干扰素α-2b治疗HBeAg阳性慢性乙型肝炎的疗效及预测

目的观察十扰素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（55．8，1223）U/L，TBIL13．3（9．8，17．8）μmol／L，HBVDNA（8．0±0．9）log10 copies／ml。治疗后1d HBVDNA下降为（7．0±1．0）log10 copies／ml（P〈0．01），15例（33．3％）下降超过2．0log10 copies／ml。治疗结束和随访结束时HBVDNA分别为（4．9±1．5）log10 copies／ml和（5：3±1．6）log10 copies／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）log10 copies／ml]和部分应答[3．0（1．4，4．1）log10 copies／ml]者在12周时HBVDNA水平较基线下降值高于无应答者[1．2（0．7，1．7）log。。copies／ml（P〈0．05）]。病程和基线HBVDNA水平影响治疗结束综合应答；基线ALT和HBVDNA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HBVDNA水平对综合应答有预测作用，基线HBVDNA水平影响治疗结束和随访结束时综合应答。

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

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.