我国有1.3亿慢性乙型肝炎(CHB)感染者,其中绝大多数为母婴传播或儿童期感染。CHB的根本性治疗是抗病毒治疗,而目前只有普通干扰素-α(interferon-α,IFN-α)和拉米夫定被美国FDA批准可用于儿童CHB患者的治疗[1]。而我国目前尚未批准拉米夫定治疗儿童乙型肝炎患者的适应证,也没有儿童用的口服液剂型上市。 There are 130 million Chronic Hepatitis B (CHB) infections in China, the vast majority of which are mother-to-child transmission or childhood infection. The fundamental treatment of CHB is antiviral therapy. At present, only interferon-α (IFN-α) and lamivudine are approved by the U.S. FDA for the treatment of children with CHB [1]. However, no indications of lamivudine treatment for children with hepatitis B have been approved yet, and no oral dosage form for children is available for marketing.