AIM:To evaluate the efficacy and safety of capsuleoxymatrine in the treatment of chronic hepatitis B.METHODS:A randomised double-blind and placebo-controlled multicenter trial was conducted.Injection ofoxymatrine was used as positive-control drug.A total of216 patients with chronic hepatitis B entered the study for24 weeks,of them 108 received capsule oxymatrine,36received injection of oxymatrine,and 72 received placebo.After and before the treatment,clinical symptoms,liverfunction,serum hepatitis B virus markers,and adverse drugreaction 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 patientswere analysed.In the capsule treated patients,76.47%became normal in AIT level,38.61% and 31.91% becamenegative both in HBV DNA and in HBeAg.In the injectiontreated patients,83.33% became normal in ALT level,43.33% and 39.29% became negative both in HBV DNAand in HBeAg.In the placebo treated patients,40.00%became normal in ALT level,7.46% and 6.45% becamenegative both in HBV DNA and in HBeAg.The rates ofcomplete response and partial response were 24.51% and57.84% 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 ofpatients,but both were significantly higher than theplacebo.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 differenceamong them.CONCLUSION:Oxymatrine is an effective and safe agentfor the treatment of chronic hepatitis B. AIM: To evaluate the efficacy and safety of capsuleoxymatrine in the treatment of chronic hepatitis B. METHODS: A randomized double-blind and placebo-controlled multicenter trial was conducted. Injection ofoxymatrine 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, 36received injection of oxymatrine, and 72 received placebo. After and 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 analyzed in the capsule treated patients, 76.47% became normal in AIT level, 38.61% and 31.91% becamenegative both in HBV DNA and in HBeAg. the injectiontreated patients, 83.33% became normal in ALT level, 43.33% and 39.29% became both in HBV DNA and in HBeAg. the pl acebo treated patients, 40.00% became normal in ALT level, 7.46% and 6.45% innegative both in HBV DNA and in HBeAg.The rates of complete response and partial response were 24.51% and57.84% 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 theplacebo. Adverse drug reaction rates of the capsule, injection and placebo were 7.77%, 6.67% and 8.82%, respectively. There was no significant significant difference in them.CONCLUSION: Oxymatrine is an effective and safe agent for the treatment of chronic hepatitis B.