聚乙二醇干扰素α-2a与阿德福韦酯联合治疗HBeAg阳性慢性乙型肝炎患者的研究

Efficacy of pegylated interferon alfa-2a combined with adefovir dipivoxil in treatment of HBeAg positive chromic hepatitis B

目的比较聚乙二醇干扰素α-2a、阿德福韦酯单药治疗及两药联合治疗HBeAg阳性慢性乙型肝炎患者的疗效。方法采用开放、随机、对照临床试验,60例HBsAg阳性入选病例分为聚乙二醇干扰素α-2a组(A组)21例,阿德福韦酯组(B组)22例和聚乙二醇干扰素α-2a加阿德福韦酯组(C组)17例,分别在治疗24周和48周进行疗效评估,应答疗效比较采用χ2检验。结果病毒学应答HBV-DNA转换率在A组为9例、B组11例、C组14例,以C组疗效为佳,C组与A、B组比较,差异有统计学意义(P<0.05);HBeAg血清学转换在A组为7例、B组3例、C组9例,C组疗效显著高于B组,差异有统计学意义(P<0.05),而C组与A组比较差异无统计学意义。结论聚乙二醇干扰素α-2a与阿德福韦酯联合治疗在48周时的病毒学应答均优于两药单独治疗时的效果。

OBJECTIVE To compare the clinical efficacy of pegylated interferon a-2a （Peg IFN a-2a） or adefovir dipivoxil （ADV）monotherpy and their combination therapy in treatment of HBeAg positive chronic hepatitis B （CHB） patients. METHODS An open randomized controlled clinical trial was performed. Sixty cases with CHB were divided into 3 groups： Peg IFN a-2a monotherapy （group A）, ADV monotherapy （group B） and Peg INF a-2a plus ADV combination therapy （group C）. The virological response（VR）, serological response （HBeAg, HBsAg clearance and seroconversion） , biochemical response （BR） were tested at week 24 and week 48 after the treatment. The efficacy was compared by using x2 test. RESULTS At week 48 of the treatment, the VR HBV DNA conversion was 9 cases in the group A, 11 cases in the group B,and 14 cases in the group C, the efficacy of the group C was better than that of the group A and group B, the difference was statistically significant （P〈 0.05）. The HBeAg serological conversion was 7 cases in the group A,3 cases in the group B,and 9 cases in the group C, the efficacy of the group C was significantly higher than that of the group B , the difference was statistically significant（P〈0.05）, but the difference between the group A and the group C was not statistically significant. CONCLUSION At the week 48 of treatment, the VR of Peg IFN a-2a combined with ADV is better than that of the monotherapy.