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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 effect of Shenqi Fugan Granules on lamivudine against hepatitis B virus (HBV) and its effect on lamivudine-induced hepatitis B virus tyrosine-methionine-aspartate-aspartate YMDD) variation. Methods: One hundred patients with moderate chronic hepatitis B with liver depression and spleen deficiency syndrome were randomly divided into two groups. In the treatment course, the treatment group was shed in 2 cases, the control group was shed in 1 case, the control group was treated with lamivudine tablets, glycyrrhizin Diammonium injection, potassium magnesium needle aspartate treatment; the treatment group of 63 cases in the control group based on the treatment of Shenqi Fugan particles. The changes of liver function (serum alanine aminotransferase (ALT), hepatitis B virus DNA, HBeAg, HBsAg, HBeAb, YMDD mutation, etc.) before and after treatment in two groups were observed The change. Results: The total effective rate of HBV-DNA treatment group was 93.65% in the control group and 76.47% in the control group. The difference between the two groups was significant (P <0.05). There was no significant difference in the HBsAg negative rate, HBeAg negative rate and anti-HBe positive rate in the two groups (P> 0.05). There was no significant difference in the YMDD mutation between the two groups in December (P> 0.05). There was significant difference between the two groups in 18 months of treatment (P <0.05). There was no significant difference between the two groups in the treatment of ALT at 6 months and 12 months (P> 0.05). The difference was significant at 18 months (P <0.05). The rate of exfoliation was 3.08% in the treatment group and 2.86% in the control group. There was no significant difference between the two groups (P> 0.05). Conclusion: Shenqi Fugan Granule can enhance the anti-HBV efficacy of lamivudine and improve the negative conversion rate of HBV-DNA and the effective inhibition rate of moderate chronic hepatitis B patients with liver-qi stagnation syndrome, reduce the mutation rate of YMDD, Moderate chronic hepatitis B patients with serum liver function index (ALT), with liver protection.