Background

Clinical importance of commercially available quantitative HBV markers has not been fully investigated.

Objective

To choice and to evaluate clinically valuable HBV markers for predicting phases of natural history with chronic HBV infection.

Methods

472 naïve patients with chronic HBV infection were enrolled, in which 21 and 220 were confirmed as HBeAg-positive inactive and active hepatitis (EPIH and EPAH), respectively, and 106 and 125 were confirmed as HBeAg-negative inactive and active hepatitis (ENIH and ENAH), respectively. HBsAg, HBcrAg and anti- HBc were measured using chemiluminescent immunoassay, and HBV DNA was measured using PCR-fluorescence probing assay.

Results

There were all statistical differences in medians of HBsAg, anti-HBc, HBcrAg and HBV DNA between EPIH and EPAH and between ENIH and ENAH (all P < 0.01). According to binary logistic stepwise regressions, HBsAg and anti-HBc were preferred variables for predicting EPAH, and HBcrAg and HBV DNA were preferred variables for predicting ENAH. Based on normalization for coefficients of preferred variables entering regression equations, a handy model of MEPAH for predicting EPAH and of MENAH for predicting ENAH was constructed, respectively. Area under receiver operating characteristic curves of MEPAH and MENAH for predicting EPAH and ENAH were 0.882 and 0.931, respectively. With standard of MEPAH ≤ 5.997 and MENAH > 10.535, sensitivity or specificity of which for predicting EPAH and ENAH were about 81.0 % and 87.0 %, respectively.

Conclusion

HBsAg and anti-HBc for predicting EPAH and HBcrAg and HBV DNA for predicting ENAH are dependable markers; MEPAH for predicting EPAH and MENAH for predicting ENAH have very good performance.

中文翻译：

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定量血清 HBV 标志物预测慢性 HBV 感染自然史阶段

背景

商业上可获得的定量 HBV 标志物的临床重要性尚未得到充分研究。

客观的

选择和评估具有临床价值的 HBV 标志物，用于预测慢性 HBV 感染的自然史阶段。

方法

入组 472 例初治慢性 HBV 感染患者，其中 HBeAg 阳性非活动性和活动性肝炎（EPIH 和 EPAH）分别为 21 和 220 人，HBeAg 阴性非活动性和活动性肝炎（ENIH 和ENAH），分别。使用化学发光免疫测定法测量 HBsAg、HBcrAg 和抗 HBc，使用 PCR-荧光探测法测量 HBV DNA。

结果

EPIH与EPAH之间以及ENIH与ENAH之间的HBsAg、anti-HBc、HBcrAg和HBV DNA中位数均存在统计学差异（均P < 0.01）。根据二元逻辑逐步回归，HBsAg 和抗-HBc 是预测 EPAH 的首选变量，而 HBcrAg 和 HBV DNA 是预测 ENAH 的首选变量。基于对进入回归方程的首选变量的系数进行归一化，分别构建了一个方便的用于预测 EPAH 的 MEPAH 模型和用于预测 ENAH 的 MENAH 模型。用于预测 EPAH 和 ENAH 的 MEPAH 和 MENAH 受试者工作特征曲线下面积分别为 0.882 和 0.931。以 MEPAH ≤ 5.997 和 MENAH > 10.535 为标准，预测 EPAH 和 ENAH 的敏感性或特异性分别约为 81.0 % 和 87.0 %。

结论

HBsAg 和 anti-HBc 预测 EPAH 和 HBcrAg 和 HBV DNA 预测 ENAH 是可靠的标志物；用于预测 EPAH 的 MEPAH 和用于预测 ENAH 的 MENAH 具有非常好的性能。