苦参素治疗慢性乙型肝炎的临床研究

目的探讨苦参素治疗慢性乙型肝炎的疗效,寻找治疗慢性乙型肝炎的有效方法. 方法采用多中心的开放、对照研究,治疗分4组,分别为苦参素、苦参素联合单磷酸阿糖腺苷、干扰素α1b及葡萄糖组,共治疗慢性乙型肝炎患者196例,观察ALT、AST 及病毒标志物的变化. 结果治疗结束时,苦参素组、苦参素与单磷酸阿糖腺苷联合治疗组及干扰素组的HBV DNA、HBeAg阴转率、抗-HBe的阳转率及ALT的复常率均较葡萄糖组高,4组HBV DNA的阴转率分别为42.3%、55.8%、40.7%和2.1%(P＜0.01),HBeAg阴转率分别为36.5%、39.5%、38.9%和10.6%(P＜0.05);抗-HBe的阳转率分别为25%、30.2%、25.9%和6.4%(P＜0.05).ALT的复常率分别为36.5%、41.9%、27.8%和8.5%(P＜0.05).随访12个月,HBV DNA和HBeAg的阴转率及抗-HBe的阳转率在苦参素组、联合治疗组和干扰素组差异无显著性(P＞0.05).总有效率分别为40.8%、60.8%和43.1%. 结论苦参素或苦参素联合单磷酸阿糖腺苷治疗慢性乙型肝炎有较好的HBV DNA及HBeAg阴转率和抗-HBe的阳转率,其远期抗病毒疗效与干扰素相似.

A clinical research on oxymatrine for the treatment of chronic hepatitis B

OBJECTIVE: To investigate the clinical effect of oxymatrine on chronic viral hepatitis B and to look for new methods for treating hepatitis B. METHODS: Multi-center, controlled study was used. In this study, 196 patients were allocated to oxymatrine, oxymatrine with Ara-AMP, IFN-a1b, and glucose groups to observe ALT, AST and viral marker changes. RESULTS: At the end of treatment, the rate of normal ALT, the negative rate of HBV DNA and HBeAg, and the positive rate of HBeAb were similar in oxymatrine, oxymatrine with Ara-AMP, and IFN-a1b groups. It was higher than that of glucose group. After 12 months follow up, the total effective rate is 40.8%, 60.8% and 43.1% in oxymatrine, oxymatrine with Ara-AMP, and IFN-a1b groups, respectively. CONCLUSIONS: Oxymatrine, oxymatrine with Ara-AMP, and IFN-a1b are effective to treat hepatitis B with a good negative rate of HBV DNA and HBeAg and positive rate of HBeAb.