乙肝防治指南缩减培训稿详解演示文稿.pptVIP

荟萃分析表明，HBeAg阳性患者经普通干扰素? (普通IFN ?) 治疗4~6个月后，治疗组和未治疗组HBV DNA转阴率 (杂交法) 分别为37%和17%，HBeAg转阴率分别为33%和12%，HBsAg转阴率分别为7.8%和1.8%，其疗效与基线血清ALT水平和肝组织学病变程度呈正相关[39] (Ⅱ)。有关HBeAg阴性患者的4次随机对照试验表明，治疗结束时应答率为38%~90%， 但持久应答率仅为10%~47% (平均24%) [40, 41] (Ⅰ)。 有人报道，普通IFN? 疗程至少1年才能获得较好的疗效[42-44]（Ⅱ）。普通IFN ? (5MU 皮下注射，每日1次) 治疗慢性乙型肝炎患者，其中部分患者可出现ALT升高，少数患者甚至出现黄疸。治疗代偿期乙型肝炎肝硬化患者时，肝功能失代偿的发生率为1%[45] (Ⅱ) 。 国际多中心随机对照临床试验显示，用聚乙二醇化干扰素?-2a (PegIFN?-2a) (Mr=40 ?103) 治疗HBeAg阳性慢性乙型肝炎 (87%为亚洲人) 48周并停药随访24周， HBeAg血清学转换率为32%[46, 47]；HBeAg阴性患者 (60%为亚洲人) 治疗48周后随访24周，HBV DNA 2?104拷贝/ml的患者为43%[48]，随访48周时为42%。 亚太地区一项II期临床研究显示，每周1次PegIFN ?-2a (Mr=40 ?103) 治疗24周，随访24周时的HBeAg血清学转换率高于普通IFNα (32%:25%，P0.05)[49]。单用PegIFN ?-2b (Mr=12?103) 或与拉米夫定联合应用治疗HBeAg阳性慢性乙型肝炎52周，停药后随访26周，两组HBeAg血清学转换率均为29%[6]。PegIFN ?-2a (Mr=40 ?103) 在我国已被批准用于治疗慢性乙型肝炎患者。 对普通IFNα治疗后复发的患者，再用普通IFNα治疗仍可获得疗效[42, 50] (Ⅱ)，亦可换用其他普通干扰素a亚型、PegIFNa-2a或核苷 (酸) 类似物治疗 (III)。 Key message Patients with raised baseline ALT have higher HBeAg seroconversion rates during one year of lamivudine compared to patients with lower ALT levels or placebo-treated patients. Points of explanation These data are from a subset analysis of patients in the Lai study. The proportion of patients with HBeAg seroconversion (HBeAg-, anti-HBe+) was analyzed according to pretherapy ALT levels (2 x upper limit of normal (ULN) and 5xULN) and by treatment group. Seroconversion rates for all patients (median baseline ALT 1.5XULN) are shown for comparison. The highest seroconversion rate was seen in lamivudine-treated patients with baseline ALT 5xULN (64%) compared to patients with ALT 2xULN (34%; p0.001) and compared to all patients (17%). Additional information Elevated ALT concentrations are an indicator of immune-mediated destruction of hepatocytes. Hence, these results suggest that HBeAg seroconversion in patients receiving lamivudine may be more likely in patients with an immune response to HBV. References Chien RN, Liaw YF, Atkins M, et al. Pretherapy alanine aminotransferase level as a det