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目的观察国产恩替卡韦(ETV)对HBeAg阴性与HBeAg阳性慢性乙型肝炎(CHB)和肝硬化感染患者的临床治疗效果。方法 97例慢性HBV感染患者,依据血清HBeAg检测结果分为HBeAg阴性组与HBeAg阳性组;根据病情程度分为CHB组与肝硬化组。给予ETV 0.5mg,1次/天(口服),研究周期共48周。观察指标:基线及治疗4、12、24、48周时血清HBV-DNA水平、ALT和TBIL变化。结果 ETV治疗前,HBeAg阴性组与HBeAg阳性组、慢乙肝组与肝硬化组,基线水平检测指标差异均无统计学意义(P>0.05)。ETV治疗4周时HBeAg阴性组与HBeAg阳性组的HBV-DNA完全抑制率分别是28%、8%,差异有统计学意义(P<0.05)。12、24、48周时HBeAg阴性组与HBeAg阳性组HBV-DNA完全抑制率分别是68%、85%、91%与56%、76%、84%,差异均无统计学意义(P>0.05)。ETV治疗4周时HBeAg阴性组HBV-DNA水平下降对数值(1.91±1.00lgIU/ml)高于HBeAg阳性组(1.07±0.78lgIU/ml),差异有统计学意义(P<0.05)。结论国产恩替卡韦对初治HBeAg阴性慢乙肝患者的早期病毒应答率优于HBeAg阳性慢乙肝患者,长期病毒应答率无统计学差异;对慢性乙肝与肝硬化患者抗病毒疗效没有差异。
Objective To observe the clinical efficacy of domestic entecavir (ETV) in patients with HBeAg-negative and HBeAg-positive chronic hepatitis B (CHB) and cirrhosis. Methods Ninety-seven patients with chronic HBV infection were divided into HBeAg negative group and HBeAg positive group according to the serum HBeAg test results. According to the severity of the disease, they were divided into CHB group and cirrhosis group. ETV 0.5mg, once daily (oral), the study period a total of 48 weeks. OUTCOME MEASURES: Changes of serum HBV-DNA, ALT and TBIL at baseline, 4, 12, 24 and 48 weeks of treatment. Results Before ETV treatment, there was no significant difference in the baseline level between HBeAg negative group and HBeAg positive group, chronic hepatitis B group and cirrhosis group (P> 0.05). The complete inhibition rates of HBV-DNA in HBeAg-negative and HBeAg-positive groups were 28% and 8%, respectively, at 4 weeks after ETV treatment (P <0.05). The complete inhibition rate of HBV-DNA in HBeAg-negative and HBeAg-positive groups was 68%, 85%, 91% and 56%, 76% and 84% at 12, 24 and 48 weeks respectively, with no significant difference (P> 0.05 ). ETV treatment 4 weeks HBeAg-negative group HBV-DNA levels decreased (1.91 ± 1.00lgIU / ml) higher than HBeAg-positive group (1.07 ± 0.78lgIU / ml), the difference was statistically significant (P <0.05). CONCLUSION: The early virus response rate of domestic entecavir to HBeAg-negative chronic hepatitis B patients is better than that of HBeAg positive chronic hepatitis B patients. There is no significant difference in long-term viral response rate between the two groups. There is no difference in anti-virus efficacy between chronic hepatitis B and cirrhosis patients.