COBAS TaqMan系统检测血清HBV-DNA的临床价值探讨

Clinical value of COBAS TaqMan system in detection of serum HBV-DNA

目的探讨Roche公司COBAS AmpliPrep/COBAS TaqMan 48系统检测慢性乙型肝炎病毒(HBV)感染患者血清HBV-DNA的临床价值。方法收集2013年12月-2015年10月医院肝病科就诊的458例慢性HBV感染患者,包括慢性乙型肝炎(CHB)患者299例和终末期肝病[失代偿期肝硬化(LC)、肝癌(HCC)、慢加急性肝衰竭(ACLF)]患者159例,所有患者采用Roche公司COBAS AmpliPrep/COBAS TaqMan48系统检测血清HBV-DNA,同时检测血清乙型肝炎三系和肝脏生化指标,比较不同病情慢性HBV感染患者各指标的差异。结果不同病情慢性HBV感染患者的年龄、血清HBV-DNA载量和阳性率、血清HBeAg滴度和阳性率、血清ALT水平的总体差异均有统计学意义(P<0.05),其中LC组血清HBV-DNA载量显著低于CHB和ACLF组,而HCC组和ACLF组HBV-DNA阳性率显著高于CHB组和LC组;CHB组病毒复制状态以HBV-DNA>1 000IU/ml为主(40.80%),LC组病毒复制状态以HBV-DNA<20IU/ml为主(37.64%),HCC组病毒复制状态以HBV-DNA 20~1 000IU/ml为主(43.18%),ACLF组病毒复制状态以HBV-DNA>1 000IU/ml为主(50.00%);终末期肝病组(包括LC、HCC、ACLF)低病毒复制状态的比例均高于CHB组(P<0.05);从HBeAg阳性到HBeAb阳性,HBV-DNA载量逐渐降低;但仍有超过50%HBeAg阴性患者其血清HBV-DNA为阳性。结论 COBAS Taqman系统检测血清HBV-DNA可以有效地发现慢性HBV感染患者低病毒复制状态,特别是为终末期肝病患者的抗病毒治疗提供理论依据。

OBJECTIVE To explore the clinical value of COBAS AmpliPrep/COBAS TaqMan 48 system of Roche company in detection of serum HBV-DNA of patients with chronic hepatitis B virus （HBV） infection. METHODS A total of 458 patients with chronic HBV infection who were treated in department of hepat01ogy of the hospital from Dec 2013 to Oct 2015 were enrolled in the study, including 229 cases of chronic hepatitis B and 159 cases of end-stage liver diseases [decompensated liver cirrhosis （LC）, hepatocellular carcinoma （HCC）, acute-on-chronic liver failure （ACLF）]. The serum HBV-DNA was detected for all of the patients by using COBAS AmpliPrep/ COBAS TaqMan48 system of Roche company, meanwhile, the serum hepatitis B markers and liver biochemical indexes were detected, and the above indexes were observed and compared among the patients with different condi- tions of chronic HBV infection. RESULTS There was significant difference in the age, load or positive rate of serum HBV-DNA, titer or positive rate of serum HBeAg, or serum ALT level among the patients with different conditions of chronic HBV infection （P〈0.05） ; the serum HBV-DNA load of the LC group was significantly lower than that of the CHB group and ACLF group, however, the positive rate of HBV-DNA was significantly higher in the HCC group and ACLF group than in the CHB group and LC group. The virus replication state of the CHB group was dominated by more than 1 000 IU/ml of HBV-DNA （40.80%）, the virus replication state of the LC group was dominated by less than 20 IU/ml of HBV-DNA （37. 64%）, the virus replication state of the HCC group was dominated by the HBV-DNA ranging between 20 ～ 1 000 IU/ml （43.18%）, and the virus replication state of the ACLF group was dominated by more than 1 000 IU/ml of HBV-DNA （50.00%） ; the proportion of the patients with low state of virus replication was higher in the end-stage liver diseases group （including LC, HCC, ACLF） than in the CHB group （P^0.05）. From HBeAg-positive to HBeAb-positive, the HBV-DNA load was gradually decreased, however, more than 50% HBeAg-negative patients showed positive for serum HBV- DNA. CONCLUSION The use of COBAS Taqman system for detection of serum HBV-DNA may facilitate the understanding of the low state of virus replication of the patients with chronic HBV infection, which, in particularly, provides theoretical basis for antiviral treatment of the patients with end-stage liver diseases.