摘要
目的评价替比夫定联合阿德福韦酯与恩替卡韦治疗HBeAg阳性慢性乙型肝炎患者的疗效及安全性。方法 138例患者单盲分组,替比夫定联合阿德福韦酯组69例,恩替卡韦组69例,比较两组患者在治疗的第4、8、12、24、52周时HBV-DNA转阴率、ALT复常率,12、24和52周HBeAg转阴及血清学转换率,及24、52周完全应答率。结果与基线相比,两组患者治疗4、8、12、24和52周时的不同时间阶段HBV-DNA转阴率及ALT复常率差异无统计学意义(P>0.05)。治疗24、52周替比夫定联合阿德福韦酯组患者的HBeAg转阴率及血清学转换率均优于恩替卡韦组,差异有统计学意义(P<0.05)。总有效率在治疗第24、52周时进行两组比较,差异有统计学意义(P<0.05)。两组安全性及耐受性均相似,差异无统计学意义(P>0.05)。结论替比夫定联合阿德福韦酯组与恩替卡韦组均具有强效的HBV-DNA抑制作用,在4、8、12、24和52周的不同时间阶段抗病毒疗效均相似。替比夫定联合阿德福韦酯组具有更显著的HBeAg转阴率及血清转换率和完全应答率,在治疗第24、52周尤为明显,两组ALT复常率相似,替比夫定联合阿德福韦酯和恩替卡韦均具有良好的安全性和耐受性。
Objective To compare the clinical efficacy and safety of telbivudine with adefovir and entecavir in HBeAg-positive chronic hepatidis B treatment.Methods 138 patients were randomly divided into two groups,telbivudine with adefovir（69 cases） and entecavir alone（69 cases）,by single-blind method.The HBV-DNA negative-conversion rate and amino transferase（ALT） normalization rate at week 4,8,12,24 and 52,the rate of HBeAg turned to negative and the ratio of seroconversion at week 12,24 and 52,as well as the complete response rates at week 24 and 52 were compared between the two groups.Results Compared with the baseline,there were no statistical significances in the rates of HBV-DNA negative conversion and ALT normalization between the telbivudine with adefovir group and the entecavir group at week 4,8,12,24 and 52（P〉0.05）.The rates of HBeAg turned to negative and HBeAg seroconversion in telbivudine with adefovir group were superior to those in entecavir group at week 24 and 52（P〈0.05）.Total effective rate of telbivudine with adefovir group was higher than that of entecavir group at week 24 and 52;the difference was statistically significant（P〈0.05）.Similarities in the safety and drug resistance were observed in both groups,with no statistical differences（P〉0.05）.Conclusion Both grups have superactive depressant effects for HBeAg-positive chronic hepatidis B patients,and have the same antivirus effects at week 4,8,12,24 and 52.Telbivudine combined with adefovir has a significant higher HBeAg seroconversion,HBeAg negative-conversion rate and complete response rate,especially at week 24 and 52.The rate of ALT normalization in telbivudine with adefovir group is similar to that in entecavir group,and both of the two medications are safe and tolerable for patients.
出处
《中国微生态学杂志》
CAS
CSCD
2012年第9期829-831,共3页
Chinese Journal of Microecology
