Treating chronic mutational hepatitis B with Chinese medicine Vitalliver (Vigconic suppositories)
ZHANG GUAN HUA, LIANG CHAO, ZHENG WAN PIN
Chengdu University of TCM, Hepatitis Laboratory in the attached hospital of Chengdu University of TCM, Sichuan, China
Quantitative determination by contrasting HBV-DNA of cases before and after the treatment.
Number of cases: 25 (n)
Case Selection: Between the age of 16 and 65, in accordance with the diagnosis standards pf chronic Hepatitis B, with negative e antigen and positive e antibody, HBV-DNA > 1×104 cp/mL.
Detection Method: All the blood samples are detected by Sichuan Clinical Detection Center; PCR-ELISA quantitative determination is used within detection range of 1×104 – 1×107-8, HBV-DNA, unit of measurement is cp/mL.
Direction Plan: one suppository provided by Vigconic (International) Ltd. Bid. The course of treatment is six months, the tracing observation after withdrawal lasts six months.
1. HBV-DNA response after the treatment.
2. Lasting HBV-DNA response (six months after withdrawal).
Criterion of Therapeutic Effect:
1. If HBV-DNA volume < 1×104 cp/mL, it is considered effective;
2. Compared with that before the treatment, if the HBV-DNA volume decreases at least two logarithmic levels, it is considered progressive;
3. If there is no change in HBV-DNA volume after the treatment, or the decrease is less than two logarithmic levels, it is considered ineffective.
Judging Levels of the side-effects: (five levels) definitely related, probably related, possibly related, possibly unrelated, definitely unrelated.
1. Response after treatment:
HBV-DNA volume < 1×104 cp/mL: 21/25 (84%)
HBV-DNA volume > 1×104 cp/mL: 4/25 (16%)
2. Lasting response:
HBV-DNA volume < 1×104 cp/mL: 23/25 (92%)
HBV-DNA volume > 1×104 cp/mL: 2/25 (8%)
Among the results of lasting response, 16 blood serum samples are detected through fluorimetric quantitative determination PCR by the instruments of PE.USD, H-7700 in the second attached hospital of Guangzhou Medical College. The result is in accordance with that in Sichuan Clinical Testing Center. (8 cases among it < 1×102 cp/mL). The testing range of this testing method is 1×102 – 1×107-8 cp/mL.
The reason for the repeatedly abnormal liver function of Chronic Hepatitis B (CHB) patients lies in the repeatedly duplication of HBV after infection, which leads to fibrosis of liver, then cirrhosis and liver cancer. It is commonly accepted that if CHB shows the transformation of HBeAg/Anti-HBe, HBV-DNA becoming negative, liver function returning to normal state, the disease is relieved. However, parts of patients with the transformation of HBeAg/Anti-HBe still remain positive in HBV-DNA and the pathological change in the liver continues. Because HBV-DNA occurs promoter mutation in the anterior C section (1896 necleoside G-A variation) or in the C section (1762 nucleoside T variation, 1764 G-A variation), HBeAg cannot come into being. Therefore, the HBeAg in the patient’s blood cannot be detected, while the virus can keep on duplicating and fixing itself. Through sequential assay of nucleic acid, it proves that promoter mutation appears in 30%-60% of HBeAg negative Chronic Hepatitis B (CHB) in the anterior C section or in the C section. In some provinces and cities of the People of China, the percentage of promoter mutation appears in HBeAg negative Chronic Hepatitis B (CHB) in the anterior C section or in the C section is from 17.6% to 78.9%. Eight out of the 25 cases of our observation go through the sequential assay of nucleic acid carried out by the Department of Microbiology of the University of Hong Kong. It all proves to have HBV-DNA mutation. The chronic mutational Hepatitis B is infectious and apt to cause cirrhosis and liver cancer since the present medicines of antivirus and immuno-modulator do not produce the expected therapeutic effects.
Vitalliver suppository is made up from a formula of Chinese herbs, including Ginseng, Deer Horn, Cordyceps, Radix Astragali, Frudctus Cnidii, Semen Cuscutae, etc. The formula is mainly for strengthening the body resistant and primarily for reinforcing Kidney Qi, which produces good therapeutic effects in treating chronic mutational Hepatitis B. The mechanism is probably that through the regulating of immune system, the duplication of virus is inhibited and meanwhile the liver is protected, so it can produce a lasting therapeutic effect. No adverse reaction and severe accident happens during clinical observation, so it is safe for using. Vitalliver is bringing hopes to the treatment of chronic mutational Hepatitis B.
* The second stage of clinical trial would be carrying out by the Microbiology Department of the University of Hong Kong and Chengdu University of Traditional Chinese Medicine.
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