| Hepatitis B, particularly chronic hepatitis B, has become a global health problem. According to statistics, over one million people have died of hepatitis B virus infection and its related diseases every year. Furthermore, hepatitis B has caused direct economic losses of 50 billion yuan in China every year. But so far, there still lack the ideal treatment for chronic hepatitis B. Therefore, how to effectively prevent and control hepatitis B is still the topic needed to be faced and addressed as a major issue for the 21st century.Clinical practice shows that the main part of the treatment for chronic hepatitis B includes suppression of virus, protection of liver cells, regulation of immunity, and prevention of liver fibrosis. Among these, finding the suppression of hepatitis B virus is the most crucial. Treatment for Chronic hepatitis B includes suppression of viral replication to reduce liver inflammation and necrotizing lesions which would, in turn, effectively improve long-term clinical prognosis of patients, prolong survival rate, and enhance quality of life.For a long time, especially after the 70s, the application of TCM treatment for chronic hepatitis B has reported more than ever, and the effective treatments have been obtained. Its advantages can be reflected in the significant improvement in symptoms and quality of life. TCM treatment also plays an important role of liver protection through multiple targets such as immune regulation, anti-fibrosis effects, and anti-virus effect. Furthermore, it shows basically no adverse reaction on the patients while keeping the health care costs relatively low. Chinese doctors think that hepatitis B virus belongs to heat/damp capsici. Clinically, chronic hepatitis B of liver-spleen dampness-heat type is the most commonly seen syndrome and serves a high research value.Objective:This study utilizes the clinical experience for the medical treatment of chronic hepatitis B combined with modern pharmacology study to form a TCM concoction. Through randomized and controlled clinical trials for chronic hepatitis B of liver-spleen dampness-heat type and strict guidelines, the clinical effects of this TCM concoction using scientific, objective, and reasonable analysis can be observed.Methods:Utilizing the principle of random grouping,60 chronic hepatitis B patients diagnosed as liver-spleen dampness-heat type are randomly divided into treatment and control groups by 1:1 ratio. Yin Ling Guan Sang Yin is developed for the treatment group while the control group is given Long Dan Xie Gan mixture. With 3 months treatments, the two groups are observed using clinical symptoms, liver function, and HBV markers. In the end, the effects of the two groups will be compared using the criteria of clinical research guiding principles for the treatment of viral hepatitis using new Chinese herbal medicine.Results:The total clinical efficiency for the treatment group is 90%; the total clinical efficiency for the control group is 85%; the total clinical efficacy of the two groups show no significant difference (P>0.05). The symptoms of the two groups after the treatment has improved significantly (P<0.01). Improvement in the treatment group for the symptoms of chest congestion and bloat has shown signicant difference compared to the control group (P<0.01). After the treatment, ALT, AST, AKP, G, and TBil have significantly improved for the two groups (P<0.01); however, the two groups show no significant difference (P>0.05). For the HBV markers of the treatment group, HBsAg negative rate is 5.6%; HBeAg negative rate is 11.8%; HBV-DNA negative rate is 10%. For the HBV markers of the control group, HBsAg negative rate is 0; HBeAg negative rate is 5.6%; HBV-DNA negative rate is 5%. Two groups show no significant different (P>0.05). For toxicity comparison, there are no adverse reactions and side effects.Conclusion:The treatment for chronic hepatitis B of liver-spleen dampness-heat type with Yin Ling Guan Sang Yin has achieved a good result. The symptoms for the chronic hepatitis B patients have improved while the liver function has being restored (lowering ALT/AST, showing anti-virus effects). Application of Yin Ling Guan Sang Yin to the treatment for liver-spleen dampness-heat type of chronic hepatitis B can significantly improve the clinical symptoms better than the control group. Results show that Yin Ling Guan Sang Yin has play a important role in Jianpi Yiqi during the treatment of liver-spleen dampness-heat type for chronic hepatitis B while reducing the clinical symptoms and improving liver function.
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