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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 investigate the efficacy and safety of Bortezomib (oxymatrine) injection in the treatment of chronic hepatitis B in combination with Ara-amp therapy in clinical trials of multiple multicentre in China. To compare the efficacy of interferon and general hepatoprotective drugs, To explore the safe and effective treatment of chronic hepatitis B drugs and treatment options. Methods: A total of 196 chronic hepatitis B patients were treated with matrine and Ara-amp combined with interferon and hepatoprotective drugs. The curative effect of three months and the follow-up of six months and one year were observed Period efficacy, and observe its side effects. Results: At the three-month treatment, the ALT normalization rate, HBeAg and HBV DNA negative conversion rates were 36.5%, 36.5% and 42.3% respectively in the oxymatrine treatment group. HbeAg and HBVDNA Turnover rates were 36.7%, 40.8%, 41.7% and 44.7%, 42.6% and 31.9% respectively. No difference with the efficacy of interferon group, combined with Ara-amps can improve the efficacy but no significant difference. Oxymatrine treatment group no significant side effects. Conclusion: Oxymatrine Injection is safe and effective in treating chronic hepatitis B, with similar efficacy and interferon.