慢性乙型肝炎临床治愈的破晓晨晖

Dawn of the clinical cure for chronic hepatitis B

乙型肝炎病毒(HBV)的发现为慢性乙型肝炎(CHB)的诊断、预防和治疗提供了科学基础。新生儿乙型肝炎疫苗的普种极大地降低了我国人群乙型肝炎表面抗原(HBsAg)阳性率,基于干扰素和/或核苷(酸)类似物的抗病毒治疗,可有效抑制HBV复制、改善肝脏炎症坏死和肝纤维化,从而减少肝硬化和肝细胞癌的发生。然而,现有治疗手段很难实现到HBsAg转阴的临床治愈目标。近年来,针对HBV生命周期的直接抗病毒药物及针对机体抗病毒应答的免疫调节药物进入研发活跃期。设计良好、执行规范、分析正确、解读恰当的临床试验,是决定乙型肝炎临床治愈新药能否研发成功的关键。希望肝脏病学、临床药理学及方法学专家通力合作,采用新型临床试验设计、新型终点指标、新型数据管理和质控技术,共同促进乙型肝炎临床治愈新药研发进程。

The discovery of hepatitis B virus(HBV)has provided a scientific basis for the diagnosis,prevention and treatment of chronic hepatitis B(CHB).The universalization of neonatal hepatitis B vaccine has greatly reduced the HBsAg positive load rate of the Chinese population.Antiviral therapy based on interferon and/or nucleos(t)ide analogues had effectively inhibited HBV replication,improved liver inflammation,liver fibrosis,and reduced the incidence of liver cirrhosis and hepatocellular carcinoma.However,the existing treatment methods can achieve the clinical cure goal of negative HBsAg.In recent years,direct antiviral drugs for HBV life cycle and immunomodulatory drugs for antiviral response have entered an active stage of research and development.Clinical trials that are well-designed,standardized,analyzed,and interpreted are the key to the success of the research and development of a clinical cure for hepatitis B.It is hoped that the experts in hepatology,clinical pharmacology and methodology will work together to promote the research and development process of new drugs for clinical cure of hepatitis B by adopting new clinical trial design,new endpoint indicators,new data management and quality control technology.