六味五灵片联合阿德福韦酯治疗HBeAg阴性慢性乙型肝炎

Effect of Liuweiwuling tablet combined with adefovir dipivoxil on HBeAg-negative chronic hepatitis B

目的观察六味五灵片联合阿德福韦酯治疗HBeAg阴性慢性乙型肝炎的临床疗效。方法将75例HBeAg阴性慢性乙型肝炎患者随机分成治疗组40例和对照组35例,均给予阿德福韦酯10mg/d,口服52周。治疗组在阿德福韦酯治疗基础上联合六味五灵片治疗26周,前13周为常规量,后13周为减量治疗期;观察治疗52周时的肝功能指标ALT、AST、TBIL,血清肝纤维化四项指标变化及治疗26周、52周HBV DNA转阴率(血清HBV DNA<500 copies/ml者为阴性)。结果 2组肝功能指标ALT、AST、TBIL水平在治疗52周时与治疗前比较,差异均有统计学意义(P<0.05);且治疗组各项指标在治疗52周与治疗前差值与对照组比较,差异均有显著统计学意义(P<0.001)。2组治疗后肝纤维化指标均较治疗前显著下降(P<0.05)。治疗组治疗前后差值与对照组比较,差异有统计学意义(P<0.05)。治疗26周时,2组患者血清HBV DNA转阴率分别为92.5%与74.3%,差异有统计学意义(P<0.05);治疗52周时,2组患者血清HBV DNA转阴率分别为97.5%与85.7%,差异无统计学意义(P>0.05)。结论六味五灵片联合阿德福韦酯治疗HBeAg阴性慢性乙型肝炎在抗病毒、抗肝纤维化、改善肝功能方面均具有一定的协同作用,且在1年内的疗效持久稳定。

Objective To investigate clinical effect of Liuweiwuling tablet combined with adefovir dipivoxil （ADV） on HBeAg- negative chronic hepatitis B （CHB）. Methods Totally 75 HBeAg-negative CHB patients were randomly assigned into a treatment group （n=40） and a control group （n=35）. Both the groups received ADV 10 mg/d orally for 52 weeks, and the treatment group was treated with Liuweiwuling tablet additionally for 26 weeks, with regular dose in the first 13 weeks and reduced dose in the following 13 weeks. Liver function markers （ALT, AST and TBIL）, 4 serum liver fibrosis indices at week 52 of treatment and proportions of patients with undetectable HBV DNA （〈500 copies/ml） at week 26 and 52 of treatment were observed. Results ALT, AST and TBIL levels of the 2 groups before treatment were significantly different from those at week 52 （P〈0.05）, and the variations of the levels before treatment and at week 52 were significantly different between the 2 groups （P〈0.001）. Liver fibrosis indices of the 2 groups decreased significantly compared with pre-therapy （P〈0.05）, and the variations of the levels before treatment and at week 52 were significantly different between the 2 groups （P〈0.05）. At week 26 of treatment, 92.5% and 74.3% of the patients in the treatment group and the control group had undetectable HBV DNA, and the difference between them was significant （P〈0.05）. At week 52 of treatment, 97.5% in the treatment group and 85.7% in the control group had undetectable HBV DNA, and the difference between them was not significant （P〉0.05）. Conclusions Liuweiwuling tablet combined with ADV has a certain cooperative effect on HBeAg- negative CHB in inhibiting HBV and liver fibrosis, and improving liver function. Moreover, the combination therapy achieves a sustainable and stable therapeutic effect during 1 year.