干扰素应答不佳或不耐受的慢性乙型肝炎患者序贯应用替比夫定的临床观察

A clinical observation of LDT for chronic hepatitis B patients with poor response or intolerance to interferon

目的评价对干扰素应答不佳或不耐受(poor interferon response or can not tolerate,PIRCT)的e抗原(HBe Ag)阳性慢性乙型肝炎(CHB)患者,序贯应用替比夫定(LDT)治疗的临床疗效及安全性。方法采用开放性、前瞻性队列研究方法。PIRCT患者停用干扰素,给予LDT(600mg/d)序贯治疗72周,于治疗基线及每12周进行丙氨酸氨基转移酶(ALT)、乙肝病毒(HBV)标志物、HBV DNA载量的检测,观察不良反应发生情况。结果序贯LDT治疗48周时,ALT复常率为100.0%,HBV DNA不可检出(<20 IU/ml)率为97.2%,HBe Ag血清学转换率为38.9%,出现病毒学反弹2例。未观察到周围神经炎及肌病的发生。结论 PIRCT的HBe Ag阳性的CHB患者停用干扰素后序贯LDT治疗48周疗效较好,安全性良好,无需洗脱期,是值得尝试的临床策略。

Objective To evaluate the effect and the safety of LDT for HBeAg positive chronic hepatitis B patients who had poor response or can not tolerate to interferon （PIRCT） therapy. Methods This was an open-label, prospective cohort observational study. PIRCT patients were enrolled into the study. LDT （600 rag/d） was used instead of interferon （IFN） in PIRCT patients. The total course was 72 weeks. ALT, HBeAg,HBV DNA were tested at the base line and every 12 weeks, adverse effect was monitored at the same time. Results The ratio of the normal level of ALT was 100.0% after 48 weeks of LDT, and the ratio of undetectable HBV DNA （〈 20 IU/ml） was 97.2%, HBeAg serum conversion rate was 38.9%, 2 cases had virology recurrence. Peripheral neuritis and myopathy were not observed. Conclusion LDT is effective and safe for HBeAg positive chronic hepatitis B patients who have PIRCT.