对核苷类似物抗HBV治疗的客观评价文件材料.ppt

对核苷（酸）类似物抗HBV治疗的评价;话 题 一、历史回顾与简介 二、比较与选择 三、变异与耐药 四、疗程的争议 五、联合治疗的利弊 六、正确评价不良反应 七、几个特殊问题探讨;?恩替卡韦： 2005年完成全球三期临床试验。 2005年3月FDA批准用于治疗慢性乙型肝炎 2005年11月在中国上市;二、比较与选择;选择过程中要考虑的因素： ?感染途径 ?病程（年龄） ?ALT水平？ ?病毒载量 ?病毒基因型 ?耐受性（与依从性有关或无关） ?肝功能情况 ?用药目的：预防？治疗？ ?给药方式与依从性 ?经济状况;Cost of Currently Available Antiviral for Treatment of Hepatitis B Cost per Dose Monthly Cost Yearly Cost LAM 6.49 194.93 2368.85﹡ ADF 19.34 580.20 6498.24? ENT 24.21 726.30 8134.56? PEGASYS 361.21 1444.84 17338.08? IFNα2b 120.96 1451.52 17418.24? (10million);六、正确评价不良反应;ABSTRACT Background Lamivudine therapy is effective for chronic hepatitis B infection in adults. We evaluated the efficacy and tolerability of lamivudine as a treatmentfor chronic infection with hepatitis B virus (HBV) in children. Methods Children with chronic hepatitis B were randomly assigned in a 2:1 ratio to receive either oral lamivudine (3 mg per kilogram of body weight; maximum 100 mg) or placebo once daily for 52 weeks. The primary end point was virologic response (defined by the absence of serum hepatitis B e antigen and serum HBV DNA) at week 52 of treatment. Results Of the 403 children screened, 191 were randomly assigned to receive lamivudine and 97 to receive placebo. The rate of virologic response at week 52 was higher among children who received lamivudine than among those who received placebo (23 percent vs. 13 percent, P=0.04). Lamivudine therapy was well tolerated and was also associated with higher rates of seroconversion from hepatitis B e antigen to hepatitis B e antibody, normalization of alanine aminotransferase levels, and suppression of HBV DNA. Conclusions In children with chronic hepatitis B, 52 weeks of treatment with lamivudine was as