摘要
【目的】探讨胸腺肽α1和拉米夫定联合治疗慢性乙型肝炎的长期疗效和安全性。【方法】按随机对照原则选择80例HBVDNA、HBeAg阳性的慢性乙型肝炎患者,按1∶1随机分配进入单一接受拉米夫定治疗组和胸腺肽α1与拉米夫定联合治疗组。【结果】治疗52周,联合治疗组HBeAg血清转换率52%(16/31)明显高于拉米夫定组5%(2/37),Ρ<0.001。停药1年,持续的HBeAg血清转换率分别为42%(13/31)和8%(3/37),Ρ=0.001。治疗过程,两组HBVDNA定量明显下降,联合治疗组下降更显著,但停药后HBVDNA反弹;治疗后,两组的ALT复常率基本一致,达80%(25/31)和68%(25/37),但停药后拉米夫定组仅有19%持续正常,明显低于联合治疗组。拉米夫定组有10例(27%)发生YMDD变异,联合组仅有1例。治疗后肝组织炎症坏死程度明显地改善,肝纤维化程度降低,HBsAg、HBcAg的表达明显减少。治疗过程无明显的不良反应。【结论】胸腺肽α1与拉米夫定联合治疗慢性乙型肝炎疗效明显优于单一用药组,是安全、有效的治疗慢性乙型肝炎的方案。
Objective] To evaluate the long term efficacy and safety of alpha 1 thymosin (Tα 1) combined with lamivudine(LAM) treatment in patients with chronic hepatitis B. Eighty patients with chronic hepatitis B were randomly assigned by 1∶ 1 proportion to receive LAM alone (LAM group) or Tα 1 combined with LAM (LAM+ Tα 1 group). 52 percent (16/31) occurred HBeAg seroconversion in LAM+ Tα 1 group as compared with 5 percent (2/37) in LAM group at 52 week, Ρ < 0.001. During one year follow up, HBeAg seroconversion rates were 42% (13/31) and 8% (3/37) in two groups, respectively( Ρ =0.001). During treatment, HBV DNA level decreased rapidly in both groups, but rebounded after withdrawal of the drugs. At week 52, 27% (10/37) of patients in LAM group had YMDD mutant as compared with 3% (1/31) in LAM+ Tα 1 group. ALT normalization occurred in 25 of 31(80% )in LAM+ Tα 1 group, in 25 of 37(68% ) in LAM group. Liver biopsy was done at baseline and endpoint of treatment. Improvement of necro inflammation and fibrosis, and decrease of HBsAg and HBcAg level were found. No significant side effects were recorded.[ Conclusion] The treatment of Tα 1 combined with LAM for chronic hepatitis B is effective and well tolerated.
出处
《中山大学学报（医学科学版）》
CAS
CSCD
北大核心
2003年第5期488-491,共4页
Journal of Sun Yat-Sen University:Medical Sciences
基金
广东省医学科学研究基金资助项目(1998A457)
关键词
慢性乙型肝炎
胸腺肽Α1
拉米夫定
药物治疗
hepatitis B virus
thymosin-α_1/therapeutic use
lamivudine/therapeutic use
