【摘要】 目的观察干扰素α-2b治疗HBeAg阳性慢性乙型肝炎的疗效及应答预测因素。方法采用多中心临床试验,共53例患者,年龄(27.5±9.1)岁,男44例(83.0%),隔日1次干扰素α-2b5MU,共24周,停药后随访24周。结果治疗前ALT131.0(99.0,192.8)U/L,AST78.5(55.8,122.3)U/L,TBIL13.3(9.8,17.8)μmol/L,HBVDNA(8.0±0.9)log10copies/ml。治疗后1dHBV DNA下降为(7.0±1.0)log10copies/m(lP<0.01),15例(33.3%)下降超过2.0log10copies/ml。治疗结束和随访结束时HBV DNA分别为(4.9±1.5)log10copies/ml和(5.3±1.6)log10copies/ml,HBeAg阴转率分别为16.0%(8/50)和20.0%(8/40),HBeAg血清转换率分别为14.0%(7/50)和20.0%(8/40),完全应答率分别为4.2%(2/48)和7.9%(3/38),部分应答率分别为35.4%(17/48)和34.2%(13/38)。治疗结束时完全应答[3.3(2.0,4.5)log10copies/ml]和部分应答[3.0(1.4,4.1)log10copies/ml]者在12周时HBV DNA水平较基线下降值高于无应答者[1.2(0.7,1.7)log10copies/m(lP<0.05)]。病程和基线HBV DNA水平影响治疗结束综合应答;基线ALT和HBV DNA水平影响随访结束综合应答。结论干扰素α-2b能快速降低HBeAg阳性慢性乙型肝炎患者的病毒载量,早期HBV DNA水平对综合应答有预测作用,基线HBV DNA水平影响治疗结束和随访结束时综合应答。更多还原

【Abstract】 Objective To evaluate the efficacy and the response prediction in the treatment of HBeAg-positive chronic hepatitis B(CHB) with interferon alpha-2b.Methods A multicenter clinical study was conducted,in which 53 patients at the age of 27.5 ±9.1 were enrolled,with 44(83.0%) males.All the patients were given interferon alpha-2b 5 MU every other day for 24 weeks and were followed up for 24 weeks after drug withdrawal.Results Baseline ALT,AST,TBIL and HBV DNA levels were 131.0(99.0,192.8) U/L,78.5(55.8,122.3) U/L,13.3(9.8,17.8)μmol/L and(8.0±0.9) log 10 copies/ml,respectively.One day after administration,HBV DNA levels decreased significantly(7.0±1.0) log 10 copies/ml,P<0.01 and those of 15 patients(33.3%) decreased more than 2.0 log 10 copies/ml.At the end of treatment and follow-up,HBV DNA levels were(4.9±1.5) log 10 copies/ml and(5.3±1.6) log 10 copies/ml,HBeAg loss rates were 16.0%(8/50) and 20.0%(8/40),HBeAg seroconversion rates were 14.0%(7/50) and 20.0%(8/40),complete response rates were 4.2%(2/48) and 7.9%(3/38),and partial response rates were 35.4%(17/48) and 34.2%(13/38),respectively.Complete responders 3.3(2.0,4.5) log 10 copies/ml and partial responders 3.0(1.4,4.1) log 10 copies/ml at the end of treatment had a greater decrease in HBV DNA levels at week 12 than nonresponders 1.2(0.7,1.7) log 10 copies/ml as compared to the baseline levels(P<0.05).The general response at the end of treatment was affected by disease course and baseline HBV DNA levels,and that at the end of follow-up by baseline ALT and HBV DNA levels.Conclusions Interferon alpha-2b can decrease HBV DNA levels of HBeAg-positive CHB patients rapidly.Early HBV DNA levels can predict the general response.Baseline HBV DNA levels can affect the general response at the end of treatment and follow-up.更多还原