Objective To compare the clinical efficacy and safety between tenofovir disoproxil fumarate (TDF) monotherapy and TDF-entecavir (ETV)therapy for ETV-refractory chronic hepatitis B (CHB)patients with prior lamivudine (LAM)treatment.Methods Eighty LAM-treated CHB patients with failure of ETV rescue therapy were randomly divided into monotherapy group and combination group.The monotherapy group received TDF (300mg/d)alone for 48 weeks,while the combination group was treated with TDF (300mg/d)plus ETV (0.5mg/d).Assessment of serum hepatitis B virus (HBV)DNA,hepatitis B e antigen (HBeAg),alanine aminotransferase (ALT)and adverse events at week 0,12,24 and 48 were performed to analyze therapy efficacy and adverse effects in both groups,respectively.Results After 48-week follow up,the virological response (VR)rate,biochemical response (BR)rate,virologic breakthrough (VB)rate,HBeAg seroconversion rate were 85.0% (34/40),76.2% (16/21 ),0% and 13.1 % (3/23)in monotherapy group and 87.5% (35/40),77.3% (17/22),0% and 16.0% (4/25)in combination group,respectively (P >0.05).There were no significant differences in all the monitoring indicators between the two groups.Both groups showed well tolerance with no serious adverse events.Conclusion The TDF monotherapy could be an effective and safe therapeutic strategy for LAM-treated CHB patients who failed to be rescued with ETV therapy.%目的：比较替诺福韦酯单药与联合恩替卡韦对恩替卡韦治疗慢性乙型肝炎拉米夫定经治患者仍应答不佳或发生病毒学突破的挽救方案的临床疗效及安全性。方法将80例恩替卡韦序贯治疗仍效果欠佳的拉米夫定经治慢性乙型肝炎患者随机分为单药组40例和联合组40例。单药组给予替诺福韦酯（300 mg／d）替换治疗；联合组使用替诺福韦酯（300 mg／d）和恩替卡韦（0．5 mg／d）治疗。所有患者均治疗48周，检测基线，治疗12、24和48周时病毒学、生化学、血清学指标。比较两组患者上述治疗时间点的完全病毒学应答率、ALT 复常率、病毒学突破率和 HBeAg 血清学转换率及观察药物不良反应。结果单药组患者治疗48周后完全病毒学应答率、ALT 复常率、病毒学突破率、HBeAg 血清学转换率分别为85．0％（34／40）、76．2％（16／21）、0、13．1％（3／23），联合组分别为87．5％（35／40）、77．3％（17／22）、0、16．0％（41／25），两组比较差异无统计学意义（均 P ＞0．05）。两组患者耐受性均良好，无一例出现严重不良反应而导致停药。结论对于恩替卡序贯治疗后仍应答不佳或发生病毒学突破的拉米夫定经治慢性乙型肝炎患者，替诺福韦酯单药替换恩替卡韦的挽救治疗仍能有效抑制 HBV DNA 复制，是一种行之有效的优化治疗方案。
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