The first part: the introduction of the A and B schemes in the table: During the 0-24th week of the study, the subject scheme is a dynamic scheme.
If HBeAg>60 S/CO at the time of enrollment, drug A, namely Tiaoganyipi granules + entecavir placebo (plan A), will be administered, and then every 4 weeks will be checked to determine the subsequent treatment plan (see Part II)
If HBeAg<60 S/CO at the time of enrollment, drug B, namely Tiaoganjianpijiedu granules + entecavir (scheme B), was administered until the end of the 24th week.
Part II: Dynamic switching of drug regimens
For the patients who applied program A after enrollment, in the first 24 weeks, liver function tests containing ALT and five tests of hepatitis B containing HBeAg were performed every 4 weeks, and drug switching was performed according to the indicators.
The initiation mechanism of drug switching is as follows: in the first 24 weeks, for the initial use of drug regimen A, if the following two conditions occur during the medication process (1. ALT≥8×ULN and HBeAg<200 S/CO, or 2.HBeAg<60 S/CO) was switched to Tiaoganjianpijiedu granules + entecavir for 24 weeks. (A→B)
Part 3: Drug Codes (only for the first 24 weeks of the drug regimen, starting from the 25th week, the regimen will be unified, see Part 4)
AB scheme: in the first 24 weeks, the initial use of the A drug scheme has drug conversion, from A to B, recorded as AB scheme
AA regimen: In the first 24 weeks, those who initially used drug regimen A did not meet the conditions for drug switching, and regimen A was always used.
BB regimen: In the first 24 weeks, there is no drug switch in the first 24 weeks for those who initially use the B drug regimen, and the B regimen is always used.
Part 4: All patients, regardless of previous regimen, were switched to regimen B starting at week 25 until the end of the 108-week study.
Part 5: Regarding the control group: The rules of Parts 1 to 4 above are also applicable to the control group. The control group also has two sets of programs, A and B. The difference from the experimental group is that both drugs in the control group, A and B, are both traditional Chinese medicine simulants + western medicine entecavir.
About efficacy indicators
HBeAg was the main efficacy indicator, and the subject evaluated the HBeAg negative (<1 s/co) rate of the two groups at 108 weeks.
HBV DNA is a secondary efficacy indicator, which is converted into Log10IU/ML in this table, and the minimum detection limit is 500IU/ml (<500 IU/Ml is negative conversion, which is uniformly counted as 2.7log10IU/ml in this table)
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