ABSTRACT
To observe the clinical efficacy of modified Chaiping decoction for HBeAg-negative chronic hepatitis B under DaBianZheng theory(syndrome differentiation theory) guidance with understanding of purgative detoxing and modern pharmacology research of traditional Chinese medicine. The patients with HBeAg-negative chronic hepatitis B(n=119) were randomly divided into treatment group(n=69) and control group(n=50). The patients in treatment group were treated with the modified Chaiping decoction(6 doses per week, one dose every day in two times by oral administration), and the patients in control group were treated with lamivudine(LAM) (100 mg/time, once a day). All of patients were treated for 48 weeks. The liver functions, levels of DNA of hepatitis B virus (HBV-DNA) and clinical symptoms were observed at weeks 12, 24, 36 and 48 in both groups. The levels of ALT and HBV-DNA in serum were also observed 24 weeks and 48 weeks after treatment in two groups. There was no significant difference in total effective rate between treatment group and control group at week 24, but the total effective rate in treatment group was higher than that in the control group at weeks 12, 36 and 48(P<0.05); the improvement of liver functions in the treatment group was superior than that in the control group at weeks 12, 36 weeks and 48(P<0.01 or P<0.05), but there was no significant difference at week 24; the improvement of serum HBV-DNA in the treatment group was significantly lower than that in the control group at week 12(P<0.01), but there was no significant difference at weeks 24, 36 and 48; the negative converse rate of serum HBV-DNA in the treatment group was lower than that in the control group at weeks 12, 24 and 36(P<0.01 or P<0.05), but there was no significant difference at week 48; the improvement of fatigue, lassitude, abdominal distension and hypochondriac pain in treatment group was significantly better than that in the control group at weeks 12 and 24(P<0.01 or P<0.05), but there was no significant difference in the improvement of fatigue and hypochondriac pain at weeks 36 and 48; the abnormal rate of ALT in treatment group was significantly lower than that in the control group 24 weeks and 48 weeks after drug withdrawal(P<0.01); there was no significant difference in abnormal rate of serum HBV-DNA 24 weeks after drug withdrawal, but it was significantly lower than that in the control group 48 weeks after drug withdrawal(P<0.05). Modified Chaiping decoction with combination of long term medication and intermittent administration showed better clinical efficacy on HBeAg-negative chronic hepatitis B. Its prescription compositions shall be further optimized and consummated under guidance of disease differentiation and syndrome differentiation, and its clinical research on hepatic fibrosis and living quality shall be carried out.