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Oxymatrine therapy for chronic hepatitis B: a randomized double-blind and placebo-controlled multi-center trial.

Abstract：

AIM:To evaluate the efficacy and safety of capsule oxymatrine in the treatment of chronic hepatitis B. METHODS:A randomised double-blind and placebo-controlled multicenter trial was conducted. Injection of oxymatrine was used as positive-control drug. A total of 216 patients with chronic hepatitis B entered the study for 24 weeks, of them 108 received capsule oxymatrine, 36 received injection of oxymatrine, and 72 received placebo. After and before the treatment, clinical symptoms, liver function, serum hepatitis B virus markers, and adverse drug reaction were observed. RESULTS:Among the 216 patients, six were dropped off, and 11 inconsistent with the standard were excluded. Therefore, the efficacy and safety of oxymatrine in patients were analysed. In the capsule treated patients, 76.47% became normal in ALT level, 38.61% and 31.91% became negative both in HBV DNA and in HBeAg. In the injection treated patients, 83.33% became normal in ALT level, 43.33% and 39.29% became negative both in HBV DNA and in HBeAg. In the placebo treated patients, 40.00% became normal in ALT level, 7.46% and 6.45% became negative both in HBV DNA and in HBeAg. The rates of complete response and partial response were 24.51% and 57.84% in the capsule treated patients, and 33.33% and 50.00% in the injection treated patients, and 2.99% and 41.79% in the placebo treated patients, respectively. There was no significance between the two groups of patients, but both were significantly higher than the placebo. The adverse drug reaction rates of the capsule, injection and placebo were 7.77%, 6.67% and 8.82%, respectively. There was no statistically significant difference among them. CONCLUSION:Oxymatrine is an effective and safe agent for the treatment of chronic hepatitis B.

journal_name

World J Gastroenterol

journal_title

World journal of gastroenterology

authors

Lu LG,Zeng MD,Mao YM,Li JQ,Wan MB,Li CZ,Chen CW,Fu QC,Wang JY,She WM,Cai X,Ye J,Zhou XQ,Wang H,Wu SM,Tang MF,Zhu JS,Chen WX,Zhang HQ

doi

10.3748/wjg.v9.i11.2480

keywords:

subject

Has Abstract

pub_date

2003-11-01 00:00:00

pages

2480-3

issue

eissn

1007-9327

issn

2219-2840

journal_volume

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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Oxymatrine therapy for chronic hepatitis B: a randomized double-blind and placebo-controlled multi-center trial.