舒莱和赛尼哌预防肾移植后急性排斥反应的效果比较  

Basiliximab vs daclizumab for prevention of acute rejection in renal transplantation

作　　者：明爱民[1] 林民专[1] 赵明[1] 顾新伟[1] 高宏君[1] 范礼佩[1] 

机构地区：[1]南方医科大学附属珠江医院器官移植科

出　　处：《中华泌尿外科杂志》2004年第11期728-730,共3页Chinese Journal of Urology

摘　　要：目的　评价比较 2剂舒莱 (basiliximab)和赛尼哌 (daclizumab)在肾移植中诱导治疗预防急性排斥的有效性及安全性。　方法　选择 5 8例肾移植患者 ,随机分成舒莱组 ( 30例 )和赛尼哌组( 2 8例 ) ,在三联免疫抑制剂基础上 (环孢素 +骁悉 +泼尼松 ,CsA +MMF +Pred。CsA首剂 6mg·kg-1·d-1,3个月减至 4～ 5mg·kg-1·d-1,6个月减至 3～ 4mg·kg-1·d-1,其间根据血药浓度调整剂量。MMF首剂 0 .5 g/次 ,3次 /d ,1个月后减至 0 .5g/次 ,2次 /d。Pred首剂 30mg/d ,3周后减至 2 0mg/d ,6个月减至 10～ 15mg/d) ,分别予 2剂舒莱 (术前 2h及术后第 4天各 2 0mg静滴 )及 2剂赛尼哌 (术前 2 4h及术后第 14天各 5 0mg静滴 )治疗。观察术后 6个月 2组急性排斥及术后 6～ 12个月不良事件和人 /肾存活情况 ,以流式细胞仪监测术前及术后每周 1次共 8周外周血中淋巴细胞CD2 5 +变化。　结果　术后 6个月 ,赛尼哌组 6例出现急性排斥反应 ,舒莱组无急性排斥发生 (P <0 .0 5 )。用药后 ,两组外周血中淋巴细胞CD2 5 +均下降 ,舒莱组由术前 ( 37.7± 2 .3) %持续下降至第 6周的 ( 1.5± 0 .1) % ,赛尼哌组由术前 ( 37.7± 2 .9) %持续下降至第 4周的 ( 1.4± 0 .1) %。随后分别上升 ,舒莱组在第 8周升至 ( 2 1.3± 1.6 ) % ,达?Objective To evaluate the efficacy and safety of two-dose basiliximab vs two-dose daclizumab for prevention of acute rejection in renal transplantation. Methods A total of 58 renal transplant recipients were randomized into 2 groups:basiliximab group ( n =30) and daclizumab group ( n =28).All the cases received the triple therapy of cyclosporine,mycophenolate mofetil and prednisolone (CsA+MMF+Pred).The 3 medications were administered as follows.For CsA,initial dose of 6 mg/kg per day was downtitrated to 4～5 mg/kg per day at 3 months,then to 3～4 mg/kg per day at 6 months.For MMF,initial dose of 0.5 g,3 times per day was downtitrated to 0.5 g,twice per day at 1 month.For Pred,initial dose of 30 mg per day was downtitrated to 20 mg per day at 3 weeks,then to 10～15 mg per day at 6 months.Basiliximab group received two-dose basiliximab (20 mg intravenous infusion) 2 hours before operation and 4 days after transplantation.Daclizumab group received two-dose daclizumab (50 mg) 1 day before operation and 14 days after transplantation.Postoperatively,acute rejection was monitored for 6 months,and adverse events and person/allograft survival were observed for 6～12 months.CD25 + cell count was tested using Beckman Coulter flow cytometer before operation and postoperatively once a week for 2 months. Results During 6-month follow-up, the number of acute rejection episodes were 5 in daclizumab group and none in basiliximab group ( P <0.05). After treatment the CD25+ cell count decreased rapidly in both groups.In basiliximab group,CD25 + cell level decreased from preoperative (37.7±2.3)% to (1.5±0.1)% for 6 weeks.In daclizumab group,CD25 + cell level decreased from (37.7±2.9)% to (1.4±0.1)% for 4 weeks. Then the CD25+ cell levels increased. In basiliximab group, it rose to (21.3±1.6)% at 8 weeks,reaching 60% of normal level [(37.3±2.6)%];while in daclizumab group,it rose to normal.During 6～12 month follow-up,there were 2 cases of bacterial infection in each group,1 and 2 cases of CMV infection,respe

关 键 词：赛尼哌 急性排斥反应 肾移植 术后 CD25^+ 术前 预防 水平 结论 情况 

分 类 号：R699[医药卫生—泌尿科学]