| Objective: To evaluate the clinical efficacy and safety of clearing heat and dampness,invigorating the spleen and promoting blood circulation combined with entecavir(beishuangding)in the treatment of chronic hepatitis B patients in the real world by using propensity score matching method and observing the changes of biochemical indexes,pathogenic indexes,fibrosis indexes and safety indexes of liver.Methods: From February 2018 to December 2019,a total of 206 patients who were hospitalized in the hepatology clinic and ward of Anhui Hospital of traditional Chinese medicine and met the western medicine diagnosis standard of chronic hepatitis B were selected.According to whether they accepted the oral treatment of traditional Chinese medicine of clearing away heat and promoting dampness and invigorating the spleen and activating blood,they were divided into 60 cases in the traditional Chinese medicine group and 146 cases in the control group.According to the tendentiousness score,the patients in the two groups were matched and treated for 4W and 8W respectively The changes of ALT,AST,GGT,ALP,TBIL,Apri scores,HBs Ag,HBV DNA,and the effects on blood routine test and renal function in the two groups.Results: 206 cases of chronic hepatitis B were included in this study.Before matching,some indexes of the two groups were statistically significant in gender,age,family history,drinking history,course of disease,whether accompanied with hypertension,type 2 diabetes,fatty liver and so on.There was no comparison between the two groups.Using 1:1 nearest neighbor matching method to match,a total of 56 pairs and 112 patients were matched successfully.There was no significant difference in the above clinical characteristics between the two groups after the successful matching,which was comparable between the two groups.The results of this study:(1)ALT and AST level comparison: after 4W,8W and 12 W treatment,the ALT and AST levels of the two groups were significantly lower than before treatment,the difference was statistically significant(P <0.05);(2)After 4W,8W and 12 W treatment,GGT,ALP and TBIL of the two groups were significantly lower than before treatment,The difference was statistically significant(P < 0.05).The improvement level of GGT,ALP and TBIL in the traditional Chinese medicine group was better than that in the control group after 4W and 8W treatment,but there was no statistical significance between the two groups after 12 W treatment;(3)Comparison of the Apri score: after 4W,8W and 12 W treatment,the Apri value in the two groups was lower than that before treatment,and the difference was statistically significant(P < 0.05).After 4W and 8W treatment,the Apri value in the traditional Chinese medicine group was lower than that before treatment There was no significant difference between the two groups(P > 0.05).With the prolongation of the course of treatment,there was significant difference between the two groups at 12W(t =-4.714,P = 0.000).The traditional Chinese medicine group was superior to the control group;(4)Comparison of HBs Ag level: after 4W,8W and 12 W treatment,the level of HBs Ag in the two groups did not change significantly compared with that before treatment,and there was no significant difference between the two groups(P > 0.05),but the overall decline trend of HBs Ag level in the traditional Chinese medicine group was slightly higher than that in the control group;(5)comparison of HBV DNA level: after 4W,8W,12 W treatment,the two groups HBV Compared with the control group,the DNA level of the two groups decreased in different degrees,the difference was statistically significant(P < 0.05);(6)safety index: before and after treatment,the safety indexes of blood routine and renal function of the two groups were normal.Conclusion:1 The method of clearing away heat and dampness,invigorating spleen and promoting blood circulation combined with entecavir can improve the inflammation of liver rapidly and effectively,which is more effective than that of entecavir alone;2 The method of clearing away heat and dampness,invigorating spleen and promoting blood circulation can reduce the indexes of cholestasis(GGT,ALP,TBIL)rapidly and effectively,and has a better effect of cholagogue and yellowing;3 After 12 W treatment,the improvement of Apri value in the Chinese medicine group was more significant than that in the control group.The improvement of liver fibrosis degree by the methods of clearing away heat and promoting dampness,invigorating spleen and activating blood circulation could be further proved with the prolongation of the course of treatment and the inclusion of more fibrosis indexes;4 12 weeks of treatment,the level of HBs Ag in the two groups was not significantly lower than that before treatment,but the decreasing trend of HBs Ag in the traditional Chinese medicine group was slightly more obvious than that in the control group;5 After 12 weeks of treatment,both groups can effectively reduce the level of HBV DNA,but the method of clearing heat and promoting dampness,invigorating the spleen and activating blood circulation can quickly inhibit the replication of HBV,which is more effective than that of entecavir alone;6 In the treatment of chronic hepatitis B,the method of clearing away heat and removing dampness,invigorating the spleen and activating blood circulation has reliable curative effect and no adverse reactions,so it can be widely used in clinic. |
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