干扰素联合核苷(酸)类似物治疗HBeAg阳性慢性乙型肝炎48周临床研究

目的比较核苷(酸)类似物nucleos(t)ide anologues,NAs]单药、干扰素(interferon,IFN)单药、NAs+IFN联合治疗HBeAg阳性CHB的抗病毒疗效。方法纳入2005年1月—2011年6月在我院接受48周抗病毒治疗的321例HBeAg阳性CHB,其中单用NAs治疗者162例(NAs组),单用IFN治疗者35例(IFN组),NAs联合IFN治疗者124例(联合组)。比较3组治疗48周HBV DNA不可检测(500 copies/ml)率、HBeAg血清学转换率、HBs Ag清除率和ALT水平。结果治疗48周时,联合组、NAs组和IFN组HBV DNA不可检测率分别为85.5%、50.6%和20.0%,差异有统计学意义(P均0.05);联合组HBeAg血清学转换率为41.1%,高于NAs组(15.4%)和IFN组(25.7%),联合组与NAs组差异有统计学意义(P0.05),但是联合组与IFN组、NAs组与IFN组差异无统计学意义(P均0.05);联合组、IFN组和NAs组HBs Ag清除率分别为7.3%、2.9%和0.0%;NAs组ALT下降幅度最大,其次为联合组。结论 IFN联合NAs可提高HBeAg阳性CHB患者抗病毒疗效,是值得探索的优化治疗策略之一。

Forty-eight weeks of combination therapy with interferon and nucleos(t)ide analogues for HBeAg-positive chronic hepatitis B

Objective To compare the therapeutic efficacy among nucleos(t)ide anologues (NAs) monotherapy, interferon (IFN) monotherapy and combination therapy with NAs and IFN in patients with HBeAg-positive chronic hepatitis B (CHB).Methods A total of 321 HBeAg-positive CHB patients receiving 48-week antiviral treatment in our hospital from January 2005 to June 2011 were included in the study. Of them, 162 patients were treated with NAs monotherapy (NAs group), 35 with IFN monotherapy (IFN group), and 124 with the combination of NAs and IFN (combination group). HBV DNA undetectable (<500 copies/ml) rates, HBeAg seroconversion rates, HBsAg clearance rates and ALT levels were compared among the 3 groups.Results At 48 weeks of treatment, HBV DNA undetectable rates were 85.5% in combination group, 50.6% in NAs group and 20.0% in IFN group, and the differences among them were significant (P<0.05); HBeAg seroconversion rate in combination group was 41.1%, higher than that in NAs group (15.4%) and that in IFN group (25.7%), and the difference between combination group and NAs group was significant (P<0.05), but the differences between combination group and IFN group and between NAs group and IFN group were not significant (P>0.05); HBsAg clearance rates were 7.3% in combination group, 2.9% in IFN group and 0.0% in NAs group; the variation of the decrease in ALT level was the greatest in NAs group, followed by that in combination group.Conclusions The combination therapy with IFN and NAs may improve the antiviral efficacy in HBeAg-positive CHB patients. It is one of the promising treatment strategies.