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目的:观察阿德福韦酯(ADV)联合拉米夫定(LAM)挽救治疗LAM耐药慢性乙型肝炎的疗效和安全性。方法:91例LAM耐药的慢性乙型肝炎患者随机分为观察组46例与对照组45例。观察组以ADV 10 mg·d-1+LAM 100 mg·d-1联合治疗48周;对照组采用ADV 10 mg·d-1+LAM 100 mg·d-1联合治疗4周,后单用ADV 10 mg·d-1治疗44周。观察两组患者治疗前后血清HBV DNA载量、乙型肝炎病毒标志物、肝功能及基因型耐药情况。结果:两组治疗24周、48周HBV DNA水平和ALT水平与治疗前比较,差异有统计学意义(P<0.01),观察组治疗12周和24周HBV DNA水平低于对照组(P<0.05),观察组治疗12周、24周、36周和48周HBV DNA转阴率和丙氨酸氨基转移酶(ALT)复常率均明显优于对照组(P<0.05);治疗24周和48周时,观察组血清HBeAg阴转率为26.1%、33.3%,血清HBeAg/抗-HBeAb转换率为8.7%、17.4%,略高于对照组,但差异无统计学意义(P>0.05);观察组基线水平≥105拷贝/ml的患者治疗12周、24周、36周、48周HBV DNA转阴率和ALT复常率明显高于对照组(P<0.05)。两组患者的基因型耐药率分别为0和2.2%(1/45),对照组1例耐药,患者为rtN236T变异。结论:LAM耐药慢性乙型肝炎患者采用ADV和LAM联合治疗有效。
Objective: To observe the efficacy and safety of adefovir dipivoxil (ADV) combined with lamivudine (LAM) in the treatment of LAM resistant chronic hepatitis B patients. Methods: Ninety-one patients with LAM-resistant chronic hepatitis B were randomly divided into observation group (n = 46) and control group (n = 45). The observation group was treated with ADV 10 mg · d-1 and LAM 100 mg · d-1 for 48 weeks. The control group was treated with ADV 10 mg · d-1 and LAM 100 mg · d-1 for 4 weeks. 10 mg · d-1 for 44 weeks. Serum HBV DNA load, hepatitis B virus markers, liver function and genotypic drug resistance were observed before and after treatment in both groups. Results: The levels of HBV DNA and ALT in the two groups after treatment for 24 weeks and 48 weeks were significantly different from those before treatment (P <0.01). The levels of HBV DNA in the observation group at 12 weeks and 24 weeks were lower than those in the control group (P < 0.05). The rates of HBV DNA negative conversion and alanine aminotransferase (ALT) recovery in observation group at 12, 24, 36 and 48 weeks were significantly better than those in control group (P <0.05) At 48 and 48 weeks, the seroconversion rates of HBeAg in the observation group were 26.1% and 33.3%, respectively, and the rates of serum HBeAg / anti-HBeAb conversion were 8.7% and 17.4%, respectively, which were slightly higher than those in the control group ). The negative rate of HBV DNA and the rate of ALT abnormality in the observation group at baseline (≥105 copies / ml) for 12 weeks, 24 weeks, 36 weeks and 48 weeks were significantly higher than those in the control group (P <0.05). Two groups of patients with genotype resistance rates were 0 and 2.2% (1/45), one case of the control group, the patient was rtN236T mutation. Conclusion: The combination of ADV and LAM is effective in patients with LAM-resistant chronic hepatitis B.