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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 observe the efficacy and response predictors of interferon α-2b in the treatment of HBeAg-positive chronic hepatitis B patients. Methods A multicenter clinical trial of 53 patients (mean age 27.5 ± 9.1 years, 44 males (83.0%)) received interferon α-2b5MU every other day for 24 weeks was followed up for 24 weeks. Results Before treatment, ALT131.0 (99.0,192.8) U / L, AST78.5 (55.8,122.3) U / L, TBIL13.3 (9.8,17.8) μmol / L and HBVDNA (8.0 ± 0.9) log10copies / ml. After 1 week of treatment, the HBV DNA was decreased by (7.0 ± 1.0) log10 copies / m (lP <0.01) and 15 cases (33.3%) by 2.0 log10 copies / ml. HBV DNA was (4.9 ± 1.5) log10copies / ml and (5.3 ± 1.6) log10copies / ml at the end of treatment and at the end of follow-up, and the negative conversion rates of HBeAg were 16.0% (8/50) and 20.0% (8/40) The HBeAg seroconversion rates were 14.0% (7/50) and 20.0% (8/40) respectively, the complete response rates were 4.2% (2/48) and 7.9% (3/38) respectively, and the partial response rates were 35.4% (17/48) and 34.2% (13/38) respectively. HBV DNA levels at 12 weeks were significantly higher than baseline at complete response [3.3 (2.0, 4.5) log10 copies / ml] and partial response [3.0 (1.4, 4.1) log10 copies / 0.7, 1.7) log10 copies / m (lP <0.05)]. The course of disease and baseline HBV DNA levels affected the treatment response at the end of treatment. Baseline ALT and HBV DNA levels affected the overall response at the end of follow-up. Conclusions Interferon α-2b can rapidly reduce the viral load in patients with HBeAg-positive chronic hepatitis B, early HBV DNA levels predict the overall response, and baseline HBV DNA levels affect the overall response at the end of treatment and at the end of follow-up.