干扰素α-2b治疗HBeAg阳性慢性乙型肝炎的疗效及预测

Efficacy and response prediction in the treatment of HBeAg-positive chronic hepatitis B with interferon alpha-2b

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。

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 muhicenter 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） log10 copies/ml, respectively. One day after administration, HBV DNA levels decreased significantly[（7.0±1.0） log10 copies/ml, P〈0.01] and those of 15 patients （33.3%） decreased more than 2.0 log10 copies/ml. At the end of treatment and follow-up, HBV DNA levels were （4.9±1.5） lOglo copies/ml and （5.3±1.6） log10 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） log10 copies/ ml] and partial responders [3.0 （1.4, 4.1） log10 copies/roll at the end of treatment had a greater decrease in HBV DNA levels at week 12 than nonresponders [1.2 （0.7, 1.7） log10 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.