CAJ | 학술논문

目的观察聚乙二醇干扰素alpha-2a联合恩替卡韦治疗高病毒载量HBeAg阳性慢性乙型肝炎的疗效及安全性.方法 60例HBeAg阳性患者随机分成三组:聚乙二醇干扰素α-2a组20例(A组),恩替卡韦组20例(B组),聚乙二醇干扰素联合恩替卡韦组20例(C组)(联合治疗12周后单用聚乙二醇干扰素治疗).观察三组患者治疗4、12及24周时丙氨酸氨基转移酶(ALT)复常率、HBV DNA阴转率、HBsAg和HBeAg血清转换情况,并观察其不良反应.结果分别在治疗第4、12、24周时比较三组,A组、B组的HBV DNA阴转率均明显低于C组(分别为:Z=-4.6,P＜0.0001；Z=-2.53,P=0.0114)；A组ALT复常率明显低于C组(Z=-2.63,P=0.0086),B组与C组的ALT复常率差异无统计学意义；C组的HBsAg、HBeAg下降幅度大于A组和B组.结论聚乙二醇干扰素alpha-2a联合恩替卡韦治疗高病毒载量HBeAg阳性慢性乙型肝炎患者,6个月疗程中HBV DNA阴转率、ALT复常率均优于聚乙二醇干扰素单药治疗,且安全性良好.
목적 관찰취을이순간우소alpha-2a연합은체잡위치료고병독재량HBeAg양성만성을형간염적료효급안전성.방법 60례HBeAg양성환자수궤분성삼조:취을이순간우소α-2a조20례(A조),은체잡위조20례(B조),취을이순간우소연합은체잡위조20례(C조)(연합치료12주후단용취을이순간우소치료).관찰삼조환자치료4、12급24주시병안산안기전이매(ALT)복상솔、HBV DNA음전솔、HBsAg화HBeAg혈청전환정황,병관찰기불량반응.결과 분별재치료제4、12、24주시비교삼조,A조、B조적HBV DNA음전솔균명현저우C조(분별위:Z=-4.6,P＜0.0001；Z=-2.53,P=0.0114)；A조ALT복상솔명현저우C조(Z=-2.63,P=0.0086),B조여C조적ALT복상솔차이무통계학의의；C조적HBsAg、HBeAg하강폭도대우A조화B조.결론 취을이순간우소alpha-2a연합은체잡위치료고병독재량HBeAg양성만성을형간염환자,6개월료정중HBV DNA음전솔、ALT복상솔균우우취을이순간우소단약치료,차안전성량호.
Objective This study aimed at evaluating the efficacy and safety of a combination treatment of entecavir and Peginterferon alpha-2a for HBeAg positive chronic hepatitis B patients with high serum hepatitis B viral loads.Methods 60 treatment-naive HBeAg-positive CHB patients with high serum hepatitis B viral loads were enrolled and randomly divided into three groups:group A received Peginterferon alpha-2a monotherapy for 48 weeks (n =20) ; group B received entecavir monotherapy for more than 48 weeks (n =20); group C received Peginterferona alpha-2a combined with entecavir for 12 weeks,then Peginterferon alpha-2a monotherapy for 36 weeks (n =20).Virological response,ALT normalization,HBeAg and HBsAg seroclearance rate were analysed at the end of 4,12 and 24 weeks after the treatment.Results The ratio of undetectable hepatitis B virus(HBV) DNA were 50％ and 10％,95％ and 25％ and 100％ and 30％ in group C and group A respectively,50％ and 20％,95％ and 75％ and 100％ and 90％ in group C and group B respectively at the end of 4,12 and 24 weeks of treatment.The differences were significant between group C and A (Z =-4.6,P ＜ 0.001),group C and B (Z =-2.53,P =0.0114).ALT normalization rate was significantly lower in group A than that of group C (Z =-2.63,P =0.0086).HBeAg levels declined more in group C than the other two groups after 24 weeks of treatment.Conclusions For HBeAg positive chronic hepatitis B patients with high serum hepatitis B viral loads,combination treament of Peginterferon alpha-2a with entecavir is more effective than Peginterferon alpha-2a monotherapy in virologic response and ALT normalization after 24 weeks of treatment.