CAJ | 학술논문

目的明确聚乙二醇干扰素α-2a (PEG-IFNα-2a)治疗效果不佳的HBeAg阳性慢乙肝患者序贯使用替比夫定治疗的疗效及安全性.方法 PEG-IFNα-2a治疗48周后HBV DNA、HBeAg未转阴的HBeAg阳性慢乙肝患者,随机分为两组:A组患者(52例)经过3个月或者以上的洗脱期后,再序贯使用替比夫定600 mg/d治疗,B组患者(49例)不经洗脱期,直接序贯使用替比夫定治疗.观察两组患者在加用替比夫定3、6、12个月后ALT复常率、HBV DNA转阴率、HBeAg转阴率及CK水平的差异.结果 A组替比夫定治疗3、6、12个月的HBeAg转阴率分别为7.69％、15.3％、21.1％,B组替比夫定治疗3、6、12个月的HBeAg转阴率分别为22.4％、32.6％、38.8％,两组之间的差异有统计学意义(P＜0.05).然而,两组患者替比夫定治疗3、6、12个月的ALT复常率、HBV DNA转阴率、CK异常率之间的差异无统计学意义(P＞0.05).结论 PEG-IFNα-2a治疗效果不佳的HBeAg阳性慢乙肝患者不经洗脱期直接序贯使用替比夫定是安全的,且比经洗脱期再序贯使用替比夫定HBeAg转阴率更高,疗效更佳.
목적 명학취을이순간우소α-2a (PEG-IFNα-2a)치료효과불가적HBeAg양성만을간환자서관사용체비부정치료적료효급안전성.방법 PEG-IFNα-2a치료48주후HBV DNA、HBeAg미전음적HBeAg양성만을간환자,수궤분위량조:A조환자(52례)경과3개월혹자이상적세탈기후,재서관사용체비부정600 mg/d치료,B조환자(49례)불경세탈기,직접서관사용체비부정치료.관찰량조환자재가용체비부정3、6、12개월후ALT복상솔、HBV DNA전음솔、HBeAg전음솔급CK수평적차이.결과 A조체비부정치료3、6、12개월적HBeAg전음솔분별위7.69％、15.3％、21.1％,B조체비부정치료3、6、12개월적HBeAg전음솔분별위22.4％、32.6％、38.8％,량조지간적차이유통계학의의(P＜0.05).연이,량조환자체비부정치료3、6、12개월적ALT복상솔、HBV DNA전음솔、CK이상솔지간적차이무통계학의의(P＞0.05).결론 PEG-IFNα-2a치료효과불가적HBeAg양성만을간환자불경세탈기직접서관사용체비부정시안전적,차비경세탈기재서관사용체비부정HBeAg전음솔경고,료효경가.
Objective To investigate the efficacy of Telbivudine as sequential therapy for HBeAg positive CHB patients with pegylated IFNα-2a (PEG-IFNα-2a)treatment failure.Methods After a 48-week pegylated IFNα-2a therapy,102 HBeAg positive CHB patients,whose HBeAg expression was positive and HBV DNA load was Detectable,were enrolled.These patients were randomly divided into two groups.Group A,included 52 patients,were treated with Telbivudine as a sequential therapy after a 3 months or longer wash-out period.Group B,included 49 patients,were treated with Telbivudine as a sequential therapy without wash-out period.The rate of ALT normalization,HBeAg seroconversion,the negative rate of HBV DNA and the level of creatine kinase in the two groups were observed and compared,respectively.Results HBeAg seroconversion of Group A at 3,6,12 months was 7.69％,15.3％,21.1％,respectively.HBeAg seroconversion undetectable of Group B at 3,6,12 months was 22.4％,32.6％,38.8％,respectively.Furthermore,there was statistically significant difference in HBeAg seroconversion between the two groups (P ＜ 0.05).However,there were not statistical difference in the rate of ALT normalization,the negative rate of HBV DNA and the level of creatine kinase between the two groups at 3,6,12 months.Conclusion Telbivudine,which was used as a sequential therapy without wash-out period for HBeAg positive CHB patients after PEG-IFNα-2a treatment failure,was secure.Moreover,HBeAg seroconversion of patients treated with Telbivudine as a sequential therapy without wash-out period was higher than those with wash-out period.