[Comparative analysis of hepatitis B virus large protein, hepatitis B virus-DNA and Pre-S1 antigen in evaluating serum hepatitis B virus replication].

Objective: To investigate the comparative study of serum hepatitis B virus (HBV) large protein (HBV-LP) , HBV-DNA, and Pre S1 antigen (Pre S1-Ag) detection in the evaluation of serum HBV replication in patients with chronic hepatitis B. Methods: A total of 482 patients infected with chronic hepatitis B virus (CHB) were enrolled and the serums were collected in a hospital of Hefei city in Anhui province from June 2013 to March 2015. The serum HBV-LP, HBV markers(HBV-M) and Pre S1-Ag were detected using ELISA, and HBV-DNA were quantified using quantitative real-time PCR. The positive detection rate difference of HBV-DNA, HBV-LP and Pre S1-Ag were compared, the correlation between the logarithm of HBV-DNA copies number and the absorbance value of HBV-LP was analyzed using Spearman rank correlation. Results: The positive rates of HBV DNA, HBV-LP, and Pre S1-Ag were 67.22% (324/482), 73.86% (356/482), and 37.34% (180/482), respectively (P<0.01). The positive rates of the three markers were 54.57% (185/339), 64.90% (220/339), and 27.73% (94/339), respectively, in 339 HBeAg-negative CHB patients (P<0.01). In HBeAg negative patients, the positive rate of HBV-LP in 185 cases of HBV-DNA positive samples was 90.81% (168/185), which was higher than that of Pre S1-Ag with rate of 39.46% (73/185) (P<0.01).The positive rate of HBV-LP was 33.77% (52/154) in 154 cases of patients with negative HBV-DNA whose positive rate was higher than Pre S1-Ag with positive rate of 13.64% (21/154)(P<0.01). The positive rates of HBV-DNA, HBV-LP and Pre S1-Ag in HBsAg, HBeAg and HBcAb positive groups were 97.04% (131/135), 94.81% (128/135), and 60.00% (81/135), (P<0.01); The positive rates of three indexes of HBsAg, HBeAb, HBcAb positive group were 53.74% (122/227), 63.88% (145/227), and 27.31% (62/227); The positive rates of three indexes of HBsAg and HBcAb positive group were 55.79% (53/95), 67.37% (64/95), and 28.42% (27/95) (P<0.01). The absorbance value of HBV-LP was positively related with the logarithm of HBV-DNA copies number (Spearman rank correlation coefficient was 0.908, P<0.01). Conclusion: There was a good correlation between HBV-LP and HBV-DNA load value, and could be used as an effective complement for the detection of HBV-DNA and HBV-M. Compared with Pre S1-Ag.目的： 对比分析乙型肝炎病毒外膜大蛋白（HBV-LP）、乙型肝炎病毒DNA（HBV-DNA）和前S1抗原（Pre S1-Ag）评价慢性乙型肝炎（CHB）患者血清中乙型肝炎病毒复制状况的有效性。 方法： 收集2013年6月至2015年3月在合肥某医院就诊的482例CHB患者的血清标本，采用ELISA法检测HBV-LP、乙型肝炎病毒标志物（HBV-M）和Pre S1-Ag；实时荧光定量PCR检测HBV-DNA。比较HBV-DNA、HBV-LP、Pre S1-Ag阳性率的差异，采用Spearman秩相关分析HBV-DNA拷贝数的对数值和HBV-LP的吸光度值相关性。 结果： 482例CHB患者HBV-DNA、HBV-LP和Pre S1-Ag阳性率分别为67.22%（324/482）、73.86%（356/482）和37.34%（180/482）（P<0.01）；339例HBeAg阴性CHB患者的3项指标阳性率分别为54.57%（185/339）、64.90%（220/339）和27.73%（94/339）（P<0.01)。在HBeAg阴性患者中，185例为HBV-DNA阳性，HBV-LP阳性率为90.81%（168/185），高于Pre S1-Ag[39.46%（73/185）] (P<0.01)；154例患者HBV-DNA阴性，其HBV-LP阳性率为33.77%（52/154），也高于Pre S1-Ag的13.64%（21/154）(P<0.01)。HBsAg、HBeAg、HBcAb阳性患者HBV-DNA、HBV-LP、Pre S1-Ag阳性率分别为97.04%（131/135）、94.81%（128/135）和60.00%（81/135）（P<0.01）；HBsAg、HBeAb、HBcAb阳性患者3项指标阳性率分别为53.74%（122/227）、63.88%（145/227）和27.31%（62/227）（P<0.01）；HBsAg、HBcAb阳性患者3项指标的阳性率分别为55.79%（53/95）、67.37%（64/95）和28.42%（27/95）（P<0.01）。HBV-LP的吸光度值随着HBV-DNA拷贝数的对数值增加而呈上升趋势（Spearman秩相关系数=0.908，P<0.01）。 结论： HBV-LP与HBV-DNA载量对数值之间的相关性良好，可作为HBV-DNA和HBV-M检测的有效补充，较Pre S1-Ag更能反映CHB患者的病毒复制状态。.