The first phase of hepatitis B treatment vaccine in China won the phased results

The first hepatitis B therapeutic vaccine (Eg) with independent intellectual property rights was jointly developed by the Medical Molecular Virus Laboratory of Shanghai Medical College of Fudan University and Beijing Institute of Biological Products. analysis. Among patients with E antigen seroconversion after treatment with the vaccine, 59.6% of patients had viral load reduced to clinically negative, 84.4% of patients had normal liver function, surface antigen levels decreased, and liver tissue biopsy and cellular immunity were all relieved by inflammation. , indicating that the vaccine has a good effect on hepatitis B patients.

It is reported that this clinical trial was registered in the International Clinical Trials Registration Network in strict accordance with international standards, and was conducted in 21 national drug clinical research institutions in accordance with the scientific “multi-center, randomized, double-blind, placebo-controlled method”. The study adopted the currently recognized and most suitable HBeAg seroconversion as a therapeutic evaluation standard.

The research team conducted Phase I clinical trials in Phase III clinical trials based on the current clinical experience of patients with chronic hepatitis B who had undergone antiviral therapy (using nucleosides and interferons) for not less than one year. Six months after the first injection of 6 doses of E-grams has been achieved, one course of treatment has been added, ie, 12 patients of chronic hepatitis B have been given a total of 12 grams of Eg. The treatment period has been extended from six months to one year, and follow-up 6 months. After 518 patients completed two courses of treatment and follow-up, there was no statistical difference between the E-serum seroconversion rate and the aluminum hydroxide group. Although the E antigen seroconversion rates of the two Phase B and Phase I phase III clinical trials were higher than those of untreated chronic hepatitis B patients, the sample size must be increased to further confirm the efficacy.

At present, the research team will further design the Phase II clinical confirmation test according to the requirements.

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