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“治疗性乙肝疫苗”是以乙肝病毒(HBV)的表面抗原(s抗原)为基础的生物制剂,目的是激发抗s抗原免疫反应,终止HBV慢性感染。HBV的e抗原与s抗原无抗原性关联,对e抗原的反应也与病毒及感染细胞的清除无关,因此以II期临床试验者血清有关病毒e抗原的数据结果,尚不能判断“治疗性乙肝疫苗”是否有效。疫苗的应用是抵御病毒入侵,而治疗性乙肝疫苗是在病毒已经进入人体后应用,在患者肝细胞可能广泛受累的情况下,疫苗一旦打破耐受激发抗s抗原免疫反应,除能清除血清中游离的病毒和s抗原颗粒外,将直接攻击被感染的肝细胞。由于无法估计慢性HBV感染者肝细胞感染程度,所以无法推测免疫反应发生后,免疫病理所致的肝损程度以及相应的风险。在应用上隐含如此风险,是“治疗性乙肝疫苗”走不出实验室的重要因素之一。
“Therapeutic hepatitis B vaccine” is a biological agent based on hepatitis B virus (HBV) surface antigen (s antigen), the purpose is to stimulate anti-s antigen immune response, termination of chronic HBV infection. HBV e antigen and s antigens antigen-free association of the e antigen reaction with the virus and infected cell clearance has nothing to do with the phase II clinical trial of serum e virus-antigen data results, yet to determine the “therapeutic Hepatitis B vaccine ”is effective. Vaccine application is to resist the invasion of the virus, and the therapeutic hepatitis B vaccine is applied after the virus has entered the human body, in patients with liver cells may be widely involved, once the vaccine breaks down to stimulate the anti-s antigen immune response, in addition to clear the serum Free virus and s antigen particles, will directly attack the infected liver cells. Because of the inability to estimate the degree of hepatocellular infection in patients with chronic HBV infection, it is not possible to speculate on the degree of liver damage due to immunopathology and the associated risk after an immune response has occurred. Implicit in the application of such a risk, is “Hepatitis B vaccine” can not get out of the laboratory one of the important factors.