Clinical Research On Adifovir Dipivoxil Treatment Effect For Patients With Chronic Hepatitis B

Background : Chronic hepatitis B which affects humans health seversly is caused by HBV. According to the reports of the Chinese Center for Disease Control and Prevention, 719000 new hepatitis B cases were reported in 2003, and the year incidence rate of hepatitis B was 53.32/100000. About 28 million hepatitis B cases were estimated totally in our country at the present time. One third of them will develop to chronic hepatitis B, liver cirrhosis , or liver cancer. In 1998 there is 2 million patients died of liver cancer caused by hepatitis virus world wide and 300000 of them was Chinese. How to prevent and treat viral hepatitis become a very important problem to be resolved. Viral hepatitis treatments include anti-virus therapy, immunity system regulation therapy, liver function protection and anti-liver cirrhosis therapy and so on. Among them, anti-virus therapy is the basically and most important. Now the anti-virus drugs are sorted into 2 groups. One is interferon and the other is nucleoside analog. Adefovir dipivoxil is one of the drug of nucleoside analoges. It was permitted by FDA to treat CHB since 2002 in America. It is different from lamivudine and is new to Chinese. The clinical research on adefovir dipivoxil is aimed to test the new drug produced by Chinese company and to help physicians choosing anti-virus drugs correctly.Methods : 48 patients with chronic hepatitis B from infectious disease department of the 1^st affiliated hospital of JNUMC in 2004 were randomly divided into control and experimental groups. During the first 12 weeks, control group was given simulated adefovir dipivoxil and the experimental group had adefovir dipivoxil, both groups had ordinary liver protection drugs. In the following 36 weeks, all patients had adefovir depivoxil only. Some laboratory examinations such as ALT, AST, TBIL, CK, TP, HBV-DNA, HBeAg, HBeAb, Cr, Bun, AFP, Blood-rutine, Urinary-routine, B-us, ECG were performed at the beginning of test, 12^th week, 48^th week respectively.Results : 48 cases finished the 48-week test. Two groups' basical data had no significant differences. At the time of 12^th week, the laboratory examinationresults between control group and experiment group had significant differences. The HBV-DNA log10 value were 7.03 and 4.25 respectively, the HBV-DNA response rate were 4.17% and 50%, the HBeAg negative rate were 4.17% and 12.5%, the HBeAg to HBeAb seraconversion rate were 0 and 4.17%, the rate of ALT normalization were 9.09% and 35.65%. At the 48^th week, the laboratory examination results between control group and experiment group had no significant differences. The HBV-DNA log value were 4.00 and 4.35, the HBV-DNA responding rate were 83.33% and 91.67%, the HBeAg negative rate were 25% and 29.17%, the HBeAg to HBeAb seraconversion rate were 12.50% and 16.68%, the rate of ALT normalization were 76.36% and 79.59%.During the test, 10 had cases occured in 10 patients of experiment group, 6 of them were related to the drug. They included ALT increasing,...