| Objective:To investigate the efficacy and safety of Fuzheng Quxie decoction in the treatment of CHB relapse after withdrawal of antiviral drugs.Method:From December 2016 to December 2018,a total of 140 cases of CHB patients with relapse after withdrawal of antiviral treatment were screened,and 60 cases met the inclusion criteria.According to the clinical random number table method,60 patients were randomly divided into two groups,one for experimental group,the other as control group.Experimental group: 30 patients were treated with Fuzheng Quxie decoction and entecavir.Control group: 30 patients were treated with entecavir.In addition to experimental drugs,it was forbidden to add other drugs that protect liver down-enzymes,fight liver fibrosis and affect virus replication and immune function during observation.The total course of treatment was 24 weeks.At week 4,8,12 and 24,the TCM syndrome score,liver function and HBV DNA results of the two groups were observed and compared.At week 12 and 24,the observation was compared with HBV M and FS value.Record adverse events in the process of the entire study.To evaluate the effect and security of two groups finally.Results:1.There was no statistically significant difference in baseline level between the two groups before treatment(P > 0.05).2.TCM symptom scores: after treatment for 4,8,12 and 24 weeks,the scores of both groups decreased significantly(P < 0.05).Compared with the control group,the score of TCM symptoms decreased more significantly in the experimental group(P < 0.05).The curative rate of TCM syndrome was 75.86% in the experimental group and 57.14% in the control group.The curative effect of experimental group was better(P < 0.05).3.ALT:during the treatment,the ALT level of both groups showed a downward trend,and the differences were statistically significant compared with the baseline(P < 0.05).In addition,compared with the control group,the experimental group showed a larger decline(P < 0.05).The ALT renormal rate of the experimental group was always higher than that of the control group since week 16.However,the difference was not statistically significant until the 24 th week when the ALT renormal rate between the two groups was compared(P < 0.05).4.HBV DNA: After 4,8,12 and 24 weeks of treatment,the negative turnover rate of HBV DNA in the test group was higher than that in the control group,but only at week 24,there was a statistical difference between the two groups(P < 0.05).5.HBe Ag: after 12 and 24 weeks of treatment,the serological conversion rate of HBe Ag in the experimental group was higher than that in the control group,but the difference between the two groups was not significant(P > 0.05).6.FS value:at the end of the entire treatment,the FS value of both groups decreased.However,there was no significant difference between the two groups(P > 0.05).7.Overall efficacy: after 24 weeks of treatment,the total effective rate of the experimental group was 89.65%,and that of the control group was 60.71%.the experimental group had better efficacy(P <0.05).8.Safety: during the study period,there was no significant adverse events occurred in both of two groups.Conclusion: For the retreatment of chronic hepatitis B recurrence after the antiviral drug withdrawal,Fuzheng Quxie decoction combined with entecavir can better improve the clinical symptoms of patients,improve the efficacy of TCM,improve the overall efficacy rate,accelerate the improvement of liver function,significantly improve the negative conversion rate of HBV DNA and the recovery rate of ALT,both of which are of high safety.However,Fuzheng Quxie decoction has no obvious advantages in the serological conversion rate of HBe Ag and the reduction of liver fibrosis degree. |
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