The Effects Of Wenshen Decoction On HBeAg-positive Chronic Hepatitis B Patients With Ultra-high ALT (20ULN≤ALT≤30ULN)

Purpose:Observe curative effect of Wenshen decoction for the ultra-high ALT (20ULN≤ALT<30ULN)HBeAg positive Patients with chronic hepatitis B.Methods:To use a prospective study design of the RCT for clinical scheme design. 60 patients were devided into two groups randomly, (29 of them were in treatment group,31 of them were in control group).ALL of them were given telbivudine、 reduced glutathione Polyene phosphatidylcholine when they were in hospital,moreover,the treatment group were also given Wenshen decoction. Set ALT < 2ULN and patient’s condition allowed as the discharge stangdard. After discharged from hospital, both of the two groups were given telbivudine, the treatment group were also given Wenshen decoction. All of the two groups’course of treatment were 52 weeks.To observe The number of days of hospitalization? TCM syndrome score, Curative effect, the MOS item short from health survey score, biochemical responses,virological response,HBeAg serological response, Fibroscan elastic value improvement, Serum CK, adverse reactions.Results:1. Clinical curative effect:The total effective rate of treatment group was higher than control group (P<0.05).2. TCM syndrome score:After treatment, compared with control group, the TCM syndrome score decreased more significantly. (P＜0.05).3. SF-36 scale scores:Compared with control group, The factors points to improve are more obvious in the treatment group (P＜0.05).4. Two groups of hospital stay (days):the average hospital stay of the treatment and control group were 15.7+4.4,20.8+5.6,respectively; the hospital stay in the treatment group was significantly shorter than that in the control group (P＜0.05).5.Biochemical responses:The recovery rate of ALT of treatment group was significantly higher than that of control group (P<0.05).6.Virological response:In treatment group, the negative rate of HBV-DNA is higher than that of control group (P＜0.05).7. HBeAg serological response:HBeAg seroconversion rates were increased in the treatment group and control group, but the treatment group was more significant (P<0.05).8.Fibroscan elastic value:After treatment,the value of Fibroscan in the treatment group was significantly higher than that in the control group(P<0.05).9.Adverse reactions:There were totally 33 patients with elevated creatine kinase.11 cases were from the treatment group while 22 cases were from the control group, and the difference was significant(P<0.05).Conclusion:Wen Shen decoction & telbivudine treatment can shorten the hospitalization time, improve the TCM syndrome, improve the quality of life, inhabit the replication of HBV, decrease the level of ALT, increase the recovery rate and the rate of HBeAg seroconversion of the ultra-high ALT (20ULN<ALT<30ULN) HBeAg positive Patients with decrease serum creatine kinase elevation ratio of chronic hepatitis B. Inspiration:Wen Shen decoction & telbivudine treatment for the ultra-high ALT (20ULN≤ALT≤30ULN)HBeAg positive Patients with chronic hepatitis B is safe and effective.