| Objective: Based on the concept of real-world study,this study retrospectively analyzed the pathogenic indexes,liver biochemical indexes and bone marrow suppression of HBe Ag-positive CHB patients treated with PEG-IFNα-2b using propensity score matching,and evaluated the efficacy and safety of real-world Chinese medicine tonics combined with PEG-IFNα-2b in the treatment of CHB,and also combined with the identification and treatment of CHB in the Liver Disease Centre of Xiamen Chinese Medicine Hospital.The study also analyzed the drug use pattern of Chinese medicine to provide reference for clinical diagnosis and treatment of CHB.Methods: This study used a real-world retrospective cohort design.The subjects were CHB and HBe Ag-positive patients who started initial antiviral therapy in Xiamen Hospital of Traditional Chinese Medicine from June 2017 to January 2022 and maintained long-term follow-up.The real diagnosis and treatment process of patients was recorded with traditional Chinese medicine treatment as the exposure factor.According to whether they received TCM decoction or not and the extent to which they received TCM decoction,the group treated with pegylated interferon α-2b combined with TCM decoction for ≥3 months and used for CHB treatment was the experimental group.The patients treated with peginterferon α-2b alone were divided into the control group to objectively evaluate the efficacy of TCM decoction combined with peginterferon α-2b in the real world.Traditional Chinese medicine decoction forms can be self-decoction,hospital decoction and granules.The pegylated interferon alpha-2b treatment course was followed by interferon antiviral treatment course for 48 weeks in both groups.Results:(1)Quantification of HBs Ag: The quantification of HBs Ag in both groups decreased with the extension of treatment course,and the difference was statistically significant(P < 0.05);There was no significant difference between the two groups at 12 weeks of treatment(P > 0.05).After 24 weeks of treatment and 48 weeks of treatment,the experimental group was better than the control group in quantitative reduction of HBs Ag,the difference was statistically significant(P < 0.05).(2)HBe Ag quantification: Intra-group comparison showed that HBe Ag quantification in both groups decreased with the extension of treatment course,and the difference was statistically significant(P < 0.05);Compared with the control group,there was a statistically significant difference in the decrease of HBe Ag in the experimental group after 48 weeks of treatment(P< 0.05).Between the two groups,there were statistically significant differences in HBe Ag serological conversion rate at 12 weeks,24 weeks and 48 weeks of treatment((P< 0.05).(3)HBV DNA quantification: In intra-group comparison,HBV DNA quantification in both groups decreased with the extension of treatment course,and the difference was statistically significant((P< 0.05);The amount of HBV DNA decreased in experimental group was better than that in control group at 24 and 48 weeks of treatment,and the difference was statistically significant(P< 0.05).At 48 weeks of treatment,the negative conversion rate of HBV DNA in the experimental group was higher than that in the control group,and the difference between the two groups was statistically significant(P < 0.05).(4)ALT and AST: The levels of ALT and AST were decreased in both groups,and the difference was statistically significant(P < 0.05).Compared with the control group at 12 weeks,24 weeks and 48 weeks,there was no statistical significance in the decrease amount of ALT and AST or the relapse rate of ALT and AST in the experimental group(P> 0.05).(5)Blood routine indexes:Compared within the two groups,the quantitative reduction of NEUT and PLT in both groups was statistically significant(P < 0.05).After 48 weeks of treatment,NEUT decreased less in experimental group than in control group,and the difference was statistically significant(P < 0.05).There was no significant difference in the incidence of bone marrow suppression between the two groups at 12 weeks of treatment(P>0.05).Compared with the control group at 24 weeks and 48 weeks of treatment,the probability of myelosuppression in the experimental group was lower than that in the control group,and the difference was statistically significant(P < 0.05).(6)The analysis of the results of Chinese herbal medicine showed that the most patients included in this study belonged to liver-depression and spleen-deficiency evidence and liver-biliary damp-heat evidence,fewer patients were identified as liver-kidney yin-deficiency and spleen-kidney yang-deficiency,and the least number of patients were identified as stasis-blood blocking evidence.A total of 144 Chinese herbal medicines were counted in the analysis of the pattern of Chinese medicine use,with a total frequency of 1369 times,which showed a relative concentration of Chinese medicine use.The total frequency of use was more than 30%: licorice,Chai Hu,Atractylodes macrocephala,Poria,Scutellaria,Radix Paeoniae Alba,Radix Angelicae Sinensis,Huang Lian,Yu Jin,and Peppermint;the most effective medicines were used to dredge the liver and strengthen the spleen;the main medicinal properties were mainly flat,warm and slightly cold medicines;the taste of medicines was mainly bitter,sweet and pungent;the statistics on the attribution of meridians basically covered all internal organs,with the most attributed to the foot Taiyin Spleen meridian.Conclusion:(1)Chinese herbal soup combined with PEG-IFNα-2b for the treatment of CHB was superior to the control group in achieving a decrease in HBs Ag and HBV DNA,negative conversion of HBV DNA and serological conversion of HBe Ag,acting as an additive effect.(2)Chinese herbal soup combined with PEG-IFNα-2b antiviral therapy can reduce the incidence of abnormal NEUT and PLT rates,reduce the adverse effects of reversible myelosuppression caused by PEG-IFNα-2b,and act as a toxicity reducer.(3)Patients included in this study were most frequently identified as having liver-depression,spleen-deficiency and liver-biliary damp-heat symptoms.A total of 144 herbal medicines were counted,with a total frequency of 1369 times.The results showed that the cumulative frequency of use of the following medicines was more than 30%: licorice,bai hu,atractylodes,poria,scutellaria,white peony,angelica,yellow lily,yujin and peppermint;the most effective medicines were used to de-stress the liver and strengthen the spleen;their properties were mainly flat,warm and slightly cold;their tastes were mainly bitter,sweet and pungent;the statistics on the attribution of meridians basically covered all the internal organs and meridians.Among them,the most belongs to the Foot Taiyin Spleen meridian.(4)The research in the real world accords with the actual clinical situation of traditional Chinese medicine,and can provide certain scientific basis for evaluating the clinical efficacy of TCM treatment based on syndrome differentiation. |
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