方的污点分析进一步表明 rCC16 禁止了原子 NF-B 和 NF-B 禁止的蛋白质 IB,和 p38 的 cytosolic NF-B, phosphorylation 和减小的减小的增加激活 mitogen 的蛋白质 kinase (MAPK ) 依赖者由在它的 p65 子单元的 Ser276 的 phosphorylation 的 NF-B 激活。而且, rCC16 被发现没另外在c6月N终端 kinase ,c6月,或c-Jun.的原子 translocation 的 phosphorylation 上有效果,TNF-的减小, IL-6 ,并且 IL-8 被颠倒内长的uteroglobin有约束力的蛋白质的水平什么时候被 RNA 干扰在 对待rCC16 、 对待LPS 的 RAW264.7 房间减少。我们的数据建议 rCC16 由在 RAW264.7 房间使 NF-B 和 p38 MAPK 然而并非 AP-1 失去活性压制调停 LPS 的煽动性的调停人 TNF- , IL-6,和 IL-8 生产。 | Min Pang Yangyang Yuan Dong Wang Ting Li Dan Wang Xiaohong Shi Min Guo Chunfang Wang Xinri Zhang Guoping Zheng Baofeng Yu Hailong Wang | 2017 | Acta Biochimica et Biophysica Sinica2017,49,5: | 14 |
| 5 | The migration of total dissolved solids during natural freezing process in Ulansuhai Lake显示文摘High total dissolved solids (TDS) content is one of the most important pollution contributors in lakes in arid and semiarid areas.Ulansuhai Lake,located in Urad Qianqi,Inner Mongolia,China,was selected as the object of study.Temperatures and TDS contents of both ice and under-ice water were collected together with corresponding ice thickness.TDS profiles were drawn to show the distribution of TDS and to describe TDS migration.The results showed that about 80% (that is 3.602×10 8 kg) of TDS migrated from ice to water during the whole growth period of ice.Within ice layer,TDS migration only occurred during initial ice-on period,and then perished.The TDS in ice decreased with increasing ice thickness,following a negative exponential-like trend.Within under-ice water,the TDS migrated from ice-water interface to the entire water column under the effect of concentration gradient until the water TDS content was uniform.In winter,6.044×10 7 kg (16.78% of total TDS) TDS migrated from water to sediment,which indicated that winter is the best time for dredging sediment.The migration effect gives rise to TDS concentration in under-ice water and sediment that is likely to affect ecosystem and water quality of the Yellow River.The trend of transfer flux of ice-water and water-sediment interfaces is similar to that of ice growth rate,which reveals that ice growth rate is one of the determinants of TDS migration.The process and mechanism of TDS migration can be referenced by research on other lakes with similar TDS content in cold and arid areas. | Yan ZHANG ChangYou LI XiaoHong SHI Chao LI | 2012 | Journal of Arid Land2012,4,1: | 12 |
| 6 | Uterine Rbpj is required for embryonic-uterine orientation and decidual remodeling via Notch pathway-independent and -dependent mechanisms显示文摘协调的子宫胚胎的轴形成并且蜕膜的改变是哺乳动物的培植以后的胚胎开发的特点。胚胎子宫的取向在起始的培植被决定并且与蜕膜的开发同步。然而,控制这些事件的分子的机制留下尽管有它的发现逃犯很长时间以前。在现在的学习,我们发现了 Rbpj 的那子宫特定的删除,槽口发信号的原子变换器,在培植以后的阶段导致了反常胚胎子宫的取向和蜕膜的 patterning,导致实质的胚胎损失。我们进一步表明在胚胎附件以前, Rbpj 授与在时间上经由身体上与子宫的雌激素受体交往的子宫的腔形状转变(ERα) 以一种槽口小径无关的方式,它为在有子宫的轴的排列的胚胎取向的起始的建立是必要的。当时在培植以后的阶段, Rbpj 直接以一种槽口小径依赖者方式调整子宫的矩阵 metalloproteinase 的表示,它为正常被要求培植以后的蜕膜的改变。这些结果证明子宫的 Rbpj 为经由指示起始的胚胎子宫的取向并且以一种阶段特定的方式保证正常蜕膜的 patterning 的正常胚胎开发是必要的。我们的数据也证实正常哺乳动物的胚胎子宫的取向要求的概念合适的指导从发展地控制了子宫的发信号。 | Shuang Zhang Shuangbo Kong Bingyan Wang Xiaohong Cheng Yongjie Chen Weiwei Wu Qiang Wang Junchao Shi Ying Zhang Shumin Wang Jinhua Lu John P Lydon Francesco DeMayo Warren S Pear Hua Han Haiyan Lin Lei Li Hongmei Wang Yan-ling Wang Bing Li Qi Chen Enkui Duan Haibin Wang | 2014 | Cell Research2014,24,8: | 12 |
| 7 | Impact of HBV replication in peripheral blood mononuclear cell on HBV intrauterine transmission显示文摘 | Xiaohong Shi Xuefei Wang Xixi Xu Yongliang Feng Shuzhen Li Shuying Feng Bo Wang Suping Wang | 2017 | Frontiers of Medicine2017,11,4: | 11 |
| 8 | A phase I study of different doses and frequencies of pegylated recombinant human granulocyte-colony stimulating factor(PEG rhG-CSF) in patients with standard-dose chemotherapy-induced neutropenia显示文摘Objective: The recommended dose of prophylactic pegylated recombinant human granulocyte-colony stimulating factor(PEG rhG-CSF) is 100 μg/kg once per cycle for patients receiving intense-dose chemotherapy.However, few data are available on the proper dose for patients receiving less-intense chemotherapy. The aim of this phase I study is to explore the proper dose and administration schedule of PEG rhG-CSF for patients receiving standard-dose chemotherapy.Methods:Eligible patients received 3-cycle chemotherapy every 3 weeks.No PEG rhG-CSF was given in the first cycle.Patients experienced grade 3 or 4 neutropenia would then enter the cycle 2 and 3.In cycle 2,patients received a single subcutaneous injection of prophylactic PEG rhG-CSF on d 3,and received half-dose subcutaneous injection in cycle 3 on d 3 and d 5,respectively.Escalating doses(30,60,100 and 200μg/kg)of PEG rhG-CSF were investigated.Results:A total of 26 patients were enrolled and received chemotherapy,in which 24 and 18 patients entered cycle 2 and cycle 3 treatment,respectively.In cycle 2,the incidence of grade 3 or 4 neutropenia for patients receiving single-dose PEG rhG-CSF of 30,60,100 and 200 μg/kg was 66.67%,33.33%,22.22% and 0,respectively,with a median duration less than 1(0–2)d.No grade 3 or higher neutropenia was noted in cycle 3 in all dose cohorts.Conclusions:The pharmacokinetic and pharmacodynamic profiles of PEG rhG-CSF used in cancer patients were similar to those reported,as well as the safety.Double half dose administration model showed better efficacy result than a single dose model in terms of grade 3 neutropenia and above.The single dose of 60 μg/kg,100 μg/kg and double half dose of 30 μg/kg were recommended to the phase Ⅱ study,hoping to find a preferable method for neutropenia treatment. | Yan Qin Xiaohong Han Lin Wang Ping Du Jiarui Yao Di Wu Yuanyuan Song Shuxiang Zhang Le Tang Yuankai Shi | 2017 | Chinese Journal of Cancer Research2017,29,5: | 11 |
| 9 | Multigene editing via CRISPR/Cas9 guided by a single-sgRNA seed in Arabidopsis显示文摘We report that a solo single-guide RNA(sg RNA) seed is capable of guiding Clustered Regularly Interspaced Short Palindromic Repeats(CRISPR)/CRISPRàassociated 9(CRISRP/Cas_9) to simultaneously edit multiple genes At RPL_(10)A, At RPL_(10)B and At RPL_(10)C in Arabidopsis. Our results also demonstrate that it is possible to use CRISPR/Cas_9 technology to create At RPL_(10) triple mutants which otherwise cannot be generated by conventional genetic crossing. Compared to other conventional multiplex CRISPR/Cas systems, a single sg RNA seed has the advantage of reducing off-target gene-editing. Such a gene editing system might be also applicable to modify other homologous genes, or even less-homologous sequences for multiple gene-editing in plants and other organisms. | Zhiming Yu Qiyuan Chen Weiwei Chen Xian Zhang Fengling Mei Pengcheng Zhang Mei Zhao Xiaohong Wang Nongnong Shi Stephen Jackson Yiguo Hong | 2018 | Journal of Integrative Plant Biology2018,60,5: | 10 |
| 10 | Autologous hematopoietic stem cell transplantation in chemotherapy-sensitive lymphoblastic lymphoma: treatment outcome and prognostic factor analysis显示文摘Objective: The study evaluated the effectiveness of autologous hematopoietic stem cell transplantation(AHSCT) in the treatment of lymphoblastic lymphoma(LL).Methods: We retrospectively analyzed the data from 41 patients with chemotherapy-sensitive LL who underwent hematopoietic stem cell transplantation(HSCT) from December 1989 to December 2009 in a single institution.Results: HSCT was conducted as first-line consolidation therapy and salvage therapy in 36 and 5 patients, respectively. The median follow-up was 97.1 months(range, 24.6-173.1 months). The 5-year overall survival(OS) and event-free survival(EFS) rate were 64% and 47% for the initially treated patients, respectively, and were both 20% for the relapsed ones. Bone marrow(BM) involvement and chemotherapy cycles prior to transplantation were identified as significant prognostic factors for EFS in multivariate analysis.Conclusions: These results confirm that AHSCT is a reasonable option for chemotherapy-sensitive LL patients in first complete remission(CR1). | Youwu Shi Shengyu Zhou Xiaohui He Xiaohong Han Shikai Wu Feng Pan Peng Liu Yinyu Liu Yingheng Lei Hongzhi Zhang Jianliang Yang Yan Qin Changgong Zhang Sheng Yang Liya Zhao Kehuan Luo Guanqing Wu Yan Sun Yuankai Shi | 2015 | Chinese Journal of Cancer Research2015,27,1: | 9 |
| 11 | AFM research on Fe-based nanocrystal crystallization mechanism显示文摘The cross-section pattern of Fe-based alloy ribbon (Fe73.5Cu1Nb3Si13.5B9) annealed at different temperatures was investigated by AFM (atomic force microscope), and the effect mechanism of Nb and Cu in Fe-based alloy ribbon annealing was analyzed with XRD diffraction crystal analysis technique and other research results. New concepts of encapsulated grain, Nb vacancy cluster, Nb-B atom cluster and so on were proposed and used to describe the formation mechanism of α-Fe (Si) nanocrystal. Finally, a three-phase (separation phase, encapsulated phase and nanocrystalline phase) interconnected structure model in Fe-based nanocrystalline alloy was established. | FANG YunZhang WU FengMin ZHENG JinJu SHI FangYe WU WenHui SUN HuaiJun LIN GenJin MAN QiKui HU JuanMei YANG XiaoHong | 2008 | Science China(Technological Sciences)2008,51,1: | 8 |
| 12 | Bph30confers resistance to brown planthopperby fortifying sclerenchyma in rice leaf sheaths显示文摘Phloem-feeding insects cause massive losses in agriculture and horticulture.Host plant resistance to phloem-feeding insects is often mediated by changes in phloem composition,which deter insect settling and feeding and decrease viability.Here,we report that rice plant resistance to the phloem-feeding brown planthopper(BPH)is associated with fortification of the sclerenchyma tissue,which is located just beneath the epidermis and a cell layer or two away from the vascular bundle in the rice leaf sheath.We found that BPHs prefer to feed on the smooth and soft region on the surface of rice leaf sheaths called the long-cell block.We identified Bph30 as a rice BPH resistance gene that prevents BPH stylets from reaching the phloem due to the fortified sclerenchyma.Bph30 is strongly expressed in sclerenchyma cells and enhances cellulose and hemicellulose synthesis,making the cell walls stiffer and sclerenchyma thicker.The structurally fortified sclerenchyma is a formidable barrier preventing BPH stylets from penetrating the leaf sheath tissues and arriving at the phloem to feed.Bph30 belongs to a novel gene family,encoding a protein with two leucine-rich domains.Another member of the family,Bph40,also conferred resistance to BPH.Collectively,the fortified sclerenchyma-mediated resistance mechanism revealed in this study expands our understanding of plant-insect interactions and opens a new path for controlling planthoppers in rice. | Shaojie Shi Huiying Wang Lingyun Nie Di Tan Cong Zhou Qian Zhang YiLi Bo Du Jianping Guo Jin Huang DiWu Xiaohong Zheng Wei Guan Junhan Shan Lili Zhu Rongzhi Chen Longjian Xue Linda L.Walling Guangcun He | 2021 | Molecular Plant2021,14,10: | 7 |
| 13 | Evaluation of oxygen transfer parameters of fine-bubble aeration system in plug flow aeration tank of wastewater treatment plant显示文摘Knowledge of the oxygen mass transfer of aerators under operational conditions in a full-scale wastewater treatment plant (WWTP) is meaningful for the optimization of WWTP, however, scarce to best of our knowledge. Through analyzing a plug flow aeration tank in the Lucun WWTP, in Wuxi, China, the oxygenation capacity of fine-bubble aerators under process conditions have been measured in- situ using the off-gas method and the non-steady-state method. The off-gas method demonstrated that the aerators in different corridors in the aeration tank of WWTP had significantly different oxygen transfer performance; furthermore, the aerators in the same corridor shared almost equal oxygen transfer performance over the course of a day. Results measured by the two methods showed that the oxygen transfer performance of fine-bubble aerators in the aeration tank decreased dramatically compared with that in the clean water. The loss of oxygen transfer coefficient was over 50% under low-aeration conditions (aeration amount < 0.67 Nm 3 /hr). However, as the aeration amount reached 0.96 Nm 3 /hr, the discrepancy of oxygen transfer between the process condition and clean water was negligible. The analysis also indicated that the non-steady-state and off-gas methods resulted in comparable estimates of oxygen transfer parameters for the aerators under process conditions. | Xiaohong Zhou Yuanyuan Wu Hanchang Shi Yanqing Song | 2013 | Journal of Environmental Sciences2013,25,2: | 6 |
| 14 | A phaseⅠtrial of an oral subtype-selective histone deacetylase inhibitor,chidamide,in combination with paclitaxel and carboplatin in patients with advanced non-small cell lung cancer显示文摘Objective: This phase Ⅰ study was to evaluate safety, maximum tolerated dose, pharmacokinetics and preliminary antitumor activity of chidamide, a novel subtype-selective histone deacetylase(HDAC) inhibitor, in combination with paclitaxel and carboplatin in patients with advanced non-small cell lung cancer(NSCLC).Methods: Ten patients received oral chidamide 20, 25, or 30 mg twice per week continuously with paclitaxel(175 mg/m^2) and carboplatin [area under the curve(AUC) 5 mg/m L/min] administered in a 3-week cycle. Patients with response and stable disease after four cycles maintained chidamide monotherapy until disease progression or unacceptable toxicity. Blood samples were collected for pharmacokinetic analysis after the first single oral of chidamide and first combination treatment in cycle 1 from all patients.Results: Two dose-limiting toxicities were recorded in the 30 mg cohort, including thrombocytopenia and prolonged neutropenia in the first cycle. Grade 3/4 neutropenia in any cycle was observed in all patients, but was not associated with significant complications. Other grade 3/4 hematologic toxicities included thrombocytopenia and leucopenia. No significant changes were observed in pharmacokinetic parameters for both chidamide and paclitaxel. One patient in the 20 mg cohort had confirmed partial response(PR). Two out of 5 patients with brain metastases had intracranial complete remission after 4-cycle treatment.Conclusions: Chidamide combined with paclitaxel and carboplatin was generally tolerated without unanticipated toxicities or clinically relevant pharmacokinetic interactions. The recommended dose for chidamide in this combination was established at 20 mg, and a phase Ⅱ trial is ongoing with this regimen in patients with advanced NSCLC. | Xingsheng Hu Lin Wang Lin Lin Xiaohong Han Guifang Dou Zhiyun Meng Yuankai Shi | 2016 | Chinese Journal of Cancer Research2016,28,4: | 6 |
| 15 | Promoter methylation of Wnt/β-Catenin signal inhibitor TMEM88 is associated with unfavorable prognosis of nonsmall cell lung cancer显示文摘Objective:Recent research has indicated that altered promoter methylation of oncogenes and tumor suppressor genes is an important mechanism in lung cancer development and progression.In this study,we investigated the association between promoter methylation of TMEM88,a possible inhibitor of the Wnt/β-Catenin signaling,and the survival of patients with nonsmall cell lung cancer(NSCLC).Methods:Twelve pairs of tumor and adjacent non-tumor samples were used for microarray analyses of DNA methylation and gene expression.For validation,more than two hundred additional samples were analyzed for methylation using bisulfite pyrosequencing and for gene expression using q RT-PCR.Then the cell function were tested by wound healing,transwell,CCK8 and cell cycle assay.Results:Our analysis of patient specimens showed that TMEM88 methylation was higher in NSCLC tumors(82.2%±10.3,P<0.01)compared with the adjacent normal tissues(65.9%±7.2).The survival analysis revealed that patients with high TMEM88methylation had a shorter overall survival(46 months)compared with patients with low TMEM88 methylation(>56 months;P=0.021).In addition,we found that demethylation treatment could inhibit tumor cell proliferation,migration,and invasion,which was supportive of an association between methylation and survival.Conclusions:Based on these consistent observations,we concluded that TMEM88 may play an important role in NSCLC progression and that promoter methylation of TMEM88 may serve as a biomarker for NSCLC prognosis and treatment. | Rongna Ma Nannan Feng Xiao Yu Hongyan Lin Xiaohong Zhang Oumin Shi Huan Zhang Shuo Zhang Lei Li Min Zheng Ming Gao Herbert Yu Biyun Qian | 2017 | Cancer Biology & Medicine2017,14,4: | 6 |
| 16 | Pathological changes in the lungs and lymphatic organs of 12 COVID-19 autopsy cases显示文摘Systematic autopsy and comprehensive pathological analyses of COVID-19 decedents should provide insights into the disease characteristics and facilitate the development of novel therapeutics.In this study,we report the autopsy findings from the lungs and lymphatic organs of 12 COVID-19 decedents—findings that evaluated histopathological changes;immune cell signature and inflammatory factor expression in the lungs,spleen and lymph nodes.Here we show that the major pulmonary alterations included diffuse alveolar damage,interstitial fibrosis and exudative inflammation featured with extensive serous and fibrin exudates,macrophage infiltration and abundant production of inflammatory factors(IL-6,IP-10,TNFo?and IL-I f).The spleen and hilar lymph nodes contained lesions with tissue structure disruption and immune cell dysregulation,including lymphopenia and macrophage accumulation.These findings provide pathological evidence that links injuries of the lungs and lymphatic organs with the fatal systematic respiratory and immune malfunction in critically ill COVID-19 patients. | Qian Liu Yu Shi Jun Cai Yaqi Duan Rongshuai Wang Hongyan Zhang Qiurong Ruan Jiansha Li Lei Zhao Yifang Ping Rong Chen Liang Ren Xiaochun Fei Heng Zhang Rui Tang Xi Wang Tao Luo Xindong Liu Xuequan Huang Zhenhua Liu Qilin Ao Yong Ren Jing Xiong Zhicheng He Haibo Wu Wenjuan Fu Pengnan Zhao Xinwei Chen Guoqiang Qu Yunyun Wang Xi Wang Jia Liu Dongfang Xiang Sanpeng Xu Xiaowei Zhou Qingrui Li Jinghong Ma Heng Li Jie Zhang Sizhe Huang Xiaohong Yao Yiwu Zhou Chaofu Wang Dingyu Zhang Guoping Wang Liang Liu Xiu-Wu Bian | 2020 | National Science Review2020,7,12: | 6 |
| 17 | Comparison of immunohistochemistry with fluorescence in situ hybridization in determining the human epidermal growth factor receptor 2 status of breast cancer specimens: a multicenter study of 3149 Chinese patients显示文摘 | Han Xiaohong Shi Yuankai Ma Li Lyu Zheng Yang Hongying Yao Jiarui Li Jian Li Bo Qin Yan | 2014 | Chinese Medical Journal2014,,2: | 5 |
| 18 | Phase I study of chimeric anti-CD20 monoclonal antibody in Chinese patients with CD20-positive non-Hodgkin's lymphoma显示文摘Objective: This study was designed to determine the safety, pharmacokinetics and biologic effects of a humanmouse chimeric anti-CD20 monoclonal antibody(SCT400) in Chinese patients with CD20-positive B-cell nonHodgkin's lymphoma(CD20+ B-cell NHL). SCT400 has an identical amino acid sequence as rituximab, with the exception of one amino acid in the CH1 domain of the heavy chain, which is common in Asians.Methods: Fifteen patients with CD20+ B-cell NHL received dose-escalating SCT400 infusions(250 mg/m^2: n=3; 375 mg/m^2: n=9; 500 mg/m^2: n=3) once weekly for 4 consecutive weeks with a 24-week follow-up period. The data of all patients were collected for pharmacokinetics and pharmacodynamics analyses.Results: No dose-limiting toxicities were observed. Most drug-related adverse events were grade 1 or 2. Two patients had grade 3 or 4 neutropenia. Under premedication, the drug-related infusion reaction was mild. A rapid, profound and durable depletion of circulating B cells was observed in all dose groups without significant effects on T cell count, natural killer(NK) cell count or immunoglobulin levels. No patient developed antiSCT400 antibodies during the course of the study. SCT400 serum half-life(T1/2), maximum concentration(Cmax) and area under the curve(AUC) generally increased between the first and fourth infusions(P<0.05). At the 375 mg/m^2 dose, the T1/2 was 122.5±46.7 h vs. 197.0±75.0 h, respectively, and the Cmax was 200.6±20.2 μg/m L vs. 339.1±71.0 μg/m L, respectively. From 250 mg/m^2 to 500 mg/m^2, the Cmax and AUC increased significantly in a dose-dependent manner(P<0.05). Patients with a high tumor burden had markedly lower serum SCT400 concentrations compared with those without or with a low tumor burden. Of the 9 assessable patients, 1 achieved complete response and 2 achieved partial responses.Conclusions: SCT400 is well-tolerated and has encouraging preliminary efficacy in Chinese patients with CD20+ B-cell NHL. | Lin Gui Xiaohong Han Xiaohui He Yuanyuan Song Jiarui Yao Jianliang Yang Peng Liu Yan Qin Shuxiang Zhang Weijing Zhang Wenlin Gai Liangzhi Xie Yuankai Shi | 2016 | Chinese Journal of Cancer Research2016,28,2: | 5 |
| 19 | Phase 1 studies comparing safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01(a rituximab biosimilar) to reference rituximab in Chinese patients with CD20-positive B-cell lymphoma显示文摘Objective: This study aimed to compare the pharmacokinetic, pharmacodynamic and safety profiles of HLX01(a rituximab biosimilar) and reference rituximab sourced from China(Mab Thera?;rituximab-CN).Methods: Here we report the results of two phase 1 studies. In the phase 1 a, open-label, dose-escalation study(NCT03218072, CTR20140400), eligible patients received 250, 375 and 500 mg/m^(2) HLX01 sequentially at 7-day intervals, after confirming no dose-limiting toxicity(DLT). In the phase 1 b, double-blind study(NCT02584920,CTR20140764), eligible patients were given a single dose of 375 mg/m^(2) HLX01 or rituximab-CN. The primary endpoints included safety and tolerability parameters for the phase 1 a and the area under the plasma concentrationtime curve from time zero to day 91(AUC0-91 d) for the phase 1 b study. Equivalence was concluded if 90%confidence interval(90% CI) for the geometric least squares mean ratio(GLSMR) fell in the pre-specified equivalence criteria(80%-125%).Results: Between June 20, 2014 and January 5, 2015, 12 patients were enrolled in the phase 1 a study. The pharmacokinetics of HLX01 showed dose proportionality and accumulation to steady state. HLX01 was well tolerated, with no serious adverse events(AEs), discontinuations or DLTs. Between November 8, 2014 and August13, 2015, 87 eligible patients were enrolled in the phase 1 b study, including 43 who received HLX01 and 44 who were treated with rituximab-CN. The equivalence endpoint was met with GLSMR for AUC0-91 d being 89.6%(90% CI: 80.4%-99.8%). AEs, anti-drug antibodies, and CD19+ and CD20+ B lymphocyte counts were similar between the HLX01 and rituximab-CN treatment groups.Conclusions: Treatment with HLX01 was safe and well tolerated in Chinese patients with B-cell lymphoma.HLX01 and rituximab-CN have similar pharmacokinetic, pharmacodynamic and safety profiles. | Yuankai Shi Qingyuan Zhang Xiaohong Han Yan Qin Xiaoyan Ke Hang Su Li Liu Jinxiang Fu Jie Jin Jifeng Feng Xiaonan Hong Xiaohong Zhang Depei Wu Bin Jiang Xiaodong Dong | 2021 | Chinese Journal of Cancer Research2021,33,3: | 5 |
| 20 | Bevacizumab biosimilar LY01008 compared with bevacizumab(Avastin)as first-line treatment for Chinese patients with unresectable,metastatic,or recurrent non-squamous non-small-cell lung cancer:A multicenter,randomized,double-blinded,phase Ⅲ trial显示文摘Background:Previous studies have demonstrated the preclinical pharmacological and toxicological consistency,and clinical pharmacokinetic equivalence of bevacizumab biosimilar LY01008 with reference bevacizumab(Avastin).This randomized controlled trial aimed to compare the efficacy and safety of LY01008 with Avastin in first-line treatment of Chinese patients with advanced or recurrent non-squamous non-small cell lung cancer(NSCLC).Methods:StageⅢB-ⅣNSCLC patients with evaluable lesions,good physical status,and adequate organ functions from 67 centers across China were randomized in a ratio of 1:1 to receive LY01008 or Avastin 15 mg/kg intravenously in combination with paclitaxel/carboplatin(combined treatment)for 4-6 cycles,followed by maintenance monotherapy with LY01008 until disease progression,intolerable toxicity,or death.The primary endpoint was objective response rate(ORR)in accordance with Response Evaluation Criteria in Solid Tumors(RECIST)version 1.1 confirmed by independent radiological review committees(IRRC).Secondary endpoints included disease control rate(DCR),duration of response(DoR),progression-free survival(PFS),overall survival(OS),and safety.This study was registered in Clinical Trials.gov(NCT03533127).Results:Between December 15^(th),2017,and May 15^(th),2019,a total of 649 patients were randomized to the LY01008(n=324)or Avastin(n=325)group.As of September 25th,2019 for primary endpoint analysis,589 patients received ORR evaluation,with a median number of combined treatment cycles of 5(range 1-6)andmedian duration of treatment of 3.0(range 0.0-5.1)months.ORRof responseevaluable patients in the LY01008 and Avastin groups were 48.5% and 53.0%,respectively.The stratified ORR ratio was 0.91(90%CI 0.80-1.04,within the prespecified equivalence margin of 0.75-1.33).Up to May 15^(th),2020,with a median follow-up of 13.6(range 0.8-28.4)months,no notable differences in DCR,median DoR,median PFS,median OS,and 1-year OS rate were observed between the LY01008 and Avastin groups.There were no clinically meaningful differences in safety and immunogenicity across treatment groups.Conclusions:LY01008 demonstrated similarity to Avastin in terms of efficacy and safety in Chinese patients with advanced or recurrent non-squamous NSCLC.LY01008 combined with paclitaxel/carboplatin is expected to become a new treatment option for unresectable,metastatic,LY01008 and Avastin groups.There were no clinically meaningful differences in safety and immunogenicity across treatment groups.Conclusions:LY01008 demonstrated similarity to Avastin in terms of efficacy and safety in Chinese patients with advanced or recurrent non-squamous NSCLC.LY01008 combined with paclitaxel/carboplatin is expected to become a new treatment option for unresectable,metastatic,or recurrent non-squamous NSCLC patients in the first-line setting. | Yuankai Shi Kaijian Lei Yuming Jia Bingqiang Ni Zhiyong He Minghong Bi Xicheng Wang Jianhua Shi Ming Zhou Qian Sun Guolei Wang Dongji Chen Yongqian Shu Lianke Liu Zhongliang Guo Yong Liu Junquan Yang Ke Wang Ke Xiao LinWu Tienan Yi Debin Sun Mafei Kang Tianjiang Ma Yimin Mao Jinsheng Shi Tiegang Tang Yan Wang Puyuan Xing Dongqing Lv Wangjun Liao Zhiguo Luo Bin Wang Xiaohong Wu Xiaoli Zhu Shuhua Han Qisen Guo Rongyu Liu Zhiwei Lu Jianyong Zhang Jian Fang Changlu Hu Yinghua Ji Guolong Liu Hong Lu Dedong Wu Junhong Zhang Shuyang Zhu Zheng Liu Wensheng Qiu Feng Ye Yan Yu Yanqiu Zhao Qinhong Zheng Jun Chen Zhanyu Pan Yiping Zhang Wenjuan Lian Bo Jiang Bo Qiu Guojun Zhang Hua Zhang Yanju Chen Yuan Chen Hongbing Duan Manxiang Li Shengming Liu Lijun Ma Hongming Pan Xia Yuan Xueli Yuan Yulong Zheng Emei Gao Li Zhao Shumin Wang Can Wu | 2021 | Cancer Communications2021,41,9: | 5 |