| 【Objectives】To evaluate the utility of serum decoy receptor 3(DcR3) in the early diagnosis, illness monitoring and the prognosis evaluation of sepsis; meanwhile, DcR3 was compared with other 3 indicators(PCT, CRP and IL-6) which are commonly used in the diagnosis of infection, thus to assess the application value of DcR3 in the early differential diagnosis of sepsis and the feasibility of DcR3 in the prognosis evaluation of sepsis. 【Methods】194 in-patients, who met two items or above of the diagnosis criteria of systemic inflammatory response syndrome(SIRS), were enrolled in the First Affiliated Hospital of Fujian Medical University from December 2012 to October 2013.Among the 194 cases, 134 were sepsis patients and 60 non-infectious SIRS patients. And 50 healthy persons were also enrolled as the control. The serum of the sepsis patients was collected on the day before and the 1st, 3rd, 5th, 7th day of the definite diagnosis was confirmed. An ELISA method of DcR3 detection was set up using two anti- DcR3 monoclonal antibodies, and the precision, sensitivity and specificity of the assay was evaluated. Then the patients’ sera and the control were tested using the established DcR3 detection method. At the same time, PCT and IL-6 were tested using the electrochemiluminescence assay and CRP was analyzed by the immunonehelomitery method. We subsequently investigated the diagnostic performance of these four biomarkers(DcR3, PCT, IL-6 and CRP) in sepsis. The data were expressed as median(P25, P75) and analyzed by SPSS 20.0. 【Results】 1 An ELISA method of DeR3 detection was established. When the concentration of the anti-DcR3 monoclonal antibody was 2μg/ml and the biotinylated secondary antibody was 0.2μg/ml, it showed the best linear relation of the standard curve. The correlation coefficient was 0.983 and the regression equation was y=0.3367+0.0965 x. The inter-assay and intra coefficient of variation(CV) was lower than 8 % and 13 %, respectively. And the average recovery rate was 95.4 %. The reference range was 0~0.37 ng/ml, and the linearity range was 0~16ng/ml.2 Evaluation of Dc R3 detection in the early diagnosis of sepsis2.1 The median serum Dc R3 level of the control, non-infectious SIRS patients and the sepsis patients on the 1st day of the definite diagnosis were 0.17 ng/ml, 1.28 ng/ml and4.25 ng/ml, respectively(P<0.001).2.2 To determine and compare the predictive value of the indicators for sepsis, the receiver operating characteristic(ROC) curves were drawn. When compared with the healthy control and the cut-off value was 0.43 ng /m L, Dc R3 had a sensitivity of98.50% and a specificity of 99.80% for sepsis. When compared with the SIRS patients,Dc R3 best predicted sepsis(0.95 vs. 0.74(PCT) vs. 0.56(IL-6) vs. 0.61(CRP)) with a Dc R3 cut-off value of 1.96 ng /m L having 90.77% sensitivity and 98.40% specificity for sepsis. Among four indicators, Dc R3 had a best correlation with PCT, and the Spearman rank correlation coefficient was 0.66.2.3 There was no statistical difference of serum Dc R3 level of sepsis patients caused by different pathogens. The pathogen could not be determined by detecting the serum concentration of Dc R3, PCT, IL-6 and CRP.3 Evaluation of Dc R3 in the illness monitoring and prognosis of sepsis3.1 The serum level of Dc R3, PCT, IL-6, CRP and APACHE II scores in the death group were all higher than that in the survival group, which was statistical significant(P<0.05).3.2 The serum Dc R3 level in the shock subgroup of sepsis patients was significantly increased than that in the general subgroup and the severe subgroup of sepsis patients(P<0.001).3.3 Serum Dc R3 level had positive correlation with APACHE II scores( R=0.821,P<0.001). Based on APACHE II scores, the sepsis patients were divided into three subgroups, <15 scores, 15-24 scores and ≥25 scores. There were statistically significances of serum Dc R3 level among the three subgroups.3.4 Based on the severity of the disease, the sepsis patients were divided into the general subgroup and the severe subgroup. The serum Dc R3 level before and after the definite diagnosis of sepsis was confirmed were continuously tested for 8 days. Except on the day before the definite diagnosis of sepsis was confirmed, there was statistically significance of serum Dc R3 level between the two subgroups(P<0.05),and the Dc R3 level in the severe subgroup was always higher than that in the general subgroup.3.5 Based on the prognosis of the disease, the sepsis patients were divided into the survival subgroup and the death subgroup. The serum Dc R3 level before and after the definite diagnosis of sepsis was confirmed were also continuously tested for 8 days. The results showed that there was statistically significance of serum Dc R3 level between the two subgroups(P<0.05),and the Dc R3 level in the death subgroup was always higher than that in the survival subgroup.【Conclusions】1 The quantifying ELISA method of serum Dc R3 was set up with high sensitivity and specificity, good repeatability and wide linear range, thus providing a platform for the further research of Dc R3 in the sepsis.2 The serum Dc R3 level could be used to differentiate the sepsis patients and the non-infectious SIRS patients. Using ROC analysis, when the cut-off value was 1.96 ng/m L, Dc R3 had better diagnostic performance for sepsis than PCT,IL-6 and CRP. Dc R3 had a best correlation with PCT, and both of Dc R3 and PCT had a better performance of sensitivity and specificity than CRP and IL-6. Therefore Dc R3 could be used in the early diagnosis of sepsis. Yet the pathogen of sepsis could not be determined by detecting the serum concentration of Dc R3.3 There was significant difference of serum Dc R3 level between the survival subgroup and the death subgroup; either was between the general subgroup and the severe subgroup. Serum Dc R3 level had positive correlation with APACHE II scores, and Dc R3 can be used as an indicator of severity of sepsis, thus dynamically monitoring serum Dc R3 level could be applied in the prognosis evaluation and monitoring the therapeutic effect of sepsis. |
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