| Objective:This trial is the clinical part of Project 863,aiming to evaluate the scavenging effect of EHC-Ⅰ disposable hemoperfusion device on serum endotoxin and proinflammatory factors in patients with endotoxemia,and to provide the basis for the clinical application of this hemoperfusion device.Methods:(1)A total of 50 sepsis patients admitted to the intensive care unit of the Affiliated Hospital of Qingdao University from May 20 to March 23,2012 were collected and randomly divided into the control group(n = 25)and the experimental group(n = 25).Among them,the experimental group was treated with EHC-Ⅰ type disposable hemoperfusion device newly developed by Weihai Yang Quan Biology Co.,Ltd.,while the control group was treated with MHC-I type disposable hemoperfusion device which has been widely used in clinical practice,and the hemoperfusion treatment lasted for 2 hours.All the time points involved in data collection in the following paragraphs are abbreviated as follows: 0 h was recorded before irrigation,15 min was recorded at the beginning of irrigation,2 h was recorded at the end of irrigation,and 26 h was recorded at 24 h after irrigation.(2)Evaluation index:①Main evaluation indexes: difference of serum endotoxin between experimental group and control group at 0 h,2 h and 26 h;Difference of endotoxin before and after treatment in test group.②Secondary evaluation indexes: 1)Tumor cell necrosis factor(TNF-α)and interleukin-6(IL-6)were different between the test group and the control group at 0h,2 h and 26 h;TNF-α and IL-6 in the test group were different before and after treatment.2)Differences in 0h and 2h mean arterial pressure,oxygenation index,APACHE Ⅱ score and SOFA score between the experimental group and the control group;Differences in mean arterial pressure,oxygenation index,APACHE Ⅱ score and SOFA score before and after treatment in the experimental group.3)Comparison of liver function,kidney function and heart function between experimental group and control group at 0 h and 2 h;Comparison of liver function,kidney function and heart function in experimental group before and after treatment.③Safety indicators: the change rates of albumin,white blood cell,red blood cell,hemoglobin and platelet at 15 min,2 h and 26 h in the experimental group compared with 0 h.④Adverse reactions during perfusion were recorded.⑤The 28-day mortality rate of the two groups was analyzed.Each data is quality-controlled by a third-party organization CRE and filled in online for review.(3)SPSS25.0 was used for statistical analysis of the obtained data.For the two groups of continuous data with normality and homogeneity of variance,two independent samples were used for t-test,and for the continuous data that did not conform to the normal distribution,two independent samples were used for nonparametric test.If there were significant differences between the two groups of data at the last time point,Covariance analysis should be used to compare the two groups of data at the next time point.Results:(1)①There was no statistical difference in endotoxin at 0 h between the experimental group and the control group.②The endotoxin in experimental group was significantly lower than that in control group at 2 h(t=-8.646,P<0.05).③The endotoxin of test group was significantly lower than that of control group at 26 h(t=12.59,P<0.05).④The endotoxin of 2 h group was significantly lower than that of 0 h group(t=13.731,P<0.001);26 h endotoxin was significantly lower than 0 h endotoxin(t=12.673,P<0.001).(2)①There was no significant difference in TNF-α and IL-6 between the experimental group and the control group at 0 h.②There was no significant difference in TNF-α and IL-6 between the two groups at 2 h.③TNF-α and IL-6 in experimental group were significantly lower than those in control group at 26 h(t=11.74,P<0.05;T =10.36,P<0.05).④The levels of TNF-α and IL-6 in experimental group at 2 h were significantly lower than those at 0 h(t=-9.755,P<0.001;T =10.567,P<0.001);The levels of TNF-αand IL-6 at 26 h were significantly lower than those at 0 h(t=6.431,P<0.05;T =-8.873,P<0.001).(3)There were no significant differences in mean arterial pressure,oxygenation index,APACHE Ⅱ score and SOFA score between the experimental group and the control group at 0 h and 2 h.There were no significant differences in mean arterial pressure,oxygenation index,APACHE Ⅱ score and SOFA score between the experimental groups before and after treatment.(4)The WBC,RBC,HB,PLT and albumin in the experimental group decreased the most at 15 min after perfusion,and the reduction rates were 9.82%,5.62%,2.04%,14.07% and 6.70%,respectively,which were all within the allowable range of the standard of disposable hemoperfusion apparatus.In addition,no 7adverse reactions occurred in the patients who received EHC-Ⅰhemoperfusion.(5)There was no significant difference in 28-day mortality between the experimental group(3/50)and the control group(2/50).Conclusion:Compared with MHC-Ⅰhemoperfusion apparatus,EHC-Ⅰhemoperfusion apparatus has higher endotoxin clearance rate,can effectively reduce the level of inflammatory factors in vivo,and has a good safety.However,a single hemoperfusion treatment is not enough to have a significant effect on the organ function and long-term prognosis of patients. |
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