| Background and aim:HBV infection is now world-wild epidemic, and becomes a global security problem. It's reported that 2 billion people have been infected by HBV all over the world, and 350 millon are chronic HBV patients. It is estimated that about one million people died of Cirrhosis, hepatocellular cancer, and hepatic failure per year that caused by HBV infection. So chronic hepatitis B infection is dangerous. Chronic Hepatitis B Virus carriers are also dangerous as a state of chronic hepatitis B infections. As more reaseachse have been done, we find that Chronic Hepatitis B Virus carriers are more possible to become cirrhosis, hepatocellular cancer, and hepatic failure patients. In the past, we thought Chronic Hepatitis B Virus carriers were healthy, and the Guide suggests not to anti virus to them without liver biopsy. Traditional medicine lack of large sample and Multi-center studies of symptoms and treatments. The aim of this study is to investigate the anti-viral effects of a Chinese Herbal Formula (invigorating the kidney and the spleen gelatin capsule) in treating chronic hepatitis B Virus carriers.Methods:This was a randomized, double-blind, placebo-controlled study.90 patients enrolled in the study who were satisfied with the following criteria: presence of hepatitis B surface antigen and hepatitis B e antigen, HBV DNA level greater than 7 log10 copies/ml, and normal alanine aminotransferase level (30-40 IU/mL for male, and 20-40 IU/mL for female). They were randomly divided into trial group (n=60) and control group (n=30). During the trial period, patients in both trial group and control group received medication invigorating the kidney and the spleen gelatin capsule and a placebo for 48 weeks respectively,4 capsules per time,3 times per day. The serum HBV DNA level, serum markers of HBV(HBsAg,HBsAb,HbeAg,HBeAb,HbcAb),the HBsAg quantitation and serum biochemistry of liver functions(ALT,AST,GGT,TBil) were measured at the before and 48th week of the treatment. And the indexes of safety, such as blood analysis, stool analysis, urinalysis, renal functions and electrocardiogram were also detected.Results:After treatments, the median decrease in serum HBV DNA levels was 3.4 log10 copies/mL in the trial group and 0.1 log10 copies/mL in the control group (P<0.01). Serum HBV DNA<31og10 copies/mL was observed in 13 of the 60 subjects (21.7%) in the trial group and 1 of the 30 subjects (3.3%) in the placebo group (P< 0.01). The HBsAg quantitation decreased in the trial group. (P<0.05). The proportion of patients with HBeAg loss was 20%(12/60) and 3.3%(1/30) respectively in the trial group and control group (P<0.01). The ratio of HBeAg seroconversion to anti-HBe was 15%(9/60) in the trial group and 0%(0/30) in the control group (P<0.05).Conclusions:Invigorating the kidney and the spleen gelatin capsule is effective in inhibiting the copy of hepatitis B virus, increasing the ratio of HBeAg seroconversion, improving the liver function and decreasing the HBsAg quantitation, which can be used to treat Chronic Hepatitis B Virus carriers.
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