论文部分内容阅读
目的:建立新的检测促红细胞生成素的判别函数,提高EPO血液检测方法的灵敏度和特异性。方法:人体实验采用随机双盲对照设计,将24名受试者分为实验组和对照组,分别注射重组EPO和安慰剂。实验阶段分为注射前(1周)、注射期(4周)和停药期(4周)3个阶段。每名受试者在整个人体实验的3个阶段中共采集血样18次。用Advia120血液分析仪检测24名受试者的红细胞压积(HCT%)、网织红细胞压积(RetHCT)、巨红细胞百分数(Macro%);血清EPO浓度的测定采用免疫化学发光法;可溶性转铁蛋白受体(sTfR)的测定采用酶联免疫吸附分析法。采用Fisher判别分析法,应用人体实验数据中注射期的数据构造判别函数,判别能力用Wilks’Lambda法进行检验;对所建立的判别函数进行回代检验,并对短期使用EPO的效果进行判别,将其结果与第一代判别函数(On_Model)进行比较。结果:两个新的判别函数为:Z_on(男性)=0.988Ln(EPO)+0.253Ln(sTfR)-0.032Ln(Macro%+0.1)+0.547HCT+0.319RetHCT,界值为3.2;Z_on(女性)=0.862Ln(EPO)-0.067Ln(sTfR)+0.103Ln(Macro%+0.1)+0.311HCT+0.439RetHct,界值为2.5。判别力经Wilks’Lambda统计检验有统计学意义(P<0.001)。采用Z_on判定男性和女性各有1例假阴性,而采用On_Model则男性有3例假阴性,女性有8例假阴性。在使用1次和2次EPO后用Z_on能全部进行正确判别,但使用On_Model均有假阴性发生。结论:新的判别函数Z_on对使用EPO的误判率低于第一代判别函数On_Model,并对短期注射EPO的判别效果高于On_Model。
Objective: To establish a new discriminant function to detect erythropoietin and to improve the sensitivity and specificity of EPO blood test. METHODS: Human subjects were randomized, double-blind, controlled trial. Twenty-four subjects were divided into experimental and control groups, with either recombinant EPO or placebo. Experimental stage is divided into three stages: injection (1 week), injection (4 weeks) and withdrawal (4 weeks). A total of 18 blood samples were taken from each subject during the entire three-phase human trial. Twenty-four subjects were tested for hematocrit (HCT%), RetHCT, and Macro% using Advia120 hematology analyzer. Immuno chemiluminescence was used to determine the concentration of serum EPO. Ferritin receptor (sTfR) was measured by enzyme-linked immunosorbent assay. The Fisher discriminant analysis method was used to construct the discriminant function based on the data of injection in the human experimental data. The discriminant ability was tested by the Wilks’Lambda method. The discriminant function was tested by the regression and the effect of the short-term EPO was discriminated. The result is compared with the first generation discriminant function (On_Model). RESULTS: The two new discriminant functions were: Z_on (male) = 0.988Ln (EPO) + 0.253Ln (sTfR) -0.032Ln (Macro% + 0.1) + 0.547HCT + 0.319RetHCT with a cutoff of 3.2; Z_on (female ) = 0.862Ln (EPO) -0.067Ln (sTfR) + 0.103Ln (Macro% + 0.1) + 0.311HCT + 0.439RetHct with a cutoff of 2.5. Discrimination force by Wilks’Lambda statistical test was statistically significant (P <0.001). Using Z_on judgment male and female each have 1 case of false negative, while using On_Model male 3 cases of false negative, female 8 cases of false negative. After using 1 and 2 EPO with Z_on can all correctly determine, but the use of On_Model have false negative occurred. Conclusion: The new discriminant function Z_on is lower than the first generation discriminant function On_Model for the use of EPO, and has higher discriminant effect than On_Model for short-term injection of EPO.