Clinical Research On Traditional Chinese Medicine Combined With Lamivudine To Treat Chronic Hepatitis B

【Objective】To investigate the therapeutic effect of Lamivudine combined with shuanghuqinggan particles and yiganyiqijieyu particles on treating chronic hepatitis B.【Means】The 64 cases of chronic hepatitis B were randomly divided into two groups. The treatment group (32 cases) was treated with Lamivudine combined shuanghudqinggan particles and yiganyiqijieyu particles. And the control group (32 cases) was treated with lamivudine alone. The latter took lamivudine (100 mg once every day) and placebo of the two particles whose appearrence and package, were the same as the two particles', while the former took lamivudine (100mg once every day)combined with shuanghudqinggan particles and yiganyiqijieyu particles (one packet once, 3times a day respectively) .Both groups receive treatment for 48 weeks, and would be followed up in the following 24 weeks. We would investigate the changes of liver function (serum ALT), HBV -M and HBV-DNA at the beginning of treatment and the point of 12 weeks, 24 weeks, 48 weeks, 72 weeks after treating, observing the condition of YMDD mutation at the beginning of treatment and the point of 48 weeks, 72 weeks after treating.【Result】After 12 weeks, 24 weeks, 48 weeks, 72 weeks of treatment, the recovery rates of ALT in the treatment group were 84.4%, 93.8%,96.9%,93.8%,which were higher than that in the control group. There was no signficant difference between the two groups at 12 weeks and 24 weeks (P＞0.05), while significant difference could be found at 48 weeks and 72 weeks (P＜0.05).After 12 weeks, 24 weeks, 48 weeks, 72 weeks of treatment, the rates of HbeAg turning negative in the treatment group were 12.5%,18.8%,28.1%,25%, which were higher than that in the control group. 12 weeks, 24 weeks, 48 weeks and 72 weeks, the results of the treatment group were not signficantly different from the control group (P＞0.05).After 12 weeks, 24 weeks, 48 weeks, 72 weeks of treatment, the rates of HBeAb seroconversion were 6.3%, 12.5%, 18.8%, 15.6% in the treatment, which were higher than that in the control group. 12 weeks , 24 weeks, 48 weeks and 72 weeks , the results of the treatment group were not signficantly different from the control group (P＞0.05).After 12 weeks, 24 weeks, 48 weeks, 72 weeks ~f treatment, the rates of HBV DNAturning negative were 53.1%,71.9%,87.5%,78.1% in the treatment group, which were higher than that in the control group. 48 weeks and 72 weeks, the results of the treatment group were signficantly different from the control group(P＜0.05).After 48 weeks and 72 weeks of treatment, the rates of YMDD mutation were 6.3%,12.5%,which were lower than that in the control group. There was significant difference between the two groups (P＜0.05).After 48 weeks and 72 weeks of treatment, the rates of complete response, partial response and non—response were 18.8%, 68.7%, 12.5%and 15.6%, 62.5%, 21.9%in the treatment group. There was significant difference between the two groups (p＜0.05).The blood, urine, renal function and electrocardiogram of the two groups were normal. In the treatment and the follow-up period of 24 weeks, there were no serious adverse reactions. In a word the treatments were safe.【Conclusion】Lamivudine combined with shuanghuqinggan particles and yiganyiqijieyu particles on treatment of chronic hepatitis B can improve the rate of HbeAg and HBV-DNAturning negative. What' s more, it can also raise the HBeAb seroconversion , reduce the occurrence of YMDD mutationcaused by using lamivudine therapy and promote liver function. There are no adverse reactions. The treatment is safe and effective.