巴利昔单抗在术前高sCD30肾移植受者中的应用研究

Treatment of renal allograft recipients with high pre-transplantation sCD30 level by Basiliximab as induction therapy

目的 探讨巴利昔单抗联合他克莫司为基础的免疫抑制剂方案在降低术前高可溶性CD30（sCD30）肾移植受者术后急性排斥反应（AR）发生率的可行性.方法 2010年8月至2012年8月120例术前sCD30水平＞150 U/ml的肾移植受者入组,按2：1的比例分为两组.治疗组（80例）：患者术前2h及术后4d分别静脉接受巴利昔单抗20 mg行免疫诱导治疗;对照组（40例）：术前不接受生物制剂诱导治疗.两组患者术后基础免疫抑制剂方案均为他克莫司（Tac）＋吗替麦考酚酯（MMF）＋泼尼松（Pred）.两组患者均接受术后1年常规随访,记录患者肾功能状况和重要的临床不良事件,包括AR、肺部感染和移植肾失功等.结果 肾移植术后AR发生率：治疗组为17.5％（14/80）,对照组为37.5％ （15/40）,两组比较差异有统计学意义（P=0.016）.术后移植肾1年存活率：治疗组为91.3％ （73/80）,对照组为85.0％ （34/40）,两组比较差异无统计学意义（P=0.230）.肾移植受者对巴利昔单抗诱导治疗的耐受性较好,并未出现明显诱导治疗相关的不良事件.结论 巴利昔单抗联合他克莫司为基础的免疫抑制剂方案可以有效地降低术前高sCD30肾移植受者术后AR的发生率.

Objective To evaluate feasibility of Basiliximab as induction therapy in reducing the acute rejection （AR） rate in the renal allograft recipients with high pre-transplantation sCD30 level.Methods This study enrolled 120 renal allograft recipients with high pre-transplantation sCD30 level,who were divided into two groups （induction group and control group） randomly according to the ratio of 2：1.Patients in induction group （n=80） received two doses of Basiliximab （20 mg per dose） on days 0 and 4 post-transplant as induction therapy.Patients in control group did not receive induction therapy.All the recipients received standard triple therapy as maintenance immunosuppressive regimen,which consists of FK-506,MMF and prednisone.Results Recipients of induction group experienced significantly fewer AR episodes than those of control group （17.5％ vs 37.5％,P=0.016）.Higher 1-year graft survival was observed in induction group （73/80,91.3％） than control group （34/40,85.0％）.But the difference did not show statistical significance （P=0.230）.Basiliximab was well tolerated in the recipients in induction group.There were no severe adverse events in induction group.Conclusions Basiliximab as induction therapy has yielded significant reduction of AR rate in renal allograft recipients with high pre-transplantation sCD30 level.