干扰素α治疗HBeAg阳性慢性乙肝个体化方案的前瞻性对照研究

目前慢性乙肝的干扰素治疗的应答并不令人满意。本研究的目的是试图通过可选方案改善治疗结果。在374例HBeAg阳性慢性乙肝病人中,对照组127例接受了500万单位干扰素α,一周三次,为期6个月的治疗,试验组247例病人接受相同剂量的干扰素,但疗程个体化。根据研究方案,如果HBV-DNA持续下降将进行持续治疗。当病毒、抗体和生化学终点达到,或HBV-DNA不再下降时停止治疗。个体化疗程的中位值是10个月(范围:6~24个月)。试验组和对照组治疗结束时应答分别为39.3%和23.6%(P=0.002),在12个月的随访后,持续病毒学应答分别为40.5%和28.3%(P=0.013)。排除失访病人,分别有228例和115例病人完成了中位期为40个月和44个月的随访。长期应答率分别为45.3%和33.1%(P=0.014)。干扰素α疗程的个体化治疗证明可显著增加慢性乙肝病人的疗效。

J Viral Hepat. 2008 Jun 11. [Epub ahead of print]

Tailored regimen of interferon alpha for HBeAg-positive chronic hepatitis B: a prospective controlled study.

Luo K, Mao Q, Karayiannis P, Liu D, Liu Z, Zhou Y, Feng X, Zhu Y, Guo Y, Jiang R, Zhou F, Peng J, Hou J.

Department of Infectious Diseases and Hepatology Center, Nanfang Hospital, Guangzhou, China.

The response to interferon-alpha treatment of patients with chronic hepatitis B under the current protocol is not satisfactory. The aim of this study was to try an alternative approach to improve treatment outcome. Of 374 HBeAg-positive patients, 127 of them received 5 million units of interferon-alpha thrice weekly for 6 months and constituted the control group, while 247 in the study group received the same dosage but the duration of treatment was tailored. The study protocol provided for continuation of treatment if HBV DNA levels were continuously decreasing. The treatment ended when viral, antigenic and biochemical endpoints were reached or when HBV DNA levels were no longer decreasing. The median length of tailored treatment was 10 (range 6-24) months. The end-of-treatment response rates were 39.3% and 23.6% (P = 0.002), and after 12-month, follow-up, the sustained response rates were 40.5% and 28.3% (P = 0.013) in the study and control groups, respectively. Excluding the patients who dropped out, 228 and 115 completed a median of 40- and 44-month-long follow-up; the long-term response was thus 45.3% and 33.1% (P = 0.014) in the respective groups. Interferon-alpha treatment tailored in length demonstrated significantly increased efficacy in patients with chronic hepatitis B.

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