Part I: Introduction to the Plan A and B in the table: during the 0-24 week of the study, the programme was dynamic.
If hbeag>60 S/co in the group, give a drug, that is, liver-invigorating spleen granule + entecavir placebo (Plan a), then every 4 weeks after the examination, decided after the treatment plan (see part II)
If hbeag<60 S/co in the group, give B drugs, namely Liver JIANPI jiedu granule + entecavir (Plan B), until the end of the 24th week.
Part II: Dynamic conversion of drug solutions
For patients who have applied a scheme after the group, in the first 24 weeks, a liver function test with ALT and five hepatitis B containing Hbeag were performed every 4 weeks, and the drug was converted according to the indicator.
The
Drug conversion Initiation Mechanism is: in the first 24 weeks, the initial use of a drug program, if the drug process in the following 2 cases (1. Alt≥8xuln and hbeag<200 S/co, or 2. Hbeag<60 S/co) was converted to a liver-invigorating spleen jiedu granule + en-entecavir treatment to 24 weeks. (a→b)
Part III: Drug code (only for the first 24 weeks of the drug programme, beginning of the 25th week of harmonization, see part Fourth)
A-B scenario: In the first 24 weeks, there was a drug conversion for the initial use of a drug programme, from A to B. recorded as a-a
A-a Scenario: In the first 24 weeks, the initial use of a drug programme did not appear to meet the conditions for drug conversion, always using a regimen.
B-b Scenario: In the first 24 weeks, a drug conversion was not present in the first 24 weeks of the initial use of the B drug programme, and the B regimen was always used.
Part IV: All patients begin in the 25th week, regardless of the previous programme, to a uniform conversion to plan B until the end of the 108-week study.
Part V: On the control group: the first to fourth part of the above rule, the control group also applies. The control group also has a, b two sets of programs, and the difference between the experimental group is that the control groups, whether a or B drugs are both traditional Chinese medicine simulator + Western medicine en entecavir.
About efficacy indicators
Hbeag was the main curative index, and the study evaluated the rate of HBEAG (<1 S/co) in two groups of 108 weeks.
HBV DNA is a secondary curative index, the table is converted to LOG10IU/ML, the minimum detection limit is 500iu/ml (<500 iu/ml for the Turn yin, in this table uniformly counted as 2.7LOG10IU/ML)
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