参芪复肝颗粒对拉米夫定抗乙肝病毒增效作用的临床研究

Clinical Study on Synergistic Action of Shenqi Fugan Granules on Lamivudine Counteracting Hepatitis B Virus

目的:观察参芪复肝颗粒对拉米夫定抗乙肝病毒(HBV)的增效作用,及其对拉米夫定诱导HBV发生酪氨酸-蛋氨酸-天冬氨酸-天冬氨酸(YMDD)变异的影响。方法:将肝郁脾虚型中度慢性乙型肝炎患者100例随机分成2组,在治疗过程中治疗组脱落2例,对照组脱落1例,对照组34例采用拉米夫定片、甘草酸二铵注射液、门冬氨酸钾镁针等治疗;治疗组63例在对照组治疗基础上采用参芪复肝颗粒治疗。观察2组患者治疗前后肝功能[血清谷丙转氨酶(ALT)]、乙肝病毒的脱氧核糖核酸(HBV-DNA)、乙肝病毒e抗原(HBeAg)、乙肝表面抗原(HBsAg)、HBeAb、YMDD变异等的变化。结果:HBV-DNA疗效总有效率治疗组为93.65%,对照组为76.47%。2组比较,差异有显著性意义(P<0.05)。2组HBsAg阴转率、HBeAg阴转率、抗HBe阳转率比较,差异均无显著性意义(P>0.05)。2组治疗12月YMDD变异情况比较,差异无显著性意义(P>0.05);2组治疗18月时比较,差异有显著性意义(P<0.05)。2组患者ALT复常情况治疗6月、12月时分别比较,差异均无显著性意义(P>0.05);治疗18月时比较,差异有显著性意义(P<0.05)。脱落率治疗组为3.08%,对照组为2.86%,2组比较,差异无显著性意义(P>0.05)。结论:参芪复肝颗粒可增强拉米夫定抗HBV疗效,提高肝郁脾虚型中度慢性乙型肝炎患者HBV-DNA阴转率及有效抑制率,降低YMDD变异率,改善肝郁脾虚型中度慢性乙型肝炎患者的血清肝功能指标(ALT),具有护肝作用。

Objective:To observe the synergistic action of Shenqi Fugan Granules(SFG) on lamivudine counteracting hepatitis B virus(HBV),and the effect of SFG on tyrosine-methionine-aspartate-aspartate(YMDD) genovariation induced by lamivudine.Methods:One hundred moderate chronic hepatitis B patients with liver stagnation and spleen deficiency were randomized 2 groups:the control group(N = 35) received lamivudine,and the treatment group(N = 65) received lamivudine combined with SFG.During the treatment,2 patients in the treatment group and one in the control group dropped out.Before and after treatment,hepatic function parameter of serum alanine aminotransferase(ALT),DNA of hepatitis B virus(HBV-DNA),e antigen of HBV(HBeAg),HBV surface antigen(HBsAg),anti-HBe and YMDD mutation were observed.Results:The total effective rate for HBV-DNA was 93.65% in the treatment group and 76.47% in the control group,the difference being significant(P < 0.05).The differences of rate for HBsAg turning negative,rate for HBeAg turning negative and rate for anti-HBe becoming positive were insignificant between the two groups(P > 0.05).So did the YMDD mutation after treatment for 12 months(P > 0.05).However,after treatment for 18 months,the difference of YMDD mutation was significant(P < 0.05).The difference of ALT becoming normal was insignificant between the two groups after treatment for 6 and 12 months(P > 0.05),while was significant after treatment for 18 months(P < 0.05).The drop out rate was 3.03% in the treatment group and 2.86% in the control group(P > 0.05).Conclusion:SFG can enhance the therapeutic effect of lamivudine for HBV and protect hepatic function by increasing rate for HBV-DNA turning negative,decreasing YMDD mutation rate and improving serum ALT level in moderate chronic hepatitis B patients with liver stagnation and spleen deficiency.