| Objective:To observe and evaluate the clinical efficacy and safety of Biejia Ruangan pills,a self-made Chinese medicine,combined with entecavir in the treatment of chronic hepatitis B liver fibrosis of blood stasis and spleen deficiency type.Methods:1.Grouping: The study subjects were chronic hepatitis B patients who visited the liver disease outpatient clinic of Wuhan Hospital of Traditional Chinese and Western Medicine from December2020 to December 2021.Total of 90 patients who met the criteria for inclusion in the study were randomly divided into 3 groups,Biejia Ruangan pill + entecavir（ETV）group,entecavir（ETV）group,Biejiajian pill + entecavir（ETV）group,30 people per group.2.Treatment method: ETV group was given entecavir dispersible tablets 0.5mg,1 time/day,Biejia Ruangan pill+ETV group:In addition to giving Entecavir dispersible tablets,combined with Biejia Ruangan pills（drug composition: vinegar turtle nail,radix rehmanniae preparata,rhizoma dioscoreae,white peony root,Goji,codonopsis pilosula,fried tribulus terrestris,danshen,radix liriopes,curcuma aromatica,fried fructus toosendan,bran fried atractylodes,vinegar south schisandra,fried endothelium corneum,angelica,agilawood,safflower,Yin Chen）3g/time,3 times/day.Biejiajian pill + ETV group: antiviral therapy with entecavir,combined with Biejiajian pills 3g/time,3 times/day.The course of treatment is 6 months.3.Observation indicators: The liver function indexes（ALT,AST）,hepatitis B virus DNA negative conversion rate,Liver stiffenss measurement（LSM）,APRI,FIB-4 index,and TCM syndrome score before and after treatment were observed in the 3 groups,and the efficacy and the adverse reactions during the treatment of the3 groups was observed and evaluated,4.Statistical methods: The statistical analysis tool is SPSS25.0 statistical software,which records all data,with P<0.05 as the basis for statistical differences,and P<0.001 as a significant statistical difference.Counting data is expressed as a percentage（%）and the comparison method uses a chi-square test.According to whether the measurement data conforms to the normal distribution,the analyzing methods vary from the analysis of variance to rank test.Results:1.TCM comprehensive efficacy analysis: After 6 months of treatment,the total effective rate of TCM symptoms in the Biejia Ruangan pill+ETV group reached 70.0%,the ETV group was 23.3%,,the Biejiajian pill+ETV group was 76.6%,and the efficacy of Biejia Ruangan pill+ETV group and the Biejiajian pill+ETV group was not obvious（P>0.05）,but it was significantly better than the ETV group（P<0.05）.2.Single TCM syndrome scores: The single TCM syndrome scores of the 3 groups of patients were comparable at first（P>0.05）.After treatment,all TCM symptoms（except for Bloating after eating symptoms in the ETV group）decreased significantly,and the differences were statistically significant（P<0.05）;compared with the ETV group,the single score of the other 2 groups was significantly reduced（P<0.05）;the Biejia Ruangan pill+ETV group had a significant decrease in scores in the two points（losing apptide and loose stools）compared with the Biejiajian pill+ETV group（P<0.05）.There was no statistical difference in residual symptoms（P>0.05）.3.Total scores of TCM symptoms: there was no statistical difference in the baseline level of TCM syndrome total scores of the 3 groups（P>0.05）.after 6 months of treatment,the scores of the 3 groups decreased than before and there was a statistical difference（P<0.05）;the difference between the 2 groups with combined therapies was not statistically significant（P>0.05）,but the decrease in TCM syndrome scores of thems was significantly better than that of ETV group（P<0.05）.4.Changes in liver function indicators: There were obvious statistical differences（P<0.001）in the 3 groups of patients comparing ALT and AST liver function indicators before and after treatment（P<0.001）,but there was no statistical significance in the comparison among groups（P>0.05）.5.Liver stiffness index: There was no statistical difference in liver stiffness values among the 3 groups of patients before treatment（P>0.05）,and after treatment of 3 months and 6 months,the liver stiffness values were compared within the group,and the statistical difference was significant（P<0.001）.（1）the liver stiffness values was compared within the group,the statistical difference was significant（P<0.001）;（2）Compared with the ETV group,the reduction of liver stiffness values in the other 2 groups was more significant,the difference was statistically significant（P<0.05）but there was no significant difference between thems（P>0.05）.6.APRI and FIB-4: There was no statistical difference in the values of APRI and FIB-4 among the 3 groups before treatment（P>0.05）,and they all reduced after treatment（P<0.001）;the values of APRI and FIB-4 in the other 2 groups decreased more significantly than that in the ETV group,with statistical differences（P<0.05）,and the difference between the 2 groups was not statistically significant（P>0.05）.7.HBV-DNA negative conversion rate: there was no significant difference in the composition ratio of the number of negatives and positives after 3 months of treatment and 6 months of treatment in the 3 groups,and the difference was not statistically significant（P>0.05）.8.Safety indicators: the patients has good tolerance,no adverse reactions,and no clinically significant changes have occurred in vital signs before and after treatment,There were no clinically significant changes in the three routine functions of blood,urine,feces,renal function,coagulation function,liver and gallbladder color doppler ultrasound.Conclusion:The effect of Biejia Ruangan pills combined with entecavir in the treatment chronic hepatitis B liver fibrosis of blood stasis and spleen deficiency type,in terms of reducing liver stiffness measurement value,reducing multi-parameter model of serological indexes（APRI,FIB-4）,improving TCM syndrome score and improving TCM syndrome efficacy,the combined therapy is better than that of monotherapy and comparable to that of entecavir combined with Biejiajian pills,which can provide an effective supplementary means for modern medicine to treat the liver fibrosis. |
PDF Full Text Request