[A clinical study of adefovir dipivoxil treatment for chronic hepatitis patients with cirrhosis in their decompensation period].

OBJECTIVE

To evaluate the efficacy and safety of 96 weeks adefovir dipivoxil (ADV) treatment for chronic hepatitis patients with cirrhosis in their decompensation period.

METHODS

Chronic hepatitis patients with cirrhosis in their decompensation period were randomly divided into two groups. An ADV group: patients treated with 10 mg ADV per day; a lamivudine (LMV) group: patients treated with 100mg LMV per day. The course of treatment lasted 96 weeks. Serum levels of ALT, AST, Alb, Tbil, HbeAg, HBV DNA, PCIII, IVC, LN and HA, renal function, Child-Pugh scores, drug adverse reactions and complication during the treatment of the two groups were analyzed.

RESULTS

During the two-year treatment, the proportions of patients with a return to normal liver function were similar in both groups. With the treatment prolonged, serum HBV DNA levels of the patients in adefovir dipivoxil group decreased gradually. The HBV DNA level in some lamivudine-treated patients was increased. The sero-conversion rate of HBeAg/HBeAb of the patients in the two groups was increased with the prolongation of the treatment. At 96 weeks, the ratio of emerging virus-resistant strains was lower in the adefovir dipivoxil group than in the lamivudine group. The levels of the serum markers of hepatic fibrosis of the patients in the two groups remained low. Child-Pugh scores of the patients in the two groups were significantly improved. No significant difference in the total incidence of complications between the two groups was noticed. Each of the two groups had a patient with liver-kidney syndrome and other serious complications.

CONCLUSION

The efficacy and safety of adefovir dipivoxil and lamivudine treatment for the above patients are similar, but the ratio of emerging virus-resistant strains of the adefovir dipivoxil treatment group is lower than that of lamivudine treatment group.