Objective To investigate the dynamic changes of quantitative hepatitis B surface antigen concentration in predicting virologic response to entecavir (ETV) therapy in patients with HBeAg-positive chronic hepatitis B (CHB). Methods Seventy-eight treatment-naive patients with HBeAg-positive CHB receiving ETV (0.5 mg/daily) were recruited and followed up for 1 year from January 2011 to January 2012. Serum samples were collected at baseline and every 3 months after ETV treatment. Serum HBsAg and HBeAg concentrations were quantitatively determined by chemiluminescence assay and serum HBV DNA levels were determined by real-time polymerase chain reaction. The correlation of HBsAg and HBV DNA level was analyzed by Pearson correlation analysis. The receiver operating characteristic curve (ROC) was used to predicted HBV virologic response and determine the optimal threshold. Results Sixty-nine(88.5%)patients achieved virologic response(VR),while 9 did not;there was no significant difference for baseline levels of serum ALT in patients with VR [(141.8±27.2)IU/ml] and without [(136.2±29.7)IU/ml,t=0.27,P=0.793];serum HBV DNA levels in patients with VR [(6.7±1.0)lg IU/ml] was significantly lower than that in patients without [(7.6 ±0.8)lg IU/ml,t =-2.27,P =0.033];there was no significant difference in HBsAg concentration between patients with VR and without [(3.8±0.6) lg IU/ml vs.(4.0± 0.4)lg IU/ml,t=-1.75,P=0.094]. HBsAg and HBV DNA levels were positively correlated(r=0.45,P=0.02). there was a rapid decline in HBsAg concentration during the first 3 months of therapy,followed by a much slower decline in the subsequent periods;from the baseline to month 3,the reduction of HBsAg concentration in patients with VR was faster than in patients without [(0.3±0.2)lg IU/ml vs.(0.2±0.1)lg IU/ml,t=2.245,P=0.035]. The lg HBsAg concentration at month 3 showed the biggest area under the curve (AUC)(AUC=0.840,P=0.005), and the max Youden index (0.602) was appeared at the cut -off value of 3.85 lg IU/ml,with a diagnostic sensitivity and specificity of 84.2% and 78.7% ,respectively. Conclusions lg HBsAg ≤3.85 lg IU/ml after 3 months of ETV treatment can be used as an indicator to predict the virologic response of patients with CHB 1-year after ETV treatment.%目的：探讨 HBeAg 阳性慢性乙型肝炎（CHB）患者血清 HBsAg 滴度的动态变化对恩替卡韦（ETV）治疗反应的预测价值。方法选择2011年1月～2012年1月在我肝病中心住院及门诊接受 ETV（0.5mg/d）治疗的HBeAg 阳性 CHB 患者78例，随访1年。于抗病毒治疗的0、3、6、9和12 m 分别收集患者血清，采用化学发光法定量检测各时间点的 HBsAg 和 HBeAg 滴度；采用实时荧光定量 PCR 法检测血清 HBV DNA 载量；采用 Pearson 相关分析分析 HBsAg 与 HBV DNA 水平相关性，采用受试者工作特征曲线（ROC）预测患者的病毒学应答和确定最佳临界值。结果在78例患者中，69例（88.5%）患者发生病毒学应答（VR），9例未发生病毒学应答；VR 组患者基线 ALT水平[（141.8±27.2）IU/ml]与未发生 VR 患者[（136.2±29.7）IU/ml]比，无统计学意义（t＝0.27，P＝0.793）；HBV DNA [（6.7±1.0）lg IU/ml]明显低于未发生 VR 患者[（7.6±0.8）lg IU/ml，t＝-2.27，P＝0.033]；HBsAg 滴度与未发生 VR患者比，无统计学意义[（3.8±0.6）lg IU/ml 对(4.0±0.4） lg IU/ml，t＝-1.75，P＝0.094）]；HBsAg 与 HBV DNA 水平呈正相关（r＝0.45，P＝0.02）；HBsAg 在治疗开始的前3个月下降较快，3个月后下降较缓慢，从基线到治疗3个月时， VR 组患者较未发生 VR 患者 HBsAg 下降更快[（0.3±0.2） lg IU/ml 对（0.2±0.1） lg IU/ml，t＝2.245，P＝0.035）]；在治疗3个月时，lg HBsAg 滴度的 ROC 曲线下面积最大（AUC＝0.840，P＝0.005），临界值为3.85 lg IU/ml 的 Youden 指数最大（0.602），其诊断敏感度为84.2%，特异度为78.7%。结论 ETV 治疗3个月时 lg HBsAg≤3.85 lg IU/ml 可作为预测 ETV 治疗1年发生病毒学应答的指标。
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