Clinical Observation Of The Therapeutic Effect Of Rougan Huaxian Granule Combined With Entecavir In The Treatment Of Hepatitis B Cirrhosis(Syndrome Of Liver-kidney Yin Deficiency)

Objective : By comparing the clinical efficacy,inflammatory factors and oxidative stress levels of Rougan Huaxian Granule combined with Entecavir alone in the treatment of hepatitis B cirrhosis(liver and kidney yin deficiency syndrome),the inhibitory effect of Rougan Huaxian Granule on the process of hepatitis B cirrhosis and its possible mechanism were clarified.Methods: 70 patients who met the inclusion criteria were collected and divided into treatment group and control group according to the random number table method,each group 35 cases.The control group was treated with entecavir dispersible tablets and the treatment group with entecavir dispersible tablets combined with Rougan Huaxian Granule.The clinical effect was observed for 48 weeks.serum HBV-DNA? liver function(ALT?AST?ALB?TBi L),hepatic fibrosis four items(PCIII?IV-C?LN?HA),inflammatory factors(TNF-??IL-6?IL-8?IL-10),oxidative stress index(ROS?MDA?SOD?GSH-Px),changes of TCM syndrome score and adverse events were observed and recorded in the two groups at 0,24 and 48 weeks.Results :1.Total effective rate comparison: the total effective rate of the control group was 50% at 24 weeks,the total effective rate of the treatment group was 68.6%,the difference was not statistically significant(P>0.05);the total effective rate of the control group was 68.8% at 48 weeks,and the total effective rate of the treatment group was 88.6%,the difference wasstatistically significant(P<0.05).2.Comparison of TCM syndrome score: compared with before treatment,the TCM syndrome score of the two groups decreased at 24 weeks and 48 weeks,the difference was statistically significant(P<0.05);the improvement of TCM syndrome score in the treatment group was better than that in the control group(P<0.05);and the curative effect increased with the increase of treatment time.3.Virus inhibition: compared with before treatment,the two groups of patients can effectively inhibit hepatitis B virus,but the two groups in the treatment of 24 weeks,48 weeks,the difference was not statistically significant(P<0.05).4.Liver function comparison: compared with before treatment,the ALT?AST?TBIL of the two groups decreased and the ALB increased(P<0.05);after 24 weeks and 48 weeks,the ALT?AST?TBIL of the treatment group decreased significantly compared with the control group,and the difference was statistically significant(P<0.05).5.Serum liver fibrosis index comparison: compared with before treatment,the PCIII ? IV-C ? LN ? HA of the two groups decreased,the difference was statistically significant(P<0.05);after 24 weeks,48 weeks,the PCIII?IV-C?LN?HA of the treatment group decreased significantly compared with the control group,the difference was statistically significant(P<0.05);and with the extension of treatment time,48 weeks compared with 24 weeks,the difference was statistically significant(P<0.01).6.Comparison of inflammatory factors: The serum inflammatory factors(TNF-? ? IL-6 ? IL-8)of the two groups decreased in different degrees compared with before treatment,the IL-10 increased,the difference was statistically significant(P<0.05);the TNF-??IL-6?IL-8 of the treatment groupdecreased significantly compared with the control group at 24 and 48 weeks,and the difference was statistically significant(P<0.05)treatment time,the improvement of inflammatory factors at 48 weeks was more obvious than that at 24 weeks,and the difference was more statistically significant(P<0.01).7.Oxidative stress index comparison: compared with before treatment,the expression of ROS ?MDA in the two groups was down-regulated,the expression of SOD?GSH-Px was up-regulated,the difference was statistically significant(P<0.05);the expression of ROS?MDA in the treatment group was down-regulated compared with the control group at 24 weeks and 48 weeks,and the expression of SOD?GSH-Px was up-regulated compared with the control group,the difference was statistically significant(P<0.01).8.Safety comparison: during the clinical observation period,the safety index of the two groups did not appear obvious abnormal,the treatment group had 3 patients with diarrhea,no drug treatment can be self-relief within 5 days,the remaining patients did not have special adverse events.Conclusions:1.The inhibitory effect of Rougan Huaxian Granule on the process of hepatitis B cirrhosis may be related to the level of antioxidant stress and inflammatory factors.2.Compared with patients treated with compensatory stage hepatitis B cirrhosis(liver and kidney yin deficiency syndrome)with Rougan Huaxian Granule combined with entecavir alone,the former is obviously the latter in terms of clinical efficacy,TCM syndromes,inhibition of virus replication,improvement of liver function,improvement of liver fibrosis index,inhibition of inflammatory factors and antioxidant stress.3.The treatment of liver cirrhosis(liver and kidney yin deficiency syndrome)with Rougan Huaxian Granule combined with entecavir iseffective and synergistic,which is worthy of clinical promotion.