目的 比较替诺福韦酯单药序贯治疗与恩替卡韦单药序贯治疗在挽救阿德福韦酯(adefovir dipivoxil,ADV)抗病毒治疗后应答不佳,或发生病毒学突破的慢性乙型肝炎患者的临床疗效及安全性。方法 将120例对ADV初治失败的慢性乙型肝炎患者随机分为替诺福韦酯 (tenofovir disoproxil fumarate,TDF) 组和恩替卡韦(entecavir,ETV)组,每组60例。TDF组给予TDF 300 mg/d,序贯治疗;ETV组给予ETV 0.5 mg/d治疗,所有患者均治疗48周。给药的治疗基线、12周、24周和48周分别进行病毒学、生化学、血清学检测。分析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肾功能损害情况。结果 TDF组治疗48周后完全病毒学应答率为63.3％(38/60), ETV组为78.3％(47/60),两组比较差异具有统计学意义(P<0.05)。TDF组的ALT复常率、HBeAg血清学转换率、病毒学突破率分别为57.8％ (26/45)、13.6% (6/44)、0,ETV组分别为60.4％(29/48)、14.9% (7/47)、0,两组比较差异无统计学意义。两组患者对药物耐受性均良好,治疗过程中未发生因血肌酐升高停药的明显不良反应。结论 对于ADV治疗后疗效欠佳或发生病毒学突破的慢性乙型肝炎患者,恩替卡韦单药序贯治疗是一种疗效理想、安全的挽救治疗方案,抗病毒疗效优于替诺福韦酯单药序贯治疗。
Abstract
Objective To compare the clinical efficacy and safety of tenofovir disoproxil fumarate(TDF) monotherapy and entecavir(ETV) monotherapy in chronic hepatitis B patients with treatment failing to adefovir dipivoxil(ADV)therapy.Methods A total of 120 chronic hepatitis B patients with of ADV failure were investigated, and randomly divided into equally two groups. Sixty patients with chronic hepatitis B on rescue treatment with TDF(300 mg/d) monotherapy for 48 weeks served as group A were analyzed retrospectively.The serum HBV DNA levels,HBeAg,ALT and serum creatinine(Cr) were evaluated at weeks 0,12,24,48. In addition,data of 60 patients treated with ETV(0.5 mg/d) monotherapy for 48 weeks serving as group B were also collected.Results After 48 weeks follow-up,the virological response(VR) rate were 63.3％(38/60) in group A and 78.3％(47/60) in group B,respectively,and P value less than 0.05 when the two groups were compared. But the ALT normalization rate,seroeonversion rate (from HBeAg to HBeAb),the virologic breakthrough(VB) rate were 57.8％ (26/45),13.6% (6/44),0 in group A,respectively.Meanwhile,in group B,they were 60.4％(29/48),14.9% (7/47),0,respectively with P value not showing significant difference between the two groups. Both groups showed comparable tolerance and not found elevated Cr at the end of treatment.Conclusions The therapy of ETV monotherapy is an effective and safe therapeutic strategy for chronic hepatitis B patients with a treatment failing to ADV therapy,and is superior to TDF monotherapy rescue strategy.
关键词
慢性乙型肝炎 /
阿德福韦酯 /
恩替卡韦 /
替诺福韦酯 /
挽救治疗
Key words
chronic hepatitis B /
adefovir dipivoxil /
entecavir /
tenofovir disoproxil fumarate /
rescue treatment
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