| Objective:By observing the effects of Shen ren Huo Xue granules combined with entecavir anti-chronic hepatitis B liver fibrosis related indicators,perform efficacy analysis.method:Select patients with chronic hepatitis B liver fibrosis diagnosis,improve ALT,AST,TCM symptom scores and liver elasticity hardness value(LSM)examination,select 60 patients who meet the enrollment,and randomly divide into two groups.There were 30 cases in the control group and the test group.The control group(CG)received entecavir dispersible tablets 0.5 mg/time before bed every night,The experimental group(EG)oral entecavir dispersible tablets(dose with the control group)was also treated with our specialized preparation Shen Ren Huo Xue Granules 10 g/time,3 times/day,respectively,for 6 months of treatment and 12 months of treatment.By comparing ALT,AST,TCM syndrome scores and liver elasticity hardness values(LSM values)for comparison and comprehensive curative effect analysis,to evaluate whether the drug efficacy and the length of medication time have an effect on the therapeutic effect;Through the blood routine,renal function,urine routine,electrocardiogram,etc.for safety evaluation,and record adverse reactions in patients.Results:Including 60 patients,56 valid cases,(In the trial group,1 casewas lost to follow-up,2 cases were lost to the control group,and 1 case was incomplete).Statistical analysis was performed on the relevant data of 56 patients.(1)Comparison of intra group comparisons After treatment with antiviral drugs and combined Chinese herbs,the decrease in transaminase was statistically significant(P<0.05),ALT(38.53 ± 8.22 for 6 months in the experimental group and 36.80±7.39 in the control group for 6 months),AST(40.13 ± 6.38 for 6 months in the experimental group and 38.87 ± 5.18 for the 6 months in the control group);There was no significant difference in the improvement of transaminase between the comparison group and the control group(P>0.05).(2)There was no significant difference(P>0.05)in the improvement of transaminase activity in 12 months of treatment compared with 6 months of treatment.ALT(32.50±5.85 for 12 months in the test group and 32.97±7.42 in the control group for 12 months),AST(35.63 ± 4.19 for12 months in the experimental group and 34.20 ± 4.90 for the 12 months in the control group);The results showed that the test group had no advantage in improving AST and ALT,but both the test group and the control group had the effect of reducing transaminase;(3)In improving liver elasticity(LSM value):The liver elasticity value(LSM)of the experimental group was significantly lower than that before treatment for 6 months and 12 months(P<0.05).(In the experimental group,it was 11.97 ± 2.12 for 6 months and14.07±3.43 for 6 months in the control group;10.25±2.43 for 12 months in the control group and 11.98±3.21 in the control group for 12 months);Thedecrease of the elastic stiffness value in the 12-month treatment group was more significant than that in the 6-month treatment(P<0.05).The liver elasticity value in the control group was significantly lower than that before treatment for 6 months and 12 months(P<0.05).The decrease in elastic stiffness of the control group at 12 months was more significant than that at 6months(P<0.05).Compared with the control group,the decrease of liver stiffness in the 6-month treatment group was more significant,with a statistically significant difference(P<0.05).After treatment for 12 months,the experimental group had lower hepatic stiffness than the control group,with a significant difference(P<0.05).Both groups could exert the effect of reducing the elastic stiffness value of the liver,and the experimental group had an advantage over the control group in reducing the elastic stiffness value of the liver.And in a certain medication cycle,the longer the duration of the Shen Ren Huo Xue Granule combined with anti-viral treatment,the more the elasticity value decreased.(4)TCM symptom scores:In the experimental group,symptom scores for traditional Chinese medicine treatment for 6 months and12 months were significantly lower than before treatment,and the difference was statistically significant(P<0.05).The decrease in TCM symptom scores in the experimental group at 12 months was more significant than that at 6months(P<0.05).(The test group was treated with 14.13 ± 4.05 for 6 months and 9.47 ± 1.83 for 12 months);In the control group,symptom scores for TCM treatment for 6 months and 12 months were significantly lower thanthose before treatment,and the difference was statistically significant(P<0.05).The decrease in TCM symptom scores in the control group at 12 months was more significant than that at 6 months(P<0.05),(18.07±3.77 at 6months in the control group and 11.60±3.00 at 12 months);After 6 months of treatment,the scores of TCM symptoms decreased in the experimental group compared with the control group,and the decrease was more significant(P<0.05).The 12-month treatment group had significantly lower TCM symptom scores than the control group,with a statistically significant difference(P<0.05).Tips In improving the symptoms of TCM,the experimental group has significant advantages,and within a certain treatment cycle,the longer the course of treatment,the higher the effective rate.(5)Comprehensive curative effect analysis:The effective rate of the control group was 6 months,the effective rate was 44.44%,the total effective rate was55.55%,the effective rate of the experimental group was 55.77%,the total effective rate was 65.51%,the effective rate of the control group was 12 months,59.26%,and the total effective rate was: 70.37%;significant rate in the test group: 68.97%,total effective rate: 82.76%.The total effective rate and markedly effective rate of the 6-month treatment group were higher than those of the control group(P<0.05).The total effective rate and effective rate of the12-month treatment group were higher than that of the control group.The difference was statistically significant(P<0.05).The total effective rate and markedly effective rate in the 12-month treatment group were higher thanthose in the treatment group for 6 months,the difference was statistically significant(P<0.05).The total effective rate and effective rate in the control group were higher than those in the treatment for 6 months,and the difference was statistically significant(P<0.05).The results showed that the comprehensive efficacy of the experimental group was better than that of the control group,and the medication course was long within a certain period,and the overall curative effect was good.Through the safety indicators showed no obvious abnormalities before and after treatment,indicating that the experiment was no serious adverse reactions.conclusion:(1)The combined effect of Shen Ren Huo Xue granules and entecavir in the treatment of liver fibrosis is superior to that of entecavir alone,that is,the combination of them has a synergistic effect,and the combination can increase the efficacy of anti-fibrosis;(2)In a certain period of time,the efficacy of the combination drug is positively correlated with the time of drug use,and the longer the drug,the better the efficacy;(3)Shen Ren Huo Xue granules combined with entecavir may play an anti-hepatic fibrosis effect by improving the TCM symptoms of patients and lowering the liver elastic stiffness value.Shen Ren Huo Xue granules is a safe and effective drug that can be used in combination with antiviral drugs to treat liver fibrosis in patients with chronic hepatitis B.It is worthy of clinical promotion. |
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