Simulect 和 Zenapax 应用于肾移植诱导治疗的5年临床观察

目的评价2剂Simulect和5剂Zenapax在肾移植中诱导治疗预防急性排斥反应(AR)的有效性、安全性以及对近、远期人/肾存活的影响。方法选择1999年4月~2001年4月首次肾移植患者102例,分成Simulect组(54例)和Zenapax组(48例),在三联免疫抑制剂基础上(环孢素A/FK506、骁悉、皮质激素)加用Simulect(术前2h和术后第4天分别予20mg静滴)或Zenapax(1mg.kg-1.d-1,最大剂量100mg,首剂术前2h,此后每2周1剂,共5剂)。观察术后3个月内肾功、AR、移植肾功能延迟恢复(DGF)、急性肾小管坏死情况;术后5年内肾功、排斥反应、并发症及人/肾存活情况。结果术后3个月内AR发生率明显降低(Simulect组:14.8%;Zenapax组:14.6%);首次AR发生时间延迟;激素治疗对大部分AR有效;5年内再次排斥反应发生率为9.3%(Simulect组)和6.3%(Zenapax组)。术后肾功能恢复明显加快,早期及远期肾功能良好。未出现细胞因子释放综合征,仅2例DGF。5年内,感染、糖尿病、高脂血症、恶性肿瘤等未见增加。5年人/肾存活良好,均达95%以上。结论2剂Simulect和5剂Zenapax预防肾移植术后AR的效果好、安全性高,有利于早期肾功能恢复和远期人/肾存活。

Five-year clinical study of Simulect and Zenapax in renal transplantation

Objective To evaluate the efficacy,safety for prevention of acute rejection(AR) and effect on long-term survival of patient/graft of two-dose Simulect and five-dose Zenapax in renal transplantation.Methods A total of 102 renal transplant recipients were randomized into 2 groups:Simlulect group(54 cases) and Zenapax group(48 cases).All the cases received the triple therapy of cyclosporine/FK506,mycophenolate mofetil and prednisolone(CsA/FK506 MMF Pred).Simlulect group received two-dose Simlulect(20 mg intravenous infusion) 2h before operation and 4d after transplantation.Zenapax group received five-dose Zenapax(50mg) at 1d before operation and once per two weeks after transplantation.The renal function,AR,delayed graft function(DGF) and acute tubular necrosis(ATN) were observed within 3 months post-transplantation.The renal function,rejection,complications and patient/graft survival were observed for 5 years.Results The rate of AR was cut down significantly(Simulect group:14.8%;Zenapax group:14.6%);the time of the first AR episodes was delayed;MP therapy was effective for most of AR;the rates of second rejection of two groups in 5 years were 9.3%(Simulect group) and 6.3%(Zenapax group),respectively.The recovery for renal function was faster.The early and later renal function was fine.No cytokine release syndrome was observed and only 2 cases of DGF.No increase in infection,diabetes,hyperlipoidemia and malignant tumor in 5 years.The survival rates of 5-year patient/graft were above 95%.Conclusion Two-dose Simulect and five-dose Zenapax for preventing AR in renal transplantation have good therapeutic effect and safety and are beneficial to early recovery of renal function and later patient/graft survival.