A Clinical Research On Oxymatrine For The Treatment Of Chronic Hepatitis B

Objectives:in the case of oxymatrine as a positive control, the two randomized, double-blind and multi-center clinical research is applied to evaluate the primary efficacy on the treatment of chronic hepatitis B HBe Ag serum conversion, to make a comparison with interferon,nucleotide a nalogues, and to discuss the difficulties in the anti-viral treatment for chro nic hepatitis B and the advantages of traditional Chinese medicine.Methods:to choose two RCT research cases (Yi Ganqing VS Oxymatrin e and Yi Gan Kang Fu Ling vs. Oxymatrine) in our hospital, form2004to2007, to reset inclusion criteria, exclusion criteria and efficacy evaluation, to summarize the primary endpoint efficacy of the positive control of oxy matrine in the treatment of HBeAg/anti-HBe seroconversion rates during the12th week,24th week, follow-up of12weeks and follow-up of24we eks, to make a non-head-to-head comparison with the interferon,nucleotid e analogues and to explore the different therapeutic effect among them.Results:Oxymatrine in the24th week and follow-up of24weeks of HBe Ag seroconversion rates were30.43%and43.47%, which compared with Yi Ganqing group and Yi Gan Kangfuling group, the difference is statistic ally significant(P<0.05).While compared with the48weeks of Peg-IFN-2a, it is less effective, but memorably higher than telbivudine. HBeAg loss rates were34.78%and56.52%, which compared with Yi Ganqing group and Yi Gan Kangfuling group, the difference is statistically significant(P <0.05).While compared with the48weeks of PEG-IFNa-2a, it is similar, but memorably higher than telbivudine.The HBVDNA negative rates in the24th week and follow-up weeks are respectively34.78%and51.51%, which slightly higher than PEG-IFNa-2a, but significantly lower than ent ecavir. ALT normalization rate of Oxymatrine in the two RCT researches is greatly different. It is statistically significant by comparison(P<0.05). The effect is not the same, which can not be further compared with interf eron, nucleotide analogues.Conclusion:1. HBeAg/anti-HBe seroconversion rate and HBeAg negativ e conversion rate of Oxymatrine are similar to PEG-IFNα and both notice ably higher than telbivudine; HBVDNA negative rate is similar to PEG-Ⅰ FN-2α and is significantly lower than entecavir.2. HBeAg/anti-HBe seroconversion rate of Oxymatrine, HBVDNA in dec line and the change of ALT are nonlinear correlation, which suggests it m ay have a class of interferon effect.3. The primary efficacy of Oxymatrine may lie in the HBeAg/anti-HBe se roconversion rather than the direct inhibition of HBVDNA.