According to experts, the vast majority of hepatitis b patients in our country is immune, immune tolerance stage, various antiviral treatment for these patients, the effect is not very satisfactory. Treatment of hepatitis b vaccine is a preventive vaccine implementation structure modification or add new adjuvants for therapeutic purposes, are currently testing in a synthetic peptide vaccine, DNA vaccines, immune complex vaccines, antibodies of Antigen for vaccine, vaccine can enhance the body immunity of body fluids and cells, to clear the virus body.
Therapeutic vaccine is still at an experimental stage, our independent research and development for the treatment of hepatitis b vaccine is now available through a phase of clinical trials (initial security test), is now entering phase II clinical trials (effective and safety study of the human body), if successful, will also need to phase III clinical trial (large multi-center study). If phase III trials successfully concluded, the test results confirmed vaccine safety and effectiveness is satisfactory before listing, so that the majority of patients, such a test cycle should be in 4 years time.
Experts believe that therapeutic vaccine application object is persistent infection with hepatitis b patients, although there are good prospects for development, but its development requires a complex process. The composition of the therapeutic vaccine is not as simple as a preventive vaccine, it needs to continually adjust the combination, in order to break the immune tolerance to increase the specificity of the hepatitis b virus immune response and, therefore, vaccines, adjuvant, awaiting the time of inspection. Due to individual differences in patients with hepatitis b, hepatitis b virus mutants, vaccine dose etc. issues outstanding, the therapeutic vaccine could not vote people at once, for clinical use. In the validation of therapeutic vaccines must be in strict accordance with the new drug development program of clinical trials, clinical trials, and only get the State food and Drug Administration's clinical drug approval number, in order to become industrialized production, so that the majority of patients in the use of vaccines. If there was on the market to profit for the purpose of selling so-called therapeutic vaccine in advertising or publicity, is deceptive. Dr. Liu and stressed that the treatment of hepatitis b vaccine is also a need for long-term clinical trial observation, vaccine therapy cannot substitute medication. Currently, the treatment of hepatitis b in many various drugs, the majority of hepatitis b patients need according to your own illness, in normal hospital doctor's guidance, the timely medication, rational use of medicines, science, medicine, never waiting for treatment of hepatitis b vaccine held-to-market.
(Editors: Han 1m1m SWE)
No comments:
Post a Comment