Observe The The Clinical Efficacy And Safety Of Using The Method Of "Nourishing Kidney To Produce Marrow And Form Liver" To Treat The Chronic Hepatitis B Of HBeAg-negative

Object:Observe the the clinical efficacy and safety of using the method of "nourishing kidney to produce marrow and form liver" to treat the chronic hepatitis B of HBeAg-negative.Method:The138enrolled patients were randomly divided into "nourishing kidney to produce marrow and form liver " treatment group, Antiviral treatment group,"nourishing kidney to produce marrow and form liver" combined with Antiviral treatment group by the way of Randomized controlled clinical trials (RCT).The patients of "nourishing kidney to produce marrow and form liver " treatment group were given the nosocomial preparation(Hubei Pharmaceutical batch Z20113160, produced by Hubei Province Chinese Medicine Hospital) for6months. The Antiviral treatment group were given the nucleoside analogues (Entikawei, Adefovir Dipivoxil Tablets, Lamivudine, and so on) according to the condition for6months. The "nourishing kidney to produce marrow and form liver" combined with Antiviral treatment group were given the nosocomial preparation and nucleoside analogues for6months. Use the way of real-time quantitative PCR to detect the HBV-DNA. Use the Roche assay for the quantification of HBV markers. Besides, use Toshiba120automatic biochemical analyzer and reagents to detect liver function. Using Liver histology to detect pathological changes. And observe these security indicators, such as the heart rate, heart rhythm, blood pressure, body weight; blood test, urine test, stool test; kidney function, ECG, etc.Results:According to the statistical analysis of124cases with complete data of clinical trial data, we find that.①the virologic response indicators:After six months’treatment,the HBV-DNA negative rate of "nourishing kidney to produce marrow and form liver " treatment group, Antiviral treatment group, "nourishing kidney to produce marrow and form liver" combined with Antiviral treatment group respectively is8.96%、30.31%、35.54%. There are significant differences(P＜0.05).②the biochemical response indicators:After5months’treatment, the ALT of "nourishing kidney (36.18±20.16) is significantly lower than Antiviral treatment group (42.67±22.03).Besides, the ALT of "nourishing kidney to produce marrow and form liver" combined with Antiviral treatment group (25.25±11.62) is lower than both the "nourishing kidney to produce marrow and form liver " treatment group and Antiviral treatment group. There are significant differences among these three groups according to the statistical analysis (P＜0.05).The AST of "nourishing kidney to produce marrow and form liver " treatment group, Antiviral treatment group,"nourishing kidney to produce marrow and form liver" combined with Antiviral treatment group respectively is28.00±7.29,49.00±33.65.28.00±7.29after5months’treatment. There are significant differences among these three groups according to the statistical analysis (P<0.05)..The GGT of "nourishing kidney to produce marrow and form liver " treatment group, Antiviral treatment group,"nourishing kidney to produce marrow and form liver" combined with Antiviral treatment group respectively is15.00±5.66,41.50±43.13,17.33±12.86after6months’treatment. There are significant differences among these three groups according to the statistical analysis (P＜0.05).③Liver histological response indicators:25cases of liver tissue test results show the rate of Liver histological response of "nourishing kidney to produce marrow and form liver " treatment group and Antiviral treatment group respectively is30.00%,28.57%. There are not significant differences between these two groups according to the statistical analysis (P>0.05).But the rate of Liver histological response of "nourishing kidney to produce marrow and form liver" combined with Antiviral treatment group is77.78%, There are significant differences among these three groups according to the statistical analysis (P＜0.05).④Safety evaluation indicators: The main safety evaluation indicators(including the heart rate, heart rhythm, blood pressure, body weight; blood test, urine test, stool test; kidney function, ECG, etc.) show that there are not abnormal reaction directly related to the treatment. There is no obvious adverse reflect events throughout the course of treatment.Conclusion:Our research based on RCT shows that there are high securitys in the treatment of "nourishing kidney to produce marrow and form liver" and "nourishing kidney to produce marrow and form liver" combined with Antiviral.By the way of nourishing kidney to produce marrow and form liver we can affect the host factors. So it can get a better virological, biochemical and histologic responses in the treatment of chronic hepatitis B of HBeAg-negative by the combined use of antiviral drugs which can affect viral factors. Through this way we improve the clinical efficacy significantly and we can say "nourishing kidney to produce marrow and form liver" combined with Antiviral treatment is better than single "nourishing kidney to produce marrow and form liver " treatment and single Antiviral treatment. It also provides a higher level of evidence of Evidence-Based Medicine for the focus on both viral and host factors by which way we can improve clinical efficacy. Though the single use of "nourishing kidney to produce marrow and form liver " to treat the chronic hepatitis B of HBeAg-negative does not get significant virologic response, it also get a good biochemical and histologic response. As the gold standard for evaluation,the liver histology results shows the single use of "nourishing kidney to produce marrow and form liver " is equivalent to the single use of antiviral drugs. This research initially provides a higher level of evidence of Evidence-Based Medicine about the effect ive effect of nourishing kidney to produce marrow and form liver " to treat the chronic hepatitis B of HBeAg-negative by affecting the host factors.