Clinical Study Of Qianyang Ruangan Decoction On The Treatment Of Chronic Hepatitis B Liver Fibrosis

OBJECTIVE:To evaluate the efficacy and safety of Qianyang Ruangan Decoction in the treatment of liver fibrosis of chronic hepatitis B by observing the changes of TCM symptom score,liver function index(ALT,AST,TBIL,DBIL),FIB-4 index,APRI index and liver hardness value(LSM)of patients with liver fibrosis of chronic hepatitis B treated with Qianyang Ruangan decoction.Research methods:According to the inclusion and exclusion criteria of this trial,60 patients with liver fibrosis of chronic hepatitis B who met the criteria of this trial were selected from the outpatients of infectious diseases department of Sichuan Provincial Hospital of traditional Chinese medicine from September 2019 to September 2020.They were randomly divided into control group(group A)and experimental group(group B).30 patients in group A were treated with entecavir capsule,while 30 patients in group B were treated with Qianyang Ruangan Decoction on the basis of group A.The course of treatment was 24 weeks.The therapeutic indexes included TCM symptom score,liver function indexes(alt,AST,TBIL,DBIL),FIB-4 index,APRI index and liver hardness.Before the beginning of the treatment,at the end of 12 weeks and 24 weeks,blood routine,liver function,liver hardness value examination,TCM syndrome score evaluation,FIB-4 index and Apri index calculation of each patient were completed,and the data was recorded.IBM SPSS statistics 23.0 was used to analyze the data of this trial.Results:(1)A total of 60 patients were included in this study.One case lost contact in group A,one case changed the dosage form and manufacturer of Entecavir by himself.Two cases withdrew from the traditional Chinese medicine treatment in group B.Ultimately,the data of 56 patients were statistically analyzed.(2)Evaluation of TCM syndrome score: the TCM syndrome score of both group A and group B decreased with the treatment time.At the end of the 12 th week of treatment,the TCM syndrome score of both group A and group B had statistical difference compared with that before the trial(P < 0.05);there was statistical difference between group A and group B at the end of the 12 th week of treatment(P < 0.05).(3)Evaluation of transaminase improvement results: the transaminases in both group A and group B decreased with the treatment time,and there was statistical difference between group A and group B at the end of 12 weeks(P <0.05);there was statistical difference between group A and group B at the end of24 weeks(P < 0.05).(4)Evaluation of bilirubin improvement results: bilirubin in group A did not decrease significantly with the treatment time,and there was no statistical difference(P > 0.05);bilirubin in group B decreased with the treatment time,and there was statistical difference within 24 weeks(P < 0.05).(5)Evaluation of liver fibrosis indexes: the liver fibrosis indexes of both group A and group B decreased with the treatment time,FIB-4 indexes of both group A and group B at the end of 24 weeks were significantly different from those before the trial(P < 0.05),and there was no significant difference between group A and group B at the end of 24 weeks(P > 0.05);APRI index and LSM values of both group A and group B at the end of 12 weeks were significantly different from those before the trial(P < 0.05),and there was no significant difference between group A and group B at the end of 24 weeks(P > 0.05)There was statistical difference between the two groups at the end of 24 weeks(P <0.05).(6)Overall efficacy rating: at the end of the trial,the average TCM efficacy index of group A was 52.39%,and that of group B was 77.89%,with statistical difference between group A and group B(P < 0.05);the comprehensive efficacy of TCM and Western medicine of group A and group B had statistical difference(P< 0.05).Conclusion:(1)"Qianyang Ruangan Decoction" combined with "Entecavir" in the treatment of chronic hepatitis B liver fibrosis is more effective than "Entecavir" alone in the ease of TCM symptoms,and reduction of transaminase and bilirubin.(2)Qianyang Ruangan decoction combined with "Entecavir" in the treatment of chronic hepatitis B liver fibrosis at the end of 12 weeks,the fibrosis index(APRI,LSM)had no significant difference compared with "Entecavir" alone,but the improvement effect of fibrosis index(APRI,LSM)was more significant than that of "Entecavir capsule" alone after 24 weeks.