OBJECTIVETo observe the effects on patients with HBeAg positive chronic hepatitis B by Baihua Xianglian Detoxification Recipe (BXDR) combined adefovir dipivoxil (AD), and to assess its clinical efficacy.

METHODSA multi-center randomized clinical trial was performed, and 240 patients with HBeAg positive chronic hepatitis B (CHB) were randomly assigned to the experimental group and the control group. Patients in the experimental group were given AD 10 mg, once daily, while BXDR was additionally given those in the control group, twice daily. The treatment course was 48 weeks. The virologic, serologic, biochemical, chronic liver disease questionnaire (CLDQ) score, and adverse event were observed for 12, 24, and 48 weeks.

RESULTS(1) In aspect of virology: From the 12th week, statistical difference existed in the HBVDNA logarithm value between the experimental group and the control group (P < 0.05). The virologic response rate was 62.71% and 77.97% in the experimental group at the 12th and 24th week, while it was 49. 57% and 67. 52% in the control group, showing statistical difference (P < 0.05). There was no significant difference in the virological response rate at the 48th week (P > 0.05). The HBVDNA negative rate in the experimental group was 22.03% at the 12th week, 41.52% at the 24th week, and 55.08% at the 48th week. It was 11.11%, 21.37%, and 30.77% in the control group, showing statistical difference (P < 0.05). (2) In aspect of HBeAg/anti-HBe serology: The serum HBeAg response rate was 26.27% at the 24th week and 39.83% at the 48th week in the experimental group, while it was 13.68% at the 24th week and 29.06% at the 48th week in the control group, showing statistical difference (P < 0.05). The HBeAg negative conversion rate at the 48th week of treatment was 22.03% in the experimental group and 11.96% in the control group, showing statistical difference (P < 0.05). (3) In aspect of biochemistry: The biochemical response rate at the 24th week and the 48th week was 74.58% and 87.29% respectively in the experimental group, while it was 60.68% and 79.49% in the control group, showing statistical difference (P < 0.05). (4) In aspect of CLDQ score: After treatment the CLDQ scores in the two groups were higher compared with before treatment with statistical difference (P < 0.05). The CLDQ scores at the 24th week and the 48th week in the experimental group were superior to those in the control group, showing statistical difference (P < 0.05). (5) In aspect of adverse reactions: The main adverse reactions were headache, abdominal pain, nausea. During the study period, the total creatine kinase (CK) increased in 9 cases with the occurrence rate of 3.83%.

CONCLUSIONSIn treating patients with HBeAg positive CHB, BXDR combined AD could significantly improve the inhibition of HBVDNA, increase the HBeAg seroconversion rates, accelerate the recovery of the liver function, improve the quality of life with higher safety.