慢性病毒性肝炎药物治疗新方案研究

Research of Medical Treatment Novel Program on the Chronic Viral Hepatitis B

目的全国多中心对照临床研究,观察博尔泰力(苦参素)注射液治疗慢乙肝的疗效及安全性,联合Ara-amp治疗能否提高疗效,并与干扰素及一般保肝药对照,探讨治疗慢乙肝的安全有效药物及治疗方案。方法:对196例慢乙肝病人分苦参素治疗组,和Ara-amp联合治疗组,干扰素组及保肝药组,观察治疗三个月的疗效及停药后随访半年及一年的远期疗效,并观察其毒副作用。结果:治疗三个月时,苦参素治疗组ALT复常率,HBeAg及HBV DNA阴转率分别为36.5％、36.5及42.3％,停药后半年及一年ALT复常率HbeAg及HBVDNA阴转率分别为36.7％、40.8％、41.7％及44.7％、42.6％、31.9％。与干扰素组疗效无差异,联合Ara-amp似可提高疗效但无统计学差异。苦参素治疗组无明显副作用。结论:苦参素注射液治疗慢乙肝安全有效、疗效和干扰素相近。

Objective To evaluate the effect and safety of oxymatrine injection (OM) and OM combined Ara AMP on serum ALT, HBeAg and HBV DNA in the patients with chronic hepatitis B (CHB) by multicenter and IFN controlled trial Methods All the 196 patients with CHB were divided into 4groups, that were OM group, OM combined Ara AMP, IFN group and general medicine group, the effect of the treatment for three months and long - term follow - up result at the end of sixth month and 12th month after treatment as well as side effect were investigafed.Results the ALT normalized rate and negative rate of HBeAg, HBV DNA after treatment for three months were 36.5% 、36.5% and 42.3% in the OM group, the ALT normalized rate and negative rate of HBeAg, HBV DNA after treatment at the end of sixth month and 12th month were36.7%, 40.8, 41.7% and 44.7% , 42.6%, 31.9% .It was similar with OM combined Ara-AMP group and IFN group.There was not any side effect in OM injection group. Conclusion OM injection is efficacy and safety on chronic hepatitis B.