氧化苦参碱治疗拉米夫定撤药性肝炎的临床研究

目的探讨氧化苦参碱治疗拉米夫定撤药性肝炎的疗效及安全性。方法将52例诊断为拉米夫定撤药性肝炎的患者随机分为A、B两组,在保肝治疗的基础上,分别给与氧化苦参碱和拉米夫定治疗6个月,观察HBV DNA、HBeAg阴转情况及ALT复常情况,并记录不良事件的发生情况。结果治疗过程中,两组各有1例发展为重型肝炎,其他不良反应轻微;治疗结束时,两组HBVDNA阴转率分别为53.6%和95.8%,差异有非常显著性意义(P<0.001);HBeAg阴转率分别为54.2%和21.0%,差异有显著性意义(P<0.05);ALT复常率分别为71.4%和64.7%,差异无显著性(P>0.05);完全应答、部分应答和无应答率在两组之间差异无统计学意义(32.1%对25.0%、53.6%对62.5%和14.3%对12.5%,P>0.05)。结论氧化苦参碱治疗拉米夫定撤药性肝炎安全有效,可以代替拉米夫定用于拉米夫定撤药性肝炎的治疗。

Clinical study of lamivudine withdrawal hepatitis treated with oxymatrine

Objective To evaluate the efficacy and the safety of oxymatrine in the treatment of lamivudine withdrawal hepatitis. Methods 52 patients with lamivudine withdrawal hepatitis defined as an increasee in ALT>2 times the upper limit of normal (80U/L) at 6 months after withdrawal of lamivudine were randomly allocated into group A and group B. All patients in two groups received the basic protecting liver therapy. The patients in group A also received oxymatrine at 400-600mg/d,im ,and patients in group B received lamivudine 100mg/d,po.The change of serum HBV DNA, HBeAg, alamine aminotransferase and adverse events in two groups were observed and compared. Results In the period of treatment, there was a patient exacerbating to chronic severe hepatitis in every group. Other side effects were mild. In the end of treatment, there was no significant difference in ALT normalization rates between the two groups(71.4% vs.64.7%,P>0.05),HBV DNA sero-negative rate was higher in group B than in group A (95.8% vs. 53.6%,P<0.001),but HBeAg negative rate in group A was higher than in group B(54.2% vs. 21.0%,P<0.05).The rates of complete response,partial response and non-response in the group A were 32.1%,53.6%,14.3% and in the group B were 25.0%,62.5%,12.5%,respectively, and there was no significant difference between the two groups. Conclussions Oxymatrine is an effective and safe agent for the treatment of lamivudine withdrawal hepatitis.