替比夫定联合胸腺素-α1与单用替比夫定治疗HBeAg阳性慢性乙型肝炎的比较研究

摘要

Objective To investigate the efficacy and safty of LDT plus thymosin-α1 combination therapy in HBeAg positive chronic hepatitis B( CHB) patients.Methods One hundred and six patients with chronic hepatitis B were randomly divided into LDT plus thymosin-α1 group 52 cases( combination therapy group) and LDT group 54 cases( monotherapy group) .The rate of ALT normali-zation, HBV DNA undetectable, HBeAg loss, HBeAg seroconversion and drug related adverse events were observed at week 24 and 48.Results At week 24, the rate of HBV DNA undetectable was 75.0%(39/52) in the combination therapy group versus 77.8%(42/54) in the monotherapy group(P﹥0.05);26.9%(14/52) of patients got HBeAg lost, 25.0%(13/52) of patients got HBeAg seroconversed in combination therapy group.When compared with that of 18.5%(10/54), 16.7%(9/54) in monotherapy group, re-spectively(P>0.05).At week 48, the rate of HBV DNA undetectable was 88.5%(46/52) and 79.6%(43/54), respectively in the combination therapy group and monotherapy group(P﹥0.05).38.5%(20/52) of patients got HBeAg lost, 36.5%(19/52) of pa-tients got HBeAg seroconversed in combination therapy group.When compared with that of 20.4%(11/54), 18.5%(10/54) in monotherapy group,respectively(P<0.05).No reverse adverse reaction was happened in both groups.Conclusion The combination of telbivudine plus Thymosin-α1 provided significant efficacy and higher safety than telbivudine monotherapy in HBeAg positive chronic hepatitis B(CHB)patients, which is a better combination therapy.%目的：探讨替比夫定联合胸腺素-α1治疗HBeAg阳性慢性乙型肝炎的疗效及安全性。方法106例HBeAg阳性的慢性乙型肝炎患者随机分为替比夫定联合胸腺素-α1治疗组（联合用药组）52例和单用替比夫定治疗组（单用药组）54例，观察两组治疗24周、48周时ALT复常率、HBV-DNA转阴率、HBeAg转阴率、HBeAg血清学转换率及不良反应。结果治疗24周时，联合用药组和单用药组HBV-DNA转阴率分别为75．0％（39／52）、77．8％（42／54），差异无统计学意义（P＞0.05）；联合用药组HBeAg转阴率为26．9％（14／52），HBeAg血清学转换率为25．0％（13／52）与单用药组的18．5％（10／54）、16.7％（9／54）相比较，差异均无统计学意义（P＞0.05）。治疗48周时，两组HBV-DNA转阴率比较差异无统计学意义[88．5％（46／52）、79．6％（43／54），P＞0.05]；联合用药组的HBeAg转阴率为38．5％（20／52），HBeAg血清学转换率为36．5％（19／52），与单用药组的20.4％（11／54）和18．5％（10／54）相比较，差异有统计学意义（P＜0.05）。治疗过程中，两组均未发生严重不良反应。结论替比夫定联合胸腺素-α1治疗HBeAg阳性慢性乙型肝炎疗效优于单用替比夫定，是安全有效的治疗方法。