普通干扰素α-2b联合治疗恩替卡韦经治未达满意终点的HBeAg阳性慢性乙型肝炎患者疗效分析

HBeAg seroconversion achieved by adding on interferon alfa-2b therapy in chronic hepatitis B patients with unsatisfactory end point following entecavir treatment

目的评估普通干扰素(IFN)α-2b联合治疗恩替卡韦经治未达满意终点的HBeAg阳性慢性乙型肝炎的疗效与安全性。方法174例慢性乙型肝炎患者经恩替卡韦治疗96周或以上,达到HBV DNA<500拷贝/ml,且1.00S/CO<HBeAg检测值<100.00S/CO,0.05U/ml<HBsAg检测值<3 000.00U/ml。83例联合普通IFNα-2b治疗(试验组),91例继续单药恩替卡韦治疗(对照组),治疗末(48周)进行生物化学、病毒学、血清学评估。统计学处理采用t检验或χ2检验。结果治疗48周,试验组和对照组比较,HBeAg阴转率(31.33%vs 8.79%)与HBeAg血清学转换率(18.07%vs 4.40%)差异有统计学意义(χ2值分别为14.020和8.347,P值均<0.05);HBsAg消失率(8.43%vs 0)和血清学转换率(6.02%vs 0)差异有统计学意义(χ2值分别为7.996和5.644,P值均<0.05)。结论恩替卡韦经治未达满意终点的HBeAg阳性慢性乙型肝炎患者,联合普通干扰素α-2b治疗有助于实现HBeAg和HBsAg的阴转与血清学转换,且安全性良好。

Objective To study the efficacy and safety of interferon alfa-2b(IFNα-2b)therapy for treating chronic hepatitis B(CHB)of patients who failed to achieve a satisfactory end point with entecavir(ETV)treatment. Methods A total of 174 HBeAg positive CHB patients who had completed a standard ETV monotherapy course for at least 96 weeks were enrolled in this study.These patients had achieved a virological response(defined as HBV DNA<500copies/ml)but without HBeAg seroconversion(defined as 1.00S/CO<HBeAg<100.00 S/CO and 0.05 U/mI%HBsAg%3 000.00 U/ml).The patients were randomly assigned to receive a 48-week treatment with adding on IFNα-2b (experimental group,n=83)or continued ETV therapy (control group,n^91).Serum samples were collected from all patients to assess biochemical,virological and serological responses to treatment.Inter-group differences were statistically evaluated by t-test or Chi-squared test.Results The baseline levels of alanine aminotransferase,hepatitis B surface antigen (HBsAg)and HBeAg were at similar levels between the experimental and controls groups.At treatment week 48,the experi- mental group showed significantly higher rates of HBeAg clearance (IFNα-2b:31.33%vs ETV:8.79%, χ^2=14.020,P<0.05)and seroconversion (18.07 %vs 4.40 %,χ^2=8.347,P<0.05).The experimental group also showed significantly higher rates of HBsAg clearance (IFNα-2b..8.43%vs ETV:0,χ^2=7.996, P<0.05)and seroconversion (6.02% vs 0 ,χ^2=5.644,P<0.05).Conclusions HBeAg-positive CHB paitents with unsatisfactory response to initial ETV monotherapy achieved HBeAg seroconversion and clear- ance following adding on IFNα-2b treatment.