益气活血解毒汤治疗ALT小于2倍正常值慢性乙型肝炎的临床研究

Clinical Trail of Decoction of Tonifying Qi Activating Blood and Detoxifcation in the Treatment of Chronic Hepatitis B Patients with Alanine Aminotransferase Less than Two-time upper Limits of Normal Level

目的:探讨益气活血解毒汤治疗丙氨酸氨基转移酶(ALT)小于2倍正常值上限(ULN)的慢性乙型肝炎(CHB)患者的有效性和安全性。方法:100例ALT<2×ULN的CHB患者随机分为两组。治疗组予中药益气活血解毒汤联合拉米夫定治疗,对照组予单用拉米夫定。疗程12周,共服2个疗程。观察两组治疗前后肝功能、HBV DNA、病毒耐药突变率、肝纤维化等指标变化。结果:治疗组ALT复常率、HBV DNA水平的改善均优于对照组(P<0.01),但HBV DNA阴转率、病毒耐药突变率的疗效没有统计学意义(P>0.05),肝纤维化的指标包括血清透明质酸、层黏蛋白、Ⅲ型前胶原和Ⅳ型胶原的改善程度优于对照组(P<0.01)。结论:益气活血解毒汤联合拉米夫定治疗ALT<2×ULN的CHB疗效优于单用拉米夫定。

Objective：To evaluate the efficacy and safety of decoction of tonifying qi, activating blood and detoxifcation in the treatment of hepatic histology in patients with chronic hepatitis B virus（HBV） infection whose alanine aminotrans- ferase（ALT） level is lower than two - time upper limits of normal level（ULN）. Methods ： A total of 100 patients with CHB with ALT 〈 2 × ULN were randomly divided into 2 groups. The treatment group was treated with decoction of tonifying qi, activating blood and detoxifcation combined with lamivudine, the control group was treated with lamivudine only. The treatment lasted for 24 weeks for each group. Outcome measurements included liver function test, HBV DNA, virus resist- ance mutation rate, hepatic fibrosis indicators were measured before and after the treatment respectively. Results ： The treatment group was more effective on ALT recovery rate and HBV DNA level than the control group（P 〈 0.01 ）, however it doesn＇t have statistical significance in HBV DNA conversion rate, virus resistance and mutation rate between the two groups（P 〉 0.05 ）. The treatment group provided more improvement with hepatic fibrosis indicators including hyalur- onate, laminin, procollagen type Ⅲ and collagen type Ⅳ than the control group（ P 〈 0.01 ）. Conclusion ： Decoction of toni- fying qi ,activating blood and detoxifcation combined with lamivudine provided more effective effect in CHB patients with ALT 〈 2 × ULN than lamivudine only.