摘要
目的研究拉米夫定联合乙肝免疫球蛋白防治肝移植术后乙肝复发的效果。方法自2004年5月～2005年10月,采用随机、阳性药物平行对照、多中心临床研究的方法,在9家医院对230例病人进行了研究。结果在有效病例,在同等剂量给药的条件下,HBIG对靶抗原HBsAg的中和量及术后7天内HBsAg阴转率的变化趋势充分体现了HBIG的量效、时效性及给药途径不同存在的量效、时效区别。在联合使用拉米夫定时,HBIG剂量若定为无肝期至术后HBV标志物转阴前HBsAb效价维持在300IU/L,HBV标志物转阴后效价维持在100IU/L似乎更科学,间隔4周给药可维持体内相对稳定的药物浓度。观察到的不良事件与HBIG无关,无效病例可能与乙肝病毒变异有关。结论拉米夫定联合乙肝免疫球蛋白防治肝移植术后乙肝复发的方案是安全、有效的。
Objective To study the efficacy of the protocol of lamivudine combined with hepatitis B immunoglobulin （HBIG） to prevent hepatitis B virus （HBV） recurrence after liver transplantation. Methods From May 2004 to October 2005, a randomization, positive drug parallel controlled multiple centric clinical trial of 230 patients were studied in 9 clinical centers. Results In the therapy effective patients, in the condition of same HBIG dosage, the quantity neutralized by HBIG to HBV surface antigen （ HBsAg）, the negative transform rate of serum HBsAg also negative turning trend within 7 days after liver transplantation, in full to give the relationship of quantity-outcome,time-outcome and the distinguish for HBIG gave by intravenous or intramuscular administration. In case of that combined with lamivudine, in the duration liver removal to serum HBsAg turning negative , put to using HBIG dosage for maintain 300 IU/L , afterwards 100 IU/L are reasonably. At 4 weeks intervals for again administration can hold relatively stable HBIG concentration. Observed harmful events of during clinical study were unconcerned with HBIG, invalid cases were probably in connection with variation of hepatitis B virus. Conclusion The protocol of lamivudine combined with hepatitis HBIG proved to be highly effective and safe in preventing the recurrence of HBV after liver transplantation.
出处
《肝胆外科杂志》
2006年第6期435-440,共6页
Journal of Hepatobiliary Surgery
关键词
乙肝免疫球蛋白
乙肝相关性肝移植
多中心临床研究
hepatitis B immunoglobulin
hepatitis B virus related liver transplantation
multiple centric clinical study
