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目的探讨替比夫定治疗乙肝e抗原(HBeAg)阳性慢性乙型肝炎(CHB)患者72周的疗效及预测因素的分析。方法选择2007年9月-2012年9月符合入选标准的82例CHB患者接受替比夫定治疗72周,于治疗前基线、治疗后每3个月查丙氨酸氨基转移酶(ALT)、乙肝病毒DNA(HBV DNA)、乙肝病毒血清标志物,观察治疗期间累计生化学应答率、完全病毒学应答率(CVR)、HBeAg血清学转换率(SR)及耐药率,分析基线ALT水平[分为<5 ULN(正常值检测下限)组及≥5 ULN组]、HBV DNA水平(分为<107copies/mL组及≥107copies/mL组)、24周HBV DNA水平(<3 log 10 copies/mL组及≥3 log 10 copies/mL组),预测72周CVR及SR。结果 172周累计生化学应答率、CVR、SR、耐药率分别为86.6%、81.7%、42.7%、18.2%;2基线ALT≥5 ULN对72周SR有预测价值(χ2=5.651,P=0.017),HBV DNA<107 copies/mL对CVR有预测价值(χ2=7.083,P=0.008);324周HBVDNA<103copies/mL对72周CVR及SR均有预测价值(χ2=27.339,5.131;P=0.000,0.023)。结论替比夫定初治HBeAg阳性CHB患者疗效及安全性好,治疗24周HBV DNA<103copies/mL是72周疗效的最佳预测指标。
Objective To investigate the efficacy and predictive factors of telbivudine in treatment of patients with hepatitis B e antigen (HBeAg) -positive chronic hepatitis B (CHB) at 72 weeks. Methods Eighty-two CHB patients who met the inclusion criteria from September 2007 to September 2012 were treated with telbivudine for 72 weeks. Before baseline treatment, alanine aminotransferase (ALT) Hepatitis B virus DNA (HBV DNA) and hepatitis B virus (HBV) serum markers were used to observe the cumulative biochemical response rate, complete virological response rate (CVR), HBeAg seroconversion rate (SR) The patients were divided into 5 ULN group and 5 ULN group, HBV DNA level (<107copies / mL group and ≥ 107copies / mL group), HBV DNA level at 24 weeks (<3 log 10 copies / mL group and ≥3 log 10 copies / mL group). CVR and SR were predicted at 72 weeks. Results The cumulative biochemical response rates, CVR, SR and resistance rates of 172 weeks were 86.6%, 81.7%, 42.7% and 18.2%, respectively. 2 Baseline ALT≥5 ULN had predictive value for SR at 72 weeks (χ2 = 5.651, P = 0.07), HBV DNA <107 copies / mL had predictive value for CVR (χ2 = 7.083, P = 0.008); 324 weeks HBVDNA <103copies / mL had predictive value for CVR and SR for 72 weeks (χ2 = 27.339,5.131; P = 0.000, 0.023). Conclusion The efficacy and safety of telbivudine-naive HBeAg-positive CHB patients are good, and HBV DNA levels <103copies / mL at 24 weeks of treatment are the best predictors of 72-week efficacy.