替比夫定治疗儿童和青少年慢性乙型肝炎临床研究

摘要

Objective To investigate the efficacy and safety of telbivudine treatment for 52 weeks of HBeAg-positive chronic hepatitis B (CHB)children and adolescents.Methods A total of 41 HBeAg-positive CHB children and adolescents aged from 3 to 16 years were treated with telbivudine for 52 weeks.Biochemical responses,hepatitis B virus (HBV) markers and HBV DNA quantitation were detected,adverse events were also recorded.Results After 52 weeks of telbivudine treatment,the rates of ALT normalization,HBeAgloss and HBeAgseroconversionwere 85.4％ (35),43.9％ (18) and 24.4％ (10),respectively.Mean HBVDNA load declined by (6.97 ± 0.96) log IU/ml (median,7.3 logIU/ml),and 31 (75.6％) cases had HBV DNA undetectable.2 cases had a decline of quantitative HBsAg ＜ 10 IU/ml.Patients who achieved HBV DNA undetectable at week 24 had higher rates of ALT normalization,HBV DNA undetectable,HBeAg loss and HBeAgseroconversion than those with HBV DNA detectable.Decline in HBV DNA levels correlated with prior treatment with interferon (IFN) (P =0.004),but did not correlate with a family history of hepatitis B (P =0.122).Mild and transient adverse events were observed,and no serious adverse events were found.No gene mutations were observed.Conclusions Telbivudine treatment for HBeAg-positive CHB children and adolescents showed good efficacy and safety.%目的 为探讨替比夫定在儿童和青少年慢性乙型肝炎(慢乙肝)抗病毒治疗中的疗效及安全性.方法 41例3-16岁HBeAg阳性慢乙肝患儿服用替比夫定片抗病毒治疗,总疗程52周.监测血生化、HBVM及HBVDNA定量并记录不良事件.结果 35例(85.4％)患儿ALT复常.HBVDNA载量平均下降了6.97±0.96logIU/ml(中位数7.3logIU/ml),31例(75.6％)低于检测下限.18例(43.9％)患儿HBeAg丢失;10例(24.4％)患儿HBeAg血清学转换.2例在52周时HBsAg定量已下降至＜ 10IU/ml.24周时HBVDNA转阴的患者52周ALT复常率、HBVDNA转阴率、E抗原阴转率、E抗原转换率明显优于HBVDNA未转阴的患者.本组患儿替比夫定抗病毒治疗HBVDNA下降与有无乙肝家族史没有相关性(P =0.122),HBVDNA下降与是否曾经接受过IFN治疗是相关的(P =0.004).本组患儿在治疗期间发生的不良事件均是轻度的,并且表现为一过性,没有一例严重不良事件.本组患儿治疗期间没有发生基因突变.结论 替比夫定在本组儿童和青少年慢乙肝抗病毒治疗中有明确的疗效,安全性较好.