替比夫定治疗乙肝e抗原阳性慢性乙型肝炎患者的疗效及预测因素的分析

Effcacy of Initial Telbivudine Treatment on HBeAg Positive Chronic Hepatitis B and Its Predictive Elements

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 analyze the efficacy of initial telbivudine treatment at 72 weeks on HBeAg positive chronic hepatitis B（CHB） and its predictive elements.Methods Eighty-two CHB patients treated with telbivudine for 72 weeks in the center of infections diseases,West China Hospital of Sichuan University between September 2007 and September 2012 were enrolled in the study.Alanine aminotransferase（ALT）,hepatitis B virus（HBV） DNA,and HBV serological markers were detected at baseline and every three months after the treatment began.The cumulative rate of complete virological response（CVR）,biochemical response（BR）,HBeAg seroconversion（SR）,and drug resistance（DR） were calculated,and baseline ALT level（ 5 ULN and ≥ 5 ULN）,HBV DNA level（ 107 copies/mL and ≥ 107 copies/mL）,HBV DNA level at week 24（ 103 copies/mL and ≥ 103 copies/mL） were analyzed to predict the CVR and SR at week 72.Results The cumulative rates of BR,CVR,SR,and DR at week 72 were 86.6%,81.7%,42.7%,and 18.2% respectively.Baseline ALT ≥ 5 ULN had predictive value for SR at week 72（χ2=5.651,P=0.017）,and HBV DNA 107 copies/mL was valuable in predicting CVR（χ2=7.083,P=0.008）.HBV DNA at week 24 103 copies/mL had predictive value for both CVR and SR at week 72（χ2=27.339,5.131;P=0.000,0.023）.Conclusions Telbivudine is an effective and safe drug for initial treatment of CHB patients.During telbivudine treatment,non-detectable serum HBV DNA at treatment week 24 is the strongest predictor for optimal outcomes at week 72.