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目的通过对恩替卡韦(entecavir,ETV)分散片单药治疗,与拉米夫定(lamivudine,LAM)加用阿德福韦酯(adefovir,ADV)挽救治疗HBe Ag阳性慢性乙型肝炎(chronic hepatitis B,CHB)患者的回顾性分析,比较两种方案的疗效。方法选取2008年1月—2016年1月的158例HBe Ag阳性CHB患者,其中使用单药ETV分散片治疗4年以上的患者80例为A组,初始使用LAM并产生耐药,而加用ADV治疗4年以上患者78例为B组。比较两组治疗24周(T1)、48周(T2)、96周(T3)、144周(T4)、192周(T5)5个时段内HBV-DNA转阴率、HBe Ag血清转换率、丙氨酸转氨酶(alanine aminotransferase,ALT)复常率等指标,分析病毒学突破及病毒耐药发生差异。结果两组患者HBV-DNA转阴率在T1~T5时段内,差异均无统计学意义(P>0.05);各组内比较,T2~T5各时段均较T1提升,差异均有统计学意义(P<0.05)。两组患者ALT复常率在T1~T3各时段内比较差异均无统计学意义(P>0.05),T4~T5时段内差异均有统计学意义(P<0.05)。A组HBe Ag血清转换率各时段均高于B组,差异有统计学意义(P<0.05)。T2~T5时段,两组ALT复常率及HBe Ag血清转换率自身前后比较,均较T1时提升,差异均有统计学意义(P<0.05)。同时,治疗过程中A组未见病毒学突破及病毒耐药发生,B组累计发生病毒学突破2例(2.6%)。结论 ETV分散片持续长期抑制乙肝病毒复制,减轻肝细胞炎性坏死,促进HBe Ag血清学转换能力较强,优于LAM加用ADV挽救治疗组。
OBJECTIVE: To treat HBeAg-positive chronic hepatitis B patients by entecavir (ETV) dispersible tablets monotherapy and with lamivudine (LAM) plus adefovir (ADV) , CHB) patients with a retrospective analysis of the efficacy of the two programs. Methods A total of 158 HBeAg-positive CHB patients from January 2008 to January 2016 were enrolled. Among them, 80 patients treated with ETV dispersible tablets for more than 4 years were Group A, initially using LAM and producing drug resistance, 78 patients with ADV over 4 years were in group B. HBV-DNA negative rate, HBeAg seroconversion rate, tumor necrosis factor-α (HBV-DNA) negative rate were compared between the two groups at 5 weeks after 24 weeks (T1), 48 weeks (T2), 96 weeks (T3), 144 weeks (T4) Alanine aminotransferase (alanine aminotransferase, ALT normalization rate and other indicators, analysis of virological breakthroughs and differences in virus resistance. Results There was no significant difference in the negative rate of HBV-DNA between the two groups in T1 ~ T5 (P> 0.05). Within each group, the levels of HBV-DNA in T2 ~ T5 were significantly higher than those in T1 (P <0.05). There was no significant difference in the normalization rate of ALT between T1 ~ T3 in both groups (P> 0.05). There was significant difference between T4 and T5 (P <0.05). The serum HBeAg seroconversion rate in group A was higher than that in group B at each time point, the difference was statistically significant (P <0.05). From T2 to T5, the normalization rate of ALT and the rate of HBeAg seroconversion in both groups were higher than those before T1 (P <0.05). At the same time, there was no virological breakthrough and viral resistance in group A in the course of treatment, and 2 cases (2.6%) of virological breakthrough occurred in group B. Conclusion ETV dispersible tablets sustained long-term inhibition of hepatitis B virus replication, reduce the inflammatory necrosis of hepatocytes and promote HBeAg seroconversion stronger than LAM plus ADV rescue treatment group.