[Oxymatrine in the treatment of chronic hepatitis B for one year: a multicenter random double-blind placebo-controlled trial].

Abstract

OBJECTIVE:

To evaluate the efficacy and safety of oxymatrine in the treatment of chronic hepatitis B.

METHODS:

A multicenter randomized double-blind placebo-controlled trial was conducted. A total of 144 patients with chronic hepatitis B entered the study for 52 weeks; of them 72 received oxymatrine, and 72 received a placebo. Before and after the treatment, clinical symptoms, liver function, serum hepatitis B virus markers, and adverse drug reactions were observed.

RESULTS:

In 144 patients, 14 were dropped and excluded due to inconsistencies in the included standard. Therefore, the efficacy and safety of 130 patients were analyzed. After being treated for 52 weeks, 70.77% of the patients in the study group had a normal ALT level, and in 43.08% and 33.33% their HBV DNA and HBeAg became negative. In the placebo group, 39.68% had normal ALT level, and 12.31% and 3.33% had their HBV DNA and HBeAg become negative. The rates of complete response and partial response in the oxymatrine group were 23.08% and 58.46%, and in the placebo group they were 3.08% and 44.62%. They were significantly higher in the oxymatrine group than in the placebo group. In the oxymatrine treated patients, 12 weeks after its withdrawal, 60.00% had a normal ALT level, 41.54% and 23.33% had both HBV DNA and HBeAg negative. In the placebo group, 31.75% had a normal ALT level, 3.08% and 1.67% had both HBV DNA and HBeAg negative. The rates of complete response and partial response in the oxymatrine group were 21.54% and 47.69%, and in the placebo group they were 0 and 41.54%. They were significantly higher in the study group than in the placebo group. The adverse reaction rates of oxymatrine in the study and the placebo group were 7.69% and 6.15%, respectively, but there was no statistical significant difference between them.

CONCLUSION:

Oxymatrine is an effective and safe agent for the treatment of chronic hepatitis B.

• Authors: Lun-gen Lu, Min-de Zeng, Yi-min Mao, Mo-bin Wan, Cheng-zhong Li, Cheng-wei Chen, Qing-chun Fu, Ji-yao Wang, Wei-min She, Xiong Cai, Jun Ye, Xia-qui Zhou, Hiu Wang, Shan-ming Wu, Mei-fang Tang, Jin-shui Zhu, Wei-xiong Chen
• Journal: Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology (Zhonghua Gan Zang Bing Za Zhi) Vol. 12 Issue 10 Pg. 597-600 (Oct 2004) ISSN: 1007-3418 [Print] China
• PMID: 15504289 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Alkaloids
• Antiviral Agents
• Quinolizines
• oxymatrine

Topics

• Adolescent
• Adult
• Aged
• Alkaloids (adverse effects, therapeutic use)
• Antiviral Agents (adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Hepatitis B, Chronic (drug therapy)
• Humans
• Male
• Middle Aged
• Quinolizines