中国慢性乙肝流行现状和药物经济.ppt

* 派罗欣是目前抗病毒药物中疗效最好的药物，取得HBeAg血清转换率可以达到41－53％。显著优于干扰素和拉米夫定。 Thomas HC et al. Comparative study of three doses of interferon-alpha 2a in chronic active hepatitis B. The International Hepatitis Trial Group. J Viral Hepat 1994;1:139–48 Carreno V et al. Retreatment of chronic hepatitis B e antigen-positive patients with recombinant interferon alfa-2a. The European Concerted Action on Viral Hepatitis (EUROHEP). Hepatology 1999;30:277–82 Perrillo RP et al. A randomized, controlled trial of interferon alfa-2b alone and after prednisone withdrawal for the treatment of chronic hepatitis B. The Hepatitis Interventional Therapy Group. N Eng J Med 1990;323:295–301 * 一项临床研究比较PEG IFN?-2a(40KD)+LAM， PEG IFN?-2a(40KD)或LAM单用治疗HBeAg阳性的CHB患者的疗效和安全性。结果显示：治疗结束时(第48周)， PEG IFN?-2a(40KD)单用组的血清平均HBV DNA 水平下降最少 -4.5 log10 cp/mL ，其次为LAM单用组 -5.8 log10 cp/mL ，联合用药组下降最多 -7.2 log10 cp/mL 。但随访24周后(第72周)， PEG IFN?-2a(40KD)单用和PEG IFN?-2a(40KD )+LAM组均较LAM单用组拥有更高的HBeAg血清转换率(分别为32%对19%，p0.001；27%对19%，P=0.02)。说明结束时HBV DNA水平未能较好预测PEG IFN?-2a(40KD)72周HBeAg血清转换。 * In total, 54 of 67 centres participated in the LT-study; data from 486 of 814 patients (60%) in the original study were available. Of 271 patients treated with peginterferon alfa-2a in the original study, 172 (63%) participated the LT-study. As in the original study, the majority of participants were male (77%) and of Asian origin (86%). In the original study, 32% of patients treated with peginterferon alfa-2a alone achieved HBeAg seroconversion or HBV DNA 100,000 copies/ml 6 months post-treatment. Among patients without a response 6 months post-treatment, an additional 14/103 (14%) achieved HBeAg seroconversion and 11/106 (10%) achieved HBV DNA 100,000 copies/ml 12 months post-treatment. Overall, among 172 patients treated with peginterferon alfa-2a alone and participating in the LT-study, 73 (42%) had HBeAg seroconversion and 64 (37%) had HBV DNA 100,000 copies/ml 12 months post-treatment. * 一项在15个国家进行的Ⅲ期、随机、部分双盲研究，比较PEG IFN ?-2a