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目的:前瞻性评估添加乙肝疫苗对恩替卡韦单药治疗HBeAg阳性慢性乙肝疗效的影响。方法:HBeAg阳性慢性乙型肝炎患者予恩替卡韦(0.5mg qd)初始治疗,12周加用乙肝疫苗(20ug q4w)治疗(B组)或继续恩替卡韦单药治疗(A组)至48周治疗结束。所有患者继续予恩替卡韦单药治疗随访至96周。观察治疗及随访过程中ALT、HBsAg、HBeAg、HBV DNA的变化,96周时HBeAg消失、HBV DNA阴转HBsAg<1000IU/ml为疗效判断终点事件。结果:B组(10例)中,9名患者HBsAg水平下降。在这9例中,有8例在治疗12周时HBsAg>1 000IU/ml,2例获得终点事件,其12~24周HBsAg中位值下降超过1log10IU/ml;另1例在治疗12周时HBsAg已小于1000IU/ml,也获得了终点事件;A组(14例)无一例获得终点事件。B组中获得终点事件患者(3例),治疗24周时HBsAg中位水平为255.00(240.00~275.00)IU/ml,而未获终点事件患者(7例)中位水平为2170(1578.31~13555.00)IU/ml,两者差异有统计学意义(P<0.05)。结论:恩替卡韦添加乙肝疫苗治疗10例患者有3例获得终点事件,而恩替卡韦单药治疗患者均未获得终点事件。恩替卡韦添加乙肝疫苗治疗方案总体安全性良好。
Objective: To prospectively evaluate the effect of adding hepatitis B vaccine on the efficacy of entecavir monotherapy in the treatment of HBeAg-positive chronic hepatitis B patients. Methods: Patients with HBeAg-positive chronic hepatitis B were initially treated with entecavir (0.5 mg qd) and treated with hepatitis B vaccine (20 μg q4w) for 12 weeks (group B) or entecavir monotherapy (group A) until 48 weeks. All patients were treated with entecavir monotherapy for up to 96 weeks. The changes of ALT, HBsAg, HBeAg and HBV DNA during treatment and follow-up were observed. The HBeAg disappeared at 96 weeks and HBsAg <1000 IU / ml was negative for HBV DNA. Results: In Group B (10 cases), 9 patients had decreased HBsAg levels. Of the 9 patients, 8 had HBsAg> 1000 IU / ml at 12 weeks of treatment and 2 had an end point event, with a median HBsAg decline of more than 1 log 10 IU / ml at 12 to 24 weeks; another, 12 weeks after treatment HBsAg has been less than 1000IU / ml, also obtained the end point; A group (14 cases) did not receive any endpoint event. Patients in group B had a median of 255.00 (240.00-275.00) IU / ml at 24 weeks of treatment and a median of 2170 (1578.31-13555.00) in patients without endpoints (n = 7) ) IU / ml, the difference was statistically significant (P <0.05). CONCLUSIONS: Endpoint events were obtained in 3 of 10 patients treated with entecavir plus hepatitis B vaccine, and none of patients entecavir monotherapy achieved an end point. Entecavir add hepatitis B vaccine treatment overall safety is good.