拉米夫定与α干扰素联合治疗慢性乙型肝炎

Therapy effect of lamivudine combination with alpha interferon on patients with chronic hepatitis B

目的 观察拉米夫定(LAM)联合干扰素α1b(IFN α1b)治疗慢性乙型肝炎的近期疗效和安全性。 方法 HBV DNA和HBeAg均阳性的90例慢性乙型肝炎患者,按1:1:1的比例进入三个不同的治疗组。联合治疗组:用IFN α1b 5 MU,隔日肌肉注射,及口服LAM 100 mg/d,共6个月,随后单用口服LAM100mg/d 6个月;LAM组:口服LAM 100 mg/d共12月;IFN组:IFN α1b 5 MU,隔日肌肉注射,共6个月。 结果 治疗结束时,HBV DNA转阴率,联合治疗组为90.0％,LAM组为80％,IFN组为46.7％。丙氨酸氨基转移酶(ALT)复常率,联合治疗组为90.0％,,LAM组为80.0％,IFN组为53.3％。HBeAg/抗HBe血清转换率,联合治疗组为46.7％,LAM组为13.3％,IFN组为33.3％。联合治疗组患者治疗结束时无一例检测到YMDD变异。结论 联合治疗组对HBV DNA抑制作用及ALT复常率高于单用干扰素组,与单用拉米夫定组接近。HBeAg/抗HBe血清转换率高于拉米夫定组,与单用干扰素组相近。初步显示联合治疗组发生YMDD变异较少。

Objective To evaluate the short-term therapeutic efficacy and safety of lamivudine (LAM) combining with alpha interferon (IFNaaaaa) on patients with chronic hepatitis B. Methods 90 chronic hepatitis B patients with HBV DNA and HBeAg positive were subdivided by 1:1: 1 proportion into three groups: (1) LAM+IFN group: 6 months therapy of IFNaaaaaa plus lamivudine followed by 6 months of lamivudine; (2) LAM group : lamivudine alone for 12 months; (3)IFN group: IFNaaaaaaaaaa alone for 6 months. Results At the end of treatment, the HBV DNA undetectable rate in LAM+IFN group (90.0%) was much higher than that in LAM group (80.0%) and IFN group (46.7%) (x2= 13.017, P < 0.001). ALT normalization occurred 90.0%, 80.0%, and 53.3% in LAM+IFN group, LAM group, and IFN group, respectively ( x2 = 9.932, P = 0.002). HBeAg/anti-HBe seroconversion rates achieved 46.7%, 13.3%, and 33.3% in LAM+IFN group, LAM group, and IFN group, respectively ( x2= 7.937, P = 0.005). YMDD mutation was not detected in serum samples from LAM+IFN group patients. Conclusions LAM+IFN therapy for chronic hepatitis B is tolerated and more effective than IFN monotherapy in inhibiting viral replication and getting ALT normalization. The HBeAg/anti-HBe seroconversion rate with LAM+IFN therapy is higher than that with lamivudine monotherapy. LAM+IFN combination therapy seems to inhibit or postpone YMDD variants appearing in patients with chronic hepatitis B.