HBV RNA检测在慢性乙型肝炎中的临床价值

Clinical role of HBV RNA detection in chronic hepatitis B

目的对检测乙型肝炎病毒(HBV)RNA的方法进行评估,比较不同乙型肝炎血清标志物模式患者血清HBV RNA水平及其与HBV DNA之间的相关性。方法对HBV RNA检测方法的精度密、灵敏度及线性范围进行评估。收集81例乙型肝炎表面抗原(HBsAg)阳性慢性乙型肝炎患者的血清,同时检测HBV RNA、HBV DNA及乙型肝炎血清学标志物。按乙型肝炎e抗原(HBeAg)是否阳性、不同乙型肝炎血清标志物模式及是否接受抗病毒药物治疗分别分组。结果HBV RNA高值、低值样本的批内精密度分别为0.56%、2.30%,批间精密度分别为3.13%、6.03%,均符合临床要求;对接近厂商声明的检测下限的样本重复检测20次,检出率为100%,灵敏度符合要求;在HBV RNA 1.0×10^(2)~1.0×10^(7)拷贝/mL范围内成线性。HBeAg阳性组血清HBV RNA和HBV DNA载量均高于HBeAg阴性组(P<0.01、P<0.05)。在不同乙型肝炎血清标志物模式中,HBeAg阳性且乙型肝炎e抗体(HBeAb)阴性患者血清HBV RNA载量最高(P<0.01)。未治疗组血清HBV DNA及HBV RNA载量均高于治疗组(P<0.01、P<0.05)。在81例慢性乙型肝炎患者中,HBV RNA水平与HBV DNA载量、HBeAg阳性滴度呈正相关(r值分别为0.348、0.544,P<0.05),与HBsAg滴度无相关性(r=0.04,P>0.05)。在HBeAg阳性的慢性乙型肝炎患者中,血清HBV RNA载量与血清HBV DNA载量呈正相关(r=0.338,P<0.05)。在HBeAg阴性的慢性乙型肝炎患者中,血清HBV RNA载量与血清HBV DNA载量无相关性(r=0.14,P>0.05)。结论血清HBV RNA是一种潜在的反映HBV活动的新型标志物,亦可用于HBV感染疗效监测。

Objective To evaluate the performance of a method for the detection of hepatitis B virus(HBV)RNA,to compare serum HBV RNA levels in patients with different results of serological markers of HBV infection,and to evaluate the relationship between HBV RNA and HBV DNA.Methods The performance of the method for HBV RNA detection was evaluated,which included precision,sensitivity and linearity.The sera of 81 patients with hepatitis B surface antigen(HBsAg)-positive chronic hepatitis B were collected,and the levels of HBV RNA,HBV DNA and serological markers were detected simultaneously.The patients were classified according to the different results of hepatitis B e antigen(HBeAg),serological markers of HBV infection and medication.Results The intra-assay precisions of high and low HBV RNA values were 0.56%and 2.30%,and the inter-assay precisions were 3.13%and 6.03%,respectively,which all met the clinical requirements.The sensitivity of the assay was achieved by repeating the assay 20 times for samples close to the lower limit of detection stated by the manufacturer,and the detection rate was 100%,which met the clinical requirement.It was linear in the range of HBV RNA 1.0×10^(2)-1.0×10^(7) copies/mL.Serum HBV RNA and HBV DNA loads in HBeAg-positive group were higher than those in HBeAg-negative group(P<0.01,P<0.05),and the HBeAg-positive and hepatitis B e antibody(HBeAb)-negative group had the highest HBV RNA loads among all the groups with different results of serological markers of HBV infection(P<0.01).Serum HBV DNA and HBV RNA loads were higher in untreated group than those in treated group(P<0.01,P<0.05).In 81 patients with chronic hepatitis B,HBV RNA loads were positively correlated with HBV DNA load and HBeAg positive titer(r=0.348 and 0.544,respectively,P<0.05)and without HBsAg titer(r=0.04,P>0.05).In HBeAg-positive patients with chronic hepatitis B,serum HBV RNA loads were positively correlated with serum HBV DNA load(r=0.338,P<0.05).In HBeAg-negative patients with chronic hepatitis B,serum HBV RNA levels did not correlate with serum HBV DNA load(r=0.14,P>0.05).Conclusions Serum HBV RNA level is a potential new marker for monitoring the viral activity and therapeutic efficacy of HBV infection.