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Efficacy and Safety Study of CA330 Hemadsorption Device on IL-6 Removal in Septic Patients: Study Protocol of a Multicenter Randomized Controlled Trial
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作者 Yao Nie Zhiyi Jiang +1 位作者 Zimeng Liu Xiangdong Guan 《Open Journal of Epidemiology》 2021年第4期517-524,共8页
<strong>Background:</strong> Sepsis persists to be the leading cause of morbidity and mortality worldwide with the huge cost of health care resources. Besides adequate antibiotics and infectious source con... <strong>Background:</strong> Sepsis persists to be the leading cause of morbidity and mortality worldwide with the huge cost of health care resources. Besides adequate antibiotics and infectious source control, definitive therapy is still being studied. The activation of multiple pro- and anti-inflammatory mediators plays a key role in the sepsis process. The application of adsorption may help deactivate and decrease the peak elevation of these mediators in the earlier course of sepsis, when levels of endotoxins and cytokines are extremely high. However, the clinical evidence to support hemadsorption for removing endotoxins and/or pro-inflammatory mediators in sepsis remains incompetent and controversial. In this study protocol, we aimed to test the efficacy of removing cytokines and the safety of a new hemadsorption device, CA330, in septic patients. <strong>Design:</strong> This is a multicenter randomized controlled clinical trial enrolling 8 tertiary hospitals in China. A total of 144 patients will be randomly divided into the experimental group and the control group according to the ratio of 1:1. The primary endpoint is the reduction rate of IL-6 serum concentration between the initiation of the first adsorption and end with the second adsorption. <strong>Discussion:</strong> To our knowledge, this clinical trial is the first to evaluate the efficacy and safety of the CA330 hemadsorption device in sepsis patients. Our study will raise the level of evidence for the treatment of sepsis patients with hemadsorption. 展开更多
关键词 SEPSIS hemadsorption CA330 Inflammatory Mediators IL-6
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Important amino acid in the hemagglutinin glycoprotein of measles virus(MV)that governs hemadsorption
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作者 Michiko Watanabe Shigeharu Ueda 《Chinese Science Bulletin》 SCIE EI CAS 1999年第7期612-617,共6页
Two strains of measles virus IMA and SMD that were isolated using B95a cell line show hemadsorption negative. After adaptation to Vero cells, these strains gain the ability to agglutinate AGM-RBC and show hemadsorptio... Two strains of measles virus IMA and SMD that were isolated using B95a cell line show hemadsorption negative. After adaptation to Vero cells, these strains gain the ability to agglutinate AGM-RBC and show hemadsorption positive. Sequence analysis of these two kinds of virus reveals that the two strains all have a Ser (HAD negative) to Gly (HAD positive) mutation at position 546 in the H protein. Site-directed mutagenesis and expression in COS cells were used to confirm that the mutation Ser→Gly is responsible for hemadsorption alteration. Then the monoclonal antibody against CD46 was used to identify that this mutation also governs the binding function of MV H protein to CD46 receptor. The data provide a new important amino acid of MV H protein that governs the hemadsorption and binding to CD46 receptor. 展开更多
关键词 H protein CD46 receptor hemadsorption SITE-DIRECTED mutagenesis.
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Multicentered prospective investigator initiated study to evaluate the clinical outcomes with extracorporeal cytokine adsorption device (CytoSorb®) in patients with sepsis and septic shock 被引量:4
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作者 Rajib Paul Prachee Sathe +3 位作者 Senthil Kumar Shiva Prasad Ma Aleem Prashant Sakhalvalkar 《World Journal of Critical Care Medicine》 2021年第1期22-34,共13页
BACKGROUND Sepsis is a severe clinical syndrome related to the host response to infection.The severity of infections is due to an activation cascade that will lead to an auto amplifying cytokine production:The cytokin... BACKGROUND Sepsis is a severe clinical syndrome related to the host response to infection.The severity of infections is due to an activation cascade that will lead to an auto amplifying cytokine production:The cytokine storm.Hemoadsorption by CytoSorb®therapy is a new technology that helps to address the cytokine storm and to regain control over various inflammatory conditions.AIM To evaluate prospectively CytoSorb®therapy used as an adjunctive therapy along with standard of care in septic patients admitted to intensive care unit(ICU).METHODS This was a prospective,real time,investigator initiated,observational multicenter study conducted in patients admitted to the ICU with sepsis and septic shock.The improvement of mean arterial pressure and reduction of vasopressor needs were evaluated as primary outcome.The change in laboratory parameters,sepsis scores[acute physiology and chronic health evaluation(APACHE II)and sequential organ failure assessment(SOFA)]and vital parameters were considered as secondary outcome.The outcomes were also evaluated in the survivor and nonsurvivor group.Descriptive statistics were used;a P value<0.05 was considered RESULTS Overall,45 patients aged≥18 and≤80 years were included;the majority were men(n=31;69.0%),with mean age 47.16±14.11 years.Post CytoSorb®therapy,26 patients survived and 3 patients were lost to follow-up.In the survivor group,the percentage dose reduction in vasopressor was norepinephrine(51.4%),epinephrine(69.4%)and vasopressin(13.9%).A reduction in interleukin-6 levels(52.3%)was observed in the survivor group.Platelet count improved to 30.1%(P=0.2938),and total lung capacity count significantly reduced by 33%(P<0.0001).Serum creatinine and serum lactate were reduced by 33.3%(P=0.0190)and 39.4%(P=0.0120),respectively.The mean APACHE II score was 25.46±2.91 and SOFA scores was 12.90±4.02 before initiation of CytoSorb®therapy,and they were reduced significantly post therapy(APACHE II 20.1±2.47;P<0.0001 and SOFA 9.04±3.00;P=0.0003)in the survivor group.The predicted mortality in our patient population before CytoSorb®therapy was 56.5%,and it was reduced to 48.8%(actual mortality)after CytoSorb®therapy.We reported 75%survival rate in patients given treatment in<24 h of ICU admission and 68%survival rates in patients given treatment within 24-48 h of ICU admission.In the survivor group,the average number of days spent in the ICU was 4.44±1.66 d;while in the nonsurvivor group,the average number of days spent in ICU was 8.5±15.9 d.CytoSorb®therapy was safe and well tolerated with no adverse events reported.CONCLUSION CytoSorb®might be an effective adjuvant therapy in stabilizing sepsis and septic shock patients.However,it is advisable to start the therapy at an early stage(preferably within 24 h after onset of septic shock). 展开更多
关键词 Acute physiology and chronic health evaluation score hemadsorption SEPSIS Sequential organ failure assessment score VASOPRESSOR
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Measles Virus(Nepal Strain)Hemagglutinin Gene: Cloning,Complete Nucleotide Sequence Analysis and Expression in COS Cells
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作者 Li, Lingyun Qi, Yipeng 《Wuhan University Journal of Natural Sciences》 EI CAS 1998年第3期123-128,共6页
Hemagglutinin gene of Measles virus(Nepal strain) was amplified by RT PCR technique, cloned and sequenced by the dideoxy mediated chain termination method. The comparison to the standard strain(Edmonston strain) sho... Hemagglutinin gene of Measles virus(Nepal strain) was amplified by RT PCR technique, cloned and sequenced by the dideoxy mediated chain termination method. The comparison to the standard strain(Edmonston strain) showed many important mutations. The homology of these two strains was 98.17%. Then H gene was cloned into expression vector pCD SRα296 and introduced into COS 7 cells by electroporation method. The expression and function of cloned H gene was checked by hemadsorption assays. 展开更多
关键词 measles virus hemagglutinin gene cos 7 cells hemadsorption assays
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