| Objective: To study the effect of traditional Chinese medicine on HBsAg quantification and Serological clearance of HBsAg in patients with chronic HBV infection,and to provide evidence-based basis for clinical practice.Methods:In the China National Knowledge Network(CNKI),China Biomedical Literature Service System(CBM),Wanfang Data,VIP,Pub Med,The Cochranelibrary,Embase,Web of Science conducted a literature search in the Chinese Clinical Trial Registry(Chi CTR)from 2005 to 2021.Inclusion criteria:(1)Study subjects who met the diagnosis of chronic HBV infection in any of the 2005,2010,2015,and 2019 editions of the Guidelines for Prevention and Treatment of Chronic Hepatitis B:HBe Ag-positive chronic HBV infection,HBe Ag-positive CHB,HBe Ag-negative chronic HBV infection,and HBe Ag-negative CHB can meet the diagnostic criteria for more than 6 months of HBsAg and/or HBV DNA positive.(2)Intervention test group should use traditional Chinese medicine(Chinese herbal medicine,Chinese patent medicine,Chinese herbal medicine preparation or extract)or integrated Chinese and Western medicine treatment,including traditional Chinese medicine +general drugs(conventional liver protection drugs,vitamins,etc.),traditional Chinese medicine + NAS or interferon,traditional Chinese medicine + NAS or interferon + general drugs,The control group can be blank control and placebo,NAS,interferon,general drugs alone or in combination.(3)Observation indexes must include either HBsAg quantity or HBsAg negative conversion rate.(4)The trial type was randomized controlled trial.Exclusion criteria :(1)subjects with concurrent infection with hepatitis A,C,D,E or other viruses such as HIV infection;Or combined with drug-induced liver injury,non-alcoholic fatty liver disease,alcoholic liver disease,autoimmune liver disease,metabolic liver disease and other liver diseases;Or liver fibrosis,cirrhosis,liver failure,liver cancer;Or combined with serious cardiovascular and cerebrovascular,lung,kidney,endocrine,hematopoietic system diseases and other system diseases.(2)Patients in the experimental group who received external treatment of traditional Chinese medicine or other traditional Chinese medicine treatment such as acupuncture.(3)case-control studies,cohort studies and other observational clinical studies,non-randomized controlled trials and experimental studies,case reports and reviews,etc.(4)Literature that does not meet the inclusion criteria or cannot obtain the full text.According to the inclusion and exclusion criteria,the literature that finally met the requirements was screened layer by layer,and the data was extracted,and the statistics were combined and analyzed by Rev Man software.Results:(1)The total HBsAg negative conversion rate at the end of treatment in the 16 cases combined with TCM group was compared with that in the non-TCM group(RR=1.72,95%CI[1.39,2.12],P <0.00001,I2=0%);Two of them were related to non-antiviral drugs(RR=5.69,95%CI[0.79,40.91],P=0.08,I2=0%).8 TCM + NAS compared with NAS(RR=1.64,95%CI[1.27,2.12],P=0.0001,I2=0%);Compared with IFN(RR=1.70,95%CI[1.17,2.47],P=0.0005,I2=0%),6 TCM +IFN were compared with IFN(RR=1.70,95%CI[1.17,2.47],P=0.0005,I2=0%).(2)There were statistically significant differences between TCM combined with antiviral drugs(NAS,IFN)treatment group at 24weeks(RR=1.55,95%CI[1.21,1.99],P = 0.0005)and non-TCM treatment group at 48 weeks(RR=2.02,95%CI[1.28,3.17],P = 0.002).(3)There was a statistically significant difference in HBsAg quantification at the end of treatment(there was no statistically significant difference in HBsAg quantification between the two groups before treatment)between the 7 TCM combined antiviral treatment group and the non-TCM treatment group(MD=-0.27,95%CI[-0.44,-0.10],P=0.002).Conclusion: Traditional Chinese medicine combined with western medicine antiviral therapy can effectively reduce the quantitative level of HBsAg and improve the negative conversion rate of HBsAg.This conclusion can provide evidence and treatment ideas for the treatment of HBV infection and the improvement of HBsAg negative conversion rate to a certain extent.However,due to the low level of evidence provided in this study,large sample and high quality RCT literature are still needed to support. |
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