| Objective:To explore the clinical efficacy of Shugan Jiedu Decoction in the intervention of chronic HBV infection immune tolerance stage based on Fibro Scan technology through clinical randomized controlled research,to regularly monitor and manage patients at this stage and seek safe and effective Chinese medicine intervention treatment to delay the disease Further development provides new ideas and new methods.Methods1.Grouping method: randomize the 60 patients who meet the inclusion criteria through the random number table method Divided into Shu gan jie du fang treatment group and Shu gan jie du fang placebo control group,30 cases in each group.2.Treatment plan: The treatment group was given Shugan Jiedu Fang Jianjian granules(produced by Jiangyin Tianjiang Pharmaceutical Co.,Ltd.).The composition of the drug was: Bupleurum 15 g,Baishao 15 g,Astragalus30g,Atractylodes macrocephala 20 g,Citrus aurantium 10 g,Codonopsis pilosula 20 g,Yexiazhu 10 g,Yinchen 10 g,Polygonum cuspidatum 10 g,Cuscuta chinensis 20 g,Eucommia 20 g,Achyranthes bidentata 15 g,Peach kernel 10 g,Turtle 20 g,Turtle shell 20 g,Roasted licorice 10 g.The control group was given Shu gan Jie du Fang placebo decoction-free granules.Themain component of the drug was leixiang,with water-soluble starch,anhydrous glucose,edible chocolate brown pigment,edible fruit green pigment,edible lemon yellow pigment).Both groups took 200 ml of boiled water and took it twice in the morning and evening,100 ml each time,for a total of 24 weeks of treatment.3.Observation indicators: observe the four items of TCM clinical syndrome score,liver hardness value(LSM),liver fibrosis(hyaluronic acid(HA),laminar adhesion)before treatment,at the 12 th week,and at the 24 th week of treatment in the two groups.Connexin(LN),type III procollagen peptide(P?NP),type IV collagen(?-C)),liver function indexes(serum alanine aminotransferase(ALT),aspartate aminotransferase(AST),Serum total bilirubin(TBi L),direct bilirubin(DBi L),albumin(ALB));HBV-DNA load,HBs Ag and HBe Ag changes,and according to the corresponding evaluation criteria for efficacy,make a therapeutic evaluation.At the same time,observe the patients' adverse reactions during treatment.Results1.Comparison of the efficacy of TCM syndromes: At the 12 th and 24 th weeks of treatment,the total effective rates of TCM syndromes in the treatment group were 70.00% and 93.33%,respectively,while the total effective rates of the control group were 33.33% and 40%,respectively.The total effective rate of syndromes in the two groups at the same time was statistically significant(P <0.05);the treatment group had a higher effective rate at the 24 th week of treatment than the 12 th week,and the difference was statistically significant(P <0.05),while There was no statistically significant difference between the control group at the 24 th week and the 12 th week(P>0.05).2.Comparison of individual TCM syndrome points: The TCM syndrome points of the two groups of patients before treatment were compared by twoindependent sample mean t tests,and the difference was not statistically significant(P> 0.05).From the 12 th week to the 24 th week of treatment,the TCM syndrome scores of the treatment group compared with the control group of the same period showed that the TCM syndrome scores of the treatment group decreased significantly better than the control group,the difference was statistically significant(P <0.05).Before treatment,at the12 th week and at the 24 th week of the treatment group,the difference was statistically significant at any two time periods(P <0.05);the control group had liver pain and pain at the 12 th week of treatment.Compared with pre-treatment,the syndrome scores of emotional depression are statistically significant(P <0.05).From the 24 th week of treatment,the syndrome scores of emotional depression and hemorrhage in the liver area also decreased significantly compared with the 12 th week The difference was statistically significant(P <0.05),and the remaining syndrome points had no significant difference during each treatment period(P> 0.05).3.Comparison of liver stiffness value(LSM): The liver stiffness value of the two groups of patients before treatment was compared by the mean t test of two independent samples,and the difference was not statistically significant(P> 0.05).From the 12 th week to the 24 th week of treatment,the liver hardness values of the treatment group compared with the control group of the same period showed that the liver hardness value of the treatment group was significantly better than that of the control group,and the difference was statistically significant(P <0.05).The comparison between the treatment group before treatment,the 12 th week of treatment,and the 24 th week of any two time periods within the group was statistically significant(P <0.05);the control group had liver hardness at 12 th week of treatment and before treatment Value comparison,the difference was not statistically significant(P> 0.05),but the liver hardness value of the patient until the 24 th week oftreatment was significantly higher than that at the 12 th week and before the treatment,the difference within the group was statistically significant(P<0.05).4.Comparison of four liver fibers: The four indexes of liver fiber before treatment in the two groups were compared by the mean t test of two independent samples,and the difference was not statistically significant(P>0.05).From the 12 th week to the 24 th week of treatment,the four indexes of liver fiber in the treatment group were significantly decreased compared with the control group in the same period,and the difference was statistically significant(P <0.05).The four indicators of liver fiber in the treatment group were statistically significant at the 12 th week and 24 th week of treatment compared with those before treatment and at the 12 th week of treatment compared with the 24 th week of treatment(P <0.05);The control group had no significant difference in the comparison of liver fiber before treatment,at the 12 th week,and at the 24 th week in the four index groups(P> 0.05).5.Changes in liver function indexes: Before and at the 12 th week of treatment and at 24 th week of the two groups of patients,there was no significant difference in all liver function indexes observed between the two groups(P> 0.05).There was no significant difference in liver function indexes between the two groups during the same period(P> 0.05).6.Comparison of HBV-DNA viral load decrease and negative conversion: in the 12 th and 24 th weeks of treatment.The difference between the treatment group and the control group in achieving the HBV-DNA logarithmic value greater than 1 log and 2 log was statistically significant(P<0.05).However,the HBV-DNA logarithmic value was greater than 3 log and the HBV-DNA negative value.There was no statistically significant difference in transfer(P> 0.05).7.Comparison of the change of HBe Ag turning negative: There was nostatistically significant difference between the treatment group and the control group at the 12 th week and 24 th week of HBe Ag turning negative during the same period(P> 0.05).8.Comparison of the change of HBs Ag turning negative: There was no HBs Ag turning negative in the treatment group and the control group during the whole treatment process.9.Safety evaluation: A total of 60 patients were included in this study.During the 24-week treatment period,all patients did not fall off and were lost to follow-up.The experimental study was completed.The safety indicators of patients were checked and treated throughout the treatment There was no obvious abnormal change in safety indicators before and after.Only one patient felt mild nausea and discomfort after taking the drug,but all could tolerate it,and the remaining cases showed no obvious adverse reactions and toxic and side effects.ConclusionsShugan Jiedu Decoction can effectively improve the clinical symptoms of traditional Chinese medicine in patients with chronic HBV infection during the immune tolerance period,inhibit HBV-DNA replication,reduce the four indicators of liver fiber and liver stiffness value,and no obvious adverse reactions occurred during the treatment..This study confirms that the traditional Chinese medicine compound Shugan Jiedu Recipe is effective and safe in intervening in the immune tolerance period of chronic HBV infection,can delay the further progress of the disease,and provides a more beneficial treatment for the clinic,making up for the modern medicine for chronic HBV infection The lack of treatment is worth further clinical promotion. |
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